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New Straits Times
2 days ago
- Health
- New Straits Times
Of approved drugs and unapproved uses
NOT many Malaysians know what off-label drug prescriptions are, but Dr Kamini Shanmugaiah, a senior lecturer at the University Wollongong Australia KDU Penang University College writes in her op-ed in this newspaper that they may account for up to 50 per cent of all medication use, particularly in paediatric and geriatric patients. One won't be wrong in calling such practice a common use, controversial though it may be. If before we were worried about side effects of modern medicine, now we have to add off-label drug prescriptions to the list. But what exactly is off-label drug prescription? It is the unapproved use of approved drugs. The use of the cancer drug, methotrexate, for psoriasis is an example of unapproved use. Because of the lack of clinical trial data, the patients prescribed such medicines may be exposed to severe side effects, Kamini warns. If so, why resort to off-label prescriptions? The simple answer is there are no other drugs available or these drugs have not been tested on certain patients such as children and geriatric patients. Corrosive commerce plays a part, too. Pharmaceutical companies choose not to invest in clinical trials on such patients because they are not profit generators. No one expected capitalism to be compassionate, anyway. For the physicians who have to treat their patients even if there aren't any approved drugs for their ailments, it is one tightrope to walk. But so long as they follow guidelines issued by professional bodies such as the Malaysian Medical Council and act responsibly, they can keep medical negligence cases as far away as possible. Doctors serving in public hospitals would, however, need the approval of a few committees before they can prescribe off-label drugs. The idea is to ensure that such prescriptions are medically justified. Informed consent of patients — meaning physicians must disclose to patients any material risks posed by the drugs — is critical to avoid any legal liability. Surprisingly, for an old practice of using approved drugs for unapproved uses, there appears to be no Malaysian case law directly on point, as far as we can tell, which means a litigant must rely on general principles of medical negligence and malpractice. The court will obviously consider the standard of care appropriate for off-label prescriptions, which means the need for the physician to answer several questions. One, was the unapproved use based on guidelines issued by a medical body? Two, did the physician obtain the informed consent of the patient? Three, was the use in the best interest of the patient? Vulnerable patients such as children and the elderly have long been ignored by clinical studies conducted by pharmaceutical companies. Malaysia may not be able to do much about getting Big Pharma to be inclusive, but it can get local ones to do so. The European Union and the United States are using the legal regime to mandate paediatric trials. Malaysia must follow their lead and include geriatric trials as well. The EU and the US are right in moving up from guidelines to regulatory oversight to ensure patient safety. Malaysia must move up, too.
The Star
07-05-2025
- Health
- The Star
Increase training capacity to resolve shortage, say experts
PETALING JAYA: Authorities must act decisively by expanding specialist training programmes and offering better incentives to address the ongoing shortage of medical professionals, experts say. Malaysian Association for Thoracic and Cardiovascular Surgery honorary secretary Prof Dr John Chan Kok Meng said specialist training was previously confined to universities through their Masters programmes. 'However, the universities and university teaching hospitals have limited capacity. 'The amendment to the Medical Act 1971 last year now permits the Health Ministry to offer specialist training in its hospitals via a parallel pathway, significantly increasing the country's training capacity,' he said yesterday. Despite this progress, Dr Chan expressed concern that the amended Medical Act has yet to be enforced, highlighting the urgency of its implementation. 'Until last year, the criteria for specialist registration were also very restrictive. In cardiothoracic surgery, for example, only four qualifications were recognised – one each from the United States, Canada, the United Kingdom and Australia. 'Without one of these qualifications, practising as a specialist in cardiothoracic surgery in Malaysia was impossible,' he said. Fortunately, the amendment to the Medical Act 1971 has expanded this list. 'Now, eight qualifications in cardiothoracic surgery are recognised. 'More importantly, the Malaysian Medical Council can now recognise specialists trained elsewhere, providing flexibility in registering specialists and moving beyond the previous restrictive list,' Dr Chan added. Private Hospitals Malaysia Association president Datuk Dr Kuljit Singh said private hospitals experience varied demands for specialists, influenced by location and the type of specialities offered. 'Some private hospitals are multi-discipline, while others are more general, affecting their staffing needs. 'By law, hospitals must have at least one full-time specialist to offer specific services,' he explained. This requirement can lead to shortages if hospitals aim to expand their services. Dr Kuljit said, unlike private hospitals, the government was obligated to provide comprehensive healthcare services and is more acutely aware of areas with specialist shortages. To fulfil the demand for medical specialists in the government sector, he suggested intensifying and refining specialisation programmes. Additionally, Dr Kuljit proposed offering incentives to entice Malaysian specialists working abroad to return home and contribute to the healthcare system.
