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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jesper Hallas, University of Southern Denmark
ClinicalTrials.gov Identifier:
NCT01128660
First received: May 21, 2010
Last updated: February 1, 2013
Last verified: February 2013
  Purpose

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
Misuse of Prescription Only Drugs

Study Type: Observational
Study Design: 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.

Further study details as provided by University of Southern Denmark:

Primary Outcome Measures:
  • FC(Pharm) [ Time Frame: cross-sectional study with data aquisition over one year ] [ Designated as safety issue: No ]
    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.


Enrollment: 283388
Study Start Date: June 2010
Study Completion Date: August 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
RSD-citizens
Residents of Southern Denmark, who filed more than 9 prescriptions during 2009.

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

Genders Eligible for Study:   Both
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:

  • None
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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.
  More Information

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
Study First Received: May 21, 2010
Last Updated: February 1, 2013
Health Authority: Denmark: Danish Dataprotection Agency

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

ClinicalTrials.gov processed this record on August 21, 2014