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PUBLIC HEALTH PHARMACY > PHARMACOVIGILANCE > Flashcards

PHARMACOVIGILANCE Flashcards

1
Q

What is Pharmacovigilance

A

ACCORDING TO WHO IT IS DEFINE AS “THE SCIENCE AND
ACTIVITIES RELATING TO THE DETECTION, ASSESSMENT,
UNDERSTANDING AND PREVENTION OF ADVERSE EFFECTS OR ANY OTHER MEDICINE-RELATED PROBLEM.

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2
Q

Why do we need to study Pharmacovigilance

A

FOR DETECTION, ASSESSMENT, UNDERSTANDING AND PREVENTION OF ADVERSE EFFECTS OR ANY OTHER MEDICINE/VACCINE RELATED PROBLEM.

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3
Q

What are the 3 major components of Pharmacovigilance

A
  1. Data collection (Passive, Active, mandatory)
  2. Data Analysis
  3. Reporting
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4
Q

What are the 3 areas of pharmacovigilance

A
  1. Product Quality
  2. Adverse Drug Reactions
  3. Medication Error
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5
Q

Refers to how well a product satisfies customer needs, serves its purpose and meets industry standards

A

Product Quality

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6
Q

Is a harmful response in the patient caused by the drug itself

A

Adverse Drug Reactions

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7
Q

Any preventable event that may cause or lead to inappropriate medication use or patient harm

A

Medication Error

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8
Q

Give the Diagram for PHARMACOVIGILANCE AND THE
PHARMACEUTICAL MANAGEMENT FRAMEWORK

A
  1. Use
  2. Selection
  3. Procurement
  4. Distribution

Management support is the center

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9
Q

Supply the missing words in the statement
Product Quality (Detection within the Pharmaceutical Management framework)

• Most product quality issues are detected in the _ portion of the pharmaceutical management cycle.
• _ inspection is done at the time of _ the product from the _ and at other points of _ to the patient.
• Complaints about _ occur during _

A

• Most product quality issues are detected in the distribution portion of the pharmaceutical management cycle.
• Physical inspection is done at the time of receiving the product from the supplier and at other points of distribution to the patient.
• Complaints about efficacy occur during use

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10
Q

Product Quality (Prevention)

• _ supplies during _.
• Establish a pharmaceutical quality _ program.
• Establish _ and _ framework that addresses pharmaceutical quality.
• Enforce _ and _ related to product quality

A

• Prequalify supplies during procurement.
• Establish a pharmaceutical quality assurance program.
• Establish policy and legal framework that addresses pharmaceutical quality.
• Enforce laws and regulations related to product quality

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11
Q

ADRs (Detection within the Pharmaceutical Management framework)

Management support functions, such as _ and _ systems, during
use are the _ methods for detecting ADR’s.

A

Management support functions, such as surveillance and monitoring systems, during use are the primary methods for detecting ADR’s.

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12
Q

ADR’s (Prevention)

• Consider ADR information during the _ process to make _ decisions and establish standard _ guidelines.
• _ health professionals about ADR.
• _ w/ patient about ADR.

A

• Consider ADR information during the selection process to make formulary decisions and establish standard treatment guidelines.
• Train health professionals about ADR.
• Communicate w/ patient about ADR.

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13
Q

Medication Error (Detection within the Pharmaceutical Management framework)

Errors can be detected in _ phases of the pharmaceutical management cycle: _, _, _, _, _, _, _, _ and _.

A

Errors can be detected in all phases of the pharmaceutical management cycle: ordering, storing, labelling, compounding, dispensing, transcribing, prescribing, administering and monitoring.

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14
Q

Medication Error (Prevention)

• Promote culture of _ through a _ environment for reporting events.
• _ and _ staff.
• Issue _ guidelines
• Establish _ guidelines.

A

• Promote culture of safety through a nonpunitiveenvironment for reporting events.
• Train and educate staff.
• Issue prescribing guidelines
• Establish monitoring guidelines.

