The dopamine-related polymorphisms BDNF, COMT, DRD2, DRD3, and DRD4 are not linked with changes in CSF dopamine levels and frequency of HIV infection.

We showed previously that higher levels in CSF dopamine in HIV patients are associated with the presence of the dopamine transporter (DAT) 10/10-repeat allele which was also detected more frequently in HIV-infected individuals compared to uninfected subjects. In the current study, we investigated further whether other genetic dopamine (DA)-related polymorphisms may be related with changes in CSF DA levels and frequency of HIV infection in HIV-infected subjects. Specifically, we studied genetic polymorphisms of brain-derived neurotrophic factor, catechol-O-methyltransferase, and dopamine receptors DRD2, DRD3, and DRD4 genetic polymorphisms in uninfected and HIV-infected people in two different ethnical groups, a German cohort (Caucasian, 72 individuals with HIV infection and 22 individuals without HIV infection) and a South African cohort (Xhosan, 54 individuals with HIV infection and 19 individuals without HIV infection). We correlated the polymorphisms with CSF DA levels, HIV dementia score, CD4+ T cell counts, and HIV viral load. None of the investigated DA-related polymorphisms was associated with altered CSF DA levels, CD4+ T cell count, viral load, and HIV dementia score. The respective allele frequencies were equally distributed between HIV-infected patients and controls. Our findings do not show any influence of the studied genetic polymorphisms on CSF DA levels and HIV infection. This is in contrast to what we found previously for the DAT 3'UTR VNTR and highlights the specific role of the DAT VNTR in HIV infection and disease.

Heparan sulfate is an attachment factor for foamy virus entry.

The cellular receptor of foamy viruses (FVs) is unknown. The broad spectrum of permissive cells suggests that the cellular receptor is a molecular structure with almost ubiquitous prevalence. Here, we investigated the ability of heparan sulfate (HS), a glycosaminoglycan (GAG) present on the extracellular matrix of many cells, to bind FV particles and to permit prototype FV (PFV) and feline FV (FFV) entry. Permissivity of different cell lines for FV entry correlated with the amount of heparan sulfate present on the cell surface. The resulting 50% cell culture infectious doses (CCID(50)s) were distributed over a range of 4 logs, which means that the most susceptible cell line tested (HT1080) was more than 10,000 times more susceptible for PFV infection than the least susceptible cell line (CRL-2242). HS surface expression varied over a range of 2 logs. HS expression and FV susceptibility were positively correlated (P < 0.001). Enzymatic digestion of heparan sulfate on HT1080 cells diminished permissivity for PFV entry by a factor of at least 500. Using fast protein liquid chromatography (FPLC), we demonstrated binding of FV vector particles to a gel filtration column packed with heparin, a molecule structurally related to heparan sulfate, allowing for the purification of infectious particles. Both PFV and FFV infection were inhibited by soluble heparin. Our results show that FVs bind to HS and that this interaction is a pivotal step for viral entry, suggesting that HS is a cellular attachment factor for FVs.

Increases in CSF dopamine in HIV patients are due to the dopamine transporter 10/10-repeat allele which is more frequent in HIV-infected individuals.

Dysfunction of dopaminergic neurotransmission has been implicated in HIV infection. We showed previously increased dopamine (DA) levels in CSF of therapy-naïve HIV patients and an inverse correlation between CSF DA and CD4 counts in the periphery, suggesting adverse effects of high levels of DA on HIV infection. In the current study including a total of 167 HIV-positive and negative donors from Germany and South Africa (SA), we investigated the mechanistic background for the increase of CSF DA in HIV individuals. Interestingly, we found that the DAT 10/10-repeat allele is present more frequently within HIV individuals than in uninfected subjects. Logistic regression analysis adjusted for gender and ethnicity showed an odds ratio for HIV infection in DAT 10/10 allele carriers of 3.93 (95% CI 1.72-8.96; p = 0.001, Fishers exact test). 42.6% HIV-infected patients harbored the DAT 10/10 allele compared to only 10.5% uninfected DAT 10/10 carriers in SA (odds ratio 6.31), whereas 68.1 versus 40.9%, respectively, in Germany (odds ratio 3.08). Subjects homozygous for the 10-repeat allele had higher amounts of CSF DA and reduced DAT mRNA expression but similar disease severity compared with those carrying other DAT genotypes. These intriguing and novel findings show the mutual interaction between DA and HIV, suggesting caution in the interpretation of CNS DA alterations in HIV infection solely as a secondary phenomenon to the virus and open the door for larger studies investigating consequences of the DAT functional polymorphism on HIV epidemiology and progression of disease.

