What is Pharmacovigilance:
PHARMACOVIGILANCE is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem.
WHO established its Programme for International Drug Monitoring in response to the thalidomide disaster detected in 1961. Together with the WHO Collaborating Centre for International Drug Monitoring, Uppsala, WHO promotes PV at the country level. At the end of 2010, 134 countries were part of the WHO PV Programme.
THE AIMS OF PHARMACOVIGILANCE:
-to enhance patient care and patient safety in relation to the use of medicines; and
-to support public health programs by providing reliable, balanced information for the effective assessment of the risk-benefit profile of medicines.
WHY DO WE NEED PHARMACOVIGILANCE?
• Humanitarian concern – Insufficient evidence of safety from clinical trials, Animal experiments & Phase 1 – 3 studies prior to marketing authorization
• Medicines are supposed to save lives – Dying from a disease is sometimes unavoidable; dying from a medicine is unacceptable.
• ADRs are expensive!! – Cost of drug related morbidity and mortality to the country exceeds the cost of the medications themselves.
• Promoting rational use of medicines and adherence
• Ensuring public confidence
• Ethics – To know of something that is harmful to another person who does not know, and not telling, is unethical
PHARMACOVIGILANCE IN INDIA
• Central Drugs Standard Control Association – DGHS, Ministry of Health & Family Welfare
• Legislative requirements of PV in India – Schedule Y of the drugs & cosmetic act 1945
PHARMACOVIGILANCE IN UK
• Yellow Card Scheme
• ADROIT – Adverse Drug Reactions Online Information Tracking system.
•Eudra Vigilance – Data processing network and management for reporting and evaluating suspected adverse reactions during the development and following market authorization of medicinal products in the EEA.
PHARMACOVIGILANCE IN USA
• MEDWATCH – Medwatch 3500 form / FDA form 3500
WHY A GUIDELINE IS NEEDED?
– In order to carefully plan an effective pharmacovigilance activities, particularly for new drugs and
– To can reduce the risk of drug toxicity and increase the benefit to public health.
NEED FOR AN ICH GUIDELINE:
– To ensure harmonization and consistency,
– To prevent duplication of effort and to minimize risk to public health.
The guideline may be of benefit to public health programs throughout the world when considering new drugs in their country.
THE PURPOSE OF THE GUIDELINE
– is to propose a structure for a Pharmacovigilance Plan, and a Safety Specification that summarizes the identified and potential risks of the product to be addressed in the Plan
THE GUIDELINE’S PRINCIPLE:
• Planning of pharmacovigilance activities throughout the product life-cycle;
• Science-based approach to risk documentation;
• Effective collaboration between regulators and industry;
• Applicability of the Pharmacovigilance Plan across the three ICH regions.
The guideline is divided into the following sections:
• Safety Specification
• Pharmacovigilance Plan
• Pharmacovigilance Methods
The Safety Specification: is intended to help industry and regulators identify any need for specific data collection and also to
facilitate the construction of the Pharmacovigilance Plan. It is recommended that sponsors follow the structure of elements provided below when compiling the Safety Specification.
At the end of the Safety Specification a summary should be provided of the:
• Important identified risks
• Important potential risks
• Important missing information
The Pharmacovigilance Plan: should be based on the Safety Specification. The Plan would normally be developed by the sponsor and can be discussed with regulators during product development, prior to approval (i.e., when the marketing application is submitted) of a new product, or when a safety concern arises post- marketing.
MINIMUM INFORMATION FOR A VALID REPORT
-Identifiable source (Healthcare professional)
WHO SHOULD REPORT?
-healthcare professionals – including doctors, pharmacists and nurses
-Marketing authorization holder and
-patients and their relatives can also make reports.
CIOMS – Council for International Organizations for Medical Sciences –
-Is a Standard form for reporting ADRs by the pharmaceutical industry
-Every country with a developed Pharmacovigilance system has its own form.
PSUR – A Periodic Safety Update Report is a pharmacovigilance
-document intended to provide an evaluation of the risk-benefit balance of a medicinal product at defined time points post-authorization.
-The objective of the PSUR is to present a comprehensive and critical analysis of the risk-benefit balance of the product taking into account new or emerging safety information in the context of cumulative information on risk and benefits.
-MAHs are required to submit PSURs according to the data lock points.
FACTORS TO BE REPORTED
Report all suspected reactions including minor ones in case of new drugs
• For established or well-known drugs – All serious, unexpected, unusual ADRs
• ADRs to traditional medicines
• All suspected drug-drug, drug-food, and drug-food supplement interactions
• ADRs associated with drug withdrawals
• ADRs due to medication errors
• ADRs due to lack of efficacy or suspected pharmaceutical defects.
REGULATORY ACTIONS ON THE BASIS OF ADR REPORTS
1. Changes in the Summary of Product Characteristics (SPC) and Patient Information Leaflets (PIL) in the part which is dealing with the product safety.
2. Changes in classification:
-From Over the counter to Prescription Only Medicine
-From renewable prescription to non-renewable
-Special medical prescription
3. Marketing Authorization withdrawal
4. Batch recall based on clustering of ADRs.
WORK FLOW OF PHARMACOVIGILANCE