Creating Value for All Healthcare Stakeholders Vol:5
Issue: 12
October 1-15
2008
Price Rs 20/-I believe .. patient
A customer is the most important visitor on our premises. He is not dependent on us. We are dependent on him. He is not an interruption in our work - he is the purpose of it. We are not doing him a favour by serving him. He is doing us a favour by giving us the opportunity to serve him.
- Mahatma Gandhi
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V. Bhava Narayana Associate Editors
EDITORIAL BOARD Prof.B.Suresh, President Pharmacy council of India
Dr. Aniruddha Malpani, M.D Dr. Mahesh Sharma,
Dr. Jawahar Bapna, Rtd Director, IIHMR
Prof. G.P.Mohanta
S.W. Deshpande, DG, AIDCOC
M.D (Ayurveda)
Dr. P.Hanumantha Rao, ASCI, Hyd
This Publication is Only for the use of Medical & Pharmacy Professionals Printed, Published and Owned by V. Bhavanarayana, and printed at Kala Jyothi Process Pvt. Ltd., 1-1-60/5, R.T.C. 'X' Roads, Musheerabad Hyderabad - 20. Published at 3-3-62/A New Gokhale Nagar, Ramanthapur, Hyderabad - 500 013, R.R. Dist. Editor : V. Bhavanarayana * RNI No.: APBIL/2004/12036 Postal LIC NO : HSE 806/2004-06. C Pharmed Trade News, 2004 * Person responsible under PRB act for selection of news Pharmed Trade News does not neccesarily subscribe to the views expressed in the publication. All views expressed to the magazine are those of the contributors Pharmed Trade News not responsible or accountble for any loss incurred, directly or indirectly as a result of the information provided.
PhaR MeD News DIABETES NICE has published its final guidance on the use of continuous subcutaneous insulin infusion (CSII or 'insulin pump') therapy. This is a review of guidance on the use this technology published in February 2003. For adults and children 12 years and older with type 1 diabetes, the guidance recommends insulin pump therapy as a treatment option provided that: - attempts to reach target haemoglobin A1c (HbA1c) levels with multiple daily injections result in the person having 'disabling hypoglycaemia' 1 or - HbA1c levels have remained high (8.5% or above) with multiple daily injections (including using long-acting insulin analogues if appropriate) despite the person and/or their carer carefully trying to manage their diabetes. Insulin pump therapy should only be continued in adults and children 12 years and over if there has been a sustained improvement in the control of their blood glucose levels. 1 Hypoglycaemia means that treatment for diabetes can also cause blood glucose levels to become too low, causing the person to become anxious, dizzy or disoriented, have convulsions or become unconscious. 'Disabling hypoglycaemia' is when hypoglycaemic episodes occur frequently or without warning so that the person is constantly anxious about another episode occurring, which has a negative impact on their quality of life. For children under 12 years with type 1 diabetes, the guidance recommends the use of Insulin pump therapy as a possible treatment if treatment with multiple daily injections is not practical or is not considered appropriate. Children who use insulin pump therapy should have a trial of multiple daily injections when they are between the age of 12 and 18 years. Insulin pump therapy is not recommended for the treatment of people with type 2 diabetes. 1ST WORLD CONGRESS ON INTERVENTIONAL THERAPIES FOR TYPE 2 DIABETES The 1st World Congress on Interventional Therapies for Type 2 Diabetes is a comprehensive and multidisciplinary forum where leaders in the global health community will conduct an organized review and discussion of the latest scientific data and theories on the use of bariatric surgery for the treatment of type 2 diabetes. The Congress, hosted by Weill Cornell Medical College and NewYork-Presbyterian Hospital, aims to create a forum for the medical community to work with health policy makers, including top public health authorities and insurers from the U.S. and around the world. The overarching aim is to craft an agenda of health policy initiatives to seize the opportunity offered by gastrointestinal surgery and novel interventional therapies for the understanding and treatment of diabetes. For more information, visit http:// www.interventionaldiabetology.org. CARDIOLOGY Predicting Heart Attack Risk with Ultrasound Repeat exams using widely available and inexpensive ultrasound imaging could help identify patients at high risk for a heart attack or other adverse cardiovascular events,
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according to a study published in the September issue of the journal Radiology. Researchers performed ultrasound imaging on the carotid arteries of 1,268 patients who were asymptomatic but at high risk for cardiovascular disease. Of those, ultrasound determined that 574 patients had carotid artery disease, as determined by the amount of plaque built up in the two vessels that supply blood to the head and neck. Each of those patients had a second ultrasound exam six to nine months later to measure changes in the plaque lining the arteries. "Determining the degree of stenosis, or how much the artery has narrowed, is insufficient to predict patient risk," said lead researcher Markus Reiter, M.D., from the Department of Angiography and Interventional Radiology at Medical University Vienna in Austria. "We know that the majority of cardiovascular and cerebrovascular events occur in patients whose blood vessels are less than 70 percent narrowed." Reiter and his team used ultrasound images and computerassisted gray scale median (GSM) measurements to determine the density of the plaque lining the carotid arteries. Plaques that appear dark on ultrasound images and have a low GSM level are suggested