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Generic name only for drugs sparks debate
A vibrant debate has surfaced in Sri Lanka’s medical profession over whether a prescription should only contain the generic name of a drug or also include a brand name. “Look at the full picture without focusing on minor details,” a top doctor has urged explaining some of the controversial points in the draft National Medicinal Drug, Devices and Cosmetic Regulatory Authority Act.
Taking up the contentious issue in the draft Act which provides for prescribing the generic and also writing a brand, Dr. Palitha Abeykoon, current President of the Sri Lanka Medical Association (SLMA), explains that the brand should be included after the doctor discusses it with the patient. At a recent seminar on the draft Act held by the Health Ministry, there was an outcry over this clause.
Dr. Abeykoon said that ideally a prescription should contain the generic name only, but in the Sri Lankan situation where there are a number of brands available in the market, if the doctor does not specify, who will make that decision. Should the choice be left to the pharmacists, is the next pertinent question which follows from Dr. Abeykoon, with the obvious third being, would not abuses occur then.
“The underlying belief is that the doctor will not be disrespectful of the right of the patient. The rationale is that the doctor’s experience of a particular drug’s clinical efficacy will be used to help the patient recover,” he points out, adding that doctors surely will not do something that will cause harm – either to the patient’s health or purse.
Dr. Abeykoon was part of the committee which prepared the draft Act. The committee, appointed by the Health Ministry, was chaired by respected medical administrator, Dr. A.M.L. Beligaswatte and included the Health Services Director-General Dr. Palitha Mahipala; Vijitha Malalgoda a representative from the Attorney-General’s Department; the Legal Draftsman Aruna Shantha de Silva; and Dr. Hemantha Beneragama, Director of the Cosmetics, Drugs and Devices Regulatory Authority, the Sunday Times learns.
Going into greater detail, Dr. Abeykoon says that in an ideal world this would not have been necessary because the availability of a number of brands of one particular drug, say an antibiotic or analgesic, would be limited. But in Sri Lanka, this is not so. Another important factor is that both doctors and patients should be certain of the quality of what is available, the quality having been assured by the authorities through many sources, according to him. What needs to be looked at is whether the draft Act provides for making regulations to do this?
It certainly does, says Dr. Abeykoon, explaining that for generic prescription only, there should be assured quality and assured safety, while the cost of the drug should be within a reasonable range. A major requirement is also a good laboratory to test the drugs. Of course, no country can test every drug that comes in, but the draft Act makes room for a dynamic National Drug Quality Assurance Laboratory (NDQAL) backed up by essential requirements for quality assurance such as purchases from companies which are registered as having Good Manufacturing Practices (GMPs); a dossier with detailed information; and reports of laboratory testing done by reputed drug regulatory authorities in other countries. Sri Lanka should be able to carry out direct testing where necessary and sample testing while conducting strong post-marketing surveys, he points out.
Referring to the large number of drugs registered for one type, Dr. Abeykoon says that such registrations — the process of which takes some time — have been sought by pharmaceutical companies to enable them to apply for tenders. It can be dealt with easily – the registrations of those drugs which have not been imported after a year should be cancelled. There is provision for this in the draft Act. Reiterating that the draft Act is not a direct result of the Senaka Bibile document put forth 40 years ago, he underscores that “it is consistent with the Bibile principles”. However, it is very much in keeping with the National Medicinal Drugs Policy (NMDP) of 2005-06.
“It is fairly faithful to the Bibile principles but there is a need to take into account that the Bibile document was written 40 years ago when Sri Lanka’s drug budget was only Rs. 24 million,” he points out. “The mandate of Bibile was to try to get as much as he could under that budget.”
Bibile’s principles included rational prescribing and bulk purchases of drugs which were to be imported only through the state and only from socialist countries. The latter, of course, is not applicable any more, points out Dr. Abeykoon, adding that it was a landmark document adopted by the WHO as the basis of its Essential Drugs Concept.
The draft Act which will provide legal coverage, meanwhile, addresses many key Bibile principles relevant for current times, while also dealing with many of the issues that are being debated in the media, according to him.
Referring to charges that the draft Act does not include a Technical Advisory Committee, he says a closer look shows that there is one with wider representation.
“The most important thing is not to pick out details in the draft Act but look at it from a wider angle – it does provide for the addressing of the issues facing the country now,” adds Dr. Abeykoon.