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The WHO collaboration center for international drug monitoring is located in ______, Sweden.
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.
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 ______.
India became a participant in the WHO Programme for International Drug Monitoring in ______.
1997
The Pharmacovigilance Programme of India was renamed in ______.
The Pharmacovigilance Programme of India was renamed in ______.
The Indian Pharmacopoeia Commission became the NCC for the Materiovigilance Programme in ______ from July 2015.
The Indian Pharmacopoeia Commission became the NCC for the Materiovigilance Programme in ______ from July 2015.
Pharmacovigilance is also known as drug ______.
Pharmacovigilance is also known as drug ______.
The ultimate goals of pharmacovigilance include the rational and safe use of medical ______.
The ultimate goals of pharmacovigilance include the rational and safe use of medical ______.
ADRs may cause 5700 deaths per year in ______.
ADRs may cause 5700 deaths per year in ______.
6.5% of hospital ______ are due to ADRs.
6.5% of hospital ______ are due to ADRs.
To improve public health and safety in relation to the use of ______.
To improve public health and safety in relation to the use of ______.
Medicines are supposed to save ______.
Medicines are supposed to save ______.
Knowing about something harmful to another person and not telling is deemed ______.
Knowing about something harmful to another person and not telling is deemed ______.
Pharmacovigilance contributes to the assessment of benefit, ______, effectiveness and risk of medicines.
Pharmacovigilance contributes to the assessment of benefit, ______, effectiveness and risk of medicines.
Adverse Drug Reaction (ADR) is any noxious change which is suspected to be due to a ___
Adverse Drug Reaction (ADR) is any noxious change which is suspected to be due to a ___
Type A ADR is characterized as 'augmented', which means it is ___ and predictable.
Type A ADR is characterized as 'augmented', which means it is ___ and predictable.
Type B ADR is known for being ___ and idiosyncratic, varying from patient to patient.
Type B ADR is known for being ___ and idiosyncratic, varying from patient to patient.
The Thalidomide tragedy highlighted severe birth defects resulting from its use in treating ___ in pregnant women.
The Thalidomide tragedy highlighted severe birth defects resulting from its use in treating ___ in pregnant women.
The Elixir sulfanilamide tragedy in 1937 led to mass poisoning due to the use of ___ as the solvent.
The Elixir sulfanilamide tragedy in 1937 led to mass poisoning due to the use of ___ as the solvent.
Pharmacovigilance includes monitoring adverse drug reactions as well as ___ errors.
Pharmacovigilance includes monitoring adverse drug reactions as well as ___ errors.
Adverse drug effects that arise from long-term use of a drug are classified as Type ___.
Adverse drug effects that arise from long-term use of a drug are classified as Type ___.
The inquiry into jaundice associated with Salvarsan occurred in the year ___.
The inquiry into jaundice associated with Salvarsan occurred in the year ___.
Aggregate reports provide information about all the adverse events related to the use of a _____
Aggregate reports provide information about all the adverse events related to the use of a _____
The manufacturer uses _____ detection from adverse reports to identify potential risks.
The manufacturer uses _____ detection from adverse reports to identify potential risks.
Serious adverse events are communicated to healthcare professionals using _____ warnings.
Serious adverse events are communicated to healthcare professionals using _____ warnings.
Types of adverse event reports include spontaneous reports, clinical trials, and _____ reports.
Types of adverse event reports include spontaneous reports, clinical trials, and _____ reports.
In phase two, the drug safety team conducts _____ validity assessment.
In phase two, the drug safety team conducts _____ validity assessment.
Event selection and coding is done using _____ during the assessment process.
Event selection and coding is done using _____ during the assessment process.
Periodic report compilation involves gathering data for _____ analysis.
Periodic report compilation involves gathering data for _____ analysis.
Risk benefit assessment is part of the necessary steps taken to prevent further _____ events.
Risk benefit assessment is part of the necessary steps taken to prevent further _____ events.
Adverse drug Reactions are reported from all over the country to ______
Adverse drug Reactions are reported from all over the country to ______
NCC-PvPI works in collaboration with the global ADR monitoring centre, ______, Sweden.
NCC-PvPI works in collaboration with the global ADR monitoring centre, ______, Sweden.
The primary goal of the Pharmacovigilance program in India is to develop and implement a ______ system.
The primary goal of the Pharmacovigilance program in India is to develop and implement a ______ system.
A short term goal of the PvPI includes encouraging health care professionals to report ______ reactions.
A short term goal of the PvPI includes encouraging health care professionals to report ______ reactions.
The long term goal of the PvPI is to make ADR reporting ______ for health care professionals.
The long term goal of the PvPI is to make ADR reporting ______ for health care professionals.
A patient can report an adverse event through social media or by contacting ______ company helplines.
A patient can report an adverse event through social media or by contacting ______ company helplines.
The manufacturer's PV team categorizes reports into valid, invalid, serious/non-serious, and related/not ______.
The manufacturer's PV team categorizes reports into valid, invalid, serious/non-serious, and related/not ______.
Manufacturers prepare regulatory documents such as ______ which combine single reports from all over the world.
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
- 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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