Generics or brands -- the battle see-saws

What should the doctors prescribe? Should they prescribe generics only, brands only or both? Are all generics cheaper than brands? Whose choice should it be – the doctor together with the patient or some so-called pharmacists with little knowledge on drug dispensation? What of quality and pricing – are generics of a lower quality or are they cheaper?

Attempting to unravel a huge tangled web amidst numerous statements and counter-statements, The Sunday Times found a shocking lack of information amidst a deluge of material. FACT – Doctors lack vital information to make an informed choice with regard to “rational prescribing”.

“Rational prescribing” or “quality drugs at reasonable prices” is the most spoken of the concepts of the Senaka Bibile vision, it is learnt. (The Sri Lanka National Pharmaceutical Policy is known to have been established in the 1970s following a report by Prof. Senaka Bibile and Dr. S.A. Wickremasinghe.)

The basic tool used by any doctor in prescribing medicines is a simple but essential booklet – the Drug Formulary which is used as a guide when prescribing, dispensing and administering medicines. The Sri Lanka Hospitals Formulary, a commendable effort, had been published way back in 1994, some 14 years ago, but never updated by the Health Ministry, The Sunday Times learns.

This is the only formulary published in Sri Lanka by the health authorities but in countries such as Britain, the Drug Formulary is published annually along with a separate Formulary for children. Of course, the arguments of the health authorities would be that Britain is a developed or First World country while Sri Lanka is a developing or Third World country. For which the counter would be that these very same health authorities are quick to compare Sri Lanka’s health indices (such as the low mortality rates with regard to infants and mothers etc) to those in the developed world.

A newer version of another essential document, the Sri Lanka Drug Index, has not seen the light of day for nearly four years and many of the general practitioners, The Sunday Times visited, were still using well-thumbed copies of it published in 2003/2004.

To aggravate matters, there is also no price list for drugs, amounting to as much as “9,000 registered drugs” going by the Drug Index of 2003/2004. Amidst the controversy of generics and brands in a life-and-death sector such as health, the plea of most doctors was: “Give us the full list of drugs, both generics and brands, and all details including their prices and the source from which they are brought and we can give a choice to the patients.”

The development of a Drug Formulary by the Health Ministry, logically would allow health-care providers to offer the most effective drug therapy within a reasonable price to the most important person in the picture – the patient. The patients, in turn, would then have an official and trusted document to go by to rein in any corruption on the part of their doctors should the patients have even the slightest suspicion that the doctors are guided by the dictates of pharmaceutical companies which might be handing out perks and foreign jaunts under the table.

Conceding that there has been a system failure with regard to vital information flow to the doctors, Dr. Joel Fernando, a general practitioner, says, “If latest drug information is adequately available to the prescribers who are the doctors, this brand-generic problem will not arise. The information such as name, price, from where it is brought, name of manufacturer is not available either to the doctor or the patient. This is a lapse in the system which has to be corrected to safeguard the patient.”
There should be Gazetted prices for drugs at the point of registration and this information should be made available to the doctors, stresses Dr. Fernando adding that earlier there was a Price Order Gazette coming form the Consumer Affairs Authority.
So where do doctors get their information from?

Regrettably, from the 2003/2004 Sri Lanka Drug Index or leaflets freely distributed by the pharmaceutical companies, he says, which makes some, not all, prescribers more familiar with particular brands than generics. What is the meaning of a generic, asks Paediatrician Dr. Ajith Fernando. “Is a generic, a drug that is the cheapest in the market? Are generics equal to cheaper drugs?”

Pointing out that generics are not available for every drug, he says that if the doctor who holds the responsibility for the treatment, cure and wellbeing of the patient writes only the ‘chemical component’ name of the drug, the decision to give the cheapest drug in the market would be taken by the pharmacist. “Otherwise, the government through the State Pharmaceutical Corporation must guarantee that all drugs in the market, with the “chemical component” name, are of good quality, so that if anything goes wrong the government can be held responsible.”

At the moment, when a so-called pharmacist dispenses “loose” tablets with no name, no pack, no origin known in the eyes of the patient, who may or may not check them out, the doctor would still be held responsible.

“Yes, that’s exactly what happened not once but many times at one pharmacy, not even with generics but specific names written very clearly by me,” says a woman GP declining to be identified, not in a remote corner of the country but in the heart of Colombo. Citing one instance she said she had written a prescription for high blood pressure and also cholesterol and the “pharmacist” had dispensed two drugs for high blood pressure.

Fortunately, the GP has a personal rapport with her patients and the patient reading the prescription had come back to her. “Otherwise, the consequences would have been bad and I would have been held responsible,” she says, adding that in many cases, the patient would have suffered side-effects, scolded the doctor in his/her mind and sought treatment from another, never knowing what really happened.

Another source told The Sunday Times that he had employed a youth who had scraped three passes at the Advanced Level examination to work in his office. Suddenly, the youth had announced that he was leaving, as his wife, a nurse had been transferred to a hospital in Uva Province and he, ironically was accompanying her to set up a pharmacy in the area. Will not the men, women and children be the victims of an unqualified “pharmacist” who will dole out some drug if only the generic is written by the doctor?

