1. PRESENTER;Maganga M.Gabriel(Pharmacist) Pharmacy Department (drug inf &Emer)

2. Presentation outline Definition of medication error Pharmacovigilance overview The different types of medication errors Factors that can contribute(cause) to medication errors The suggested ways of reducing medication errors

3. Definitions A Medication error (ME) is any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of health professional, patient or consumer. (US National Coordinating Council for Medication Error Reporting and Prevention)

4. Definition of Medication Error An error in prescribing, dispensing or administering of a drug, irrespective of whether such errors lead to adverse consequences or not

5. Pharmacovigilance overview

6. 6 Why do we need pharmacovigilance ? Will PV prevent these?

7. 7 What is Pharmacovigilance? The science and activities relating to the detection, evaluation, understanding and prevention of adverse drug reactions (ADR) or any other drug-related problems (WHO, 2002)

8. Pharmacovigilance (PV or PhV), also known as Drug Safety, is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products.(wikipedia) pharmakon (Greek for drug),and vigilare (Latin for to keep watch).

9. 9 The Goal of Pharmacovigilance and Medicines Safety The goal of Pharmacovigilance is to safeguard public health and improve rational medicines use.

10. 10 Aims of Pharmacovigilance A.To identify/quantify New adverse drug reactions (ADRs) Risk factors/populations at risk Increase in frequency of known ADRs B.Detect Drug interactions with other drugs administered concomitantly

11. 11 Aims of Pharmacovigilance cont.. C.To monitor ADR profile of medicines within therapeutic class the safety profile of medicines during their whole life cycle To contribute to good clinical practice in pharmacotherapy To prevent patients from unnecessary harm.

12. 12 Pharmacovigilance From Historical Perspective Drugs’ potential for harm has been recognized very early. In 1937 a sulfonamide elixir containing over 70% of diethylene glycol (DEG) was given to over 300 patients in US. → 105 deaths (34 children) due to renal failure.

13. Growing awareness of the importance of ADRs in pharmacotherapy since the Thalidomide tragedy 1961 phocomelia in babies born to mothers treated with thalidomide while pregnant (>470 babies in one year in Germany alone). In 1970 Inman discovered the causal relationship between thromboembolic disease and high dose oestrogen oral contraceptives.

14. 14 16th World Health Assembly 1963 Assembly Resolution 16.36 - Clinical and Pharmacological Evaluation of Drugs INVITES Member States to arrange for a systematic collection of information on serious adverse drug reactions observed during the development of a drug and, in particular, after its release for general use.

15. 15 Pharmacovigilance History... International community response 1968 the WHO International ADR monitoring programme was founded. In 1971, WHO international ADR database was established Tanzania joined the program in 1993

16. 16 WHO Collaborating Centre for Drug Monitoring DRUG SAFETY MONITORING BY THE TFDA Pharmaceutical industry Kilimanjaro KCMC Mbeya MRH Muhimbili MNH Bugando BMC PATIENT HEALTH PROFESSIONNALS

18. Medication Errors… ME may be related to professional practice, products, procedures, working environment or systems. They may occur at any stage during : Prescribing (doctor) Dispensing (pharm) Administration of medicines. (Nurse etc) Use of medicines by patients.

19. Prescribing Errors cont… Prescribing errors may be described as incorrect medicine selection (not indicated or contraindicated), wrong dose or quantity for a patient.

20. Prescribing Errors cont.. Example: Prescribing adult dose to a child Prescribing medication for a prolonged duration Prescribing antimicrobials for viral diseases Prescribing contraindicated medicines eg. Prescribing zidovudine to anaemic patients

21. Dispensing Errors May occur at any stage of dispensing process, from the receipt of the prescription to issuing medicine to the patient. The errors may include: Selection of the wrong strength or product. For example Amiloride 5mg instead of Amlodipine 5 mg tablets. Dispensing wrong dose Dispensing medicines to wrong patient.

22. Administration Errors:  May occur when there is difference between the medicine or dose received by the patient and what was prescribed. Examples  Medicine given to the wrong patient

23. Administration Errors cont…  Wrong medicine or IV fluid administered  Wrong dose or strength given-Overdosing or underdosing  Wrong dosage form given  Medicine given for wrong duration

24. Administration Errors cont…  Wrong preparation of a dose (e.g. Incorrect dilution)  Incorrect administration technique (e.g., unsterile injection)

25. Administration Errors:  Medicine given to a patient with known allergy  Wrong route of administration use  Wrong time or frequency of administration  Wrong administration duration

26. Medication Error at Patient Level  This may occur when a patient fails to follow treatment instructions. Lack of adherence Overdose

27. What are causes of Med errors?

28. Too many telephone calls ? Overload/ unusually busy day ? Too many customers ? Lack of concentration ? No one available to double check ? Staff shortage ? Similar drug names ? No time to counsel ? Illegible prescription ? Misinterpreted prescription

29. 29 Possible Causes classified…. Human Factors Errors in interpreting prescriptions(abbreviations etc), Illegible handwriting, lack of experience, lack of training, poor handwriting, verbal orders, heavy staff workload and fatigue,(errors in calculations?) Workplace factors Poor lighting, Interruptions, Excessive workload Pharmaceut ical factors, confusion of medicine names, packaging, or labeling,, complexity of calculations needed to prescribe, dispense, or administer a medicine,

30. Problem: Look alikes medicines from same company (falls under which factor?)

36. Example: Poor handwriting (falls under which factor?) 36

37. Easy to read…

38. Difficult to read

40. Difficult to read..

41. handwriting

42. Fluid not understood ….

43. What is that insulin type ?

44. Required to apply indomethacin?

45. Piroxicam frequency?

46. ……………………?

47. Meloxicam,…..?

48. Extremely …..

49. ………………?

51. Same drug family

52. Medication Errors - Implications What are the consequences of medication errors?

53. Medication Errors - Implications  1.Therapeutic failure – Increased Morbidity – Prolonged hospital stay – Mortality

54. Medication Errors - Implications  2.Economic consequences – Wasted resources – Increased cost of care, prolonged hospital stay – Loss of man hours/ absenteeism  3.Adverse Drug Reactions

55. Ways of reducing medication errors Enhance communication(landl ines, mobiles Supervise, develop SOP, guidelines(seniors to supervise Juniors Adhere to quality improment programs Other ways………? Let us Report ADR,s

56. Take Home Messages Medication errors are one of the most preventable causes of patient injury although the incidence of such errors varies widely. The majority of medication errors occur as a result of poor prescribing, emphasizing the need to improve prescribing skills. A non-punitive approach should be adopted to improve the rate of reporting of medication errors, allowing further investigation of these important causes of preventable patient harm 56

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