NTA Level 4 • Semester 1 • PST04101

Adverse Drug Reactions, Drug Overdose and Intoxication

Dispensing • Source Session/Topic 13

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Session 13: Adverse Drug Reactions, Drug Overdose and Intoxication

Total Session Time: 120 minutes

Prerequisites

• None

Students Learning Tasks

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

• Define ADRs, Drug Overdose and Intoxication

• Identify suspected adverse drug reactions (ADRs), drug overdose and

intoxication

• Report suspected adverse drug reactions (ADRs)

Resources Needed:

• Flip charts, marker pens, and masking tape

• Black/white board, chalk and whiteboard markers

• Handout 13.1 Adverse Drug Reactions Cases

• Worksheet 13.1 TFDA ADR form

SESSION OVERVIEW

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: Definition of Adverse Drug Reactions (5 minutes)

• Adverse Reaction is a situation where someone experiences harmful effects

from the application of a drug

or is an unfavourable or harmful unintended action of a medicine

• Serious adverse drug reaction: any reaction that is fatal, life-

threatening, permanently/significantly disabling, requires or prolongs

hospitalization, causes a congenital anomaly, or requires intervention to

prevent permanent impairment or damage

• Drug Overdose describes the ingestion or application of a drug or other

substance in quantities greater than are recommended or generally

practiced

▪ An overdose may result in a toxic state or death

• Combined drug intoxication (CDI), also known as multiple drug

intake (MDI) or lethal polydrug/polypharmacy intoxication is due to the

simultaneous use of multiple drugs, whether the drugs

are prescription, over-the-counter, recreational, or some other

combination

STEP 3: Identification of Adverse Drug Reactions (ADRs) (35 minutes)

|Activity: Buzzing (5 minutes) |

| |

|ASK students to pair up and buzz on the following question for 2 |

|minutes |

| |

|How will one identify Adverse Drug Reactions? |

| |

|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 |

• Patients may experience one or more adverse reactions when they are given

medicines Adverse reactions (Side effect) are undesirable drug effects

which may be common or may occur infrequently

• They may be mild, severe, or life-threatening. They may occur after the

first dose, after several doses, or even after many doses

• An adverse reaction often is unpredictable, although some drugs are known

to be cause certain adverse reactions in many patients

• For example the drugs used in the treatment of Cancer and those used in

treating HIV/AIDS, commonly known as Anti-Retralviral Therapy(ART) are

very toxic and are known to produce adverse reactions in many patients

receiving them

• Other medicines produce adverse reactions in fewer patients

• Some adverse reactions are predictable, but many adverse drug reactions

occur without warning

• When dealing/ dispensing medicines that are suspected to have ADRs:

o Counsel all patients regarding the possibility of ADRs

o Inform patients of signs and symptoms that may indicate an ADR

o Instruct patients that in the event of an ADR, they should return to the

clinic/hospital immediately if the reaction is life-threatening or

contact the MO as soon as possible in all other instances

o Refer all patients with suspected ADRs to the MO

o After a period to be determined by the ART Eligibility Committee,

complete one ADR form for each ADR reported

▪ Refer patients with suspected serious ADRs or patients requiring

treatment to the MO

o Work with the Records Officer and the nursing staff to make sure that the

original ADR form is placed in the patient record and the duplicate is

received by the pharmacist

o Maintain a file of all completed ADR forms and related reports

o Review ADR forms on an ongoing basis and alert the ART Eligibility

Committee of unusual trends or findings

o Provide verbal feedback at ART Eligibility Committee meetings, or written

feedback to staff regarding outcomes of referred ADRs so as to encourage

continued reporting

o Prepare ADR Summary Report

o Present the ADR Summary Report and findings to the ART Eligibility

Committee

• Signs and symptoms of drug overdose vary depending on the drug or

toxin exposure

o The substance that has been taken may often be determined by asking the

person

o For patients with altered level of consciousness, questioning of their

friends and family may be helpful in order to get information of the

drug involved

[pic][pic] Refer students to Worksheet 13.1: TFDA ADR FORM

STEP 4: Reporting Adverse Drug Reactions (ADRs) (60 minutes)

|Activity: Small Group Discussion (30minutes) |

| |

|DIVIDE students into small manageable groups. |

| |

|[pic]REFER students to Worksheet 12.1: TFDA ADR FORM |

| |

|READ the form and CLARIFY |

| |

|ASK all groups to discuss about the following question for 15 minutes.|

| |

|Where to report in case of ADR? |

|What to report on ADR form? |

|Who should report? |

|How to report? |

| |

|ALLOW few groups to present and the rest to add points not mentioned |

| |

|CLARIFY and SUMMARIZE by using the content below |

Where to report

• The National ADRs monitoring centre: This is under the Tanzania Food and

Drugs Authority (TFDA), with offices near EPI-Mabibo, Dar es Salaam.

