Pharmacovigilance: patient and community-centred approach

Pharmacovigilance: patient and community-centred approach Dr Socorro Escalante WHO Country Office for Vietnam Pharmacovigilance is not just about the number of ADR reports: it is for the safety of the public, the community and patient So what we want to know today? • • • • • What is pharmacovigilance What is the goal? Why it is important? The Role of the Hospital in PV? Why we need a safety network? What is Pharmacovigilance? WHO definition The sciences and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug related problem What is Pharmacovigilance? Medication Errors Adverse Drug Events Recognized Assessed Prevented Managed Quality Defects Disseminated What is Pharmacovigilance? Management and Response Point of Care Community What are the goals of PV? • Improve patient care and safety in relation to the use of medicines and all medical and paramedical interventions • Improve public health and safety in relation to the use of medicines • Contribute to the assessment benefits and risk of medicine & encourage safe, rational and more effective use of medicines • Promote understanding, education and clinical training in ADR monitoring and its effective communication to the general public Why PV? • Risks of medicines in the population – Minimize risks of adverse reactions • Medicinal products with uncertain safety – Monitor product safety • Unsafe practices – Promote safe usage by provider and consumers Why PV? Adverse drug reactions • Harmful and fatal • Occurs both at the community and hospital setting • Monitoring lead to long term outcomes: safety of individuals and general public Why PV? Adverse drug reactions: Examples • Bromfenac ( 1998) • Thalidomide (1965) • Phocomelia • Benoxaprofen (1982) • Liver necrosis • Practolol (1975) • Sclerosing peritonitis • Clioquinol (1970) • SMON (sub acute myelooptic neuropathy) • Terfenadine (1985) • Cardiac arrythmia • Hepatotoxicity • Encainide (1997) • Excessive mortality • Flosequinan (1993) • Excessive mortality • Mibefradil (1998) • Multiple interactions • Temafloxacin (1992) • Haemolytic anemia Why PV? Medication Errors: Drug-induced illness • Poor prescribing decision despite availability of clear evidence, • Dispensing & administration errors, • Poor compliance by patient leading to mis-usage, • The occurrence of previously unanticipated ADRs, which was not clearly predicted pre marketing trial Why PV? Medication Errors: Drug-induced illness • • • • • Right patient Right drug Right time Right dose Right route of administration Why PV? Quality Defects A deadly catastrophe due to warfarin contamination EPIDEMIC OF HAEMORRHAGIC DISEASE IN VIETNAMESE INFANTS CAUSED BY WARFARIN-CONTAMINATED TALCS • G Martin-Bouyer, P D Linh, L C Tuan, C Barin, N B Khanh, D Q Hoa, J Tourneau, H Guerbois and T V Binh Lancet, 321, issue 318, January 1983 – In August 1981, paediatric hospitals in Ho Chin Minh began reporting cases of haemorrhagic syndrome – 741 cases detected & 177 cases died – Warfarin concentration in talc : 1.7 – 6.5 % Why PV? Quality Defects Di-ethylene glycol poisoning - deadly recurring catastrophe due to contaminated cough mixtures • Recurring events – where and when the next ? • • • • • • • • • • • USA (1937)  over 100 deaths India (1986)  14 deaths Argentina (1992)  23 deaths Nigeria (1990) 47 deaths Bangladesh (1992) 236 deaths Haiti (1995)  89 deaths India (1998)  30 deaths China (2006)  20 deaths Panama (2006)  100 deaths Nigeria (2010)  84 deaths Common Pitfalls • Only focusing on the detection and reporting of (new ADRs), • Only relying on providers, • Lack of communication and feed back for prescribers & consumers to improve safe use, • Disconnect with regulatory system and health professionals The Role of the Hospital • Point of care-centred pharmacovigilance • Appropriate identification: immediate • Appropriate response: immediate Goal: SAVE HARM FROM THE PATIENT SAVE LIFE OF THE PATIENT The Role of the Hospital What will you do? Ignore it? Keep it? Appropriate response Assess and investigate Manage and withdraw Document and Inform Report to Management Report to NI-ADR Centre Report to