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15
Q

What are the People in the PHARMACOVIGILANCE FRAMEWORK

A

Reporters
Evaluators

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16
Q

Who are the reporters in the Pharmacovigilance Framework

A

• Doctors
• Pharmacists
• Nurses
• Other health care
workers
• Consumers

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17
Q

Who are the evaluators in pharmacovigilance framework

A

• Medical specialists
• Clinical
pharmacologists
• Pharmacists
• Epidemiologists

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18
Q

Functions of Reporters in the Pharmacovigilance Framework

A

Reporting (detection and generation)
Reports suspected side effects, adverse events, quality concerns, and errors

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19
Q

Structure of the Reporters of the Pharmacovigilance Framework

A

Manufacturers
Hospitals/Institutions

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20
Q

Functions of the Evaluators in the Pharmacovigilance Framework

A

Decision making and appropriate action
Package insert amendments, warnings, scheduling changes, risk management,
market withdrawal, product recall.

21
Q

Structures of the Evaluators in the Pharmacovigilance Framework

A

Regulatory authority
Industry
Health services
Professional groups
Advisory committees

22
Q

Other Functions in the Pharmacovigilance Framework

A

Data Collation (evaluation)
Causality analysis and risk determination

23
Q

Collate data, conduct initial analysis

A

Data Collation (Evaluation)

24
Q

Establish casuality or determine if further epidemiologic studies are required to establish association

A

Causality analysis and risk determination

25
Q

Other structures in the Pharmacovigilance Framework

A

Pharmacovigilance center
Drug and therapeutics
Committees
Safety advisory Committee

26
Q

Who are the PARTNERS OF PHARMACOVIGILANCE

A

Government
Industry
Hospitals
Academia

27
Q

• Establishes a pharmacovigilance system
• Develop regulations for medicine monitoring
• Provide up-to-date information in adverse drug reactions to professionals and consumers.
• Monitor effect of pharmacovigilance through indicators and outcomes.

A

Government

28
Q

• Provide quality medicines of assured safety and efficacy
• Assess and share ADRs that are reported.

A

Industry

29
Q

• Promote the incorporation of pharmacovigilance into procedure and clinical practice.

A

HOSPITALS

30
Q

• Teach, train, conduct research, and develop policy about pharmacovigilance
• Include pharmacovigilance curriculum

A

Academia

31
Q

Medical and Pharmaceutical Professional associations

A

Poisons and medicine information center
Health Professionals (including physicians, nurses, pharmacists, Dentist)
Patients and consumers
Media

32
Q

• Provide information on medication safety and pharmacovigilance
• Collaborate with national with pharmacovigilance center, if applicable.

A

Poisons and medicine information center

33
Q

• Detect investigation, manage, and report ADRs, medication error, and product quality concerns.
• Counsel patients about ADRs

A

Health Professionals (including physicians, nurses, pharmacists, Dentist

34
Q

• Understand to the extent possible their own health problems and participate in the treatment plan by following medication instructions
• Report adverse reactions to health professionals as well as concomitant use of other medications, including traditional medicines.

A

Patients and Consumers

35
Q

• Create awareness in the community about the safe use of medicines

A

Media

36
Q

NATIONAL PHARMACOVIGILANCE CENTERS IS RESPONSIBLE FOR:

• _ THE REPORTING OF ADE’S
• _ CASE REPORTS OF ADE’S
• _ _ CASE REPORTS
• _, _ AND _ PATTERNS OF ADE’S
• PROMOTING _ AND _ THAT HELP PREVENT MEDICATION ERROR
• _ WHAT CASE REPORTS CONSTITUTE _ ADVERSE DRUG REACTION
• RECOMMENDING OR TAKING _ ACTION IN RESPONSE OF FINDINGS SUPPORTED BY GOOD EVIDENCE.
• _ PRESCRIBERS, MANUFACTURERS, AND THE PUBLIC _ RISKS OF ADVERSE EVENTS.
• _ THEIR REPORTS WITH THE WHO _ FOR _ DRUG MONITORING (WHO/UMC _)

A

NATIONAL PHARMACOVIGILANCE CENTERS
IS RESPONSIBLE FOR:

