Use of References in Responses from Scandinavian Drug Information Centres.

Background: The aim of this study was to compare use of references in responses from Scandinavian drug information centres (DICs). Methods: Six different fictitious drug-related queries were sent to each of seven Scandinavian DICs. The six queries concerned adverse effects, pharmacokinetics, pregnancy, complementary medicine, polypharmacy, and breast feeding. References in the responses were categorised into five types of drug information sources: primary (original studies), secondary (reviews), tertiary (drug monographs, handbooks, etc.), DIC database, or personal communication. Results: Two hundred and forty-four references were used in the 42 responses. The mean number of references varied from 3.0 to 10.6 for the six queries. The largest difference between centres with regard to number of references used (range 1⁻17) was found for the query on complementary medicine. In total, 124 references (50.8%) were tertiary, and only 10 of the 42 responses (23.8%) did not have any tertiary references included. Complementary medicine, breast feeding, and pregnancy were query types associated with relatively frequent use of primary references. Use of DIC database was not uncommon, but personal communications were seldom used. Conclusions: Scandinavian DICs differ substantially in number and type of references to identical drug-related queries. Tertiary sources are mainly preferred irrespective of type of query.

[Self-medication with cannabidiol oil in a patient with primary lateral sclerosis].

Many patients with neurological disorders have symptoms which are difficult to treat with conventional medication. In this case report we present a 40-year-old male patient with primary lateral sclerosis who used cannabidiol oil as therapy. We discuss the evidence of the effects of cannabidiol in the treatment of patients with neurological disease, and we raise the question: "Should patients who use illegal cannabis products as self-medication be diagnosed as drug abusers?"

Quality assessment of structure and language elements of written responses given by seven Scandinavian drug information centres.

PURPOSE: The aim of this study was to identify structure and language elements affecting the quality of responses from Scandinavian drug information centres (DICs). METHODS: Six different fictitious drug-related queries were sent to each of seven Scandinavian DICs. The centres were blinded for which queries were part of the study. The responses were assessed qualitatively by six clinical pharmacologists (internal experts) and six general practitioners (GPs, external experts). In addition, linguistic aspects of the responses were evaluated by a plain language expert. RESULTS: The quality of responses was generally judged as satisfactory to good. Presenting specific advice and conclusions were considered to improve the quality of the responses. However, small nuances in language formulations could affect the individual judgments of the experts, e.g. on whether or not advice was given. Some experts preferred the use of primary sources to the use of secondary and tertiary sources. Both internal and external experts criticised the use of abbreviations, professional terminology and study findings that was left unexplained. The plain language expert emphasised the importance of defining and explaining pharmacological terms to ensure that enquirers understand the response as intended. In addition, more use of active voice and less compressed text structure would be desirable. CONCLUSIONS: This evaluation of responses to DIC queries may give some indications on how to improve written responses on drug-related queries with respect to language and text structure. Giving specific advice and precise conclusions and avoiding too compressed language and non-standard abbreviations may aid to reach this goal.

Clinical Pharmacology in Denmark in 2016 - 40 Years with the Danish Society of Clinical Pharmacology and 20 Years as a Medical Speciality.

The Danish Society of Clinical Pharmacology was founded in 1976, and mainly thanks to the persistent efforts of the society, clinical pharmacology became an independent medical speciality in Denmark in 1996. Since then, clinical pharmacology has gone from strength to strength. In the Danish healthcare system, clinical pharmacology has established itself as an indispensible part of the efforts to promote the rational, safe and economic use of drugs. Clinical pharmacologists are active in drug committees both in hospitals and in the primary sector. All clinical pharmacology centres offer a local medicines information service. Some centres have established an adverse drug effect manager function. Only one centre offers a therapeutic drug monitoring service. Clinical pharmacologists are responsible for the toxicological advice at the Danish Poison Information Centre at Bispebjerg University Hospital in the Capital Region. The Department of Clinical Pharmacology at Aarhus University Hospital works closely together with forensic toxicologists and pathologists, covering issues regarding illicit substances, forensic pharmacology, post-mortem toxicology, expert testimony and research. Therapeutic geriatric and psychiatric teach-inns for specialist and junior doctors are among the newest initiatives organized by clinical pharmacologists. Clinical pharmacologists work also in the Danish Medicines Agency and in the Danish pharmaceutical industry, and the latter has in particular a great growth potential for creating new jobs and career opportunities for clinical pharmacologists. As of July 2016, the Danish Society of Clinical Pharmacology has 175 members, and 70 of these are specialists in clinical pharmacology corresponding to approximately 2.5 specialists per 1000 doctors (Denmark has in total 28,000 doctors) or approximately 12 specialists per one million inhabitants.