Evaluating categorisation and clinical relevance of drug-related problems in medication reviews.

OBJECTIVES: We aimed to evaluate the categorisation and clinical relevance of DRPs identified by community pharmacists, and further, to assess the quality of interventions with the patients and the physicians as documented by the pharmacists. SETTING: 23 Norwegian community pharmacies. METHOD: Patients with type 2 diabetes were recruited by 24 community pharmacists who performed structured medication reviews based on the patients' drug profiles and patient interviews. The DRPs identified were subsequently categorised. An evaluation group (EG) retrospectively evaluated the reviews. Clinical/practical relevance of each DRP and quality of community pharmacists' intervention with patients and physician were scored. Average agreement between the EG and the community pharmacists was calculated. Internal agreement in the EG was calculated using a modified version of Fleiss' Kappa coefficient. RESULTS: A total of 73 patients were included (mean age 62 years, 52% female, on average prescribed 8.7 drugs). The pharmacists identified 88 DRPs in 43 of the patients. The most common DRPs were adverse drug reactions (22%) and wrong drug or dose used by patient (14%). Anti-diabetic drugs and lipid modifying drugs were associated with the most DRPs. The EG agreed with detection and categorisation of DRPs in more than 80% of the cases. The clinical/practical relevance of the detected DRPs was scored by the EG to be high or medium in 87% of the cases. The quality of the follow-up with patients and physicians was scored to be good or satisfactory in 93 and 98% of the cases, respectively. CONCLUSIONS: Pre-defined categories of DRPs supported by structured forms were reliable and valid tools for identifying DRPs. The evaluation demonstrated that community pharmacists were able to identify DRPs of high to medium clinical/practical relevance, and to perform follow-ups of the DRPs with the patients and the physicians with a good or satisfactory quality.

Price control as a strategy for pharmaceutical cost containment - what has been achieved in Norway in the period 1994-2004?

OBJECTIVES: To describe and evaluate the different price control strategies implemented in Norway after its accession to the European Economic Area (1994-2004). METHODS: Interviews with ten key persons who had broad insight into the field in question were held. All the available literature was reviewed. RESULTS: Direct price control involving international reference pricing of prescription drugs, and the subsequent price revisions, that occurred from the year 2000 onwards, resulted in predictable and substantial price reductions. With respect to the indirect methods which targeted the off-patent market, the price reductions resulting from reference-based pricing (1993-2000) were only marginal and the achieved savings derived mainly from increased patients' charges. The introduction of generic substitution in 2001 led to increased market shares for non-branded products, but discounts from the manufacturers were not reflected in retail prices. An index price system (2003-2004) was therefore created; but as it entailed negative economical incentives for the pharmacy chains, the price changes did not meet the expectations. CONCLUSION: The direct pricing strategy, i.e. the international reference pricing, was considered to be the most successful method. In contrast, due to the unpredictability of the market situation, the resulting effects of the indirect methods, i.e. reference-based pricing, generic substitution, and index pricing, were more limited.

[Communication about prescription interventions between pharmacists and general practitioners]. / Samhandling mellom allmennleger og apotek ved korreksjon av resepter.

BACKGROUND: Pharmacists intervene on about 2 % of prescriptions dispensed in Norwegian community pharmacies. The aim of this study was to explore how general practitioners (GPs) and community pharmacists communicate and document prescription interventions, and to discuss what both professions consider to be best practice. MATERIAL AND METHODS: Five GPs, five community pharmacists and two medical secretaries were recruited, from two regions in Norway, to form two focus groups. The groups were invited to discuss 12 real examples of prescription interventions (from a former study of pharmacy practice) from six intervention categories. Statements from the focus groups were analyzed and recurrent themes identified. RESULTS: The GPs and pharmacists described varying management of the pharmacists' prescription interventions. Both expected the other profession to file these interventions and would only file a selection themselves. Correction of prescription interventions was not a well-established functionality of the GPs' electronic medical record systems. Lack of guidelines caused individual variations in both GP and pharmacist handling of such interventions. In general, the pharmacists prioritized to contact GPs for the clinically relevant interventions. GPs wanted more feedback than that provided by the pharmacists. INTERPRETATION: Joint guidelines for use in pharmacies and GP surgeries, are needed on communication, documentation, and priorities of prescription interventions. IT-software should be developed to facilitate real-time communication between the parties.

