Blood is now being taken in pharmacy aisles. This is not a grey area \u2014 it is an enforcement failure.<\/p>\n
The Federation of Private Medical Practitioners\u2019 Associations Malaysia (FPMPAM) is alarmed by ongoing reports, and now clear video evidence, of blood being drawn within retail pharmacy premises.<\/p>\n
That this has continued despite public concerns reflects a clear breakdown of clinical governance.<\/p>\n
The Pathology Laboratory Act 2007 (Act 674) was enacted to regulate laboratory services, but was never operationalised.<\/p>\n
FPMPAM has long warned that failure to implement proper regulation would eventually lead to uncontrolled expansion of diagnostic practices beyond safe boundaries. We are now seeing exactly that.<\/p>\n
We have seen the consequences before. During the Covid-19 pandemic, gaps in regulation led to questionable practices such as PCR pooling, commercialisation of testing beyond appropriate medical oversight, and involvement of non-medical entities in clinical decision pathways.<\/p>\n
Those lessons were clear. When regulation is weak, standards fall, and commercial interests fill the vacuum.<\/p>\n
Now it has crossed into retail spaces. What is being observed today is even more concerning: blood being drawn within retail pharmacy premises, including in narrow aisles and procedures conducted in environments never designed or licensed for clinical care.<\/p>\n
There\u2019s no visible framework for medical oversight, accountability, or complication management within these settings. This is not a grey area anymore. The issue is not only who performs the procedure, but where and under what governance it is performed.<\/p>\n
We need to be clear on the law. The absence of operational regulations under Act 674 does not create a legal vacuum for clinical procedures. The Private Healthcare Facilities and Services Act 1998 remains in force.<\/p>\n
Place Of Practice Is Not Optional<\/strong><\/p>\n Under the Private Healthcare Facilities and Services Act 1998, medical services \u2014 including blood taking (phlebotomy) \u2014 are regulated not only by who performs them, but where they are performed.<\/p>\n Such procedures must be conducted within a duly licensed or registered health care facility, such as a clinic, hospital, or approved medical laboratory.<\/p>\n A medical practitioner cannot simply perform procedures at any location based on convenience or commercial arrangement.<\/p>\n The setting of care is part of the standard of care.<\/p>\n Even in permitted circumstances such as home visits, these are conducted under the authority of a licensed facility, properly documented and clinically justified, and considered an extension of regulated care, not independent practice.<\/p>\n Retail pharmacy premises are not licensed health care facilities for the purpose of performing invasive medical procedures.<\/p>\n Therefore, the conduct of routine blood withdrawal in such settings raises serious concerns regarding regulatory compliance, patient safety, and quality assurance, and warrants review by the relevant authorities.<\/p>\n Any invasive procedure is a health care service, and must be conducted within properly registered or licensed premises. Anything less is a compromise of patient safety.<\/p>\n Professional Boundaries And Clinical Governance<\/strong><\/p>\n Pharmacists are vital to patient care, and medical practitioners play a central role in diagnosis and management.<\/p>\n However, embedding clinical procedures within retail environments, without clear facility registration, licensing, governance, and accountability, risks blurring critical professional and regulatory boundaries.<\/p>\n If this continues unchecked, we risk misdiagnosis and inappropriate follow-up, patient harm without clear accountability, and a fragmented system where no one is ultimately responsible.<\/p>\n A Caution For Medical Practitioners<\/strong><\/p>\n FPMPAM also wishes to caution medical practitioners who may be engaged to provide such services within retail premises.<\/p>\n Participation in clinical procedures outside properly registered or licensed health care facilities may expose practitioners to significant medico-legal and regulatory risk.<\/p>\n Medical practitioners remain accountable for the setting in which care is delivered, patient safety and complication management, and compliance with applicable laws and professional standards.<\/p>\n Convenience or commercial arrangement does not absolve a practitioner of professional and legal responsibility.<\/p>\n Doctors are urged to exercise due diligence and ensure that any clinical service they provide is conducted within appropriately registered, licensed, regulated, and clinically governed environments.<\/p>\n The Real Question: Where Is The Enforcement?<\/strong><\/p>\n Health care facilities are subjected to licensing under strict conditions, inspections and compliance requirements, and legal accountability for every clinical act.<\/p>\n Yet we now see similar procedures occurring in retail environments without visible enforcement. This is not just a safety issue, but a failure of regulatory consistency.<\/p>\n FPMPAM\u2019s Position<\/strong><\/p>\n FPMPAM will not accept the normalisation of unsafe practices under the guise of accessibility or convenience.<\/p>\n We call on the Ministry of Health (MOH) to act immediately to stop unregulated invasive procedures in retail premises, clarify, and enforce the legal boundaries of clinical practice, address the long-standing regulatory vacuum in diagnostic services, and ensure that standards apply equally across all sectors, without exception.<\/p>\n Malaysia is at a crossroads. We can either uphold clinical standards, or allow them to be eroded, one \u201cservice\u201d at a time. Health care cannot be allowed to drift into a retail free-for-all.<\/p>\n The longer this is allowed to continue, the clearer it becomes that the issue is no longer ambiguity, but enforcement.<\/p>\n This statement was issued by FPMPAM president Dr Shanmuganathan Ganeson.<\/p>\n\n