Clinical trial NCT01128660: Assessment of the Prescriber's and the Pharmacies Overview of Patient Medication by Use of the Fidelity Coefficient.
Official title: Assessment of the Prescriber's and the Pharmacies Overview of Patient Medication by Use of the Fidelity Coefficient.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Misuse of Prescription Only Drugs
Keywords: Prescription, General practitioner, Pharmacy
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
First posted: 2010-05-24
Enrollment: 283388
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Residents of Region of Southern Denmark during 2009.

Brief summary: The purpose of this study is to twofold. The investigators wish to introduce a new patient-descriptive parameter, the 'Fidelity Coefficient', and use it to assess and compare the overview of patient's medication possessed by the general practitioners and the pharmacies.

Detailed description: The fidelity coefficient, FC, is a measure of what proportion of individual patients' medication that are accounted for by the most used prescriber and the most used pharmacy. Each patient therefore has two values, one describing his fidelity towards his most used prescriber, FCPresc, and one describing his fidelity towards his most used pharmacy, FCPharm.

The investigators intend to assess this parameter in an observational population scale database study, using standard descriptive statistics, and subsequently compare the obtained average FCPresc and FCPharm.

Furthermore, the investigators will analyze the two obtained FCs for dependency of a predefined list of variables: age, gender, number of prescriptions, whether the most frequent prescriber was a GP and whether the most used pharmacy was urban.

Finally, the investigators intend to analyze which medications (grouped using the ATC-system with 4 digits, e.g. C07A) that has the highest proportion of prescriptions that were either issued by a non-main prescriber or redeemed at a non-main pharmacy, which roughly translates into the most 'infidel' medications. To insure relevance we intend to use a cut-off-value of the medication being prescribed at least 50.000 times, which equals about 85 % of the data according to preceding analyses.

The data for this study will be obtained from the Odense University Pharmacoepidemiological Database (OPED). In brief, it is a research database with full coverage of all reimbursed prescriptions in the Region of Southern Denmark (1.2 million inhabitants). The data included in each prescription record includes the prescription holder, the prescriber, the pharmacy, the date of dispensing and a full account of the dispensed product, including substance, brand name, route of administration, ATC-code and Defined Daily Dose (DDD).

Some drugs are exempt from re-imbursement and thus not covered by the database, including benzodiazepines, oral contraceptives, laxatives and certain antibiotics.

Eligibility criteria: Inclusion Criteria:

* Having filed more than 9 prescriptions during 2009.

Exclusion Criteria:

* None

Primary outcomes:
measure: FC(Pharm)
timeFrame: cross-sectional study with data aquisition over one year
Secondary outcomes:
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Research Unit of Clinical Pharmacology, University of Southern Denmark
state: Funen
Study officials:
affiliation: Professor, Research Unit of Clinical Pharmacology, University of Southern Denmark.
name: Jesper Hallas, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Guest Researcher, Research Unit of Clinical Pharmacology, University of Southern Denmark.
name: Anton Pottegard, BSc in Pharm
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pottegard A, Hallas J. Physicians' and pharmacies' overview of patients' medication. An analysis of fidelity coefficients. Eur J Clin Pharmacol. 2011 Sep;67(9):919-24. doi: 10.1007/s00228-011-1026-3. Epub 2011 Mar 12.