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Wednesday, December 26, 2012

Government of India to crack whip on India`s pharma-doctor nexus

 The government of India is all set to crack the whip on India's shameful pharma-doctor nexus. The National Development Council (NDC), led by Prime Minister Manmohan Singh, will meet on December 27 to discuss bringing a legislation requiring drug companies to mandatorily disclose payments made to doctors for research, consulting, lectures, travel and entertainment. Doctors involved in ghost writing to promote pharma products will also be disqualified.
The official NDC document says, "Mandated disclosure by pharmaceutical companies of the expenditure incurred on drug promotion, and penalty on the company and vetting of drug related material in continuing medical education would be considered."
The Planning Commission says pharmaceutical marketing and aggressive promotion contributes to irrational use of drugs and therefore there is a need for a mandatory code to identify and penalize unethical promotion by pharma companies. The government will also make compulsory the use of generic names or the International Non-proprietary Name (INN), instead of brand names, at all stages of government procurement, distribution, prescription and use.
"Brand manufacturers will be encouraged to bid for government procurement, but should provide medicines in generic names," the document says.
Health minister Ghulam Nabi Azad recently said the ministry had received several complaints on this unholy pharma-doctor nexus.
According to the Medical Council of India (MCI), it received 702 such complaints in 2011-12 of which 343 were referred to state medical councils. In 2010-11, MCI received 824 such complaints following which it cancelled the registration of 10 doctors and warned four others.
Drug companies were recently caught red-handed writing scientific recommendations of their own products and submitting them to the Drug Controller General of India (DCGI) after getting them endorsed by top doctors for quicker marketing approval.
Usually, scientific recommendations are submitted by experts after they have studied a drug's content. The endorsement is considered a crucial testimony that convinces the DCGI to trust the drug's effectiveness, in turn, allowing it to be launched in the market.
Some of India's top medical experts — even heads of departments — from the country's most prestigious medical institutes such as PGI Chandigarh, CMC Vellore, AIIMS Delhi and St John's Medical College, Bangalore had signed recommendations for drug companies which may have been written by the companies themselves.
A recent study by the Planning Commission's high-level expert group (HLEG) said the pharmaceutical industry spent more than 25% of its annual turnover on sales promotion alone as compared to a paltry 7% on research and development in 2008-09.
India plans to soon introduce the 'Uniform Code of Pharmaceutical Marketing Practices' after which the word "safe" cannot be used on a drug without qualification and it must be stated categorically that a medicine has no side-effects, toxic hazards or risk of addiction.
The code says, "No gifts, pecuniary advantages or benefits in kind may be supplied, offered or promised to persons qualified to prescribe or supply by a pharmaceutical company. Gifts for the personal benefit of healthcare professionals (such as tickets to entertainment events) also are not be offered or provided. Companies must not organize meetings to coincide with sporting, entertainment or other leisure events. Venues that are renowned for their entertainment must not be used."
It adds, "Any hospitality offered to healthcare professionals must not be extended to spouses. Funding of healthcare professionals to compensate them for the time spent in attending the event is not permitted."
Planning Commission member Syeda Hameed recently took the example of the Food and Drugs Administration (FDA) of the US and how it has mandated strict regulations to curb unethical promotions.
These include mandated disclosure by pharmaceutical companies of the expenditure incurred on drug promotion, ghost writing in promotion of pharma products to attract disqualification of the author and penalty on the company and vetting by FDA of drug related material in CME.

Monday, December 17, 2012

Diagnosis and Management of Prosthetic Joint Infection: Clinical Practice Guidelines by the Infectious Diseases Society of America

These guidelines are intended for use by infectious disease specialists, orthopedists, and other healthcare professionals who care for patients with prosthetic joint infection (PJI). They include evidence-based and opinion-based recommendations for the diagnosis and management of patients with PJI treated with debridement and retention of the prosthesis, resection arthroplasty with or without subsequent staged reimplantation, 1-stage reimplantation, and amputation. (FullText)                    