The Star
22-04-2025
- Health
- The Star
Big mistake should medical profession be described as ‘trade', say practitioners
PETALING JAYA: Regulating the doctor profession as a trade will be a big mistake, say a group of medical practitioners. In a statement on Monday (April 22), they said general practitioner clinics are not retail outlets. 'Treating the sick is not a commercial transaction. 'Doctors and their practice of medicine is a strictly licensed profession, governed by a social contract of trust, statutory mandated ethical responsibility, duty and continuity of care between the doctor and patient. 'It is not a trade,' they said in a joint statement. Additional layers of regulation, they said, will only drive up healthcare costs and counter national efforts aimed at controlling the cost of living. 'If the Domestic Trade and Cost of Living Ministry intends to bring doctors' professional services under the scope of the Price Control and Anti-Profiteering Act 2011, proper procedure must be followed. 'This includes gazetting the medical profession as a trade, which will have far-reaching future implications, including the formation of trade unions and trade protective practices,' it said. The group said this will then make one-to-one personalised patient-doctor experiences a thing of the past. 'Union rules and business-oriented standard operating procedures will prevail much to the detriment of today's tailored patient-centred clinical care,' it said. They said one-stop general practitioner clinics have been the cornerstone of healthcare for all Malaysians, across generations. They also said Malaysia's general practitioners system is widely recognised as one of the most affordable, efficient and patient-centred in the region. 'However, this vital healthcare pillar now faces increasing pressure from unnecessary and disruptive regulatory proposals,' they said, adding that these efforts risk compromising both the safety of patient care and integrity of the medicine supply chain. They stressed that general practitioners already operate under robust regulatory oversight through the 'Good Dispensing Practice Guidelines' of the Malaysian Medical Council, which governs ethical and evidence-based choices and the dispensing of medicines within clinics. 'Patients' rights and choices are also clearly stated,' read the statement. 'This is a testament to the medical profession's self-regulation and ongoing commitment to transparency, patients' rights, choice, patient safety and ethical care,' it added. The statement was jointly issued by DRSforALL founding chairman Dr Steven Chow, who is also part of the Federation of Private Medical Practitioners Associations, Malaysian Crime Prevention Foundation's Tan Sri Robert Phang Miow Sin, Malaysia Society for Harm Reduction chairman Prof Dr Sharifa Ezat Wan Puteh, Malaysian Psychiatry Association fellow Prof Dr Mohamad Hussain Habil, Persatuan Insaf Murni Malaysia president Dr Mohd Khafidz Mohd Ishak and Dermatological Society of Malaysia president Assoc. Prof. Tan Wooi Chiang. Also included are the Addiction Medicine Association of Malaysia, Medical Practitioners' Coalition Association Malaysia, Penang Medical Practitioners' Society, Perak Medical Practitioners' Society, Private Medical Practitioners' Society Kedah/Perlis, Private Medical Practitioners' Society Selangor/Kuala Lumpur, Pahang Private Medical Practitioners' Society Association of Private Practitioners' Sabah. This comes after the Domestic Trade and Cost of Living ministry said the government will proceed with the implementation of the Medicine Price Transparency Mechanism on May 1. It said the draft order, which, among others, will require private healthcare facilities to display medicine prices, is currently under review by the Attorney General's Chambers.
