Adherence to long term therapy and Pharmacovigilance Dr H. Sefiani CAPM hsefiani@gmail.com
«patients often dissemble when they say they've taken their medecine» Hippocrate «improve patient adherence to long-term therapy should be more beneficial than any biomedical discovery» OMS Adherenceto long-termtherapies. Evidence for action.2003. 2
The recovery of chronic disease is rare, then it s difficult for patient to accept his disease and, therefore, to accept a long-term treatment. 3
Clinical case Woman 44 years old, pulmonary tuberculosis PIT Followed in the National TB program Medication: ERIP K4, 4 tablets per day for 2months After 3 weeks : Disabling peripheral neuropathy Contact Pharmacovigilance Centre Laboratory analysis: INH 3.1ug / l (overdose) See doctor to adjust here dose Ask for appointement 15 days later 4
Clinical case Self medication: zyloric (Brother treatment) Physician decision: Extend refusal of sick leave Refusal to change treatment The patient took 3 tablets instead 4 during the last 10 days: incorrect dose 10 days more of treatment 5
Adverse event?? Drug Neuropathy Incorrect dose Therapeutic failure Self medication No harm 6
Adverse eventtype? Adverse drug reaction?? Medication Error?? A failure in the treatment process that leads to, or has the potential to leadto, harm to the patient. National Patient safety Agency UK Problem of adherence?? «the extent to which a person s behaviourtaking medication, following a diet, and/or executing lifestyle changes, corresponds with agreed recommendations from a health care provider» Rand CS. Measuring adherence with therapy for chronic diseases American Journal of Cardiology, 1993, 72:68D-74D.
Adverse Drug Reaction Medication Error Low Adherence 8
9
Adherence compliance Compliance suggests yielding, complaisance and submission Adherence requires the patient s agreement to the recommendations Low adherence may be unintentional or intentional 10
Adherence to treatment Primary determinant of the effectiveness of treatment key link between process and outcome in medical care Low-adherence can lead to adverse event Adverse event can lead to Low adherence The scope of pharmacovigilance should be extend to adherence to treatment 11
Categories of factors identified from the literature review Factors affecting therapeutic adherence: A review from the patient s perspective; Jing Jin Therapeutics and Clinical Risk Management 2008:4(1) 269 286 12
Deteminents of therapeutic adherence Knowledge Patient Beliefs motivation attitude Therapy Route of administration Adverse Event Complexity Health care system Availability The Relationship Severity Disease symptoms Adherence Social and economic Cost Social suport Impact 13
Impact Individual Risk of complications Risk of developing AE More severe relapses Infectious risk entourage (Infectious Diseases) Loss of confidence in the health system Community Increased morbidity Increase health care cost credibility of health programs Work Stoppages 14
Which adverse reaction can lead to low adherence? Unexplained Severe Symptomatic on silent disease impact Quality of life Psychologic Social Economic 15
Exemples Dry cough with ACE inhibitors Dry mouth and tremors with antidepressants Weight gain with steroids Muscle aches with statins 16
Low adherence can lead to which Therapeutic failure Drug resistance Misuse Overdose adverse event? 17
Adherence to enhance patient safety Educate healthcare professionals Explain to the patient Optimize and simplify the prescription Verify adherence level Identify individuals risk surround better 18
Conclusion Key to therapy success Patient is not solely responsible Some factors can be anticipated and controlled Part of pharmacovigilance scope Underestimated Detected from ICSR?? 19
Thankyou 20