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

Thank you for your attention!

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