Pharmacy Student Survival Guide for Pharmcare Clerkship by liana zainal

PREFACE The aim of this guide is to be a quick and simplified reference for pharmacy students especially in their final year where they will apply their scientific knowledge on clinical pharmacy practice. The content of this guide will help students to understand the expectations of lecturers, preceptors during case clerking and discussions. It also discusses on ethical considerations during Pharmcare Clerkship in the hospitals and relationship with other healthcare providers and patients. Important basic skills required to ensure smooth clerkship activities are also highlighted. It is hoped that this repository of useful information will benefit the students and accessible when most needed.

Editors: Fatimatuzzahra’ Abd Aziz Hadzliana Zainal Nur Aizati Athirah Daud Nur Hafzan Md. Hanafiah Sabariah Noor Harun Siti Maisharah Shekh Ghadzi

3 Pharmacy Student Survival Guide 2

for Clinical Pharmacy Practice

CONTENTS 1.0

Course Expectations 1.1 Practice Site 1.2 Orientation 1.3 Professional Attributes

2.0

Clerkship Activities 2.1 2.2 2.3 2.4 2.5

3.0

Laboratory Tests & Interpretation 3.1 3.2 3.3 3.4 3.5 3.6 3.7

4.0

Overview of The Chapter Learning Objectives General Principles PWDT Component

Identifying Drug Related Problems (DRP) and Case Studies 5.1 5.2 5.3 5.4

6.0

Overview of The Chapter Learning Objective General Principles Normal Values Laboratory Errors Common Clinical Chemistry Tests Reference Ranges

Pharmacist Workup Drug Therapy (PWDT) Concept: The Component 4.1 4.2 4.3 4.4

5.0

Physical Assessment Skills History Taking Pharmacy Calculations Therapeutic Drug Monitoring (TDM) Interpretation of Laboratory Tests

Overview of The Chapter Learning Objective General Principles Types of DRPs

Bedside and Discharge Medication Counselling 6.1 6.2 6.3 6.4 6.5 6.6

Overview of The Chapter Learning Objectives General Principles Process of Patient Counselling Medication with Special Instruments Case Example

COURSE EXPECTATIONS 1.0 COURSE EXPECTATIONS

1.1

PRACTICE SITE

The practice site for fourth year students will be in the designated hospitals in Penang (depending on the clerkship) and the clinical pharmacy labs (J05 building, School of Pharmaceutical Sciences, Universiti Sains Malaysia). 1.2

ORIENTATION

There will be an orientation session by pharmacists who are appointed as preceptors in the hospital to help students familiarise with the hospital setting, rules and regulations during your clerkship. 1.3

PROFESSIONAL ATTRIBUTES 

Appearance Students must dress formally and it is mandatory to wear a lab coat bearing the USM logo and students’ name at all times during clerkship in the hospital and clinical pharmacy labs.



Attitude Students are expected to adhere to rules and regulations set by the hospital and clinical pharmacy labs including being punctual, create good rapport and maintaining professionalism.



Student

and

patient/other

healthcare

provider

relationship

Students are expected to be professional at all times. Proper designations with other healthcare provider (i.e doctor, staff nurse) or patients (i.e encik, puan) must be addressed. Permission is needed to move the case notes or other patients’ related records and should remain within the wards. Any recording devices (audio and visual) is NOT ALLOWED to be used to document the disease, procedure or case notes. Recording within the hospital is a serious offence.

2.0 CLERKSHIP ACTIVITIES CLERKSHIP ACTIVITIES 2.1

PHYSICAL ASSESSMENT SKILLS

Physical examination is the process of gathering objective anatomical findings which will be incorporated with the patient's history to gain insight on patient’s medical condition. Below are the physical examinations done on admission and daily case monitoring. Students are not expected to perform any physical examinations but the information is crucial in understanding the pathophysiology of the disease and for drug therapy monitoring. Please note this list is not exhaustive and only includes some of the most common physical examinations.

System/Area

Examinations

Notes

Vital signs

Temperature Blood pressure Pulse Respiratory rate Oxygen saturation Height, weight, body mass Index

Can be found in the case Notes

General Cardiovascular system

Central and peripheral nervous system Gastrointestinal system

Pulmonary system

Patient’s current condition (pale, distress etc.) Auscultation of heart rhythm irregularities, murmurs Examination of pulses (radial, brachial, tibial and pedal) Mini mental status examination Signs of neuropathy Auscultation of bowel sounds Abdomen tenderness Palpation for signs of Hepatosplenomegaly Interview patient’s bowel habits, abdominal pain, nausea/vomiting Auscultation and percussion of lungs, changes in breath sounds Interviewing patient’s pulmonary complaints

Occasionally recorded but may be obtained through interview with patient Observation Can be found in the case notes Can be found in the case notes Can be found in the case Notes

May be obtained through interview Can be found in the case notes May be obtained through interview

8 Head, eyes, ears, nose and throat (HEENT) Extremities

Chest x-ray (CXR)

2.2

Examination of conjunctiva, mucous membrane, redness or swelling and tonsils Swelling, redness, oedema, bruising, tingling sensations

Can be found in the case notes

Lung abnormalities presented as increased density or opacity

Can be found in the case notes and with accompanying x-ray films

Can be found in the case notes and observed/interview patients

HISTORY TAKING

Students are expected to know the techniques to obtain medication history from patients, either from the case notes or patient interview. A lot of information can be obtained through interview especially on compliance and herbal consumption. This is important to evaluate drug efficacy, polypharmacy, interactions, toxicity or the need for counselling. Scenario

Evaluation

Patient claims to be compliant towards medication and lives a healthy lifestyle but blood pressure control is poor.

Drug efficacy: A need to adjust current drug dosing or additional antihypertensive

An 80 year old patient from nursing home came in with a history of 11 different medications, having nausea and vomiting, not able to stand for very long due to dizziness and is afraid to mobilise.

Polypharmacy: Probable inappropriate medication than clinically indicated and needs to be revised, simplified and reduce pill burden

A patient complaining gum bleed and prolonged bleeding after a cut. Patient claims to take warfarin, antihypertensives and ginkgo biloba for well being.

Interaction: Ginkgo biloba may increase bleeding tendency when taken with warfarin. Patient needs to be advised to stop ginkgo while on warfarin therapy

A 3 years old patient was admitted due to prolonged fever and elevated liver enzyme level. Mother claimed to have visited multiple private clinics and given medications which were administered to the patient. It was found that patient was administered paracetamol received from every visit to the doctor and adult dose was administered by mistake.

Toxicity: Multiple supratherapeutic ingestion should be suspected and dose ingested calculated. Therapeutic drug monitoring and N-acetylcysteine treatment for paracetamol toxicity should be considered

Patient with chronic obstructive pulmonary disease complained of shortness of breath despite using inhalers. Patient is also an occasional smoker.

Counselling: Patient needs to be counselled to quit smoking and to review the inhaler technique to ensure effective drug therapy

9 2.3 PHARMACY CALCULATIONS Some useful values to remember are: Dilutions: 10mg in 1ml = 1% w/v or 1gm in 100ml 1mg in 1ml = 0.1% w/v or 1gm in 1000mls (1 litre) 1mcg in 1ml = 0.0001% w/v or 1gm in 1,00,000 ml 1000mls = 1 Litre 1 ml = 1 millilitre 1 mol = 1000 millimols (normally written as 1000 mmol) 1 millimole = 1,0000 micromoles 1 micromole = 1,000 nanomoles 1 mol/litre = 1 mmol/ml, 1 mmol/litre = 1 microlmole/ml 1 Mole = Molecular Weight in grams or Relative Molecular Mass in grams 1 Molar solution = Gram Molecular Weight or Relative Molecular Mass in grams in 1 litre Duration of supply 1/7 = 1 day 1/52 = 1 week 1/12 = 1 month (28 days) 7/7 often means give a full weeks supply

Frequency of administration tds or TDS = three times a day qds or QDS = four times a day stat = immediately od or OD = daily

Body weight and BMI Ideal body weight IBW = (0.9xH) - X H = height in cm X = 88 for males, X = 92 for females BMI = weight (kg) / height (m)2 Creatinine clearance Creatinine clearance(ml/min) = ( Y (140 - age) x weight(kg)) / serum creatinine (µmol/l) Y = 1.23 for males and 1.04 for females

Common calculations for pharmacists 1) A two year old child is prescribed Tagamet Syrup to relieve severe gastro-oesophageal reflux. The dose (which you may assume to be safe and correct) is to be 120mg tds. To aid with drug administration the prescription states that the doses should be given as 5ml units. How much Tagamet Syrup and how much diluent (syrup BP) would you need to use to provide exactly 7 days’ supply of the product? Need strength of 120mg/5ml Tagamet is 200mg/5ml Final volume is 5mls x 3 (tds) x 7 (days supply) = 105ml Therefore: 120/200 x 105 = 63ml of Tagamet 105 (final volume) – 63 (ml of Tagamet) = 42mls syrup BP 2) Mrs X is a patient who has had difficulty withdrawing from benzodiazepines. She is currently taking two Temazepam 20mg tablets each night. The decision is taken to transfer Mrs X to Diazepam tablets and instigate a reduction protocol. How many diazepam 10mg diazepam tablets would be needed to supply the equivalent dose of benzodiazepine to the patient for the first fortnight of treatment, where there is no dose equivalent reduction? 40mg temazepam is equivalent to 20mg diazepam therefore need 2 x 10mg tablets diazepam x 14 days = 28 tablets

3) You give a patient 200ml of a 0.09% w/v mouthwash. He needs to prepare doses of 20ml of a 0.045% w/v solution, by diluting the mouthwash with water. What dilution would this constitute? 0.09% to 0.045% is a 1:1 dilution 4) A seven year old patient of ideal body weight is admitted to hospital with suspected severe accidental iron poisoning. The decision is taken to immediately begin the patient on desferrioxamine mesilate at a dose of 15mg/kg/hour for the first hour and then reduce to 10mg/kg/hour for a further 2 hours How much desferrioxamine mesilate would the patient receive in the first three hours of treatment? 15mg x 23 kg = 345mg in the first hour 10mg x 23kg x 2 = 460mg for next two hours Total in three hours = 345 + 460mg = 805mg

5) An ampoule contains 12.5% w/v of active ingredient. The ampoules are supplied as 10ml volume. How many ampoules are needed to produce a 1 litre bag of final concentration 0.5% w/v active ingredient? Active ingredient = 12.5g in 100ml One ampoule ≡ 1.25g in 10ml Need 0.5% active ingredient in 1 litre = 0.5g in 100ml = 5g in 1 litre Therefore ampoules required = 5/1.25 = 4 ampoules

7) How much glucose 5% w/v would you need to add to Diazepam solution 0.5% w/v to make an intravenous infusion of Diazepam of 200mg in 1 liter Diazepam (0.5% w/v) ≡ 500mg in 100ml ≡ 5000mg in 1 litre Need 200mg in 1 litre 200/5000 x 1000ml = 40ml of original solution Amount of Glucose 5% = 1000 – 40 = 960ml

8) You receive a prescription asking you to provide a patient with nitrofurantoin oral suspension at a dose of 200mg daily in 4 divided doses, to be taken with food for seven days. What volume of suspension do you need to supply the patient? (You supply Furadantin Suspension) Furadantin suspension is 25mg/5ml need 200/25 x 5ml = 40ml each day 40ml x 7 = 280ml total supply

9) A stock solution of Potassium permanganate is 0.25%. How much of this is needed to prepare 6 litres of 1 in 12,000 solution 0.25% = 0.25g in 100 = 2.5g in 1000 = 1g in (2,000/2.5) = 1 in 800 The dilution is therefore 1 in 1200/800 = 1 in 1.5 and the quantity required 6 litres / 1.5 = 4 Litres

10)

A solution of frusemide is needed and to prepare this you will need to dissolve 40mg

tablets in water. If you need to prepare a solution containing 50mcg in 10mls, what volume must you prepare from one 40mg tablet. 50µg in 10ml = 500µg in 100ml = 1mg in 200mls = 40mg in 200 x 40mls = 8,000mls = 8 litres

2.4

THERAPEUTIC DRUG MONITORING

Therapeutic drug monitoring (TDM) involves measuring drug levels and applying clinical pharmacokinetics knowledge to improve patient’s drug therapy. TDM ensures that drug levels are in therapeutic range especially for drugs with:  



narrow therapeutic window



significant correlation between drug levels and clinical effects



significant pharmacokinetic variability in different individuals and disease state

There are several common drugs that are monitored in the hospital setting such as digoxin, aminoglycosides, theophylline, carbamazepine and phenytoin. Paracetamol and acetylsalicylic acid are also performed usually for toxicity cases.

There are several things that would affect drug therapy and dose adjustments that students should know of: Drug related Therapeutic range Time to achieve steady state Drug dosage form *Bioavailability *Distribution *Clearance

2.5

Patient related Patient’s disease state that would affect (*) Last dose taken Sampling time Compliance Drug history and concurrent medications Sample storage (degradation/haemolysis)

INTERPRETATION OF LABORATORY TESTS

Laboratory tests are often requested to confirm a suspected diagnosis, stages or severity of disease, recurrence of disease and to assess patient’s drug therapy. Laboratory tests often reported with reference ranges which includes the lower and upper limit which serve as guidance that there is a possibility of clinical significance beyond the range. Reference range may differ from time to time and from different institutions and factors like new disease information or treatments that become available may change the reference range. Laboratory test results need to be interpreted with caution as the results may be affected by:      

Patient’s condition - creatinine kinase elevates about 6 hours post myocardial infarction and returns to baseline about 48-72 hours after MI



Age - physiological function deteriorates with age with different organs decline at different rate



Biologic rhythms – glomerular filtration and alanine aminotransferase (ALT) are examples that follow circadian rhythm



Drugs – doxorubicin causing thrombocytopenia or amphotericin-induced serum creatinine elevation



Pregnancy – plasma volume increases, resulting in relative hyponatremia



Diet – serum glucose and lipid profile are best tested in fasting state

  

Fluid status – dehydration may cause hemoconcentration where the all blood constituents such as sodium, creatinine and glucose become concentrated



Organ status – liver dysfunction may reduce clotting factor production leading to prolonged prothrombin times



Altitude – hypoxia stimulates haemoglobin production and increased blood viscosity thus haemoglobin reference range are adjusted for individuals living above 1000 feet

A review of laboratory tests is crucial in therapies such as: Antibiotics

Review of culture and sensitivity to determine appropriateness of empirical therapy

Warfarin

Review of International normalisation ratio (INR)

Amphotericin B

Review of serum creatinine

Insulin

Review of HbA1C level to manage therapy and assess Compliance

Levothyroxine

Assess thyroid function

Diuretics

Assess electrolyte levels

Methotrexate

Review liver function tests

A more detailed elaboration on the laboratory tests available will be discussed in the subsequent chapter.

REFERENCES 1. R Sinclair, Pharmacy 18.8.2005 through 4 Pharm Limited© 2016 ResourcePharm. 2. Mary Lee, Basic Skills in Interpreting Laboratory Data, 5th Edition, American Society of Health-System Pharmacists, 2013. 3. Karen Tietze, Definitions and concepts, Basic Skills in Interpreting Laboratory Data, 5th Edition, American Society of Health-System Pharmacists, 2013.

15 3.0

3.1

LABORATORY TESTS & INTERPRETATION

OVERVIEW OF THE CHAPTER

This chapter provides the reader with an overview of laboratory tests commonly used in clinical medicine.

3.2

LEARNING OBJECTIVES

After completing this section you should be able to: • Describe the kinds of analytes that are measured using clinical chemistry tests. • Identify different types of biologic specimens that may be used for testing. • Describe how the results of tests are interpreted.

3.3

GENERAL PRINCIPLES

Generally, laboratory tests should be ordered only if the results of the test will affect decisions about the care of the patient. The serum, urine, and other bodily fluids can be analysed routinely; however, the economic cost of obtaining these data must always be balanced by benefits to patient outcomes.

3.4

NORMAL VALUES

Clinical laboratory test results that appear within a predetermined range of values are referred to as “normal,” and those outside this range are typically referred to as “abnormal.” Laboratory findings, both normal and abnormal, can be helpful in assessing clinical disorders, establishing a diagnosis, assessing drug therapy, or evaluating disease progression. In addition, baseline laboratory tests are often necessary to evaluate disease progression and response to therapy or to monitor the development of toxicities associated with therapy. Clinical laboratories can analyze sample specimens by different laboratory methods; therefore, each laboratory has its own set of normal values. Consequently, clinicians should rely on normal values listed by their own clinical laboratory facility when interpreting laboratory tests.

3.5

LABORATORY ERROR

A variety of factors can interfere with the accuracy of laboratory tests. Patient-related factors (e.g., age, gender, weight, height, time since last meal) can affect the range of normal values for a given test. Laboratory-based issues can also influence the accuracy of laboratory values. For example, a specimen can be spoiled because of improper handling or processing (e.g., hyperkalemia due to hydrolysis of a blood specimen); because it was taken at a wrong time (e.g., fasting blood glucose level taken shortly after a meal); because collection was incomplete (e.g., 24-hour urine collection that does not span a full 24-hour period); Errors also can arise due to faulty or poor quality reagents (e.g., improperly prepared, outdated); due to technical errors (e.g., human error in reading result, computer-keying error); due to interference from medical procedures (e.g., cardioconversion increases creatinine kinase [CK] serum concentrations); due to dietary effects (e.g., rare meat ingestion can cause a falsepositive guaiac test); and because medications can interfere either with the testing procedure or by their pharmacologic effects (e.g., thiazides can increase the serum uric acid concentration, β-agonists can reduce serum potassium concentrations). Clinicians might not be aware of when laboratory-related issues arise. As a result, laboratory findings must always be interpreted carefully, and the validity of a test result questioned when it does not seem to correlate with a patient's clinical status. 3.6

COMMON CLINICAL CHEMISTRY TESTS



ELECTROLYTES AND IONS

Electrolytes and ions are small charged particles; cations are positively charged and anions are negatively charged. They are found in all body fluids – both inside of cells and in extracellular fluids. They maintain osmotic pressure (pressure across membranes or between different fluid compartments) and fluid balance, and play an important role in many metabolic processes.

Profile Sodium (Na+)

Potassium (K+)

Chloride (Cl-)

Carbon dioxide (CO2) Anion gap

Description

Why measured

Major extracellular cation responsible for maintaining fluid balance in circulation; blood levels are controlled through excretion and resorption by the kidneys

To evaluate and Monitor fluid and electrolyte balance And therapy. These tests are most often ordered together to assess overall electrolyte balance. Some conditions in which electrolyte balance is of concern include edema, weakness, confusion, cardiac arrhythmias, high blood pressure, heart failure, liver disease and kidney disease.

