Pharmacovigilance is defined by the WHO as the science focused on the detection, assessment, and prevention of adverse effects related to medicines. The objectives include improving patient safety, timely detection of problems, and promoting education about pharmacovigilance among health professionals. In Pakistan, a national pharmacovigilance center is being established to monitor pharmaceutical products and expand its scope to include vaccines and medical devices.

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Pharmacovigilance
Presented by
Mah gull khan

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Pharmacovigilance
• According to the WHO, Pharmacovigilance is the science and
activities relating to the detection, assessment, understanding and
prevention of adverse effects or any other medicine related problem.

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Objective of pharmacovigilance
 To improve patient care and safety in relation to the use of medicines, and all medical and
paramedical interventions.
 To Detect problems related to the use of medicines and communicate the findings in a timely
manner.
 To contribute to the assessment of benefits ,effectiveness and risk of medicines encouraging
their safe, rational and cost-effective use .
 To promote understanding, education and clinical training in pharmacovigilance and its
effective communication to health professionals and the public.

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What to report
 Any undesirable adverse event suspected to be associated with use of
drug, biological, herbal drugs, cosmetics or medical devices should be reported.
 All ADRs as a result of prescription and non-prescription.
 ADRs occurring from overdose or medication error.
 ADRs in special field of interest such as drug abuse and drug use in pregnancy and during lactation.
 All suspected ADRs associated with drug-drug, drug-food or drug-food supplements interactions.
.

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Who should report:
All health care professionals including specialists, doctors, dentists,
pharmacists, nurses and others health care providers.
Manufacturers or Product registrants.
All government hospitals, private hospitals, health Centre, dispensaries,
private clinics, private pharmacies and private nursing homes have
obligation to report all ADR cases encountered or reported to them by
the patients.

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When to report
• Any suspected ADR should be reported as soon as possible. Delay in
reporting will make reporting inaccurate and unreliable. If possible,
report while the patient is still in the health facility. This gives a
chance to reporter to clear any ambiguity by re-questioning or
examining the patient.

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How Consumers Can Report an Adverse
Event or Serious Problem to FDA
• If you think you or someone in your family has experienced a serious
reaction to a medical product, you are encouraged to take the reporting
form to your doctor. Your health care provider can provide clinical
information based on your medical record that can help FDA evaluate
your report or you may complete the Online Reporting form yourself.
• You will receive an acknowledgement from FDA when your report is
received. Reports are reviewed by FDA staff. You will be personally
contacted only if we need additional information.

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The yellow card scheme
• Run by the Medicines and Healthcare product Regulatory Agency
(MHRA) – a UK government agency.it collects reports of suspected side
effects submitted in confidence by healthcare professionals and patients.
• Completed Yellow Cards should be submitted either directly to the
MHRA. Once a Yellow Card has been received by the MHRA, the
person who made the report will be sent an acknowledgement which
will quote the unique identification number assigned to the report. The
Yellow Card is then scanned into the MHRA’s pharmacovigilance
database

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• Pharmacovigilance Expert Advisory Group (PEAG) advise the MHRA
on drug safety so that decisions can be made on whether changes in
the use of a medicine are needed.
• Regulatory changes may include restrictions in use, reduction in
dosage, special warning and precautions. In some instances, where it is
considered that the risks of a medicine outweigh the benefits, that
medicine may be withdrawn from the market.

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Pharmacovigilance in Pakistan
Pakistan is in the process of establishing a national Pharmacovigilance
center in (Drug Regulatory Authority of Pakistan)DRAP, Islamabad.
Although primarily concerned with pharmaceutical products,
Pharmacovigilance system can also be expanded to vaccines,
diagnostics, drugs used in traditional practice etc.
Another important area of attention would be development of resistance
against antibiotics. Besides, poison control and drug information system
will be included once the pharmacovigilance center is well established

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Pharmacovigilance in Pakistan
• Pharmacovigilance center may also cover problems related to medical
devices and equipment, although different expertise will be required.
• The reporting by health care professionals and public will be intended.
It can however, be a mandatory responsibility of pharmaceutical
companies to report suspected adverse drug reactions to the center.

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