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Drug Information Centre (DIC) Indian Pharmaceutical Association

Drug Information Bulletin

Bengal Branch Tele fax: 033 24612776, E-mail: ipabengal.dic@gmail.com Web Site: http://www.ipabengal.org Contact: 09830136291

th

Year

Volume: 05

Number: 47

3rd March 2012

Content Exenatide once weekly may be more effective than Insulin Glargine for glycemic control Advinus partners with Celgene to develop therapies for Kala Azar Europe to speed Pricing & Reimbursement decisions China to keep track of drugs prescribed by doctors Forgotten Antibiotics: An inventory in Europe, the United States, Canada, and Australia IPA urges defence ministry to create a wing of Pharmacy Corps in military services IPA Bengal Branch collaborated with 12th Congress of International Society of Ethnopharmacology at Kolkata during 17th -19th February 2012

Exenatide once weekly may be more effective than Insulin Glargine for glycemic control MedWire reports, "Long-term treatment with exenatide once weekly (EQW) provides significantly better glycemic control than once-daily insulin glargine (IG) in patients with poorly controlled diabetes," according to a study published online Feb. 22 in the journal Diabetes Care. In 390 patients who received either EQW 2 mg or IG 10 IU/day for up to 84 weeks, researchers found that at "84 weeks, the mean reduction in HbA1c from baseline was significantly greater in the EQW group than in the IG group, at 1.2% versus 1.0%." What's more, "treatment with EQW was associated with a significant group mean weight loss of 2.1 kg as opposed to

a mean weight gain of 2.4 kg in the IG group." Advinus partners with Celgene develop therapies for Kala Azar to

Bangalore: Advinus Therapeutics has partnered with Celgene Global Health (CGH) to develop therapies for Visceral Leishmaniasis (Kala Azar), the second-largest parasitic killer in the world with an estimated 500,000 cases each year. Recent estimates show that more than 90 per cent of VL cases occur in India, Bangladesh, Nepal, Brazil and Sudan. Dr Rashmi Barbhaiya, CEO and MD, Advinus, said, Such collaborative models are needed to fulfil unmet medical needs for neglected diseases and it can also provide guidance for a new paradigm of developing medicines for

global needs with effective resource utilization, speed and cost-effectiveness. VL is a true unmet medical need, said Dr Jerome B Zeldis, CEO, Celgene Global Health. We look forward to working with Advinus to derive VL drugs using the vast chemical library of Celgene as a starting point for development. Europe to speed Reimbursement decisions Pricing &

2 has grown more complex amid complaints that local drugmakers are sometimes favored and a general lack of clarity. To get results, the EC proposes that each member nation designate a panel to assess alleged violations; award damages to a complainant; introduce requirements for member nations to report on approval decisions and performance; notify the EC of pricing and reimbursement measures; and ensure decisions are in line with the European Court of Justice on transparency obligations. Not surprisingly, the European Generic Medicines Association welcome the move, since greater access to generics may be achieved (here is the statement). But the trade group for brand-name drug makers, European Federation of Pharmaceutical Industries and Associations, had a mixed reaction, saying that still more must be done given the European debt crisis. The practice of international price referencing prevents differential pricing between markets something that is standard in other parts of the world where it is not only accepted but indeed welcomed that companies charge lower prices in low- and middle-income countries. In Europe too, access to medicines could be improved for patients if governments embraced differential pricing, EFPIA president Richard Bergstrom says in a statement. Especially in times of economic crisis, the focus of Member States on pricing measures such as international or therapeutic reference pricing poses a threat to the long-term innovative capability of Europe and hinders access to medicines. This is even more worrying if emergency price cuts under exceptional circumstances such as in Greece lead to automatic and arbitrary price cuts in 15 other Member States. China to keep track of drugs prescribed by doctors

Plagued by complaints that regulatory approval is too slow, the European Commission has issued a proposal to speed things along. Specifically, the idea is that member states should decide on pricing and reimbursement within 120 days if the drugs are innovative medicines and make decisions within 30 days for generics. Currently, the rule allows 180 days for such decisions. Studies have shown that delays in pricing and reimbursement decisions can last 700 days for innovative meds and up to 250 days for generics. A key problem is that a 1989 directive has never been amended to reflect new realities on the ground, notably, the growing availability of lower-cost generics, the EC writes in its proposal (which you can read here). Our proposal will lead to substantial savings for public health budgets, for example by allowing earlier market entry of generic products. It also creates a more predictable environment with greater transparency for pharmaceutical companies, thus improving their competitiveness, EC vp Antonio Tajani, who is responsible for Industry and Entrepreneurship, says in a statement. Another issue has been compliance with the older directive, which required transparency (you can about this here). The hope had been to smooth out distortions in trade between member nations seeking to control spending. Over the years, however, government pricing