Major intracellular cation responsible for muscle contraction and maintenance of normal heart rate

Major extracellular anion; changes in concentration typically mirror sodium concentrations Major anion that buffers blood to physiologic pH of 7.4 The anion gap is a calculated value; one formula for it is: Anion gap = sodium – (chloride + bicarbonate); an alternate formula includes potassium with sodium; a high anion gap reflects the presence of unmeasured anions, possibly from an acute or chronic disease process from ingestion of a toxic substance

Reason for Increased and decreased values ↑ Dehydration, Cushing's syndrome, diabetes insipidus ↓ GI loss (diarrhea and vomiting), Addison’s disease, renal disease ↑ Shock, circulatory failure, renal disease ↓ GI loss (vomiting and diarrhea), diuretic use, some cancers ↑ Dehydration ↓ Low blood sodium, vomitting ↑ Metabolic alkalosis ↓ Metabolic acidosis ↑ Ketoacidosis (starvation, uncontrolled diabetes), lactic acidosis, toxicity from ingestion of substances such as alcohol, salicylates, ethylene glycol (antifreeze), oxalate

Profile

Reason for Increased and decreased values

Description

Why measured

Calcium (Ca2+)

Mineral required for bone formation and for blood clotting and important in nerve and muscle function

Often measured as a screening test since it is usually tightly controlled and held in a very narrow concentration range; abnormalities can signal a wide range of metabolic problems

↑ Hyperparathyroidism, some cancers, excess vitamin D intake ↓ Hypoparathyroidism, vitamin D deficiency, chronic kidney disease, pancreatitis

Phosphorus (phosphate) (PO4-3)

Mineral important in bone metabolism, energy production and nerve and muscle function

Usually measured along with other analytes to help diagnose problems with calcium metabolism

↑ Renal insufficiency, vitamin D overdose, high phosphate intake ↓ Overuse of diuretics or antacids, hyperparathyroidism

Magnesium (Mg2+)

Essential mineral for the function of many enzymes, especially those converting energy for muscle function; also important in bone structure

Often ordered as a follow-up test for low calcium or potassium or to assess symptoms of muscle problems like weakness, twitching, cramping or cardiac arrhythmias

↑ Renal disease, severe dehydration, eclampsia, treatment and obstetric emergencies ↓ Malabsorption, pancreatitis, diarrhea alcoholism

Iron (Fe2+)

Critical component of oxygen transport proteins like haemoglobin and myoglobin; also a part of many enzymes involved in energy pathways

Used primarily to determine "iron status"; to determine if patient is iron deficient or to determine if patient has an iron overload syndrome

↑ Multiple blood transfusions, iron injections, hereditary hemochromatosis ↓ Iron-poor diet, loss of blood, anaemia



SMALL MOLECULES AND METABOLITES

Profile

Description

Glucose

A major source of energy or many tissues regulated by hormones, such as insulin, cortisol and glucagon

Vitamin B12

Required for red blood cell function and important in nerve function

Folic acid

Needed for red blood cell function and important for cell division, especially needed in pregnancy for the developing fetus; deficiency can lead to neural tube defects This breakdown product of haemoglobin is excreted by the liver into the bile—it circulates in blood in two forms referred to as conjugated and unconjugated, reflecting whether the carboxyl groups are free (unconjugated) or esterified (conjugated)

Total bilirubin



Why measured To test for diabetes (high blood glucose reflecting insulin deficiency or insulin resistance); in critical care setting to test metabolic state To identify a deficiency when low iron and large red blood cells are present (macrocytic anaemia) and to monitor therapy for low vitamin B12 Measured with Vitamin B12 to determine the cause of macrocytic anaemia, and to monitor therapy for low folate To assess liver function

Reason for increased and decreased values ↑ Diabetes, Cushing’s disease, stress ↓Insulin excess, starvation, adrenal insufficiency ↑ Some leukemias ↓ Malnutrition, malabsorption, pernicious anaemia

↑ Pernicious anaemia ↓ Malnutrition, malabsorption (e.g., In celiac disease or alcoholism) ↑ Hepatitis, cirrhosis, haemolytic diseases and obstruction of biliary or hepatic

Profile

Reason for increased and decreased values

Description

Why measured

The conjugated form is water-soluble, made in the liver and excreted in the blood; it reacts directly with diazo dyes, so it is called direct reacting The unconjugated form is fat-soluble and the product of haemoglobin breakdown; it reacts with diazo dyes only in the presence of activators so it is called indirect reacting

To test the liver’s ability to conjugate bilirubin and excrete it

↑ Obstruction of biliary or hepatic ducts, and in hereditary conditions like DubinJohnson syndrome

Indirect bilirubin is calculated as Total Bilirubin Direct Bilirubin; it reflects the difference between the total and direct forms↑

↑ Hereditary conditions like Gilbert's disease and Crigler-Najjar syndrome

Lactic acid

This metabolite is released from muscle under conditions of anaerobic energy production; if high amounts are released into the blood, it can disrupt acid/base balance (lactic acidosis)

↑ Shock, muscle fatigue, diabetic ketoacidosis, tissue hypoxia, severe infections like meningitis

Uric acid

A waste product from breakdown of purines (DNA components) that is excreted by the kidneys; too much uric acid can lead to deposits of urate crystals in joints (gout) or in kidneys (kidney stones)

Creatinine

A waste product from the muscle breakdown of a compound called creatinine, which is excreted into urine by the kidneys

To evaluate symptoms that suggest poor oxygen delivery to tissue such as shortness of breath and muscle weakness; to evaluate patients in shock, congestive heart failure or coma To evaluate joint Inflammation that may be due to gout; often ordered to monitor uric acid production in patients undergoing chemotherapy or radiation treatments To evaluate kidney function and monitor therapy for kidney disease; creatinine may be measured in blood, urine or both to evaluate kidney function.

Direct bilirubin (Conjugated bilirubin)

Indirect bilirubin (Unconjugated bilirubin)

↑ Gout, kidney disease, leukaemia

↑ Kidney dysfunction may be due to a variety of different causes such as drug toxicity, uncontrolled diabetes or Inadequate blood flow as seen with shock or congestive heart failure

Profile Urea nitrogen (BUN)

Description A waste product from protein breakdown formed by the liver and excreted by the kidney

Why measured Often ordered with creatinine to evaluate kidney function; also used to monitor dialysis patients To evaluate disorientation, confusion and coma in adults; to evaluate irritability, lethargy and seizures in new born babies

Ammonia (NH4+)

A waste product of amino acid breakdown converted to urea by the liver; increased ammonia levels can cause mental and neurologic changes in the brain

Thyroid Stimulating Hormone (TSH)

Made by the pituitary gland, it maintains stable amounts of thyroid hormones (T3 and T4) in the blood

To screen for or diagnose thyroid disorders; to monitor treatment of thyroid

T4 is made by the thyroid gland and converted to T3 by the liver; these hormones control energy production (metabolic rate) in tissues; both circulate with the majority bound to protein

As follow-up to an abnormal TSH test; lab tests may measure either the total hormone or free hormone (not bound to protein)

Thyroxine (T4) And Triiodothyronine (T3)



Reason for increased and decreased values ↑ Kidney dysfunction, stress, high protein diets ↓ Low protein diets, liver disease ↑ Severe liver disease, cirrhosis, severe hepatitis, Reye’s syndrome, inherited genetic deficiencies

Interpretation of T4 and T3 depend on the pattern of results from all three tests – TSH, T4 and T3.

PROTEINS Profile

Total protein (serum/plasma)

Description

Why measured

Measures the amount of proteins, primarily albumin and globulins, found in serum or plasma, maintains circulatory system oncotic pressure

It is a screening test to see if protein levels are at expected value

Reason for increased and decreased values ↑ Dehydration, infections, some cancers like myelomas and lymphomas ↓ Protein loss (from kidney or GI tract), liver disease, malnutrition

Profile Urine protein

Albumin (serum/plasma)

Description Normally very little protein is found in urine; if protein level is high, the kidneys are failing to retain/reabsorb protein appropriately Major protein in blood made in the liver, it binds and transports many substances

Why measured

Reason for increased and decreased values

To evaluate kidney ↑ Kidney failure (nephrotic function; it is often syndrome), diabetes used to monitor patients taking certain nephrotoxic drugs Albumin level is a general indicator of health and nutritional status Used to monitor kidney function and to screen for early stages of kidney dysfunction in diabetics or people with high blood pressure

↑ Dehydration, infection, malignancy ↓starvation, burns, kidney disease, liver disease

Ferritin is often tested along with iron and transferrin to assess iron status Test for iron status

↑ Iron overload, inflammation, multiple blood transfusions ↓ iron deficiency

↑ Kidney disease

Albumin (microalbumin)

Albumin is too large to escape from plasma into urine; its presence in urine signals a problem with the glomerular filtration system of the kidney

Ferritin

Iron storage protein found primarily inside cells

Transferrin

Primary protein for transport of iron; made by the liver

Total Iron Binding Capacity (TIBC)

Maximum amount of iron that can be transported by the transferrin in blood

Tests iron status; describes amount of transferrin in terms of its iron transport capacity

↑ Iron deficiency, pregnancy and oral contraceptives ↓ Haemolytic anaemia, malnutrition, inflammation and liver disease

Unsaturated Iron Binding capacity (UIBC)

Reserve capacity of transferrin for additional iron transport

Sometimes used to monitor treatment for iron toxicity

↑Iron deficiency, pregnancy and oral contraceptives ↓ Haemolytic anaemia, malnutrition, inflammation and liver disease

↑ Iron deficiency, pregnancy and oral contraceptives ↓ Haemolytic anaemia, malnutrition, inflammation and liver disease

Profile

Description

Why measured

Fibrinogen

Fibrinogen is a soluble protein that is converted by clotting factors into insoluble fibrin threads that stabilize a clot at a site of injury, protecting the site until it heals

To determine if enough fibrinogen is present for normal blood clotting and if fibrinogen has been consumed in a process called disseminated intravascular coagulation (DIC)

Alanine aminotransferase (ALT)

Primarily found in liver

To assess liver disease more specific for liver diseases than AST

Aspartate Aminotransferase (AST)

Widely present in tissue especially liver, heart and skeletal muscle Found in many tissues, especially bone, intestine, kidney and liver

To assess liver disorders

Present in liver and some other tissue very sensitive indicator of any liver disorder Widely distributed in tissues like heart, lung, liver, kidney, skeletal muscle; occurs in five forms, numbered LD-1 to LD-5, with different forms predominating in different tissue

Assess liver disease or damage

Alkaline Phosphatase (ALP)

Gamma Glutamyltransferase (GGT) Lactate Dehydrogenase (LD)

Assessment of bone diseases and liver diseases

General indicator of tissue damage

Reason for increased and decreased values

↑ Hepatitis, cirrhosis, Reye’s syndrome, hepatomas (liver cancers), monitor drug induced liver damage ↑ Liver disease, heart attack, trauma ↑ Liver disease, bone disease and periods of bone growth ↓ Low phosphate, hypothyroidism, pernicious anaemia ↑ Biliary obstruction, alcoholic liver disease

↑ Heart attack, liver disease, lung disease, trauma

Profile Creatine kinase

Amylase

Lipase

Description

Why measured

Muscle enzyme different forms of the enzyme are specific for different kinds of tissue; CK-BB is found primarily in brain and neurologic tissue; CK-MB, primarily in heart muscle; CK-MM, primarily in skeletal muscle

Indicator of muscle damage the CK-MB enzyme is elevated about 4-6 hours after a heart attack (myocardial infarction, MI); prior to the availability of the troponin test CK-MB was used for diagnosis of MI To diagnose pancreatitis

Digestive enzyme secreted by salivary and pancreatic glands responsible for digestion of starches Digestive enzyme secreted by pancreas and salivary glands responsible for breakdown of triglycerides

HbA1c glycated haemoglobi n

Haemoglobin molecule with a glucose molecule covalently bound

Troponin I and Troponin II

Troponins are intracellular proteins found specifically in heart muscle; they are released when there is damage to cardiac cells

Rheumatoid Factor

Human IgM autoantibody that is increased in autoimmune diseases like rheumatoid arthritis

C-Reactive Protein (CRP)

CRP is a protein produced in response to infection or inflammatory processes

To diagnose pancreatitis

In diabetics, gives a good estimate of glucose control over a 3-month period (the lifetime of a red blood cell). Diagnosis of heart attack (myocardial infarction, MI)

Ordered as part of an evaluation of joint Inflammation and pain to diagnose rheumatoid arthritis To evaluate the severity of inflammatory diseases like rheumatoid arthritis or inflammatory bowel disease

Reason for increased and decreased values ↑ Muscle damage, extreme exercise, trauma ↓ People with very low muscle mass

↑ Acute pancreatitis, blocked pancreatic ducts ↓ Some liver diseases ↑ Acute or chronic pancreatitis or other pancreatic disease, Sometimes with gallstones ↑ poorly controlled patients with DM.

↑ Myocardial injury

↑ Bacterial infections, myocardial infarction, traumas, surgeries, tumour diseases



LIPIDS AND LIPOPROTEINS Profile

Description

Why measured

Reason for increased and decreased values

Total Cholesterol

Important steroid lipid, made by the liver and used for production of steroid hormones and cell walls

High cholesterol has been implicated as a risk factor for coronary artery disease,

↑ Hypothyroidism, uncontrolled diabetes, kidney disease. ↓ Liver diseases, starvation, anaemia

High Density Lipoprotein (HDL) Cholesterol

HDL removes excess cholesterol from tissue for disposal; elevated HDL has been found to protect against coronary artery disease LDL carries cholesterol from the liver to peripheral tissue; contributes to formation of plaques that clog arteries and lead to coronary heart disease

Part of cardiovascular risk profile

↑ Estrogen therapy, alcohol consumption. ↓ Smoking.

Part of cardiovascular Risk profile

Triglyceride-rich lipoprotein that is secreted by the liver and is the precursor to LDL

Part of cardiovascular risk profile

↑ High saturated fat diets, inherited disorders of cholesterol metabolism. ↓ High fiber intake, drug treatment. ↑ High saturated fat diets, inherited disorders of cholesterol metabolism. ↓ High fiber intake, drug treatment.

Chemical form of fatty acids for transport and storage in adipose tissue

Part of cardiovascular risk profile

Low Density Lipoprotein (LDL) Cholesterol

Very Low Density Lipoprotein (VLDL)

Triglycerides



↑ Hypothyroidism, alcoholism, liver disease, uncontrolled diabetes

Haematology Profile

Red blood cells (erythrocytes)

Description Red blood cells carry oxygen from the lungs to the rest of the body. They also carry carbon dioxide back to the lungs so it can be exhaled

Why measured To detect anaemia

Reason for increased and decreased values ↓ With anaemia, bleeding

Profile Haematocrit

Haemoglobin

Red blood cell indices (Wintrobe indices) Mean cell volume (MCV)

Description Hemoglobin is the major substance in a red blood cell. It carries oxygen and gives the blood cell its red color The haematocrit or Packed cell Volume represents the percentage of red blood cells as compared to the total blood volume

Why measured To detect anaemia

To detect anaemia

Mean cell volume To classify (MCV), Mean cell anaemia haemoglobin (MCH), Reticulocytes Describes average RBC To diagnose and size distinguish between different types of anaemia

Mean cell haemoglobin (MCH)

Measures average weight of Hgb in RBC

To diagnose and distinguish between different types of anaemia

Mean cell Hgb concentration (MCHC)

Measures average concentration of haemoglobin in RBC.

To diagnose and distinguish between different types of anaemia

Reason for increased and decreased values ↓ With anaemia, bleeding, hemolysis. ↑With polycythemia, chronic hypoxia. ↓ With anaemia, bleeding, hemolysis. ↑With polycythemia, chronic hypoxia.

↑ Macrocytic anaemia, ↓ Microcytic anaemia ↑Liver diseases, overactive thyroid gland ↓Microcytic anaemia, celiac disease. ↑ Hyperchromic anaemia ↓ Hypochromic anaemia

Profile

Reticulocytes

Erythrocytes Sedimentation Rate

White blood cells

Neutrophils

Description

Why measured

Reason for increased and decreased values

Reticulocytes are young, immature erythrocytes (RBCs). The reticulocyte count measures the percentage of these new cells in the circulating blood. An increase in the number of reticulocytes implies an increased number of erythrocytes are being released into the blood in response to a stimulus. Because erythrocytes regenerate rapidly, reticulocytosis can be noted within 3 to 5 days after hemolysis or after a hemorrhagic episode The ESR is the rate at which erythrocytes settle to the bottom of a test tube through the forces of gravity and in response to fibrinogen level in the blood.

To diagnose and distinguish between different types of anaemia

↑Acute bleeding, chronic blood loss, haemolytic anaemia, kidney disease ↓ iron deficiency anaemia, aplastic anaemia,folic acid deficiency, Vitamin B12 deficiency

To measure degree of inflammation present in the body (indirectly)

White blood cells protect the body against infection. The terms “polys,” “segs,” “polymorphonuclear neutrophils,” and “granulocytes” are synonymous with the term “neutrophil”in clinical practice.

To detect infection

↑ Acute and chronic inflammatory processes, acute and chronic infections, tissue necrosis, rheumatoid-collagen disease, dysproteinemias, nephritis, and pregnancy. ↑ Infection, trauma, major stress ↑ Bacterial or fungal infections.

Profile Lymphocytes

Monocyctes

Eosinophils

Basophils

Description Lymphocytes constitute the second most common WBC in circulating blood. These leukocytes respond to foreign antigens by initiating the immune defense system. The vast majority of lymphocytes is located in the spleen, lymph nodes and other organized lymphatic tissue Monocytes are formed in the bone marrow and are the precursors to macrophages and antigen-presenting cells (dendritic cells), which are found in the body's tissues. Macrophages and dendritic cells are phagocytic cells that engulf foreign antigens or dead or dying cells. Eosinophils have phagocytic activity, catalyse the oxidation of many substances, facilitate killing of microorganisms, initiate mast cell secretion, protect against various parasites and play some role in host defence During infection or inflammation, basophils leave the blood and mobilize as mast cells to the affected site and release granules. These granules contain histamine, serotonin, prostaglandins, and leukotrienes

Why measured

Reason for increased and decreased values â&#x2020;&#x2018; Lymphoma, viral infections

Monocytosis may be observed in mononucleosis, subacute bacterial endocarditis, malaria, and tuberculosis, as well as during the recovery phase of some infections. â&#x2020;&#x2018; Allergic reactions to drugs, allergic disorders, asthma, eczema, parasitic infections

â&#x2020;&#x2018; Allergic and anaphylactic responses, chronic myeloid leukemia, myelofibrosis and polycythemia vera

Profile

Description

Why measured

Platelet count (Thrombocytes)

Platelets (thrombocytes) are the smallest type of blood cell. They play a major role in blood clotting. When bleeding occurs, the platelets swell, clump together, and form a sticky plug that helps stop the bleeding. If there are too few platelets, uncontrolled bleeding may be a problem. If there are too many platelets, there is a risk of a blood clot forming in a blood vessel. Also, platelets may be involved in hardening of the arteries (atherosclerosis).

