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Prescription event monitorig
Prescription event monitorig
Prescription event monitorig
Prescription event monitorig
Prescription event monitorig
Prescription event monitorig
Prescription event monitorig
Prescription event monitorig
Prescription event monitorig
Prescription event monitorig
Prescription event monitorig
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Prescription event monitorig

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Prescription event moitoring

Prescription event moitoring

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  • 1. Prescription Event Monitoring (PEM) Arvind Nag. K, ABMRCP, Bangalore. India Dr. Arvind Nag. K
  • 2. Definition <ul><li>A non interventional cohort technique, which involves health professionals submitting data on all clinical events reported by a patient subsequent to the prescribing of a new drug </li></ul><ul><li>It is a method of studying the safety of new medications that are used by general practitioners </li></ul>Dr. Arvind Nag. K
  • 3. <ul><li>It was first started in the UK after Practolol was found to cause the Oculomucocutaneous syndrome, which could not be detected from the spontaneous reporting which was already in place </li></ul><ul><li>In New Zealand, the medicines adverse reactions committee (MARC) is responsible for conducting such studies for academic purposes and the programe is known as the Intensive medicine monitoring programe (IMMP). </li></ul>Dr. Arvind Nag. K
  • 4. <ul><li>Here patients being prescribed monitored drugs, which include virtually all New Chemical Entities are studied. The criteria for study drug are: </li></ul><ul><li>NCE </li></ul><ul><li>New Pharmacological Principle </li></ul><ul><li>Predicted wide spread use </li></ul><ul><li>Suspected problems </li></ul><ul><li>Identified but unquantified risks </li></ul>Dr. Arvind Nag. K
  • 5. <ul><li>The Information on the 1 st 5000-18000 prescriptions for that drug are then obtained. </li></ul><ul><li>Prescribers are contacted with a questionnaire to determine subsequent events or clinical outcomes </li></ul><ul><li>Experiences with the drugs can then be examined and the incidence of various events can be estimated </li></ul><ul><li>Comparisons are made between periods before &amp; after drug use </li></ul><ul><li>e.g.: The occurrence of Jaundice with Erythromycin Estolate was found be such method of study </li></ul>Dr. Arvind Nag. K
  • 6. <ul><li>In one such study conducted by MARC, a Cohort of 3926 patients taking perhexiline &amp; 2837 taking labetolol, 25% of all patients discontinued taking their drug under the study. </li></ul><ul><li>ADRs were the reason for stopping in 20% &amp; 43%, for each drug, respectively. </li></ul>Dr. Arvind Nag. K
  • 7. <ul><li>PEM provides clinically useful information because it establishes </li></ul><ul><li>Numerator = No. of reports of each event </li></ul><ul><li>Denominator = No. of patients exposed to the drug </li></ul><ul><li>A definite time frame = The period of treatment for each patient </li></ul><ul><li>From these data, Incidence densities are calculated for all events reported during the treatment with the monitored drug </li></ul>Dr. Arvind Nag. K
  • 8. <ul><li>These Incidence Densities/Incidence rates are ranked in order of frequency </li></ul><ul><li>These ranked lists indicate both the nature &amp; relative frequency of the events reported when these drugs are used in general practice </li></ul>Dr. Arvind Nag. K
  • 9. Advantages <ul><li>If suitable care is taken, the data permit assessment of the nature of any apparent association between the events as recorded and the drug exposure </li></ul><ul><li>They also permit a useful degree of comparison between drugs of the same therapeutic class </li></ul><ul><li>It provides estimates of incidence of events over a defined follow up period </li></ul>Dr. Arvind Nag. K
  • 10. Disadvantages <ul><li>The is limited to those from a specific place only </li></ul><ul><li>The percentage of non respondents (i.e. 30% - 50%) is large &amp; it is difficult to establish whether these doctor’s patients are different from those whose doctors responded </li></ul><ul><li>Confounding by indication may also pose a problem </li></ul>Dr. Arvind Nag. K
  • 11. <ul><li>Thank You </li></ul>Dr. Arvind Nag. K

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