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08 GxP > Week 5 - Good Pharmacovigilance Practice > Flashcards

Week 5 - Good Pharmacovigilance Practice Flashcards

1
Q

Define “adverse medicine reaction”

A
  • An adverse drug reaction (ADR) is an unwanted or harmful reaction which occurs after administration of a drug or drugs
    • This can include anaphylaxis, blood disorders, endocrine disturbances, effects on fertility, etc.
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2
Q

Define pharmacovigilance

A
  • The science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other medicine-related problems
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3
Q

What are the aims of pharmacovigilance?

A
  • To improve public health and safety in relation to the use of authorised medicines
  • To identify problems related to the use of authorised medicines
  • To improve the assessments concerning the benefits, risk and efficacy of authorised medicines
  • To promote safe and effective use of authorised medicines
  • To encourage clinical training in pharmacovigilance and effective communication to the public
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4
Q

What is pharmacovigilance mandatory for and what does it help with?

A
  • An effective medicine safety and pharmacovigilance service is mandatory for early discover of risks associated with authorised medicines and the deterrence of adverse medicine reactions.
  • It helps health care professionals and patients to obtain the best benefit/risk assessment with safe and effective therapies.
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5
Q

What does pharmacovigilance assess?

A
  • Pharmacovigilance assesses adverse reactions to medicines, including complementary medicines, herbal remedies, vaccines, blood products, medication faults, inefficacies, and other medicine-related areas.
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6
Q

Outline the range of methods used in pharmacovigilance practice

A
  • An impulsive reporting system focused on the identification of alleged adverse medicine reactions
  • Rigorous procedures focused on systematic collection of data
  • Epidemiologic research
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7
Q

Outline the range of methods used in pharmacovigilance practice

Describe in detail the impulsive reporting system

A
  • Impulsive reporting system focused on the identification of alleged adverse medicine reactions, carried out by health professionals in their daily duties and the forwarding of this information to the relevant authorities.
  • The most widely used pharmacovigilance method (also known as the ‘yellow card system’)
  • Achieving successful pharmacovigilance activity relies on the reporting of adverse reactions.
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8
Q

Outline the range of methods used in pharmacovigilance practice

Describe in detail the systematic collection of data

A
  • Rigorous procedures focused on systematic collection of data on all unsafe effects that can be anticipated as medicine-induced.
  • These strategies are separated into two main groups:
    • Medicine-centered systems
    • Patient-centered systems
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9
Q

Outline the range of methods used in pharmacovigilance practice

Describe in detail the epidemiologic research

A
  • Epidemiologic research that is focused on determining causality between adverse reactions and the use of a medicine.
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10
Q

What does pharmacovigilance essentially focus on and what are the methods of doing this?

A
  • Pharmacovigilance essentially focuses on the identification of adverse events associated with medicines.
  • Generally, the fastest and most effective methods for raising awareness of the adverse effects of drugs are through clinical observation and the reporting of suspected adverse reactions
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11
Q

In pharmacovigilance, what may the reporting of adverse events lead to?

A
  • May lead to a causality hypothesis for designing specific studies on active pharmacovigilance to establish the safety profile of medication used by the general public
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12
Q

For a pharmacovigilance system to be operational what are the requiremements and what does this ensure?

A
  • For any pharmacovigilance system to be operational, all health professionals in contact with patients, who use medications, must participate in reporting systems.
  • The aim is to ensure that medicines are safe, especially for new medications that are released on the market.
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13
Q

What does pharmacovigilance require to be operations (think rules etc)

A
  • Operational pharmacovigilance requires a structured set of rules, procedures and practices that must be adhered to, which will ensure that the quality and integrity of the data produced is upheld
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14
Q

What does pharmacovigilance depend on?

What is Good Pharmacovigilance Practice (GPvP / GVP) designed to ensure?

