Epic Pharmacy Circuit Newsletter 2020, Edition 2

2020 Edition 2

clinical initiatives, research and current updates in treatment

Handling Hazardous Drugs Maggie Patterson, Pharmacy Practice Unit Advisor When the topic of hazardous drugs is raised, cytotoxic drugs are arguably the first that come to mind. However, there are many types of hazardous drugs which may be used across a range of indications, including psoriasis, rheumatoid arthritis, hypertension, epilepsy, and organ transplant.

In a recent Australian study, 46% pharmacists and 33% nurses reported handling hazardous medications at least once a week.1 A hazardous drug is one that exhibits one or more of the following characteristics: 2 1. Carcinogenicity, or the ability to cause cancer 2. Teratogenicity, or the ability to disrupt the development of an embryo or foetus 3. Reproductive toxicity, or fertility impairment 4. Genotoxicity, or the ability to cause genetic mutations 5. Organ toxicity at low doses 6. Drugs that mimic existing drugs determined hazardous in structure or toxicity Cytotoxic drugs are well known to be hazardous agents. Cytotoxic drugs damage or destroy both healthy and diseased cells within the body.3 All cytotoxic drugs are hazardous, however, not all hazardous drugs are cytotoxic.

Whilst there are a number of welldefined guidelines for the handling and administration of cytotoxic medications, there is little guidance and consensus on non-cytotoxic, hazardous drugs, which may lead to inadvertent exposure, confusion and anxiety amongst healthcare workers.

Healthcare workers are at risk of occupational exposure to medications as part of their day-to-day activities and, as a result, may experience adverse health effects. Inadvertent drug exposure may occur through skin absorption, aerosolised particle and vapour inhalation, contact with the eyes (e.g. splashes), ingestion of contaminated items, other hand-tomouth contact or needle-stick injuries.

As such, it is important to ensure medications are handled safely and appropriately.4 When deciding on appropriate safe handling requirements, it must be considered if and how the drug is hazardous, and the actual risk of exposure based on the dosage form, administration method and frequency of exposure. A number of resources are available to assist, including: ¬ 2016 NIOSH List of Antineoplastic and Other Hazardous Medicines in Healthcare Settings which lists hazardous medications and provides general guidance on their safe handling.2 ¬ Australian Don’t Rush to Crush

which details whether a drug is hazardous and offers practical guidance on options for patients unable to swallow solid oral medicines, and the appropriate personal protective equipment (PPE) to be used.5

¬

New South Wales eviQ website, a cancer treatment related resource, includes a hazardous drugs table and general recommendations for safe handling. It, however, only includes drugs used in cancer treatment. 3

Occasionally, the drug may not be specifically listed as hazardous in these references or there may be contradictory information between different resources, therefore, clinical judgement must be used.

Appropriate risk mitigation strategies are required to minimise exposure of healthcare workers to hazardous drugs. These include engineering controls, administrative controls, and PPE. For vulnerable staff (e.g. pregnant, breastfeeding or immunocompromised), reassignment to other duties which exclude potential hazardous drug exposure is the most effective strategy but is not always possible. Engineering controls, such as biological safety cabinets and ventilation systems, are important during hazardous drug compounding and aim to protect the worker by removing the hazardous condition or by placing a barrier between the worker Continued on page 2

and the hazard.2,4,6 Administrative controls are aimed at changing the way people work to minimise exposure to risk and include workplace procedures and staff training programs.6,7 PPE is often thought of as the main mitigation strategy to prevent hazardous drug exposure, however, it relies on good technique, suitable equipment choice and appropriate staff training. Common examples of

PPE include gloves, masks, gowns, goggles or face shields.2,4,6,7 The choice of PPE depends on the risk of exposure.

Some drugs may not pose a significant risk due to their dosage formulation, whereas others may require additional PPE e.g. administering a single intact capsule versus cutting a tablet with significant tablet dust. Furthermore, the specific risk to the worker should be considered. Some drugs are hazardous due to their effects on the reproductive

system, therefore, are of particular risk to men and women trying to conceive, or women who are pregnant or breastfeeding. Affected staff must wear PPE when handling these medicines and may consider additional PPE with other classes of hazardous drugs e.g. cytotoxic medications.1-3 Some recently proposed recommendations for handling hazardous, non-cytotoxic medicines are shown in Table 1.

