Key Technical Terms

Report suspected side effects and safety concerns related to blood products (which are considered medicines) to the ZAMRA Safety Watch.

What is blood product?

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 you receiving blood, which your doctor or a healthcare professional will be able to advise on.

Safety concerns related to blood components

The Zambia Medicine Regulatory Authority (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 the ZAMRA Safety Watch?

Everyone has a different genetic makeup and therefore it is very difficult to predict whether an individual will experience a side effect. Whether you are a healthcare professional or a member of the public, you can help others by reporting side effects which you or your patients experience to the ZAMRA Safety Watch. Reports help us gain a better understanding of safety aspects of blood, it’s preparation or use and safeguard patients through safety monitoring.

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 of Blood products are 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 you receiving the blood product, which your doctor or a healthcare professional will be able to advise on.

Safety concerns related to blood components

The Zambia Medicine Regulatory Authority (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 the ZAMRA Safety Watch?

Everyone has a different genetic makeup and therefore it is very difficult to predict whether an individual will experience a side effect. Whether you are a healthcare professional or a member of the public, you can help others by reporting side effects which you or your patients experience to the ZAMRA Safety Watch. Reports help us gain a better understanding of 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.

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.

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 taking either medicines prescribed by a healthcare professional or those purchased without being prescribed by a healthcare professional.

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 and they include:

• Creams, emulsions, lotions, gels and oils for the skin
• Face masks including chemical peeling products
• Tinted bases (for example liquids, pastes, powders)
• Make-up powders, after-bath powders, hygienic powders
• Pure Glycerin
• Toilet soaps, deodorant soaps
• Perfumes, toilet waters and eau de Cologne
• Deodorants and anti-perspirants
• Hair care products such as:
  • hair tints and bleaches
  • products for waving, straightening and fixing
  • setting products
  • cleansing products (for example lotions, powders, shampoos)
  • conditioning products (for example lotions, creams, oils)
  • hairdressing products (for example lotions, lacquers, brilliantines)
  • anti-hair loss and hair growth enhancer products
• Shaving products (for example Depilatories; creams, foams, lotions, waxes etc.);
• Aftershave products
• Products for make-up and removing make-up from the face and the eyes
• Products intended for application to the lips
• Products for care of the teeth and the mouth
• Products for nail care and make-up
• Products for external intimate hygiene
• Sunbathing products
• Products for tanning without sun
• Anti-wrinkle products
• Anti-aging products
• Sunscreen products
• Cosmetic glue (hair, eye lashes 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 taking a product after long-term usage
• change a dosage or amount of a product you already take
• take 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, this could be another cosmetic, medicine, food, drink or herbal supplement.

Not everyone may experience these side effects. These side effects may be more severe in some people and less severe in other people. Some people may not even experience any side effects. This is because everyone is different, and our bodies may have different experiences with different medications.

Safety concerns related to cosmetics

Side effects could also be the result of defective, fake/unauthorised cosmetic (one that is not authentic).

Defective cosmetics (product quality problem)

A defective cosmetic is a product that is not working properly or not to the manufacturer’s specifications.

If you do not think your cosmetic is good enough to take or use, report this to ZAMRA Safety Watch. You can also consult your healthcare provider or distributor of the cosmetic who can provide advice and report to us.

Defects in cosmetics can occur due to:

• Quality issues with the product itself
• Quality issues with the packaging (carton, bottle)
• Problems with labeling on the packaging or packaging components
• Lack of efficacy which can be decided by speaking to a healthcare professional or a beauty specialist.

Fake/unauthorised cosmetics

A fake cosmetic is a product that tries to pass off as a genuine authorised cosmetic. An unauthorised cosmetic does not hold the relevant authorisations for sale and supply to patients 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 concerning what it is, where it has come from or details provided on the packaging (e.g. expiry date).

Why report side effects to ZAMRA Safety Watch? 

Everyone has a different genetic makeup and therefore it is very difficult to predict whether an individual will experience a side effect. Whether you are a healthcare or beauty professional or a member of the public, you can help others by reporting side effects which you or your clients experience to ZAMRA Safety Watch. Reports help us gain a better understanding of the safety of cosmetics and safeguard users through safety monitoring. Reporting can also help ZAMRA identify a potentially dangerous product and possibly remove it from the market.

