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

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ClinicalTrials.gov Identifier: NCT01128660
Recruitment Status : Completed
First Posted : May 24, 2010
Last Update Posted : February 4, 2013
Sponsor:
Information provided by (Responsible Party):
Jesper Hallas, University of Southern Denmark

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.

Condition or disease
Misuse of Prescription Only Drugs

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.


Study Type : Observational
Actual Enrollment : 283388 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Assessment of the Prescriber's and the Pharmacies Overview of Patient Medication by Use of the Fidelity Coefficient.
Study Start Date : June 2010
Actual Primary Completion Date : June 2010
Actual Study Completion Date : August 2010

Group/Cohort
RSD-citizens
Residents of Southern Denmark, who filed more than 9 prescriptions during 2009.



Primary Outcome Measures :
  1. FC(Pharm) [ Time Frame: cross-sectional study with data aquisition over one year ]
    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.



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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Residents of Region of Southern Denmark during 2009.
Criteria

Inclusion Criteria:

  • Having filed more than 9 prescriptions during 2009.

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01128660


Locations
Denmark
Research Unit of Clinical Pharmacology, University of Southern Denmark
Odense, Funen, Denmark, 5000
Sponsors and Collaborators
University of Southern Denmark
Investigators
Principal Investigator: Jesper Hallas, MD, PhD Professor, Research Unit of Clinical Pharmacology, University of Southern Denmark.
Principal Investigator: Anton Pottegard, BSc in Pharm Guest Researcher, Research Unit of Clinical Pharmacology, University of Southern Denmark.

Publications:
Responsible Party: Jesper Hallas, Professor of Clinical Pharmacology, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT01128660     History of Changes
Other Study ID Numbers: JH-AP-001
First Posted: May 24, 2010    Key Record Dates
Last Update Posted: February 4, 2013
Last Verified: February 2013

Keywords provided by Jesper Hallas, University of Southern Denmark:
Prescription, General practitioner, Pharmacy