1.0 ADR Reporting and Management PDF

Download as pdf or txt
Download as pdf or txt
You are on page 1of 35

Adverse Drug Reactions Reporting

and Monitoring

K.Swapna
Introduction

“ one which is noxious and unintended, and


which occurs at doses normally used in man for
the prophylaxis, diagnosis, or therapy of
disease, or for the modification of physiological
function ”
Introduction

The terms ‘adverse drug event’ and ‘adverse drug


reaction’ are not synonymous
Why Monitor Adverse Drug
Reactions
 Worldwide, the incidence of occurrence of ADRs
is steadily increasing

 Up to 35% of hospitalised patients experience an ADR

 Approximately 5% to 10% of all hospital admissions


are due to ADRs

 The incidence of fatal ADRs is estimated to be 0.23%


to 0.41%
Need for Monitoring Adverse
Drug Reactions
 Major clinical problem in terms of human
sufferings and increased healthcare costs

 Adversely affect patients’ quality of life

 ADRs are one of the leading causes of morbidity


and mortality
Traditional Classification

As proposed by Rawlins and Thompson (1977)

Type A (Augmented)
Type B (Bizarre)
Newer Classification

As proposed by Rene J Royer (1997)

Type A (Augmented)
Type B (Bizarre)
Type C (Continuous)
Type D (Delayed effects)
Predisposing Factors
 Age
 Gender
 Polypharmacy
 Multiple and intercurrent diseases
 Race and genetics
 Drug characteristics
 Previous history of allergy / intolerance
 Inappropriate dosing and prolonged therapy
Detection of ADRs

• Detection of an ADR is crucial in the


management of any patient

• Always suspect a drug as cause of symptoms in


a patient
How do we detect ?
• By patient interview

• Reviewing prescriptions containing drugs like


anti-histamines and corticosteroids

• Checking for abrupt cessation of any


medications

• Obtaining previous medical history


How do we detect ?
• Firstly, find out whether a patient taking a
medicinal product

• Obtain complete details of the patient


pertaining to both event and medications and
other relevant information
How do we detect ?
• Details pertaining to suspected reaction

Nature and severity of suspected reaction


Time of onset of suspected reaction
Duration of suspected reaction
Previous report on reported reaction
How do we detect ?
• Details pertaining to suspected drug

Name of the suspected drug


Time of administration
Complete dosing regimen
Previous report on suspected drug
How do we detect ?
• Other relevant information

Patients demographic data


Presenting complaints
Past medication history
Current drug therapy details including OTC
medications
Treatment with any other system of medicine
Risk factors
How do we detect ?
• Correlate the collected information with the
event

• To find out whether the effect could be due to


a medicine consider the following

– The temporal time relationship between the


administration of the suspected drug and the
reaction
How do we detect ?

– Background frequency of the event

– Possible involvement of other causes (non –


drug causes)

– Previous exposure / allergy

– Outcome of the reaction upon dechallenge


and rechallenge
Reporting of an ADR

 To report an ADR you need not be certain just


be suspicious

 Make sure that sufficient /adequate information


is available

 The most commonly adopted method is


spontaneous reporting
Spontaneous reporting

• It was, and still is, the main way of detecting


early drug safety signal

• Widely accepted method of ADR reporting


worldwide

– Simple to operate, easy to report and cheap


Spontaneous reporting
Limitations

– Under reporting

– Reporting bias

– Incidence cannot be studied


Who can report ?

Reports can be completed by

• Doctors
• Dentists
• Pharmacists
• Nurses
• Consumer reporting is the need of the hour
Reporting - What should be the
minimum information ?
 patient identity
 description of reaction
 exposure to the drug
 temporal time relationship between the
exposure and the reaction
 other possible causes (disease or concomitant therapy)
 reporter’s identity
What to report ?

• Serious and or life threatening reactions

• Fatal reactions

• Reactions resulted in disabilities/ permanent


harm

• Reactions resulted in increased healthcare costs


What to report ?

• Severe reactions of any type

• Any reactions to newer drugs

• Newer reactions to any drugs in the market

• Rare and uncommon adverse reactions


How to report ?
• Reporting can be made through reporting forms

• Can be reported through telephone

• Can be reported directly to WHO database


through ‘vigiflow’ on-line program
How to report ?
• You may report by filling the ADR notification form with
following details

Patient’s demographic details


Prescriber’s details
Suspected drug(s)
Date of suspected drug started and stopped
Date of ADR started
Brief description of the reaction
Name and address of the reporting community
pharmacist with date of reporting
Where to report ?

• Local / peripheral centre


• Regional pharmacovigilance centre
• National pharmacovigilance centre
• WHO collaborating centre
• Manufactures (in case of trial drugs, newly marketed drugs)
Management of an ADR

Rapid action is sometimes important

• First and foremost step is withdrawal of


suspected drug (s)

• If the reaction is likely to be dose related, dose


reduction should be considered
Management of an ADR
• Treatment for suspected reaction
– Symptomatic
– Specific

• While managing an ADR,


Always have a clear therapeutic objective in mind, do
not treat for longer than is necessary, and review the
patient regularly and look for ways to simplify
management
Role of Pharmacist

 Monitor the patients who are at greater risk of


developing ADRs

compromised ability to handle drugs

previous documentation of allergy or ADR

those with multiple disease process


geriatric or pediatric patients
Role of Pharmacist
Monitor the patients who are prescribed with
drugs highly susceptible to cause ADRs

high incidence of adverse effects


low therapeutic index
potential for multiple interactions
Role of Pharmacist
 Assess and document the patient’s previous
allergic status

 Assess the patient’s drug therapy for its


appropriateness

 Create awareness about ADRs amongst


patients, HCP and public
Role of Pharmacist
 Assist HCP in detection and assessment of
ADRs

 Educate and encourage the HCPs and patients


in reporting of an ADR

 Document the reported ADR in the patient’s


medical record

 Communicate the reported ADRs to


appropriate concerned
Role of Pharmacist

 Present the reports in meetings and conferences

 Conduct workshops or seminars on ADRs for


HCPs

 Disseminate the signals generated through


publication of reports in bulletins/journals
Conclusion
• ADRs are inevitable risk associated with drug
therapy

• Prompt recognition of potential ADRs, and


early detection and intervention may prevent

• morbidity and mortality


• unnecessary investigations and treatments
• unnecessary human suffering and healthcare costs

You might also like