A
  • It depends on gathering data from spontaneous reports of adverse reactions.
  • GPvP is designed to assure:
    • The veracity of the data, which will enable accurate assessment of the associated risks
    • Confidentiality of the health professional that reported the adverse effects
    • A standardised criteria to assess reports
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15
Q

Outline the pharmacovigilance guidelines and what they should include

A
  • Should have guidelines consisting of SOPs that describe the practical details of the flow of information.
  • These guidelines should clearly state information on:
    • What comprises a reportable adverse event
    • Who is eligible to report adverse events
    • Method for submitting reports
    • Routine assessments for monitoring care reports
    • Good communication practices
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16
Q

In order to follow the GPvP guidelines what happens regarding reports

A
  • Reports of suspected adverse reactions in relation to medicines need to be recorded.
  • All reports concerning any suspected adverse reaction must be confirmable, verifying its authenticity.
  • All reports that have not yet been validated should be assessed with caution.
  • There should be a time limit for reporting serious suspected adverse reactions.
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17
Q

In order to follow the GPvP guidelines what happens regarding information

A
  • Information must be regulated in a way that maintains the reliability of the data.
  • All information on adverse reactions must be handled (i.e. recorded, processed and stored) in a fashion that allows for the information to be communicated, verified, and accurately interpreted.
  • The National Pharmacovigilance Program must be informed before any information concerning adverse reactions to medicines, are communicated to the scientific community.
  • The information documented in the reports should not be used to make valid judgment concerning medical intervention.
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18
Q

In order to follow the GPvP guidelines what happens regarding assessors

A
  • All assessors involved in the evaluation of an adverse reaction must have the required expertise.
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19
Q

Where does GPvP fit into the drug discovery and manufacture process?

A
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20
Q

What does QPPV stand for?

What is the QPPV responsability regarding managementt?

A
  • qualified person for pharmacovigilance
  • Responsible for determining and managing a system, which ensures that information relating to all suspected adverse reactions are reported to the appropriate medical representatives, so that the relevant personnel may access it.
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21
Q

What is the QPPV responsability regarding reports?

A
  • Responsible for the preparation of reports for suspected serious adverse events and periodic safety update reports, to the appropriate authorities, in compliance to applicable legislative requirements and guidance.
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22
Q

What is the QPPV responsability regarding information?

A
  • Providing any relevant information concerning the evaluation of the benefits and risks associated with the medicinal product, including relevant information on post-authorisation safety studies.
  • Responsible for ensuring that any additional information requested by the authorities, for the assessment of the benefits and risks for the medicinal product, is addressed promptly and appropriately.
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23
Q

What is at the core of the pharmacovigilance system and what is the main source of information?

A
  • At the core of any quality assurance system and good pharmacovigilance practices is up-to-date documentation.
  • The quality of reports is vital for proper assessment of a potential causal relationship between adverse reactions and authorised medicines.
  • Spontaneous reports on supposed adverse reactions to medicines is the main source of information in pharmcovigiliance
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24
Q

How can pharmacovigilance reporting vary from country to country?

Why is this?

A
  • Depending on the country, reporting of this nature can be voluntary or health professionals may be required to submit regular reports
  • WHO found that it would not be an operational strategy to have a universal reporting form for spontaneous reporting systems
25
Q

What are the WHO guidelines regarding GPvP?

What does individual care report refer to?

A
  • There are only guidelines indicating the essential data that should be incorporated in reporting forms.
  • Individual care reports used in pharmacovigilance refers to a report of adverse medical reaction, supposedly caused by medicine, experience by a particular patient.
26
Q

What does WHO recommend to include in pharmacovigilance reporting forms?

A

Contain the following basic information:

  • Patient information: clinical history, health status, weight, age and sex.
  • Explanation of the adverse medical event: symptoms, magnitude, progression, and the aftermath.
  • The medicine: dosage, route of administration, start and end date of use, manufacture details
  • Health professional who filled the report: this must be considered to be confidential and should also be used for verification purposes.
27
Q

Describe strategies for phamcovigilance

A
  • Strategies for pharmacovigilance are just as important as spontaneous reports because they provide valued data on medicines in question.
  • Two examples of these methods are:
    • Prescription event monitoring (PEM)
    • Case-control surveillance
28
Q

Besides reporting documents, what other documents are required for GPvP?

A
  • Quality manuals and operating procedures
29
Q

Documents required for GPvP

Outline manuals

A

Two main types of manuals that are important for operational pharmacovigilance which are quality manual and manual of procedures.

