Assessment of the Prescriber's and the Pharmacies Overview of Patient Medication by Use of the Fidelity Coefficient.

Misuse of Prescription Only Drugs Clinical Trial

Official title:

Assessment of the Prescriber's and the Pharmacies Overview of Patient Medication by Use of the Fidelity Coefficient.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01128660
• Other study ID #: JH-AP-001
• Status: Completed
• Phase: N/A
• First received: May 21, 2010
• Last updated: February 1, 2013
• Start date: June 2010
• Est. completion date: August 2010

Study information

• Verified date: February 2013
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 283388
• Est. completion date: August 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Having filed more than 9 prescriptions during 2009.

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Misuse of Prescription Only Drugs

Locations

Country	Name	City	State
Denmark	Research Unit of Clinical Pharmacology, University of Southern Denmark	Odense	Funen

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

Pottegård 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. Erratum in: Eur J Clin Pharmacol. 2012 Jan;68(1):107. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FC(Pharm)	The pharmacy fidelity coefficient, FC(Pharm), is a measure of what proportion of individual patients' medication that are accounted for by the most used pharmacy.	cross-sectional study with data aquisition over one year	No