to be associated with an increased risk for clinical complications and seem to represent unstable plaques, which are more likely to rupture or burst. The study's follow-up ultrasounds revealed that GSM levels had decreased in 230 (40 percent) of the patients. Of those, 85 (37 percent) experienced a major adverse cardiovascular event within three years of the second ultrasound. Examples of these events include heart attack, stroke, coronary artery bypass, surgery or other intervention. In 344 (60 percent) of the patients, ultrasound GSM levels had increased between the baseline and follow-up ultrasound examinations. Of those patients, 92 (28 percent) experienced a major adverse cardiovascular event. "Patients with a reduction in GSM levels from their baseline ultrasound to the follow-up ultrasound exhibited a significantly increased risk for near-future adverse event compared to patients with increasing GSM levels," said Dr. Reiter. It is important to note that the results showed that vulnerable plaque in the carotid artery was not only an indicator of increased risk of stroke downstream from the carotid artery, but also was associated with disease progression elsewhere in the cardiovascular system. Although additional studies are needed, Dr. Reiter said measuring GSM levels on serial ultrasound examinations may be a noninvasive way to identify the presence of vulnerable plaques and improve the effectiveness of therapeutic strategies. "This technique will give us additional information to use in selecting patients that need aggressive treatment," he said. GASTROENTEROLOGY In a new study, researchers at the University of Michigan Health System reveal that, from the perspective of a longterm payer, over-the-counter PPIs are worth the price for coronary heart disease patients taking low-dose aspirin as a preventative measure. At prescription costs, however, PPIs
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are cost-effective only for elderly patients and patients at high risk for upper GI bleeding. "Our study was also able to demonstrate that, for patients at an average risk for GI bleeding, starting PPI cotherapy at a younger age was marginally cost-effective, while starting PPI cotherapy at an older age was highly cost effective," says Sameer Dev Saini, M.D., M.S., clinical lecturer in the Division of Gastroenterology at the U-M Medical School. "Ultimately, physicians should discuss the gastrointestinal risks of lowdose aspirin with their patients and consider PPI cotherapy." Study results appear in the Aug. 11/25 issue of Archives of Internal Medicine. n estimated 2 million children in developing countries die each year from diarrhea, but simple zinc treatment could reduce the risk of such deaths. Researchers reached this conclusion in a new review of studies involving more than 6,000 children of all ages. "Our most important finding is that there is strong evidence that zinc supplementation benefits children suffering from diarrhea in developing countries, but only in infants over six months old," said lead investigator Marzia Lazzerini, M.D. "Zinc reduces acute diarrhea duration in terms of mean duration and risk of diarrhea at given days. Zinc also reduces the duration of persistent diarrhea." Nearly 30 percent of children in the world are zinc deficient, Lazzerini said. She is a pediatrician with the World Health Organization (WHO) Collaborating Centre for Maternal and Child Health in Trieste, Italy. Zinc deficiency is due primarily to inadequate dietary intake. Relatively expensive foods such as meat and fish contain high levels of zinc, the authors say. Although zinc also appears in cheap foods such as nuts, seeds, legumes and whole grain cereal, these foods can reduce absorpti on of zinc by the body. Zinc cannot be stored in the body. PTC124 Shows Promising Activity In Cystic Fibrosis; Phase 2 Proof-of-Concept Data Published In The Lancet 21 Aug 2008 New phase 2 data published today in The Lancet show that the investigational oral drug PTC124 demonstrates activity in nonsense-mutation cystic fibrosis (CF). The data show that treatment with PTC124 results in statistically significant improvements in the chloride channel function of patients with nonsense-mutation CF. The study was conducted at the Hadassah Hebrew University Hospital in Jerusalem, Israel and sponsored by PTC Therapeutics (PTC). Patients with CF lack adequate levels of the cystic fibrosis transmembrane conductance regulator (CFTR) protein, a chloride channel which is required for normal function of the lung, pancreas, liver, and other organs. Nonsense mutations are single-point alterations in the genetic code that prematurely stop the translation process, preventing production of a full-length, functional protein. Patients with nonsense-mutation CF generally make virtually no CFTR protein and thus often have a more severe form of CF. By inducing the production of functional CFTR, PTC124 is addressing the underlying genetic defect responsible for CF. Nonsense mutations are responsible for approximately 10 percent of the cases of cystic fibrosis worldwide. However, in Israel, nonsense mutations are responsible for the majority of CF cases. Study results: PTC124 Restored Functional Production of
