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The WHO collaboration center for international drug monitoring is located in ______, Sweden.
Uppsala
Pharmacovigilance in India was initiated in ______ with a formal adverse drug reaction monitoring system.
1986
India became a participant in the WHO Programme for International Drug Monitoring in ______.
1997
The Pharmacovigilance Programme of India was renamed in ______.
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The Indian Pharmacopoeia Commission became the NCC for the Materiovigilance Programme in ______ from July 2015.
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Pharmacovigilance is also known as drug ______.
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The ultimate goals of pharmacovigilance include the rational and safe use of medical ______.
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ADRs may cause 5700 deaths per year in ______.
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6.5% of hospital ______ are due to ADRs.
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To improve public health and safety in relation to the use of ______.
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Medicines are supposed to save ______.
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Knowing about something harmful to another person and not telling is deemed ______.
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Pharmacovigilance contributes to the assessment of benefit, ______, effectiveness and risk of medicines.
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Adverse Drug Reaction (ADR) is any noxious change which is suspected to be due to a ___
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Type A ADR is characterized as 'augmented', which means it is ___ and predictable.
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Type B ADR is known for being ___ and idiosyncratic, varying from patient to patient.
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The Thalidomide tragedy highlighted severe birth defects resulting from its use in treating ___ in pregnant women.
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The Elixir sulfanilamide tragedy in 1937 led to mass poisoning due to the use of ___ as the solvent.
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Pharmacovigilance includes monitoring adverse drug reactions as well as ___ errors.
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Adverse drug effects that arise from long-term use of a drug are classified as Type ___.
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The inquiry into jaundice associated with Salvarsan occurred in the year ___.
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Aggregate reports provide information about all the adverse events related to the use of a _____
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The manufacturer uses _____ detection from adverse reports to identify potential risks.
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Serious adverse events are communicated to healthcare professionals using _____ warnings.
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Types of adverse event reports include spontaneous reports, clinical trials, and _____ reports.
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In phase two, the drug safety team conducts _____ validity assessment.
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Event selection and coding is done using _____ during the assessment process.
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Periodic report compilation involves gathering data for _____ analysis.
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Risk benefit assessment is part of the necessary steps taken to prevent further _____ events.
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Adverse drug Reactions are reported from all over the country to ______
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NCC-PvPI works in collaboration with the global ADR monitoring centre, ______, Sweden.
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The primary goal of the Pharmacovigilance program in India is to develop and implement a ______ system.
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A short term goal of the PvPI includes encouraging health care professionals to report ______ reactions.
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The long term goal of the PvPI is to make ADR reporting ______ for health care professionals.
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A patient can report an adverse event through social media or by contacting ______ company helplines.
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The manufacturer's PV team categorizes reports into valid, invalid, serious/non-serious, and related/not ______.
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Manufacturers prepare regulatory documents such as ______ which combine single reports from all over the world.
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Study Notes
Pharmacovigilance
- Pharmacovigilance is the science and activities related to the detection, assessment, understanding and prevention of adverse drug reactions or any other drug-related problems.
- The goal of pharmacovigilance is to enhance patient care and safety regarding medicine use and all medical and paramedical interventions.
- Pharmacovigilance aims to promote the understanding, education and training of professionals and the public regarding the rational and safe use of medicines.
- Pharmacovigilance is crucial for informing and educating patients, assessing the risk and benefit of marketed drugs, and ensuring the rational and safe use of medical drugs.
Adverse Drug Reactions
- Any untoward medical occurrence that may present during treatment with a drug is known as an Adverse Event (AE)
- Any change suspected to be due to a drug, occurring at doses normally used in human beings, requiring treatment or dose reduction, or indicating caution in future drug use, is an Adverse Drug Reaction (ADR).
- A Serious Adverse Event is an adverse reaction that results in death, is life-threatening, or a significant disability or incapacity.
- All ADRs are adverse events, but not vice versa.
- ADRs can be classified into different types:
- Type A: Augmented, on-target (too much of a good thing) – predictable.
- Type B: Bizarre, idiosyncratic, vary from patient to patient – unpredictable.
