NTA Level 6 • Semester 2 • PST06211

Documentation of Pharmacovigillance Data

Monitoring and Evaluation of Medicine Use • Source Session/Topic 10

Full source-text version: all educational wording from the extracted learning source is retained; only presenter/tutor metadata and web-layout noise are removed, while formatting is improved for readability.

Session 10: Documentation of Pharmacovigillance Data

Total Session Time: 120 minutes

Prerequisites

• None

Learning Tasks

By the end of this session students are expected to be able to:

• Explain pharmacovigillance tools

• Explain handling pharmacovigillance data

• List characteristic of good documentation practices in pharmacovigillance

Resources Needed:

• Flip charts, marker pens, and masking tape

• Black/white board and chalk/whiteboard markers

• Computer and LCD Projector

SESSION OVERVIEW

Activity/

Step Time Content

Method

1 05 minutes Presentation Introduction, Learning Tasks

Presentation

2 10 minutes Pharmacovigillance Tools

Brainstorming

50 minutes Handling Pharmacovigillance Data

3 Presentation

45 minutes Presentation Characteristic of Good Documentation

Buzzing practices in Pharmacovigillance

5 05 minutes Presentation Key Points

6 05 minutes Presentation Evaluation

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

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: Pharmacovigillance Tools (10 minutes)

Activity: Brainstorming (5 minutes)

Ask students to brainstorm on the following question:

• What are the Guidelines for Monitoring of Medicines safety?

ALLOW few students to respond?

WRITE their responses on the flip chart/ board

CLARIFY and SUMMARISE by using the content below

• Guidelines for Monitoring of Medicines safety

o These are guidelines provided regulatory authority (TFDA) that facilitate the collection

of pharmacovigillance information

• Tanzania Pharmacovigillance Training Manual- manual for training stakeholders who are

involve in documenting and reporting of pharmacovigillance information

• Other tools include;

o Yellow forms (ADR forms)

 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.

o Patient reporting forms –are used by patients to report any ADRs during the cause of

treatment

o Poor Quality Products reporting forms-they are used to report medicines that show poor

efficacy or poor quality products

o Patient alert cards-are carried by patient to identify them as patient with hypersensitive or

allergic to particular kind of drug

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

STEP 3: Handling Pharmacovigillance Data (50 minutes)

• Companies are required to take appropriate measures against unauthorised or unlawful

processing of personal data and against accidental loss, destruction or damage.

• Documentation containing Pharmacovigillancedata should not be left unattended and

companies should adopt a clear desk policy for Pharmacovigillance documents.

• Hard copies of documents, including those in workflow progress should be stored in a

secure and robust area such as fire- retardant cupboards/archives.

• Any database containing personal data used in PV should be fully validated or tested, as

appropriate, to ensure changes to data can be identified and access to these systems should

be restricted to named individuals. Companies may also consider configuring

Pharmacovigillance databases to restrict access to sensitive personal data so only the

country of collection has access, although this is not a requirement of the law.

• Sensitive data should be encrypted to ensure the integrity of data transmissions.

• Data and record management

o All data, documents and records related to pharmacovigillance system are physically and

electronically stored in designated folders and databases, and retained in accordance

with the relevant legislation and requirements of the regulatory integrated quality

management system on data and record management.

o Acknowledgement on receipt of the Pharmacovigillance information

o Entering the data into Vigi Flow

 Done by trained officer

 Manager review and audit the data before commitment

 A web based data management tool used to manage ADR database.

 All data are stored on a database server in Uppsala, Sweden.

o Receipt of pharmacovigillance data and follow up

 Companies collect data using a variety of tools and sources.

 When an Adverse Effect is reported to a company it is important that some personal

data is collected to meet the Pharmacovigillance requirements of having an

identifiable patient and reporter.

 Good Vigilance Practices requires that companies ensure individual case safety

reports (ICSRs) contain a minimum set of information.

 It also specifies that information relating to the patient is as complete as possible, in

accordance with local privacy laws.

 However, data subjects (persons who have experienced an Adverse Effect and if

different, the persons making the Adverse Effect reports) must understand what

personal data relating to them is being collected, by whom and for what purposes.

 Data subjects should be allowed to give their consent.

 Company follow-up request forms or Adverse Effect forms sent to a reporter for

completion.

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

 Data entered into safety databases must only be processed for Pharmacovigillance

purposes and should not be processed for purposes not disclosed to the data subject.

STEP 4: Characteristics of Good Documentation practices in

Pharmacovigillance (55 minutes)

Activity: Buzzing (10 minutes)

ASK students to pair up and buzz on the following question

• Which are characteristics of good pharmacovigillance practices in documentation?

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

• To ensure good pharmacovigillance practices, it is essential to have documentation with the

following characteristics :

• They must be designed, prepared, reviewed, and distributed on the basis of their usefulness;

• They must be approved, signed, and dated by the authorized personnel.

• They must be written unambiguously; their title, nature, and objective must be clear and

they must be distributed in an orderly and easily verifiable fashion;

• Reproductions of documents must be clear and legible, and the introduction of errors and

distortions in materials taken from original sources must be avoided;

• All documentary entries must be periodically reviewed and duly updated. When a document

is modified, care should be taken to prevent reappearance of previously deleted information.

• Documents should not be handwritten; however, if data need to be introduced, they can be

entered by hand clearly and legibly in indelible ink. Enough space should be left for

additional data;

• Any changes in writing the data must be signed and dated; changes should not prevent the

original data from being read. If necessary, the reason for the change will be indicated;

• Documents connected with the same report of a suspected adverse reaction should be kept in

the same file or, in its absence, clear reference should be made to their location, so that

important activities related to the report and its documentation or assessment can be

monitored;

• There should be a record book containing the number assigned to the report, dates of

reporting and entry, data on the origin of the report, and a brief description of the adverse

reaction and the medicines. It will also contain other data, such as an importability

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

algorithm, communications with the author of the report, and other comments. This book

can be generated from a computer database;

• The data can be entered through electronic data processing systems, photographic systems,

or other reliable methods.

o However, detailed information on procedures for the system used should be kept, and

the accuracy of the entries should be verified. If the documentation is processed

electronically, only authorized personnel may enter or change the data on the computer,

and a record should be kept of any alterations or deletions.

o Access should be restricted with passwords or other security measures, and it

should be possible to verify independently the results of introducing basic data.

• The confidentiality of data on the patient and the author of the report should be preserved

with codes.

o Electronically stored report files should be protected through back-up copies, so that

data can be easily accessed as long as they are kept.

STEP 5: Key Points (5 minutes)

• When an Adverse Effect is reported to a company it is important that some personal data is

collected to meet the Pharmacovigillance requirements of having an identifiable patient and

reporter.

• The confidentiality of data on the patient and the author of the report should be preserved

with codes.

• The data can be entered through electronic data processing systems, photographic systems,

or other reliable methods

STEP 6: Evaluation (5 minutes)

• What are the tools used for Monitoring of Medicines safety?

• What are characteristics of good documentation practices in pharmacovigillance?

• How are pharmacovigillance Data and records managed?

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

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

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