Table 1: Proposed use of PPE for handling hazardous non-cytotoxic medicines1

Chemical-safe gloves

Gown

Mask (P2/N95)

Goggles or face shield

Oral administration of an intact, solid-dose form



Administration of a liquid or modified tablet or capsule





If risk for aerosolising

If risk for splashing

Preparation of an injectable product (i.e. addition to a bag)









Administration of an injectable product





If risk for aerosolising

If risk for splashing

All staff working with hazardous drugs should be aware of the fundamental practices and precautions required to prevent occupational exposure and

minimise any risks to themselves, their co-workers and their patients. Whilst there are many resources to refer to, and most hospitals should have their

own guidelines, pharmacists are also a valuable resource to refer to for advice.

References are available on request.

Complications of Type 2 Diabetes Jaslyn Chandler, Slade Pharmacy Currumbin Diabetes is a fast-growing condition whose incidence has quadrupled over the past 30 years.1,2 It is estimated to affect 8.5% of the global population. 1,2 In Australia, approximately 1.7 million people have diabetes, with type 2 diabetes (T2DM) accounting for 85% to 90% of all cases.3 T2DM is a slow progressing metabolic disorder, which causes high blood glucose levels (hyperglycaemia), as a result of inadequate insulin production, decreased insulin sensitivity or both.

By the time someone is diagnosed with T2DM, 50% to 70% of the insulin producing cells have usually already been lost.3 Persistent hyperglycaemia affects normal cell functioning within the body and can result in long term complications.4 These complications are usually classified as macrovascular or microvascular.

Macrovascular complications are those associated with the cardiovascular, cerebrovascular and peripheral vascular systems, whereas microvascular complications involve the kidneys, retina and nervous system.

Macrovascular complications Hyperglycaemia and insulin resistance are believed to cause narrowing and obstruction of arteries (atherosclerosis), leading to macrovascular complications.2 These complications may arise in both the presence or absence of risk factors, such as hypertension or hyperlipidaemia.5 Cardiovascular disease is the most common cause of mortality in T2DM, responsible for 52% of T2DM related deaths.2 Each year in Australia 1% to 3% (11,000-33,000) of people with T2DM have a diabetes-related heart attack.3 The risk of stroke and cerebrovascular

disease is also significantly increased in T2DM. People with T2DM have a 150% to 400% increased risk of stroke.6 Approximately 8% of diabetic related deaths are due to either foot ulcers or lower leg wounds.3 The increased risk of peripheral arterial disease in T2DM is caused by atherosclerotic occlusion of the lower limb. This results in decreased blood flow and nutrient supply to the legs and feet, causing nerve damage (peripheral neuropathy), reduced sensation and poor wound healing.5,7 Peripheral neuropathy leads to injuries going unnoticed and, if paired with reduced foot or limb care, results in slow tissue repair and significantly increased rates of lower limb ulceration, increasing the risk of amputations or death. 5,7

Microvascular complications Diabetic nephropathy, also known as diabetic kidney disease, is the most

common long-term complication of diabetes, affecting around 40% of diabetics, and is one of the main causes of end-stage renal disease worldwide.8,9,10 Over 60% of individuals with T2DM develop a form of diabetic eye disease (e.g. retinopathy, glaucoma or macular disease) within 20 years of being diagnosed.11 Diabetic retinopathy is the main cause of preventable blindness in Australia. 3

Preventative strategies and health solutions Macrovascular and microvascular complications increase with the degree and duration of hyperglycaemia, therefore, managing and improving glucose control early in disease onset is crucial.12 Evidence based treatment for T2DM is focussed on achieving timely and optimal glycaemic control, with targets tailored to each individual patient.13,14 Lifestyle modifications such as a healthy diet, increased physical activity, weight control, smoking prevention and moderating alcohol intake, all assist in regulating blood glucose levels.1 If medication is required, metformin is the first-line antihyperglycaemic medication for T2DM and is usually continued indefinitely unless poorly

tolerated.12 If glycaemic targets are not maintained with lifestyle modifications and maximum doses of metformin, a second antihyperglycaemic medication is added. This is usually a sulfonylurea (e.g. gliclazide), gliptin (e.g. sitagliptin) or SGLT2 inhibitor (e.g. empagliflozin).

