New Delhi: What is the first thing that a doctor expects from a drug advertisement while turning the pages of a medical journal that usually features endless drug promotions by pharmaceuticals companies? He would probably look for adverse drug reactions, precautions, contraindications, warnings and major interactions of the drugs advertised.
But what if he finds himself in utter confusion for lack of information or no mention at all of the adverse drug reactions and precautions to be observed while prescribing the medicine? This is perhaps the real scenario if the results of a new study, which assessed the promotional advertisements of drugs in a medical journal, are to be believed.
The study appears in the Indian Journal of Medical Ethics.
A group of doctors from MGM Medical College and LSK Hospital at Kishanganj in Bihar, after studying 54 advertisements for 145 different drugs printed in the Journal of Indian Medical Association (JIMA) between December 2011 and November 2012, found that a majority of the advertisements in the journal violated national and international guidelines on how medicines should be advertised.
According to the study, less than two per cent of the advertisements fulfilled the criteria of mentioning all vital information.
Major adverse drug reactions or side-effects were mentioned in only two advertisements (1.37%); precautions, contraindications and warnings in only two (1.37%); and major interactions in only one (0.68%). Only three advertisements (2.06%) were well substantiated with references.
The approved therapeutic uses were mentioned in only 89 (61.37%) advertisements; the dosage form was provided in 118 (81.37%); and the names of active ingredients were mentioned in 128 (90.14%) advertisements.
Most of the advertisements carried only basic information like the brand name, generic name and content of active ingredients of the drug, according to the researchers.
The developments in the field of drug discovery is an inevitable phenomenon, so to keep themselves updated about the new medicines flooding the market, doctors usually depend on advertisements in medical journals or direct marketing by the pharmaceutical companies’ representatives.
But the reluctance of pharmaceutical companies to list the adverse effects carries a great risk of misleading doctors, especially those who are often too busy to stay updated about the new medicines in the market. Indeed doctors doubt prescribing a medicine that does not carry any disclaimer.
Though there are guidelines by the World Health Organization (WHO) and the Organisation of Pharmaceutical Producers of India on how pharmaceutical companies should advertise their drugs, there is no legislation in this regard. It is more of a self-regulated industry because of which there is no mandatory rule for them to provide the necessary information.
Dr B Dinesh Kumar, president, Indian Pharmacological Society, told India Medical Times, “The doctors usually find themselves in a fix when they are bombarded with plenty of drug advertisements either in print or other forms. While practising, it is difficult for doctors to stay updated and it is for this purpose that we expect every drug manufacturing company to lay out clear points about the drugs – side effects, therapeutic use, interactions etc. Not surprisingly, many advertisements have been found to conceal these vital information.”
Dr Kumar further said, “Ideally the pharmaceutical companies should do it as their responsibility, if not, then the medical journals should first do the scrutiny of the material published so that there should be at least some sort of pressure on advertisers to comply with the guidelines.”
“But I would also like to add that the doctors should take an interest in continuing medical education (CME). It helps them to keep themselves abreast with recent developments in medicine,” he said.
Likewise, the authors of the study have also concluded that advertisements of drugs should be published in medical journals after a stringent process of assessment by a dedicated review board constituted within the editorial team of the journal. “The board should include at least one member trained in pharmacology and one representative from the medical division of pharmaceutical industry. This will help in estimating the rate of compliance with the standard recommended guidelines,” said the study.
Dr Bikash Medhi, secretary (clinical), Indian Pharmacological Society, told India Medical Times, “The incomplete information in a drug advertisement is a frequent occurrence. We need to have a legislation in place so that punitive actions can be taken against pharmaceutical companies that do not mention adverse effects of the drugs.”
The study also advised that the editorial board of a journal should issue warning letters to the pharmaceutical companies concerned as a preventive measure. “It would be a good idea for the review board to publish in the journal a list of the companies which constantly submit incomplete promotional advertisements. This would increase awareness among the readers of the unethical promotion of drugs,” it said.
Dr Sandeep Manral, a general physician based in Dehradun, told India Medical Times, “Mentioning when not to use a particular drug is way more important information that we expect from a drug advertiser. Most of the physicians do not fully know the adverse impacts of a drug. It is very important to mention its reaction with other medicines.”
Dr Manral said, “Advertisers make tall claims even about those drugs whose results are unequivocal. They do not shy away from advertising a drug that has been found to do no good to a patient. Case in point is use of a drug called Statin that is used for cholesterol control. The studies done to assess effective use of this drug have never been conclusive. I guarantee that most of the physicians do not know that it does not influence the cholesterol control very strongly, but they still continue to give it to the patients. Similarly, antibiotics are also given without full knowledge that leads to drug resistance in patients.”
“For the convenience of the doctors, the side effects and other important warnings should be mentioned in quick bullet points. We need a system in place – from top to end,” he added.
Experts opine that till the time pharmaceutical companies are not obliged to print all required information or follow the guidelines sincerely, doctors should observe a rationale recommendation of drugs. Meanwhile, the medical fraternity also awaits a legislation that could tighten its noose around unethical promotion of drugs.
Until the system is in place, doctors can best use their judgment while prescribing drugs by discarding those drugs that do not have clear information about its pros and cons.
by Vidhi Rathee