Reporting Of Medicine Side Effects by Consumers
Side Effects/Adverse Drug Reaction
What Is A Side Effect/Adverse Drug Reaction?
- An unwanted effect or a harmful reaction experienced following the administration of a drug/medicine or combination of medicines
- The reaction may be a known side effect of the medicine or it may be new and previously unrecognised
- It can also suddenly occur with medicines that you have taken often without side effects previously
Some Examples of Side Effects
Rashes
Nausea, vomiting
Difficulty in breathing
Swelling (lips, eyes & tongue)
What Should I Do If I Experience A Side Effect?
Step 1
If you believe you are having a side effect, it is important to speak/see your doctor or pharmacist.
Step 2
- Report to the National Pharmaceutical Regulatory Agency (NPRA)
- Use ConSERF (Consumer Side Effect Reporting Form). Please report any side effect you find troubling, even if you are not certain it is due to the medicine
Please note down the following information:
How Do I Make A Report?
How to Report?
- Please complete as many sections as possible to ensure your report is useful. You may consult your pharmacist for assistance in filling the form
- Submit online, or post/email directly to NPRA
- Please provide your contact details to allow NPRA to obtain further information about your report if necessary. Your details will remain confidential.
Role of NPRA, Ministry of Health Malaysia
The National Pharmaceutical Regulatory Agency (NPRA) monitors the safety of medicines in Malaysia to contribute to a better understanding of their possible side effects. Analysis of side effect reported has contributed to the following steps to improve medication safety:
- Issuing safety alerts & prescribing restriction of at-risk medicine
- Updating the package inserts & consumer medicine information leaflets with the latest safety information
- Removal of certain at-risk medicine from the market
What Can I Report & Why?
What To Report?
You can report side effects from:
- Medicines or vaccines (prescription medicines from the doctor or over-the-counter medicines)
- Vitamins and health supplements
- Herbal or traditional medicines
Besides oral medicines (tablets, capsules and syrups); other medicines like creams, lotions, suppositories and inhalers can also cause side effects.
Role of NPRA, Ministry of Health Malaysia
Unfortunately it is impossible to know all side effects of a medicine before it is approved for use. When people report about their experiences using a particular medicine it helps us to understand more about the possible side effects of the medicine and identify new problems that we might not have known before.
Drug Allergy
What Is A Drug Allergy?
What should you do if you think you have a drug allergy?
If you know or suspect you are allergic to a drug:
- AVOID / STOP taking that drug
- Seek medical advice from your doctor to confirm
DRUG ALLERGY CARD
- Useful for patients with confirmed drug allergy
- Alerts healthcare professionals about a patient’s drug allergies
- Helps prevent patients from taking drugs that may cause allergic reactions
Tips for allergy card holders:
- Bring along the drug allergy card at all times
- Show the drug allergy card to any healthcare professionals involved in your care
For severe allergic reactions, consider obtaining a medical alert bracelet
What Are The Symptoms of Drug Allergy?
Itch
Swelling
Difficulty Breathing
Skin Reaction
Symptoms may vary from one patient to another
Mild allergic reactions:
- Skin rashes or urticaria (hives)
- Repeated-itching
ANAPHYLAXIS – life-threatening and requires urgent medical attention!
- Skin rashes or urticaria (hives)
- Itching
Drugs commonly associated with allergic reactions:
- Antibiotics – penicillin (cloxacillin, amoxycillin), trimethoprim/sulphamethoxazole
- Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) – mefenamic acid, ibuprofen, diclofenac
Drug Allergy VS Side Effect To A Drug
DRUG ALLERGY
A drug allergy is a rare condition in which the body’s immune system responds to a drug and causes adverse effects.
SIDE EFFECT
A side effect to a drug is:-
- an unwanted effect from a drug
- different from a drug allergy
- does not involve an immune reaction
*Sometimes a side effect to a drug may disappear as drug therapy continues
