METHODS OF ADR REPORTING

Seminar/Assignment Report
(MSA206P)
Submitted to

Gujarat Technological University,

Ahmedabad
M Pharm SEM –II
(Pharmacology)
Guided by: May 2019 Presented by:
Dr. Digvijay Rana Denish D Ghodasara
M Pharm. PhD. M. Pharm (Pharmacology)
(Pharmacology)
Associate Professor
Babaria Institute of Pharmacy
BITS Edu Campus
Vadodara Mumbai NH#8,
varnama, Vadodara
ADVERSE DRUG REACTION
• Any response to a drug which is noxious and
unintended, and which occurs at doses
normally used in man for prophylaxis,
diagnosis, or therapy of disease, or for the
modification of physiological function
IMPORTANCE OF ADR REPORTING

• To enhance Patient Safety

• To keep records of efficacy
• Provide optimal information to users
• Identifying New Information about hazards
associated with medicines
• Evaluates Changes in Benefits and Risks
• Monitor impact of Action Taken
• Identify Previously unknown Hazards
 WHO CAN REPORT?

 Patients, patients relatives or patient’s caretakers

 Health care professionals (physicians, dentists,

pharmacists, radiographers,
nurses and any other health care professionals)

 Manufacturers

 Authorities
 WHAT TO REPORT?

All suspected ADRs with pharmaceutical medicines &vaccines

 Known or unknown
Serious or non-serious
Frequent or rare

Adverse reactions associated with

Drugs used in traditional medicine (e.g. herbal remedies)

Medical devices
Contrast media
Other pharmaceuticals
 HOW TO REPORT?

Suspected ADR reporting forms for healthcare

professionals

 Suspected ADR reporting forms for consumers

Consumers directly can report to NCC-PvPI through

Helpline no-18001803024

Through ADR reporting mobile application available in

Google play store
 WHERE TO REPORT?

 A reporter can send filled ADR reporting form

directly to NCC or their nearest AMC

 In case of AMC, these reports are confirmed by

healthcare professionals and entered into VigiFlow
and sent to NCC for further assessment

The submitted ADR report does not have any legal

implication on the reporters
 Passive surveillance
• Passive surveillance is the most common form
of surveillance

• The term passive is used to convey the idea that

health authorities/ sponsors take no action while
waiting for reports/ forms to be submitted.
 SPONTENIOUS REPORTING
• A spontaneous report is a voluntary communication
by healthcare professionals or consumers

• Made to a company, regulatory authority or other

organization (e.g., WHO, Poison Control Center)

• Communication describes one or more adverse drug

reactions in a patient who was given one or more
medicinal products

• Data not derived from a study or any organized data

collection scheme.
 Spontaneous Reporting
Aims
• Early detection of new ADRs

• Detection of increase in frequency of known

ADRs

• Identification of risk factors and possible

mechanisms underlying ADRs

• Estimation of quantitative aspects of benefit/risk

analysis
Spontaneous Reporting
What to report
• All suspected adverse reactions known or not,
serious or not (advanced systems more selective
– all ADRs for new drugs, serious/unusual ADRs
for established drugs) of

 Pharmaceutical Medicines
 Traditional medicines (e.g herbal medicines)
Spontaneous Reports
• Spontaneous reports play a major role in the identification
of safety signals once a drug is marketed.

• In many instances, a company can be alerted to rare adverse

events that were not detected in earlier clinical trials or
other pre-marketing studies.

• Spontaneous reports can also provide important

information on
▫ at-risk groups,
▫ risk factors, and
▫ clinical features of known serious adverse drug reactions.

• The data accompanying spontaneous reports are often

incomplete, and the rate at which cases are reported is
dependent on many factors including the time since launch,
pharmacovigilance-related regulatory activity, media
attention, and the indication for use of the drug.
REPORTING FORM
ELEMENTS
• The Patient: age, sex, brief medical history

• Adverse event
▫ Description – nature, localization, severity,
characteristics
▫ Results of investigations
▫ Start date
▫ Course & Outcome

• Suspected drug(s)
▫ Name (brand or generic name + manufacturer, batch
number)
▫ Dose & route
▫ Start/stop dates
▫ Indication for use
REPORTING FORM
ELEMENTS
• Other drugs (including self medication)
▫ Names
▫ Doses
▫ Routes
▫ Start/stop dates

• Risk factors
▫ Organ- system failures
▫ Previous exposures to suspected drug
▫ Previous allergies

• Name & address of reporter (confidential)

Spontaneous Reporting
Reasons for not reporting
• Ignorance of the requirements for reporting.

