ADVERSE EVENTS

WHAT IS PHARMACOVIGILANCE (PV)

PV is the science and activity relating to the detection, assessment, understanding and prevention of adverse effects or any drug-related problem.

WHAT IS AN ADVERSE EVENT (SIDE EFFECT)

An adverse event (or side effect) is any unwanted medical occurrence in a patient who has been given a pharmaceutical product. This can be any unfavourable and unintended sign, symptom, or disease associated with the use of the product. Adverse events should be reported.

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Some examples of adverse events are:

• Allergic reactions

• Rashes

• Diziness

• Headache

• Nausea and vomitting

WHAT TO REPORT

If you experience a side effect that causes you concern, please tell your healthcare professional immediately.

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Patients and healthcare professionals should report adverse events to their regulatory health body who should also provide forms with further information.

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Adverse events associated with a GB Pharma product should also be reported to us using the following criteria listed below to ensure it is handled in a manner consistent with the applicable local laws. 

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• Name of the drug:
  Description of when the patient started the medication, including dosing strength and frequency (amount and how often, e.g. 40mg twice daily). Any action taken with the medication (e.g. reduced dose, stopped) and impact of that action on the side effect.

• The side effect associated with the drug:
  Symptom evolution over time. Description of any treatment needed for the side effect. Name of healthcare provider who provided treatment and contact information.

• Your name (optional):
  Please note that your personal identifying information (e.g. name) will not be shared with the health authorities. We may contact you for further information about the side effect. If you do not wish to be contacted, you should indicate this in your email.

• Information about the person who experienced the side effect:
  Any other medical conditions currently ongoing. Medications currently taken (name, dosing strength, frequency, and when medication was started). Gender and age of the person taking medication (optional).

• Country Of incidence: Please specify the country of incidence; e.g. Great Britain (GB) or Ghana (GH)

WHY TO REPORT ADVERSE EVENTS

Patient safety is our priority. Receiving regulatory approval for a medicine is a judgement on the safety of a medicine, but it is not the final safety checkpoint. Pre-registration clinical trials cannot detect every possible side effect, and more may become apparent when the medicine is used.

By reporting side effects for GB Pharma products you help us to ensure the safety of our products and our patients. Your information will also enable us to fulfill our reporting responsibilities to health authorities, which requires that we provide information on side effects with our products - even in cases where a relationship between the product and the effect is not clear.