  • Quality Manual: describes the aims, methods, and procedures for assuring quality. This document is of vital importance because it enables internal and external staff members to learn about the current quality assurance system.
  • Manual of procedure: provides an systematic description of SOPs.
30
Q

Documents required for GPvP

Outline operating procedures

A
  • SOPs have a vital role in any quality assurance system.
  • A written description of all activities involved in reporting a suspected adverse reaction is necessary to help determine whether a particular process has been carried out effectively (which needs to be compared to an existing standard).
31
Q

Documents required for GPvP

Outline what procedures are recommended for regarding data entry

A
  • Collection and passage of information: validation of the information stated in the reports, attainment of supplementary information.
  • Administrative duties: data entry.
  • Assessment and initiation of reports: acceptance and rejection of reports, preventions of duplications, feedback of reports.
32
Q

In GPvP what does risk management refer to and what are the two components?

A
  • Risk management system refers to a set of pharmacovigilance activities designed to identify, characterise and minimise risks relating to medicinal products.
  • Risk management plan is classified as the implementation stage of a risk management system.
  • Two components need to be characterised: risk analysis and risk management.
33
Q

GPvP Risk

What is the difference between risk analysis and risk management?

A
  • Risk analysis involves the identification, quantification, and assessments of risks, whereas risk management is concerned with implementation and monitoring of regulatory practices created to communicate risks associated with medicines to health professionals or the general public.
34
Q

GPvP risk

What is the main objective of risk management plans?

A
  • All medicinal products are associated with some type of risk, however, the main objective of risk management plans, is to ensure that these risks are effectively managed, in hope to minimise spontaneous adverse reactions.
35
Q

GPvP Risk Analysis

What does the investigation of risk involve?

A
  • The identification of risks primarily involves the generation of signals and the assessment of causality.
36
Q

GPvP risk analysis

What does “signal” refer to?

What do signals serve as?

A
  • Signal is referred to as the information communicated concerning the suspected causal relationship between an adverse medical reaction and a medicine, when the relationship is not well established.
  • Serve as an indication that further investigation is needed to assess the causality
37
Q

GPvP risk analysis

When assessing the causal relationship between the use of a medicine and the appearance of the adverse medical reaction, what points should be considered?

A
  • The characteristics of the adverse event (e.g. allergic reaction)
  • The symptoms associated with exposure to the particular medicine
  • Proof of positive discontinuity
  • The connection between the adverse medical reaction and known toxicological effects of the medicine
  • The existence of other evidence gathered from preclinical, clinical and/or pharmacoepidemiological safety studies
  • The absence of alternative clarification of the adverse chemical reaction
38
Q

GPvP risk analysis

What are the categories of causation according to WHO?

A

WHO have also developed categories concerning the causality assessment, which include:

  • Certain
  • Likely
  • Possible
  • Unlikely
  • Conditional
39
Q

GPvP risk analysis

Describe the quantification of risk

A
  • Once causal relationship identified,the magnitude of the association between the adverse event and the specific medicine and also the impact that it may have on public health is quantified.
  • The risk can be calculated using the results concerning the use of medicine, which can be expressed in months or years of treatment, based on the daily dosage in association with the number of known cases.
40
Q

GPvP risk analysis

What is the risk equation?

A
41
Q

GPvP risk analysis

What is a “pharmacovigilance plan”?

A
  • It should document for each potential risk, what specific measure will be used to monitor the risk and obtain further information, in relation to any future research studies that plan to extend safety knowledge on the medicinal product
  • May include routine pharmacovigilance and pharmacoepidemiology studies or preclinical studies.
42
Q

GPvP Risk Assessment and Risk Management

After risk has been identified and quantified, what is the next step?

A
  • Determine whether the severity of the risk, is adequate for use by the general public. Therefore, the potential benefit of using the ‘suspected’ medicine also needs to be taken into account.
  • Main objective is to establish whether the benefit/risk ratio of the medicine continues to be satisfactory.
43
Q

GPvP Risk Assessment and Risk Management

What makes benefits and risks difficult to express?

A
  • Benefits and risks are rarely expressed in the same units which make it difficult to quantify this ratio
  • There is no definitive line between what is acceptable and what is unacceptable, in relation to each individual case
44
Q

GPvP Risk Assessment and Risk Management

Describe the process of assessing risk

What does determining the acceptability of a suspected medicine require?

A
  • Evaluating the benefit/risk ratio is a process that takes into account the element of ‘value’ when assessing the data.
  • Determine the acceptability of the suspected medicine requires assistance from experienced health specialist or expert committees, which always take into consideration:
    • Advice issued by pharmacoepidemiologic studies
    • The methodical review of scientific literature
45
Q

GPvP Risk Assessment and Risk Management

What does risk management aim to implement and what does risk management refer to regarding pharmacovigilance?