Malaysiakini
22-04-2025
- Health
- Malaysiakini
Doctoring is not a trade
LETTER | For generations, our one-stop general practitioner (GP) clinics have been the cornerstone of healthcare for all Malaysians. GPs have performed a multitude of duties from treating everyday illnesses to supporting families through difficult times and serving on the frontline of major public health crises such as the Covid-19 pandemic. Our nationwide community-based medication-assisted therapy programme by GPs for heroin addicts started in 2002. By 2006, it had contributed to the national effort to successfully stop the rising epidemic of HIV deaths among IV drug users. And by 2016, this programme had taken more than 30,000 heroin addicts off the streets and reconnected them with their families and community. Thus, the role of GPs in the health of all Malaysians should be duly appreciated and recognised. In fact, Malaysia's GP system is widely recognised as one of the most affordable, efficient, and patient-centred in the region. However, this vital healthcare pillar now faces increasing pressure from unnecessary and disruptive regulatory proposals. These efforts, often driven by large corporate interests, risk compromising both the safety of patient care and the integrity of our medicine supply chain. A recent reference to a 2022 survey cited by the Federation of Malaysian Consumers Associations (Fomca), which reported 'medicine price mark-ups of up to 900 percent and price variations exceeding 400 percent for the same drugs at different private clinics' is mischievous. The study warrants critical scrutiny. Blanket interpretations of such data, without context, can be misleading and serve only to create a toxic environment and to generate mistrust of the very system that delivers reliable, affordable care to successive generations of Malaysians, including many of our present leaders and cabinet members. Doctors do not condone any unethical practices by unprofessional colleagues, but when we want to throw away the dirty bathwater, we should be careful not to throw away the bathtub and the baby as well. It must also be emphasised that GPs already operate under robust regulatory oversight. The Good Dispensing Practice Guidelines of the Malaysian Medical Council govern the ethical and evidence-based choice and dispensing of medicines within clinics. Patients' rights and choice are also clearly stated. Among others, these guidelines state that, 'in all registered medical clinics with dispensing facilities, it is recommended that a notice be displayed in a prominent area of the registration counter to inform patients that the clinic has a pharmaceutical service and that patients have the choice to have their medication/drugs dispensed at the clinic or at any pharmacy. Patients who do not wish to have their medication/drugs dispensed in the clinic should request to indicate so at their time of registration, and will be provided with a written or printed prescription.' This is a testament to the medical profession's self-regulation and ongoing commitment to transparency, patients' rights, choice, patient safety and ethical care. It is important to reaffirm that GP clinics are not retail outlets. Treating the sick is not a commercial transaction. Doctors and their practice of medicine are a strictly licensed profession, governed by a social contract of trust, statutorily mandated ethical responsibility, duty and continuity of care between the doctor and the patient. It is not a trade. If the Domestic Trade and Cost of Living Ministry intends to bring doctors' professional services under the scope of the Price Control and Anti-Profiteering Act 2011, then proper procedure must be followed. This includes the gazettement of the medical profession as a trade - a move which would have far-reaching future implications, including the formation of trade unions and trade protective practices. Thereafter, the one-to-one personalised patient-doctor encounter of today will be a thing of the past. Union rules and business-oriented standard operating procedures will prevail, much to the detriment of today's tailored patient-centred clinical care. The public and the ministry can rest assured that our doctors remain steadfast in their commitment to treat the sick and to do so in the most cost-effective, caring, and responsible way. Additional layers of regulation will only drive up healthcare costs and run counter to national efforts aimed at controlling the cost of living. This letter is signed by: Dr Steven KW Chow, founding chairperson of DRSFORALL/FPMPAM Robert Phang Miow Sin JP, founder and chairperson of Social Care Foundation, exco of Malaysian Crime Prevention Foundation Professor Dr Sharifa Ezat Wan Puteh, chairperson of MSHR Professor Dr Mohamad Hussain Habil, fellow of Malaysian Psychiatry Association Dr Khafidz Ishak, president of Persatuan Insaf Murni Malaysia Associate professor Tan Wooi Chiang, president of Dermatological Society of Malaysia Addiction Medicine Association of Malaysia Association of Specialists in Private Medical Practice Medical Practitioners' Coalition Association Malaysia Penang Medical Practitioners' Society Perak Medical Practitioners' Society Private Medical Practitioners' Society Kedah/Perlis Private Medical Practitioners' Society Selangor/Kuala Lumpur Pahang Private Medical Practitioners' Society Association of Private Practitioners Sabah The views expressed here are those of the author/contributor and do not necessarily represent the views of Malaysiakini.