Sunday, June 17, 2012

Antimicrobial Stewardship

The issue of continuously increasing antimicrobial resistance has necessitated actions on the part of the society in general and stakeholders in antibiotic use in particular, to create pathways to minimise antimicrobial resistance. A particular programme which has attracted worldwide attention currently is the ‘Antimicrobial Stewardship programme’.
The term ‘antimicrobial stewardship’ is defined as the optimal selection, dosage, and duration of antimicrobial treatment that results in the best clinical outcome for the treatment or prevention of infection, with minimal toxicity to the patient and minimal impact on subsequent resistance. With the emerging knowledge of antimicrobial residues in the environment and the non-human use of antimicrobials contributing to antimicrobial resistance, an all round multidisciplinary approach involving also the veterinarians and environmentalist would in effect result in a really reduced existence of resistant bacteria. Such an `Augmented Antibiotic Stewardship Programme’ (AASP) is thus a need of the hour.
Studies have established a strong relationship between antimicrobial use and resistance. Therefore prescribing antimicrobial therapy when and only when it is beneficial to the patient, targeting therapy to the desired pathogens, and using the appropriate drug, dose, and duration are important contributions towards reducing resistance. Overuse and misuse must be decreased to reduce the selective pressure that results in the spread of resistance.
Current ‘Antimicrobial stewardship programmes’ have evolved as a means for clinicians to optimize antimicrobial use in hospitals in accordance with consensus recommendations. The literature describes a multitude of strategies ranging from many individual interventions (e.g., formulary manipulations, dosing recommendations, and academic detailing) to less common but more broad and programmatic approaches (e.g., prior-approval programs, concurrent review and feedback).All of these strategies seem to impact on appropriate antimicrobial use, clinical outcomes, antimicrobial resistance and costs.
Antimicrobial stewardship programs, whose goal is to improve the use of antimicrobials at the institutional level, have been successful. Two dominant strategies exist for these programs -- prior approval, and concurrent review and feedback. Many issues, including measurable outcomes, barriers, funding, and personnel, must be identified before a program is implemented. studies indicate that oversight of antimicrobial use (whether restrictive or more subtle through concurrent review and feedback) has had a measurable impact on appropriateness of antimicrobial use, antimicrobial consumption, and/or expenditures, resistance rates, infection rates, and clinical outcomes.
Antimicrobial stewardship programs should have definite goals ensuring that performance outcomes are easily measured and relevant. Financial issues will automatically resolve themselves as ‘money saved is money gained’.
Measured outcomes and performance indicators include recommendation acceptance rates, adherence rates with antibiotic use guidelines, microbiologic and clinical response rates, frequency of antibiotic re-administration within 7 days, adverse drug events, time to approve antimicrobials and time to their administration to the patient, hospital readmission rates related to infectious diagnoses, length of hospital stay, mortality rates, antimicrobial resistance rates, infection rates, antibiotic expenditures and use rates measured in terms of defined daily dose, associations between antimicrobial use and resistance or infection rates, overall hospital costs, and costs directly attributable to the infectious process. Outcome measurements should be institution specific and discussed and agreed on before the program is implemented. Surveys may be used before the introduction of an antimicrobial stewardship program and should be used as a continuing tool. Depending on the programme, population-based antimicrobial use and resistance correlation can also be studied.  Interrupted time series with segmented regression analysis can result in a sophisticated means of measuring the true impact of interventions on antimicrobial use.
When considering the `Augmented Antibiotic Stewardship Programme’ (AASP), involvement of appropriate management of bio-medical waste and hospital waste water which create environmental residues that generate resistant bacteria is a must and proper guidelines for this must be created.   Veterinarians should be considered a must as their prescriptions also constitute a risk to development of antimicrobial resistance and actually several Antibiotic Stewardship Programme guidelines could be common to them.
 Barriers/ Impediments
The perception of threatened autonomy can be a significant impediment to the effort.  This can be resolved by creating Multidisciplinary Committees. Being proactive and not reactive is also very helpful, e.g. provide program's antibiotic guidelines to all faculty members and important administrative personalities for review to gain consensus before they are circulated for implementation. Monitoring of ‘pseudo-outbreaks’ (i.e. increased rate of infections represented by clinicians attempting to justify the use of a particular restricted antimicrobial by documenting in the medical record that infection existed) is also crucial to the success of the programme.

Saturday, May 12, 2012

Environment and the antibiotic resistance

Environment is all around us and is influencing antibiotic use by us as well as the development of antibiotic resistance. We are dumping antibiotics in our environment, which in turn is not only helping resistance development in bacteria but is also toxic to us.

We may not be able to control the environment fully
We may become wise
Manage antibiotic resistance better
If we know
What`s the relationship between
The environment and the antibiotic resistance

Ashok J. Tamhankar

Monday, April 2, 2012

Interactive Health Tutorials

 This site  gives interactive health tutorials. Learn about the symptoms, diagnosis and treatment for a variety of diseases and conditions, about surgeries, prevention and wellness. Each tutorial includes animated graphics, audio and easy-to-read language.

Monday, March 19, 2012

A new book from the World Health Organization follows on the theme of World Health Day 2011: antimicrobial resistance (AMR).  "The evolving threat of antimicrobial resistance – Options for action" describes policy activities that have addressed antimicrobial resistance in different parts of the world as well as some of the progress made since the publication of the WHO's 2001 AMR strategy. 