DAV Source: Michael Khan, D.D.S http://ocw.tufts.edu/Content/51/lecturenotes/551485/551603 The Role of the Hospital Safety of patient is most important: Immediate response is critical The Role of the Community CONSUMER PURCHASE OF MEDICINES IS ACCOMPANIED WITH “ BANTAY GAMOT” FORM IF THE CONSUMER EXPERIENCES ADVERSE DRUG REACTIONS MAKE A REPORT BY USING HOTLINE: THE “BANTAY GAMOT FORM” 0928-4821045/09058100210 Return to designated drop points - Lim, 2008 Drugstores DTI San Pedro College- Pharmacy Dept BFAD (medicine regulatory authority) When is pharmacovigilance useful? • A number of ADR reports coming to your center everyday • Report sent to UPPSALA? Or • Patient is aware of ADR reactions and other events and knows to report them • Doctors are aware of ADR reactions and other events and is capable to treat and manage them • Medicines with safety issues are carefully given and monitored • Hospital and community monitor ADR, medication errors and other events from medicines • Reports are analyzed and sent to national regulatory authorities for action What needs to be done? What needs to be done? • Establish the national network of safety for medicines and pharmacovigilance • Ensure timely response and feedback systems • Comprehensive: involves community, hospital, PV centres and regulatory authorities What needs to be done? The Medicines Safety and PV Network The National DI-ADR Centre Regional Centre Regional Centre Regional Centre Hospital network Hospital network Hospital Network Community Community Community Way Forward Set-up the regional centre Set-up the hospital network Undertake training in hospitals Develop hospital-centred PV systems Establish community surveillance Thank you [...]... Report sent to UPPSALA? Or • Patient is aware of ADR reactions and other events and knows to report them • Doctors are aware of ADR reactions and other events and is capable to treat and manage them • Medicines with safety issues are carefully given and monitored • Hospital and community monitor ADR, medication errors and other events from medicines • Reports are analyzed and sent to national regulatory... detection and reporting of (new ADRs), • Only relying on providers, • Lack of communication and feed back for prescribers & consumers to improve safe use, • Disconnect with regulatory system and health professionals The Role of the Hospital • Point of care-centred pharmacovigilance • Appropriate identification: immediate • Appropriate response: immediate Goal: SAVE HARM FROM THE PATIENT SAVE LIFE OF THE PATIENT. .. of the Hospital What will you do? Ignore it? Keep it? Appropriate response Assess and investigate Manage and withdraw Document and Inform Report to Management Report to NI-ADR Centre Report to DAV Source: Michael Khan, D.D.S http://ocw.tufts.edu/Content/51/lecturenotes/551485/551603 The Role of the Hospital Safety of patient is most important: Immediate response is critical The Role of the Community... What needs to be done? What needs to be done? • Establish the national network of safety for medicines and pharmacovigilance • Ensure timely response and feedback systems • Comprehensive: involves community, hospital, PV centres and regulatory authorities What needs to be done? The Medicines Safety and PV Network The National DI-ADR Centre Regional Centre 1 Regional Centre 2 Regional Centre 2 Hospital... decision despite availability of clear evidence, • Dispensing & administration errors, • Poor compliance by patient leading to mis-usage, • The occurrence of previously unanticipated ADRs, which was not clearly predicted pre marketing trial Why PV? Medication Errors: Drug-induced illness • • • • • Right patient Right drug Right time Right dose Right route of administration Why PV? Quality Defects A deadly... Guerbois and T V Binh Lancet, 321, issue 318, January 1983 – In August 1981, paediatric hospitals in Ho Chin Minh began reporting cases of haemorrhagic syndrome – 741 cases detected & 177 cases died – Warfarin concentration in talc : 1.7 – 6.5 % Why PV? Quality Defects Di-ethylene glycol poisoning - deadly recurring catastrophe due to contaminated cough mixtures • Recurring events – where and when