Reporting of ADRs

Session 14: Reporting 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

15 minutes Presentation Objective of ADRs Monitoring

2

Buzzing

70 minutes presentation and Procedures for Reporting ADRs

3

group discussion

4 10 minutes presentation Centres for Monitoring ADRs

5 10 minutes Presentation Key Points

6 10 minutes Presentation Evaluation

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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: Objectives of ADRs Monitoring (15 minutes)

case reports of ADR are reported by health care professionals and pharmaceutical

manufacturers to TFDA.

medical devices circulating in the Tanzanian market

prevention of counterfeit and substandard products in clinical practice.

supported by health care professionals

o To detect the nature and frequency of ADRs including periodic re-evaluation of the

benefit-risk ratio of medicinal products in order to assist the drug regulatory authority,

public health programs, scientists and consumer society take appropriate action to

minimize risks of ADRs to consumers.

o To identify risk factors that may predispose, induce or influence the development,

severity and incidence of adverse reactions in the population of Tanzania, examples;

 Patient factors: genetics, racial differences, diets, diseases, prescribing practices,

culture of drug use and traditions of the people e.g. high carbohydrate, fat diet etc

 Drug interactions, drug distribution, storage and use including indications, dose,

availability and other underlying condition

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STEP 3: Procedures for Reporting ADRs (70 minutes)

Activity: Small group discussion (30 minutes)

ASK students to form small manageable groups and discuss following questions

ALLOW few groups to respond and let other groups to add on points not mentioned

WRITE their response on the flip chart/board

CLARIFY and SUMMARIZE by using the content below

The following are procedures for reporting ADRs as per TFDA guidelines

o Any undesirable adverse event suspected to be associated with use of drug; biological

(including blood products), herbal drugs, cosmetics or medical devices should be

reported. They should include;

 All ADRs as a result of prescription and non-prescription medicine

 All suspected adverse drug reactions regardless of whether or not the product was

used in accordance with the product information provided by the company

marketing the product

 Unexpected reaction, regardless of their nature or severity, whether not consistent

with product information or labelling

 An observed increase in frequency of a given reaction

 A serious reaction, whether expected or not

 All suspected ADRs associated with drug-drug, drug-food or drug-food supplements

interactions

 ADRs in special field of interest such as drug abuse and drug use in pregnancy and

during lactation

 ADRs occurring from overdose or medication error

 Unusual lack of efficacy or when suspected pharmaceutical defects are observed

o What information is required for ADRs case report?

 The minimal standard information to be provided for proper assessment of the ADR

case report are;

 Patient information

 Adverse reactions description (include laboratory results if available)

 Information related to the suspected drug(s)

 Information on management of the adverse reactions

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 Information about the reporter

o Patient information

 Patient identity: indicate initials or record number of the patient in hospital, medical

institution, dispensary, clinic or pharmacy.

 Birth dates or age: indicate date, month and year

 Sex: Male or Female

 Weight: should be in Kilograms

o Brief description of the ADR(s): indicate the adverse(s) reaction by marking X in the

appropriate box. Preferably describe briefly the nature of the adverse reaction being

reported but as clearly as possible, including the body site and severity.

o Time/date of onset of the adverse reactions: State the time of onset or the occurrence of

the adverse reaction in relation to the administration of the drug. Indicate the date of

onset in the following order; day, month and year. For example, did the drug reaction

appear immediately following drug administration or there was temporal or spatial

correlation with administration.

o Other relevant information:

Patient medical history or laboratory data including dates if available, considered

relevant to the case or the adverse reaction being reported should be entered.

 Mention appropriate laboratory tests done to the patient and results to confirm the

adverse reaction.

 State this concisely but clearly

o Name of the suspected drug (s): trade name should preferably be used, if trade name not

available, generic name may be used. Strength of the drug (s) should be stated

 Dosage, frequency and route of administration should be clearly notified.

For example;

 Dosage (specify dosage form; tablet, capsules, syrup, injection, cream, eye drops,

etc. including total amount of drugs).

times daily.

 Route of administration by which the drug was administered.

