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Focus on emerging antibiotic resistance By Dr Sharda Jain Indian Government and medical fraternity should wake-up to minimize the emergence of antibiotic resistant micro-organism and to promote effective economic antibiotic prescribing policy. Resistance to antibiotics by previously susceptible microorganisms is becoming a cause of worry in recent years. It is often a case of treatment failure or require the use of larger doses of expensive antibiotics. Recent editorial in British Medical Journal should be an eye-opener for everybody. It warns that we are heading for global pandemic of antibiotic resistance being developed by misuse of antibiotics. No doubt infections are great killer of a man kind and their prevention is an important part of health care of an individual. Antibiotics are the greatest discovery of 20th century. If infection develops, antibiotics need be given. As far as choice and administration of antibiotics is concerned the choice begins empirically with the selection of drug(s) that is most likely to be effective against the organism causing the illness. If bacterial culture and sensitively are possible, the results of these investigations guide the doctor for further treatment, particularly if individual is not responding to the empirically chosen antibiotic(s). If bacterial culture and sensitively are not possible and individual is not responding to the initial antibiotic(s), a second line of antibiotic or combination of antibiotics for the infection are prescribed. While these drugs are wonder drugs, but their rampant use by doctors, overuse and misuse by BIMS, BAMS doctors and so called RMP who do not have any medical qualiﬁcations is rendering them ineffective. This is a malpractice and it breeds resistant strains. The organisms are known to undergo mutation, which allows them to survive, live and reproduce and pass the trait to offspring which does not respond to antibiotics at all, forming fully resistant strain of organism. Medical experts and medical bodies have been advising and cautioning their colleagues and people
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for rational use of antibiotics and stop its abuse and misuse. Failing which it will become very difﬁcult to carry out major surgeries, organ transplantation and give cancer chemotherapy in near future. It seems if medical bodies do not press Government and WHO for strict guidelines of antibiotic and its sale, we will soon return to another pre-antibiotic era. You will ask what are the live examples? Important examples of antibiotics resistance in India are tuberculosis and bacterial pneumonias, which could be treated easily in recent past but now posing major problem of drug resistance. Resistant cases of tuberculosis alone amount to 15-20 per cent cases now. Medical fraternity is worried as newer molecules of antibiotics are not readily coming in the market due to lack of incentive for development research. Secondly the antibiotics are over prescribed both by qualiﬁed and unqualiﬁed doctors. Self medication is the biggest menace with leftover medicines in India. Any antibiotics can be picked up as over the counter drug. Not like USA, where for majority of antibiotics, a doctor’s prescription is must. Lastly, most people do not complete the course of prescribed antibiotics, which makes the antibiotic work as a kind of ‘vaccination’ for surviving bacteria. If one goes by USA experience, it is scary that deaths related to antibiotic resistance to stapholo-coccus were more than double than the number of HIV related deaths.
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Indian Government and medical fraternity should wake-up to minimise the emergence of antibiotic resistant micro-organism and to promote effective economic antibiotic prescribing policy. On war footing, they should organise public education measures and put stop to self medication of drugs. It is high time that the medical bodies like IMA should classify antibiotics in to three groups. Unrestricted use (safe, effective and relatively economical). Restricted use: based on prevalence of antibiotic resistance, cost, safety and supply. In simple words, mechanism must exist whereby an initial dose of restricted antibiotic can be given in an emergency, for which an approval can be sought for subsequent doses and future use. Excluded (no advantages, over already existing drugs). Lastly, it is not humanly possible to remember 50 brands of same antibiotics by doctors. The medicine should be available by generic name only. The primary objective should be not to prevent access to useful drugs but to justify the use of antibiotic based on peer review. Similarly government should launch audit of antibiotic usage and study of prescribing habits which may suggest educational interventions for public and doctors. (The writer can be contacted at sharda.lifecare@ gmail.com)
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Renal artery stenosis After diabetes and hypertension, renal artery stenosis is the leading cause of kidney failure. Recent changes in the opinions of nephrologists and cardiologists, as well as new medical guidelines, are increasing doctors’ awareness of the need to screen for it. For a screening to be medically required, one of these conditions must exist: ◆ The patient is over 65-years old and diagnosed with high blood pressure (hypertension) for the ﬁrst time. ◆ The patient has medically controlled blood pressure that is worsening. ◆ The patient has an acute kidney injury. ◆ The patient has a chronic kidney disease that’s not explained by diabetes, volume depletion or some form of vascular disease. This approach excludes routine screenings for renal artery stenosis in low risk hypertensive patients -- for example, a signiﬁcantly obese young patient with no vascular disease, who also doesn’t have other diseases, such as diabetes or sleep apnea would not need screening. The inability to control a patient’s hypertension who is not on more than two blood pressure medications doesn’t justify screening IF the patient doesn’t meet one of the above four conditions. Doctors should avoid screening low risk patients because most times the positive results are “false positives” so additional testing only leads down blind alleys. When one of the reasons to do renal artery stenosis screening is present, a renal artery doppler is the only initial medical screening needed. While it is less expensive than other tests, its drawbacks include its availability and the ultrasonographer’s skill. Also screening larger patients is more difﬁcult. For an obese patient whose body-mass-index (BMI) exceeds 35, a doctor might consider imaging for other reasons. In this case, a CT angiogram or magnetic resonance angiography (MRA) of the renal arteries is needed only if the doppler test returned uncertain results or did not show the renal arteries clearly and is ordered by a cardiologist or nephrologist.
