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1.  Impact of information letters on the reporting rate of adverse drug reactions and the quality of the reports: a randomized controlled study 
Background
Spontaneous reporting of adverse drug reactions (ADRs) is an important method for pharmacovigilance, but under-reporting and poor quality of reports are major limitations. The aim of this study was to evaluate if repeated one-page ADR information letters affect (i) the reporting rate of ADRs and (ii) the quality of the ADR reports.
Methods
All 151 primary healthcare units in the Region Västra Götaland, Sweden, were randomly allocated (1:1) to an intervention (n = 77) or a control group (n = 74). The intervention consisted of one-page ADR information letters administered at three occasions during 2008 to all physicians and nurses in the intervention units. The number of ADR reports received from the 151 units was registered, as was the quality of the reports, which was defined as high if the ADR was to be reported according to Swedish regulations, that is, if the ADR was (i) serious, (ii) unexpected, and/or (iii) related to the use of new drugs and not labelled as common in the Summary of Product Characteristics. A questionnaire was administered to evaluate if the ADR information letter had reached the intended recipient.
Results
Before the intervention, no significant differences in reporting rate or number of high quality reports could be detected between the randomization groups. In 2008, 79 reports were sent from 37 intervention units and 52 reports from 30 control units (mean number of reports per unit ± standard deviation: 1.0 ± 2.5 vs. 0.7 ± 1.2, P = 0.34). The number of high quality reports was higher in intervention units than in control units (37 vs. 15 reports, 0.5 ± 0.9 vs. 0.2 ± 0.6, P = 0.048). According to the returned questionnaires (n = 1,292, response rate 57%), more persons in the intervention than in the control group had received (29% vs. 19%, P < 0.0001) and read (31% vs. 26%, P < 0.0001) an ADR information letter.
Conclusions
This study suggests that repeated ADR information letters to physicians and nurses do not increase the ADR reporting rate, but may increase the number of high quality reports.
doi:10.1186/1472-6904-11-14
PMCID: PMC3182972  PMID: 21899766
2.  Characteristics of primary health care units with focus on drug information from the pharmaceutical industry and adherence to prescribing objectives: a cross-sectional study 
Background
Adherence to prescribing guidelines varies between primary health care units. The aim of the present study was to investigate correlations between characteristics of primary health care units and adherence to prescribing objectives for rational drug use with focus on drug information from the pharmaceutical industry.
Methods
A cross-sectional study was performed in all 25 primary health care units in Göteborg, Sweden. A questionnaire on characteristics of practice settings [(i) size of unit, (ii) profession of head, (iii) use of temporary physicians, (iv) drug information from the pharmaceutical industry, (v) producer-independent drug information, and (vi) education on prescribing for newly employed physicians] was sent to the heads of the units. A national sales register for prescribed drugs (Xplain) was used for evaluation of adherence to the six regional prescribing objectives concerning proton pump inhibitors (PPIs), angiotensin converting enzyme inhibitors (ACEIs), statins and antidepressants.
Results
Twenty-two out of 25 primary health care units responded to the questionnaire (response rate 88%). A physician as head and presence of producer-independent drug information was positively correlated with adherence to the prescribing objectives (median number of prescribing objectives adhered to (25th - 75th percentile): 2.5 (1-3.25) vs 1 (0-2), P = 0.013; 2 (1-3) vs 0, P = 0.043, respectively. Presence of drug information from the pharmaceutical industry and education on prescribing for newly employed physicians was negatively associated with adherence to the prescribing objectives: 1 (0-2) vs 3.5 (2.25-4.75), P = 0.005; 1 (0-2) vs 3 (1.5-4), P = 0.034, respectively.
Conclusion
Several characteristics of the primary health care units correlated with adherence to prescribing objectives for rational drug use. Further research on this topic is needed and would constitute valuable information for health care decision makers.
doi:10.1186/1472-6904-10-4
PMCID: PMC2831842  PMID: 20156362
3.  Use of and attitudes towards the prescribing guidelines booklet in primary health care doctors 
Background
In the region of Västra Götaland in Sweden, prescribing guidelines, drawn up by 24 expert groups and determined by the regional board for drugs, are since 2006 available in the form of an annually published booklet. This study investigates, for the first time, the use of and attitudes towards this publication.
