Another wake-up call

The recent death of an infant due to a case of acute dystonic reaction after being administered an injection of the pro-kinetic drug metoclopramide, raises issues that directly indict the pharmaceutical industry, the drug regulators and the doctors in this country. This is because PMS data has revealed ADRs in those below 20 years of age. Metoclopramide is under restrictive use in the US, the UK and other countries since 1995. The above three players cannot profess ignorance about this fact almost a decade after the ADRs have been reported. The first question that arises is what was the dose given and why was it injected? Another tragedy with the doctors is the low levels of scientific inquiry and knowledge about pharmacology. The pharmaceutical researcher determines the dosage of a new drug on experimental animals on a mg/kg body weight basis. The paediatric dose has to be similarly determined. Sub-dividing an adult dosage into half or quarter for children is highly unscientific. The British National Formulary specifically mentions children’s dosages on mg/kg. In the case of metoclopramide, for infants it does not recommend more than 500 micro gm/kg body wt. For young adults it is up to 5 mg/kg and for older adults it is 10 mg/kg. The BNF not only warns of severe dystonic reactions in children, but also recommends that injections be administered over a period of time going up to 15 minutes. The IP Committee must sit up and take note of this aspect. This episode also underlines the importance of the yet to be seriously implemented compulsory CME for doctors in India as also for Indian doctors to eschew a ‘‘holier-than-thou’’ attitude and allow the pharmacist to play his professional role.

It is the responsibility of the pharmaceutical industry to educate the doctors. Unfortunately, most of their time and resources is spent on wooing the medical profession for mutual gains. When doctors themselves obtain first-hand knowledge about a drug from the MRs, the industry should also convey the negatives, especially warnings and cautions in a very prominent manner. And where will they communicate this? Packaging inserts have long been discarded by the industry on cost considerations. If the NPPA’s drug pricing is inclusive of conversion costs and packaging norms, it would be worthwhile looking deeper into this aspect as well. The less said about the regulators the better. With hardly any exposure to technical and medical issues, they are the weakest in the healthcare link. The pharmaceutical industry and the medical profession in this country is acknowledged to be among the best in the world. The tragedy is that it does not behove well of them to perform in a casual and callous manner. Should the patients not take umbrage at the collective guilt or perhaps crime of these people? The answer has to be in the affirmative. It is high time that all three players receive a wake-up call and public interest litigations, as in the nimesulide case, should be initiated at every lapse. The healthcare delivery system in this country has indeed a long way to go in catching up with the developed world.

nvramamurthy@express2.indexp.co.in