A quantum chemical study of the generation of a potential prebiotic compound, cyanoacetaldehyde, and related sulfur containing species.

Cyanoacetaldehyde (NCCH 2CHO), which may have played a role in the prebiotic formation of the pyrimidine bases cytosine and uracil, is formed in water solutions by addition of water to cyanoacetylene (HCC-CN), a compound that exists in interstellar space, in comets, and planetary atmospheres. A gas-phase model of the uncatalyzed addition of water to cyanoacetylene is explored by ab initio calculations at the MP2/6-311++G** level of theory. A reaction path consisting of several steps was found in these calculations, but the activation energy of the first step is relatively high, which makes it unlikely that cyanoacetaldehyde is formed in an uncatalyzed reaction. Similar calculations were also performed for the uncatalyzed reaction of water to protonated cyanoacetylene (HCCCNH (+)), a component of the interstellar medium, forming protonated cyanoacetaldehyde (HNCCH 2CHO (+)), but a high activation energy was found for this reaction as well. Moreover, the corresponding addition reactions of hydrogen sulfide (H 2S) to HCCCN, as well as to HCCCNH (+), have been explored with similar results.

Self-efficacy in counseling in Norwegian chain pharmacies: a cross-sectional study.

BACKGROUND: After pharmacy reform in Norway in 2001, pharmacy chains have systematically trained their personnel in advising self-medication of some symptoms and diseases to increase their competence. It may be important to reveal factors at work that increase self-efficacy in counseling as part of enhancing good pharmacy practice. OBJECTIVES: The aims of this study were to investigate (1) self-efficacy in counseling among pharmacy personnel in respect to a range of medical complaints, and (2) the relationship between self-efficacy in counseling and pharmacy staff's education, age, years of work in pharmacy and psychosocial factors. METHODS: A web-based questionnaire about self-efficacy in counseling, psychosocial factors, and demographic variables was completed by 693 individuals from 299 randomly selected community chain pharmacies in Norway. Multiple regression analysis was used to assess the relationship between self-efficacy and gender, age, years of work in pharmacy, and psychosocial factors. RESULTS: On a scale from 0 (very difficult) to 10 (no problem), the mean score for self-efficacy on all 21 symptoms or needs was 7.2 (SD=1.3). Allergy, flu, and headache received the highest self-efficacy scores and leg ulcer treatment, self-test kits, and tiredness received the lowest scores. Significant associations between self-efficacy in counseling and years of work in pharmacy (P=.017), role clarity (P<.001), positive challenges at work (P=.002), and role conflict (P<.001) were observed. CONCLUSIONS: Self-efficacy in counseling among pharmacy personnel seems to be high for providing advice for symptoms where over-the-counter medicines are available. Role clarity, positive challenge, and years of work in pharmacy are associated positively with self-efficacy in counseling, whereas role conflict is associated negatively. Future research may examine implications for self-efficacy in actual behavior and patient outcomes.

[Prescription changes in pharmacies]. / Endring av resepter i apotekene.

BACKGROUND: Prescriptions must sometimes be changed or clarified before dispensing in order to provide a safe and professional service. The aims of this study were to gain insight into the types of prescription interventions performed by pharmacists, to explore the reason behind the interventions and to describe to which extent and how interventions are documented and communicated to the prescribers. MATERIAL AND METHODS: Prescription interventions (N = 1,084) performed at a community pharmacy in Norway from January 2002 to September 2004 were categorised. Two focus groups were used to validate the categories. The pharmacists in these groups were invited to discuss working procedures and professional judgements related to prescription interventions. RESULTS: The prescription interventions were grouped into seven categories. The two largest categories were "drugs not available" (37%) and "clarification of drug choice and dosage" (22%). Many interventions are not communicated to the prescribers. In principal, the pharmacists felt that interventions should be communicated to the prescriber even if this is often not the case. CONCLUSION: Pharmacists intervene on a range of prescription issues that are not communicated to the prescribers. Feedback requires time and resources for all involved. By ensuring that computer systems used by general practitioners comply with reimbursement legislation and technical requirements for prescriptions, the demand for many prescription interventions will be reduced. There is a need for a joint professional discussion on differentiation and standardisation of feedback on prescription interventions.

[Prescription errors--dimension and measures]. / Forskrivningsfeil--omfang og oppklaring.

