Blood
Report suspected side effects and safety concerns related to blood products (which are considered medicines) to the ZAMRA Safety Watch.
What is blood?
Blood means whole human blood collected from a donor and processed either for transfusion or for further manufacturing, excluding blood specimens intended for pathology testing.
Side effects and adverse reactions from blood
A side effect is an unintended effect that happens in addition to the main intended effect of blood. An adverse reaction is when the resulting effect causes harm this can be both physical and mental.
There will be common side effects to receiving blood, which your doctor or a healthcare professional will be able to advise on.
Safety concerns related to blood components
ZAMRA also regulates human blood collected from a donor and processed either for transfusion or for further manufacturing, excluding blood specimens intended for pathology testing. Healthcare professionals can report side effects of blood through the ZAMRA Safety Watch.
Why report side effects to ZAMRA Safety Watch?
Everyone has a different genetic makeup, so it's difficult to predict who will experience a side effect. Whether you're a healthcare professional or a member of the public, reporting side effects you or your patients experience helps ZAMRA gain a better understanding of the safety of blood its preparation and use and safeguard patients through safety monitoring.
Blood product
Report suspected side effects and safety concerns related to blood products (which are considered medicines) to the ZAMRA Safety Watch.
What is a blood product?
A blood product is a medicinal product manufactured from human blood or plasma. Examples include albumin, coagulation factors such as Factors I to XIII, Anti-D, and immunoglobulins.
Side effects and adverse reactions from blood products
A side effect is an unintended effect that happens in addition to the main intended effect of the blood product. An adverse reaction is when the resulting effect causes harm this can be both physical and mental. There will be common side effects to receiving the blood product, which your doctor or a healthcare professional will be able to advise on.
Safety concerns related to blood components
ZAMRA also regulates blood components, such as red blood cells, platelets, and fresh frozen plasma. Healthcare professionals can report side effects of blood components through the ZAMRA Safety Watch.
Why report side effects to ZAMRA Safety Watch?
Reports help us gain a better understanding of a medicine's safety and safeguard patients through safety monitoring. Reporting can also help ZAMRA identify a potentially dangerous product and possibly remove it from the market.
Cosmetic
Any cosmetic including body lotions, deodorants and toothpastes can cause an unwanted side effect. These are commonly referred to as adverse cosmetic events (ACEs) by healthcare professionals. You can report any safety concerns involving cosmetics to the ZAMRA Safety Watch. We advise that you complete the report as soon as possible.
What is a cosmetic?
Cosmetics are used in cleansing, beautifying or altering the hair, eyes, teeth, nails or the skin. Most cosmetics come in a variety of types or formats, including:
- Creams, emulsions, lotions, gels and oils for the skin
- Face masks, including chemical peeling products
- Tinted bases (liquids, pastes, powders)
- Make-up and hygienic powders
- Pure glycerin
- Toilet and deodorant soaps
- Perfumes, toilet waters and eau de cologne
- Deodorants and anti-perspirants
- Hair care products (tints, bleaches, styling, cleansing and conditioning products, anti-hair loss products)
- Shaving and aftershave products
- Make-up and make-up removal products for face and eyes
- Lip care products
- Oral and dental care products
- Nail care and make-up products
- Products for external intimate hygiene
- Sunbathing and sun-tanning products
- Anti-wrinkle and anti-ageing products
- Sunscreen products
- Cosmetic glue (hair, eyelashes and nails)
Side effects and adverse reactions to cosmetics
A side effect is an unintended effect that happens in addition to the main intended effect of the cosmetic. An adverse reaction is when the resulting effect causes harm this can be both physical and mental. Side effects can happen at any time, but particularly when you:
- Take or use a cosmetic for the first time
- Stop using a product after long-term use
- Change the dosage or amount of a product you already use
- Use a product that interacts with another product, cosmetic, medicine or device
A cosmetic interaction happens when another substance affects the way a cosmetic works for example, another cosmetic, medicine, food, drink or herbal supplement. Not everyone experiences these side effects, and their severity can vary from person to person, because everyone's body is different.
Safety concerns related to cosmetics
Side effects could also be the result of a defective, fake or unauthorised cosmetic.
Defective cosmetics (product quality problem)
A defective cosmetic is a product that is not working properly or not to the manufacturer's specifications. Defects can occur due to:
- Quality issues with the product itself
- Quality issues with the packaging (carton, bottle)
- Problems with labelling on the packaging or packaging components
- Lack of efficacy, which can be assessed by a healthcare professional or beauty specialist
If you don't think your cosmetic is good enough to use, report it to ZAMRA Safety Watch. You can also consult your healthcare provider or the product's distributor for advice.
Fake / unauthorised cosmetics
A fake cosmetic tries to pass off as a genuine, authorised cosmetic. An unauthorised cosmetic does not hold the relevant authorisations for sale and supply in Zambia, and ZAMRA has no evidence of its safety, quality or effectiveness. Look out for signs such as:
- Being different to how it is described and how it looks
- Any misrepresentation of what it is, where it came from, or details on the packaging (e.g. expiry date)
Why report side effects to ZAMRA Safety Watch?