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, including physical items such as:

• latex products such as condoms and gloves
• prescription contact lenses and crutches
• implantable medical device such as a breast implant or pacemaker
• defibrillator
• x-ray machine
• ophthalmoscope (Fundoscope) that is used by opticians
• blood glucose monitors

or software such as:

• computer-Aided Detection (CAD) software that performs image post-processing to help detect breast cancer
• apps and software that are intended to calculate the dose of insulin a diabetic needed to treat their diabetes based on carbohydrate in a meal

They can be used for the diagnosis, prevention, monitoring, or treatment of illness.

Safety concerns related to medical devices

An adverse incident in relation to a medical device, is an event that caused (or almost caused) an injury to someone or affected the treatment or diagnosis one could receive.

Practical examples of problems with medical devices 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

Medical devices can be found to be faulty, defective, fake/counterfeit, poor quality or have inherently unsafe design. If any of these could cause an adverse incident or have a safety concern, these can all be reported through the ZAMRA Safety Watch.

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 is a product that tries to pass off as a real, authorised medical device.

Look out for signs such as:

• being different to what it is described as
• misrepresenting its identity, source, or history

Poor quality

This may be manufactured to a poor standard mean it does not last as expected.

Inherently unsafe design

Inherently safe design means that through design mistakes in how the device is used can be avoided e.g. components of a device can only be assembled in the correct way.

We would like to know when something easily be done with a medical device that is unsafe but could be avoided through better design.

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 the ZAMRA Safety Watch?

Everyone is different and therefore it is very difficult to predict whether an individual will experience a side effect. Whether you are a healthcare professional or a member of the public, you can help others by reporting side effects which you or your patients experience to the ZAMRA Safety Watch. Reports help us gain a better understanding of safety issues with medical devices and safeguard patients through safety monitoring. Reporting can also help ZAMRA identify a potentially dangerous product and possibly remove it from the market.

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 taking either medicines prescribed by a healthcare professional or those purchased without being prescribed by a healthcare professional.

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.

Most medicines come in a variety of types or formats, some are only available on prescription from your doctor or other healthcare professional, some are available from a pharmacy on recommendation by a pharmacist and others can be purchased without a prescription or a pharmacist’s recommendation.

Medicines come in different forms, including:

• tablets and powders
• cough syrups
• drops for the eyes or ears
• asthma inhaler holding medication
• 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) will be included inside the pack. This lists important information including common side effects that can occur when taking the medicine. Not everyone may experience these side effect. These side effects may be more severe in some people and less severe in other people. Some people may not even experience any side effects. This is because everyone is different, and our bodies may have different experiences with different medications.

Side effects and adverse reactions to medicines

A side effect is an unintended effect that happens in addition to the main intended effect of the medicine. 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 a 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, this could be 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 defective, fake/unauthorised medicines (one that is not authentic).

Defective medicines (product quality problem)

A defective medicine is a product that is not working properly or not to the manufacturer’s specifications.

If you do not think your medicine is good enough to take or use, report this to ZAMRA Safety Watch. You can also consult your doctor or pharmacist who can provide advice and report to us.

Defects in medicines 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 (PIL)
• Lack of efficacy which can be decided by speaking to a pharmacist or healthcare professional.

Fake/unauthorised medicines

A fake medicine is a product that tries to pass off as a genuine authorised medicine. An unauthorised medicine does not hold the relevant authorisations for sale and supply to patients in the 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 concerning what it is, where it has come from or details provided on the packaging (e.g. expiry date).

Why report side effects to ZAMRA Safety Watch? 

Everyone has a different genetic makeup and therefore it is very difficult to predict whether an individual will experience a side effect. Whether you are a healthcare professional or a member of the public, you can help others by reporting side effects which you or your patients experience to ZAMRA Safety Watch. Reports help us gain a better understanding of medicines’ safety and safeguard patients through safety monitoring. Reporting can also help ZAMRA identify a potentially dangerous product and possibly remove it from the market.