To determine the number of platelets in blood; to screen for, diagnose, or monitor conditions that affect the number of platelets, such as a bleeding disorder, a bone marrow disease

Coagulation Tests

International Normalized Ratio (INR), Prothrombin Time (PT), Activated Partial Thromboplastin time (aPTT)

Activated Partial Thromboplastin Time

aPTT measures the intrinsic clotting system, which depends on factors VIII, IX, XI, and XII and the factors involved in the final common pathway of the clotting cascade (factors II, X, and V).

To diagnose coagulation abnormalities or to monitor the effectiveness of anticoagulation therapy To diagnose coagulation abnormalities or to monitor the effectiveness of anticoagulation therapy. To monitor unfractionated heparin therapy

Reason for increased and decreased values â&#x2020;&#x2018; Essential thrombocythemia, post-splenectomy, malignancy â&#x2020;&#x201C;Thrombocytopenia dengue fever

Profile Prothrombin time

International Normalized Ratio

ď&#x201A;ˇ

Description Prothrombin is synthesized in the liver and is converted to thrombin during the blood clotting process. Thrombin formation is the critical event in the homeostatic process because thrombin creates fibrin monomers that ultimately assemble into a clot and stimulates platelet activation. The PT test directly measures the activity of clotting factors VII, X, prothrombin (factor II), and fibrinogen. INR is the recommended method to accurately monitor anticoagulant therapy.

Why measured

Reason for increased and decreased values

To diagnose coagulation abnormalities or to monitor the effectiveness of anticoagulation therapy.

To diagnose coagulation abnormalities or to Monitor the effectiveness of anticoagulation therapy.

ARTERIAL BLOOD GASď&#x20AC;

To evaluate lung function by measuring blood pH, oxygen (O2) and carbon dioxide (CO2); to monitor treatment for lung diseases; to detect an acid-base imbalance in your blood, which may indicate a respiratory, metabolic, or kidney disorder; to evaluate the effectiveness of oxygen therapy

Profile pH

Partial pressure of carbon dioxide (pCO2)

Description Measurement of the acidity of the blood, reflecting the number of hydrogen ions present. Reflects the amount of carbon dioxide gas dissolved in the blood.

Why measured

Reason for Increased and decreased values

Profile Partial Pressure of oxygen (PO2)

Bicarbonate (HCO3)

Total carbon dioxide (TCO2)



Description

Why measured

Reason for Increased and decreased values

Reflects the amount of oxygen gas dissolved in the blood. It primarily measures the effectiveness of the lungs in pulling oxygen into the blood stream from the atmosphere. A negatively charged ion that is used by the body to help maintain the body's acid-base (pH) balance measurement of all the CO2 in the blood. Measurement of all the CO2 in the blood.

URINALYSIS

Urinalysis (UA) is part of routine diagnostic and screening evaluations. It can reveal a significant amount of preliminary information about the kidneys and other metabolic processes. UA is routinely done in all patients admitted to the hospital, pregnant women and pre-surgical patients. It is done diagnostically in patients with abdominal or back pain, dysuria, hematuria, or urinary frequency. It is part of routine monitoring in patients with chronic renal disease and some metabolic diseases. It is the most frequently ordered urine test.

Profile

Description

Appearance of Urine

Normal urine is strawyellow and the intensity of this colour usually roughly corresponds to Urine density

Urine odour

May warn of ketoacidosis (sweet, fruity odour) or an inherited metabolic disorder (e.g. the “musty” or “mousy“smell in phenylketonuria, or maple syrup smell in maple syrup urine disease).

Why measured

Reason for increased and decreased values

Profile Specific Gravity (Density)

Leukocytes

Nitrites

Ketones

Description The specific gravity of urine reflects renal tubule functions (the secretion and absorption of ions and water, in particular) and may be one of the first signs of renal damage (in particular a loss of reaction to changes in fluid intake). Hydrogen ion concentration in urine reflects the balance of H+ production, metabolism and excretion; however, it may also be a sign of a kidney or urinary tract disease. Leukocyte is a screening test used to detect leukocytes in the urine Nitrite test is a screening test for identification of urinary tract infection (UTI). This test is based on the principle that many bacteria produce an enzyme called reductase, which can reduce urinary nitrates to nitrites. Normally, no ketones are present in the urine. However a patient with poorly controlled diabetes and hyperglycemia may have massive fatty acid catabolism. Ketones are the end products of this fatty acid break down.

Why measured Distinguishing Between pre-renal and renal cause of renal failure, test for renal concentrating ability

Reason for increased and decreased values ↑ Pre-renal cause of renal failure (e.g. dehydration with ↓ renal tubule functions damage

Primarily the diagnosis of urinary tract infection, but also the evaluation of acid-base balance disorders or the diagnosis and monitoring of urolithiasis treatment. Urinary tract infection screening

Acidic urine is found in acidosis and alkaline urine in alkalosis (compensation or correction) of the disorder by the kidneys

Urinary tract infection screening

↑UTI



THERAPEUTIC DRUG MONITORING

In general, most prescribed drugs do not require any special monitoring of the drug level in blood, although occasionally they do require tests to ensure that the drug is not adversely affecting liver or kidney function. The drugs that do require monitoring of their blood concentration are those that have a narrow therapeutic window. This means that there is a very narrowly defined concentration at which the drug is active and effective, but not toxic. If the drug level falls below the lower limit, the drug is ineffective. If it rises above the upper limit, the patient is at risk of health issues due to toxicity. Ensuring that the patient is receiving the appropriate treatment is a challenge when using drugs with narrow therapeutic windows like some antibiotics. The laboratory is frequently called upon to test drug concentrations at times when the concentration is expected to reach a maximum to assess for risk of toxicity, and again when the drug is expected to reach a minimum concentration, usually immediately before the next dose, to ensure minimum therapeutically effective amounts are maintained. These two times of measurement are referred to as peak and trough concentrations, respectively. Most therapeutic drugs monitor trough concentrations with the exception of some antibiotics with high risk of toxicity (where peak and trough concentrations are medically necessary). Analyte Amikacin

Description Antibiotic

Carbamazepine Digoxin Gentamicin

Antiepileptic Treatment of chronic atrial fibrillation and heart failure Antibiotic

Phenorbabital Phenytoin Theophylline Valproic acid

Used for sedation and antiepileptic Antiepileptic Asthma treatment Antiepileptic

Vancomycin

Antibiotic

Paracetamol

Relieves pain and fever

Salicylate

Relieves pain and fever

Therapeutic range Trough: < 10 mcg/ml Peak : 20-30 mcg/ml 4-12 mcg/ml AF: 0.8-2.0 ng/ml CCF : 0.5-0.9 ng/ml Trough: < 2 mcg/ml Peak : 5-10 mcg/ml 15-40 mcg/ml 10-20 mcg/ml 5-20 mcg/ml Seizures: 50-100 mcg/ml Psychiatric disorder: 50125 mcg/ml Trough: 10-15 mcg/ml Peak: 25-40 mcg/ml Toxic : > 1324 µmol/L (after 4 hrs) > 662 µmol/L ( after 8 hrs) > 331 µmol/L ( after 12 hrs) Toxic : > 2.2 nmol/L

3.7

REFERENCE RANGES

A reference range is a set of values that includes upper and lower limits of a lab test based on a group of otherwise healthy people. The values in between those limits may depend on such factors as age, sex, and specimen type (blood, urine, spinal fluid, etc.) and can also be influenced by circumstantial situations such as fasting and exercise. These intervals are thought of as "normal ranges or limits." Though the term "reference interval" is usually the term preferred by laboratory and other health professionals, the more commonly-known term is "reference range," so that is the term used throughout this section. Reference ranges provide the values to which your healthcare provider compares your test results to and determines your current health status. However, the true meaning of a test result—whether it indicates that you are sick or well or at risk for a health condition—can only be known when all the other information your provider has gathered about your health, including the results of a physical exam, your health and family history, recent changes in your health, any medications you are taking, and other non-laboratory testing. The accuracy of laboratory testing has significantly evolved over the past few decades, but some lab-to-lab variability can occur. This may be due to differences in lab testing equipment, chemical reagents, and analysis techniques. You must use the range supplied by the laboratory that performed your test to evaluate whether your results are "within normal limits." Reference ranges help describe what is typical for a particular group of people based on age, sex, and other characteristics. In the context of your personal information, you and your provider can use reference ranges as a guide to what your results mean and to help make decisions about managing your health. 

ARTERIAL BLOOD GAS (ABG) Test pH PCO2 PO2 HCO3 TCO2

Reference ranges 7.35 – 7.45 35 – 45 mmHg 75 – 100 mmHg 24 – 32 mmol/L 24 – 30 mmol/L



RENAL FUNCTION TEST (RFT) Test

Reference ranges 136 – 146 mmol/L 3.5 – 5.1 mmol/L 101-109 mmol/L 2.8 – 7.2 mmol/L 59-104 µmol/L (male) 45-84 µmol/L (female) 208.3 – 428.4 µmol/L (male) 154.7 – 357.0 µmol/L (female) 2.20 – 2.65 mmol/L 0.81 – 1.45 mmol/L

Sodium Potassium Chloride Urea Creatinine Uric Acid Calcium Inorganic Phosphate 

LIVER FUNCTION TEST (LFT) Test

Reference ranges 66 – 83 g/L 35 – 52 g/L <50 U/L (male) <35 U/L (female) <50 U/L (male) <35 U/L (female) 30 – 120 U/L 5 – 21 µmol/L < 3.4 µmol/L

Total Protein Albumin Alanine Transaminase (ALT) Aspartate Aminotransferase (AST) Alkaline Phosphate (ALP) Total Bilirubin Direct Bilirubin 

LIPID PROFILE

Test Total Cholesterol

Triglyceride

High Density Lipoprotein (HDL)

Reference ranges < 5.2 mmol/L 5.2 – 6.2 mmol/L ≥ 6.2 mmol/L < 1.70 mmol/L 1.70 – 2.25 mmol/L 2.26 – 5.64 mmol/L ≥ 5.65 mmol/L < 1.03 mmol/L ≥ 1.55 mmol/L

Low Density Lipoprotein (LDL)

< 2.6 mmol/L 2.6 – 3.3 mmol/L 3.4 – 4.1 mmol/L 4.1 – 4.9 mmol/L ≥ 4.9 mmol/L

Notes/comments Desirable Boderline High High Normal Boderline High High Very high Major risk factor for coronary heart disease “Negative” risk factor for coronary heart disease Optimal Near optimal Boderline High High Very high



CARDIAC PROFILE (CE) Test

Reference ranges ≤ 171 U/L (male) ≤ 145 U/L (female) < 248 U/L (male) < 247 U/L (female) < 35 U/L (male) < 31 U/L (female)

Creatinine Kinase (CK) Lactate Dehydrogenase (LDH) Aspartate Aminotransferase (AST) 

DIABETIC PROFILE Test

Reference ranges 4.1 – 5.9 mmol/L ≤ 7.8 mmol/L Normal: <6.1 mmol/L DM: >7.0 mmol/L IGT: <7.8 mmol/L Normal: <7.8 mmol/L DM: >11.1 mmol/L IGT: 7.8-11.1 mmol/L 4.5-6.4%

Glucose MGTT

HbA1c 

Thyroid Stimulating Hormone (TSH) Free Thyroxine (FT4) Free Triiodothyronine (FT3)

White blood cell Neutrophils Lymphocytes Monocytes Eosinophiols Basophils

Hgb Hct

2 hours

Reference ranges 0.35 – 4.94 uIU/mL 9.009 – 19.048 pmol/L 2.627 – 5.699 pmol/L

COMPLETE BLOOD COUNT & ANAEMIA TEST Test

RBC

Fasting

THYROID FUNCTION TEST Test



Notes/comments Fasting random

Reference ranges 5.2-12.4 x 109/L 40-80 % 20-40 % 2-10 % 1-6 % <1-2% 4.1-6.5 m/uL (male) 4.2-5.4 m/uL (female) 13.5-18.0 g/dL (male) 12-16 g/dL (female) 42-52 % (male) 37-47 % (female)

Test MCV MCH MCHC Platelet ESR Vitamin B12

21.81 – 274.66 ng/mL (male) 4.63 – 204.00 ng/mL (female)

Ferritin Folate Transferrin Unsaturated Iron Binding capacity (UIBC)



Reference ranges 80-94 Fl 27-32 pg 33-37 g/dL 130-400 x 109/L 2 – 20 mm/hr 187 – 883 pg/mL

3.1 – 20.5 ng/mL 2.0-3.6 g/L 22.3-61.7 umol/L (male) 24.2-70.1 umol/L (female)

COAGULATION TEST Test

Reference ranges

International Normalized Ratio (INR)

0.91 – 1.05

Prothrombin Time (PT) Activated Partial Thromboplastin time (aPTT)

10.5 – 14 seconds



OTHERS Test

Amylase Magnesium C-Reactive Protein (CRP) 

25 – 40 seconds

Reference ranges 34 – 117 U/L 0.73 – 1.06 mmol/L (male) 0.77 – 1.03 mmol/L (female) < 5 mg/L

URINALYSIS Test

pH Specific Gravity Erythrocytes Leukocytes Nitrite Glucose Protein Bilirubin Urobilinogen Ketone

Reference ranges 4.6 – 8.0 1.001 – 1.035 < 3 Ery/µL NEG Leu/µL NEG < 30 mg/dL < 15 mg/dL < 0.02 mg/dL < 1.0 EU/dL NEG

CASE STUDY A 72-YEAR-OLD FEMALE nursing home resident suffered a minor stroke about 5 weeks ago. Her neurological deficits improved leaving her with residual weakness on her left side. Patient has not been eating much and has been drinking even less. She has a history of chronic iron and folate deficiency anaemia with her usual Hgb around 10 g/dL (reference range: 12–16 g/dL), Hct around 30% (reference range: 37% to 47%), iron concentration around 35 mcg/dL (reference range: 60–150 mcg/dL), and folate less than 1–3 ng/mL (reference range 4–15 ng/mL). Patient takes daily iron and folate supplements as well as many other drugs. Her blood pressure has remained stable, but her heart rate has increased from 70s to 90s over the past 5–7 days. Her mucous membranes became dry, her skin turgor diminished, and her urine output decreased over that same time period. A complete blood count is ordered. Tests results indicate an Hgb of 13 g/dL and an Hct of 40%. Her BUN is 40 mg/dL (reference range: 8–20 mg/dL), creatinine is 0.8 mg/dL (reference range: 0.5–1.1 mg/dL), and sodium is 145 mEq/L (reference range: 136–145 mEq/L). Question: Has the patient’s anaemia resolved? What is happening here? Discussion: All the patient’s laboratory values, including Hgb and Hct, have become temporarily hemoconcentrated because the patient is dehydrated. Thirst mechanisms are sometimes disrupted after a stroke. Her dry mucous membranes, decreased skin turgor, diminished urine output, and increased heart rate are all consistent with dehydration. As the patient is rehydrated, Hgb and Hct values should return to baseline. If the patient is overhydrated, the opposite scenario can occur.

REFERENCES

1. Lab Tests Online; Retrieved (2018) from; http://labtestsonline.org 2. Anita Dickson, Lab Values and their Meanings; 2011 3. Mary Lee, Basic Skills in Interpreting Laboratory Data, 5th Edition, American Society of Health-System Pharmacists, 2013.

4.0

PHARMACIST WORKUP DRUG THERAPY (PWDT) CONCEPT: THE COMPONENT

THE COMPONENT

4.1

OVERVIEW OF THE CHAPTER

Pharmacist Workup Drug Therapy (PWDT) is a formatted guideline use as a part of the pharmaceutical care process which utilized the patient database. PWDT serves as a thought process to provide a systematic and guided patient documentation, followed by pharmacy intervention in identifying any drug-related needs and any drug related problems (DRP). PWDT can be utilized as a structured tool for the pharmacist to analyse and provide the pharmaceutical care plan.

4.2

LEARNING OBJECTIVES

Upon completion of the chapter, the student will be able to: 1. Understand the concept and component of PWDT 2. Understand the importance of PWDT components in assessment process 3. To obtain and document the required patientâ&#x20AC;&#x2122;s information using the PWDT format 4. Know how to apply the information to assess patientâ&#x20AC;&#x2122;s drug related problems.

4.3

GENERAL PRINCIPLES

1. Patient-specific medical information must be collected, organized, recorded, and maintained using PWDT format. 2. Appropriate extraction of patient information and integration with drug information to formulate a process for monitoring drug therapy using deductive reasoning.

40 4.4

PWDT CONCEPT

PART I: Data Collection

PART II: Identifying DRP

•Gather patient’s demographic and clinical data •Gather patient’s medication experience

•Identify patient’s drug related need(s) •Identify patient's drug related problem(s)

PART III: Pharmaceutical Care Plan •Develop Pharmaceutical Care Plan •Implement Pharmaceutical Care Plan

Demographic Information One might ask, what makes this person unique and therefore have different drug-related needs than the last patient met? The student should be able to extract out the patient demographic details such as name, age, registration number, gender, admission date, race, religion, weight, and height. Please refer the example of completed PWDT.

Age

Age can be identified and documented as birth date and is a vital information to provide pharmaceutical care by identifying the patient as being either paediatric, adult or geriatric. These patients may have altered pharmacokinetics and pharmacodynamics. Example: The appropriate approach to drug therapy for pneumonia is different in a 7-week-old patient, a 7-year-old patient, and a 70-year-old patient.

Gender

Gender of the patient needs to be specified as either male or female. It is important to assess the risk factors and the safety of medication use (pregnant or breast-feeding women). Example: Pregnant women or breast-feeding patient require special attention for the safety use of medication.

Race/Religion

The ethnicity and race may affect the pharmacokinetics and pharmacodynamics of the drugs, while religious beliefs may conflict with medical treatment. Example: Muslim patient will not receive a porcine based medicine, and Hindu patient may not receive bovine based medicine.