Whether you're a healthcare or beauty professional or a member of the public, reporting side effects helps ZAMRA better understand the safety of cosmetics and safeguard users through safety monitoring and can help identify a potentially dangerous product for removal from the market.
Medical device
You can report any safety concerns involving medical devices to the ZAMRA Safety Watch. We advise that you complete the report as soon as possible and keep hold of the device, as a further review might be needed from us or the manufacturer.
What is a "medical device"?
The term "medical device", or medical appliance, covers a broad range of healthcare products used for the diagnosis, prevention, monitoring, or treatment of illness including physical items and software, such as:
- Latex products, such as condoms and gloves
- Prescription contact lenses and crutches
- Implantable devices, such as breast implants or pacemakers
- Defibrillators
- X-ray machines
- Ophthalmoscopes (fundoscopes) used by opticians
- Blood glucose monitors
- Computer-Aided Detection (CAD) software for image post-processing (e.g. breast cancer detection)
- Apps that calculate insulin dosing based on carbohydrate intake
Safety concerns related to medical devices
An adverse incident involving a medical device is an event that caused, or almost caused, an injury to someone, or affected the treatment or diagnosis they could receive. Practical examples include:
- Faulty brakes on a wheelchair
- Wrong readings on a thermometer, blood pressure machine or test kit
- Blood glucose strips giving the wrong readings
- Unclear labelling or instructions
- Unsafe design
- Other quality issues that impact safety
Faulty medical devices
A faulty or defective medical device is a product that is not working properly or not to the manufacturer's specifications.
Fake medical devices
A fake or counterfeit medical device tries to pass off as a real, authorised device. Look out for signs such as being different from what it's described as, or misrepresenting its identity, source, or history.
Poor quality and unsafe design
A device manufactured to a poor standard may not last as expected. Inherently safe design means the device is built so that mistakes in how it's used can be avoided for example, components that can only be assembled correctly. We want to know when a device could easily be misused unsafely in a way that better design could prevent.
If you suspect any of the above applies to a medical device, report it to the ZAMRA Safety Watch as soon as possible.
Why report side effects to ZAMRA Safety Watch?
Everyone is different, so it's difficult to predict who will experience a problem. Reporting helps ZAMRA gain a better understanding of safety issues with medical devices, safeguard patients through safety monitoring, and identify potentially dangerous products for removal from the market.
Medicines
Any medicine including vaccines, herbal and traditional medicines can cause an unwanted side effect. These are commonly referred to as an adverse drug reaction (ADR) by healthcare professionals. Side effects can result from medicines prescribed by a healthcare professional or purchased without a prescription.
What is a medicine?
A medicine helps to treat or prevent disease and can be made up of synthetic (pharmaceutically prepared), herbal or traditional active ingredients. Medicines come in different forms, including:
- Tablets and powders
- Cough syrups
- Drops for the eyes or ears
- Asthma inhalers
- Allergy tablets
- Skin creams or gels
In Zambia, unless all the information relating to the medicine is on the packaging, a patient information leaflet (PIL) is included inside the pack, listing important information including common side effects. Not everyone experiences these side effects, and their severity can vary from person to person, because everyone's body is different.
Side effects and adverse reactions to medicines
A side effect is an unintended effect that happens in addition to the medicine's main intended effect. An adverse reaction is when the resulting effect causes harm this can be both physical and mental. Side effects can happen at any time, but particularly when you:
- Take or use a medicine for the first time
- Stop taking a product after long-term usage
- Change the dosage of a product you already take
- Take a product that interacts with another medicine or device
A medicine interaction happens when another substance affects the way a medicine works for example another medicine, food, drink or herbal supplement. Types of interaction include:
- Drug–drug interactions — when two or more healthcare products interact
- Drug–food interactions — when a certain food changes the action of a medicine
Safety concerns related to medicines
Side effects could also be the result of a defective, fake or unauthorised medicine.
Defective medicines (product quality problem)
A defective medicine is not working properly or not to the manufacturer's specifications. Defects can occur due to:
- Quality issues with the product itself
- Quality issues with the packaging (carton, blister pack)
- Problems with other packaging components, such as the patient information leaflet
- Lack of efficacy, which can be assessed by a pharmacist or healthcare professional
If you don't think your medicine is good enough to take, report it to ZAMRA Safety Watch. You can also consult your doctor or pharmacist for advice.
Fake / unauthorised medicines
A fake medicine tries to pass off as a genuine, authorised medicine. An unauthorised medicine does not hold the relevant authorisations for sale and supply in Zambia, and ZAMRA has no evidence of its safety, quality or effectiveness. Look out for signs such as:
- Being different to how it is described and how it looks
- Any misrepresentation of what it is, where it came from, or details on the packaging (e.g. expiry date)
Why report side effects to ZAMRA Safety Watch?