▪ The Centre collects and evaluates ADR reports and feedbacks its

findings to the healthcare professionals and the general public.

▪ Reported information is also communicated to the World Health

Organisation (WHO).

• Zonal Drug Information Centres: Four Zonal Drug information Centres

located at;

o Muhimbili National Hospital (Dar es salaam)

o Bugando Medical Centre (Mwanza)

o Kilimanjaro Christian Medical Centre and Mbeya Consultant Hospital

▪ are responsible with co-ordinating the collection of ADR reports at

respective hospitals and zones.

What to report

• All suspected adverse reactions should be reported whether known or

unknown, serious or not, including minor ones.

• Reports on the new drugs are of great interest because they make easier

to monitor the performance of these drugs in the country for any

suspected adverse drug reactions.

Who should report

• All health care providers including specialists, doctors, dentists,

pharmaceutical personnel and nurses can report ADRs

• All affected consumers are encouraged to report ADRs directly to their

healthcare professionals and zonal Drug Information centers

How to report

• Adverse drug reaction forms may be obtained from TFDA headquarters, Zonal

Drug Information Centres, offices of Regional Medical Officers or

Regional Pharmacists and healthcare facilities

o The form can be filled online or downloaded from the website

• Suspected adverse reactions for drugs marketed in Tanzania should be

reported using a standardised form which is postage pre-paid and self

adhesive

• The reports should be sent to the Director General, TFDA, P.O. Box 77150,

Dar es Salaam, fax +255 22 2450793 email adr@tfda.or.tz This email

address is being protected from spambots. You need JavaScript enabled to

view it. [pic]

• The forms or reports should contain the following elements:

o Patient information including Patient’s name, Age/Date of birth, Sex,

Weight and relevant medical history

o Description of the adverse reaction including date of onset

o Suspected drug(s): name (including brand name, if known), dosage,

route, start and stop dates and reasons for use.

o Treatment given for the reaction(s)

o Other relevant history, including pre-existing medical conditions

o Outcome of reactions

o Name, date, signature and address of the reporter

• All sections of the form should be dully filled prior submission

o A separated form should be used for each patient

STEP 5: Key Points (10 minutes)

• Adverse reaction is a response to a medicine that is noxious and

unintended, and which occurs at doses normally used in man for the

prophylaxis, diagnosis, or therapy of disease or the modification of

physiological function

• All suspected adverse reactions should be reported whether known or

unknown, serious or not, including minor ones

• The word "overdose" implies that there is a common safe dosage and usage

for the drug; therefore, the term is commonly only applied to drugs,

not poisons, though even poisons are harmless at a low dosage

• Reports on the new drugs are of great interest because they make easier

to monitor the performance of these drugs in the country for any

suspected adverse drug reactions

• The reports should be sent to the Director General, TFDA, P.O. Box 77150,

Dar es Salaam, fax +255 22 2450793 email adr@tfda.or.tz This email

address is being protected from spambots. You need JavaScript enabled to

view it. [pic]

• Adverse drug reaction forms may be obtained from TFDA headquarters, Zonal

Drug Information Centres, offices of Regional Medical Officers or

Regional Pharmacists and healthcare facilities

• All sections of the Yellow form should be dully filled prior submission

STEP 6: Evaluation (5 minutes)

• What is adverse drug reaction?

• When adverse drug reaction occur?

• Why is it important to report adverse drug reaction?

• What is drug overdose?

• What is intoxication?

• Where should the report be sent?

• Who should fill the ADR (Yellow Form) for a patient?

• Why is it important to keep a copy of complete ADR (Yellow Form) for your

record?

References

Malestrom.(2004) Dictionary of Medical Terms (4th ed.). London, United

Kingdom: A & C Black.

Rice, J. (2011). Principles of pharmacology for medical assisting (5th

ed.). Boston, United States of America: Cengage Learning.

TFDA, (2006). Guidelines for Monitoring and Reporting Adverse Drug

Reactions – ADRs. Dar; MoH&SW

|[pic] |Worksheet 13.1: TFDA ADR FORM |

[pic]

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