• Hesitancy about reporting due to fear that it

might perhaps lead to ridicule

• Lethargy – an mix of procrastination, lack of

interest or time, an inability to find a report form
etc
Spontaneous Reporting
• Advantages

• Inexpensive and simple to operate

• Covers all drugs during their whole life cycle

• Covers the whole patient population, including

special subgroups such as the elderly

• Does not interfere with prescribing habits

• Can be used for follow-up studies of patients with severe

ADRs, to study mechanisms
Spontaneous Reporting
• Disadvantages

• The amount of clinical information available is often too

limited to permit a thorough case evaluation

• Underreporting decreases sensitivity and makes the

systems sensitive to selective reporting

• The reporting rate is seldom stable over time

• No direct information on incidence

Intensified spontaneous reporting
• To enhance ADR reporting of specific medicines
in early post ‐marketing phase

• Extension of Spontaneous Reporting

Programme
Targeted spontaneous reporting
• Intensified ADR Reporting within a defined
cohortIntensified ADR Reporting within a
defined cohort
Targeted spontaneous Reporting
TSR Uganda
• Specific population:
Patient with HIV infection
• Specific clinics:
Regional Pharmacovigilance Centres of Masaka
and Mbale
• Specific medicines: Tenofovir
• Specific ADRs: Renal toxicity
 Pros with TSR
• Can utilise existing ADR reporting infrastructure
• Targets specific medicines of interest
• Possible to implement monitoring programme
that targets specific issue of concern (ADR,
medicine, patient group)
• Captures useful information (less‘background
noise’)
• Denominator known
Cons with TSR
• Under‐reporting remains a problem

• Captures only suspected ADRs or known

toxicities

• May limit reporting only to specific ADRs

• Relies on diagnostic capability of reporter

Possible factors underlying poor reports
of ADRs

• Education
▫ Undergraduate training defective in Pharmacovigilance
▫ Post graduate training defective in PV

• Absence of a National Policy guidelines/

Pharmacovigilance scheme

• Poor quality and inaccessibility of Drug information

facilities/sources

• Aggressive and inaccurate marketing and advertising

• Poor reporting culture

 Case Series
• Case report- describes the particular outcome or
experience of a person who has been exposed to
a drug
• A case series involves reports on 2 or more
people with common exposure to a drug or a
common outcome
• These reports are useful for generating
hypotheses
• Hypotheses could be about effects of the drug
• This in turn could lead to further studies to test
these hypotheses
Case Series
• Series of case reports can provide evidence of an
association between a drug and an AE

• However, they are more useful for generation of

hypothesis rather than verifying an association
between drug exposure and outcome
 Stimulated Reporting
• Stimulated reports are those that have been
▫ Motivated
▫ Prompted or
▫ Induced

• Eg: public advisory, literature report, questioning

of healthcare professionals by MAH
representatives

• These reports should be considered as voluntary

in nature and as a form of spontaneous reporting
Stimulated Reporting
• Methods used to stimulate reporting:
▫ On-line reporting

▫ Sponsor encouragement of AE/ADR reporting for

a new drug

▫ Sponsor providing education on safety concerns of

new drug may prompt/ induce reporting
 Active surveillance
• Active surveillance, in contrast to passive surveillance,
seeks to determine more completely the number of
adverse events in a given population via a continuous
organized process.

• An example of active surveillance is the follow-up of

patients treated with a particular medicinal product
through a risk management system. Patients who fill a
prescription for this product may be asked to complete a
brief survey form and give permission for later contact.
In general, it is more feasible to get comprehensive data
on individual adverse event reports through an active
surveillance system than through a passive reporting
system.
 Active Surveillance
Aims
• Identify drug safety signal

• Validate drug safety signal identified through

passive surveillance
Challenges of Active Surveillance
• Obtaining timely information
• Obtaining validated information
• Obtaining information from both in-patient and
out-patient settings
• Finding signals for rare events
• Having a system that efficient
• Obtaining broad enough scope across U.S.
 Cohort Study
• In a cohort study, a population-at-risk for an event of interest is
followed over time for the occurrence of that event.

• In this type of study two groups/ cohorts of patients are identified

▫ Eg: based on exposure status
▫ Group 1 – exposed to risk factor i.e. drug of interest
▫ Group 2 not exposed to risk factor i.e. comparative drug / no drug

• It then involves following up / observing the two cohorts for an

adequate period of time for the occurrence of the outcome

• Companies may set up or sponsor prospective, non interventional

cohort type studies either to answer safety questions raised after
marketing or as a general hypothesis generating and testing tool
 Case Control Study
• In a case-control study, cases of disease (or events) are
identified.

• Controls, or patients without the disease or event of

interest, are then selected from the source population
that gave rise to the cases.

• Case control studies are particularly useful when the

goal is to investigate whether there is an association
between a medicinal product and one specific rare
adverse event, as well as to identify risk factors for
adverse events
Reference
• Methods in Pharmacovigilance,Dr. Linda
Harmark, PharmD, epidemiologist, Head
Innovation, Netherlands Pharmacovigilance
Centre Lareb.
• Text book of clinical pharmacy practice – G
Parthasarathy . Page no: 105-107
• Ramesh et al. Pharmacoepidemiol & Drug Saf
2003 2.Devi et al, Pharmacoepidemiol & Drug
Saf 13:859 (2004)