Gastrointestinal bleedings during therapy with new oral anticoagulants are rarely reported.

INTRODUCTION: Post-marketing surveillance of drugs relies on spontaneous reporting of adverse drug events to the Danish Health and Medicines Authority. A number of new oral anticoagulants (NOAC) have recently been marketed in Denmark. The purpose of this study was to evaluate the reporting of serious adverse drug events in patients treated with a NOAC and admitted for gastrointestinal bleeding. METHODS: This study is based on an electronic free text search in patient records and a search in the electronic medication records of all patients admitted to the Department of Gastroenterology, Surgical Section, Hvidovre Hospital, during a one-year-period. Patients in treatment with NOAC and admitted for gastrointestinal bleeding were identified. Relevant patients were cross-checked for a reported adverse drug event in the Danish Health and Medi-cines Authority's database on adverse medical events. RESULTS: A total of 20 patients were acutely admitted for gastrointestinal bleeding while in treatment with a NOAC, an adverse medical event was reported for one of these patients (5%; 95% confidence interval: 0-25%). CONCLUSION: Serious adverse events in patients treated with NOAC are underreported which questions the current effectiveness of post-marketing surveillance of adverse drug effects. FUNDING: not relevant. TRIAL REGISTRATION: The study was registered with clin-icaltrials.gov (NCT02107651).

Factors associated with time consumption when answering drug-related queries to Scandinavian drug information centres: a multi-centre study.

PURPOSE: There is little research-based documentation on the services provided by drug information centres (DICs). The aim of this multi-centre study was to explore for the first time the factors associated with time consumption when answering drug-related queries at eight different but comparable DICs. METHODS: During an 8-week period, staff members at eight Scandinavian DICs recorded the number of minutes during which they responded to queries. Mixed model linear regression analyses were used to explore the factors associated with time consumption when answering queries. RESULTS: The mean time consumption per query was 178 min (range 4-2540 min). The mean time consumed per query increased by 28 (95 % confidence interval (CI) 23 to 33, p < 0.001) min higher for queries for which there was a lack of documentation and 139 (95 % CI 74 to 203, p < 0.001) min higher when conflicting information was present in the literature. Staff members with less than 1 year of experience consumed a mean of 91 more minutes (95 % CI 32 to 150, p = 0.003) per query than staff members with more than 2 years of experience. CONCLUSIONS: This study demonstrates the large variation in time consumed answering queries posed to Scandinavian DICs. The results highlight the need for highly competent staff members and easy access to drug information sources. Further studies are required to explore the association between time consumption and response quality.

[Treatment of degenerative dementia disorders--who should be treated?]. / Behandling af demenssygdomme--hvem skal behandles?

Recommendations for treatment with specific antidementia drugs in Denmark are given on the basis of recent evidence. Such evidence supports treatment of mild to moderate Alzheimer's Disease (AD) with acetylcholinesterase inhibitors (AchEI), and moderate to severe AD with memantine. Combination therapy with these drugs can be considered in moderate AD. Dementia with Lewy bodies and Parkinson's disease with dementia should be treated with rivastigmine. There is not sufficient evidence to recommend treatment with AchEI or memantine in pure vascular dementia or frontotemporal dementia.

[Compliance to drug prescriptions]. / Komplians ved behandling med laegemidler.

Non-adherence or incomplete adherence to drug prescriptions is common. In long-term therapy for chronic disease, it has been estimated that only half of all drug doses are taken as prescribed. In this article we discuss poor adherence in terms of prevalence, clinical significance, treatment opportunities and ethical aspects.

Creating knowledge about adverse drug reactions: a critical analysis of the Danish reporting system from 1968 to 2005.

