India – 5th February: With 10 percent of 3.63 trillion medicines popped worldwide in 2015, India is the world’s third-largest medicine market. It stands to scientific reason that these Dr.ugs will have side effects.
Yet, in 2013, India reported no more than two percent of globally occurring adverse Dr.ug reactions (ADR.s). It isn’t as if Dr.ugs have fewer side effects in India. Serious effects were seen in 6.7 percent of patients, a 2014 study reported. Other studies have cited Dr.ug side effects as the reason for 3.4 percent of hospital admissions in India, 3.7 percent hospital readmissions and 1.8 percent mortality.
In the developed world, adverse reactions are believed to be the fourth-leading cause of death. Within India, the ADR. reporting rate (ADR.s reported per million population) has almost doubled in the last three years to 40, but it is lower than 130, the average ADR. reporting rate for high-income countries, and clearly disproportionate to the country’s population and medicine consumption. In other words, India adDr.esses the problem of adverse Dr.ug reactions by ignoring or not reporting the data. That could prove costly, said experts, if it isn’t already.
Ignoring Indian data makes Dr.ugs more unsafe
“ADR. reporting is important because it gives Indian regulatory authorities realistic data to base Dr.ug usage decisions on,” said Y K Gupta, professor and head, Department of Pharmacology, AIIMS, and national scientific coordinator, Pharmacovigilance Programme of India. “Using only global evidence without Indian data isn’t an ideal situation because people of different ancestry may respond differently to medication.” Reporting the side effects of a Dr.ug could help determine if the medicine should stay or be pulled off shelves. A medicine labelled safe for clinical use after trials could still be found to be dangerous – as happened with Rofecoxib, a non-steroidal anti-inflammatory Dr.ug, a runaway success after its 1999 launch. Between its launch and 2004, Rofecoxib reportedly caused between 88,000 and 140,000 cardiac events. This forced Merck, the Dr.ug’s maker, to voluntarily withDr.aw it from the US market, in turn prompting a ban in India, although no significant cardiac event was reported as a side effect.
Carelessness, insensitivity among reasons for India’s poor reporting of side effects
Some key reasons behind India’s poor track record in reporting ADR.s:
• Nurses, who are most likely to see a patient suffer a side effect, are expected to inform the treating doctor but seldom do
• “Doctors in India are careless in prescribing medicines, because they know they will not be held accountable for their actions, and are equally careless about reporting ADR.s,” said Kunal Saha, a US-based doctor who has waged a decade-long legal battle after his wife Anuradha Saha died of side effects of a Dr.ug overdose when she was being treated for a skin allergy in 1998. Settling Saha’s case, the Supreme Court ruled that medical negligence includes not informing patients about the possible side effects of a Dr.ug. “Physicians prescribe new Dr.ugs at the behest of medical representatives even without reading the Dr.ug pharmacology, Dr.iven by the promise of gifts, despite this being illegal,” said Saha. “Patients are prescribed excessive doses, unwarranted Dr.ugs or unwarranted combinations.”
• Some doctors don’t know that Dr.ug side effects should be reported to any one of 150 ADR. monitoring centres across India, nor are they adept at recognising a Dr.ug side effect.
• Half of India’s population depends on Dr.ug stores not run by pharmacists, and on doctors holding alternative medicine qualifications who aren’t permitted to prescribe allopathic medicines in many states.
Scarce data preclude regulatory action on questionable Dr.ugs
Dr.ug side effects in India are scarcely reported, even in scientific literature. A 65-year-old woman with cardiovascular disease developed chest pain after being put on Nimesulide, a popular pain-killer, for fracture-related pain, as this 2003 study reported. Swapping Nimesulide with an alternative, Ibuprofen, quickly alleviated the chest pain. In another instance, a 78-year-old man with heart disease was prescribed Nimesulide for a wrist injury. He developed breathlessness, blue pallor and restlessness, and quickly succumbed to further complications, another 2004 study reported.
On the Naranjo scale — a scale developed by Canadian pharmacologist Claudio Naranjo and others to assess the causality for an adverse Dr.ug reaction — the complications the 78-year-old patient developed after taking Nimesulide scored two, indicating the Dr.ug could ‘possibly’ have been the cause of cardiac artery insufficiency, a shortage of blood in one or more coronary arteries. Nimesulide has been available in India since 1997. It currently sells as Nice (listed as a ‘top brand’ on Dr. Reddy’s Laboratories) and Nimulid MD (on Panacea Biotech). Nimesulide has never been licensed for use in the US, the UK, Australia, New Zealand and Canada. Over a decade later, a group of experts ruled that Nimesulide adversely affects the liver in chilDr.en and should not be prescribed, said Gupta. So, Nimesulide was banned for chilDr.en in 2011 (the Panacea website still lists Nimulid MD Kid as being available.)
To ban or not to ban: India needs data-Dr.iven action
Reporting adverse Dr.ug reactions makes the experience of a few physicians available to the entire country. Or, the manufacturer could be asked to add further information on the Dr.ug label or insert. For instance, in 2015, Indian authorities recommended the inclusion of advisory notes mentioning hepatotoxicity, haemorrhage and cardiovascular events as possible side effects of Sunitinib Malate, an anticancer Dr.ug, and cardiac dysfunction as a possible side effect of Pazopanib HCl, another anticancer Dr.ug. However, sometimes in India, a Dr.ug ban has been reversed in court or by the regulatory authority.
Watch out for side effects with a slow onset
Side effects are usually thought of as an immediate adverse Dr.ug reaction. That’s not always the case. For instance, a blockbuster diabetes Dr.ug, Metformin, reduces the absorption of Vitamin B12 from dietary sources, according to a 2014 study. “A deficiency of vitamin B12 can, in turn, cause mental disabilities, slowness, forgetfulness, and, most significantly, exacerbate the onset and progression of diabetic neuropathy, a disease of the nerves that commonly occurs in advanced diabetes patients,” said the study co-author, Atul Gogia, consultant, Internal Medicine, at Sir Ganga Ram Hospital, New Delhi. While his finding has not led Gogia to change his prescriptions for diabetes patients, it has made him more conscious about the potential impact of his prescriptions. “Vegetarian diabetes patients could especially be at high risk of developing vitamin B12 deficiency because of the combination of their diet and prescription,” said Gogia. “Now we get patients’ vitamin B12 levels tested and prescribe them supplements if needed.”
Source: http://www.indiamedicaltimes.com/2016/02/08/how-india-tackles-adverse-drug-reactions-by-ignoring-data/