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CFTR Protein in Patients This Phase 2 Israeli study enrolled 23 adult patients (median age 25 years) with nonsense-mutation CF. More than 90 percent of patients had severe CF with compromised lung function, pulmonary infection with Pseudomonas or other pathogenic bacteria, and pancreatic insufficiency. Patients were assessed in two 14-day treatment courses of oral PTC124 therapy, the first given at a lower dose and the second given at a higher dose. Results showed that at both dose levels, treatment with PTC124 was associated with statistically significant improvements (p<0.05) in CFTR-mediated chloride transport with over half of the patients entering the normal range during at least one treatment course. PTC124 induced chloride transport responses and normalization of CFTR activity across the variety of patient genotypes tested. Improvements in lung function values and body weight were also observed. PTC124 was generally well tolerated and all patients had >90 percent treatment compliance. "This study demonstrates the potential for personalized medicine, combining selection of patients with a specific type of genetic mutation and a drug treatment that has been specifically designed to overcome that mutation," said Eitan Kerem, MD, head of pediatrics and the CF center at the Hadassah University Hospital in Mount Scopus, Jerusalem and the lead author of the study. "The publication of these ground-breaking results in the Lancet offers new hope to those patients with CF due to a nonsense mutation in the CFTR gene and establishes a path forward for evaluating the efficacy and long-term safety of PTC124." "We are very pleased by this positive outcome from our ongoing collaboration with PTC," noted Preston Campbell, III, M.D., Executive Vice President of Medical Affairs at the Cystic Fibrosis Foundation. "The development of PTC124 fits well with our strategic goal of supporting approaches that have the potential to modify the course of CF. We are continuing to work together with PTC and the broader CF medical community to support the next steps in the evaluation of PTC124 for the clinical benefit for the treatment of nonsense-mutation CF." "The publication of these data provides clinical proof of concept in CF for the PTC124 mechanism of action in overcoming nonsense mutations as the basis for treating genetic disease," said Stuart W. Peltz, Ph.D., President and Chief Executive Officer of PTC Therapeutics. "Based on these results, we intend to initiate a Phase 2b study later this year to evaluate the clinical benefit of PTC124 in adults and children with nonsense-mutation-mediated CF. Given the potential applicability of PTC124 to multiple genetic disorders, we have a pivotal study of PTC124 for nonsensemutation Duchenne/Becker muscular dystrophy ongoing and are planning proof-of-concept studies in additional genetic disorders." The paper entitled "Effectiveness of PTC124 treatment of cystic fibrosis caused by nonsense mutations: a prospective phase II trial" is available in an advanced online publication of Lancet on Thursday, August 21st (http://www.lancet.com). About Cystic Fibrosis Cystic fibrosis (CF) is a life-threatening genetic disease that causes serious lung infections and digestive complications. According to the Cystic Fibrosis Foundation, CF affects approximately 30,000 adults and children in the United States and nearly 70,000 people worldwide. There is a commercially available genetic test to determine if a patient's CF is caused by a nonsense mutation, and it is estimated that nonsense
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mutations are the cause of CF in approximately 10 percent of patients in the United States and Europe and over 50 percent of patients in Israel. There is currently no available therapy to correct defective CFTR production and function. Instead, available treatments for CF are designed to alleviate the symptoms of the disease. These treatments include chest physical therapy to clear the thick mucus from the lungs, antibiotics to treat lung infections, and a mucus-thinning drug designed to reduce the number of lung infections and improve lung function. In addition, the majority of cystic fibrosis patients take pancreatic enzyme supplements to assist with food absorption in digestion. There is a significant unmet medical need for treatments that address the underlying cause of CF. More information regarding CF is available through the Cystic Fibrosis Foundation (http://www.cff.org). About PTC124 PTC124 is an orally delivered, investigational new drug discovered by PTC Therapeutics. The drug is being developed for the treatment of genetic disorders due to nonsense mutations. Nonsense mutations are single-point alterations in the genetic code that prematurely stop the translation process, leading to production of truncated, non-functional proteins. PTC124 induces the cellular translation machinery to read through nonsense mutations, inducing production of full-length, functional proteins. PTC124 has demonstrated proof of concept in phase 2a clinical trials. Across all clinical studies to date, PTC124 has been generally well tolerated. PTC124 is currently in phase 2b development with the goal of demonstrating that increasing functional protein levels in patients with nonsense-mediated genetic disorders will safely provide clinical benefits. PTC124 has been granted orphan drug status by the FDA and the European Commission for the treatment of CF and DMD due to nonsense mutations. The FDA has also granted PTC124