Beijing: China will keep track of all drugs prescribed by doctors by 2015 using an electronic monitoring system, authorities said. The system, launched in 2006, applies to 56,000 types of drugs till the end of February. Another 119,000 types will be covered by the end of 2015, according to a five-year drug supervision plan published by the State Food and Drug Administration. Drugs that are part of the countrys basic medicine system are already covered by the electronic monitoring network, reported Xinhua. The system is used to monitor the entire drug production and circulation process, allowing for the timely and effective control of drugs in the event of safety risks, said authorities. The system will also help prevent counterfeit drugs from entering the market. [Source: IANS] Forgotten Antibiotics: An inventory in Europe, the United States, Canada, and Australia In view of the alarming spread of antimicrobial resistance in the absence of new antibiotics, this study aimed at assessing the availability of potentially useful older antibiotics. A survey was performed in 38 countries among experts including hospital pharmacists, microbiologists, and infectious disease specialists in Europe, the United States, Canada, and Australia. An international expert panel selected systemic antibacterial drugs for their potential to treat infections caused by resistant bacteria or their unique value for specific criteria. Twenty-two of the 33 selected antibiotics were available in fewer than 20 of 38 countries. Economic motives were the major cause for discontinuation of marketing of these antibiotics. Fourteen of 33 antibiotics are potentially active against either resistant Grampositive or Gram-negative bacteria. Urgent measures are then needed to ensure better availability of these antibiotics on a global scale.
Source: ReAct:

3 Long-term opioid therapy may lead to Hormonal abnormalities MedPage Today reported, "Intractable pain patients on long-term, high doses of opioids should be screened for hormonal abnormalities," researchers reported in an abstract at the American Academy of Pain Medicine meeting. "In a small, long-term, single-clinic study, the majority of patients had, as expected, low testosterone -- but some also had abnormalities in cortisol and other hormones that may indicate an incomplete resolution of pain," the study found. "To assess potential hormone abnormalities in intractable pain patients who've been on long-term opioid therapy," researchers "studied 22 patients ages 47 to 71 who were on continuous opioid therapy for at least 20 years" whose "daily morphine equivalence doses ranged from 450 mg to 5,650 mg." IPA urges defence ministry to create a wing of Pharmacy Corps in military services The hospital pharmacy division of the Indian Pharmaceutical Association (IPA) has urged the Union Ministry of Defence to establish a Hospital Pharmacy Services or Pharmacy Corps in the 127 defense hospitals in the country. In a memorandum to the union defence minister, A K Antony, the IPA said for better patient care and rational use of drugs among defence personnel, the services of a separate sect of Pharmacy Corps are inevitable. The missive to the minister also requested the minister to consider the National Human Rights Commission report of 1999 and the Hathi Committee report of 1975 while implementing the drugs dispensing wing in the defense sector. Dr R N Gupta, the chairman of the hospital pharmacy division of the IPA said it is high time a pharmacy wing created in the defence services as there are services of

4 Army Medical Corps, Army Dental Corps, Veterinary Corps, Military Nursing Service, etc. in the Indian military, but so far a wing of Pharmacy Corps was not created. While medicine is the actual component due to its judicious use, only through right handling, right dose and right storage, patients are being cured or are protected from diseases. The pharmacists are the experts of drugs for its proper use and handling. Currently, there are pharmacists with qualifications such as PhD, Pharm D, M Pharm, B Pharm and D Pharm available to provide hospital pharmacy services. They can be utilized in our military services, he said over telephone from Chhattisgarh. Gupta pointed out that the NHRC Report of 1999 suggested for engagement of graduates and post graduates in pharmacy in each hospital, and those suggestions were similar to the recommendations of the Hathi Committee of 1975. On the 28th of June, 2011 the Drug Controller General of India (DCGI) issued guidelines on IV Fluids storage, distribution and administration to be followed in each hospital. So, in view of these, we would like to request our union defense minister to implement hospital pharmacy services in all defense hospitals as per NHRC report and Hathi Committee report to utilize the services of qualified pharmacists in the health care of our defense personnel, Dr Gupta said. According to him, due to the advancement of Pharmaceutical Technology, the hospital pharmacy services have been upgraded now, which on implementation provide better health care to patients in an economical manner. The medication therapies and their delivery systems are becoming more and more complex day by day due to potent drugs, new drugs, costly drugs and non-conventional advanced drug delivery system. Besides, due to wrong handling of drugs, improper patient counselling, adverse drug reaction, lack of drug information centre, and improper dispensing of medicines by nonpharmacists, there are chances for medication-error, more hospitalization, costly treatments and irrational drug therapy. Only qualified pharmacist can solve all these problems by properly managing a dispensary, he commended. He opined that a defence military hospital must be attached with a full-fledged pharmacy with qualified pharmacists as their services are not limited to mere dispensing of drugs, but included in drug store inventory management, hospital formulary and drug procurement, indoor and outdoor dispensing, clinical pharmacy, pharmacovigilance, patient counseling and a host of other service.
Source: Pharmabiz.com

IPA- Bengal Branch collaborated with 12th Congress of International Society of Ethnopharmacology held at th th Kolkata during 17 -19 February 2012

Prof. Luc Antoine Montagnier, Nobel Laureate in Medicine & President, World Foundation AIDS Research & Prevention addressing a press Conference at Kolkata, India during ISE-

2012