Height and weight are utilized in calculation of ideal body weight (IBW), body mass index (BMI), or body surface area (BSA). The calculations used such as creatinine clearance or modification of diet in renal disease (MDRD) or carboplatin dosing the monitoring of drug therapy in a patient and allows dosage individualisation. Height and weight

Example:

Chief Complaint (CC) The CC is the first question being asked to the patient and is usually written in the patient’s own words to describe his or her primary symptoms or medical problem or condition that the patient is experiencing until it brought him/her to the hospital. In an event when the patient is unable to be interviewed, the student may need to interview the family, or caregivers to ask specific questions about the patient’s symptoms. Example: “My tummy hurts and feels like being stabbed every time I breathe” or “My chest is pounding heavily, and it is difficult for me to breath.”

History of Present Illness (HPI) The history of present illness describes chronologically details when the symptoms started, quality, anatomic location, time course, concurrent symptoms, what causes the symptoms to worsen or aggravated, lessened or relieved, and what the patient has done to relieve the symptoms (including prescription or OTC medication). It is important to investigate past episodes of similar symptoms and treatment received on prior occasions. This includes diagnostic tests done prior to admission. Any other significant ongoing problems should be included in the HPI in a separate section or paragraph.

Example: Patient with poorly controlled diabetes mellitus comes to the emergency room because of chest pain, the HPI would first include information regarding the chest pain followed by a detailed history of the diabetes mellitus.

Past Medical History (PMHx) The primary purpose of the assessment is to describe and make appropriate connections between the existing chief complaints with the relevant past medical history. It may contain information about past serious illnesses, hospitalizations, surgical procedures, pregnancies, deliveries, accidents, or injuries. Any information that may suggests a high risk or predisposition to develop a serious condition, or that would represent a contraindication to future drug therapies, should be described as part of the patient's past medical history. Example: Patients who have a history of peptic ulcer disease are at higher risk for gastrointestinal erosion from nonsteroidal anti- inflammatory agents than patients with no history of peptic ulcer disease. Thus, precaution is needed if physician plan to start NSAID in this patient.

Medication History Interview (Past, Surgical, Hospital) Gathering a comprehensive medication history will help the practitioner avoid repeating mistakes, treatment failures, and side effects of the past. If it caused the patient harm in the past, it is likely to cause harm if used again. However, if you fail to determine what your patient wants from her medications, you have no reference point, no starting place. Prescribed Medication: What Medicines are you having now? Record here what the patient says, noting any anomalies with their current prescription. The reason we ask this question is to know patientâ&#x20AC;&#x2122;s general attitude/behaviour, knowledge and perception towards his/her medications and disease. Other drug prescribed previously (with dates if possible): What have you had in the past? The medication that patients have taken in the past can provide useful information to assess if the present problem has been treated before with medications and if so, what was the outcome or result and to determine if the patient has experienced any treatment failures and unwanted side effects to medications used in the past

Non-Prescribed Medication: Do you take anything that you buy from shops without a prescription â&#x20AC;&#x201C; community pharmacy, health food store and supermarket? This may include over the counter drugs and those that is not being prescribed by the physician. Allergies: Any potential allergies exist (drug, food, etc), true allergic reactions occurred in the past? Patient that had experience of allergies to any medication, food, etc. which may need consideration in choosing the current medication. Detail information on the symptoms occurring during the reaction (rash, swelling, etc.) should be recorded. Response to drug therapy: Do you think your current/previous medication is benefiting you? The patient's medication experience will reveal how patients perceives the medications, and later how patients make personal decisions about whether to take the medication or not. A pharmacist must assess the compliance and adherence of the patient. Non-compliance towards the prescribed medication can be factors lead to patient admission into hospital. The patients should have the ability and willingness to take a therapeutic regimen that had been prescribed accordingly. Example: Patient describes â&#x20AC;&#x153;I have to take so many pills every day,â&#x20AC;? so, the pharmacist should re-evaluate to minimize the number or frequency of doses for the patient.

Cardiovascular Risk Assessment Risk Assessment/Preventive Measures/Quality of Life Cardiovascular Risk Assessment Male > 45 years old Female > 55 years old or female <55 years old with history of ovariectomy not taking oestrogen replacements Define MI or sudden death before age 55 years in father or male first-degree relatives or before 65 years in mother or female first-degree relative Current cigarette smoking Hypertension Diabetes Mellitus HDL cholesterol < 35mg/dL (< 0.9mmol/L) LDL cholesterol > 60mg/dL (< 1.55mmol/L) Total

Is patient at risk for complication of current conditions?

Yes

How to analyse: Step 1: Identify patients who have two or more risk factors and no CHD and CHD risk equivalent history. Step 2: Assess their global CHD risk with an instrument such as that illustrated in table above from the Framingham Heart Study. For each Yes =1, No=0 Step 3: Calculate the total score and analyse: > 3 of total points- patient has high risk of having cardiovascular complication in 10 years times < 3 of total points- patient has low risk of having cardiovascular complications in 10 years times

Family History Family history may include health status and patient’s living arrangements. It will allow us to identify any risk factor predisposing to disease progression or drug-taking behaviour Occupational information may be an important part of the patient’s history, as it may reveal exposure to toxins. Example: 1. A handicapped patient may require care-giver to administer the medications and making health care decisions. 2. Ship-builder’s exposure to asbestos, painter’s exposure to lead, etc.

Social Drugs/Lifestyle History Knowing your patient's exposure to caffeine, nicotine, alcohol, and drugs of abuse will avoid detrimental drug interactions, dosage errors, and even toxic reactions. The information is assessed as what compound and how much/many were taken in a week? Example: Smoking: 1 pack of 20’s “Rokok Daun” per week

Current medical problem/Diagnosis/Provisional Diagnosis List the diagnosis of current medical problem or diagnosis or differential diagnosis that leads the patient to hospital admission. The diagnosis is normally being made by the physician attending to the patient Example: Uncontrolled Hypertension or septicemia secondary to uncontrolled diabetes mellitus

Current medications (in the ward) Therapeutic assessment is to be done to determine which problems are active or require maintenance therapy, appropriateness of laboratory results, physical findings, and subjective patient reports, pharmacist will be ab le to assess drug efficacy of current regimen. Drug Treatment in Ward

Blood Product transfusion This information is needed if patient receiving blood product transfusion due to any problems that lead to excessive blood loss e.g. vehicle accident; severe anaemia

Patientâ&#x20AC;&#x2122;s Medication Experience The pharmacist must understand patient's medication experience because it directly affects the drug taking behaviour of a patient. Although suggestions and recommendations had been made to a patient, the patient is the one deciding the degree of adherence and compliant towards the medicine. The medication experience includes having an insight of the patient's beliefs, perceptions, understandings, attitudes, and behaviours about drug therapy.

Clinical information: Review of System (ROS) Review of system can be done during hospital admission as to determine the patient’s baseline status, so we can measure the potential side effects. Be familiarise with medical terms that are commonly used. ROS

Explanation

Example

General Status

Patient’s description of his/her overall feelings of wellness

Weight gain or loss, fever, chills and night sweats, fatigue and weakness

Define and identify each of the vital sign by comparing with the value of normal range

Body temperature, heart rate, respiration rate, blood pressure

Incontinence, frequency, urgency, Information on conditions of Kidney & Urinary hesitancy, dysuria, haematuria, these two organs at the time of Tract (KUT) polyuria, nocturia, change in urinary admission stream

Hepatic/Liver

Examined by techniques such and percussion.

Chest (Cardiovascular / Pulmonary)

Observation and examination on chest to determine configuration and symmetry of the lungs

Abdomen

Examined by techniques such and percussion.

Skin/Muscle

examination Enlargement or nodularity of liver or as palpation spleen. Clear to percussion and auscultation (P&A), rhonchi, crackles and wheezing sound

examination Soft, non-tender, as palpation bowel sounds

Observation on abnormalities of patient’s and muscle condition

non-distended,

Skin: rashes, pruritus, bruising, any dryness, skin cancer or other skin lesions. Muscle: arthralgias, arthritis, joint swelling, redness, tenderness, back pain, trauma.

ROS

Explanation

Example

Neuro/mental

Examination and observation on neurological system and mental status to determine any deficiency in neurological function.

Alert & Oriented Ă&#x2014; 3, cranial nerve IIâ&#x20AC;&#x201C; XII intact, focal deficits, syncope, seizures, weakness, coordination problems, alterations in sensations, memory, mood, and sleep pattern.

Fluid status (hydration)

Hydration status of patient may Input/output chart, electrolytes, acidindicate the fluid status in the base, oedema, skin turgor. body Head: Trauma, headache, tenderness, dizziness, syncope

Eyes: pupils, extraocular movements, Vision and visual changes, photophobia, blurring, diplopia, Spots or floaters, Head, Ear, Evaluates the size and shape of inflammation, discharge, dry eyes, Eyes, Nose and the system, their reaction to excessive tearing, history of Throat (HEENT) cataracts or glaucoma stimuli, and their ability to accommodate. Ears. Hearing changes, tinnitus, pain, discharge, vertigo, history of ear infections Nose. Sinus problems, epistaxis, obstruction, polyps, changes in or loss of sense of smell

Clinical information: Laboratory test Laboratory tests are conducted with the intention for use on samples of blood, urine, or other tissues or substances taken from the body to help diagnose disease or other conditions. It may be invasive or non-invasive. The laboratory tests functions to identify changes in health condition in relation to the treatment given. It is also used as an aid of diagnostic and to evaluate the response of the patients throughout the progression of the disease. Components of laboratory test may include blood chemistry, fluid status, liver function, coagulation profile, blood gases, lipid profile, cardiac biomarkers, microbiologic tests and

therapeutic drug monitoring. Pharmacist should know the normal range and the reasons of the abnormalities to provide the pharmaceutical care for the patient.

Assessing patientâ&#x20AC;&#x2122;s drug therapy and drug related problem (DRP) Upon assessing the patient PWDT, the pharmacist will determine if there is/are any DRP to be resolved or prevented and describe the specific DRP. Examples of DRP can be referred to in Chapter 4: Identifying Drug Related Problems and Case Studies.

Developing Care Plan(s) & Implementation Pharmacistâ&#x20AC;&#x2122;s assessment of drug therapy will be recorded in the Pharmacistâ&#x20AC;&#x2122;s care plan monitoring worksheet (PMW). It will allow the pharmacists to provide drug recommendation and individualization inclusive of therapeutic drug monitoring. Patient will be provided with education and counselling by applying effective therapeutic communication (bedside counselling, drug information, medication history taking, in service group education, ADR reports). In the process of implementing the individualized regimen and monitoring plan, the information shall be conveyed to the other health professional. Continuous and planned follow-up on patients will allow the pharmacist to evaluate the effectiveness of the intervention.

Pharmacotherapeutic Goal

Monitoring Parameter

Desired Endpoint

Monitoring Frequency

Date/ Time

5.0 5.1

IDENTIFYING DRUG RELATED PROBLEMS AND CASE STUDIES OVERVIEW OF THE CHAPTER

This chapter introduces the types of drug related problems (DRPs) and how to identify DRPs or other relevant pharmaceutical care issues using some case study examples. 5.2

LEARNING OBJECTIVES:

a) To understand the types of DRP b) To identify DRPs using examples of case studies 5.3

GENERAL PRINCIPLES

A drug related problem (DRP) is any undesirable event experienced by the patient that involves or is suspected to involve drug therapy and that actually or potentially interferes with a desired patient outcome. This chapter lists 13 major types of DRP, including specific questions that may facilitate pharmacist in the detecting each problem and some examples of case studies. 5.4

TYPES OF DRPS

5.4.1

Correlation between drug therapy & medical problems

a) Any drugs without a medical indication? b) Any unidentified medication? c) Any untreated medical condition? Do they require drug therapy?

Case study JK Roling, 53 years old, complained of pain, burning sensation and difficulty when passing stool with occasional events of bloody stool. He claimed to have a reduced bowel output since two weeks ago. He was diagnosed with haemorrhoid and was given AnusolÂŠ cream for local application. Pharmacistâ&#x20AC;&#x2122;s assessment: JK Roling is also having constipation which is a risk factor of haemorrhoid and may worsen this condition. In this case, constipation is an untreated medical condition. Bulk forming laxatives can be recommended to him.

5.4.2. Appropriate therapy a) Is therapy achieving desired goals or outcomes? b) Is the therapy tailored to this patient? c) Do they require any lab test to confirm drug use safety or side effects? d) Is non-drug therapy appropriately used? (e.g. diet & exercise) e) Comparative efficacy of chosen medication(s) & relative safety of chosen medication(s) f) Is medication on formulary?

Case study Mrs Anna, a pregnant woman aged 26 years, is found to have bacteriuria at her first antenatal visit. There are no white or red cells seen in her urine. Urine culture demonstrates E. coli at a count of more than 100,000 bacteria/mL, sensitive to trimethoprim, nitrofurantoin and cefalexin but resistant to amoxicillin. However, Mrs Anna does not complain of any urinary symptoms. The doctor planned for antibiotics for her and asked your second opinion. Pharmacistâ&#x20AC;&#x2122;s assessment: Considering that Mrs Anna is pregnant, any consequences of untreated urinary tract should be avoided, and asymptomatic bacteriuria should be treated. A repeat urine specimen should be obtained to confirm the finding, and treatment started with either cefalexin or co-amoxiclav for 7 days. Trimethoprim should be avoided during early pregnancy because of its theoretical risk of teratogenicity, and nitrofurantoin should be avoided in late pregnancy as it may cause neonatal haemolysis. Following treatment, she should be reviewed throughout the pregnancy to ensure eradication of the bacteriuria, and to permit early treatment of any relapse or reinfection.

5.4.3. Drug regimen a) Are the dose and dosing regimen appropriate and/or within usual therapeutic range and/or modified for patient factor? b) Appropriateness of PRN medications? c) Is the route, dosage form, mode of administration, length of therapy appropriate? Is the length or course of therapy consider the efficacy, safety, convenience, patient limitation and cost?

Case study Booboo, 18 months old, were admitted to the hospital for emergency appendectomy due to perforated appendicitis. Medications in ward include IV infusion morphine 50 mg in 50 mL to run at 1–4 mL/h (10–40 mcg/kg/h), paracetamol 125 mg QID PRN per rectum IV Gentamicin 70 mg OD for 10 days. Pharmacist’s assessment: a) The morphine dose is incorrect. If the infusion is prepared as directed, 1 mL/h will actually provide 100 mcg/kg/h. This is a 10-fold overdose which is a medication error frequently seen in children. b) Consider giving larger rectal dose of paracetamol to be administered to Booboo, since rectal bioavailability is lower than oral bioavailability. Possible recommendation is 250 mg/rectum 8 hourly rather than 125 mg 6 hourly, for up to 48 hours, but not exceeding 90 mg/kg/day.

Case study Mr CK was diagnosed with ulcerative colitis 12 months ago. His past medical history includes surgical resection, and as a result of this, he was using enteral feeding for nutrition and medication. He is currently prescribed T. Mesalamine MR 2 g/day and a reducing course of prednisolone. Pharmacist’s assessment: Mesalamine MR tablets disperse in water to give M/R granules, but these granules must not be crushed as this will destroy the modified release mechanism. This formulation is not suitable to be administered through the enteral tube. An alternative would be sulfasalazine in liquid preparation.

5.4.4. Therapeutic duplication/polypharmacy

Case study Jamil, 47 years old, has been successfully treated for his first episode of duodenal ulcer with ranitidine 150mg orally twice daily for the past 4 weeks. At the same time, he was also using cimetidine, which he purchased from a pharmacy without prescription. Pharmacistâ&#x20AC;&#x2122;s assessment: Jamil should be checked for any symptoms related to the high dose of both H2receptor blockers, and counselling is needed to avoid recurrent event.

5.4.5. Adverse drug reaction a) Is the symptom represented is drug-induced or a new medical problem? b) What is the likelihood that the problem is drug related?

Case study A 65-year-old man with heart failure is admitted to hospital with a complaint of fatigue and muscle weakness. His potassium level of 7.1 mmol/L and serum creatinine is 1.8 mg/dL. Already stabilised on lisinopril 20 mg daily, he had recently been started on spironolactone 25 mg daily. Pharmacistâ&#x20AC;&#x2122;s assessment: He is having hyperkalemia induced by spironolactone, as spironolactone can increase potassium serum levels due to its effect on aldosterone. The risk of hyperkalemia is increased in this case because spironolactone was used in combination with ACE inhibitors. A mildly increased serum potassium can be managed with a reduced dose of spironolactone. In severe hyperkalemia, spironolactone may be substituted with other therapy such as diuretics, while close monitoring should be done for potassium level.

5.4.6. Interactions a) Drug-drug: Any drug-drug interaction with clinical significance b) Drug-disease: Any relative contraindications given patient characteristics and current/past disease state? c) Drug-food: Any food interactions with clinical significance? d) Drug-herb: Any drug-lab interactions with clinical significance?

Case study Kassim, a 70-year-old man currently treated in a medical ward, has a fast pulse rate and falling blood pressure. His recent drug history is warfarin as thromboembolic prophylaxis for chronic atrial fibrillation and erythromycin for a recent chest infection. He has vomited a moderate quantity of blood. (Haematology results: Hb 8.8 g/dL, RBC 4.7 × 1012/L, Platelets 570 × 109/L, INR 6.0). Other blood profile, renal function test and electrolytes are normal. Pharmacist’s assessment: The symptom of haematemesis and coagulation profiles (platelet, INR) may signify gastrointestinal bleeding. Erythromycin inhibits the cytochrome P450 system, particularly the CYP3A4 isoenzyme. CYP1A2 and CYP3A4 are the main enzymes for the inactivation of (R)-warfarin. Erythromycin, therefore, potentiates warfarin's action. Kassim has been ill and in hospital and, therefore, his recent intake of vitamin K containing foods, for example, green leafy vegetables may well have been lower than usual.

Case study An 80-year-old woman with a previous history of hypothyroidism presented with a history of abdominal pain and vomiting. She had not moved her bowels for the previous 7 days. Two weeks earlier her general practitioner had prescribed a combination of paracetamol and codeine to control pain in her osteoarthritic hips. Pharmacist’s assessment: This patient developed severe constipation after taking a codeine-containing analgesic. Ageing is associated with decreased gastro-intestinal motility. Hypothyroidism, which is common in the elderly, is also associated with reduced gastrointestinal motility. Therefore, drug-disease interaction occurs in this case. Whenever possible, drugs that are known to reduce gastro-intestinal motility should be avoided in the elderly.

