23
IBE J. Hasford Munich Bridging the Gap - Research into Practice Prof. Joerg Hasford, M.D., Ph.D. German Pharmacovigilance Study Group IBE Department of Medical Informatics, Biometry and Epidemiology, University of Munich, Germany Email: [email protected] muenchen.de Pharmacovigilance Research and Patient Safety Policies

Bridging the Gap - Research into Practice

  • Upload
    remy

  • View
    46

  • Download
    0

Embed Size (px)

DESCRIPTION

Bridging the Gap - Research into Practice. Pharmacovigilance Research and Patient Safety Policies. Prof. Joerg Hasford, M.D., Ph.D. German Pharmacovigilance Study Group IBE Department of Medical Informatics, Biometry and Epidemiology, University of Munich, Germany - PowerPoint PPT Presentation

Citation preview

Page 1: Bridging the Gap - Research into Practice

IBEJ. Hasford

Munich

Bridging the Gap -Research into Practice

Prof. Joerg Hasford, M.D., Ph.D.

German Pharmacovigilance Study Group

IBE Department of Medical Informatics, Biometry and Epidemiology, University of Munich, Germany

Email: [email protected]

Pharmacovigilance Research and Patient Safety Policies

Page 2: Bridging the Gap - Research into Practice

IBEJ. Hasford

Munich

Frequency of ADR-related Hospital Admissions

Meta-Analysis of 25 publications covering medical departments

Median (all): 5.8%

Median (age > 60): 10.2%

Mühlberger N, Schneeweiss S, Hasford J. Pharmacoepidem Drug Safety 1997; 6 Suppl. 3: S71-S77.

Page 3: Bridging the Gap - Research into Practice

IBEJ. Hasford

Munich

Direct Costs of ADR-related Hospital Admissions in Germany

• 4.5 Mio Admissions to Medicine Departments / year

• 5.8% due to ADR• 8.7 days median length of stay• 310 € costs per day in hospitals (2000)

704,000,000 € / year

Page 4: Bridging the Gap - Research into Practice

IBEJ. Hasford

Munich

Preventability of ADRs

Meta-Analysis of 14 publications

Goettler M, Schneeweiss S, Hasford J. Pharmacoepidem Drug Safety 1996;6 Suppl.3:S79-S90

30.7% (median) of ADRs leading to hospital admission are preventable.

Page 5: Bridging the Gap - Research into Practice

IBEJ. Hasford

Munich

Pharmacovigilance

The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.

WHO

Page 6: Bridging the Gap - Research into Practice

IBEJ. Hasford

Munich

Pharmacovigilance

collects, records, codes ADEs / ADRs

analyses and assesses the reports

promotes the safe use of drugs

creates appropriate structures and means of communication needed to perform its tasks

Page 7: Bridging the Gap - Research into Practice

IBEJ. Hasford

Munich

Aims of Pharmacovigilance

to improve patient care and safety to improve public health and safety to contribute to the assessment of benefit, harm,

effectiveness and risk of medicines to promote education and clinical training to promote effective communication to the public to promote rational and safe use of medicines

Page 8: Bridging the Gap - Research into Practice

IBEJ. Hasford

Munich

Safe Use of Drugs ?Antibiotics use in pregnancy in Germany 2000/2001

Actions in Germany: None

Tetracyclines count among the 10 most prescribed antibiotics during pregnancy (1/1000 pregnant women).

It is well known for more than 30 years that tetracyclines can severely damage teeth and bone structures of the fetus.

Page 9: Bridging the Gap - Research into Practice

IBEJ. Hasford

Munich

Safe Use of Drugs ?

The Case of digitoxin-intoxication

Actions in Germany: None

Intoxications with digitoxin count still among the most common causes of ADR-related hospital admissions (12 - 14/10,000 / quarter year).

The therapeutic benefit of digitoxin is rather limited, however.

Hippius M et al. Int J Clin Pharmacol 2001;39:336-343.

Page 10: Bridging the Gap - Research into Practice

IBEJ. Hasford

Munich

Safe Use of Drugs ?The case of long acting beta agonists

Actions in the U.S.: Dear Dr. LetterBlack Box Warning

Germany: None

There are two large randomized trials, both showed an increased mortality with salmeterol.

Mortality

Castle et al. 1993 Salmeterol vs Salbutamol 0.32% vs 0.24%SMART 2002 Salmeterol vs Placebo 0.31% vs 0.24%

Number needed to harm (kill): 1250 - 1428 patients

Page 11: Bridging the Gap - Research into Practice

IBEJ. Hasford

Munich

The Problem is:

Who is responsible for Patient Safety?

