From left, Betton, Allen-Young, and Whitbourne
Glenda Anderson, Staff Reporter
SOME DOCTORS and pharmacists are routinely rejecting some imported generic drugs saying they cause more problems than they solve.
This follows repeated complaints from patients of allergic reactions to some of these drugs. The complaints relate mainly to those medications often prescribed for chronic diseases, including asthma and diabetes. Other problem generics fell within the range of those described as "non-steroidal anti-inflammatory" drugs, some of which are sold without a prescription.
One pharmacist in upper St. Andrew said she was frustrated to the point of now only stocking certain generics and not others after having repeat instances of customers returning with numerous complaints about generics they had been sold.
She pointed to instances where persons reported having from mild to severe allergic reactions, some indicated by rashes.
"There are some that are good, very reliable, but some that you really wonder about the standards. The safest thing is to go with those drug companies which are out there a long time, and from a recognised drug house," she said.
A Manchester pharmacist said it was now the norm for her to order completely 'from the script' (prescription) to avoid having unwanted products on her hand. "When it comes to generics it's just by demand," she said.
One local medical doctor explained that he had lost confidence in generic drugs to the point where he now regularly includes on his prescriptions the instruction "Do Not Substitute".
But he has that right, says Permanent Secretary in the Ministry of Health, Grace Allen-Young. "It may be for some clinical reasons that he has that desire and the law does allow clinicians that right."
Pharmacists too, have the right to make generic substitutions where doctors have not indicated that there should be no substitutes.
The last word, however, rests with the patient or customer on affordability.
A brand-name drug is manufactured by the innovating company, (the company to first develop the new drug), while a 'generic' or copy drug is manufactured by companies after the innovator company's patent has expired, usually five to seven years.
Generics may, however, be manufactured during the patent period with collaboration between the 'branded' company and the 'generic' house.
According to the local Pharmacy Act and the Food and Drugs Regulations Act, generic drugs are similar to brand-name drugs as far as quality, purity, effectiveness and safety are concerned.
In general this also means that the generic must produce the same therapeutic effect in the user as the brand name or original drug.
Some practitioners, however, feel that customers are being short-changed, in that particular generics do not stand up to this comparison.
"I'm seeing allergic reactions to medications that directly relate to the purity of the drug. For example, persons come in with reactions to sulphur but are presenting with more severe reactions to the generic, says Dr. Audley Betton, general practitioner at Mancare Medical Centre.
In other cases he said, doctors were forced to increase continually the dosage of the drug to achieve the effect that the brand would have produced in a minimal dose. In this case he says the cost effectiveness of the drug is compromised.
"When the drug is ineffective, it means you have to now begin to take a larger dosage each time so it actually works out to be more expensive," he said.
According to Dr. Betton, in the presence of repeat complaints some doctors simply change the medication. "I don't know if the process is adequate."
Dr. Fay Whitbourne of the Diabetes Centre in Kingston explained that while for the most part the quality of generics was good, there were cases which had sparked concern.
ABSORPTION RATE
"We found that, for example, the absorption rate of some (generic drugs) was not really as good as the brand. Also there were instances where a patient will tell you that they 'don't feel good' after using the particular generic," she said. "If a patient says that, I will change the brand."
This has led some practitioners to question the merits of the local system of determining which generics are imported for sale in Jamaica, and the extent to which these are monitored for quality.
Under the Food and Drugs Regulations Act, any drug coming into the island has to be registered. The Act also stipulates that once a drug is registered it must receive further approval for importation through the permit system carried out by the Standards and Regulations Division of the Ministry of Health. Recently the Food and Drugs Act was amended to specifically include Generic Drugs.
Sources from the Health Ministry's Standards Division, explain that, "There is a system of ongoing evaluation". It is not limited, however, to generic drugs. The system of post-market surveillance exist for all drugs.
This ensures that the quality of drugs once registered remain the same, the Ministry said.
Responding to the question of a complaint or recall list for particular generics, a Ministry official said, "There is a list of products which have been recalled after introduction to the market, based on the results of ongoing clinical studies. When the results of such studies show greater risks than benefits associated with the use of the drugs, then cessation of their use becomes necessary. However, it should be noted that it is the active ingredient in the drug to which the recall relates. This is therefore not limited to generic drugs as the brand name drug with the same ingredient would be withdrawn as well."
Despite complaints, however, the Ministry admits, "there has not been any large scale study as to the effectiveness of generic drugs.
"Whilst there are isolated reports about some generic drugs, for the most part the feedback has been positive. Generics usually increase patient compliance as they are usually more affordable."
Medical Association of Jamaica (MAJ) President, Dr. Errol Daley, also expressed confidence in the local monitoring system. He said that the Association had not received major complaints but there were systems in place to address any concerns.