5.4.7. Drug allergy or intolerance a) Is allergy or intolerance to any medication currently being taken? b) Is patient using a method to alert me health care provider of the allergy/ intolerance? Case study Mr. Shah, 50 years old, was diagnosed with infective endocarditis. He was given IV Ceftriaxone 2g BD, but later developed generalized pruritis that subsided after the discontinuation of this antibiotic. Later, they doctor planned to start him with IV Sulperazone 1g BD. Pharmacistâ&#x20AC;&#x2122;s assessment: Mr. Shah was possibly having an allergic reaction to ceftriaxone. There is also a chance for him to develop the same reaction with sulperazone, which is a combination of cefoperazone and sulbactam. Cefoperazone and ceftriaxone are both third generation cephalosporins and there is a risk for cross reactivity.

5.4.8. Risk and quality of life impact a) Is patient at risk for complications with an existing disease state? b) Is therapy adversely impacting patientâ&#x20AC;&#x2122;s quality of life? How so? c) Is patient on track for preventive measures (immunizations, mammograms)?

Case study A 75-year-old lady who suffered from osteoarthritis of hip and knee joints presented with a history of passing black stools. Her drug therapy included diclofenac 50 mg three times daily and paracetamol 1 g as required.

Pharmacistâ&#x20AC;&#x2122;s assessment: The likely cause of black stool is upper gastro-intestinal bleeding due to diclofenac, which is an NSAID. Elderly people are more prone to develop ulceration in stomach and duodenum with NSAIDs compared with young patients.

5.4.9. Social or recreational drug use (drug abuse) a) Is current use of social drug problematic? b) Are symptoms related to sudden withdrawal or discontinuation of social drugs? Case study MJ, a 27-year old, came to the emergency department after involved in a motor vehicle accident. He was given a normal dose for codeine as a pain reliever, but he still complained of intolerable pain. Upon questioning, he admitted to morphine drug abuse. Pharmacistâ&#x20AC;&#x2122;s assessment: MJ had developed tolerance to opioids due to long term use of morphine. Higher dose of codeine is needed to achieve the same effect of codeine.

5.4.10. Financial impact a) Is therapy cost-effective? b) Does cost of therapy represent a financial hardship for the patient? Case study Patient cannot afford the drug product: A 52-year old woman with chronic kidney disease was presented with severe anemia. The best treatment for her is erythropoietin, but due to the high cost of this product, she can only be prescribed with iron and folic acid supplementation.

5.4.11. Patient knowledge of therapy a) Does the patient understand the role of their medication, how to take it and potential side effects? b) Does the patient understand the role of non-pharmacological therapy? c) Would patient benefit from education tools?

Case study Patient does not understand the instructions: A 33-year old man with a chronic back injury was prescribed naproxen 500mg three times daily for 10 days. After the first 5 days he is still uncomfortable because he has been taking it only when the pain becomes quite unbearable. Patient does not understand the role of non-pharmacological therapy: Pak cik Adam, 50 years old, had been diagnosed with type 2 diabetes mellitus12 years ago. He recently underwent right toe amputation due to diabetic foot ulcer. During counselling session, he admitted that he neither comply to diet restriction nor put an extra care on the wound on his toe.

5.4.12. Adherence/compliance a) Is there a problem with non-adherence to drug and non-drug therapy? b) Are there barriers to adherence or factors hindering the achievement of therapeutic efficacy? Case study Patient forgets to take the medication: A 37-year old construction worker with asthma was prescribed with budesonide/formoterol (Symbicort) turbuhaler two puffs twice daily. He works during the day and seldom remembers to carry his inhaler and use it while on the job. Patient prefers not to take medication: A 2-year-old girl with her first episode of acute otitis media was prescribed with amoxicillin/clavulanic acid (Augmentin) suspension, given as 5 ml three times daily for 10 days. The child does not like the banana flavouring and refused to take her doses.

5.4.13. Self-monitoring a) Does the patient perform appropriate self-monitoring? b) Is self-monitoring performed consistently, at appropriate times and with appropriate frequency? c) Is correct technique employed?

Case study Patient fails to perform self-monitoring: Hajar is 35-year-old woman with gestational diabetes. She was advised to perform regular self-monitoring blood glucose for fasting and 2-hour postprandial readings. Due to some reasons like forgetfulness, the fear of needle prick injection and the cost of the glucose strips, she failed to adhere to the routine self-monitoring as recommended.

REFERENCES 1. Schwinghammer, T.L. and Koehler, J.M. (2008). Pharmacotherapy Casebook: A Patient-Focused Approach (7th ed.). McGraw Hill, USA. 2. Walker, R. and Whittlesea, C. (2012). Clinical Pharmacy and Therapeutics (Fifth Edition). Elsevier Ltd. China. 3. Cipolle, R.J., Strand, L.M., Morley, P.C. (1998). Pharmaceutical Care Practice. McGraw Hill, USA.

6.0

6.1

BEDSIDE AND DISCHARGE MEDICATION COUNSELLING

OVERVIEW OF THE CHAPTER

This chapter is related to some important information about bedside and discharge medication counselling. This chapter will also describe the general principle of medication counselling and the role of pharmacist in medication counselling, especially related to the bedside and discharged medication counselling. A list of most commonly used medical devices, special dosage forms and drugs with a special instruction will be included in this chapter. In addition, the patient counselling process will be discussed in this chapter, with an example of the proses application in a case related to warfarin use. This chapter will mainly focused on the general process of conducting a medication counselling. Further reading is required for each medication, especially the ones involving medical devices, special dosage forms and special instruction related to specific medications.

6.2

LEARNING OBJECTIVES At the end of this chapter, the students should be able to:

      

Explain the definition of medication counselling Describe the process of medication counselling Identify various types of medications that needs special instruction (devices) Develop understanding regarding roles and functions of a pharmacist in providing bedside and discharge medication counselling to the patients.

6.3

GENERAL PRINCIPLES Medication counselling is an individualized process to help patient better manage the health problem. Based on the Merriam-Webster Dictionary, counselling is defined as a professional guidance of the individual by utilizing psychological methods especially in collecting case history data, using various techniques of personal interview and, and testing interest and aptitudes. In addition, counselling is skill of integrating drug information, patient information, patient assessment and therapeutic communication. The aim of a medication counselling are to increase patientsâ&#x20AC;&#x2122; knowledge on his/her health issue, especially related to the medication therapy, through exchanging information between the patient and healthcare providers. The information obtained will be used to assess the patientâ&#x20AC;&#x2122;s need to further design, select, implement and modify the health intervention. The counselling may be performed in the form of verbal or written forms on an individual basis or in groups. Pharmacists are expected to be play a role in conducting a bedside counselling for the patients who are warded. Usually, the counselling is needed when for the medicines with special dosage form or medical devices, or the ones that need special instructions to be taken. The bedside counselling is usually performed by clinical pharmacists, who had identified the patients during the ward round, or when requested by the doctors in-charge of the wards. In some cases, pharmacist are also requested by the other healthcare professionals to conduct a group counselling for the patients in the wards, even though the individualized counselling is more often needed. The discharged medications counselling however, are usually performed by the pharmacist in-charge of the counter for discharged medicines. The discharged patients will bring the prescription to the counter, and the pharmacists will identify the patients with prescriptions to be counselled.

6.4

PROCESS OF PATIENT COUNSELLING The process of patient counselling can be divided into 3 mains parts, which are the introduction, body of counselling and conclusion.

6.4.1

Introduction

1. Introduce yourself 2. Identify to whom you are speaking. 3. Ask if the patient has time to discuss the medicine. 4. Explain the purpose/importance of the counselling session. 5. Ask the patient what the physician told him/her about the drug and what condition it is treating. (Use Prime Question and Show & Tell Techniques ) 6. Prior to providing information, ask the patient if he/she has any concerns. 7. Listen carefully and respond with appropriate empathy.

6.4.2

Body of counselling

1. Tell the patient the name (generic and brand name), indication, 2. Tell the patient the indication (how it helps the patient) and the goal of therapy. 3. Inform the patient of the route of administration of the medication dosage regimen (how much, how often to take the medicine). 4. Ask the patient if he/she will have a problem taking the medication as prescribed. 5. Tailor the medication regimen to the patientâ&#x20AC;&#x2122;s daily routine (before, during or after meals? At bed time? Or at any special time?). 6. Tell the patient how long it will take for the drug to show an effect. 7. Tell the patient how long he/she might be taking the medication.

8. Tell the patient when he/she is due back for a refill (and the number of refills needed). 9. Emphasize the benefits of the medication. 10. Discuss major side effects of the drug.( common & unavoidable side-effects, and steps to overcome the side-effects ) 11. Point out that additional, rare side effects are listed in the information sheet. 12. Use written information to support counselling when appropriate. 13. Discuss precautions (e.g., activities to avoid) and beneficial activities (e.g., exercise, decreased salt intake, diet, self-monitoring). 14. Discuss drug-drug, drug-food, drug-disease interactions. 15. Discuss storage recommendations, ancillary instructions (e.g., shake well, refrigerate), expiry date. 16. Explain to the patient in precise terms what to do if he/she misses a dose.

6.4.3

Conclusion

1. Check for further understanding by asking the patient to repeat back additional key information. 2. Check for any additional concerns or questions. 3. Advise patients to always check their medicine before they leave the pharmacy. 4. Use appropriate language throughout the counselling session. 5. Maintain control of the counselling session. 6. Organize the information in an appropriate manner. 7. Follow up to determine how the patient is doing. 8. Thank the patient

6.5

MEDICATION WITH SPECIAL INSTRUCTIONS

Common medications and medication devices/ special dosage form that needs specials instruction are as below:

6.5.1

Medical devices



Insulin (pen-filled, pre-filled)



Inhalers (metered-dose inhalers (with and without aerochamber/spacer),

 Accuhaler, Handihaler, Easyhaler, Turbuhaler) 



Nasal spray

6.5.2 Special dosage forms 

Ear drop



Eye drop



Ointment



Suppositories



Pessary



Enema

    

6.5.3

Drugs needs special instruction



Warfarin



Alendronate (Fosamax)

   

68 6.6

CASE EXAMPLE

Mr Abu Lahab, a 40-years old patient who was diagnosed with atrial fibrillation had just prescribed with T. Warfarin 3mg OD in the ward. Youâ&#x20AC;&#x2122;re the pharmacist in-charge of the Warfarin Medication Therapy Adherence Clinic (MTAC). The doctor-in-charge has requested you to counsel the patient regarding the warfarin use before the patients starts to take it. How would you provide bedside counselling to the patient?

Introduction 1. Introduce yourself 2. Identify to whom you are speaking, confirm patientâ&#x20AC;&#x2122;s name 3. Ask if the patient has time to discuss the medicine. 4. Explain the purpose/importance of the counselling session. 5. Ask the patient what the physician told him/her about the drug and what condition it is treating. Use prime question for this case. 6. Prior to providing information, ask the patient if he/she has any concerns. 7. Listen carefully and respond with appropriate empath

Body of counselling 1. Tell the patient the name (generic and brand name), indication 

Warfarin : A blood thinner, also known as anti-coagulant, and it can decrease the formation of blood clots

   2. Tell the patient the indication (how it helps the patient) and the goal of therapy 

You are asked to take warfarin because you have irregular heartbeat.



Irregular heart beat increases the risk of blood clot formation. By taking warfarin, it

 should prevent you from having abnormal clotting event. 



Abnormal blood clot is dangerous, as it can travel to the other parts of your body, for example the brain and heart, and may cause stroke and heart attack.





How it works: Liver makes clotting factors to help clot the blood in the body, for example in order to stop bleeding cause by injury.





Warfarin blocks the clotting factors block by the liver.



So, it means that the clotting factors depends on Vitamin K in the body.



Taking too much Vitamin K decrease the warfarin effects, so less blood clotting.



Your initial warfarin dose should be changed based on your regular blood tests, in

   which INR value will be checked for you. 



You need to have a regular INR test. INR is the test to check whether your blood is too thin or too thick.





The targeted level for you is in the range of 2-3.



It is very important that you meet all your appointments so that the dose can be

 managed closely and the dose is suitable for you.

3. Inform the patient of the route of administration of the medication dosage regimen (how much, how often to take the medicine). 

You need to take this medicine one tablet, once daily. No matter what the dose, you must take your warfarin every day and at the same time every day, preferably at 6pm.

 4. Ask the patient if he/she will have a problem taking the medication as prescribed. 5. Tailor the medication regimen to the patient’s daily routine (before, during or after meals? At bed time? Or at any special time?). 

Warfarin can be taken before or after food.



You can take the warfarin at 6 pm, after you come back from work. Then, I suggest

 that you can take your dinner at your usual time, before or after dinner.  6. Tell the patient how long it will take for the drug to show an effect. 

Warfarin will take about 3-5 days to show its effect.

 7. Tell the patient how long he/she might be taking the medication. 

You will need to take warfarin for your whole life, as it is a long-life treatment.

 8. Tell the patient when he/she is due back for a refill (and the number of refills needed). 

Pharmacist will help you to manage your warfarin taking, so that the medicine will be effective and safe for you.





It is very important that you meet all your appointments so that the dose can be managed closely and the dose is suitable for you.





You may need to have a more frequent appointments at first.



Once your dose is determined, your scheduled will be less frequent.



9. Emphasize the benefits of the medication. 10. Discuss major side effects of the drug (common & unavoidable side-effects, and steps to overcome the side-effects) 

Possible side-effects of warfarin are bleeding problems, liver problems, allergy, low BP, swelling, paleness, fever and rash





Blood test are done to make sure the INR within the target.



Your diet is consistent, so that warfarin dose is suited with your stable diet.



Alert your doctor/pharmacist if you have any of the following signs of bleeding.



Pain, swelling or discomfort



Headache, dizziness or weakness in any part of the body



Bruises



Bleeding nose and gums



Pink or brown urine



Red or black stools



Vomiting blood or coffee ground-like substances

          11. Point out that additional, rare side effects are listed in the information sheet. 12. Use written information to support counselling when appropriate. 13. Discuss precautions (e.g., activities to avoid) and beneficial activities (e.g., exercise, decreased salt intake, diet, self-monitoring). 

It is very important to take a consistent diet.



Eat the same amount of leafy vegetables every day to maintain a consistent diet.





For the physical activity, do the same amount of mild-to-moderate intensive physical activity every day. Avoid physical activity with a high risk of injury and bleeding

 14. Discuss drug-drug, drug-food, drug-disease interactions (provide written information or diagram). 

Drug-drug interaction o

Pain killer (e.g. NSAIDS) and gastric medication (e.g. cimetidine) : increase the risk of bleeding

o 

Coenzyme 10 : increase risk of bleeding

Drug- food interaction

 o

Large amount of green leafy vegetables (high amount of vitamin K) can lower the effect of warfarin

Example of food high in Vitamin K : kale, parsley, spinach, turnip greens, broccoli, brussel sprout



Other food to avoid: cranberry juice, alcohol



Eat the same amount of leafy vegetables every day to maintain a consistent diet

  15. Discuss storage recommendations, ancillary instructions (e.g., shake well, refrigerate), expiry date. 

Keep warfarin in a safe place for example in medicine drawer, room temperature and away from children.

 16. Explain to the patient in precise terms what to do if he/she misses a dose. 

If you miss a dose: take the dose as soon as you remember it within the same day. Don’t double the dose to make up for the missed dose.

Conclusion 1. Check for further understanding by asking the patient to repeat back additional key information. 2. Check for any additional concerns or questions. 3. Advise patients to always check their medicine before they leave the pharmacy. 4. Use appropriate language throughout the counselling session. Use appropriate tone, gesture and eye contact 5. Maintain control of the counselling session. 6. Organize the information in an appropriate manner. 7. Follow up to determine how the patient is doing. 8. Thank the patient.

REFERENCES 1. Bruce A. Berger, Bill G. Felkey. Professional Communication I (Pcs 471) Syllabus, A Handbook for Teaching Courses in Pharmacy Communications. 1194. American Association of Colleges of Pharmacy 2. "Counseling." Merriam-Webster.com.2017. https://www.merriam-webster.com (9 September 2017).

3. Jaffer A & Bragg L. Practical tips for warfarin dosing and monitoring. Cleveland Clinic Journal of Medicine. 2003; 70(4):361-37

Case Notes For PWDT

PHARMACIST WORKUP OF DRUG THERAPY IN PHARMACEUTICAL CARE

Date

: 18.11.2017 to 23.11.2017

Case

: Deep Vein Thrombosis

Ward

: C5

Bed No

Reg. No

: 1243369

Student

: KK

PROBLEM ORIENTED PHARMACIST RECORD Clinical Pharmacy Program School of Pharmaceutical Sciences Universiti Sains Malaysia

75 PHARMACIST’S PATIENT DATABASE

1 A.

Patient Description Name : MAPV Reg. No. : 1243369 Admission : 18.11.2017 @ 7.01pm Race : India

Age Gender Weight Height

: 78 years old : Female : 54kg : 160cm (BMI: 21.1)

Chief Complaint (CC)  Right foot, leg and thigh swelling

History of Present Illness (HPI)  Right foot and leg swelling x 4/7 ago, then right thigh swelling x 2/7 ago  Previously able to ambulate with support  Unable to ambulate at all since last 3 days  Tender upon applying pressure (most pain over right thigh region)



 

  

 D.

 No ulcer and no bleeding Recent fall x 3/52 ago Patient is not bed bound No fever, N&V, diarrhoea, abdominal pain, haematuria

Past Medical History (PMHx) / Past Surgical History  Type 2 Diabetes Mellitus (since 1997 – diagnosed 20 years ago)  Closed Left IT (Intertrochanteric) fracture  Done PFN (proximal femoral nail) of left femur  Under Hospital Pulau Pinang ortho follow up

  

 

 

Cataract surgery at left and right eyes (in 2009) Hysterectomy (in 2007)

Family History / Social History  Strong family history of DM, HPT , Heart Disease  ADL partially dependent  Married with 5 children  Staying with son and family  Worked at factory previously (retired 20 years ago)

Medication History Interview



1. PRESCRIBED MEDICATION - What medicines are you having at the moment? a) Record here what the patient says, noting any anomalies with their current prescription: 



Nil

b) Other drugs prescribed previously (with dates if possible): What have you had in the past?