Reporting helps ZAMRA gain a better understanding of medicines' safety, safeguard patients through safety monitoring, and identify a potentially dangerous product for removal from the market.
Nutritional supplement
Nutritional supplements can be beneficial to your health, but they can also involve health risks talk with a healthcare professional to help decide if a supplement is right for you. Any nutritional supplement can cause an unwanted side effect, commonly referred to as an adverse event or adverse reaction. You can report any safety concerns involving nutritional supplements to the ZAMRA Safety Watch we advise you complete the report as soon as possible.
What are nutritional supplements?
Nutritional, dietary, food or health supplements (nutraceutical products) are intended to add to or supplement the diet and are different from conventional food. Generally, to the extent a product is intended to treat, diagnose, cure or prevent disease, it is a drug even if labelled as a nutritional supplement. Supplements come in many forms, including tablets, capsules, soft gels, gel caps, powders, bars, gummies and liquids. Common supplements include:
- Vitamins (multivitamins, vitamin D, biotin)
- Minerals (calcium, magnesium, iron)
- Botanicals or herbs (echinacea, ginger)
- Botanical compounds (caffeine, curcumin)
- Amino acids (tryptophan, glutamine)
- Live microbials ("probiotics")
Side effects and adverse reactions to nutritional supplements
A side effect is an unintended effect that happens in addition to the main intended effect. An adverse reaction is when the resulting effect causes harm this can be both physical and mental. Side effects can happen at any time, but particularly when you:
- Take or use a supplement for the first time
- Stop taking a product after long-term usage
- Change the dosage or amount of a product you already take
- Take a product that interacts with another product, supplement or medicine
A supplement interaction happens when another substance affects how a supplement works for example another supplement, medicine, food or drink. Not everyone experiences these side effects, and their severity varies from person to person, because everyone's body is different.
Safety concerns related to nutritional supplements
Side effects could also be the result of a defective, fake or unauthorised product.
Defective supplements (product quality problem)
A defective supplement is not working properly or not to the manufacturer's specifications. Defects can occur due to quality issues with the product or packaging, labelling problems, or a lack of efficacy assessed by a healthcare professional or dietician. If you don't think your supplement is good enough to use, report it to ZAMRA Safety Watch, or consult your healthcare provider or distributor.
Fake / unauthorised supplements
A fake supplement tries to pass off as a genuine, authorised product. An unauthorised supplement does not hold the relevant authorisations for sale and supply in Zambia, and ZAMRA has no evidence of its safety, quality or effectiveness watch for products that look or are described differently than expected, or that misrepresent origin or details such as expiry date.
Why report side effects to ZAMRA Safety Watch?
Reporting side effects helps ZAMRA better understand supplement safety and safeguard users through safety monitoring and can help identify a potentially dangerous product for removal from the market.
Vaccine
Any medicine including vaccines, herbal and traditional medicines can cause an unwanted side effect, commonly referred to as an adverse event following immunisation (AEFI) by healthcare professionals.
What is a vaccine?
A vaccine is a medicine administered to prevent a specific disease. Examples include:
- Childhood vaccinations, such as BCG (Bacillus Calmette–Guérin), MMR (measles, mumps and rubella), Polio and HPV (human papillomavirus)
- Vaccinations available in adulthood, such as tetanus, rabies and COVID-19
- Travel vaccines, such as yellow fever
What vaccines are used for
Vaccines are simple and effective ways to protect you against harmful diseases. They work by training your body's natural defence, the immune system, to recognise specific infections and produce antibodies to prevent disease. Vaccines are mainly given by injection, but can also be given orally or sprayed into the nose.
Side effects and adverse reactions to vaccines
A side effect is an unintended effect that happens in addition to the main intended effect of the vaccine. An adverse reaction is when the resulting effect causes harm this can be both physical and mental. Side effects can happen at any time, but particularly when given a vaccine for the first time. Most side effects are normal, mild, and last only a couple of days this occurs as the vaccine teaches your immune system how to protect your body from disease.
Safety concerns related to vaccines
Side effects could also be the result of a defective or fake vaccine.
Defective vaccines
A defective vaccine is a product that is not working properly or not to the manufacturer's specifications.
Fake / unauthorised vaccines
A fake vaccine tries to pass off as a genuine, authorised vaccine. An unauthorised vaccine does not hold the relevant authorisations for sale and supply in Zambia, and ZAMRA has no evidence of its safety, quality or effectiveness.
Why report side effects to ZAMRA Safety Watch?
Everyone has a different genetic makeup, so it's difficult to predict who will experience a side effect. Reporting helps ZAMRA gain a better understanding of vaccine safety, safeguard patients through safety monitoring, and identify a potentially dangerous product for removal from the market.
Seen a side effect or safety concern?
Report it to ZAMRA Safety Watch your report helps us monitor product safety and protect patients across Zambia.