A
  • Risk management is not only concerned with assessing the benefit/risk ratio of a medicine, but it also aims to implement risk minimisation strategies.
  • In regards to pharmacovigilance, risk management is the ‘action’ stage in assessing the safety of the medicine in question.
46
Q

GPvP Risk Assessment and Risk Management

What are the three actions of risk management in pharmacovigilance?

A

Three main actions that are practiced, which include:

  1. Adopting measures for risk reduction
  2. Informing health professional and patients of the identification and relevance of associated risks
  3. Implementing specific prevention strategies.
47
Q

GPvP Risk Assessment and Risk Management

What are some of the activities that are involved in risk mangement?

A
  • Communicating information internally within the institution or to health professions and the general public with regards to the appropriate use of medicines.
  • Informing authorities of emergency restrictions on medicines.
  • Determining if there are any changes that may affect the benefit/risk ratio of medicine and to notify pharmaceutical industries and health professionals.
48
Q

GPvP risk minimisation

What must pharmaceutical companies try to do regarding risk minimisation?

A
  • Must try to maximise benefits and minimise risks, to ensure the safety and effectiveness of medicines on the market
    *
49
Q

GPvP risk minimisation

What do risk minimisation measures include?

A
  • Risk minimisation measures include: accurate report of the uses, safety, and efficacy of medicines, in addition to continuous updates from post marketing research on new benefits, adaptions in the formula and any new risks that have been identified.
  • Therefore, it is important to design a risk minimisation plan.
50
Q

GPvP risk minimisation

What do risk minimisation plans consist of?

When are minimisation plans developed?

A
  • Consist of a methodical safety procedure for addressing specific objecting in hope to decrease the risks identified, which preserving their benefits.
  • This type of plan is developed in preclinical, clinical and post-marketing studies.
51
Q

GPvP risk minimisation

What strategies are employed to meet the objectives of the minimisation plan?

A

Strategies include:

  • Training in risk communication and safety guidelines for health professionals.
  • Access systems that provide guidance on the use and prescription of medicines.
52
Q

GPvP risk minimisation

When designing a minimisation plan what should the analysis be based on and what should be taken into account?

A
  • Analysis should be based on the type of medicine in question

Taking into account:

  • The characteristic of the medicine and the preexisting benefit/risk ratio
  • The prevention of adverse medical reactions
  • The possible benefits
53
Q

GPvP risk minimisation

Who are risk minimisation plans submitted to and for what reason?

A
  • All risk management plans will be submitted to the health authorities, as a regulatory document, to ensure that they are compliant with the health authority requirements.
54
Q

GPvP risk prevention

Why is risk prevention important?

A
  • Prevention strategies are highly important because many adverse events are the result of misusage of the medication, which could have been avoided.
55
Q

GPvP risk prevention

Who is responsible for developing risk prevention strategies?

What is essential between these groups?

A
  • Developing risk prevention strategies is a responsibility shared by heath professional, pharmaceutical companies and health authorities
  • Communication among these groups is essential to systematic prevention
56
Q

GPvP risk prevention

Who can risk prevention be targeted at?

What is the main objective regarding unoavoidable averse reactions?

A
  • Rigorous pharmacovigilane can be targeted to specific medicines or risk groups (e.g. elderly patients).
  • In regards to unavoidable adverse reaction, the main objective is for early detection, which will help decrease the extent of harm.
57
Q

What type of information would be collected when compiling an adverse events report?

What are the essential requirements?

A
  • Patient information: clinical history, health status, weight, age and sex.
  • Explanation of the adverse medical event: symptoms, magnitude, progression, and the aftermath.
  • Information concerning the questionable medicine: dosage, route of administration, start and end date of use, manufacture details
  • Information on the health professional who filled the report: this information must be considered to be confidential and should also be used for verification purposes.
58
Q

What type of information would be collected when compiling an adverse events report?

What is desirable information?

A
  • Risk factors: e.g. allergies, use of recreational drugs.
  • Diagnosis documentation: including the methods used to obtain the diagnosis.
  • Patient outcome.
  • Laboratory results: e.g. blood results, start of treatment, the duration that the suspected medicine was used, subsequent therapies.
  • Information concerning the patient’s response after the medication was suspended.

08 GxP (5 decks)

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