Subpart E designation for expedited development, evaluation, and marketing. PTC has an exclusive collaboration with Genzyme Corporation to develop and commercialize PTC124 outside the U.S. and Canada. The development of PTC124 has also been supported by grants from, the Muscular Dystrophy Association, Parent Project Muscular Dystrophy, FDA's Office of Orphan Products Development, the National Center for Research Resources and notably, the Cystic Fibrosis Foundation Therapeutics Inc. (the nonprofit affiliate of the Cystic Fibrosis Foundation), which recently expanded support of PTC124 to include funding up to $25 million. About PTC Therapeutics Inc. A diseased kidney has been surgically extracted using a minimally invasive technique that utilizes 3D robotics, at the Henry Ford Hospital, the first surgery of its kind in Michigan. About 55,000 people are diagnosed with kidney cancer every year. Treatment options, most commonly, involve open surgery with an incision approximately one foot (300 mm) long. Sometimes it is necessary to remove a rib and divert muscle in order to remove the kidney. This is associated with very long recovery times, including a week-long hospital stay and up to two months total recovery. The name of the novel procedure is, aptly, Single Incision Robotic Surgery (SIRS,) Las it is so minimally invasive. Many potential benefits come from using this therapy, including improved cosmetic damage, a faster recovery time, less scarring, and less blood loss. Dr. Craig Rogers, M.D., Henry Ford's director of robotic renal surgery, commented on the procedure: "We made several improvements in the technique that could allow us to perform this type of procedure routinely."
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KSPC SET TO ENFORCE SECTION 42 OF PHARMACY ACT THROUGHOUT STATE The Kerala State Pharmacy Council (KSPC) is all set to enforce the Section 42 of the Pharmacy Act, 1948 by ensuring services of a pharmacist in each pharmacy outlet in the state. With this objective, the council is planning to launch a registration renewal and survey campaign within next two months. The council has already compiled details of community pharmacists from 8 out of 14 districts with the support of the private and government pharmacists associations in the state. The campaign, to compile details of practicing pharmacists in the state, is expected to complete in the next two months, according to KSPC officials. With the support of the data compiled through the campaign the council will invoke Section 42 of the Pharmacy Act which awards a punishment of imprisonment up to 6 months or fine for the unauthorised dispensation of medicine, by November 2008. The campaign will also help the council to monitor the drug dispensing system in nursing homes and clinics which comes as violation of Section 42 of the Pharmacy Act. The renewal programme, commenced in March 2008 has enabled the Council to compile details of the retail pharmacists in the northern districts of Kerala including Kasargode, Kannure, Vayanad, Kozhikkode, Malappuram, Palakkad and Trissur. ”So far in the programme, we have identified that many of the pharmacy outlets offers the services of a registered pharmacist for limited hours. The pharmacists will be available in these outlets for eight hours in the day time, but the outlets are working without the services of a registered pharmacist for the rest of the hours. We will insist that the outlets should be closed for the hours when the pharmacist is not available. Otherwise the owner should appoint more qualified pharmacists to carry on the operations in a shift basis,” said K C Ajith Kumar, president, KSPC. The council has cancelled the registration of four pharmacists and suspended the registration of less than a dozen pharmacists since the commencement of the campaign. The campaign is carried out with the support of the two factions of Kerala State Private Pharmacists’ Association (KSPPA) and the Kerala Government Pharmacists’ Association (KGPA). The council has also initiated awareness programmes among its members to ensure better pharmacy practices in retail outlets throughout the state. The Council has mandated that the pharmacists, at the time of registration, should take the Pharmacists’ Oath and should attend a practical training classes to underline the importance of disseminating drug information at the time of dispensing. The training sessions will emphasise the need of keeping better storage practices and the importance of proper billing, according to the training guidances prepared by the Practical Training Guidelines Committee under KSPC. The council is also modernising its office and website to offer faster registration and monitoring process for its members. ”All our efforts are to make the services of a qualified pharmacists manadatory in every single pharmacy outlets in the state. KSPC will ensure that there will not be any violation of section 42 of Pharmacy Act in the state. We are also
computerising our office to keep every documents update. With this, we would be able to monitor the professional activities of each registered pharmacists in KSPC. Thus we can also ensure that no pharmacist is working in more than one institution or retail outlet at a time,” added Ajith. The council will also publish all the data collected through the campaign in its newly launched website and will offer personal pages for each registered pharmacist to keep their professional documents readily available online. The computerisation programme, with an allocated budget of Rs 8 lakh, is in the final stage of implementation. The council expects to complete the project of ensuring strict implementation of section 42 within next three years, he averred. The council has been monitoring the pharmacy practices and the violation of Section 42 in pharmacy outlets in the state through its inspection system commenced 12 years ago with inspectors for three regions. Currently, there are seven parttime pharmacy inspectors offering services to two district each, under pharmacy council. The pharmacy inspection with a team of inspectors, is to inspect whether the pharmacists abide the job ethics, to monitor the duties like rendering of pharmaceutical services to the patients, according to the laws are executed promptly and to submit reports to State Pharmacy Council on the complaints against its member pharmacists.
