Tiêu đề 12. PRESCRIPTION EVENT MONITORING.pdf ✅

PHARMD GURU Page 1 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. EVOLUTION OF PRESCRIPTION EVENT MONITORING:  Pre-marketing clinical trials are effective in studying the efficacy of medicine but are not able to define many aspects of drug safety because: a) Small no of patients. b) Large no of patients receiving the drug for small durations. c) Doses and formulations of the drug may change during drug development. d) Exclusion of special population from the clinical trials.  The contribution of spontaneous reporting system in detecting hazards such as oculomucocutaneous syndrome with Practolol led to establish the system of Prescription event monitoring at DSRU.  In New Zealand, the medicines adverse reaction committee (MARC) is responsible for conducting such studies for academic purposes and the program is known as Intensive medicine monitoring program (IMMP). PRESCRIPTION EVENT MONITORING PROCESS IN UK:  DSRU (Drug safety research unit) makes the decision to carry out PEM studies for a new drug.  This information is conveyed to PPA (Prescription pricing authority).  If a patient comes to the pharmacy with prescription of the drug of interest (drug we are conducting PEM), then the information is sent to PPA  Electronic copies of that prescription forwarded to DSRU  DSRU prepares a longitudinal record for each of the patient, which comprises date- wise order.  From the date of the first prescription, Green form questionnaire are sent to the prescribing physician, for getting information on any event, which may have occurred since the drug was first prescribed. PRESCRIPTION EVENT MONITORING
PHARMD GURU Page 2  In any month, not more than 4 green form questionnaires are sent to one physician.  These green forms are sent back to the DSRU by the physician.  The DSRU uses the information sent by physicians about the drug of interest, for signal generation, Hypothesis testing and follow-up studies etc. PRESCRIPTION EVENT MONITORING PROCESS: FOLLOW-UP DATA FROM QUESTIONNAIRE ENTERED ON DSRU DATABASE GP RETURNS QUESTIONNAIRE TO DSRU: SCANNED; REVIEWED DSRU SENDS QUESTIONNAIRE (GREEN FORM) TO GP PPA SENDS PRESCRIPTION DATA TO DSRU IN STRICT CONFIDENCE PHARMACIST DISPENSES DRUG AND FORWARDS PRESCRIPTION TO PPD FOR REIMBURSEMENT PURPOSES PATIENT TAKES PRESCRIPTION TO PHARMACIST DSRU NOTIFIES PPA OF NEW DRUG TO BE STUDIED SPECIAL EVENTS: QUESTIONNAIRE SENT TO GP DEATHS: CAUSE OF DEATH PREGNANCIES: QUESTIONNAIRE SENT TO GP FOR OUTCOME
PHARMD GURU Page 3 ADVANTAGES:  Calculation of incidence density.  Carried out on a national scale.  Comparison of 'reasons for withdrawal' and incidence density.  Outcome of exposed pregnancies.  Signal generation and exploration.  Delayed reactions can be detected.  Disease investigation. DISADVANTAGES:  No method of measuring compliance.  No method to determine the non-prescription medication.  Non-return of green forms.  Does not extend to hospital monitoring.  Data collection is an operational difficulty.