Professional Documents
Culture Documents
Pharmacoepidemiology: Past, Present and Future
Pharmacoepidemiology: Past, Present and Future
William Osler,1891
What is pharmacoepidemiology?
• Defined as the study of the utilization and effects
of drugs in large numbers of people.
• Pharmacoepidemiology borrows from both
pharmacology and epidemiology, a bridge
science spanning both pharmacology and
epidemiology.
• Pharmacoepidemiology can also be defined
as the application of epidemiological methods to
pharmacological issues.
Pharmacoepidemiology in practice
• To quantify adverse events with medicines
in the population
• Patterns of drug utilisation, including
adherence
• Hypothesis generating
Pharmacoepidemiology –
Observational studies
• Without treatment allocation by chance,
bias due to different baseline risks for
disease in users and non-users of drugs
cannot be ruled out completely -
confounding by indication.
• The potential for confounding is probably
larger in observational studies assessing
medications than in studies assessing
lifestyle factors.
Pharmacovigilance
• There are also some areas that are altogether
unique to pharmacoepidemiology, e.g.
pharmacovigilance.
• Pharmacovigilance is a type of continual
monitoring for unwanted effects and other
safety-related aspects of drugs that are already
on the market.
• Pharmacovigilance refers almost exclusively to
the spontaneous reporting systems which allow
health care professionals and others to report
adverse drug reactions to a central agency.
• It relies heavily on reporting of safety events by
health professionals.
Pharmacoeconomics
• Pharmacoeconomics is that branch of
health economics that focuses upon the
costs and benefits of drug therapy.
• Definition: The comparative analysis of
alternative courses of action in terms of
BOTH their costs and consequences.
Pharmacoeconomic Evaluation
Pharmaceutical Expenditure Under the
Community Drug Schemes: 1991-2007
• Thalidomide
• Chloramphenicol and Grey Baby Syndrome
• Gynaecological cancer in offspring of women
receiving Diethyl Stilboestrol
• Oculomucocutaneous syndrome with
practolol
• Liver disease from benoxaprofen
• Valvular heart disease from Dexfenfluramine
• Cardiac arrhythmias with terfenadine
• Multiple drug interactions with mibefradil
What papers have shaped
Pharmacoepidemiology?
Controversies
Pharmacoepidemiology in Ireland
1
Dept Pharmacology & Therapeutics,
Trinity College Dublin.
2
Academic Unit of Clinical & Molecular Oncology
Trinity College Dublin & St. James’s Hospital.
Email: barront@tcd.ie
Background
• Adherence & Persistence
• Definitions
• Adherence (Synonym: Compliance) is the extent to which a
patient takes medication in accordance with the prescribed
interval and dose.1
1
ISPOR Medication Compliance & Persistence Special Interest Group.
http://www.ispor.org/sigs/MCP_accomplishments.asp#definition
Background
• Tamoxifen
• 5 years of treatment reduces the relative breast
cancer recurrence risk by 46% and the relative risk
of death by 26%.1
1 2
Lancet 1998; 351: 1451-67; Lancet 2005; 365: 1687-717
Aims
• Aims
• To evaluate persistence with tamoxifen therapy, in
women aged 35 years or older, using prescription
refill data from a national prescribing database.
Study cohort of 2816 women ≥35yrs commenced on tamoxifen as initial hormonal therapy
(January 2000 – January 2004)
716 (25.4%) Stop tamoxifen & switch hormonal therapy before 180 days
34 (1.2%) Stop tamoxifen & switch hormonal therapy after 180 days
Non-persistent
143 (5.1%) Stop tamoxifen & restart tamoxifen after180 days Population 746
(26.5%)
• The determinants
• Extremes of age, treatment with an antidepressant with
non-persistence
• Increasing numbers of prescribed medications associated
with better tamoxifen persistence.
• Conclusion
• Persistence with tamoxifen cannot be assumed
• Raises concerns about persistence with other oral hormonal
therapies/anti-neoplastics in general
Pharmacoepidemiology –
Methodological developments
• Studies based on large health care
utilization databases tend to use data
collected for reasons unrelated to the
research hypothesis thus lacking data on
all important confounders.
• To address unmeasured confounding and
bias in database studies, several
approaches have been proposed.
Some examples of methodological
developments
William Osler
Acknowledgements
HSE-PCRS for supply of data for research purposes.
Dr Ian Barron, Dr Lesley Tilson