Section 42, Chapter 5, PCI Act 42.Dispensing by unregistered persons.–(1) On or after such date as the State Government may by notification in the Official Gazette appoint in this behalf, no person other than a registered pharmacist shall compound, prepare, mix, or dispense any medicine on the prescription of a medical practitioner 2[***]; Provided that this sub-section shall not apply to dispensing by a medical practitioner of medicine for his own patients, or with the general or special sanction of the State Government, for the patients of another medical practitioner. (2) Whoever contravenes the provisions of sub-section (1) shall be punishable with imprisonment for a term which may extend to six months, or with fine not exceeding one thousand rupees or with both. (3) Cognizance of an offence punishable under this section shall not be taken except upon complaint made by 3[order of the State Government or any officer authorized in this behalf by the State Government or by order of the Executive Committee of the State Council]: 4) [Provided further that where no such date is appointed by the Government of a State, this sub-section shall take effect in that State on the expiry of a period of5 [eight years] from the commencement of the pharmacy (Amendment) Act, 1976.]
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Hospital Directory Narayana Hrudayalaya 258/A, Bommasandra Industrial Area, Hosur Road Bangalore (080) 27835000, 27835001info@hrudayalaya.com National Institute of Mental health and Neurosciences (NIMHANS) H. S. Road, Near Diary CircleBangalore 6642121 Sagar Apollo Hospital 44/54, 30th Cross, Tilak Nagar, Jayanagar Extension Bangalore 6536700-7086536714info@sagarapollo.com Sanjay Gandhi Hospital
No.5, Nrupathunga Road Bangalore - 560001080-40128200/ 41149192080-22212427 admin@stmarthashospital.org Swarna Nursing HomeI RC village, Bhuabaneswar Bhuabaneswar 410388 Capital (Govt.) Hospital Unit-VI, Bhubaneshwar Bhubaneshwar 417955, 400754, 400688 Assembly Dispensary (Govt.) Unit-V, Bhubaneswar Bhubaneswar 2400531 ESI Hospital (Govt.) Sahid Nagar, Bhubaneswar Bhubaneswar 0674-2510647
4T Block, Tilak NagarBangalore 6565948 Sri Jayadeva Institute of Cardiology Jayanagar 9th Block, Bennerughatta Road, East End CircleBangalore Details: Sri Jayadeva Institute of Cardiology is a 540 bedded super speciality cardiac hospital.
Kalinga Hospital Chandrasekharpur, Bhubaneswar Bhubaneswar 2300726 / 2301227 / 2300570 / 2300997 kalinga@sancharnet.in Municipality Hospital Old Bhubaneswar Bhubaneswar 0674-2415237
St. John’s Medical Hospital
OMC Dispensary(Govt.)
MadivalaBangalore 5531101, 5530724
Unit-VIII, Bhubaneswar Bhubaneswar 0674-2562284
St. Philomenas Hospital
Prachi Clinic
VK Nagar Bangalore
Unit-III, Bhubaneswar Bhubaneswar 558656
St. Philomenas Hospital
Railway Hospital
VK Nagar PostBangalore 5577046, 5305367
Unit-1, Bhubaneswar Bhubaneswar 532258
Wockhardt Hospital
Rajdhani Nursing Home
14, Cunningham Road Bangalore 91-080-22610372281149 whhi@vsnl.com, www.whhi.com
Sahid Nagar Bhubaneswar 411860
Yellamma Dasappa Hospital
Old Station Square Bhubaneswar 416716
No.25, Andree Road Shanthi Nagar Bangalore 2225642, 2222505
Tibetan Medical Institute
St. Marthas Hospital
Unit-I, Bhubaneswar Bhubaneswar 401496
Sunflower Nursing Home
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