 Therapy date: the dates of beginning and termination of the administration of each

drug should be stated, and preferably recorded as follows:- date, month and year. If

dates are not available, record duration of treatment. If drug administration has not

been terminated at the time of reporting, state ‗Continuing‘

 Batch number and expiry date: provide these information if are available

 Reason for use: state indication or condition for which the drug(s) was given for.

 Particular of concurrently drugs(or other treatment): state particulars of other drug

administered by the patient concurrently with the suspected drug, including drug

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administration for at least 1 month back with dosage, route of administration,

duration of administration and indications.

 Provide relevant information on medical devices

o Details on reporter of an ADR: mention the particulars:-name, address of the health

facility (hospital, institution, dispensary, clinic, company, pharmacy or maternity home).

E-mail address (optional), signature, telephone number and date of reporting the reaction

(indicate date, month and year)

o Pharmaceutical personnel, traditional medicine practitioners and others health care

providers

o Manufacturers or Product registrants

they should develop system for ADR follow-up within their company and assessment of

impact of notification of significant safety data on their products.

o All government hospitals, private hospitals, health centres, dispensaries private clinics,

private pharmacies and private nursing homes have obligation to report all ADR cases

encountered or reported to them by the patients.

In charge of the following facilities; government and private hospitals, health centres

and dispensaries they are required to nominate a focal person who will coordinate the

ADRs collection and reporting within the facility. This person will be a link between the

institution and TFDA

o Any suspected ADR should be reported as soon as possible. Delay in reporting will

make reporting inaccurate and unreliable. If possible, report while the patient is still in

the health facility this gives a chance to reporter to clear any ambiguity by re-

questioning or examining the patient

o Reporters should send accurate information to achieve a better and efficient program on

ADRs monitoring in Tanzania.

o Report should be sent in a standardized form for reporting ADRs. The reporting form is

self adhesive postage paid ―yellow form‖

o Dully fill in the ADRs reporting form (annexed) when encountering an ADR to the

patient.

o Use a separate form for each patient (refer to filling guides)

o A completed ADRs case report form should immediately be sealed and mailed

preferably directly to TFDA within three days or through other reporting centres for

onward transmission to the TFDA

o Reports can also be submitted online by going to the TFDA website

http://www.tfda.or.tz and clicking on ―adverse drug reaction reporting‖ on the bottom-

right

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o Reports may be sent by e-mail through the following e-mail address; adr@tfda.or.tz

o ADR reports may be faxed in cases of perceived urgency

o Any follow-up information for an ADR case that has already been reported can be sent

on another ADR form, or communicated by telephone, fax or e-mail. To enable this

information be matchedwith the original report it is very important that follow-up

reports are identified and the following should be indicated in the report;.

o All reports must have the following four data elements

 An identifiable patient

 A suspected adverse effect

 A named suspected drug (s)

 An identifiable reporter

 Always write legibly.

o Report any suspected ADRs for pharmaceutical products marketed in Tanzania to the

appropriate channels as follows:-

o Preferably directly to TFDA by post or online

o Via Zonal Drug Information Centres at Muhimbili National Hospital (MNH), Mbeya

Consultant Hospital, Bugando Medical Centre (BMC) and Kilimanjaro Christian

Medical Centre (KCMC), for onward transmission to TFDA

o Via a focal person in the following health facility; government hospitals, private

hospitals, health centres, dispensaries for onward transmission to TFDA

o The ADR reporting form is obtained free of charge from;

 TFDA offices,the website of TFDA, downloaded at http://www.tfda.or.tz

 Zonal Drug Information Centres.

 Regional hospital,district hospitals and ADRs focal persons in hospitals, health

centres, clinic and dispensaries.

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Figure 14.1:Adverse drug reaction patient reporting form

Source: TFDA (2003).

Figure 14.2: Flow of ADR information

Source:TFDA(2003).

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STEP 4:Centres for Monitoring ADRs (10 minutes)

adverse drug reactions include

highland Zone

STEP 5: Key Points(10 minutes)

report are; Patient information, Adverse reactions description (include laboratory results if

available), Information related to the suspected drug(s)

Information on management of the adverse reactions, Information about the reporter

suspected adverse effect, a named suspected drug (s) and an identifiable reporter

STEP 6: Evaluation (10 minutes)

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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/

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