IJNSB assures heart patients covered by govt that branded drugs not the only option
PETALING JAYA: Generic drugs prescribed for heart patients covered by the government are as safe and effective as branded drugs, says National Heart Institute Sdn Bhd (IJNSB) chairman Tan Sri Dr Noor Hisham Abdullah.
He said there should be no concern as such drugs are also approved by international regulatory bodies like the Food and Drug Administration (FDA) and the Medicines and Healthcare products Regulatory Agency (MHRA), as well as the local National Pharmaceutical Regulatory Agency (NPRA).
He said despite usually costing less, generic prescription drugs have the same active-ingredient formula as brand-name varieties.
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The former Health director- general explained that all generic drugs had to go through bio-equivalence studies, where two drugs or two sets of formulation of the same drug was compared to show that it had nearly equal bio-availability and PK/PD (pharmacokinetics-pharmacodynamics) parameters.
“These studies are often done for generic drugs or when a formulation of a drug is changed during development. There is no issue on safety,” he told The Star, adding that IJNSB is only complying with the government’s circular on prescribing generic drugs.
On Nov 8, the Pharmaceutical Association of Malaysia (PhAMA) said its statement on generic drugs was taken out of context by a health news portal which erroneously implied that it could compromise safety in the treatment of patients.
PhAMA said its views were in specific reference to IJN’s patient load, which mostly comprised critically ill patients and many with comorbidities, adding that it recognised that generics and biosimilars had an equally important role to play in the healthcare system.
In a meeting with the Health Ministry recently, PhAMA members were provided more clarity on the government’s future direction, with assurance that treatment safety and efficacy would remain the topmost priority, while balancing financial considerations.
The ministry had said that unsubstantiated claims could raise concerns among patients, whether in its facilities or private healthcare, and could encourage them to reject treatment regimens.Meanwhile, several senior medical practitioners came out in defence of generic drugs, saying they are produced by reputable pharmaceutical companies with good quality control and widely used in treatment.
Malaysian Association for Thoracic and Cardiovascular Surgery (MATCVS) honorary secretary Dr John Chan Kok Meng said there is generally no concern with the use of generic drugs produced by well-established companies.
The consultant cardiothoracic surgeon at CVSKL Hospital said the key thing is to ensure that generic drugs are sourced from reliable companies which have gone through the necessary accreditation and quality assurance process.
“In many clinical situations, the effectiveness of the drugs can be measured, for example, by measuring blood cholesterol and blood sugar levels, as well as blood pressure, among others.
“In these cases, there is less of a concern with using generic drugs because we will know if the drugs are not effective and we can then consider changing to alternative drugs,” he pointed out.
However, he said there are clinical situations when it is difficult to measure the effectiveness of drugs, for example, blood thinners to treat coronary disease or prevent blood clots in patients with irregular heartbeats.
“In such cases, it is particularly important to ensure that the generic drugs are sourced from reliable companies with good quality control, or to use innovator drugs,” Dr Chan said.
Dr Wong Teck Wee, a consultant interventional cardiologist and physician at the iHEAL Medical Centre in Kuala Lumpur, said there might be some difference in the production process of innovator or patented drugs and generics, adding that the formula for innovator drugs are protected with confidentiality during the patented period.
He said while he had personally seen some generic drugs disintegrating after two to three years, generic drugs are generally safe and effective.
“If the company (manufacturing the generic drugs) is good and can ensure their drug is stable, then I think generic drugs will save the country a lot of money and benefit more patients,” added Dr Wong, who had previously served at Hospital Serdang.
He said he estimated the cost of original drugs to be between five and 10 times more than the generic versions, adding that even Singapore, the United Kingdom and Australia are using generic drugs.
Dr Wong suggested that doctors give patients the option of using innovator drugs or generics based on affordability.
As for IJN, he said the centre would have to ensure that it monitors its stocks to ensure that it is able to trace back problematic batches of medicine.
Rachel Gan, honorary secretary of the Malaysian Community Pharmacy Guild (MCPG), said the perception that only innovator drugs are effective is not true.
“This has become an issue, especially when certain innovator drugs run out of stock in the market, with patients running around pharmacies to source for what has been prescribed,” she said in reassuring that generic drugs are safe.