   

Last review of medication:  Tab. Metformin 500mg BD  Tab. Calcium Carbonate 500mg OD  Tab. Mecobalamin (Vitamin B12) 500mcg TDS  Tab. Calcitriol 0.25mcg BD

2. NON-PRESCRIBED MEDICATION - Do you take anything that you buy from a shop without a prescription – chemist, health food store, supermarket? a) Currently being used: Nil b) used previously (with dates if possible): Nil 3. SOCIAL DRUGS - Ask what and how much/many per week? a) Smoking: Nil b) Alcohol: Nil c) Illicit drugs: Nil 4. RESPONSE TO DRUG THERAPY a) Do you think your current medication is benefiting you? If yes, how? Yes, by helping to control the diabetes and the bone. If no, why? Nil b) Do you think your previous medication benefited you? If yes, which ones and how? Nil If no, why? Nil 5. Do any of the things you buy without a prescription help you? If yes, how and which ones? Nil

77 6. What have you been told about your medicines and by whom? Pharmacist in government (Hospital pharmacy) 7. SIDE-EFFECTS a) Are you suffering any side effects now? If yes, what side effects? Non significant b) Which of your medicines do you think is causing the problems? Nil c) Have you suffered any side effects with previous drug treatments? Nil 8. COMPLIANCE- Medication Compliance Assessment a) How do you remember to take your medication? Patientâ&#x20AC;&#x2122;s son claimed that patient was compliant to medication - served by him every day and always bring the medication when away from home b) What do you do when you miss a dose? Serve the medications when the son remembers Patientâ&#x20AC;&#x2122;s son will skip giving the dose to his mother when it is near to the next dose 9. What medicines would you usually take for: a) A headache: Paracetamol b) Aches/pains and flu: Nil 10. Allergies? Drug: NKDA Food: NKFA 11. ANY OTHER PROBLEMS WITH DRUG THERAPY? Nil

12. COMMENTS Patient has high adherence to the medications as the medication is served by her son. It is important to encourage him to continue serving the medications to his mother as always. 13. RECOMMENDATIONS Suggest to re-emphasize counselling points for this patient regarding: -

Importance of adherence to medication

78 -

Indication and long term benefit of each medication Disease progression (if uncontrolled) or the consequences of non-adherence

G.Risk Assessment/Preventive Measures/Quality of Life From The Framingham Heart Study

Enter Values Here

General CVD Risk Prediction Risk Factor

Units male (m) or female (f) years mmHg yes (y) or no (n) yes (y) or no (n) yes (y) or no (n) mg/dL mg/dL

Sex Age Systolic Blood Pressure Treatment for Hypertension Smoking Diabetes HDL Total Cholesterol Your 10-Year Risk

f 78 124.0 n n y 30.9 193.35 28.8%

(The risk score shown is derived on the basis of an equation. Other print products, use a point-based system to calculate a risk score that approximates the equation-based one.)

>85 Your Heart/Vascular Age

YOUR RISK

OPTIMAL NORMAL

0.0%

5.0%

10.0%

15.0%

20.0%

25.0%

30.0%

35.0%

Calculator prepared by R.B. Dâ&#x20AC;&#x2122;Agostino and M.J. Pencina based on a publication by Dâ&#x20AC;&#x2122;Agostino et al. in Circulation

Patient has high risk (>20% CHD risk at 10 years)

79 H.

Review of Symptom (ROS) on admission

System General status

Assessment Alert, conscious

BP (mmHg)

124/76

PR (bpm)

Vital RR (/min) Signs Temp. (Â°C)

21 (not tachypnoeic) 37 (not septic looking)

SPO2 (%)

99% under RA

Pain score

0/10

CVS Chest/Lung Abdomen Renal/ Uro (KUT)

S1S2 DRNM Clear Soft, tender over right hypochondriac region Non significant

Skin/ Muscle

Right LL swelling (swollen, tender - up to thigh region - tenderness, more over thigh region - no erythematous, no ulcer - posterior tibial pulse felt X ray Right femur: no fracture seen

Hematology

Non significant

Neuro/ Mental

Non significant

Sugar profile (mmol/L) Impression:

Plan:

Reflo: 6.3 Likely Right Lower Limb Deep Vein Thrombosis 1. For USG Doppler Right LL cm 2. KIV for anticoagulant after review USG Doppler 3. To start a. S/C Enoxaparin 60mg STAT and BD b. Cap. Tramadol 50mg PRN 4. Reflo qid

80 I. LABORATORY DATA BLOOD CHEMISTRY Na+ K+ BUN Creatinine CrCl HEMATOLOGY Hct HgB WBC RBC PLT LIVER FT Total Protein Albumin COAGULATION PROFILE PT INR APPT D-dimer LIPID T.Chol C-TG C-HDL C-LDL

NORMAL 135-145 mmol/L 3.5-5.0 mmol/L 1.7-8.3 mmol/L 57-130 mmol/L 75-125 ml/min

18.11.17 136 4.2 6.4 83 36

36- 46 I 12-16g/dl 4.5-11 x109/L 4.7-6.1 x 1012/L 130-400 x103/ml

34.2 11.0 10.8 3.9 189

66-87g/L 38-51g/L

64 24

NORMAL 10.7-13.7 sec 0.9 – 1.2 27.6 – 38.8 sec <0.2 ng/mL

18.11.17 11.4 1.1 29.7 >0.20

< 3.6 mmol/L < 1.7 mmol/L > 1 mmol/L < 1.8 mmol/L

5 1.8 0.8 3

MICROBIOLOGY TESTS (Culture & Sensitivity) Source Date (Sampling) Date (Result) Blood Sputum Urine Rectal (stool)

19.11.17

20.11.17

21.11.17

22.11.17 140 3.2 2.8 61 49

23.11.17

19.11.17

20.11.17

21.11.17

22.11.17

23.11.17

Results Nil Nil Nil Nil

Sensitive to

Resistant to

81 Ultrasound Doppler right lower limb (19/11/2017)  The right common femoral, superficial femoral and popliteal veins are dilated and show no flow on colour Doppler and are non-compressible. Impression: Features are suggestive of right lower limb DVT NCCT Brain (21/11/2017)  Hypodensities in left thalamus and right corona radiate in keeping with infarcts.  No midline shift.  Prominent ventricles, basal cisterns & sulci in keeping with cerebral atrophy.  No obvious skull vault fracture. Impression: No intracranial haemorrhage. Comments:  Haematocrit is the measure of the fraction or percentage of red blood cells in whole blood. Haemoglobin is the main transport of oxygen and carbon dioxide in the blood. It consists of globin (a protein) and haem, which contains iron atoms and the red pigment porphyrin. Red blood cells (erythrocytes) carry oxygen to the tissues and to transfer carbon dioxide to the lungs. When haemoglobin is used in conjunction with the haematocrit value, low level of haematocrit, haemoglobin and red blood cells can be an indicator of anemia andhaemolysis,

 





which can be caused by haemorrhage due to trauma (Patient is presented with laceration wound with right scalp hematoma 2 o to alleged fall). Low level of albumin and protein showed that the patient is in malnutrition state. Dose and frequency of protein-bound drugs need to be adjusted accordingly. D-dimer levels are tested to help diagnose, exclude or monitor thrombotic or bleeding conditions, such as deep vein thrombosis (DVT) or pulmonary embolus. It is usually undetectable in the blood. However, in this case, D-dimer levels are raised and hence it is possibly DVT. Treatment with heparins and oral anticoagulants can lower D-dimer levels. Low level of HDL and high level of Total cholesterol, LDL and TG indicate patient has very high risk of ASCVD.

82 J.

Diagnoses/Provisional Dx/Acute/Chronic Medical Problems

[1] Provoked DVT 2o to immobilisation 2o to closed left IT fracture [2] Laceration wound with right scalp hematoma 2o to alleged fall [3] Type 2 Diabetes Mellitus K.

Drug treatment in the ward MEDICATION RECORD

Drug Name/Route

Duration

Dose/Frequency

Indication/Safety/Efficacy

Start-Stop Dates

S/C Enoxaparin

60mg BD

18.11- 23.11.2017 (off)

Cap. Tramadol Tab. Metformin

50mg PRN 500mg BD

18.11- 23.11.2017 (D) 19.11- 20.11.2017 (off)

Tab. Mecobalamin (Vitamin B12) Tab. Calcium Carbonate

500mcg TDS

19.11- 23.11.2017 (D)

500mg OD

19.11- 23.11.2017 (D)

Cap. Calcitriol

0.25mcg BD

19.11- 23.11.2017 (D)

Flavin dressing over right scalp laceration wound Tab. Simvastatin

1 app TDS

19.11- 23.11.2017 (off)

20mg ON

20.11- 23.11.2017 (D)

Tab. Potassium Chloride CR Tab. Metformin

1.2g TDS x 3/7

22.11- 23.11.2017 (D)

500mg BD

23.11.2017 (D)

Tab. Dabigatran

110mg BD x 3 months 1/1 PRN

23.11.2017 (D)

LA Aqueous Cream

23.11.2017 (D)

Deep Vein Thrombosis (DVT) Acute pain due to DVT Type 2 Diabetes Mellitus Neuropathy 2o Type 2 Diabetes Mellitus Prevention of Osteopenia Prevention of Osteopenia Laceration wound 2o to alleged fall Primary prevention of ASCVD Hypokalaemia Type 2 Diabetes Mellitus DVT Emollient for skin

BLOOD PRODUCT TRANSFUSIONS Product Date

Whole blood NIL

Packed cells

Platelet concentrate

Cryopredicitate

Fresh frozen plasma

Cyrosupermatant

83 L. Date

Daily Progression Progression

19.11.17

 BP: 118/69mmHg; PR: 95bpm; RR: 20/min; Temp: 37oC; Pain score: 0/10  SPO2: 97% under RA  Reflo: 9.4/9.8/8.6/6.7  Currently afebrile, alert, and conscious  Still having weakness and pain over right lower limb o Pain Score: 4/10  Also had poor appetite and LOW  Hematoma with laceration

20.11.17

 BP: 145/86mmHg; PR: 91bpm; RR: 20/min; Temp: 37°C  SPO2: 95% under RA  Reflo: 9.6/10.0/8.8/7.3  USG Doppler: o Impression: Suggestive of Right LL DVT  Still having pain over right lower limb o Pain score: 3/10  Otherwise afebrile, no vomiting or chest pain and tolerating orally  BP: 121/73mmHg; PR: 100bpm; RR: 18/min; Temp: 37°C  SPO2: 95% under RA  Reflo: 9.4/9.8/6.4/6.0  Currently comfortable under RA  Still C/O pain over right lower limb but in reducing trend o Pain score: 2/10  Spoken to son regarding warfarin vs NOAC, indication, risk factors and complications o Son is keen to buy NOAC o Suggestion: Tab. Dabigatran 110mg  Disorientated o Occasionally speak irrelevantly  Still have hematoma with laceration o No active bleeding after compression

21.11.17

Plan If  USC Doppler suggestive of DVT, to start Tab. Warfarin 5/5/3mg Start  Flavin dressing over o right scalp of lower limb Restart  Tab. Metformin o 500mg BD Tab. Mecobalamin o (Vitamin B12) 500mcg TDS Tab. Calcium o Carbonate 500mg OD Cap. Calcitriol o 0.25mcg BD Continue other medications  Reflo qid  Withhold Metformin  o If to do CT Brain Start  o Tab. Simvastatin 20mg ON Continue other medications  To  counsel family regarding warfarin/NOAC Reflo qid  Supervise feeding  For  family members to buy suggested NOAC (Tab. Dabigatran 110mg) Continue  all other medications Reflo qid  Supervise feeding and  encourage orally To  do CT brain with bone window (TRO ICB)

84 22.11.17

 BP: 131/63mmHg; PR: 66bpm; RR: 20/min; Temp: 37°C  SPO2: 95% under RA  Reflo: 9.0/9.7/8.2/6.1  Currently comfortable under RA  Right lower limb o Swelling reduced o Pain reduced (Pain score: 1/10)



    

23.11.17

 BP: 138/78mmHg; PR: 78bpm; RR: 20/min; Temp: 37°C; Pain Score: 0/10  SPO2: 99% under RA  Reflo: 8.4/9.6/7.7/6.4  Currently no chest pain/SOB, vomitting  Tolerating orally  Alert, answer in full sentences  Right lower limb o Swelling reduced o Pain reduced  Right scalp hematoma reduced in size  CT Brain (22.11.17) o No ICB



  

Start o Tab. Potassium Chloride CR 1.2g TDS x 3/7 Continue all other medications Family members to bring and buy the Tab. Dabigatran to hospital Reflo qid Supervise feeding and encourage orally Trace formal report of the CT brain Continue all other medications o Family members bring Tab. Dabigatran to hospital o Counselling by doctors and pharmacists Encourage orally Allow discharge TCA at MFUC x 6/52 with FB, RP, Alb, FLP, FBS o Review right DVT and bleeding tendency

Drug therapy assessment/Identifying drug related problems QUESTION DRUG RELATED PROBLEM 1) Correlation Between Drug Therapy & Medical Problem

2) Appropriate Therapy

ANSWER (ď&#x192;&#x2013;)

COMMENTS

Any drugs without a medical indication? Any unidentified medication?

YES

Any untreated medical conditions?

YES

Do they require drug therapy?

YES

Comparative efficacy of chosen medication(s)? Relative safety of chosen medication(s) Do they require any lab test? To confirm drug use safety or side effect Is medication on formulary? Is non-drug therapy appropriately used (eg. diet & exercise) Is therapy achieving desired goals or outcomes?

YES

? ?

All in formulary.

NO NO

Not yet.

YES

YES YES YES

Primary prevention of ASCVD in diabetic patient. Refer DRP 2 Statin should be given for the primary prevention of ASCVD in patient with diabetes. Refer DRP 2

3) Drug Regimen

4) Therapeutic Duplication/ Polypharmacy 5) Adverse Drug Reaction

6) Interactions: Drug-Drug, Drug-Disease, Drug-Food, Drug-Herbal

Is therapy tailored to this patient? Are dose and dosing regimen appropriate and/or within usual therapeutic range and/or modified for patient factor? Appropriateness of PRN medications? Is route, dosage form, mode of administration appropriate, length or course of therapy considering efficacy, safety, convenience, patient limitation, length or course of therapy and cost? Any therapeutic duplication?

YES YES

? ?

NO NO

YES

Are symptoms or medical problem drug induced? What is the likelihood the problem is drug related? Any drug-drug interaction with clinical significance? Any relative contraindications given patient characteristics and current/past disease state? Any food interactions with clinical significance? Any drug-lab test interactions with clinical significance?

YES

Inappropriate dose and duration of anticoagulation in provoked DVT. Refer DRP 1

7) Drug allergy or intolerance

8) Risk and Quality of Life Impact

9) Social or Recreational Drug Use (Drug Abuse)

10) Financial Impact

11) Patient Knowledge of Therapy

Allergy or intolerance to any medication currently being taken? Is patient using a method to alert health care provider of the allergy/intolerance? Is patient at risk for complications with an existing disease state?

YES

Is patient on track for preventive measures (immunizations, mammograms)

YES

Is therapy adversely impacting patientâ&#x20AC;&#x2122;s quality of life? How so? Is current use of social drug problematic? Are symptoms related to sudden withdrawal or discontinuation of social drugs? Is therapy cost-effective? Does cost of therapy represent a financial hardship for the patient? Does patient understand the role of their medication, how to take it and potential side effect?

YES

? ?

NO NO

YES

YES YES

YES

Patient has Type 2 Diabetes mellitus; hence she is at high risk of developing macrovascular (cardio) and microvascular (opthal, neuro, nephro) complications. No immunization is given for this patient to reduce incidence of vaccine preventable diseases. Refer DRP 3

We should re-emphasize in educating her family members regarding the indication and long term benefit of each medication.

12) Adherence/Compliance

13) Self-Monitoring

Would patient benefit from education tools? Does the patient understand the role of non-drug therapy?

YES

Is there a problem with nonadherence to drug and non-drug therapy? Are there barriers to adherence or factors hindering the achievement of therapeutic efficacy? Does the patient perform appropriate self-monitoring?

YES

Is correct technique employed? Is self-monitoring performed consistently, at appropriate times and with appropriate frequency?

YES

YES YES

? ?

YES

/ /

NO NO

We should educate patient to follow a diet low in saturated fat. We should also promote low glycemic index (GI) food for this patient.