Thursday, March 8, 2012

Cross-contamination From Flexible Endoscopes
Improper cleaning and disinfection techniques of flexible endoscopes can lead to patient cross-contamination, resulting in life-threatening infections.
It is essential to adhere to a multistep procedure for reprocessing endoscopes. Any missed step could compromise the process.

Make sure to review instructions before purchase to help identify and avoid devices that are complicated. Have a specific reprocessing protocol for each flexible endoscope. Ask the manufacturer of the device to identify unique requirements for cleaning and sterilization.

Sunday, January 29, 2012

                                                     Totally Drug Resistant TB in India 
TB is already one of the world’s worst killers, up there with malaria and HIV/AIDS, accounting for 9.4 million cases and 1.7 million deaths in 2009, according to the WHO. At the best of times, TB treatment is difficult, requiring at least 6 months of pill combinations that have unpleasant side effects and must be taken long after the patient begins to feel well.
Tuberculosis is a bacterial disease, treated with antibiotics. As has been documented in other places, over time many kinds of bacteria develop resistance to antibiotics. TB bacteria have been especially adept at this. We’ve already seen multi-drug resistant TB, and extensively drug resistant TB. Totally drug resistant tuberculosis was the logical progression, and we’ve reached it.
At least 12 patients were reported infected with TB that has become resistant to all the drugs used against the disease, tech site said. The discovery makes India the third country in which a completely drug-resistant form of the disease has emerged, following cases documented in Italy in 2007and Iran in 2009.  Because of the mismatch between treatment and symptoms, people often don’t take their full course of drugs — and from that (and some other factors I’ll talk about in a minute) we get multi-drug resistant and extensively drug-resistant, MDR and XDR, TB. MDR is resistant to the first-choice drugs, requiring that patients instead be treated with a larger cocktail of “second-line” agents, which are less effective, have more side effects, and take much longer to effect a cure, sometimes 2 years or more. XDR is resistant to the three first-line drugs and several of the nine or so drugs usually recognized as being second choice.
As of last spring, according to the WHO, there were about 440,000 cases of MDR-TB per year, accounting for 150,000 deaths, and 25,000 cases of XDR. At the time, the WHO predicted there would be 2 million MDR or XDR cases in the word by 2012. 
This awful news leaves us with a lot of what-do-we-do-next questions. How do we handle the people who have TDR TB? How do we keep it from spreading? Is this a sign we’re taking the wrong approach to fighting the disease? Here’s hoping we can find some kind of answers.
Since the 1960s, two drugs — isoniazid and rifampicin — have been the standard TB treatment. Although episodes of resistance cropped up periodically, during the 1990s the incidence of multiple drug resistance grew significantly, leading researchers in 2006 to refer to it as extensively drug-resistant tuberculosis (XDR-TB). Surveillance data from the WHO indicate that XDR-TB is present in at least in 58 countries, with an estimated 25,000 cases occurring each year.
Epidemiologist Carole Mitnick of Harvard Medical School in Boston, Massachusetts, agrees that TDR-TB is not new, and points to the history of XDR-TB. “When XDR-TB was first named, it was a phenomenon that had existed but hadn’t gotten much attention before. TB in general doesn’t receive a lot of attention,” she says.
As the full form of TDR-TB suggests, none of the known TB combination drugs work on the patient. All 12 showed resistance to 12 drugs. "The TB bacilli have obviously mutated. The emergence of TDR-TB has grave implications for public health," said Hinduja Hospital's Dr Zarir Udwadia, whose observations have been published in the latest issue of the US-based Clinical Infectious Diseases (CID) peer review journal. His team started isolating TDR-TB cases among patients with pulmonary TB in October 2011.
Dr Amita Athawale, who heads KEM Hospital's chest department, said TDR-TB was a reality in India. "The cases we clinically isolate are just the tip of the iceberg," she said. TB is one of the biggest killers in India, along with heart attack.
Controversy over TDR TB
Mumbai continues to paint a gory picture of extremely resistant tuberculosis (XDR-TB) TB with Bai Jerbai (BJ) Wadia hospital alone having identified at least 11 children infected with XDR-TB after testing 500 children infected with TB in the last three years.Amid the current controversy over TDR-TB, a term which is being rejected by state and government health agencies, Dr Shah told DNA, “We have diagnosed 11 patients with ‘partial XDR-TB’ which shows that the bacteria is mutating fast due to poor and partial treatment.”Dr PY Gaikwad, joint director, health (TB) at the state health department, said, “There is no term like partial XDR-TB. To say XDR, patient needs to have resistance to fluoroquinoline and aminoglycoside both. However, we need to know the details of such patients and also whether the testing lab is accredited. Otherwise, one cannot confirm that the patient has XDR-TB.” He further added that doctors must try to get details of the two missing children with XDR-TB so that the state and BMC can provide help.