Managing pharmaceutical risks in cross-border care

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 globalisation, there is 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 guide 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 set out parameters in which practitioners may refer patients abroad, and to which facilities. Such guidelines are needed to ensure that patients’ health and safety is prioritised, that adequate health-system responses are in place, and that risks to patients and others are minimised.

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.

BLURRED LINES

However, medical tourism cannot be judged without considering ethics, safety, costs to the community, and continuity of care. 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 this tourism 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, and Counterfeit (SSFFCs) medicines are a global health problem, spread across an international marketplace.

As the distinction between foreign and domestic products continues to blur and the supply chain becomes 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 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 recalls, for example, is something we take very seriously as patient safety and product integrity are critical to the Pharmacy and Poisons Board as a national regulator of pharmaceuticals.

Ensuring the quality of medicines used in public health treatment programmes is critical. Without this quality assurance, investment in health programmes to treat diseases such as cancer, HIV/Aids, TB, and malaria may be wasted and desired health outcomes compromised.

LINKED SYSTEMS

In Kenya, the Pharmacy and Poisons Board has a good record in ensuring that medicines, medical devices and other health technologies are safe, efficient and of accepted quality to promote and protect public health.

To assure quality, the board 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.

The nine functions are control of clinical trials; inspection of manufacturing facilities and distribution channels; product assessment and registration (marketing authorisation and de-authorisation); laboratory testing and lot release (where necessary); post-market surveillance of quality and safety; control of imports and exports, including control at points of entry and exit; control of product promotion and advertising; consumer education 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 minimise the risk of sub-standard or counterfeit products moving across borders, national systems for regulation and law enforcement must be seamlessly linked.

That is why the Pharmacy and Poisons Board is collaborating with international, regional and bilateral organisations like Interpol and the World Health Organisation in the fight against sub-standard medicines.

The medicines regulator is part of an ongoing East African Community Medicines Regulation Harmonisation Project (EAC-MRH) to improve access to safe and good quality essential medical products within the EAC. 

The board’s inspectors routinely visit manufacturing facilities for medical products to ensure they comply with Good Manufacturing Practices (GMP).

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In case of any suspicion, members of the public are advised to report to the Pharmacy and Poisons Board on email at

[email protected]; [email protected];

or  [email protected].

Alternatively, blog your views on our Facebook page, Pharmacy and Poisons Board, on Twitter @ppbkenya, or call our hotline, O72060881.