Report medicines’ side effects — MCAZ
THE Medicines Control Authority of Zimbabwe (MCAZ) has said it is important for the public to report adverse events (side effects) they experience after taking certain medications so that the information can be used to improve patient safety.
MCAZ is a statutory body established by an act of Parliament, The Medicines and Allied Substances Control Act (MASCA) [Chapter 15.03] and is mandated to protect public health ensuring that medicines and medical devices on the market are safe, effective and of good quality.
Responding to questions from
Sunday News,
MCAZ public relations officer, Mr Davison Kaiyo called upon the public to report possible side effects.
“It is important to report adverse events (side effects) to the MCAZ because the information is used to improve patient safety by ensuring that the relevant safety information pertaining to medicines is made available to the doctors, pharmacists, nurses and other healthcare professionals, as well as to the patients.
“This information is used in various ways, including development of safer medicines, updating of medicines labels to include appropriate warnings, phasing out of harmful medicines and development of safer medicines,” said Mr Kaiyo.
He said some adverse events brought to light through reporting to MCAZ have resulted in removal of unsafe medicines from the market, or updating of treatment guidelines through new medicine-safety knowledge acquired.
Mr Kaiyo said once a report is made, it would be evaluated and tabled before a specialist MCAZ committee known as the Pharmacovigilance and Clinical Trials (PVCT) committee for causality assessment.
“Causality assessment is a process
of evaluating the likelihood that a particular medicine caused the reported adverse events (side effects). Relevant action is then taken based on the outcome of the PVCT committee meeting for each report evaluated.
“Where causality assessment shows that the reported adverse event is likely due to the medicine in question, steps are taken to minimise the risk associated with the medicine and improve patient safety,” he added.
He said once laboratory analysis (tests) are conducted for some of the reported adverse events, each report is evaluated individually and some reports result in the medicine being sent to the laboratory for analysis.
“Some side effects are due to the nature of the medicine and not due to any quality problems, for example red meat can cause gout in some people, even if cooked correctly and not having any quality problems this is usually indicated in the package inserts of the medicines.
“These do not go for laboratory analysis, but still undergo the process of causality assessment.”
He said after each report is evaluated individually, action taken varies depending on the issue. Mr Kaiyo said if the seller has sold unregistered, expired medicines, substandard or falsified medicines, then regulatory action is taken, which can include cancellation of licences and prosecution among others.