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Post Market Surveillance Programme

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Medicines Quality Control and Surveillance Department
Hope Gardens,
Kingston 6,
Jamaica
(+876) 977-3540
(+876) 702-4235
carphajam@carpha.org

Post Market Surveillance Programme

The quality of any medicine is determined by its effectiveness, safety and ultimately the health outcome of a patient. If that quality is questionable, then any efforts and investment into public health systems and medicines regulatory systems will be compromised. MCQSD functions as a critical part of robust mechanisms for regulating medicines in CARICOM, in close cooperation with Member States, CARPHA Caribbean Regulatory System (CRS) and other partners such as PAHO/WHO. In June 2018, the Department established a post-market surveillance (PMS) programme for medicines circulating in the pharmaceutical markets of the Caribbean.

Programme Objectives

The programme’s objectives are to:

Develop risk-based criteria for the selection of medicines to be tested, in order to prioritize those that pose risks to public health.
Proactively monitor selected medicines on the Caribbean market for quality, safety and efficacy.
Develop competencies to enable sampling and testing of medicines on the market, as routine surveillance of the quality of medicines.
Collaborate with the CARPHA CRS, CARICOM Expanded Technical Advisory Committee on Pharmaceutical Policy (TECHPHARM), and national focal points to select medicines for annual post-market surveillance, including drawing on the CARPHA CRS regional network for pharmacovigilance and post-market surveillance.

Programme Activities

The post market surveillance programme focuses on two strategic components:

All CARPHA Member States are eligible to participate. The activities of the programme will involve:

Identification of priority medicines by focal points for compendial testing, based on risk-based criteria
Sampling of medicines by assigned personnel of the National Medicines Regulatory Authority (NMRA)
Shipping of samples to the MQCSD with appropriate permits and documentation;
Testing of samples
Communication of results to NMRAs, and
Annual reporting of programme activities to CARPHA Member States.

A pre-determined list of medicines will be selected and revised annually, in collaboration with regional NMRAs, CRS and TECHPHARM. The procedures of the programme are subject to review during the annual evaluation of the programme.

Risk-based Criteria used in Selection of Medicines

The following criteria will be used to select the medicines for the post-market surveillance programme:

Medicines/manufacturers reported by NMRA/Ministry of Health, procurement agencies, MQCSD for quality/substandard/falsification issues
Medicines produced by countries with limited regulated systems
Medicines with limited time on market (less than 5 years on the market of a stringent regulatory authority)
Medicines listed on recognized standard guidelines and used in high volume/wide regional distribution such as the WHO Essential Medicine List, National Institute for Health and Care Excellence, Joint National Committee 8 Guidelines, National Guidelines, CRS recommended medicines.
Medicines with narrow therapeutic index/drug therapeutic monitoring
Medicines with formulation challenges/ complex production processes

MQCSD has developed a Post-Marketing Surveillance Guide for Small Island Developing States. The Guide aims to

To assist national medicines regulatory authorities of CARPHA Member States and associates in the design and conduct of programs for national post-market surveillance of medicines; and
To describe the procedures for sample collection, and the submission of samples of medicines for compendial testing to the MQCSD.

This Guide serves as one of many tools that may be used by National Medicines Regulatory Authorities and procurement bodies. It may be supplemented by training workshops, and updated as new approaches are developed to improve medicines regulatory systems and to meet the evolving public health needs of the Caribbean people.

Post Market Surveillance Documents