BACKGROUND: A prescription should contain sufficient information to dispense the right medicine with correct instructions for use. The information given on the prescription also forms the basis for reimbursement of drug expenses. Knowledge of prescription errors may improve the procedures of the prescribing physician and the pharmacy. MATERIAL AND METHOD: Prescriptions without information on the indication of the drug therapy were registered in ten Norwegian pharmacies during two days in the autumn of 2004. Other errors and omissions on prescriptions were registered in nine of the pharmacies during a five week period. RESULTS AND INTERPRETATION: A total of 1884 (39%) of the 4667 prescriptions included in the first part of the study contained no information on the indication. A total of 1696 other errors and omissions were registered on 1359 (2%) of the 69,315 prescriptions included in the second part of the study. The most common errors and omissions were incomplete instructions for use (26%), missing information about the patient (17%), and errors and omissions related to reimbursement of drug expenses. 294 (17%) of the errors were judged to have potential clinical significance if they had not been corrected. The most common intervention was to interview the patient or to contact the prescribing physician. The most common changes were to change or clarify drug and dose.

Effects of Prednisolone on Disease Progression in Antiretroviral-Untreated HIV Infection: A 2-Year Randomized, Double-Blind Placebo-Controlled Clinical Trial.

BACKGROUND: HIV-disease progression correlates with immune activation. Here we investigated whether corticosteroid treatment can attenuate HIV disease progression in antiretroviral-untreated patients. METHODS: Double-blind, placebo-controlled randomized clinical trial including 326 HIV-patients in a resource-limited setting in Tanzania (clinicaltrials.gov NCT01299948). Inclusion criteria were a CD4 count above 300 cells/µl, the absence of AIDS-defining symptoms and an ART-naïve therapy status. Study participants received 5 mg prednisolone per day or placebo for 2 years. Primary endpoint was time to progression to an AIDS-defining condition or to a CD4-count below 200 cells/µl. RESULTS: No significant change in progression towards the primary endpoint was observed in the intent-to-treat (ITT) analysis (19 cases with prednisolone versus 28 cases with placebo, p = 0.1407). In a per-protocol (PP)-analysis, 13 versus 24 study participants progressed to the primary study endpoint (p = 0.0741). Secondary endpoints: Prednisolone-treatment decreased immune activation (sCD14, suPAR, CD38/HLA-DR/CD8+) and increased CD4-counts (+77.42 ± 5.70 cells/µl compared to -37.42 ± 10.77 cells/µl under placebo, p < 0.0001). Treatment with prednisolone was associated with a 3.2-fold increase in HIV viral load (p < 0.0001). In a post-hoc analysis stratifying for sex, females treated with prednisolone progressed significantly slower to the primary study endpoint than females treated with placebo (ITT-analysis: 11 versus 21 cases, p = 0.0567; PP-analysis: 5 versus 18 cases, p = 0.0051): No changes in disease progression were observed in men. CONCLUSIONS: This study could not detect any significant effects of prednisolone on disease progression in antiretroviral-untreated HIV infection within the intent-to-treat population. However, significant effects were observed on CD4 counts, immune activation and HIV viral load. This study contributes to a better understanding of the role of immune activation in the pathogenesis of HIV infection. TRIAL REGISTRATION: ClinicalTrials.gov NCT01299948.

Vibrational spectroscopic studies, conformations and ab initio calculations of 3,3,3-trifluoropropyltrichlorosilane.

Infrared spectra of 3,3,3-trifluoropropyltrichlorosilane (CF3CH2CH2SiCl3) were obtained in the vapour, amorphous and crystalline solid phases in the range 4000-50 cm-1. Additional spectra in argon matrices at 5.0 K were recorded before and after annealing to 20-36 K. Raman spectra of the compound as a liquid were recorded at various temperatures between 298 and 210 K and spectra of the amorphous and crystalline solids were obtained. The spectra suggested the existence of two conformers (anti and gauche) in the fluid phases and in the matrix. When the vapour was shock-frozen on a cold finger at 80 K and subsequently annealed to 120-150 K, six weak or very weak Raman bands vanished in the crystal. Similar variations were observed in the corresponding infrared spectra after annealing and four very weak IR bands disappeared after crystallization. From intensity variations between 298 and 210 K of three Raman band pairs an average value Delta(conf)H degrees (gauche-anti)=6.1+/-0.5 kJmol-1 was obtained in the liquid. Annealing experiments indicate that the anti conformer also has a lower energy in the argon matrices. The conformational equilibrium is highly shifted towards anti in the liquid, and the low energy conformer also forms the crystal. The spectra of the abundant anti conformer and the few bands ascribed to the gauche conformer have been interpreted. Ab initio calculations at the HF/6-311G(**) and B3LYP/6-311G(**) gave optimized geometries, infrared and Raman intensities and vibrational frequencies for the anti and gauche conformers. The conformational energy differences derived were 11.8 and 9.2 kJmol-1 from the HF and the B3LYP calculations, respectively.

