Prescription event monitorig


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Prescription event moitoring

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Prescription event monitorig

  1. 1. Prescription Event Monitoring (PEM) Arvind Nag. K, ABMRCP, Bangalore. India Dr. Arvind Nag. K
  2. 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. 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. 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. 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 & 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. 6. <ul><li>In one such study conducted by MARC, a Cohort of 3926 patients taking perhexiline & 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% & 43%, for each drug, respectively. </li></ul>Dr. Arvind Nag. K
  7. 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. 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 & relative frequency of the events reported when these drugs are used in general practice </li></ul>Dr. Arvind Nag. K
  9. 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. 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 & 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. 11. <ul><li>Thank You </li></ul>Dr. Arvind Nag. K