CARPHA Meets with Regional Stakeholders to Discuss Post Market Surveillance for Medicines
It is the right of all Caribbean people to have access to healthcare services, including essential quality medicines and pharmaceutical products they can trust. Poor quality and falsified medicines if left unchecked, can reverse progress the Region has made in its fight against diseases.
“We live in a world where medicines are being developed and consumed at an increasingly higher rate; and there are increased findings of substandard and falsified medicines reported to global monitoring systems. We cannot have that proliferated in the Caribbean. Manufacturers are seizing the opportunity to import and flood markets in countries where medicines are of short supply or where the regulatory systems for medicines are weak. Thanks to CARPHA Medicines Quality Control and Surveillance Department (MQCSD) and its efforts to implement a “proactive, risk-based, planned sampling programme” for the post market surveillance of medicines, we are in a position to guard against this,” stated Dr the Honourable Christopher Tufton, Minister of Health, Jamaica.
Minister Tufton was speaking at the opening of the CARPHA Meeting on Post Market Surveillance and the Caribbean Pharmaceutical Policy which is taking place from 12 – 13 March at the conference room of the MQCSD in Kingston, Jamaica.
He went on to say “The importance of the CARPHA MQCSD, as the only accredited medicines quality control laboratory in the English-speaking Caribbean, cannot be over stated. It is to the MQCSD that we now look to implement a Post Marketing Surveillance (PMS) strategy, that is, among other things, to provide test results that confirm the good quality of medicines or otherwise identify problems with them; and provide test results that give the opportunity for national medicines regulatory authorities to evaluate and make decisions on the actual quality of products used in country.”
In closing, Minister Tufton stated “The systematic and emergency monitoring of medicines by CARPHA MQCSD through its PMS strategy, has the support of the Ministry of Health – recognising that its success is dependent on nurtured collaboration among Member States and key stakeholders, and on it being adequately resourced.” Other speakers at the opening ceremony were Dr Virginia Asin-Oostburg, Director, Surveillance, Disease Prevention and Control, CARPHA; Mrs. Jesse Schutt-Aine, Sub-regional Program Coordinator, Caribbean, PAHO/ WHO; and Dr Rudolph Cummings, Programme Manager, Health Sector Development, CARICOM Secretariat.
In her welcome and opening remarks, Dr Virginia Asin-Oostburg, Director, Surveillance, Disease Prevention and Control stated “This is the first meeting CARPHA is hosting with key regional partners of the Post Market Surveillance (PMS) programme that is organised by CARPHA’s Medicines Quality Control and Surveillance Department. We see this as an important milestone for CARPHA and its Member States. Since Jamaica is host country to CARPHA MQCSD, it is more than fitting to experience this milestone with our host. We consider this meeting, a milestone in repositioning what used to be the Drug Testing Laboratory and rebranding the laboratory as the Medicine Quality Control and Surveillance Department that also offers a surveillance programme to our Member States to actively monitor the safety of registered drugs. PMS is a programme developed by MQCSD that will further shape and form in collaboration with our partners and colleagues from Member States.”
The importance of the CARPHA MQCSD as the only ISO/ IEC 17025 accredited medicines quality control laboratory in the English-speaking Caribbean, cannot be over-emphasized. The department has embarked on a post market surveillance programme for medicines, which seeks to monitor the quality of selected medicines circulating in the pharmaceutical markets of participating CARPHA Member States. This will ensure that Member States have access to information which can be utilized to develop evidence-based approaches such as issuing of alerts, implementing risk reduction strategies and overall management of national public health risks.
Given the limited resources and other challenges facing small island developing states such as CARICOM countries, the responsibilities related to regulatory systems are difficult to carry out single-handedly or individually. In collaboration with other partners such as PAHO/WHO, CARPHA MQCSD will function as a critical part of a robust mechanism for regulating medicines in CARICOM.
Mrs. Jesse Schutt-Aine, Sub-regional Program Coordinator, Caribbean, PAHO/ WHO stated “PAHO is happy to be working with CARICOM and CARPHA and Member States on this initiative. Strong regulatory systems are the foundation for strong health systems. A strong health system is what’s needed for universal health, and universal health is essential for the attainment of the sustainable development goals. PAHO has been working on these issues for many years supporting the development of the Caribbean Pharmaceutical Policy, as well as a roadmap for a regional regulatory platform. More recently PAHO has been working closely with CARICOM and CARPHA and Member States to advance the Caribbean Regulatory Systems – the regional regulatory system that is managed by CARPHA. Ms. Schutt-Aine acknowledged “CARPHA as a regional public health platform that is transforming its drug testing laboratory into something that can enhance post market surveillance in the Region through risk based sampling of products in Caribbean markets.”
The introduction of the new surveillance programme will allow CARPHA MQCSD laboratory to monitor medicines such as those used for the control of non-communicable diseases and other medicines. This programme is aligned with CARICOM’s strategy of advancing initiatives for health and wellness by ensuring access to safe, reliable medicines thereby improving the quality of life of the Region. The Caribbean region will have access to information to undertake evidence-based approaches to enable warning, risk reduction and management of national public health risks.
Speaking at the opening, Dr Rudolph Cummings, Programme Manager, Health Sector Development, CARICOM Secretariat said, “The Medicines Quality Control and Surveillance Department needs to be complemented for the tremendous work that it has done to prepare for this meeting and in positioning itself to support the efforts require for a successful regional pharmacovigilance program.”
Access to healthcare and essential quality medicines and pharmaceutical products is critical for the Caribbean population's well-being and optimal health. Through dossier evaluation and pre-marketing quality control of generic medicines for the purpose of registration, some countries are ensuring that quality medicines are on the market.
At the closing of the opening ceremony, Ms. Sonia Thomas-Gordon, Acting Head/Senior Chemist, CARPHA MQCSD, in her vote of thanks, acknowledged the commitment and endorsement by partners and participants to the MQCSD post surveillance programme. She said “Post market is a small component of pharmacovigilance, and the laboratory component is important. What we are trying to do is be proactive and monitor those medicines that are on the market. Most Member States do not have capacity to monitor and we are hoping to bridge the gap to have one central area, where medicines come to us for testing and we issue the results.”
The 2-day meeting will seek to sensitize CARICOM's Technical Advisory Committee on Pharmaceutical Policy (TECHPHARM) and Caribbean Regulatory Systems (CRS) focal points on MQCSD’s post market surveillance program with a view to strengthen regional integration and partnerships for sustainable development of the programme. The meeting will also aim to reaffirm the role of TECHPHARM in regional PMS and as a Technical Advisory Committee (TAC) to MQCSD. Also, down for discussion are the acknowledgement and endorsement of MQCSD’s PMS Strategy and Field Guide.