Reporting adverse events
AMONG the primary worries of anti- vaccination movements are the negative effects the vaccine could cause.
Vaccines are safe and vaccine reactions are generally mild, such as injection site swelling, injection site pain, rash and fever.
These reactions can be better anticipated and managed if healthcare professionals as well as consumers are aware of the possible adverse effects.
Occasionally, serious reactions have been reported soon after immunisation and the public is fast to put blame on the vaccine.
However, investigations have shown that most of the serious reactions are due to other underlying medical conditions in the patient.
This is why the Health Ministry ( MOH) closely monitors these adverse events through a reporting system under the National Pharmaceutical Bureau ( NPCB).
“From 2000 until June this year, we received only 133 reports of reactions to the measles vaccination.
“About 25% of the reports were of fever, rash and pain at site of injection. These are considered mild side effects,” says Rokiah Isahak, senior principal assistant director at the Centre for PostRegistration of Products, National Pharmaceutical Control Bureau ( NPCB).
The NPCB created this reporting system in 1987 as a channel for the public to report the adverse effects they experienced from vaccines.
This system is called the Reporting of Adverse Events Following Immunisation ( AEFI).
When a drug or a vaccine is registered, it has to be proven to be of good quality, safe and effective through clinical trials.
Side effects are normally discovered during clinical trials, but these trials only involve a select group of healthy individuals.
Thus, when a drug is released into the market and consumed by members of the public, some people, especially those with existing health conditions, may experience different, specific reactions.
“We want to be able to keep track of these adverse cases and investigate them further, as well as discover new effects of existing drugs,” says Rokiah.
The NPCB continuously monitors all drugs after they have been released into the market.
It collects these reports and presents its findings to the Malaysian Adverse Drug Reaction Advisory Committee ( Madrac), which provides the Drug Control Authority ( DCA) with information and recommendations pertaining to drug safety issues.
The DCA implements changes through directives, most commonly to update information on drug labels to include the new side effects or precautionary measures.
Occasionally, when a risk is unacceptable, a drug product may be withdrawn from the market.
Rokiah says this is why it is important for members of the public to report adverse effects of drugs in the market.
“We pick up the signal that something is wrong through these reports and rectification is carried out to prevent it from happening in the future,” she explains.
The NPCB also carries out regular risk communication with doctors, pharmacists and other healthcare professionals so they are aware of any update, can share it with their patients and can do their part to monitor adverse events.
As a member of the World Health Organization ( WHO) Drug Monitoring Programme, the NPCB also has a responsibility to report all adverse effects in the country so this information can become accessible to a global audience.
WHO has a global database that members from all over the world use as an important reference to