Methods
A questionnaire was administered to doctors working in primary health care in the region of Västra Götaland in Sweden. Questions included characteristics of the responding doctor and use of the prescribing guidelines booklet, as well as attitude questions constructed as statements to which the responder should grade his level of agreement from 1 (total disagreement) to 6 (total agreement).
Results
Totally 603 filled-in questionnaires were returned (estimated response rate 60%). The majority of the doctors (n = 571, 97%) responded that they use the prescribing guidelines booklet, and when prescribing a drug for a new diagnosis, a drug from the booklet is chosen in most cases [median (25th – 75th percentile) 80 (75–90)]. However, at renewal of a drug prescription, active change to a drug from the prescribing guidelines booklet occurs less often [median (25th – 75th percentile) 50 (20–70)]. The booklet also includes short therapy advice sections, which 231 doctors (42%) use every day and 191 (34%) use every week. The attitudes towards the prescribing guidelines booklet were generally positive. Doctors in privately run primary health care units and doctors running their own business were generally more negative and judged themselves to be less adherent to the prescribing guidelines booklet compared with doctors in publicly run primary health care units.
Conclusion
The prescribing guidelines booklet is frequently used and is generally appreciated, though differences exist between subgroups of users.
doi:10.1186/1472-6904-8-8
PMCID: PMC2556993  PMID: 18808661
4.  Individual case safety reports in children in commonly used drug groups – signal detection 
Background
Due to few paediatric drug safety studies, knowledge on risks of drug treatment in children is limited. The knowledge needs to be increased to make proper risk-benefit analyses possible when treating paediatric patients with drugs. The aim of the present study was to investigate drug groups commonly used in children concerning type and frequency of individual case safety reports in children.
Methods
Number and type of individual case safety reports in the 30 groups of drugs (5th level ATC-code) most sold (number of defined daily doses) in outpatient treatment to children (<15 years old) during 2005 were obtained. Descriptive analyses of the adverse drug reactions reported in children were performed.
Results
The number of individual case safety reports per million defined daily doses in children varied in the groups of drug between 0 and 24. The largest number was found in the drug group R03DC, the leukotriene receptor antagonist montelukast; the majority of the children being <5 years old and experiencing psychiatric adverse drug reactions.
Conclusion
The number of individual case safety reports per million defined daily doses varies in different groups of drugs. A possible signal for montelukast and psychiatric adverse drug reactions was found, which should be further explored.
doi:10.1186/1472-6904-8-1
PMCID: PMC2279106  PMID: 18366638
5.  Influence of an e-mail with a drug information attachment on sales of prescribed drugs: a randomized controlled study 
Background
To provide doctors with producer-independent information to facilitate choice of treatment is an important task. The objective of the present study was to evaluate if an e-mail with a drug information attachment has effects on sales of prescribed drugs and if the design of the attachment is of importance.
Methods
The Swedish pharmaceutical benefit board found rizatriptan (Maxalt®) 10 mg to be the most cost-effective triptan. All 119 heads of primary care units in western Sweden were randomized to receive information concerning this conclusion via (i) e-mail with attachment I, (ii) e-mail with attachment II or (iii) no information (control). Attachment I was a short one (heading plus three lines text), whereas attachment II was a long one (heading plus one page text and one page with tables). The change in percentage rizatriptan of total triptans sold before and after the intervention (May – July 2004 and May – July 2005, respectively) was compared between the groups.
Results
Totally 48,229 (2004) and 50,674 (2005) defined daily doses of triptans were prescribed and sold during May – July in primary care units in the western part of Sweden. The absolute change in percentage rizatriptan was greater in the intervention groups compared with the control group 2 (25th – 75th percentile: -3 – 7) vs 0 (-7 - 5), P = 0.031). The absolute change in percentage rizatriptan did not differ between the two attachment groups (P = 0.93).
Conclusion
An e-mail with a drug information attachment may influence sales of prescribed drugs. No difference between different designs of the attachment could be detected.
doi:10.1186/1472-6904-7-12
PMCID: PMC2203966  PMID: 17942000

Results 1-5 (5)