EU-Regulations National Law

Page 12: Bridging the Gap - Research into Practice

IBEJ. Hasford

Munich

Market Authorization Holder

collect, collate, validate and follow up (SAEs) of all reported suspected Adverse Events

screen the relevant world-wide literature at least once / week

report all serious suspected ADRs within 15 days submit PSURs company-sponsored Post-Authorisation Safety

Studies regularly checks risks and benefits and acts

accordingly

Page 13: Bridging the Gap - Research into Practice

IBEJ. Hasford

Munich

Drug Authority collect, validate, code, store and analyse

reports transmit ADR data to the MA holder inform health care professionals and, when

needed, treated patients, of any significant changes

Decision Making Communication with all interested parties Evaluation of the actions taken

Page 14: Bridging the Gap - Research into Practice

IBEJ. Hasford

Munich

Marketing Authorisation Holder

• Establish and maintain a system, accessible at a single point in the EU, to collect, collate, and evaluate pharmacovigilance data

• Meet legal obligations for reporting suspected adverse drug reactions

• Meet legal obligations regarding the preparation and the submission of PSURs

• Respond fully to requests from authorities for additional information necessary for the evaluation of the benefits and risks of a medicinal product

• Ensure the Marketing Authorisation is maintained and reflects the latest information

Member States • Have in place national pharmacovigilance systems

• Inform the European Commission, the CPMP, the Agency, the member states and the MAHs of any relevant actions

• Collect and collate risk / benefit data

• Provide serious ADRs which have occurred in its territory to the Agency and the relevant MAH within 15 calendar days of receipt

• Identify and evaluate drug safety alerts and conduct risk / benefit evaluations

• Provide representation on CPMP, PhVWP and Rapporteurs / Co-Rapporteurs

• Implement Commission Decisions

• In case of urgent action to protect public health, suspend the use of the product in the member state’s territory and inform, in accordance with the legislation, the Agency and the European Commission of the basis for action

Summary of the Role and the Responsibilities

Volume 9 - Pharmacovigilance

Page 15: Bridging the Gap - Research into Practice

IBEJ. Hasford

Munich

There are a lot of laws and regulations, but with very little impact on routine medical care, except when a drug is withdrawn from the market.

There are too many parties involved, e.g. hospitals, physicians, sickness funds, patients, industry, government institutions, media, juris-diction and the like, but there is

No institution solely devoted on Patient Safety

The Problem is:

Page 16: Bridging the Gap - Research into Practice

IBEJ. Hasford

Munich

Patient Safety Policies

October 2004The World Alliance for Patients’ Safety was launched.

AIMS• to coordinate international actions and avoid

duplication of effort in coping with escalating problems of iatrogenic disease and health care misadventures

Page 17: Bridging the Gap - Research into Practice

Edwards RI. The WHO World Alliance for Patient Safety - A New Challenge or an Old One Neglected? Drug Safety 2005;28:379-386.

Page 18: Bridging the Gap - Research into Practice

IBEJ. Hasford

Munich

Pharmacovigilance Planning

starts PV early, i.e. before the license is granted

is proactive tries to demonstrate safety, as opposed to

looking for harm

Tools

Pharmacovigilance Specification Pharmacovigilance Plan

Page 19: Bridging the Gap - Research into Practice

IBEJ. Hasford

Munich

Pharmacovigilance Specification (PVS)

Summary of the identified risks, the potential risks and any important missing information

All relevant data, e.g. preclinical toxicology, pharmacology, target organ findings, potential for interactions and all clinical data collected during the phases of drug development are evaluated.

Assessment of trials population vs. patient population (e.g. women, children)

Consideration of class effects for the medicine

at time of submission / approval

Tsinitis P and La Mache E. Drug Safety 2004;27:509-517.

Page 20: Bridging the Gap - Research into Practice

IBEJ. Hasford

Munich

Pharmacovigilance Plan

is based on PV specification includes appropriate proposals for

key issues as identified in the PVS, e.g. epidemiological studies

provides the rationale for such studies, the objectives and mile-stones for evaluation

Page 21: Bridging the Gap - Research into Practice

IBEJ. Hasford

Munich

A concerted action with transparent and com-prehensive responsibilities is essential

Annual reports about the state of patient safety in health care competition

Access to the data Pharmacovigilance Planning and Risk Manage-

ment Systematic and continuous use of pharmaco-

epidemiologic data bases, e.g. GPRD (UK, PHARMO (NL), MEMO (Scotland)

Starting points for improvement

Page 22: Bridging the Gap - Research into Practice

IBEJ. Hasford

Munich

Low threshold AE-reporting systems regional (i.e. at least EU-member state level)

ADR and Drug Utilisation monitoring Effective strategies to modify physicians’

prescribing and patients’ compliance are urgently needed

More use of modern information technologies

Page 23: Bridging the Gap - Research into Practice

IBEJ. Hasford

Munich

ADEs are a major public health threat with significant financial cost implications.

Pharmacovigilance has made and will make es-sential contributions to the safer use of medicines.

There is still a considerable gap between the results of Pharmacovigilance research and medical practice.

A concerted action of all parties involved and a reliable and proactive partner are essential to gain the full benefit of pharmacovigilance research.

Conclusions