Prescription event monitoring

PEM a step towards safe and effective use of drugs

1. NATIONAL INSTITUTE OF PHARMACEUTICAL EDUCATION AND RESEARCH Prescription Event Monitoring (PEM) Presented By: Rayaz Ahmad Bhat Deptt . Of Pharmacy Practice Roll No. 01 Batch: 2016-18

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 1 st 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 ID t = × 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 monitoring The 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 PEM is non-interventional The method is national in scale and thus provides real world data Method can detect adverse reactions or syndromes that none of the reporting doctors suspected to be due to the drug Method allows close contact between the research staff and reporting doctors Contd …

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

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