Vibrational spectra, quantum chemical calculations and spectral assignments of 1,1-difluoro-1-silacyclohexane.

Raman spectra of 1,1-difluoro-1-silacyclohexane as a liquid, and as a solid at 78 K were recorded and depolarization data obtained. The infrared spectra of the vapour, liquid and amorphous and crystalline solids have been studied. In the low temperature IR and Raman spectra eight and three bands, respectively, were shifted a few cm(-1) when the sample crystallized. No bands vanished after crystallization in agreement with the assumption that only one conformer (chair) was present in all the states of aggregation. The compound exists in the stable chair conformation, whereas in the parent silacyclohexane a possible twist form should have more than 15 kJ mol(-1) higher energies than the chair, as derived from various calculations. The wavenumbers of the vibrational modes were calculated in the harmonic and anharmonic approximation employing B3LYP/cc-pVTZ calculations. The 27 A' and 21 A″ fundamentals were assigned on the basis of the calculations, infrared vapour contours, Raman depolarization measurements and infrared and Raman band intensities. An average, relative deviation of 1.5% was found between the observed and the anharmonic wavenumbers for the 48 modes.

HIV drug resistance (HIVDR) in antiretroviral therapy-naïve patients in Tanzania not eligible for WHO threshold HIVDR survey is dramatically high.

BACKGROUND: The World Health Organization (WHO) has recommended guidelines for a HIV drug resistance (HIVDR) survey for resource-limited countries. Eligibility criteria for patients include age below 25 years in order to focus on the prevalence of transmitted HIVDR (tHIVDR) in newly-infected individuals. Most of the participating sites across Africa have so far reported tHIVDR prevalences of below 5%. In this study we investigated whether the rate of HIVDR in patients <25 years is representative for HIVDR in the rest of the therapy-naïve population. METHODS AND FINDINGS: HIVDR was determined in 88 sequentially enrolled ART-naïve patients from Mwanza, Tanzania (mean age 35.4 years). Twenty patients were aged <25 years and 68 patients were aged 25-63 years. The frequency of HIVDR in the study population was 14.8% (95%; CI 0.072-0.223) and independent of NVP-resistance induced by prevention of mother-to-child transmission programs. Patients >25 years had a significantly higher HIVDR frequency than younger patients (19.1%; 95% CI 0.095-0.28) versus 0%, P = 0.0344). In 2 out of the 16 patients with HIVDR we found traces of antiretrovirals (ARVs) in plasma. CONCLUSIONS: ART-naïve patients aged over 25 years exhibited significantly higher HIVDR than younger patients. Detection of traces of ARVs in individuals with HIVDR suggests that besides transmission, undisclosed misuse of ARVs may constitute a significant factor in the generation of the observed high HIVDR rate. The current WHO tHIVDR survey that is solely focused on the transmission of HIVDR and that excludes patients over 25 years of age may therefore result in substantial underestimation of the prevalence of HIVDR in the therapy-naïve population. Similar studies should be performed also in other areas to test whether the so far reported optimistic picture of low HIVDR prevalence in young individuals is really representative for the rest of the ART-naïve HIV-infected population.

Community pharmacists' prescription intervention practices--exploring variations in practice in Norwegian pharmacies.