• PROMOTING THE REPORTING OF ADE’S
• COLLECTING CASE REPORTS OF ADE’S
• CLINICALLY EVALUATING CASE REPORTS
• COLLATING, ANALYZING AND EVALUATING PATTERNS OF ADE’S
• PROMOTING POLICIES AND INTERVENTIONS THAT HELP PREVENT MEDICATION ERROR
• DETERMINING WHAT CASE REPORTS CONSTITUTE TRUE ADVERSE DRUG REACTION
• RECOMMENDING OR TAKING REGULATORY ACTION IN RESPONSE OF FINDINGS SUPPORTED BY GOOD EVIDENCE.
• ALERTING PRESCRIBERS, MANUFACTURERS, AND THE PUBLIC NEW RISKS OF ADVERSE EVENTS.
• SHARING THEIR REPORTS WITH THE WHO PROGRAME FOR INTERNATIONAL DRUG MONITORING (WHO/UMC 2006)

37
Q

• PHARMACOVIGILANCE ACTIVITIES AS PART OF PUBLIC HEALTH PROGRAM

-COUNTRIES MAY HAVE PUBLIC HEALTH INITIATIVES THAT ARE _-SPECIFIC AND OPERATE _ FROM THE _ HEALTH SYSTEM (FOR EXAMPLE HIV/AIDS, TUBERCULOSIS, MALARIA, VACCINATIONS) ALSO KNOWN AS _.

THE MAJOR AIMS OF PHARMACOVIGILANCE IN PUBLIC HEALTH INITIATIVES ARE THE _ AS THOSE OF THE _ PHARMACOVIGILANCE SYSTEM.

THE _ AND _ OF THE _ NATIONAL SYSTEMS WILL HELP DETERMINE HOW THE PUBLIC HEALTH PROGRAM PHARMACOVIGILANCE EFFORTS SHOULD BE _.

A

• PHARMACOVIGILANCE ACTIVITIES AS PART OF PUBLIC HEALTH PROGRAM

-COUNTRIES MAY HAVE PUBLIC HEALTH INITIATIVES THAT ARE DISEASE-SPECIFIC AND OPERATE SEPARATELY FROM THE PRIMARY HEALTH SYSTEM (FOR EXAMPLE HIV/AIDS, TUBERCULOSIS, MALARIA, VACCINATIONS) ALSO KNOWN AS VERTICAL.

THE MAJOR AIMS OF PHARMACOVIGILANCE IN PUBLIC HEALTH INITIATIVES ARE THE SAME AS THOSE OF THE NATIONAL PHARMACOVIGILANCE SYSTEM.

THE STRUCTURE AND ORGANIZATION OF THE EXISTING NATIONAL SYSTEMS WILL HELP DETERMINE HOW THE PUBLIC HEALTH PROGRAM PHARMACOVIGILANCE EFFORTS SHOULD BE DESIGN.

38
Q

• PHARMACOVIGILANCE ACTIVITIES AT THE INTERNATIONAL LEVEL

  • AT THE INTERNATIONAL LEVEL, WHO INITIATED ITS PROGRAM FOR INTERNATIONAL DRUG MONITORING OF _ TO POOL EXISTING DATA ON ADR’S FROM _ COUNTRIES. THE WHO PROGRAM NOW WORKS WITH _ PHARMACOVIGILANCE PROGRAMS IN ALMOST _ COUNTRIES (UMC _). THE _ CENTRE ESTABLISHED STANDARDIZED REPORTING BY ALL _ CENTERS AND FACILITATES COMMUNICATION BETWEEN COUNTRIES ON MEDICINE _ ISSUES.
A

• PHARMACOVIGILANCE ACTIVITIES AT THE INTERNATIONAL LEVEL

  • AT THE INTERNATIONAL LEVEL, WHO INITIATED ITS PROGRAM FOR INTERNATIONAL DRUG MONITORING OF 1968 TO POOL EXISTING DATA ON ADR’S FROM TEN COUNTRIES. THE WHO PROGRAM NOW WORKS WITH NATIONAL PHARMACOVIGILANCE PROGRAMS IN ALMOST 100 COUNTRIES (UMC 2010). THE UPPSALA CENTRE ESTABLISHED STANDARDIZED REPORTING BY ALL NATIONAL CENTERS AND FACILITATES COMMUNICATION BETWEEN COUNTRIES ON MEDICINE SAFETY ISSUES.
39
Q

PASSIVE DATA COLLECTION

passive reporting of ADR’s and medication errors (also known as _ case reporting) requires health care provider to be active participants in a culture of safety.

Voluntary reporting should always be _, because it helps a team approach to improving patient care and reducing risks.

