The Pharmacy Unit, Ministry of Health and Human Services (MoHHS) is pleased to report that it is in receipt of the TCI’s 1st-ever certificate of analysis following testing and analysis of medicines utilized within the country. This significant milestone is a result of the partnership formed with the Medicines Quality Control and Surveillance Department (MQCSD) of the Caribbean Public Health Agency (CARPHA) as a part of their risk-based Post-Market Surveillance (PMS) Programme for medicines. The medicine that was tested and analyzed met the required quality standard.
A Certificate of Analysis is a legal document that certifies the quality of a medicine and/or its ingredients known as excipients. The certificate demonstrates that the batch/sample tested meets all the required quality control standards which confirms product quality and safety.
The Pharmacy Unit views this development as a very significant step in strengthening the systems and capacities required to improve the effective monitoring of drug/patient safety. The Unit is committed to ensuring the utilization of good quality, effective, and safe medicines within the TCI. The TCI’s involvement in the PMS Programme will strengthen and continue to support the effectiveness of its medicines regulatory system by:
Providing data and information that will better inform the government on the appropriate and effective regulatory actions and strategies to implement (that will improve the availability of safe and essential good quality medicines), and
Identifying in a timely manner, possible substandard and falsified products/medicines on the TCI market.
The MoHHS notes that it is essential to improve fair access to safe quality medicines which are hallmarks of effective disease management/treatment and will continue to actively monitor and regulate all medicines used within the TCI. The MoHHS is committed to patient safety and anticipates that this will positively impact the health and wellbeing of all TCI residents.
In light of this initiative, the MoHHS is also encouraging persons to report any adverse events – suffered from the use of medicines – via the MoHHS’ Adverse Drug Reaction Form found at https://gov.tc/docs/ADR.pdf. Consequently, suspected substandard and or falsified medicines can be flagged for testing and analysis.