Practice Guideline The Endocrine Society has released a new clinical practice guideline for the primary prevention of cardiovascular disease and type 2 diabetes in patients at metabolic risk. The guideline appears in the October issue of the Journal of Clinical Endocrinology & Metabolism (JCEM), a publication of The Endocrine Society. There is growing evidence that many patients who develop cardiovascular disease or diabetes have a preexisting metabolic risk. This risk includes conditions such as enlarged waist circumference, hypertension, and elevated plasma glucose levels. The presence of three of more such conditions should alert a clinician to a patient at metabolic risk, said Dr. James Rosenzweig, director
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of diabetes services in the Section of Endocrinology, Diabetes and Nutrition at Boston Medical Center, and chair of the task force that developed this guideline. “The dramatic increase in the incidence of patients at risk for cardiovascular disease and diabetes throughout the developed and developing world requires physicians and other care providers to be aware of the risk factors for these conditions and identify patients at risk in order to initiate treatment,” said Dr. Rosenzweig. “This guideline was developed for just this purpose.” The guideline recommends that: - Health care providers should incorporate into their practice concrete measures to reduce the risk of developing cardiovascular disease or diabetes. These include the regular screening and identiﬁcation of patients at metabolic risk with measurement of blood pressure, waist circumference, fasting lipid proﬁle, and fasting glucose. - Patients with pre-diabetes should be screened at 1to 2-year intervals for the development of diabetes with either measurement of fasting plasma glucose or a 2hour oral glucose tolerance test. - For the prevention of cardiovascular disease and diabetes, priority should be given to lifestyle management. This includes anti-atherogenic dietary modiﬁcation, a program of increased physical activity, and weight reduction. - All patients having metabolic risk should undergo a 10-year global risk assessment for cardiovascular disease. This scoring will determine the targets for lipoprotein-lowering therapy. The level of intensity of lipoprotein-lowering therapy should be determined by risk reduction, safety, and cost-effectiveness. NIFEDIPINE & PREGNENCY When a pregnant woman goes into early labor, her obstetrician may give her drugs to quiet the woman’s uterus and prevent premature birth. New research shows, however, that one popular drug works no better than a placebo at maintaining pregnancy after the initial bout of preterm labor is halted, say scientists at the Stanford University School of Medicine, Lucile Packard Children’s Hospital and Santa Clara Valley Medical Center. The new trial is the ﬁrst-ever placebo-controlled test of nifedipine, a muscle relaxant originally developed to lower blood pressure, and its effect on premature delivery with prolonged treatment. “Medication use should be minimized in pregnancy unless it’s clearly indicated,” said Deirdre Lyell, MD, assistant professor of obstetrics and gynecology at Stanford and the study’s lead author. Serious side effects of nifedipine in pregnancy are rare, Lyell said, but even a low risk isn’t worthwhile if the drug has no beneﬁt. “We all want to prevent preterm birth, but prolonged treatment with nifedipine doesn’t appear to be an answer.” The ﬁndings will appear in the December issue of the journal Obstetrics and Gynecology.