Patientâ&#x20AC;&#x2122;s family members do not perform self-blood glucose monitoring on her as they do not have the blood glucose meter at home. N/A N/A

DRUG THERAPY PROBLEM LIST (DTPL)

No 1

Date DRP (medication related) 23.11.17 Inappropriate duration of anticoagulant in elderly patient with DVT

Goals of therapy To reduce the recurrence and complications of DVT

No 2

Date DRP (medication related) 20.11.17 Omission of statin therapy in patient with diabetes

Goals of therapy To achieve blood lipid target and prevent incidence of ASCVD event

No 3

Date DRP (medication related) 23.11.17 Inappropriate preventive measures ie. lack of vaccination for patient with diabetes

Goals of therapy To reduce incidence of vaccine preventable diseases (influenza, pneumococcal diseases, tetanus, diphteria, pertussis, and Hepatitis B)

1. DRP: Goals of therapy: Issue:

Literature Review:

23.11.2017 Inappropriate dose and duration of anticoagulant in elderly patient with DVT To reduce the recurrence and complications of DVT This patient is newly diagnosed with DVT and her family members agreed to purchase Tab. Dabigatran from community pharmacy instead of getting warfarin in government hospital. However, she was prescribed with lower dose of dabigatran (110mg) for 6 months, which is inappropriate for the provoked DVT with known cause. Rapid therapeutic anticoagulation is necessary in patients with acute DVT to prevent thrombus extension, cardiovascular and hemodynamic collapse, and ultimately mortality. According to the 2016 European Society of Cardiology (ESC) Guidelines: Diagnosis and management of acute deep vein thrombosis, 2016 Chest Guideline and Expert Panel Report and 2012 American College of Chest Physicians (ACCP) Antithrombotic therapy for VTE disease: Antithrombotic Therapy and Prevention of Thrombosis, acute-phase treatment consists of parenteral anticoagulation LWMH heparin (in this case, enoxaparin is used) for the first 5 – 10 days, which should overlap warfarin until INR is 2 – 3.1,2,3 Alternatively, parenteral anticoagulation can be followed by NOAC, for example dabigatran or edoxaban. In this case, warfarin is not the most appropriate option for this patient because her family members described difficulty in traveling to the clinic for PT/INR determinations, which precludes this patient’s ability to undertake this therapy safely. Hence, dabigatran is selected and it is an appropriate choice for this patient as it does not need dose titration as per warfarin. In the RE-COVER trial, the direct thrombin inhibitor dabigatran was

90 compared with warfarin for the treatment of VTE.4 The primary outcome was the 6month incidence of recurrent, symptomatic, objectively confirmed VTE. Overall, 2539 patients were enrolled and parenteral anticoagulation was administered for a mean of 10 days in both groups. With regard to the efficacy endpoint, dabigatran was noninferior to warfarin (HR 1.10; 95% CI 0.65 – 1.84).4 No significant differences were observed with regard to major bleeding episodes, but there were fewer episodes of any bleeding with dabigatran (HR 0.71; 95% CI 0.59 – 0.85). Its twin study, RE-COVER II, enrolled 2589 patients and confirmed these results (primary efficacy outcome: HR 1.08; 95% CI 0.64 – 1.80; major bleeding: HR 0.69; 95% CI 0.36 – 1.32).5 Goldhaber SZ et al conducted a pooled analysis of both RE-COVER I and RE-COVER II trial dabigatran 150mg BD after standard parenteral therapy for a mean of 10 days and it gave hazard ratios for recurrent VTE of 1.09 (95% CI, 0.76 – 1.57), for major bleeding of 0.73 (95% CI, 0.48 – 1.11), and for any bleeding of 0.70 (95% CI, 0.61 – 0.79).6 These results showed that dabigatran has similar effects on VTE recurrence and a lower risk of bleeding compared with warfarin for the treatment of acute VTE. Hence, it is appropriate to use Tab. Dabigatran for the treatment of DVT in this patient. Patient has mild renal impairment (CrCl > 30 mL/min, but < 50mL/min), hence based on 2016 European Society of Cardiology (ESC) Guidelines: Diagnosis and management of acute deep vein thrombosis, she still can use the full dose of dabigatran, which is 150mg BD instead of 110mg BD. In addition, dabigatran is not metabolized through the CYP enzyme system and is not expected to have a drug interaction with any strong CYP inducer/inhibitors, which is good for the elderly patient.7 This patient is prescribed for 6 months use of dabigatran. According to both 2016 European Society of Cardiology (ESC) Guidelines: Diagnosis and management of acute deep vein thrombosis and 2016 Chest Guideline and Expert Panel Report, they recommended 3 months of anticoagulation therapy for patient with provoked DVT (with known causes, in this case closed left IT fracture).1,2 This is supported by a few evidences. In a 2011 meta-analysis of seven randomized trials with 2925 men or women with a first VT who did not have cancer and received different durations of anticoagulant treatment conducted by Boutitite F et al, it is found that VTE recurrence was similar if treatment was stopped at three months, compared with six months or later (RR 1.19, 95% CI 0.86 – 1.65).8 However, recurrence was higher if anticoagulation was stopped at 1 – 1.5 months compared with at 3 months or later (HR 1.52; 95% CI 1.14 – 2.02).8 In addition, according to a 2012 meta-analysis of five trials conducted by Kearon C et al, 6 or 12 months of therapy did not lower the risk of recurrence in patients with acute provoked VTE as compared with 3 months of therapy (RR 0.89, 95% CI 0.69 – 1.14), but did increase the risk of bleeding by approximately 2.5-fold.1,9 Therefore, it is safe to prescribe 3 months of Tab. Dabigatran to this elderly patient for provoked DVT.

91 Recently, Hospital Pulau Pinang obtained Idarucizumab (Praxbind) for the use of dabigatran reversal for life-threatening and uncontrolled bleeding.10 This agent is a humanized monoclonal antibody fragment with >350-fold preferential binding to dabigatran compared to thrombin. Once idarucizumab is bounded to dabigatran’s active site, dabigatran binding to thrombin is inhibited without triggering thrombin-induced coagulation. Interim results from RE-VERSE AD, a phase III study that enrolled 90 patients on dabigatran with uncontrolled or life-threatening bleeding requiring emergency procedures, demonstrate reversal of anticoagulant effect with idarucizumab.10 It is now comparable to warfarin in terms of availability of reversal agent. Pharmacists play an important role in ensuring the adherence of taking Dabigatran as prescribed. This is illustrated in a study conducted by Shore S et al, where there was variation in anticoagulation management strategies used, with some Veterans Health Administration sites using pharmacists and others deferring management solely to clinicians.11 Appropriate patient selection (RR 1.14; 95% CI, 1.05 – 1.25) and provision of pharmacist-led monitoring (RR 1.25; 95% CI, 1.11 – 1.41) were associated with better patient adherence of Dabigatran.11 Besides, adherence was improved by longer duration of monitoring and provision of more intensive care to nonadherent patients in collaboration with the pharmacist and clinician. Recommendation: Suggest to increase the dose from Tab. Dabigatran 110mg BD to Tab. Dabigatran 150mg BD Suggest to reduce the duration from 6 months to 3 months Monitoring: Efficacy:  Thrombin inhibitor to prevent and reduce the recurrence of DVT  D-dimer (aim for D-dimer <0.20 ng/mL) Safety:  Side effect of Dabigatran (aim for No adverse effects)  o Symptoms of bleeding: Bruises, gum, nose bleed, haemoptysis, haematuria, melena, red or black, tarry stools  o Symptoms of renal failure: Excessive or rapid weight gain, oedema, dehydration, nausea & vomiting, pruritus  o Gastrointestinal adverse reaction: dyspepsia, burning or nausea, abdominal pain or discomfort, epigastric discomfort, GERD   Complications of DVT o Further clot extension, recurrence, embolization, post-thrombotic (post-phlebitic) syndrome, chronic thromboembolic pulmonary hypertension, thrombocytopenia, thrombosis-related death  Renal function  Complete blood count  Presence of drug interactions (P-gp inhibitors)

92 References:

1. Mazzolai L, Aboyans V, Ageno W, Agnelli G, Alatri A, Bauersachs R, et al. Diagnosis and management of acute deep vein thrombosis: a joint consensus document from the European society of cardiology working groups of aorta and peripheral vascular diseases and pulmonary circulation and right ventricular function. European Heart Journal. 2017:ehx003-ehx. https://doi.org/10.1093/eurheartj/ehx003 2. Kearon C, Akl EA, Ornelas J, et al.; Antithrombotic Therapy for VTE Disease: CHEST Guideline and Expert Panel Report. Chest. 2016 Feb;149(2):315-352 3. Kearon C, Akl EA, Comerota AJ, et al.; American College of Chest Physicians (ACCP) Antithrombotic therapy for VTE disease: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians EvidenceBased Clincial Practice Guidelines. Chest. 2012;141:e419S-94S 4. Schulman S, Kearon C, Kakkar AK, Mismetti P, Schellong S, Eriksson H, Baanstra D, Schnee J, Goldhaber SZ, RE-COVER Study Group; Dabigatran versus warfarin in the treatment of acute venous thromboembolism. N Engl J Med. 2009;361(24):2342. 5. Schulman S, Kakkar AK, Goldhaber SZ, Schellong S, Eriksson H, Mismetti P, Christiansen AV, Friedman J, Le Maulf F, Peter N, Kearon C, RE-COVER II Trial Investigators; Treatment of acute venous thromboembolism with dabigatran or warfarin and pooled analysis. Circulation. 2014;129(7):764 6. Goldhaber SZ, Schellong S, Kakkar A, Eriksson H, Feuring M, Kreuzer J, Fraessdorf M, Schulman S; Treatment of acute pulmonary embolism with dabigatran versus warfarin. A pooled analysis of data from RE-COVER and RE-COVER II. Thromb Haemost. 2016 Sep;116(4):714-21 7. Nutescu E, Chuatrisorn I, Hellenbart E. Drug and dietary interactions of warfarin and novel oral anticoagulants: an update. J Thromb Thrombolysis 2011;31:326-43 8. Boutitie F, Pinede L, Schulman S, Agnelli G, Raskob G, Julian J, Hirsh J, Kearon C; Influence of preceding length of anticoagulant treatment and initial presentation of venous thromboembolism on risk of recurrence after stopping treatment: analysis of individual participants' data from seven trials. BMJ. 2011;342:d3036 9. Kearon C, Akl EA. Duration of anticoagulant therapy for deep vein thrombosis and pulmonary embolism. Blood. 2014 Mar 20;123(12):1794-801. 10. Pollack CV Jr, Reilly PA, Eikelboom J, et al. Idarucizumab fordabigatran reversal. N Engl J Med. 2015;373:511-20. 11. Shore S, Ho M, Lambert-Kerzner A, et al. Site-level variation in and practices associated with dabigatran adherence.JAMA 2015;313:1443-50.

2. DRP: Goals of therapy: Issue:

20.11.2017 Omission of statin therapy in patient with diabetes To achieve blood lipid target and prevent incidence of ASCVD event Patient has Type 2 Diabetes Mellitus. However, she is not given statin therapy as part of the management of primary prevention of ASCVD.

93 According to the population-based prospective cohort analysis done by Rana JS et al, the risk of future coronary heart disease (CHD) for patients with diabetes of long duration (>10 years) was similar to the patients with a history of CHD. 12 As this patient has 20 years of diabetes, she has the equivalent risk factors of developing CHD and has to be treated with statin. The need of statin in diabetic patient also supported by the prospective metaanalysis by Kearney PM et al. It is conducted based on data from 17220 individuals with Type 2 diabetes mellitus in the context of a further 71370 without diabetes in 14 randomised trials of statin therapy.13 Weighted estimates were obtained of effects on clinical outcomes per 1 mmol/L reduction in LDL-C (low density lipoprotein cholesterol). During a mean follow-up of 4.3 years, there was a significant 21% proportional reduction in major vascular events per 1 mmol/L reduction in LDL-C in diabetic patients (RR 0.79, 95% CI 0.72 – 0.86; p < 0.0001), which was similar to the effect observed in those without diabetes (RR 0.79, 95% CI 0.76 – 0.82; p < 0.0001).13 In diabetic participants, there were reductions in myocardial infarction or coronary death (RR 0.78, 95% CI 0.69 – 0.87; p < 0.0001), coronary revascularisation (RR 0.75, 95% CI 0.64 – 0.88; p < 0.0001), and stroke (RR 0.79, 0.67 – 0.93; p = 0.0002). Among diabetic patients, the proportional effects of statin therapy were similar irrespective of whether there was a prior history of vascular disease and irrespective of other baseline characteristics. After 5 years, 42 (95% CI 30 – 55) fewer people with diabetes had major Literature Review:

vascular events per 1000 allocated statin therapy.13

Based on Malaysia CPG Management of Type 2 Diabetes Mellitus 2016 and Malaysia CPG Management of Dyslipidemia 2017, as she has diabetes with major risk such as dyslipidemia, she is categorised to be ‘very high CV risk’. Therefore, this patient’s target of LDL-C levels would be <1.8 mmol/L.1,14 This is in concordance with the Part 1 of National Lipid Association and American Association of Clinical Endocrinologists/American College of Endocrinology 2017 guidelines recommendations, where this patient would be considered very high risk because she has diabetes with two major ASCVD risk factor (Female > 55yo and low HDL).3,15,16 Hence, as mentioned before, her LDL goal should be less than 1.8 mmol/L and non-HDL goal should be 0.8 mmol/L higher (<2.6 mmol/L). 2017 American Diabetes Association Standards of Medical Care in Diabetes recommended lifestyle modification focusing on weight loss (if indicated); the reduction of saturated fat, trans fat, and cholesterol intake; increase of dietary ω-3 fatty acids, viscous fiber, and plant stanols/sterols intake; and increased physical activity should be recommended to improve the lipid profile in patients with diabetes on top of statin therapy. (Grade A)17 This is tallied with both American Association of Clinical Endocrinologists/American College of Endocrinology 2017 guidelines and Malaysia CPG Management of Dyslipidemia 2017.

94 2017 American Diabetes Association Standards of Medical Care in Diabetes (Diagram 1) also recommended that for patients with diabetes aged >75 years with atherosclerotic cardiovascular disease (ASCVD) risk factors (LDL cholesterol >2.6 mmol/L and family history of premature ASCVD), high or moderate-intensity statin therapy and lifestyle therapy can be considered. (Grade B)17 Hence, it is recommended to prescribe moderate-intensity statin to this patient in addition to lifestyle therapy due to higher risk of intolerance and adverse effects of statin in older patient. A recent systematic review of the U.S. Food and Drug Administration’s postmarketing surveillance databases, randomized controlled trials, and cohort, case-control, and cross-sectional studies evaluating cognition in patients receiving statins found that published data do not reveal an adverse effect of statins on cognition. Therefore, a concern that statins might cause cognitive dysfunction or dementia should not deter their use in individuals with diabetes.18

*In addition to lifestyle therapy ASCVD risk factors include LDL cholesterol ≥100 mg/dL (2.6 mmol/L), high blood pressure, smoking, chronic kidney disease, albuminuria, and family history of premature ASCVD.

Diagram 1 The moderate-intensity statin (lowers LDL-C by 30 – 50%) consists of both Tab. Atorvastatin 10 – 20 mg and Tab. Simvastatin 20 – 40mg. Due to the Ministry of Health and local hospital prescribing policy, the available and most reasonable statin for this patient will be Tab. Simvastatin 20mg ON. Recommendation: Suggest to prescribe Tab. Simvastatin 20mg ON for this patient. Efficacy:  Fasting Lipid Profile (LDL level is expected to decrease approximately 30 – 50% from baseline)   Presence of ASCVD event (aim for No ASCVD event) Safety: (aim for No adverse effects) Monitoring:  Side effects of simvastatin o Muscle symptoms (myalgia, stiffness etc.) o Hepatotoxicity symptoms (unusual fatigue or weakness, loss of appetite, abdominal pain, dark-coloured urine etc.)

References:

3. DRP: Goals of therapy:

Issue:

 Baseline liver function test and creatine kinase o For reference in case muscle symptoms develop o If ALT/AST is 1 – 3 X ULN during statin therapy, there is no need to discontinue the statin o If ALT/AST exceeds 3 X ULN during statin therapy, follow the patient and repeat the measure. There is no need to discontinue the statin (unless it is symptomatic) o If CK level is more than 5 X ULN on 2 occasions, the drug should be discontinued. 1. Clinical Practice Guidelines: Management of Type 2 Diabetes Mellitus 5th ed. Ministry of Health, Malaysia; 2016 3. Garber AJ, Abrahamson MJ, Barzilay JI, et al.; Consensus Statement by The American Association of Clinical Endocrinologists and American College of Endocrinology on the Comprehensive Type 2 Diabetes Management Algorithm – 2017 Executive Summary. Endocr Pract 2017;23(2):207-238 12. Rana JS, Liu JY, Moffet HH, Jaffe M, Karter AJ. Diabetes and Prior Coronary Heart Disease are Not Necessarily Risk Equivalent for Future Coronary Heart Disease Events. J Gen Intern Med. 2016;31:387–393. 13. Kearney PM, Blackwell L, Collins R, et al; Cholesterol Treatment Trialists’ (CTT) Collaborators. Efficacy of cholesterol-lowering therapy in 18,686 people with diabetes in 14 randomised trials of statins: a meta-analysis. Lancet 2008;371:117–125 14. Clinical Practice Guidelines: Management of Dyslipidemia 5th ed. Ministry of Health, Malaysia; 2017 15. Jacobson TA, Ito MK, Maki KC, et al. National Lipid Association recommendations for patient-centered management of dyslipidemia: part 1 - full report. J Clin Lipidol 2015;9:129-69. 16. Grundy SM, Cleeman JI, Merz CN, et al. Implications of recent clinical trials for the National Cholesterol Education Program Adult Treatment Panel III guidelines. Circulation 2004;110:227-39. 17. American Diabetes Association Standards of Medical Care in Diabetes. Cardiovascular disease and risk management. Diabetes Care 2017; 40 (Suppl. 1): S75S87 18. Richardson K, Schoen M, French B, et al. Statins and cognitive function: a systematic review. Ann Intern Med 2013;159:688–697

23.11.2017 Inappropriate preventive measures ie lack of vaccination for patient with diabetes To reduce incidence of vaccine preventable diseases (influenza, pneumococcal diseases, tetanus, diphteria, pertussis, and Hepatitis B) Patient is a diabetic patient with recent admission due to DVT. She is definitely more susceptible to be infected with vaccine preventable diseases compared to the healthy adults. Hence, it is appropriate for this patient to be injected with influenza, pneumococcal, Tdap and Hepatitis B vaccines.