Many people with T2DM will eventually require the addition of insulin, usually starting with a once daily basal insulin e.g. glargine. 12 T2DM medication regimes are individualised and complex, and often include medications to treat co-existing conditions, as well as medications to reduce the risk of complications. Common examples include statins (e.g. atorvastatin) to reduce cholesterol, and ACE inhibitors (e.g. ramipril) or “sartans� (e.g. irbesartan) to treat high blood pressure and slow the progression of diabetic kidney disease.15 Unfortunately, treatment complexity can lead to patient confusion, reduced compliance and an increased risk of medication errors. 16 The coexistence of multiple complications of T2DM often occurs without obvious signs or symptoms, leading to delayed diagnoses. 2,5 Initial screening for complications and associated comorbidities should therefore begin at diagnosis and continue regularly thereafter.12 The

Diabetes Cycle of Care (Image 1) is a useful checklist which promotes the early adoption of health interventions to optimise clinical targets and reduce potential complications.17 Collaboration between various health care professionals including pharmacists, optometrists, podiatrists, credentialed diabetes educators, and dieticians is essential to provide specialised advice throughout the different areas of patient care.

Social support is also central to reducing mental barriers and stigmas surrounding disease management.

Conclusion The incidence of diabetes and its associated complications is a significant and increasing health burden worldwide. Many individuals with T2DM already have macrovascular and microvascular diseases complications before even diagnosed with diabetes.

Timely detection of diabetes and associated complications can be achieved by routine monitoring and increasing health awareness. Early application of interventions to reach optimal health targets is critical to reduce the onset, progression and severity of diabetes and its complications.

References are available on request.

Image 1: Diabetes Cycle of Care12

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What’s New An update on new generic medications on the market Luxshiyaa Sukumar, Epic Pharmacy Wesley Optisulin (R) and Semglee (R) (insulin glargine) In July 2020, Lantus® (insulin glargine 100 units/mL) was discontinued and replaced by two new products, the biosimilar (Semglee®) and the generic (Optisulin®).

are not required when changing brands.2 Patients transitioning should continue to administer their dose at the same time of the day and monitor blood glucose levels as usual. 2

Biosimilar medicines, such as Semglee®, are a highly similar version of an already registered biological medicine.1 Semglee® demonstrates physiochemical, biological, immunological, efficacy and safety comparability to Lantus®.1

Toujeo® the concentrated insulin glargine formulation (300 units/mL) is unaffected by this change. It is three times the concentration and is NOT equivalent nor interchangeable with the other forms of insulin glargine.

Lantus®, Optisulin® and Semglee® are all interchangeable and dosage adjustments

A summary of insulin glargine products available are shown in Table 1.

Table 1: Insulin glargine products3

Insulin Glargine

Generic name

Presentation

Brand name (manufacturer)

Concentration

Description

3mL Cartridge

Disposable Pen

Comments

Lantus® (Sanofi-Aventis)

100 units per mL

Reference biological medicine





Removed from PBS June 30 2020

Optisulin® (Sanofi-Aventis)

100 units per mL

Reference biological medicine marketed under a second brand





PBS listed

Semglee® (Mylan/Alphapharm)

100 units per mL

Biosimilar medicine



PBS listed

Toujeo® (Sanofi-Aventis)

300 units per mL

High concentration reference biological medicine



CAUTION: Three times the concentration, NOT interchangeable

Braltus® Zonda® (tiotropium bromide) Braltus® capsules with a Zonda® inhaler device is the new generic for Spiriva® capsules and Handihaler®. Braltus® (tiotropium 13mcg) and Spiriva® (tiotropium 18mcg) capsules are bio-equivalent, delivering the same dose of medication (tiotropium 10mcg) to the airways when used with their appropriate (brand specific) inhalation devices.4 Neither capsule can be taken orally.

Each Braltus® prescription supply includes a new Zonda® device, which is only used for that supply and must be discarded after the 30 doses have been taken. The Spiriva® Handihaler® is purchased separately and used for 12 months before requiring replacement.

These inhalers must not be used with the other brand’s capsules.

References are available on request.

If you have any queries regarding Circuit content and authors please contact the Epic Pharmacy Practice Unit by email: circuit.editor@epicpharmacy.com.au Every effort has been made to ensure this newsletter is free from error or omission.

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