GAD –TOOLKIT The World Federation for Mental Health (WFMH) is delighted to announce the publication of a comprehensive toolkit “Understanding generalised anxiety disorder” which represents a major advance in helping people understand this debilitating condition. The toolkit provides essential, up-to date information about generalised anxiety disorder (GAD) in both adults and children, its current treatments, and the effects of stigma on those living with the disorder. Through the information presented, the toolkit aims to both educate and inform those with GAD, their physicians, families and friends, and the general public about a condition that affects the lives of millions of people, and results in marked disability and signiﬁcantly impaired quality of life.1 In addition to the information about GAD, the toolkit also contains a list of national and local organisation which can be contacted for further information and support. The GAD toolkit is produced by the WFMH and supported by an unrestricted educational grant from AstraZeneca, and is available at http://www.wfmh. org. PREMARIN – NEW INDICATION PREMARIN® (conjugated estrogens) Vaginal Cream 0.5 g has been approved by the U.S. Food and Drug Administration (FDA) for a new indication and a new less frequent twice-weekly dosing regimen to treat moderate to severe postmenopausal dyspareunia (painful sexual intercourse) announced Wyeth Pharmaceuticals, a division of Wyeth (NYSE:WYE). “This approval is welcome news, especially when you consider that more than one in four untreated postmenopausal women experience dyspareunia, a symptom of vulvar and vaginal atrophy, which typically does not subside without treatment,” says Gloria Bachmann, M.D., Director of the Women’s Health
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Institute at the University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School, New Brunswick, N.J. and Chief of the OB/GYN service at the teaching hospital. PREMARIN Vaginal Cream is the ﬁrst vaginal estrogen therapy indicated for the treatment of moderate to severe dyspareunia due to menopause. A low-volume regimen of PREMARIN Vaginal Cream can treat painful intercourse due to menopause, restore vaginal tissue, and reverse changes in the vagina that occur with menopause. The approval is based on efﬁcacy results from a multicenter clinical study that included a 12-week randomized, double-blind placebo phase followed by a 40-week open-label phase. Results from the 12-week phase showed that both low-dose regimens of PREMARIN Vaginal Cream (0.5 g daily [21 days on/7 days off] or twice weekly) signiﬁcantly improved the dyspareunia score versus placebo at 12 weeks. In this study, dyspareunia was one of the most bothersome symptoms of vulvar and vaginal atrophy. Endometrial safety was assessed in women who completed the 52-week study period and had evaluable endometrial biopsies. There were no reports of endometrial hyperplasia or endometrial carcinoma in these women in either regimen. “This new indication for PREMARIN Vaginal Cream, with a low volume of 0.5 g and two different dosing regimens - 21 days on/7 days off or twice weekly - gives health care professionals and women a new option in treating moderate to severe dyspareunia due to menopause,” says Eileen Helzner, M.D., Assistant Vice President, Global Medical Affairs, Wyeth Pharmaceuticals.
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Insufﬁcient DOTS Coverage Leads to Increased MDR-TB Prevalence in Nepal, Ofﬁcial Says Although more than 90% of tuberculosis patients in Nepal complete treatment successfully, inadequate DOTS performance could be contributing to an increase in multi-drug resistant TB in the country, Dirgh Singh Bam, secretary of Nepal’s Ministry of Health and Population, said recently, the American Chronicle reports. According to Bam, MDR-TB accounts for up to 1.8% of new TB infections in Nepal. Bam said Nepal’s TB program has received praise in Southeast Asia because of its community support, government commitment, partnerships and access to DOTS. However, Bam cited numerous factors that could contribute to inadequate DOTS coverage in Nepal, including noncompliance among patients, incorrect treatment or dosage, insufﬁcient drug availability and poor quality medications. About 29% of TB patients in Nepal are coinfected with HIV, Bam said, adding that injection drug users also are at a high risk of developing HIV/TB coinfection. “Without addressing HIV and IDU issues, it will be very difﬁcult to effectively respond to TB,” Bam said. He also emphasized the importance of coordinating TB and HIV programs, adding that community participation is “essential” for effective HIV/TB care. In addition, Bam said patients who had successfully completed TB treatment courses are helping district committees to improve TB programs (Ramakant, American Chronicle, 11/19).