96 Literature Review:

Diabetic patients are at higher risk for the pneumococcal infection and nosocomial bacteremia, with a mortality rate as high as 50% compared with non-diabetic patients.19 Hence, according to CDC ACIP Recommended Immunization Schedule for Adults Aged 19 years and older 2017 and American Diabetes Association Standards of Medical Care in Diabetes 2017, elderly patients with diabetes (this patient is aged 78 years old) should receive influenza vaccination yearly and pneumococcal vaccination (Pneumococcal Conjugate Vaccine 13 (PCV13) once, followed by Pneumococcal Polysaccharide Vaccine 23 (PPSV23) at least 1 year later).20,21 Administration of the influenza vaccine has been associated with approximately a 30% reduced incidence of pneumonia, and an overall reduction in the risk of allcause mortality of up to 50%.22 This also applied to diabetic patients in which they have appropriate serologic and clinical responses towards influenza vaccinations.23 For the 2015-2016 influenza season, CDC estimates that influenza vaccination prevented approximately 5.1 million influenza illnesses, 2.5 million influenzaassociated medical visits, and 71,000 influenza-associated hospitalizations.24 In addition, according to the cost-effectiveness study done by Maciosek MV et al, there is a savings of $980 per quality-adjusted life year with influenza vaccination among person aged more than 65 in the year 2000 dollars.25 PPSV23 provides protection against 23 serotypes of Streptococcus pneumoniae and PCV13 provides protection against 13 serotypes of S. Pneumoniae.26 PCV13 is thought to induce a stronger immune response, providing longer-lasting protection, but patients are still recommended to also receive the PPSV23 especially for those with age > 65 years old because of the protection against additional pneumococcal serotypes.26 Tdap (tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis) vaccination followed by Td (Tetanus-diphteria) booster dose every 10 years is also recommended to be given to this patient.20 A dose of Tdap for older adults resulted in a moderate decrease in the number of aforementioned infection cases and outcomes (eg. outpatient visit, hospitalizations, and deaths) and increase in boosting immunity to pertussis, hence will help to prevent the transmission of pertussis to young children.27,28 This recommendation is mainly based on the pertussis outbreaks in 2009 and 2012 (> 21000 and > 48000 cases respectively) at United States of America which occured particularly in infants younger than 1 year old). For convenience sake, influenza vaccine is safe to be given simultaneously with PCV13 or PPSV23 and Tdap among adults at different sites.29,30,31,32 Besides, Hepatitis B vaccination may be recommended to be administered to unvaccinated patients with diabetes who aged more than 60 years old at the discretion of the physician after assessing patientâ&#x20AC;&#x2122;s risk and the likelihood of an adequate response to vaccination.33 This is based on the Hepatitis B outbreaks in

Recommendation

patients who were undergoing blood glucose monitoring in nursing homes or assisted-living facilities since 1996. Hepatitis B vaccination is also proved to be a cost-effective management.33 Suggest to prescribe IM influenza vaccine, IM PCV13 then IM PPSV23 1 year later IM Tdap vaccine and IM Hepatitis B vaccine immune 

Efficacy: - Effective against vaccine preventable diseases (aim for No vaccine preventable diseases) - Give the correct vaccine at the dose, site and route specified; this will optimise response and/or reduce risks of adverse effects



Safety: (aim for no adverse effect) -

Transient injection-site reactions - Pain, soreness, redness, itching, or swelling at the injection site - Symptoms usually resolve within a few days

Transient fever or flu-like illness - Usually begins within 24 hours of vaccine administration and resolves in 1 – 2 days 19. Smith SA, Poland GA.; Use of influenza and pneumococcal vaccines in people with diabetes. Diabetes Care 2000;23:95–108 20. Centre for Disease Control and Prevention (CDC). Advisory Committee on Immunization Practices (ACIP). Recommended Immunization Schedule for Adult Aged 19 Years and Older: United States 2017. Available at www.cdc.gov/vaccines/schedules/downloads/adult/adult-combined-schedule.pdf Accessed November 30, 2017. 21. American Diabetes Association Standards of Medical Care in Diabetes. Comprehensive Medical Evaluation and Assessment of Comorbidities. Diabetes Care 2017; 40 (Suppl. 1): S25-S32 22. Mandell LA, Wunderink RG, Anzueto A, et al.; Infectious Diseases Society of America/American Thoracic Society consensus guidelines on the management of community-acquired pneumonia in adults. Clin Infect Dis 2007; 44:S27-72. 23. Feery BJ, Hartman LJ, Hampson AW, Proietto J. Influenza immunization in adults with diabetes mellitus. Diabetes Care 1983;6: 475–478 24. Centre for Disease Control and Prevention (CDC). Influenza (Flu). Estimated influenza illnesses, medical visits, hospitalizations, and deaths averted by vaccination in the United States. Updated April 19, 2017. Available at https://www.cdc.gov/flu/about/disease/2015-16.htm Accessed November 30, 2017.

98 25. Maciosek MV, Solberg LI, Coffield AB, et al; Influenza vaccination health impact and cost-effectiveness among adults aged 50 to 64 and 65 and older. Am J Prev Med. 2006;31:72â&#x20AC;&#x201C;79. 26. Prina E, Ranzani OT, Torres A.; Community-acquired pneumonia. Lancet 2015;386:1097-108 27. Centers for Disease Control and Prevention (CDC). Advisory Committee on response and/or reduce risk of adverse effects Immunization Practices (ACIP). Updated recommendations for use of tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine in adults aged 65 years and old. MMWR 2012;61(25):468-470 28. Rubin LG, Levin MJ, Ljungman P, Davies EG, Avery R, Tomblyn M, Bousvaros A, Dhanireddy S, Sung L, Keyserling H, Kang I; 2013 IDSA clinical practice guideline for vaccination of the immunocompromised host. Clin Infect Dis. 2014;58(3):e44. 29. McNeil SA, Noya F, Dionne M, et al. Comparison of the safety and immunogenicity of concomitant and sequential administration of an adult formulation tetanus and diphtheria toxoids adsorbed combined with acellular pertussis (Tdap) vaccine and trivalent inactivated influenza vaccine in adults. Vaccine 2007; 25:346430. Song JY, Cheong HJ, Tsai TF, et al. Immunogenicity and safety of concomitant MF59-adjuvanted influenza vaccine and 23-valent pneumococcal polysaccharide vaccine administration in older adults. Vaccine 2015;33:4647-52. 31. Frenck RW Jr, Gurtman A, Rubino J, et al.; Randomized, controlled trial of a 13-valent pneumococcal conjugate vaccine administered concomitantly with an influenza vaccine in healthy adults. Clin Vaccine Immunol 2012;19:1296-303 32. Schwarz TF, Flamaing J, RĂźmke HC, et al. A randomized, double-blind trial to evaluate immunogenicity and safety of 13-valent pneumococcal conjugate vaccine given concomitantly with trivalent influenza vaccine in adults aged >65 years. Vaccine 2011;29:5195-202. 33. Centre for Disease Control and Prevention (CDC); Use of hepatitis B vaccination for adults with diabetes mellitus: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Morb Mortal Wkly Rep. 2011;60(50):1709

Cost

Predictability

Interaction

Supply

IM Influenza vaccine 0.5mL, IM PCV13 0.5 mL then IM PPSV23 0.5mL 1 year later, IM Tdap vaccine 0.5mL and IM Hepatitis B 0.5mL

1 = > effective, practical, safe, least expensive, predictable, insignificant, standard drug 2 = > unapproved, least practical, more toxic, expensive, unpredictable, significant, special request 3 = > donâ&#x20AC;&#x2122;t know (Not enough data to evaluate)

COMMENTS

Safety

Tab. Dabigatran 150mg BD for 3 months Tab. Simvastatin 20mg ON

Dosage Practicality

ALTERNATIVES (Drug, dose, dosage, frequency, route and duration)

Efficacy

FEASIBLE PHARMACOTHERAPEUTIC ALTERNATIVES FOR EACH DRUG THERAPY PROBLEM

Refer DRP 1 above Refer DRP 2 above Refer DRP 3 above

100

No. 1.

PHARMACIST’S CARE PLAN MONITORING WORKSHEET (PMW) Pharmacotherapeutic Goal To reduce the recurrence and complications of DVT

Monitoring Parameter

Desired Endpoint

Monitoring Frequency

Efficacy: Thrombin inhibitor to prevent and reduce the recurrence of DVT D-dimer

No new incidence or recurrence of DVT No complications of DVT No adverse effects from the medication.

Patients with, CrCl 30 – 60mL/min, low baseline haemoglobin/haematocrit and age > 75 years old a) CBC: At baseline and every 6 months or more often if clinically indicated b) Renal function: At baseline and every 3 months

Safety:  Side effect of Dabigatran Symptoms of bleeding: Bruises, gum, nose bleed, haemoptysis, haematuria, melena, red or black, tarry stools. Symptoms of renal failure: Excessive or rapid weight gain, oedema, dehydration, nausea & vomiting, pruritus. Gastrointestinal adverse reaction: dyspepsia, burning or nausea, abdominal pain or discomfort, epigastric discomfort, GERD. 

Complications of DVT Further clot extension, recurrence,embolization, postthrombotic (postphlebitic) syndrome, chronic thromboembolic pulmonary hypertension, thrombocytopenia, thrombosis-related death

101    2.

To achieve blood lipid target and prevent incidence of ASCVD event

Renal function Complete blood count Presence of drug interactions

Efficacy:  

Fasting Lipid Profile Presence of ASCVD event

LDL-C level is maintained at the target of < 1.8 mmol/L -

Safety:  Side effects of atorvastatin Muscle symptoms (myalgia, stiffness etc.) Hepatotoxicity symptoms (unusual fatigue or weakness, loss of appetite, abdominal pain, dark-coloured urine etc.) 

Baseline liver function test and creatine kinase For reference in case muscle symptoms develop If ALT/AST is 1 – 3 X ULN during statin therapy, there is no need to discontinue the statin. If ALT/AST exceeds 3 X ULN during statin therapy, follow the patient and repeat the measure. There is no need to discontinue the statin (unless it is symptomatic) If CK level is more than 5 X ULN on 2 occasions, the drug should be discontinued.

Test

No ASCVD event

No adverse effects from the medication.

Cholesterol /HDL cholesterol Triglycerides Liver function test Creatine kinase

Initial 3Visit monthly (Basevisit line) / /

Annual visit /

/ /

/ x

/ /

Note: Creatine kinase not routinely measured unless myositis is suspected.

Every day at home: Observe any signs and symptoms of side effects stated

102 3.

To reduce incidence of vaccine preventable diseases (influenza, pneumococcal diseases, tetanus, diphteria, pertussis, and Hepatitis B)

Efficacy:  Effective against vaccine preventable diseases  Give the correct vaccine at the dose, site and route specified; this will optimise response and/or reduce risk of adverse effects Safety:  Transient injection-site reactions Pain, soreness, redness, itching, or swelling at the injection site Symptoms usually resolve within a few days 

Transient fever or flu-like illness Usually begins within 24 hours of vaccine administration and resolves in 1 – 2 days

No new incidence of vaccine preventable diseases No adverse effects from the medication

Observe 1 – 2 days for adverse effects after injection

103

IMPLEMENTATION OF THE INDIVIDUALIZED REGIMEN AND MONITORING PLAN

Pharmaceutical Care intervention on Accepted medication related problems and date code (Y,N,C) (i) 23.11.2017 To reduce the recurrence and complications of DVT Suggest to increase the dose from Y Tab. Dabigatran 110mg BD to Tab. Dabigatran 150mg BD. Suggest to reduce the duration of from 6 months to 3 months (ii) 20.11.2017 To achieve blood lipid target and prevent incidence of ASCVD event Suggest to prescribe Tab. Y Simvastatin 20mg ON for this patient.

Comments/problems

Intervention was accepted.

(iii) 2311.2017 To reduce incidence of vaccine Preventable diseases (influenza, pneumococcal diseases, tetanus, diphteria, pertussis, and Hepatitis B) Suggest to prescribe IM influenza vaccine, IM PPSV23, IM Tdap vaccine and IM Hepatitis B vaccine

Intervention was accepted. A new prescription is written for patient to get the injection at community pharmacy / general practitioner.

Consultations to other health professional and date

Requester/ professional/ Agency

Comments/outcome

(i)

Therapeutic communications (Bedside counselling, Drug Target/proinformation, Medication history fessionals/ taking, In-service group education, Agency ADR reports) and Date. (i) 23.11.2017 Patient and Counselled patient regarding patient’s dabigatran family members (ii) 23.11.2017 Patient and Informed patient to do home blood patient’s glucose monitoring with family pharmacist’s collaboration members

Comments/outcome

Patient and patient’s family members claimed understood Patient and patient’s family members claimed understood

104 (ii) 23.11.2017 Informed the patient to follow a diet low in saturated fat and glycemic index (GI).

Patient

Patient claimed understand

Accepted Code: Y=Yes, recommendation accepted, N=No, Not accepted, C=Accepted with changes

105 6.

DISCHARGE SUMMARY ON DRP/DTP AND COMMUNICATION A. SUMMARY: 23.11.2017 Discharge medications: IM Influenza Vaccine IM PCV 13 , then IM PPSV23 1 year later IM Tdap Vaccine IM Hepatitis B Vaccine Tab. Dabigatran 110mg BD x 3 months Tab. Metformin 500mg BD Tab. Simvastatin 20mg ON Tab. Mecobalamin (Vitamin B12) 500mcg TDS Tab. Calcium Carbonate 500mg OD Cap. Calcitriol 0.25mcg BD LA Aqueous Cream Cap. Tramadol 50mg PRN Tab. Potassium Chloride CR 1.2g TDS

To be purchased at community pharmacy or GP

6/52

3/7

Review date: 6/52 at MFUC B. COMMUNICATION/DOCUMENTATION:



Patient and patient’s family members are counselled on how to take Tab. Dabigatran. The counselling points (First-time counselling) of Tab. Dabigatran are listed below.  Take the capsule twice daily at about the same time every day. 



Remind patients not to discontinue Dabigatran without informing the health providers (doctors and pharmacists) who prescribe and dispense it.



Keep Dabigatran in the original blister pack to protect from moisture. Do not put Dabigatran in pill boxes. (Dabigatran deteriorates immediately when exposed to humidity).



Instruct patient to remove only one capsule from the blister pack at the time of use. Do not chew or break the capsule before swallowing. Swallow capsule whole with water. Dabigatran can be taken with or without food.

 



 

If a dose of Dabigatran is not taken at the scheduled time, take it as soon as possible on the same day. The missed dose can still be taken up to 6 hours prior to the next

106

 

    



dose. Do not double dose to make up for the missed dose.



Do not run out of Dabigatran. Refill the prescription before it finished.



Inform healthcare providers (doctors, dentists and pharmacists) if there are new drugs prescribed or procedures planned. (to check for drug-drug/supplement interaction and drug-disease/lifestyle interaction)



If any of the side effects occurred, please inform health providers (doctors or pharmacists) o Symptoms of bleeding: Bruises, gum, nose bleed, haemoptysis, haematuria, melena, red or black, tarry stools o Symptoms of renal failure: Excessive or rapid weight gain, oedema, dehydration, nausea & vomiting, pruritus o Gastrointestinal adverse reaction: dyspepsia, burning or nausea, abdominal pain or discomfort, epigastric discomfort, GERD

Compression socks associated with early mobilization and walking exercise has shown significant efficacy in venous symptom relieve in patients with acute DVT. Therefore, it is recommended for the family members to ensure patient has sufficient exercise for better improvement of DVT. For patient’s blood glucose self-monitoring, she and her family members are informed to maintain blood glucose level between 4 – 6 mmol/L before meals and less than 8 mmol/L after meals. Besides, it is important to follow a diet low in saturated fat and glycemic index (GI) as following.

107

108

Patientâ&#x20AC;&#x2122;s family members understood the indication, dose and frequency of the medications given. Besides, the importance of compliance been emphasized to patientâ&#x20AC;&#x2122;s family members. Patientâ&#x20AC;&#x2122;s family members claimed understand all information given by the ward pharmacist.

109

110

111

112

113

114

Bed-Head Ticket

Ward CX5 Bed: 14 Name ID Admission date

HD RN78910 3 February 2018

115 3/2/2018, 0800 40 years old, Malay, female, 70kg, 158cm (estimated) Arrived ED at 0900 pm yesterday, brought by her husband

c/o Agitation, anxiety Shortness of breath, Tachycardia Weakness, Giddiness Fever Pt claimed having agitation with tremor 5 days ago. Also had rapid heartbeats in the past days.

PMH: HTN for 5 years on perindopril 4mg OD

FHx: -Married, live with husband -Her father with hypertension and diabetes -non-smoker & non-alcoholic

ROS: -alert and conscious, cooperative -BP 196/121, HR 127, T 38.2oc -SPO2 97% Abd: SNT -Rapid Breathing (orthopnea) -Chest with neck x-ray: No cardiomegaly, mild thyroid enlargement -CVS: S1S2 DRNM, no chest pains, no palpitations -skin warm and intact, able to walk without support -look dehydrated but

opedal

edema 2

116 Sodium 139

Urea 6.2

Potassium 3.4

Creat 144

Hct 41.4

HgB 13.1

WBC 13.5

RBC 4.8

Plt 188

pH 7.41

pO2 97 HCO 25 3-

pCO 32 2 CK 40

LDH 140 Albumin 39 ALT 29 AST 31 Free T3 46.5

Tol protein 69 Globulin 34 ALP 170 TSH 0.0 Free T4 3.57

Imp: Thyroid Storm, TRO Community Acquired Pneumonia (CAP)

Plan: To start paracetamol 1g PRN To start bisoprolol 5mg OD To order blood culture

117 04/2/2018, 0800 40 years old, Malay, female, 70kg, 158cm (estimated) Currently unwell and lethargy for few days Otherwise alert and conscious

BP: 170/86, HR104 Temp: 37.8oC; Pain score: 0/10 SPO2: 98% under RA Abdomen: no pain, no tender, soft agitation, increase appetite

Plan: Continue the previous plan Add IV Augmentin 1.2 g TDS Add T. Amlodipine 10 mg OD Add T. Propythiouracil 200 mg TDS Add T. Carbimazole 30 mg OD Start IVD 30 NS/24 Monitor FBC

04/02/18, 1400 Sodium 143 Potassium 4.3 Hct 39.8 WBC 12 Plt 188 pO2 95

Urea 4.7 Creat 60 HgB 12.7 RBC 5.3 pH 7.37 pCO2 41

HCO3- 23 Phosphate 1.44

Ca2+ 2.35

118 05/02/18, 0900 pt conscious and alert T= 37⁰C, RR= 25 bpm, So2=100% BP: 150/84, HR= 97 bpm DRNM, Abdomen: no pain, no tender, soft increase in appetite no tremor, no agitation

Sodium 142

Urea 5.1

Potassium

Creat 62

4.5 pH 7.31

Blood C&S: no growth Imp: Thyroid Storm, TRO Community Acquired Pneumonia (CAP)

Plan: Continue the previous plan Control Patient’s symptoms

06/2/2018, 0830 conscious and alert, T= 37.0⁰C RR= 28 bpm, So2=98%

BP: 143/77, HR= 75 bpm, DRNM Abdomen-no pain, no tender, soft Thyroid gland still enlarged

Plan: Continue the previous plan IVD 30 NS/34 hr

119 5

120 To be discharged tomorrow and refer to outpatient clinic for further diagnosis

07/02/18, 0900 40 years old, Malay, female, 70kg, 158cm (estimated) conscious and alert patient with T= 37.0â °C Lungs: clear, RR= 28 bpm, So2=99% CVS: BP: 141/80, HR= 68 bpm, DRNM Abdomen: no pain, no tender, soft

Treated as Hyperthyroidism

Plan: Continue the previous plan To start T. Augmentin 625 mg TDS To discharge today and refer to outpatient clinic -T. Augmentin, 625 mg, TDS

-T. Propythiouracil, 200 mg, TDS -T. Carbimazole, 30 mg, OD -T. Bisoprolol, 5 mg, OD -T. Amlodipine, 10 mg, OD To do U/S neck in outpatient clinic To control symptoms To check TSH, Free T3, T4

121 Medication chart 03/2/18 8am

12pm 2pm

4pm

8pm 10pm 12am

4/2/18 8am 12pm 2pm

4pm

5/2/18 8pm 10pm 12am

8am

12pm 2pm

4pm

8pm 10pm 12 am

T. Bisoprolol OD T. amlodipine 10mg OD IV Augmentin 1.2g TDS T. PCM 1g PRN T. Propylthiouracil 200mg TDS

T. Carbimazole 30mg OD 6/2/18

7/2/18

T. Bisoprolol OD

8/2/18 D

T. amlodipine 10mg OD

IV Augmentin 1.2g TDS

T. Augmentin 625mg TDS

T. Propylthiouracil 200mg TDS

T. Carbimazole 30mg OD