Doctors confused over new drug rule

Patients at risk if only generic name is prescribed

By Lakwimashi Perera

Confusion reigned amongst doctors and pharmaceutical firms this week following comments made by Health Minister Nimal Siripala de Silva enforcing a ban on prescribing branded drugs from January 1.

According to his comments at a public meeting reported in the media, doctors in government hospitals can only give the generic name of the drug in a prescription and not the brand name while doctors in the private sector will have to explain to the patient the generic alternatives available when giving brand names of drugs. Any violation of this regulation will result in the doctor being penalised, the minister was quoted as saying.

However doctors in the private sector and the pharmaceuticals industry were completely in the dark about such a regulation which has not been communicated outside, resulting in a lot of confusion. Many private doctors were unsure whether they would be penalised if they prescribed branded drugs. The only indication of a change in the rules came through a Health Ministry circular dated December 28 to all state hospitals and provincial health authorities saying that the ministry has decided to promote the generic prescription of drugs to reduce the burden of the cost to patients when purchasing drugs. "As a preliminary step, visiting of Medical/Sales Representatives to government health institutions to promote their products will be prohibited from January 1," the circular said.

President of the Sri Lanka Chamber of the Pharmaceutical Industry (SLCPI) Adrian Basnayake told The Sunday Times FT that the Chamber has not been consulted on this matter at all. "As far as we know such a directive has not been released by the Ministry at the moment. We also got to know about this through the media," he said, adding that a ban on prescribing branded drugs will put the patients at risk. When asked if there will be an adverse effect on the industry, he said "Yes there will be, but that's not the point. The industry will be there, it might operate on lower profits, and there might be employment terminated, that is true. But the point is one of quality and people being mislead to believe they are getting the same quality drug," Basnayake said.

"We have no stringent quality assurance mechanisms to check the drugs before and after they enter the market and because of this we have all sorts of drugs entering the market," he explained adding that in India and Pakistan pharmaceuticals is a cottage industry and these drugs make their way into the local market here through unsafe channels. When a doctor prescribes a certain brand, he does it because he has used it over a period of time and knows that it is of an acceptable quality and that it is effective and at the moment this discretion is with the doctor, he said. "If you make it unlawful for the doctor to prescribe branded drugs you put the patient at the mercy of the person in the pharmacy, who in Sri Lanka is mostly not qualified and can't even read the prescriptions," Basnayake went on to explain.

Most doctors were annoyed over the new rules. Dr. H.H.R. Samarasinghe, a senior consultant, spoke to The Sunday Times FT and said, "I didn't become a doctor to be told what to do by a Minister." According to Dr Samarasinghe, one problem with enforcing regulations directing doctors to only prescribe generic medication, as pointed out before, is that the government does not have a proper quality control lab where all drugs in the market are tested. "Also, the government allows hundreds of brands to be imported into the country. Then they ask doctors to prescribe only generic medicine, for reasons best known to them," he said. Another issue, also pointed out earlier was the lack of qualified pharmacists in the country. "Doctors in their practice build trust on certain brands. If a doctor prescribes a generic drug, the discretion as to what drug to give the patient out of the many varieties available and it doesn't work, who is going to take the responsibility? Is it the government, the Minister, the doctor or the pharmacist?" he questioned.

Dr B.G.D. Bujawansa, past president Independent Medical Practitioners' Association, said "As private practitioners we are not under the Health Ministry. They can't make us follow it unless they change the Cosmetics, Devices and Drugs Act of 1980. At the moment, if we specify a brand and say do not substitute and the pharmacist does so, he is liable."

A senior official of the Health Ministry, when contacted by The Sunday Times FT said, "If all medicines are the same, there is no reason to give some at a higher price and another at a lower price."

When asked why the SLCPI was not contacted or their input sought on this matter he said the government works for benefit of the people and therefore they do not need to ask the private sector.

A joint WHO-Health Action International report titled "Medicine prices, a new approach to measurement. Illustrative examples of results from pilot studies 2001-02" found that Sri Lanka has the lowest drug prices in the world.

SLCPI's Basnayake said a company that carries out research and does tests for years and comes up with a drug is the innovator and that drug is the original. That is usually very expensive as it has to cover the research costs. After about four years the patent runs out and other companies start producing it. That is a generic but as they produce it under their own brand name they are branded generics. There are companies in India that produce generics under their brand names that are of good quality and are known to maintain quality standards. "What people don't realize is that our market has around 80% generics. We switched to generics about 20 years ago. Originals are rarely used in this country as they are very expensive," he said.

"By making it illegal to prescribe branded drugs the government gives a false assurance that all generic drugs in the market are of the same quality, which is not so" Basnayake said. He explained that one cannot compare the quality in the case of a drug that costs just Rs 2 to one company and the same one Rs 20 to another that carries out tests and maintains standards. Doctors hardly prescribe the medicine at the top end of the price spectrum and instead prescribe a good quality generic from a reputed company, he said.

Speaking of another danger of making it compulsory for only generic medicine to be prescribed, he said that bio equivalence tests have never been carried out on any drug in Sri Lanka. The US Food and Drug Administration (FDA) has defined bioequivalence as, "the absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose under similar conditions in an appropriately designed study." Taking a person afflicted with epilepsy as an example, he said when medication is prescribed under a brand name, the patient obtains medicine with the same bio equivalent every time, from any pharmacy in the country. If it is prescribed under a generic name, the chances of receiving drugs from different manufacturers with different bio equivalents are very high. "If the person is used to a drug that is effective for a certain period of time and that changes in the second batch and the drug is effective for a lesser period of time the patient will be prone to seizures. A person is considered cured of epilepsy if he remains seizure-free for three years. If he gets a seizure anytime during that period, he has to start his treatment again for another three years," he explained.

Another industry representative, speaking on terms of anonymity said that most generic names are confusing and sound similar while their medicinal properties are very different to each other and unqualified pharmacists who don't know the difference might mix them up with grave consequences to the patient. This will not happen if the doctor prescribes branded drugs as the brand names are different and not as confusing, he said.

The minister was unavailable for clarification on the comments he had made.