Clinical Establishments Bill to expand purview to cover all healthcare bodies The Government will redraft the Clinical Establishments (Registration and Regulation) Bill 2007 to expand its purview the entire gamut of healthcare establishments including public health institutions, laboratory and diagnostic services, R&D facilities taking up clinical trials on patients and all systems of medicine for mandatory registration. The original bill seeking to make mandatory registration of all clinical establishments will be retitled as ``the Healthcare Establishments (Registration and Regulation) Bill, 2007” to expand the purview in line with the recent recommendations in this regard by the Parliamentary Standing Committee on Health and Family Welfare, sources said. The panel, headed by Amar Singh, in its report also wanted the Government to persuade all States governments to adopt the central legislation so that uniformity in health standards is maintained across the length and breadth of the country. For this, ﬁnancial as well as other infrastructural support, as and when required, may also be provided to the States to motivate them in adopting the same, the panel said, as the proposed Act was originally planned for a few states where a similar legislation is absent. “The Committee, after going through the objections and suggestions, observes that contrary to some of similar existing State laws, this is a comprehensive Central Legislation aimed at not only covering all categories of healthcare establishments but also practising all the recognized systems of medicine. Therefore, its title should be such which covers all the desired entities or
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reﬂects them through some common term. The word clinical, though it means related to medical, appears to be restrictive to allopathic clinics only. The word ‘healthcare’ takes care of most of the objections. Healthcare means related to health and it may be through any system of medicine and includes laboratory and diagnostic services also,’’ the report said. The reworked bill is also likely to include OPD services as the panel felt that even surgical interventions could be done without patient’s stay in the hospital or nursing home. “Many Healthcare Establishments are now also involved in independent Research & Development activities specially in the context of research in new drugs/drug combinations followed by their clinical trial on patients. The Bill in its present form does not categorically provide for inclusion of these establishments under the deﬁnition of clinical establishments. The Committee strongly feels that their exclusion would be detrimental to the rights of the patients who form part of the experiments/research studies undertaken by such establishments,’’ the panel said. It also endorsed the provision for making mandatory the registration of single-doctor clinics, despite widespread protests from the medical fraternity. The new Act now will also be binding for all establishments set up by partnerships, societies, charity/missionary, and mobile units. In line with the change of deﬁnition, the proposed national council would also be named as National Council for Healthcare Establishments. The Committee does not ﬁnd any substance in exclusion of Government/public health institutions/ autonomous institutions from the purview of the Act as put forth before it through some representations.
Treatment during primary HIV infection has limited beneﬁt A short course of HIV treatment soon after a person if infected with HIV protects CD4 cell count in the longterm, but only if such treatment lasts for at least twelve months, according to the results from the CASCADE cohort collaboration published in the November 30th edition of AIDS. The investigators found few other beneﬁts of treatment at this stage of HIV infection (often called primary infection), although individuals who received treatment at this time were less likely to die of non-HIV-related causes than patients whose HIV treatment was started at a later stage. There is uncertainty about the beneﬁts of starting HIV treatment during primary HIV infection. There is some evidence to suggest that treatment at this time can have long-term beneﬁts for the immune system. However, such evidence is inconclusive and a large randomised controlled trial, the SPARTAC study, is currently investigating the possible beneﬁts or risks of early HIV therapy. As the results of this study will not be available until 2009, researchers from the CASCADE collaboration, which involves 23 cohorts of HIV-positive patients in Europe, Australia and Canada, designed an observational study to see if treatment during the six months after infection with HIV had long term beneﬁts. Their study involved 1023 individuals, all of whom had a documented date of HIV seroconversion. A total of 348 (34%) patients started treatment within six months of their infection with HIV. The investigators divided these patients according to the duration of HIV treatment: under six months; six to twelve months; or over twelve months. They then compared changes in CD4 cell count and viral load, and rates of death, progression to AIDS and other serious illness amongst the patients who started HIV treatment early and those who deferred HIV treatment until later. As expected, providing HIV treatment boosted CD4 cell count, and overall patients taking