A

PASSIVE DATA COLLECTION

passive reporting of ADR’s and medication errors (also known as voluntary case reporting) requires health care provider to be active participants in a culture of safety.

Voluntary reporting should always be encouraged, because it helps a team approach to improving patient care and reducing risks.

40
Q

Barriers to voluntary reporting of medication events are:
• Fear of _ by _ or fellow _
• Fear of _ for the _ or _.
• Failure to _ that an _ has occurred
• _ or _ methods for reporting
• Poor track record of _ by the institution
• Lack of _

A

Barriers to voluntary reporting of medication events are:
• Fear of punishment by supervisor or fellow workers
• Fear of liability for the provider or facility.
• Failure to recognize that an incident has occurred
• Unclear or cumbersome methods for reporting
• Poor track record of improvements by the institution
• Lack of time.

41
Q

-Many country regulations require manufacturers and distributors of
pharmaceuticals to report information on ADR’s that they gather during post marketing surveillance to health authorities.

A

MANDATORY DATA COLLECTION

42
Q

Barriers to voluntary reporting of medication events of Mandatory Data Collection

A

None

43
Q

Carried out as a focused and structured activity and include trigger tools, patient chart audits, and direct observation methods. Using a consistent methodology for active data collection provides more reliable calculated medication event occurrence rates and evidence of trends.

A

Active Data Collection

44
Q

Barriers to voluntary reporting of medication
events of Active Data Collection

A

• Trigger tools
• Laboratory triggers
• Medication order

45
Q

provide clues that an ADR occurred

A

Trigger tools

46
Q

are identified from defined parameters indicating an ADR might be associated (serum glucose under 50,WBC count below 3,000
platelets below 50,000 toxic drug levels, and the like.

A

Laboratory triggers

47
Q

are prescription orders for antidotes or reversal agents such as dextrose

A

Medication order triggers

48
Q

TAKING ACTIONS FOR IMPROVEMENT

• PHARMACEUTICAL MANUFACTURERS SENDING OUT “_” LETTERS TO ALERT HEALTH CARE PROVIDERS OF NEWLY DISCOVERED ADVERSE REACTIONS
• PHARMACEUTICAL _ REVISING _ THAT REFLECT THE NEW INFORMATION.
• PHARMACEUTICAL _ OR NATIONAL REGULATORY AUTHORITIES INSTIGATING A _.

A

TAKING ACTIONS FOR IMPROVEMENT
• PHARMACEUTICAL MANUFACTURERS SENDING OUT “DEAR DOCTOR” LETTERS TO ALERT HEALTH CARE PROVIDERS OF NEWLY
DISCOVERED ADVERSE REACTIONS
• PHARMACEUTICAL MANUFACTURERS REVISING MEDICINE PACKAGE INSERTS THAT REFLECT THE NEW INFORMATION.
• PHARMACEUTICAL MANUFACTURERS OR NATIONAL REGULATORY AUTHORITIES INSTIGATING A MEDICINE RECALL.

49
Q

AT THE _ LEVEL, ACTIONS CONCERNING SERIOUS OR RECURRING ADE’S INCLUDE:

• CHANGING THE MEDICATION _ IF NECESSARY
• IMPLEMENTING NEW _ PROCEDURES
• IMPLEMENTING NEW _ PROCEDURES
• MODIFYING _ PROCEDURES
• EDUCATING _ (FACE-TO-FACE; IN SERVICE EDUCATION; BULLETINS; REPORTS OF COLLECTED ADR’S)
• EDUCATING _

A

AT THE CLINICAL LEVEL, ACTIONS CONCERNING SERIOUS OR RECURRING ADE’S INCLUDE:
• CHANGING THE MEDICATION FORMULARY IF NECESSARY
• IMPLEMENTING NEW PRESCRIBING PROCEDURES
• IMPLEMENTING NEW DISPENSING PROCEDURES
• MODIFYING PATIENT-MONITORING PROCEDURES
• EDUCATING PROFESSIONAL STAFF (FACE-TO-FACE; IN SERVICE EDUCATION; BULLETINS; REPORTS OF COLLECTED ADR’S)
• EDUCATING PATIENTS

PUBLIC HEALTH PHARMACY (3 decks)

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