Documentation of ADRs
Session 13: Documentation of ADRs
Total Session Time: 120 minutes
Prerequisites
Learning Tasks
By the end of this session students are expected to be able to:
Resources Needed:
SESSION OVERVIEW
Activity/
Step Time Content
Method
1 05 minutes Presentation Introduction, Learning Tasks
30 minutes Presentation Necessary Information for Documentation of
2
Brainstorming ADRs
30 minutes Presentation
3 Types of ADR Reporting Forms
Buzzing
5 40 minutes Presentation Handling of ADR Data
6 10 minutes Presentation Key Points
7 05 minutes Presentation Evaluation
PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide
97
SESSION CONTENTS
STEP 1: Presentation of Session Title and Learning Tasks (5 minutes)
READ or ASK students to read the learning tasks and clarify
ASK students if they have any questions before continuing.
STEP 2: Necessary Information for Documentation of ADRs (30 minutes)
Activity: Brainstorming (5 minutes)
Ask students to brainstorm on the following question:
ALLOW few students to respond?
WRITE their responses on the flip chart/ board
CLARIFY and SUMMARISE by using the content below
your facility from legal problems.
on the market, serious ADRs should be reported to TFDA.
that will be needed.
record. Then complete an incident report.
o Patient information, such as date of birth, sex, race, and weight; pre-existing or
coexisting medical conditions; other medications taken, allergies; and relevant
diagnostic and lab results
o The date of the event
o Specific patient outcomes attributed to the ADR, such as prolonged hospitalization
o A clear, factual, objective and chronologic description of the problem or event.
o Document your assessment findings and interventions, all persons notified and their
responses, the dates and times of these notifications, and the actions taken by those
you've informed and the patient's response to interventions.
PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide
98
o The name of the drug, the manufacturer, the lot number and expiration date on the
packaging (if available), dosage, frequency, duration, route, and times of administration.
Returning any packaging or containers to the pharmacy or retaining them as evidence.
o Your name, title, and credentials as a reporter.
STEP 3: Types of ADR Reporting Forms (30 minutes)
Activity: Buzzing (5 minutes)
ASK students to pair up and buzz on the following question
What are types of documents used to report ADRs?
ALLOW few pairs to respond and let other pairs to add on points not mentioned
WRITE their response on the flip chart/board
CLARIFY and SUMMARIZE by using the content below
o Yellow form -for reporting ADRs to medicines or vaccines
The Yellow card system for collecting information on suspected adverse drug
reactions (ADRs) to medicines.
The system allows the safety of the medicines and vaccines that are on the market to
be monitored.The system was founded in 1964 after the thalidomide disaster.
Yellow Cards are available from TFDA and a few are presented near the back of the
BNF as tear-off pages.
Blue form -for reporting poor quality products. This can be used to report
substandard and counterfeit drugs
o Pharmacovigillance Register – For recording details on filled forms
o Green form -for reporting ADRs by patients themselves
o Pink card -Patient ADR alert card. The criteria for issue of alert card to patient include
Patients who are hypersensitive/allergic/intolerance to particular drug
Patient who develop near fatal reaction to any particular drug
Patient who had a drug induce morbidity to any drug
Patient who had hospital admission due to an ADR to any drug
patients such as
PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide
99
o The personal medication record (PMR) is a comprehensive record of the patient‘s
medications (prescription and non-prescription medications, herbal products, and other
dietary supplements).
o Pharmaceutical personnel in their carrier may use personal medication record to include
what medication caused the problem? What was the problem?)
o This will help to trace signal
STEP 5: Handling of ADR Data(40 minutes)
received with an additional reporting form.
sent to the WHO database of International Programme on safety monitoring of drugs to
which all case reports received by the National centres are sent.
adverse drug reaction are used or communicated to others.
taken.
used for commercial purposes.
by reducing the risks associated with drug prescribing and administration and to ultimately
improve patient care, safety and treatment outcome.
circumstances.
communicating the findings and evaluation reports.
consumers on drug safety issues at facility level, national and international level.
o Researchers in clinical trials, patients using medicines, Pharmaceutical companies,
database, pharmacovigillance personnel, Regulatory managers, health practitioners in
general e.g. pharmacists, physicians.
o Data collected will be used for provision of timely advice to health-care professionals
and consumers on drug safety issues at facility level, national and international level. A
well-documented adverse drug reaction case could result in one or more of the
following;
o Further investigation of signals. For example, identifying `at risk‘ group, a dose range
which might be more suspected, suggesting a pharmaceutical group effect,
PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide
100
pharmacological mechanisms, lack of effect by a particular drug or investigation into the
use of a drug in the country
o Drug regulation and dissemination of information of current importance
o Education and training initiatives to improve the safe use of the medication and other
health promotion interventions as the situation may warrant including change in supply
status or withdrawal
STEP 6: Key Points(10 minutes)
date of the event and name of the drug
sent to the WHO database.
details about a specific adverse drug reaction are used or communicated to others.
pharmacovigillance personnel, Regulatory managers, health practitioners in general e.g.
pharmacists, physicians helps in gathering data relating to ADRs occurrences
STEP 7: Evaluation (5 minutes)
PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide
101
References
Quick, J. D. (1997). Managing drug supply the selection, procurement, distribution and use of
pharmaceuticals. West Hartford, CT: KumarianPress.Bartsch, S. (2007).
The Global Fund to Fight AIDS, Tuberculosis and Malaria. Global Health Governance and the
Fight Against HIV/AIDS,146-171. doi:10.1057/9780230591349
WHO Operational package for assessing, monitoring and evaluating country pharmaceutical
situations. (2015, November 20). Retrieved from
https://www.who.int/medicines/publications/WHO_TCM_2007.2/en/
PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide
102
Unataka kutumiwa notes hizi kupitia WhatsApp?Kwa notes zilizopangiliwa vizuri kwa kusoma offline au PDF, bonyeza kitufe hapa chini. Ujumbe wenye Level, Semester, Module na Topic utaandaliwa moja kwa moja.TUMIWA NOTES WHATSAPP