Pharmacovigilance – quality assurance of pharmaceutical management in healthcare
Sten OlssonWHO Programme Expert
Uppsala Monitoring CentreSweden
Pharmaceuticals
Among the most important health interventions in any healthcare
system
Getting value for money
Medicines
• Efficacious• Good
quality• Safe
Healthcare professionals
• Competent• Dedicated• Quality
conscious
Healthcare delivery system
• Well managed• Effective, safe
processes
Measuring lack of performance
Medicines
• Efficacious• Good quality
• Safe
If suboptimal
Lack of effect
Lack of effect or toxicityAdverse reactions
Measuring lack of performance
Healthcare professionals
• Competent• Dedicated• Quality
conscious
If suboptimal
Lack of effect
Adverse reactions
Medication errors
Measuring lack of performance
Healthcare delivery system
• Well managed• Effective, safe
processes
If suboptimal
Lack of effect
Adverse reactions
Medication errors
Pharmacovigilance WHO definition
The science and activities relating to thedetection, assessment, understandingand prevention of adverse effects or any other possible drug-related problems
The importance of pharmacovigilance, WHO, 2002
Pharmacovigilance
Adverse Reactions
• Properties of drug and patient • Pharmacologic• Hypersensitivit
y• Other
Unexpected lack of effect
•Inadequate quality•Failing GMP, distribution, storage etc.•SSFFC•Antimicrobial resistance•Inadequate use
Medication errors
•Inadequate use•Human factors•Failing health systems
No, not necessarily
• All medicines have adverse reactions
• All human beings make mistakes
• All systems fail occasionally
We get very few reports of medicine related harm from healthcare –
does it show that we have a high-quality healthcare system?
European Union
• Hospital admissions due to ADR5%
• Hospitalized patients suffering an ADR5%
• Most common cause of death5th• Deaths per year197 000
• Cost to society /year €79 billionRef. Report to European Commission Sept 2008
• 2% of outpatients had preventable ADRs• 52% of ADRs were preventable
• 1.6% of inpatients had preventable ADRs• 45% of ADRs were preventable
2012
If we don’t find adverse reactions, medication errors or unexpected lack of effect
It just means that we are not looking well enough
We are not vigilant
Our pharmacovigilance system is not working
High-quality healthcare delivery systems
• Encourage reporting of ADRs, errors and unexpected lack of effect
• Is non-punitive• Analyse underlying reasons (root-cause)• Learn from mistakes• Provides feed-back for continous
improvement of practices• Prevent harm to future patients
Good models exist
Aqeela Taqi Lawati & Nibu Nair
Sultan Qaboos University HospitalMuscat, Oman
Examples from Sultanate of Oman
Number of ADR reports/million inhab/year 2007 – 2012 as reported to WHO/VigiBase™
Contribution from Sultan Qaboos University Hospital
Support from WHO
Why pharmacovigilance indicators?
• Measure status of pharmacovigilance system
• Able to identify strengths, weaknesses, achievments, growth, impact
• Return on investments in PV
Classification
• Structure – qualitative - yes/no
• Process• Output/impact
• Specific indicators for Public Health Programmes
Core structural indicators
Existance of :1. A PV centre with a standard accommodation?2. A statutory provision for PV? (legislation, policy)3. A Drug Regulatory Authority/Agency4. A regular financial provision for the PV centre?5. Human resources to carry out its functions properly?6. A standard ADR reporting form?
– 4 subset indicators
7. A process in place for collection, recording and analysis of ADRs?8. Is PV included in national curriculum of schools for health care
professionals?9. A newsletter/information bulletin/website for PV information
dissemination?10. A national ADR or PV advisory committee or expert committee in
the setting?
Core process indicators (Tot 9)1. Total number of ADR reports received last calender year2. Total number of reports in national/local database3. Percentage of total annual reports acknowledged4. Percentage of reports subjected to causality assessment in
the year5. Percentage of national reports satisfactorily completed and
submitted to NC last yeara) Submitted to WHO
6. Percentage of reports on therapeutic ineffectiveness7. Percentage of reports on medication errors8 Percentage of registered MAH having functional PV system9 No of active surveillance activities initiated, ongoing or
completed the last 5 years
Core outcome/impact indicators1. No of signals identified by PV centre the last 5 years2. No of regulatory actions taken last year based on national
data– Label change– Safety warning– Medicine suspension/withdrawal/other restrictions
3. Number of medicine related hospital admissions/1000 admissions
4. No of medicine related deaths/1000 persons served by hospital
5. No of medicine related deaths/ 100 000 in the population6. Average cost of treatment of medicine-related illness7. Average duration of extension of medicine-related hospital
stay8. Average cost of medicine related hospitalization
Conclusion
Pharmacovigilance is the system by which the pharmaceutical management in any healthcare setting is being quality assured
Through pharmacovigilance indicators the appropriateness of the pharmacovigilance system can be measured
The ultimate goal is to minimize the occurrence of preventable medicine-related harm to patients
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