Data on adverse drug reactions (ADRs) have been collected in Denmark since 1968 and the process is ongoing. This article explores knowledge created by the system, including how the collected data have been used to monitor the safety of licensed drugs. Nonaka's theory of knowledge creation was used to discriminate between tacit and explicit knowledge. A total of 56,802 ADR case reports were received from 1968 to 2005. The analysis shows a rather stable number of ADR cases from 1980, with about 2000 reports per year. The distribution of cases into serious and non-serious ADRs has been one to four throughout the period under study, but with large variations. Analysis of selected ADR cases shows that the system lacked the potential to capture available knowledge. Consequently the ADR reports have had limited value and significance in the process of creating scientific knowledge. Thus, the analysis questions the way available data can become explicit as a basis for regulatory decisions and whether all data can become knowledge, including who decides what knowledge is.

Promotional methods used by representatives of drug companies: a prospective survey in general practice.

OBJECTIVE: To examine the extent and composition of pharmaceutical industry representatives' marketing techniques with a particular focus on drug sampling in relation to drug age. DESIGN: A group of 47 GPs prospectively collected data on drug promotional activities during a six-month period, and a sub-sample of 10 GPs furthermore recorded the representatives' marketing techniques in detail. SETTING: Primary healthcare. SUBJECTS: General practitioners in the County of Funen, Denmark. MAIN OUTCOME MEASURES: Promotional visits and corresponding marketing techniques. RESULTS: The 47 GPs recorded 1050 visits corresponding to a median of 19 (range 3 to 63) per GP in the six months. The majority of drugs promoted (52%) were marketed more than five years ago. There was a statistically significant decline in the proportion of visits where drug samples were offered with drug age, but the decline was small OR 0.97 (95% CI 0.95;0.98) per year. Leaflets (68%), suggestions on how to improve therapy for a specific patient registered with the practice (53%), drug samples (48%), and gifts (36%) were the most frequently used marketing techniques. CONCLUSION: Drug-industry representatives use a variety of promotional methods. The tendency to hand out drug samples was statistically significantly associated with drug age, but the decline was small.

The effects of introducing a clinical pharmacist on orthopaedic wards in Denmark.

OBJECTIVE: To assess the effects and cost effects of introducing clinical pharmacists on hospital wards. METHODS: Comparative prospective study on four orthopaedic surgical wards in two hospitals. The primary effect variables were 10 target areas widely considered to be indicators of good prescription practice. Prescriptions not following good practice in these intervention areas were defined as "sub-optimal prescriptions," and then discussed between a physician and a clinical pharmacist. The primary parameter was the difference in the number of days with a sub-optimal prescription (Mann-Whitney test). RESULTS: On an average 20% of all the patients had a sub-optimal prescription. Of these, 70% were changed by the physician after intervention by the clinical pharmacist. There was a statistically significant difference in the duration of days in treatment with a sub-optimal prescription. Where sub-optimal prescriptions were changed, 43% resulted in cost reductions. The reductions achieved could cover 47% of the costs of clinical pharmacy service. CONCLUSION: Clinical pharmacy services offered to four orthopaedic surgical wards resulted in reduction of sub-optimal prescriptions. Every time the pharmacist screened seven patients one sub-optimal prescription was found and adjusted. The reduction in medicine costs due to adjusted sub-optimal prescriptions could not cover the whole cost of clinical pharmacy service.

Factor analysis improves the selection of prescribing indicators.

OBJECTIVE: To test a method for improving the selection of indicators of general practitioners' prescribing. METHODS: We conducted a prescription database study including all 180 general practices in the County of Funen, Denmark, approximately 472,000 inhabitants. Principal factor analysis was used to model correlation between 19 register-based indicators for the quality of non-steroidal anti-inflammatory drug (NSAID) prescribing. RESULTS: The correlation between indicators ranged widely from 0 to 0.93. Factor analysis revealed three dimensions of quality: (1) "Coxib preference", comprising indicators directly quantifying choice of coxibs, indicators measuring expenditure per Defined Daily Dose, and indicators taking risk aspects into account, (2) "Frequent NSAID prescribing", comprising indicators quantifying prevalence or amount of NSAID prescribing, and (3) "Diverse NSAID choice", comprising indicators focusing on the width of GPs' formularies. The number of indicators for measuring the important aspects of quality in prescribing of NSAIDs could be reduced substantially by selecting the indicator in each dimension with the highest factor loading. A high preference for coxibs indicated both appropriate and inappropriate prescribing, as revealed by the correlation of the indicators in the first factor. CONCLUSION: Correlation and factor analysis is a feasible method that assists the selection of indicators and gives better insight into prescribing patterns.