Misuse of Prescription Only DrugsNCT01128660
Assessment of the Prescriber's and the Pharmacies Overview of Patient Medication by Use of the Fidelity Coefficient.
An observational study of Misuse of Prescription Only Drugs, run by University of Southern Denmark at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Misuse of Prescription Only Drugs
- How many people
- 283,388 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2010to Aug 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Residents of Region of Southern Denmark during 2009.
Who may be able to join
- Having filed more than 9 prescriptions during 2009.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Research Unit of Clinical Pharmacology, University of Southern Denmark
Odense, Funen, 5000
About this study
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.
Read the 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.
- Conditions
- Misuse of Prescription Only Drugs
- Keywords
- Prescription, General practitioner, Pharmacy
- Medical subject headings
- Prescription Drug Misuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| RSD-citizens | Residents of Southern Denmark, who filed more than 9 prescriptions during 2009. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: cross-sectional study with data aquisition over one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2010 (estimated)
- Study startJun 2010
- Primary completionJun 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Misuse of Prescription Only DrugsStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 283,388 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jesper Hallas, University of Southern Denmark
- Investigators
- Jesper Hallas, MD, PhD, Principal investigator, Professor, Research Unit of Clinical Pharmacology, University of Southern Denmark.Anton Pottegard, BSc in Pharm, Principal investigator, Guest Researcher, Research Unit of Clinical Pharmacology, University of Southern Denmark.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01128660
- Sponsor's protocol ID
- JH-AP-001
- Status last verified
- Feb 2013
- First submitted
- 21 May 2010
- Last updated
- 4 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21399945
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Prescriber's and the Pharmacies Overview of Patient Medication by Use of the Fidelity Coefficient.
- ClinicalTrials.gov ID
- NCT01128660
- Acronym / sponsor ID
- JH-AP-001
- Conditions
- Misuse of Prescription Only Drugs
- Keywords
- Prescription, General practitioner, Pharmacy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 283,388 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Jun 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 24 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RSD-citizens | – | –Residents of Southern Denmark, who filed more than 9 prescriptions during 2009. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Residents of Region of Southern Denmark during 2009.
Key inclusion criteria (1 listed)
- Having filed more than 9 prescriptions during 2009.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2013.
- Background: PubMed 21399945Pottegard 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jesper Hallas, MD, PhD principal investigator
Professor, Research Unit of Clinical Pharmacology, University of Southern Denmark.
Anton Pottegard, BSc in Pharm principal investigator
Guest Researcher, Research Unit of Clinical Pharmacology, University of Southern Denmark.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Misuse of Prescription Only Drugs, run by University of Southern Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FC(Pharm) (time frame: cross-sectional study with data aquisition over one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01128660, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2013.