Public Health Communications Specialist
Ministry of Health/Social Development
Chief of Drugs and Pharmaceutical Services, Mrs. Gracia Wheatley-Smith has said her office is equipped with skills in signal detection and drug safety as part of ongoing efforts to enhance pharmacovigilance locally.
Mrs. Wheatley-Smith said following her participation in training at a Signal Detection and Causality Assessment Workshop in Sweden last month, the VI now has the capacity to recommend several actions to Market Authorisation Holder through regulatory action. These she said include change of dose/formulation, addition of black box warning to the container so that prescribers would be aware of this reaction before prescribing and can weigh the risk benefit ratio to the patient, restricting prescribing and recommending withdrawal of the medicine from the market.
Mrs. Wheatley-Smith said the training spanned many weeks of online and in person sessions following which she was selected along with 17 other participants from countries including Paraguay, Egypt, Peru and Sierra Leone to participate in the face to face course at the Uppsala Monitoring Centre in Sweden.
Mrs. Wheatley-Smith cautioned that although medicines and vaccines undergo established processes of research before being approved for administration, adverse drug reactions and the adverse events after the administration of vaccines can still occur.
“This is why it is important to report any side effects or adverse drug reactions that are experienced to your doctor, pharmacist or to the Chief of Drugs for investigation,” she said.
During research the population taking the drug is small compared to the number of persons taking the drug once it is released on market. “Hence additional reactions may be experienced in this large population. Through reporting, recommendations are made to improve medicines safety for you, for me and for our children,” the Chief of Drugs said.
Mrs. Wheatley-Smith added, “I want the community to get in the habit of reporting adverse drug reactions to the Ministry of Health. Adverse drug reactions (ADRs) can range from rash, swelling, loss of appetite and more serious reactions. Reporting ADRs is the only way that drug safety can be improved.”
Persons can send reports via email to firstname.lastname@example.org or telephone 468-9850. Once the information is submitted it can be compiled, analysed and submitted to the Uppsala Monitoring Centre through the data base where it can be added to reports from other countries and analysed at that global level for signal detection and causality assessment.
The Ministry of Health and Social Development is committed to improving the health of the people of the Virgin Islands by increasing pharmacovigilance and medicine safety.