Pharmacovigilency Flashcards
PHARMACOVIGILANCE
Defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug related problem
Adverse drug event-
Any untoward occurrence that may be present during treatment with a medicine but dose not have necessarily have a causal relationship with this treatment(an adverse outcome that occurs while the patient is taking the medicine but is not ,or not necessarily, attributable to it).
Adverse drug reaction-
A response to a medicine which is noxious and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease.
Adverse effect-
A negative or harmful patient out come that seems to be associated with treatment, including there being no effect.
Adverse event-
Any harmful occurrence that takes place during treatment that may or may not be associated with a medicine (a fall could be such an event that may –or may not –have any association with a medicine
Drug interaction-
A drug interaction is a situation in which a substance affects the activity of a drug. The effects are increased ,or decreased
HOW TO RECOGNIZE ADVERSE DRUG REACTIONS
❖verify that the suspected medicine was the one consumed. Consider all medicines possibly taken by the patient including general sales medicines, contraceptives, herbal/traditional medicines, drugs of abuse, alcohol and drugs being taken on the long term basis
❖Verify that the onset of the suspected ADR was after the medicine was taken, not before
❖Consider whether the event is pharmacologically plausible
❖Evaluate suspected ADR after discontinuing medicines or reducing dose and monitor patients status
❖Consider the possibility of drug reaction with GS medicines, contraceptives, herbal/traditional medicines, drugs of abuse, alcohol. Long term medicines.
❖Use relevant upto date literature and personal experience on medicines and their ADRs
WHAT EVENTS SHOULD BE REPORTED
❖Suspected reactions, including minor ones, in the case of new (<5years on the market)medicines
❖All serious or unexpected or unusual ADRs, in the case of established or well known medicines
❖If an increased frequency of a given reaction is observed
❖Suspected ADRs associated with drug-drug ,drug- food interaction.
❖All medicines related problems
❖When there is non response, therapeutic ineffectiveness or when suspected pharmaceutical defects are observed
HOW AND WHERE TO REPORT
• The adverse drug reaction reporting forms may be obtained from ZAMRA offices, health facilities, district and provincial health offices
• The completed report form should be sent to ZAMRA with copies to the district or provincial health offices
• National Pharmacovigilance Unit (NPVU)
• Pharmaceutical Regulatory Authority (PRA)
❖Telephone
❖Online e-reporting form
❖Mobile App(med safety)
• Email
District Health Office (DHO)
The District Health Office have roles and responsibilities, which include:
a) Providing administrative, technical, capacity-building and logistical
support to health centres and first level hospitals;
b) Coordinating the collection of reports and samples from health
facilities within their jurisdiction;
c) Distributing blank ADR reporting forms, receiving and forwarding
completed forms to ZAMRA;
d) Verifying or investigating ADR, medication error, and product
quality problem reports whenever required;
e) ReceivingfeedbackfromZAMRA.
Provincial Health Office (PHO)
The Provincial Health Office have roles and responsibilities which include:
a) Providing administrative, technical, capacity-building and logistical
support to DHOs and second level hospitals;
b)DistributingblankADRreportingforms; and
c)VerifyingorinvestigatingADR,medicationerrorandproductquality
problem reports whenever required;
d) ProvidingfeedbacktoandfromZAMRA.
