SAFETY FIRST - IMPORTANCE OF PHARMACOVIGILANCE

verifier1

Department of General Medicine

Pharmacovigilance (PhV or PV), also known as Drug Safety, is the pharmacological science and activities relating to the collection, detection, assessment, monitoring, understanding  and prevention of adverse effects(ADR) or any other drug-related problem with pharmaceutical products.The word "pharmacovigilance" Pharmakon (Greek) = Medicinal Substances , Vigilia (Latin) = To keep watch.

All medicines such as pharmaceuticals and vaccines have side effect some are known many are still unknown even this medicine has been in clinical use. It is important to monitor both known and unknown side effects of medicines in order to determine any new information related to their safety profile .

Aims and Scope

• To improve the patient care and safety in relation to the use of medicines, and all medical and paramedical interventions.
• To contribute the assessment of benefit, harm, effectiveness and risk of medicines,  inspiring their safe, rational and more effective use.
• To improve public health and safety by the use of medicines.
• To promote understanding, education and clinical training in pharmacovigilance and its effectual, communication to public and health professionals.

How Pharmacovigilance Woks?

• Detecting and reporting an ADR form is filled out with the patient and reaction details, this later forms basis for data entry.

1. Spontaneous reporting
2. Mandatory reporting 

Spontaneous reporting : It is most common form of ADR reporting .In which Healthcare professionals identify and report any suspected ADR to their national pharmacovigilance centers or to the manufactuters.

Mandatory reporting : Manufacturers are needed to submit reports to they receive from healthcare providers to the national authority, in the form of PSUR (Periodic Safety Update Report). A regulatory document is prepared by the Marketing Authorisation Holder and submitted to the Agency .It is a Worldwide post-authorisation safety reporting. It Includes information on all ADRs collected irrespective of the reporting country.

• Data Collection and Capture
• Data Storage & Maintenance
• Data selection, Retrieval & Manipulation

The Minimum requirements for a functional Pharmacovigilance System.

1.  A National Pharmacovigilance Centre with delegate staff (atleast one in full time), stable basic funding, clear mandates, well defined structures and rolesparticipating with the WHO Programme for International Drug Monitoring.

2. The existence of National spontaneous reporting system with a national individual case safety report (ICSR) form i.e. ADR reporting form.

3. A national database or system for assembling and managing of ADR reports.

4. A national  pharmacovigilance advisory committee is able to provide the technical assistance on risk assessment, causality assessment, risk management case investigation and  mandatory crisis management including crisis communication.

5.Clear communication master plan for routine communication and crises communication.

Prevention

Some ADRs are unpreventable and cannot be prevented. Although most ADRs can be prevented by following basic principles of rational use of drugs that are described as follows:

• Use drug that you know well
• Do not change therapy from known drugs to unknown one without good reasons.
• Analys all the drug used by your patients regularly, taking special notice with those purchase without prescription.
• Beware of the interaction of drugs with certain food stuffs, alcohol and even with house hold chemicals.
• Extra care should be take when you prescribe drugs known to exhibit different types of interactions and ADR.

Responsibility for the holistic approach to drug safety that is  encircled in the practice and science of pharmacovigilance.The scientists, pharmaceutical manufacturers, clinicians,regulators,public policy makers,drug developers, patients and the general public all have their own complementary roles in pharmacovigilance.

Reference:

Pharmacovigilance ; From Wikipedia, the free encyclopedia.

Pharmacovigilance  from  Pharmaceutical management PDF.

Pharmacovigilance Guidelines ; WHO-draft-guidelines-pharmacovigilance.pdf.

Pharmacovigilance Challenges; Advanced Workshop : Review Of Drug Development In Clinical Trials.