1. M ONITORING A DVERSE D RUG R EACTIONS (ADR S ) Dr. Dorothy Aywak 1

2. O UTLINE Definition of ADR Burden of ADR Reporting of ADR ADR encountered in KNH Challenges in reporting. 2

3. I NTRODUCTION Pharmacovigilance (PV) From Greek words: pharmakon (drug) vigilare (keep alert) Adverse drug reaction (ADR) - an appreciably harmful or unpleasant reaction, resulting from an intervention related to the use of a medicinal product. Adverse Event (AE)- unpleasant reaction following use of medicinal product, however no causal relationship. 3

4. “Drugs are double edged weapons” They do good but can also kill! 4

5. “Some remedies are worse than the disease” Publilius Syrus, Roman writer, 1 st century BC Thalidomide disaster 1960’s Phocomelia Eastern Province Kenya-2009 5

6. B URDEN OF ADR In Australia, ADRs account for 2.4-3.6% of all hospital admissions. Leading cause of morbidity and mortality 4-6 th largest in the USA In Kenya, ADR reporting has increased since setting up of the Pharmacovigilance department. In 2011, PPB received 1490 ADR reports ( 79% ART related,5% Antimalarial, 3% Anti-TB) In 2012, 3945 ADR reports (93% ART related) 6

7. Adverse Drug Reaction (ADRs) can be avoided at EVERY STAGE (diagnosis, prescribing, dispensing and administering)… including very early stages! 7

8. ADR R EPORTING IN KNH PV CME conducted in various departments within KNH. Medicine Paediatrics Pharmacy PPB ranked KNH among top 10 in reporting (The Lifesaver, Dec 2012). 8

9. Report all suspected adverse reactions to: - allopathic (modern) medicines, - traditional / alternative / herbal medicines, - x-ray contrast media, - medical devices and cosmetics. - “Yellow form” ADR reporting form 9

10. P ATIENT A LERT C ARD Issued based on criteria Informs clinician of past ADR experience in patient Prevents same or similar ADR in future Patient to carry card at all times! 10

11. KNH CASE REPORT : P HENYTOIN Class: anticonvulsant Uses :  most types of seizure disorders and status epilepticus  Antiarrhythmic agent, especially of dysrhythmias due to digoxin toxicity.  Prevent and treat seizures during and after neurosurgery and head injury. 11

12. ADR REPORTED August 2013, 4 ADR reports received from surgical ward, following Phenytoin IV administration. Description of reaction: Extravasation Cardiotoxicity (hypotension, cardiac arrhytmias) 12

13. G ENERAL A DVERSE EFFECTS OF PHENYTOIN Depend on the route of administration, duration, exposure, and dosage. Hypersensitivity, headache, dizziness, tremor, insomnia, GI disturbances Hyperplasia of the gums, acne, hirsutism, coarsening of the facial features, osteomalacia, local irritation or phlebitis. Prolonged use may produce subtle effects on mental function and cognition, especially in children. Potentially Fatal: Toxic epidermal necrolysis, Stevens-Johnson syndrome. 13

14. A DVERSE EFFECTS RELATED TO ADMINISTRATION Phenytoin administered intravenously at a rate higher than 50 mg/min may cause hypotension and cardiac arrhythmias and impaired cardiac conduction. Orally administered phenytoin is rarely, if ever, associated with cardiac toxicity. Extravasation of the IV solution may cause skin irritation or phlebitis since the solutions are very alkaline. E.g. purple glove syndrome 14

15. E XTRAVASATION, PURPLE GLOVE SYNDROME 15

16. C HALLENGES IN REPORTING ADR Staff constraints Fear of victimization Lack of awareness 16

17. T HANK Y OU “You need not be certain… Just be suspicious” Report all suspected ADRs and Poor Quality Medicines to PPB 17