Nutritional supplements can be beneficial to your health, but they can also involve health risks. So, it’s important that you talk with a health care professional to help you decide if a supplement is right for you.

Any nutritional supplement can cause an unwanted side effect. These are commonly referred to as adverse events or adverse reactions by healthcare professionals. You can report any safety concerns involving nutritional supplements to the ZAMRA Safety Watch. We advise that you complete the report as soon as possible.

What are nutritional supplements?

Nutritional or dietary or food or health supplements or 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 diseases, it is a drug, even if it is labeled as a nutritional supplement. Supplements are ingested and come in many forms, including tablets, capsules, soft gels, gel caps, powders, bars, gummies, and liquids.

Common supplements include:

• Vitamins (such as multivitamins or individual vitamins like vitamin D and biotin).
• Minerals (such as calcium, magnesium, and iron).
• Botanicals or herbs (such as echinacea and ginger).
• Botanical compounds (such as caffeine and curcumin).
• Amino acids (such as tryptophan and glutamine).
• Live microbials (commonly referred to as “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 (of nutritional supplement). 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 nutritional supplement for the first time
• stop taking a product after long-term usage
• change a dosage or amount of a product you already take
• take a product that interacts with another product, nutritional supplement or medicine.

A nutritional supplement interaction happens when another substance affects the way a nutritional supplement works. For example, this could be another nutritional supplement, medicine, food or drink.

Not everyone may experience these side effects. These side effects may be more severe in some people and less severe in other people. Some people may not even experience any side effects. This is because everyone is different, and our bodies may have different experiences with different medications.

Safety concerns related to nutritional supplements

Side effects could also be the result of defective, fake/unauthorised cosmetic (one that is not authentic).

Defective nutritional supplement (product quality problem)

A defective nutritional supplement is a product that is not working properly or not to the manufacturer’s specifications.

If you do not think your nutritional supplement is good enough to take or use, report this to ZAMRA Safety Watch. You can also consult your healthcare provider or distributor of the nutritional supplement who can provide advice and report to us.

Defects in nutritional supplement can occur due to:

• Quality issues with the product itself
• Quality issues with the packaging (carton, bottle)
• Problems with labeling on the packaging or packaging components
• Lack of efficacy which can be decided by speaking to a healthcare professional or a dietician.

Fake/unauthorised nutritional supplements

A fake nutritional supplement is a product that tries to pass off as a genuine authorised nutritional supplement. An unauthorised nutritional supplement does not hold the relevant authorisations for sale and supply to patients 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 concerning what it is, where it has come from or details provided on the packaging (e.g. expiry date).

Why report side effects to ZAMRA Safety Watch? 

Everyone has a different genetic makeup and therefore it is very difficult to predict whether an individual will experience a side effect. Whether you are a healthcare or beauty professional or a member of the public, you can help others by reporting side effects which you or your clients experience to ZAMRA Safety Watch. Reports help us gain a better understanding of cosmetic safety and safeguard users through safety monitoring. Reporting can also help ZAMRA identify a potentially dangerous product and possibly remove it from the market.

Any medicine (including vaccines, herbal and traditional medicines) can cause an unwanted side effect, commonly referred to as an adverse events following immunisation (AEFI) by healthcare professionals.

What is a vaccine?

A vaccine is a medicine which is 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 diseases. Vaccines are mainly given through an injection but can also be given orally (by mouth) or sprayed into 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 you are 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 the disease.

Safety concerns related to vaccines

Side effects could also be the result of defective, fake vaccines (one that is not authentic).

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 is a product that tries to pass off as a genuine authorised vaccine. An unauthorised vaccine does not hold the relevant authorisations for sale and supply to patients 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 and therefore it is very difficult to predict whether an individual will experience a side effect. Whether you are a healthcare professional or a member of the public, you can help others by reporting side effects which you or your patients experience to ZAMRA Safety Watch. Reports help us gain a better understanding of the vaccine safety and safeguard patients through safety monitoring. Reporting can also help ZAMRA identify a potentially dangerous product and possibly remove it from the market.