- Type C: Continuous, adverse effects that arise from long-term drug use.
- Type D: Delayed, adverse drug effects long after the drug is gone.
Scope of Pharmacovigilance
- The scope of pharmacovigilance encompasses aspects beyond ADRs, including:
- Medication errors
- Herbal medicines
- Counterfeit medicines
- Medicine abuse and misuse
- Drug interactions
- Blood banks
- Immunization and vaccination
History of Pharmacovigilance
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Significant Historical Events Led to Pharmacovigilance:
- 1922: Inquiry into jaundice associated with Salvarsan, an organic arsenical used for syphilis treatment.
- Thalidomide Tragedy: Thalidomide, widely used for treating nausea in pregnant women in the 1950s and early 1960s, caused severe birth defects in thousands of children.
- Sulfanilamide Tragedy: Elixir sulfanilamide, an improperly prepared antibiotic using diethylene glycol (DEG) as a solvent, caused mass poisoning in the United States in 1937, taking more than 100 lives.
- WHO Collaboration Center for International Drug Monitoring in Uppsala, Sweden: Supports and coordinates the WHO international drug monitoring program.
Pharmacovigilance in India
- Pharmacovigilance in India was initiated formally in 1986 with an adverse drug reaction (ADR) monitoring system under the supervision of the Drug Controller of India.
- India joined the World Health Organization (WHO) Programme for International Drug Monitoring in 1997 but was not successful.
- The National Programme of Pharmacovigilance was launched in 2005 and renamed the Pharmacovigilance Programme of India (PvPI) in 2010.
- The Ministry of Health and Family Welfare initiated a nation-wide pharmacovigilance program in 2010 with All India Institute of Medical Sciences (AIIMS) as the National Coordinating Centre (NCC) for monitoring ADRs.
- In 2011, the program transitioned to the Indian Pharmacopoeia Commission (IPC) as NCC.
- IPC-PvPI became the NCC for Materiovigilance (monitoring the safety and quality of medical devices used in the country) from July 2015.
- IPC-PvPI became a WHO Collaborating Centre for Pharmacovigilance in Public Health Programmes & Regulatory services from July 2017.
- PvPI works to ensure that the benefits of medicines outweigh the risks associated with their use.
- PvPI has achieved remarkable success with the establishment of 250 ADR monitoring centers across India and training provided to healthcare professionals.
- ADRs are reported from all over the country to NCC-PvPI, which collaborates with the global ADR monitoring center (WHO-UMC) in Sweden to contribute to a global ADRs database.
- NCC-PvPI monitors ADRs among the Indian population and helps the regulatory authority of India (CDSCO) make safe use of medicines decisions.
Goals of the Pharmacovigilance Program in India (PvPI)
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Short-term Goals:
- Develop and implement a pharmacovigilance system in India.
- Encourage healthcare professionals to report adverse reactions to drugs, vaccines, and medical devices.
- Collect adverse reaction reports.
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Long-term Goals:
- Expand the PvPI to all hospitals across India.
- Develop and implement an e-reporting system.
- Make ADR reporting mandatory for healthcare professionals.
Process of Pharmacovigilance
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Phase 1: Information about an adverse event is collected from various sources:
- Spontaneous/Voluntary Reports: Patient reports, health authorities, and social media platforms.
- Clinical trials and post-marketing studies.
- Regulatory reports.
- License partner reports.
- **Literature reports **
- Legal reports
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Phase 2: The drug safety team assesses the information in multiple steps:
- Case validity assessment.
- Database entry.
- Event selection and coding with MedDRA (Medical Dictionary for Regulatory Activities).
- Product coding.
- Labelling assessment.
- Writing narratives.
- Medical input.
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Phase 3: After assessment, the team understands why an event occurred and takes steps to prevent future occurrences:
- Periodic report compilation.
- Signal analysis.
- Risk–benefit assessment.
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Description
This quiz covers the essential concepts of pharmacovigilance, focusing on its role in ensuring drug safety and understanding adverse drug reactions. Participants will learn about the practices aimed at monitoring and improving patient care concerning medication use. Test your knowledge on the critical elements surrounding medication safety and reporting drug-related problems.