early HIV treatment had an average CD4 cell count of over 700 cells/mm3 compared to an average count of a little under 500 cells/ mm3 in the patients who deferred treatment. The slope of CD4 cell decline was steeper, however, amongst patients who took early HIV treatment in the ﬁrst six months after they stopped HIV therapy. The investigators estimated that the CD4 cell count ﬁve years after infection with HIV for the “average” patient whose CD4 cell count was 550 cells/mm3 at the time of seroconversion would be 234 cells/mm3 for patients who deferred HIV treatment, 241 cells/mm3 for patients who started HIV treatment during primary infection and who took such treatment for less than six months and 304 cells/mm3 for patients who started treatment early and remained on such treatment for six to twelve months. These CD4 cell counts were not signiﬁcantly different. However, the researchers did ﬁnd evidence that early HIV treatment beneﬁted the CD4 cell count in the longterm, but only if such treatment lasted for over twelve
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months, with such patients having an average CD4 cell count of 430 cells/mm3. Starting a short course of HIV treatment during primary infection had no long-term effect on viral load. Once patients ceased taking early treatment, their viral load reached levels comparable to that seen in patients who deferred treatment (p = 0.57). The duration of treatment did not affect this outcome. Next, the researchers examined whether a short period of HIV treatment delayed the need to take HIV treatment later. Of the patients who started treatment during primary infection, 61% stopped their HIV treatment. The investigators’ ﬁrst analysis suggested that these patients were 35% less likely to have to start taking HIV subsequently than patients who deferred the initiation of HIV therapy. However, after taking into account the amount of time the early treatment group had already spent on treatment the researchers found that this group of patients had signiﬁcantly higher odds (hazard ratio, 2.63, 95% CI: 2.05-3.37) than individuals who deferred taking HIV treatment. They also found that patients who reinitiated therapy did so at signiﬁcantly higher CD4 cell counts (351 cells/mm3) than patients who started HIV treatment for the ﬁrst time (278 cells/mm3, p < 0.001). Finally, the investigators looked at rates of disease progression. During the whole period of follow-up, similar proportions of patients taking early or deferred HIV treatment developed AIDS (approximately 3%). A lower proportion of patients taking early HIV treatment died (0.6% vs. 1.8%), a difference that just reached statistical signiﬁcance. Furthermore, the researchers found that three-quarters of the deaths in the delayed treatment group were not due to causes normally associated with HIV, including bacterial infections, respiratory disease and non-HIV-related cancer. “Our ﬁndings suggest that the early immunologic gain from initiating early combination antiretroviral therapy within the six months following HIV seroconversion is unlikely to maintained”. They speculate that treatment was being started too late to have any long-term beneﬁts, noting recent research that suggests that most of the damage sustained by the immune system occurs in the two weeks following infection with HIV. A number of limitations with their research are also noted by the investigators. These include the study’s observational design which meant that they were unable to determine the reasons why patients taking early HIV treatment stopped or restarted their therapy. “Uncertainty in relation to the long-term clinical beneﬁts of early treatment for HIV persists” conclude the investigators, however they add, “evidence from our data suggests that higher CD4 cell gains may result when treatment is maintained for at least twelve months. Continued careful monitoring of such individuals, however, will be crucial while on treatment and once it is stopped.” Reference Pantazis, N. et al. The effect of antiretroviral treatment on different durations of primary HIV infection. AIDS 22: 2441-50, 2008.
Baxter India Has announced the launch of Renal Home Care (RHC), an integrated patient care system that brings together highly trained counselors, clinical and technical services team to provide patient care to renal patients. It will facilitate better and more frequent contact with those on peritoneal dialysis (PD), provide easy accessibility to renal dietician, besides supporting and addressing the product delivery and distribution enquiries. It will also update nephrologists on Baxter therapy and product information. RHC counselors can be reached at 180 010 211 10, the toll free number “This initiative is launched in pursuit of making a meaningful difference in the lives of patients with end stage renal disease (ESRD). It is a continuation of the company’s ongoing efforts to improve patient care and enhance quality of life of patients,” said general manager of Baxter India Raj Airey at a press conference here on Thursday. Every year, nearly 1.5 lakh new ESRD patients are diagnosed in India who join an increasing patient population, of these only ﬁve to seven per cent are able to get some form of treatment, while the rest succumb to the disease without getting any deﬁnite healthcare intervention, according to AIIMS and Indian Council of Medical Research (ICMR) report.
