Reporting and Management of Adverse Drug Reaction

Reporting and Management of Adverse Drug Reactions.
Pharmacy Practice
Semester 7, B. Pharm
Soniya M. Sunil
Mar Dioscorus College of Pharmacy, Trivandrum.

1. ADVERSE DRUG REACTIONS

2. CONTENTS Reporting of adverse drug reactions. Management of adverse drug reactions.

3. ADVERSE DRUG REACTIONS According to WHO, an adverse drug reaction is defined as, “A response which is noxious and unintended, and which occurs at doses normally used in humans for the prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological function.”

4. WHY ADR REPORTING? ADR are among the leading causes of death in many countries ( according to WHO 2008 ). Constitutes a significant economic burden on the patient and government.

5. BENEFITS OF ADR REPORTING Assess the safety of drug therapies. Provides updated drug safety information to health care professionals and other stake holders. Measuring the economic impact ADR prevention. Regulatory action on the basis of ADR reports to ensure patients safety.

6. WHO CAN REPORT? All health care professionals like clinicians, dentist, pharmacists, nurses etc. All non – healthcare professionals including patients can also report.

7. WHAT TO REPORT ? Serious and life threatening reactions like anaphylaxis. Fatal reactions. Reactions that results in disabilities. Rare and uncommon adverse drug reactions. Any reactions to newer drugs.

8. ADR REPORTING PROCESS HEALTHCARE PROFESSIONALS PERIPHERAL CENTRES REGIONAL CENTRES ZONAL CENTRES Central Drugs Standard Control Organisation(CDSCO) WHO / UMC

9. ADR REPORTING FORM Patients demographic details. Prescriber's details. Suspected drugs. Date of drug administration started and stopped. Date of ADR started. Brief description of reaction. Name and address of reporting centre with reporting date.

10. HOW TO REPORT? Report should be on a standard ADR reporting form. Duly filled the ADR’s in the reporting form when an ADR is encountered. Use a separate form for each patient and filled with complete information. The completed ADR form is then returned to the nearest Adverse drug reaction Monitoring office ( AMC ) or the National Coordinating Centre. Any follow up information for an ADR case that has already been reported can be sent on another ADR form, or communicated by telephone, fax or email. Follow up reports should be identifiable and the following should be indicated on the report. Follow up information. Date of original report. Patient identity should be recorded.

11. DIFFERENT APPROACHES FOR ADR REPORTING Various approaches for ADR reporting are :- Cohort study – This study involves short term and long term clinical trials and post marketing surveillance of established and new drug. Also known as longitudinal study or forward looking study. Cohorts are identified prior to appearance of disease under investigation. The study groups are observed over a period of time to determine the frequency of disease among them. FRAMEWORK OF COHORT STUDY COHORT POPULATION EXPOSED UNEXPOSED DISEASED NON-DISEASED DISEASED NON-DISEASED

12. SPONTANEOUS REPORTS of suspected adverse drug reaction occurs when prescribers report suspected reaction to investigator agency. Passive surveillance system. The process includes :- Data acquisition – which depends largely on the input information derived from reports submitted by the health professionals who have encountered what they suspect is an ADR. Data assessment – which involves assessment of the individual case reports and assessment of pooled data obtained from various sources such as the international database of the WHO. Data interpretation – based on the available data and the assessments made, a signal related to the adverse reaction may be generated.

13. REVIEW OF VITAL STATISTICS –regular review of national and regional vital statistics. CASE CONTROL STUDIES – patients with suspected drug induced diseases are compared with a reference population. It is a retrospective study. A case – controlled study is an observational study in which subjects are sampled based upon presence or absence of disease and then their prior exposure status is determined. BASIC STEPS – Selection of cases and control. Matching. Measurement of exposure and Analysis and interpretation. ADVANTAGES – Efficient for the study of rare diseases. Efficient for the study of chronic diseases. DISADVANTAGES – Risk of diseases cannot be estimated directly.

14. MANAGEMENT OF ADR

15. HOW TO MANAGE ADR? The main and primary in management is withdrawal of suspected drugs. However, in case the reaction is expected to be dose related, then dose of the drug must be reduced, and treatment of suspected reaction must be considered. When an ADR reaction is managed, clear therapeutic objective must be maintained. The drug treatment must not be unnecessarily continued for longer time period and the patient must be reviewed regularly and simplify management should be followed. Following steps must be followed during the management of any type of suspected, or unexpected ADR :- Monitoring patient who are at greater risk of developing ADR. Monitoring patients who are prescribed with drugs highly to cause ADR. Assessing and documenting the patients previous allergic status. Changing the dose of drugs. Replacement with alternate medicine. Obtaining feedback about the reported reaction. Educating patients. Conducting workshops/seminars on ADR for healthcare professionals.

16. THANK YOU SUBJECT – PHARMACY PRACTICE NAME – SONIYA M. SUNIL SEMESTER – 7 MAR DIOSCORUS COLLEGE OF PHARMACY