Making the lack of information a more complex problem is the shocking disclosure that there are some 20,000 pharmacies in the country, but, ONLY around 3,000 qualified pharmacists, according to the Government Medical Officers’ Association (GMOA).

Echoing Dr. Joel Fernando’s concerns and lamenting the lack of essential information, GMOA Secretary Dr. Anuruddha Padeniya says the generics-brands issue should not be the theme of political statements but should be resolved after checking the ground reality.

According to him the Sri Lanka Drug Index 2003/2004 gives 9,000 drugs as being registered in the country. “When there are 300-400 types of Amoxycillin, and we have no record of what they are, from where they are or what price they are, how do I follow the Senaka Bibile concept of rational prescribing which is a good one, but has to be adapted to current conditions? It is the duty of the government to provide this information and excuses such as no money to print are not good enough. We are even ready to buy the book ourselves.” (Prof. Bibile’s concept came in the early 1970s, 30-odd years ago, when the country had a closed economy and the world including Sri Lanka was in a different era).

Publishing the Drug Index is a routine affair. If it is too costly, at least put the information on the Health Ministry website, urges Dr. Padeniya, adding that the Health Ministry claims that many drugs are withdrawn and also de-registered, but how would the doctors know that. “Due to the unavailability of the Drug Index, a doctor may even prescribe a de-registered drug,” he says in horror.

The GMOA has also been pushing for a Drug Information Centre for the past 3-4 years. Where is it, he asks, confirming what the woman GP said that some pharmaceutical companies do put out a drug index, but stridently reiterating, “Should doctors go by that?”

Regrettably, according to him, as echoed by Dr. Joel Fernando, some doctors may be relying on the freely available material given out by multi-national drug companies. Explaining that in a sense, doctors are guided by market forces in their practice, he says: Our aim is to give quality drugs at a reasonable price. For, if we give the cheapest drug that may or may not be effective or the most expensive drug that also may or may not be effective, will the patient come back to us?

Agreeing that like in all professions there may be a few corrupt doctors, Dr. Padeniya says the innermost feeling of a majority of doctors is to see their patients getting cured. Debunking another myth, he challenges anyone to show him that ALL generics are the cheapest adding that in both brands and generics there are price variations. Quality-wise there could be both brands and generics of low quality. Also certain companies use generic names as their brand names.

He also brings up the possibility of unqualified people running pharmacies selling the priciest drugs to the patient if they have the choice, as they will be profit-oriented. Usually, a doctor goes by his or her experience when prescribing the most effective drug at the most reasonable price, says Dr. Padeniya, which view is confirmed by a cross-section of doctors.

Adds Paediatrician Dr. Ajith Fernando that in America all prescription pads have a small box at the bottom where the doctor must indicate whether or not the pharmacist has the freedom to substitute the drug prescribed. And what of the choice of the forgotten entity, the patient, who patronizes a particular doctor because of even a small quantum of trust?

The woman GP gives two examples of a wealthy mother asking her to give the best drug at any cost for her child and the case of a poor mother. “I will discuss with the wealthy mother and give her a drug which would be effective but in reality may not be of the highest price. For the needy mother, I would still give an effective drug but maybe of a lower price, which once again may not be the cheapest.”

The crucial question of quality draws a quick response from both doctors and patients (who have experienced generic drugs melting in the pack before being taken or fevers in children not coming down even after administering of certain drugs), that the registration method of the thousands (9,000 according to the 2003/2004 Drug Index) of drugs may be stringent but what of post-market surveillance.

“Does Sri Lanka have adequate laboratories and staff to do the testing? Do we have adequate squads to do swoops on pharmacies not only for substandard drugs but also for counterfeits?” asks Dr. Padeniya, while Dr. Joel Fernando too queries on post-market surveillance. Implement the new National Medicinal Drug Policy, which has got Cabinet approval, says Dr. Padeniya.

The resolution would be – yes, get the doctors to write both the generic and then the brand of their choice, but reduce the number of drugs being brought in but with strict quality checks, giving a reasonable variety (eg: 10 types of amoxicillin as against 300), strengthen registration procedures, post-marketing surveillance and quality-testing facilities to provide the information doctors require to make the right choice.

Transparency is the need of the hour with vital information available to all and sundry.

Drug information

Plans are underway to set up a National Drug Information Centre in the Drug Authority, says Health Ministry Secretary Dr. Athula Kahandaliyanage when contacted by The Sunday Times. “Discussions in this regard are scheduled to be held next week with the relevant officials such as the Director of the Drug Authority, the State Pharmaceutical Corporation, the GMOA, pharmacologists etc.,” he said. Drug information will also be put on the Health Ministry website in the near future, he adds.

Interest of patients

The all-important indirect step needed would be to cut out corruption not only among doctors but also decision-makers, both politicians as well as bureaucrats, as reliable sources alleged that the whole issue of generics came about after a high-level person in the health sector opened a front organization to import drugs from questionable origins into the country under the “generic” tag.

In an environment where even most senior public servants bow to pressure, corruption is another angle that needs looking into if the government has the interest of the “poor patient” at heart.

Generics or brands - the battle see-saws