Dr VM Katoch, MD, Has taken over dual charge as the ﬁrst secretary, Department of Health Research (DHR), government of India and also the director general, Indian Council of Medical Research (ICMR). Dr Katoch has been appointed to hold the charge of secretary, DHR and DG, ICMR for the next ﬁve years until February, 2013. A former director of National JALMA Institute for Leprosy & other Mycobacterial Diseases, an Institute of ICMR at Agra, Dr Katoch is a distinguished scientist who has won several accolades as well as awards for his research work on Leprosy, tuberculosis and HIV-AIDS including the prestigious JALMA Trust Fund Oration Award (1999) accorded by ICMR. After assuming charge, in his ﬁrst address to the scientists and other employees of ICMR, Dr Katoch reiterated the commitment of the Department of Health Research and ICMR to work for the health of Indian population. He said that after the period of expansion seen in the last few years, the ICMR should strive hard to consolidate the gains and take the new initiative forward to face the new challenges. He urged the scientists and employees of ICMR to use their talent and capacity to make ICMR the fulcrum of Department of Health Research. He is Fellow of all the national academies in India. Among his other achievements are awards such as SherI-Kashmir Sheikh Mohd Abdualla Oration Award, Dr C G S Iyer oration Award, Erwin Stindll Memorial Oration Award and Dr S C Agarwal oration Award. He is recipient of Ranbaxy Science Foundation Award 2003. He has 25 years of experience working on microbiology and molecular biology of mycobacterial
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diseases and has contributed over 170 research papers on various aspects such as different taxonomy markers, in-vitro viability methods, molecular mechanisms of drug resistance etc. His current interests are molecular mechanisms of drug resistance, molecular epidemiology and genomics on which, until recently he was conducting studies.
PCI efforts In its efforts to identify and clamp down on the pharmacy colleges which are hoodwinking the authorities by reportedly running without proper faculties, the Pharmacy Council of India (PCI) has started surprise inspections of the pharmacy colleges. After completing the inspections, the PCI will soon come out with a report card on the status of the pharmacy colleges which are working without proper faculties. The PCI’s action comes in the wake of reports that several pharmacy colleges in the country are running without proper faculties. At the time of inspections by the AICTE team before giving permission to start the colleges, these institutions will hoodwink the team by arranging to parade the required staff on the day of site inspection. But, once the site inspection is over, this arrangement will come to an end as there is hardly any follow-up inspections by the AICTE, mainly due to lack of staff. PCI chairman Dr B Suresh said that such mal-practices by educational institutions will have a telling effect on the quality of pharmacy education in the country. PCI is concerned that these actions will work against the PCI’s efforts to improve the quality of pharmacy education. It was due to the relentless efforts of PCI that the central government has given permission to start Pharm D course in the country which will bring the pharmacists in the country at par with the international level. The main reason for this kind of practices by the educational institutions is the dual powers for regulating the pharma education in the country. At present, the pharmacy education is regulated by both the AICTE and the Pharmacy Council of India (PCI), a statutory body exclusively constituted for the pharmacy education in the country. While the PCI has D Pharm registration and related powers, all other statutory powers are vested with the AICTE on the same pattern of Dental Council of India, Nursing Council of India and Medical Council of India. As per norms, the permission to the colleges is given by the AICTE after verifying that the colleges have the required infrastructure. But there have been hardly any follow-up inspections after according permission to begin the colleges. Though the AICTE has been on a permission giving spree to the pharmacy colleges, it was not conducting the mandatory follow-up inspections to ensure that these colleges are run by a proper professional team. During the last two years, the AICTE has given permission to around 500 pharmacy colleges in the country. In the last one year, it has given permission to 120 colleges in Andhra Pradesh alone. There are more than 800 pharmacy colleges in the country.
