Managing pharmaceutical risks in cross border healthcare | Blog

Managing pharmaceutical risks in cross border healthcare← Back

By Dr. Fred Siyoi, Deputy Registrar
Pharmacy and Poisons Board
We live in a dramatically transforming world with huge implications for health, medicine and the role of the regulators. While, there are many benefits of globalization, there can be no doubt that with the increasing interconnectedness of the world, comes new vulnerabilities to a range of serious even catastrophic health threats.
Patients travelling across borders in pursuit of medical care are an evolving global trend in healthcare that has surged in recent years. Recent legislative changes which clarify Medical Practitioners and Dentist Referral of Patients abroad are likely to have important impacts on national policies. The number of people crossing Kenyan borders has increased exponentially over the past two decades, and patient mobility is high on the agenda at national level. The movement of patients has provoked calls for better coordination of health systems and policies across the country.
The Medical Practitioners and Dentist Referral of Patients Abroad rules regulate the referral of patients abroad by setting out parameters in which practitioners may offer a patient requirement for the said referral and facilities , where the patients can be referred. Such guidelines are needed to ensure that patients’ health and safety is prioritized, that adequate health-system responses are in place, and that risks to patients and others are minimized.
At face value, medical tourism presents as a positive avenue for sufficiently wealthy consumers to obtain health care without being limited by what is available to them locally. However, medical tourism cannot be judged without considering ethics, safety, costs to the community and continuity of care. Lack of sustainability of having patients taking health care abroad is not healthy for the local economy as cash to build our own local health systems is being diverted abroad. Thus weakening our own local capacity to manage and treat patients locally.
The move by the Ministry of Health is creditable since the medical tourism, phenomenon, can lead to healthcare delivery challenges including pharmaceutical risks for patients.
The rise of global markets and supply chains has been rapid and profound. Emerging markets and developing economies are gaining new prominence and the increased flows of people, capital information and goods across borders have realigned many roles, relationships and risks exposing, patients to drugs and treatments that may have not been approved by the regulator. Substandard/Spurious/Falsely labelled/Falsified, counterfeits (SSFFCs) medicines are a global health problems, spread across an international market place for pharmaceuticals and their ingredients, which demands a cooperate solution.
As the distinction between foreign and domestic products continues to blur and supply chain become more complex, the job of ensuring the safety and efficacy of drugs and medical devices becomes more challenging. As far as the medical device industry is concerned, fragmentation, new directives and increased regulation mean that, once again, there is a drive for consolidation. 
The time is now for the regulators to work together to create a stronger and safer system of medical products and more broadly, to forge more comprehensive and collective public health responses to the new realities that virtually all countries face. Product recall for example is something we take very seriously as patient safety and product integrity are critical to PPB as a national regulator of pharmaceuticals.
Ensuring the quality of medicines used in public health treatment programs is critical. Without this quality assurance, investment in health programs to treat diseases such as cancer, HIV/AIDS, TB, and malaria may be wasted and desired health outcomes compromised.
In Kenya, the Pharmacy and Poisons Board (PPB) has a good record in ensuring that medicines, medical devices and other health technologies are safe, efficacious and of accepted quality to promote and protect public health.
To assure the quality, safety and efficacy of medical products in Kenya, PPB ensures regulator’s oversight throughout the product life cycle. This oversight occurs through nine critical functions, each targeting an aspect or attribute of product quality, safety or efficacy; Control of clinical trials; Inspection of manufacturing facilities and distribution channels; Product assessment and registration (marketing authorization & de-authorization); Laboratory testing and lot release (where necessary); Post-market surveillance of quality & safety; includes monitoring adverse reactions; Control of imports and exports, including control at points of entry and exit; Control of product promotion and advertising; Consumer education/advertising and promotion materials and Licensing of pharmaceutical practitioners.
Everyone participating in the healthcare system has a role to play in keeping patients safe and free from harm. To minimize the risk of substandard or counterfeit products moving across borders, national systems for regulation and law enforcement must be seamlessly linked. That is why PPB is collaborating with International, Regional and Bilateral organizations like the Interpol and World Health Organization in the fight against substandard medicines.
The medicines regulator is part of an ongoing East African Community Medicines Regulation Harmonization Project (EAC MRH) to improve access to safe, efficacious and good quality essential medical products within the EAC.  The board also works closely with other government agencies and regulators e.g. KRA, ACA, KEBS, KENTRADE in ongoing initiatives to streamline cross-border trade.
PPB Inspectors routinely visit manufacturing facilities for medical products to ensure they comply with Good Manufacturing Practices (GMP). Where possible, such inspections are performed jointly with WHO or other regulators. In any case, as part of technical collaboration and regulatory harmonization, the PPB shares and receives confidential information about regulatory inspections or other significant findings by regulators worldwide.
The PPB remains committed to engaging with multiple stakeholder groups to advance global solutions and minimize exposure of consumers to unsafe products. 
In case of any suspicion, members of the public are advised to report to the PPB email; Facebook; pharmacy and poisons board, Twitter @ppbkenya, hotline O72060881


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