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New Straits Times
2 days ago
- Health
- New Straits Times
Off-label drug prescriptions a growing challenge in Malaysia
Off-label drug prescriptions — where medications are used outside their approved indications, dosages, age groups or routes of administration — have become a significant issue in Malaysia's healthcare landscape. This practice raises legal, ethical and safety concerns for patients and practitioners. Legal ambiguity continues to surround off-label prescriptions in Malaysia, with loopholes giving practitioners some leeway. However, this flexibility raises ethical questions, particularly regarding patient safety. Simply obtaining patient consent or informing them about the off-label nature of a prescription does not eliminate the risk of adverse drug reactions associated with such use. The core issue is that legal or procedural compliance alone cannot protect patients from harm when clinical evidence is lacking for off-label use. Off-label prescribing occurs when doctors prescribe a drug for a purpose, patient group or method not included in its official approval by regulatory bodies, such as Malaysia's Drug Control Authority (DCA) or the US Food and Drug Administration. For example, Methotrexate, originally approved for cancer, is sometimes prescribed off-label for psoriasis, potentially exposing patients to severe side effects not anticipated for their condition. Studies indicate that off-label prescriptions may account for up to 50 per cent of all medication use, with particularly high rates in paediatric and geriatric populations. In children, this practice is often driven by a lack of suitable paediatric formulations, insufficient clinical trial data and the absence of approved medications for certain conditions. In Malaysia, common off-label prescriptions for children include anti-asthmatic and cough and cold medications. The primary concern with off-label drug use is the risk of adverse drug reactions (ADRs), which can range from mild side effects to life-threatening complications. Notable historical examples include the thalidomide tragedy of the 1950s, where off-label use in pregnant women led to thousands of birth defects. Pharmacists play a critical role in monitoring and reporting suspected ADRs, while doctors are expected to be fully informed about any drug they prescribe off-label, basing their decisions on scientific evidence and clinical judgment. In Malaysia, the Control of Drugs and Cosmetics Regulations 1984 mandates that all pharmaceutical products must be registered with the DCA, including details of intended use, dosage and target patient groups. However, many drugs used in hospitals, especially for children, are either unlicensed for paediatric use or are prescribed off-label due to the exclusion of children from clinical trials during drug development. This regulatory gap places the burden of responsibility on medical practitioners, who must carefully weigh the risks and benefits when considering off-label prescriptions. The lack of clear legal guidance means that the practice is largely left to the discretion of individual doctors, with potential medico-legal implications if adverse outcomes occur. The Patents Act 1983 should also support incremental innovations but with safeguards requiring full disclosure of clinical trial safety data. Experts and researchers emphasise the urgent need for well-designed clinical studies on commonly prescribed off-label medications, especially in vulnerable groups like children and the elderly. Enhanced monitoring, better practitioner education and clearer legal frameworks are essential to ensure patient safety and uphold ethical standards in medical practice. As off-label prescribing continues to be a common, yet controversial, aspect of modern medicine, striking the right balance between innovation, patient safety and regulatory oversight remains a pressing challenge for the healthcare system.
Daily Mirror
10-05-2025
- Health
- Daily Mirror
'My one-year-old has condition common in old people - we couldn't believe it'
While arthritis is more commonly known to affect older people, it can occur in youngsters too. We speak to the father of one of 10,000 UK children living with the condition When Stuart Harley was looking after his young son Rox, he noticed that one of his ankles suddenly became inflamed. "Rox had walked early, he was always on the move," said the project engineer. "Then when he was about one and half, we noticed his left ankle was swollen. He went on to develop a limp." Stuart and Rox's mother, who are not together, sought medical attention and doctors initially thought the cause could be an infection. "At first we wondered if he'd twisted the ankle and being so tiny, didn't know to rest it," said Stuart. "We sought help and Rox was given antibiotics for a possible infection early on but his ankle flared up once more. We went back and forth with appointments." With blood tests ruling out more common causes and the problem not improving, Rox was referred to a rheumatologist, a doctor specialising in diseases affecting the joints, muscles, bones, and connective tissues. To Stuart's astonishment, his young son was diagnosed with arthritis. "I was so shocked," he said. "Rox was so little so it's not the first thing you think of." Juvenile Idiopathic Arthritis or JIA, affects 10,000 children in the UK and causes joint pain, swelling and stiffness. Limping and fevers are among the symptoms to look out for. JIA is an autoimmune disease which sees the body's immune system mistakenly attack healthy tissues, particularly the joints. The exact causes for developing arthritis under the age of 16 are unknown but some researchers believe genetics can play a part, making some children more susceptible to the condition than others. Following his diagnosis, Rox was put under anaesthetic and given cortisone injections in his ankle, providing much-needed, temporary pain relief. Now three, he has weekly injections of Methotrexate, which slows down the body's immune system and helps to reduce swelling and and monthly infusions of infliximab, a medicine used to treat inflammation. "I'm trying not to get upset but it was heartbreaking," said Stuart of seeing his son put to sleep. "Rox is doing so well now but it was so, so hard." There is no single test for JIA, with doctors diagnosing it using a process of elimination. In February, a national report into the quality of care for children and young adults suffering from the disease was released and the conclusion was a swift diagnosis was based 'on luck'. Early diagnosis is crucial for preventing joint damage, managing symptoms and achieving remission but the report, commissioned by the Healthcare Quality Improvement Partnership, highlighted a lack of awareness among health professionals of the condition. The National Confidential Enquiry into Patient Outcome and Deaths' publication found fewer than half of patients who would go on to be diagnosed with JIA were seen within the recommended 10 weeks from the onset of symptoms. The longest a patient had to wait was 175 weeks. In more than a third of cases looked at referrals were sent to the wrong specialities, with undiagnosed patients frequently seen to 'bounce' between primary care and various specialties and then back to primary care before being seen by rheumatology services. "We met the family of a four year old girl undergoing the same treatment, it had taken them two years to be given a diagnosis," said Stuart. "I really wanted to raise awareness, I felt I needed to do something." Stuart completed this year London Marathon's in 4 hour and 24 minutes, raising more than £3,000 for leading charity Versus Arthritis. "I wanted to show Rox anything was possible," he said. "Arthritis is part of his life now, he has his medication and he gets tired." Many young sufferers of the condition can experience good outcomes, with their arthritis going into remission meaning symptoms significantly reduce or even disappear altogether. For others, further health problems can occur including slow growth, osteoporosis or problems with the heart or kidneys. "I get a bit scared, I just want Rox's joints to be ok and for him to be able to live a normal life, free from pain," said Stuart, from Stirling in Scotland. "I'd love him to run the London Marathon himself one day." Versus Arthritis offers help to young sufferers and their families - visit their support page here. To donate to Stuart's London Marathon fundraising for the charity, visit his Just Giving page.