SPURIOUS DRUGS The Centre has issued detailed guidelines to the State governments to undertake focussed surveillance over possible movement of spurious drugs, even as tests in the state drugs testing laboratories showed that only 0.29 per cent of samples tested were found to be spurious on an average during the last three years. Union health ministry sources said the laboratories tested about 40,000 samples on average during the last three years and the rate of spurious drugs was minimal, contrary to the reports especially in the international media about large presence of spurious drugs in the country. Apart from passing the Drugs and Cosmetics (Amendment) Bill, 2005 to enhance the penalties on the manufacturing and marketing of spurious drugs and make ofﬁces cognizable and non-bailable, the Centre had taken a number of measures to check the sale of spurious drugs, sources said. The bill, passed by both the Houses recently, also seeks to authorise any gazetted ofﬁcer to ﬁle prosecution for drug related offences. Under the capacity building project through World Bank, assistance had been given to upgrade testing facilities and to establish new drug testing laboratories so as to enhance the capacity to test larger number of samples. Under the project, 23 States and six Central drug laboratories have been strengthened. Besides, speciﬁc training programmes for regulatory ofﬁcials of state governments on logistics of intelligence work, prosecutions and monitoring have been conducted with the assistance of FDA, Maharashtra. The health minister also revealed that it had taken the help of pharma industry and trade to ﬁght menace of spurious drugs as a shared responsibility. Number of cases could be successfully detected through the initiative taken by the industry involving hiring of retired intelligence ofﬁces. A massive survey would also be launched soon to ascertain the exact quantum of spurious drugs in the markets and settle at rest the controversy triggered by conﬂicting reports by different agencies and organisations, sources added.
PREGNENCY AND COFFEE The Food Standards Agency (FSA) has lowered its recommended levels of the stimulant from a maximum of 300mg a day to 200mg - a reduction of a third. It follows research by Leicester and Leeds universities linking caffeine to babies born with low birth weight. The study will be published in the British Medical Journal this week. Children born with a low birth weight are more likely to suffer health problems like heart disease and diabetes.
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The advice means women should stick to a maximum of two average-sized cups of coffee per day - although those who have been drinking three cups have been told not to panic. The FSA’s chief scientist Andrew Wadge said: “This is new advice but these are not new risks. “I want to reassure women that if you’re pregnant and have been following the previous advice, the risk is likely to be small.” The FSA guidance means women should limit themselves to three or four cups of tea a day and watch their intake of cola, chocolate and energy drinks. Drinks bought from coffee shops may be far higher than the FSA estimates for the average-sized home-made cup. The university study which prompted the revised guidance involved 2,500 pregnant women.
INSURANCE COMPANIES CALL FOR GENERICS USAGE All the doctors had to do was show up, enjoy a free dinner at an elegant Rochester, N.Y., area restaurant specializing in steaks, chops and top-shelf wines, and pocket $100 on the way out the door. Health insurance companies had invited the physicians to hear a pitch about the beneﬁts of prescribing generic drugs instead of their pricier, name-brand competitors. Meet the ﬂip side of a concern about corporate inﬂuence in the doctor’s ofﬁce that’s been criticized - often stridently - when the pharmaceutical industry entices doctors to prescribe brand-name drugs. Under pressure, that industry has since reined in its promotional efforts. But insurance companies are allowed to push doctors toward cheaper prescriptions, frequently by offering the physician a form of bonus, a cut from the savings that insurance companies get when doctors prescribe generic drugs. For example, Independent Health, a Buffalo, N.Y.based insurer, offered doctors who prescribe 70 percent or more generic prescriptions in a month a bonus of 50 cents per patient per month. A doctor seeing 500 patients per month who meets the 70 percent minimum can collect $3,000 a year. “On either side you’ve got corporate bottom-line interests putting pressure on physicians who should be putting patients ﬁrst,” said Dr. Jean Silver-Isenstadt, executive director of the National Physicians Alliance, an industry organization that prioritizes patient interests. John Rodgers, executive vice president and chief marketing ofﬁcer for Independent Health, said the incentive program rewards doctors for prescribing generics when possible - but it doesn’t punish them if they don’t.
