Have you ever experienced any side effects from your medicine?

Do you know what side effects are?

Side effects or adverse reactions of medicines are undesirable symptoms which occur with the use of any medications, including health supplements, traditional products and cosmetics. Side effects are diverse. They may occur as minor conditions such as mild skin irritation, nausea and vomiting or more serious ones such as liver damage and heart problems. Side effects sometimes occur within a short time after administration, while under other circumstances, after prolonged use.

Why should side effects be reported?

All medicines in Malaysia, including those classified as health supplements and traditional products, must be registered with the Drug Control Authority (DCA), Ministry of Health Malaysia (MOH). Only pharmaceutical products evaluated to be of quality, efficacious and safe, as well as health supplements and traditional products deemed to be safe and of quality will be registered.

Although medicines have been studied in clinical trials prior to approval, it is not until larger population has taken the medicine that rare side effect or those that appear only after long-term use become apparent. Reporting side effects allows new safety risks to be identified. Any changes in the frequency of known side effects can also be detected. In addition, this enables us to understand a medication’s safety profile and subsequently be able to assess the benefit-risk balance of the product.

According to Regulation 28, Control of Drugs and Cosmetics Regulations 1984 (r28 CDCR’84), the product registration holder or any person who possesses any registered product is required to report to the National Centre of Adverse Drug Reactions Monitoring, National Pharmaceutical Control Bureau (NPCB) of any side effects arising from the use of registered products.

All personal information related to reporting consumers will be kept confidential. If a consumer experiences any unexpected therapeutic effect from the use of certain products especially in the case of traditional medicines and suspect it to contain other substance, then they can report this immediately. In this case the consumer is advised to attach a sample of the product with the report during submission.

When do you need to report and how?

Side effects should be reported as soon as possible after they occur, especially if the side effects interfere with normal daily activities, or those that are serious. Serious side effects include death, those that are life-threatening, require in-patient hospitalisation and those result in disability or birth defects.

There are two easy ways to report side effects:

• Report to your doctor or pharmacist where the medicine was obtained.
• Report to the National Centre of Adverse Drug Reactions Monitoring located in the NPCB. Reports can be made either by phone or by filling in the Reporting Form for Medicines Complaints by Consumers, which can be obtained in the NPCB website, www.bpfk.gov.my, under the Malaysian Adverse Drug Reactions Advisory Committee (MADRAC) subsection.

Participation of consumers in reporting side effects of medicine is very important in enhancing the effectiveness of drug safety monitoring activities because the incidence rate for the local demographics can be determined and hence appropriate preventive measures can be taken.