The document describes Prescription Event Monitoring (PEM), a method of pharmacovigilance that involves collecting information on patient outcomes after being prescribed new medications. PEM was developed in the 1980s in the UK to address limitations of spontaneous adverse event reporting. It involves sending questionnaires to prescribers to obtain follow-up data on patients. Analysis of the data provides incidence rates of adverse events and allows detection of potential safety issues with new drugs. Modified PEM (M-PEM) expands the method to collect additional targeted safety information.

2. CONTENTS
 Introduction
 Evolution
 How PEM is initiated
 PEM process
 M-PEM
 Advantages and disadvantages of PEM
 Applications
 References

3. Introduction
 PEM is a non-interventional, observational cohort form
of pharmacovigilance.
 It is the method of studying the safety of new
medications used by the general practitioner.
 UK based concept
 Individualized form of Pharmacovigilance
 Collaborative effort between Doctor , Pharmacist,
Patient and Government.

4. Evolution
 The whole ethos of drug safety monitoring came into
existence after Thalidomide disaster 1961.
 Professor William Inam , man who developed Yellow
card system in UK –method of spontaneous
monitoring.
 Prof. Inam recognized the the limitations of
spontaneous monitoring (PRACTOLOL-
Occulomucocutaneos syndrome) and he established
DSRU(Drug Safety Research Unit) in 1980 at
University of Southampton and devised a method for
early detection of potential drug hazards know as PEM

5. WILLIAM HOWARD WALLACE BILL INMAN
In1990’s , a new version of PEM known as Modified
PEM was developed which offers a great flexibility in
the data requested from prescribers

6. How PEM is initiated
Here patient being prescribed monitored drug, which
include virtually all new chemical entities are studied
the criteria for study drug are:
NCE(New Chemical Entities)
New pharmacological Principle
Predicted wide spread use
Suspected problems
Identified for unquantified risks
Continued…..

7. Contd..
The information on the 1st 5000-18000
prescriptions for that drug are then obtained.
Prescribers are contacted with a questionnaire to
determine subsequent events or clinical
outcomes.
Experiences with the drugs can be examined and
the incidence of various events can be estimated.

8. Contd..
Collection of exposure data begins soon after the new
product is launched
For each patient in the study, DSRU prepares a
computerized longitudinal record in the date
order of drug use
After prescription to a patient, the DSRU sends the
prescriber a green form of questionnaire
Doctor receives maximum of 4 green forms in a month
The study period varies between 1 month to 12 months.

9. Statistical analysis
The number of events observed during the treatment
period in each individual patient is recorded and the
incidence density for each event is calculated using the
equation:
No of events during treatment period t
IDt = × 1000
No of patient-months exposed to drug
The incidence density is the measure of the
number of reports of each event per thousand patient
months of exposure to the drug.

10. Process of PEM
In UK, all the patients are registered with NHS-GP
which provides the primary care and act as a
gateway to specialist and hospital care.

11. The process of prescription event monitoringThe process of prescription event monitoring
Drug Safety
Research
Unit
Prescription
Pricing Authority
Electronic copies of prescriptions for
study drug sent to DSRU
Signal Generation,
Hypothesis
Testing,
Follow-up studies
General
Practitioner
PATIENT
DSRU sends Green
From to GP for details
of patient events
Prescription
sent to PPA
PHARMACY
Prescription for
new drug to
patient by GP
Green From
questionnaire sent back
to DSRU this is the
OUT COME DATA
Patient goes to
pharmacy

12. Green
form
for
PEM
study

13. Each green form is reviewed by a medical/
scientific officer monitoring the study, to identify
possible serious ADRs or events requiring action
Events are coded and entered in database

14. M-PEM
M-PEM expands the range of conventional PEM to
facilitate more targeted safety surveillance .
The questionnaires are designed to collect relevant
supplementary information in order to perform more
detailed exploration of specific safety issues.
The underlying process remains the same as in
conventional PEM

15. Advantages
1. PEM is non-interventional
2. The method is national in scale and thus
provides real world data
3. Method can detect adverse reactions or
syndromes that none of the reporting doctors
suspected to be due to the drug
4. Method allows close contact between the
research staff and reporting doctors
Contd…

16. 6. ADR reporting is more complete by this
method
7. Method is found to be successful in regularly
producing data in 10,000 or more patients
given newly marketed drugs
8. Method identifies patient with ADRs who can
be studied further
9. Allows comparison of safety profile of drugs
belonging to the same therapeutic group
10.Evaluate signals generated by other systems
or databases

17. Disadvantages
No method to determine non-prescription
medications
Non-return of green forms
Data collection is an operational difficulty

18. Applications
 Searching for signal
 Assessment of important AE
 Medically important events
 Reason for stopping the drug
 Ranking of ID and reason for withdrawal
 Automated signal generation
 Long latency adverse reactions
 Comparison with external data
 Outcomes of pregnancy

19. A PEM study to assess the safety profile of Garenoxacin in Indian settings
Anoop Hajare et al
Department of Medical Services, Glenmark Pharmaceuticals Ltd., Mumbai, Maharashtra, India
Introduction
Garenoxacin, a newer fluoroquinolone offers an excellent
spectrum of antimicrobial coverage, which includes
Gram-positive, Gram-negative, anaerobes and atypical
microorganism. This broad spectrum of activity is
attributed to its unique structure.
Methodology
Conducted between july 2013 and september 2013 .A
total of 400 doctors participated in the study.Data
from 12,498 patients was obtained.Monitoring of
each patient was done for any adverse events.
Results
Adverse events were reported in 159 patients
which included 0.5% cases with nausea/vomiting,
0.1% cases with diarrhea. Central nervous system
side-effects like drowsiness or dizziness was
reported in 0.02% of the cases. All the adverse
events were of mild to moderate severity and did
not require hospitalization
Conclusion
Garenoxacin a novel desfluoroquinolone appears
to be an ideal antimicrobial agent for the
treatment of various respiratory tract infections
including CAP. With superior safety profile,
excellent antimicrobial coverage and a convenient
once a day dosing garenoxacin appears to
improve the patient compliance
0.06
0.13
0.01
0.5
0.02 0.02
0
0.1
0.2
0.3
0.4
0.5
0.6
CNS side effects Diarrhea Dysgeusia Nausea and/or
Vomiting
Rash Abnormal LFT
Percentageofpatients
EVENTS

20. References
Website: htpp//www.dsru.org
R. D. Mann, Prescription event monitoring-recent progress
and future horizons, Drug safety research unit, Bursledon
Hall, Southamton, UK
Deborah et al, Modified Prescription-Event Monitoring
studies, A tool for Pharmacovigilance and risk
management, Drug safety research unit, Bursledon Hall,
Southamton, UK
Rumana Hameed, Prescription Event Monitoring, Slideshare
Satish Veerla, Prescription Event Monitoring and Record
Linkage System, Slideshare
A PEM study to assess the safety profile of Garenoxacin in
Indian settings, Anoop Hajare et al,Department of Medical
Services, Glenmark Pharmaceuticals Ltd., Mumbai, Maharashtra, India

21. Thank you!
For your kind attention