OUR LADY OF FATIMA UNIVERSITY

College of Pharmacy

MODULE 4
PHARMACOVIGILANCE
PUBLIC HEALTH & REGULATORY
PHARMACY
(Supervised Pharmacy Practice Experience)
 ACTIVITY:
• ON-LINE LECTURE
THROUGH ZOOM
• DURATION: 1 HOUR
• TOPIC:
PHARMACOVIGILANCE
OUTCOMES:
• At the end of the lecture, the
students should be able:
• To define what is Pharmacovigilance
• Explain various internal policies on
pharmacovigilance
• Discuss the SOP of pharmacovigilance
and the process of ADR surveillance
WHAT IS PHARMACOVIGILANCE?

• 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.
WHY DO WE NEED TO STUDY
PHARMACOVIGILANCE?

FOR DETECTION, ASSESSMENT, UNDERSTANDING AND PREVENTION OF ADVERSE

EFFECTS OR ANY OTHER MEDICINE/VACCINE RELATED PROBLEM.
THREE MAJOR COMPONENTS OF
PHARMACOVIGILANCE

Data
collection
Data
(Passive, Reporting
Analysis
Active,
mandatory)
THREE AREAS OF PHARMACOVIGILANCE
Is a harmful
response in
the patient
Adverse caused by
Drug the drug
Refers to Reactions itself
how well a Any
product preventable
satisfies event that
customer may cause or
Product Medication lead to
needs,
Quality Error inappropriate
serves its
purpose and medication
meets use or patient
industry harm
standards.
PHARMACOVIGILANCE AND THE
PHARMACEUTICAL MANAGEMENT FRAMEWORK

Selection

Use Management support Procurement

Distribution
Pharmacovigilance Activity Detection within the Pharmaceutical Prevention
Management framework

Product quality • Most product quality issues are detected in the • Prequalify supplies during procurement.
distribution portion of the pharmaceutical • Establish a pharmaceutical quality assurance program.
management cycle. • Establish policy and legal framework that addresses
• Physical inspection is done at the time of pharmaceutical quality.
receiving the product from the supplier and at • Enforce laws and regulations related to product quality
other points of distribution to the patient.
• Complaints about efficacy occur during
use

ADR’s • Management support functions, such as • Consider ADR information during the selection proces
surveillance and monitoring systems, during to make formulary decisions and establish standard
use are the primary methods for detecting treatment guidelines.
ADR’s. • Train health professionals about ADR.
• Communicate w/ patient about ADR.

Medication Error • Errors can be detected in all phases of the • Promote culture of safety through a nonpunitive
pharmaceutical management cycle: ordering, environment for reporting events.
storing, labelling, compounding, dispensing, • Train and educate staff.
transcribing, prescribing, administering and • Issue prescribing guidelines
monitoring. • Establish monitoring guidelines.
 THE PHARMACOVIGILANCE FRAMEWORK
People Functions Structures

Reporters Reporting (detection and generation) Manufacturers

Hospitals/Institutions
• Doctors Reports suspected side effects, adverse events, quality concerns, and errors
• Pharmacists
• Nurses
• Other health care
workers
• Consumers
Data Collation (evaluation) Pharmacovigilance center
Collate data, conduct initial analysis Drug and therapeutics
Causality analysis and risk determination Committees
Establish casuality or determine if further epidemiologic studies are required to Safety advisory Committee
establish association
Evaluators Decision making and appropriate action Regulatory authority
Industry
• Medical specialists Package insert amendments, warnings, scheduling changes, risk management, Health services
• Clinical market withdrawal, product recall. Professional groups
pharmacologists Advisory committees
• Pharmacists
• Epidemiologists
 ROLES AND RESPONSIBILITIES OF
PARTNERS OF PHARMACOVIGILANCE
PARTNER RESPONSIBILITIES

GOVERNMENT • 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.
INDUSTRY • Provide quality medicines of assured safety and efficacy
• Assess and share ADRs that are reported.
HOSPITALS • Promote the incorporation of pharmacovigilance into procedure and clinical practice.

ACADEMIA • Teach, train, conduct research, and develop policy about pharmacovigilance
• Include pharmacovigilance curriculum
 Medical and Provide training and awareness to health professionals regarding
Pharmaceutical pharmacovigilance
Professional associations
Poisons and medicine • Provide information on medication safety and pharmacovigilance
information center • Collaborate with national with pharmacovigilance center, if applicable.

Health Professionals • Detect investigation, manage, and report ADRs, medication error, and product
(including physicians, quality concerns.
nurses, pharmacists, Dentist) • Counsel patients about ADRs
Patients and consumers • 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.
Media • Create awareness in the community about the safe use of medicines
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)
• 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.
• 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 ESTABLISHED STANDARDIZED REPORTING BY ALL
NATIONAL CENTERS AND FACILITATES COMMUNICATION BETWEEN COUNTRIES ON
MEDICINE SAFETY ISSUES.
DATA COLLECTION
PASSIVE DATA COLLECTION Barriers to voluntary reporting of medication
events are:

passive reporting of ADR’s and medication errors (also known as voluntary case • Fear of punishment by supervisor or fellow
reporting) requires health care provider to be active participants in a culture of workers
safety. • Fear of liability for the provider or facility.
Voluntary reporting should always be encouraged, because it helps a team • Failure to recognize that an incident has
approach to improving patient care and reducing risks. occurred
• Unclear or cumbersome methods for reporting
• Poor track record of improvements by the
institution
• Lack of time.

MANDATORY DATA COLLECTION

-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.

ACTIVE DATA COLLECTION • Trigger tools provide clues that an ADR occurred
-Carried out as a focused and structured activity and include trigger tools, patient • Laboratory triggers are identified from defined
chart audits, and direct observation methods. Using a consistent methodology for parameters indicating an ADR might be associated
active data collection provides more reliable calculated medication event (serum glucose under 50,WBC count below 3,000
occurrence rates and evidence of trends . platelets below 50,000 toxic drug levels, and the
like.
• Medication order triggers are prescription orders
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.

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
CASE PRESENTATION

• RESEARCH A CERTAIN SITUATION OR PROBLEM ENCOUNTERED BY THE PHARMACEUTICAL INDUSTRIES,

OR IN A COMMUNITY, HOSPITAL, PUBLIC HEALTH WHERE PHARMACOVIGILANCE IS REALLY IN NEED
• IDENTIFY THE AREA OF PHARMACOVIGILANCE & APPLY THE PHARMACEUTICAL MANAGEMENT
FRAMEWORK
• WRITE REFERENCE/S
REFERENCE
• FILE:///C:/USERS/LEN/DOWNLOADS/WHO-PHARMACOVIGILANCE-GUIDELINES%20(3).PDF
• HTTP://WWW.JOURNALOFSOPI.COM/INDEX.PHP/SOPI
• HTTPS://JOURNALS.INDEXCOPERNICUS.COM/