IMS Health Forecasts 4.5 – 5.5 Percent Growth for Global Pharmaceutical Market in 2009, Exceeding $820 Billion Key Dynamics Shaping Market: Robust, double-digit growth in ‘pharmerging’ markets Increased focus on specialty-driven therapies Leveling of U.S. growth at 1 – 2 percent Worldwide economic volatility The global pharmaceutical market is expected to grow 4.5 - 5.5 percent next year, a pace similar to 2008, according to the IMS Global Pharmaceutical and Therapy Forecast™ released today by IMS Health (NYSE: RX). The forecast, the leading annual industry indicator of market dynamics and therapy performance, predicts global pharmaceutical sales to surpass $820 billion in 2009, reﬂecting sustained double-digit growth in key emerging countries tempered by a slower pace in more established markets. This includes the U.S., where growth is expected to be in the 1 - 2 percent range for both 2008 and 2009. “In many respects, 2009 will reﬂect the new shape of the global pharmaceutical market, the result of market factors that have gained momentum over the past several years,” said Murray Aitken, senior vice president, Healthcare Insight, IMS. “Pharmaceutical growth next year will hold steady at 2008 levels. The market will continue to contend with a number of forces – among them, the shift in growth from developed countries to emerging ones, specialist-driven products playing a larger role, blockbuster drugs losing patent protection, and the rising inﬂuence of regulators and payers on healthcare decisions. Layered on top is the uncertainty in the global economic environment and its effect on demand.” In its 2009 forecast, IMS identiﬁes the following key market dynamics: Slowing Growth in Mature Markets. This year, the U.S. pharmaceutical market, the world’s largest, is forecast to grow 1 - 2 percent to $287 - $297 billion, down from the 2 - 3 percent rate expected earlier this year. Contributing to the slower growth is less-than-expected demand for recently introduced products, as well as the economic climate, which appears to be having an impact on doctor visits and pharmaceutical sales. In 2009, the expected 1 - 2 percent growth rate in the U.S. will result in sales of $292 - $302 billion, and reﬂects the impact of continuing patent expirations, fewer new product launches and a tighter economy. The top ﬁve E.U. countries (France, Germany, Italy, Spain and the United Kingdom) are forecast to grow 3 - 4 percent next year, reaching sales of $162 - $172 billion. In Europe, growth driven by the continued aging of the region’s population and rising demand for preventive care will be tempered by the increased impact of health technology assessments, the use of contracting by payers as a means to control costs, and the decentralization of government healthcare budgets. Japan, the world’s second-largest market, is expected to see higher growth of 4 - 5 percent, reaching $84 - $88 billion. Approvals of new anti-cancer
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agents, disease prevention programs, and the absence of the Japan government’s biennial price cuts all will contribute to stronger growth. Government efforts to promote the use of generics will have only a modest impact on the Japan market in 2009. Rapid Expansion of “Pharmerging” Markets. The pharmerging markets of China, Brazil, India, South Korea, Mexico, Turkey and Russia are forecast to grow at a combined 14 - 15 percent pace to $105 - $115 billion. Along with the pharmaceutical industry’s increased focus on these high-growth markets, these countries are beneﬁting from greater government spending on healthcare and broader public and private healthcare funding – which is driving greater access to, and demand for, innovative medicines. An Emphasis on Specialist-Driven Markets. Products mainly prescribed by specialists are forecast to grow 8 - 9 percent in 2009 and are expected to contribute 67 percent of total market growth. Biologics are forecast to grow at an 11 - 12 percent pace, while oncology products will achieve 15 - 16 percent growth, and HIV therapies 13 - 14 percent growth. In contrast, products generally prescribed by primary care physicians are expected to grow 2 - 3 percent, due to the loss of patent exclusivity for several blockbusters and fewer signiﬁcant product launches. Fewer Products Winning Regulatory Approval. New product approvals remain at historically low levels, with only 25 to 30 new chemical entities slated for launch in 2009. In addition, many of these are specialist-driven and niche products with relatively limited market potential. Expected launches for 2009 include four or ﬁve potential blockbusters for treating acute coronary syndrome, diabetes, rheumatoid arthritis and meningitis. An Economic Slowdown, Most Pronounced in the U.S. Economic conditions will be a complicating factor impacting the worldwide pharmaceutical market in 2009. In the U.S., the correlation between economic factors and pharmaceutical growth is stronger in the current slowdown than in previous downturns, given the continued shift of drug-related costs to patients. IMS estimates that in 2009, the downturn will effectively reduce growth in the U.S. by 2 - 3 percentage points. Other markets with large out-of-pocket spending requirements – including Brazil, India and Russia – also are likely to be affected by economic changes. Generics Market Continues to Evolve. An additional $24 billion of branded products, including anti-epileptics, proton pump inhibitors and anti-virals, will lose their market exclusivity in the top eight markets in 2009. This will contribute to generics sales of more than $68 billion next year, and a 5 - 7 percent growth rate – similar to 2008 and lower than the levels experienced in 2006 and 2007. The decline is being driven by growth slowdowns in the U.S. and U.K., where many competitors in large therapy areas are creating a ﬁerce price war and cutting margins for generics manufacturers. Other countries are striving to increase the use of generics through various government efforts.