BACKGROUND: Evidence suggests that prescription intervention frequencies have been found to vary as much as 10-fold among Norwegian pharmacies and among pharmacists within the same pharmacy. OBJECTIVE: To explore community pharmacists' perceptions of how their prescription intervention practices were influenced by their working environment, their technological resources, the physical and social structures of the pharmacies, their relations with colleagues, and to the individual pharmacist's professional skills. METHODS: Two focus groups consisting of 14 community pharmacists in total, from urban and rural areas in Norway, discussed their working procedures and professional judgments related to prescription interventions. Organizational theories were used as theoretical and analytical frameworks in the study. A framework based on Leavitt's organizational model was to structure our interview guide. The study units were the statements of the individual pharmacists. Recurrent themes were identified and condensed. RESULTS: Two processes describing variations in the dispensing workflow including prescription interventions were derived--an active dispensing process extracting information about the patient's medication from several sources and a fast dispensing process focusing mainly on the information available on the prescription. Both workflow processes were used in the same pharmacies and by the same pharmacist but on different occasions. A pharmacy layout allowing interactions between pharmacist and patients and a convenient organization of technology, layout, pharmacist-patient and pharmacist-coworker transactions at the workplace was essential for detecting and solving prescription problems. Pharmacists limited their contact with general practitioners when they considered the problem a formality and/or when they knew the answers themselves. The combined use of dispensing software and the Internet was a driving force toward more independent and cognitively advanced prescription interventions. CONCLUSION: Implementation of a general organizational model made it easier to analyze and interpret the pharmacists' intervention practices. Working environment, technology, management and professional skills may all contribute to variations in pharmacists' prescription intervention practices in and between community pharmacies.

Nanostructured wrinkled surfaces for templating bionanoparticles--controlling and quantifying the degree of order.

We present a novel method to align the tobacco mosaic virus (TMV) on topographically structured surfaces. In order to gain defined patterns we use wrinkled polydimethlysiloxane (PDMS) sheets as templates. We aligned the virus with a simple spin-coating procedure on the PDMS sheet. The concentration of the virus solution and the spin speed are varied in order to identify ideal conditions for the arrangement of the viruses on the wrinkled templates. Here, we establish a simple analytical approach which allows quantifying the degree of order of the patterns, which is the basis for a quantitative discussion of templating efficiency. Furthermore, we discuss the role of dewetting processes for the particle assembly. TMVs can be used as reactive nanoparticles due to their well-defined surface chemistry. They can as well serve as a model system for alignment of anisotropic particles via spin coating from solution.

A lithography-free pathway for chemical microstructuring of macromolecules from aqueous solution based on wrinkling.

We report on a novel lithography-free method for obtaining chemical submicron patterns of macromolecules on flat substrates. The approach is an advancement of the well-known microcontact printing scheme: While for classical microcontact printing lithographically produced masters are needed, we show that controlled wrinkling can serve as an alternative pathway to producing such masters. These can even show submicron periodicities. We expect upscaling to larger areas to be considerably simpler than that for existing techniques, as wrinkling results in a macroscopic deformation process that is not limited in terms of substrate size. Using this approach, we demonstrate successful printing of aqueous solutions of polyelectrolytes and proteins. We study the effectiveness of the stamping process and its limits in terms of periodicities and heights of the stamps' topographical features. We find that critical wavelengths are well below 355 nm and critical amplitudes are below 40 nm and clarify the failure mechanism in this regime. This will permit further optimization of the approach in the future.

Pharmacists' attitudes towards the reporting of suspected adverse drug reactions in Norway.

BACKGROUND: In Scandinavian countries, pharmacists have not reported adverse drug reactions (ADRs), either due to legislative restrictions or because of lack of tradition. From 1 January 2005, Norwegian pharmacists have been encouraged by the Norwegian Medicines Agency to take a larger role in the reporting of ADRs. OBJECTIVE: To explore pharmacists' attitudes towards pharmacovigilance and their experiences with ADR reporting, to evaluate the effect of an educational programme and to compare these findings to the attitudes in a control group. METHODS: From September 2004, pharmacies in two of Norway's five health regions were invited to attend a 3-month ADR reporting study, and 39 pharmacies were recruited. One pharmacist from each pharmacy participated in a 1 day pre-study educational programme and a 1 day post-study evaluation meeting. Pharmacists involved in the study answered a questionnaire (A) regarding their attitudes to ADR reporting (active group). A control group answered the same questionnaire. One reminder was sent. The active group evaluated the study by answering questionnaire A once more and an evaluation questionnaire (B). Qualitative aspects of ADR reporting were discussed with the active group post-study. RESULTS: The response rate for questionnaire A was 97% (n = 158) in the active group, 74% (n = 184) in the control group and the response rate for questionnaire A and B post-study was 68% (n = 105) in the active group. Pharmacists in the active group had more positive attitudes to ADR reporting after taking part in the study than the control group (p < 0.001). Lack of time, confidence and knowledge of reporting rules could potentially prevent them from reporting ADRs. CONCLUSIONS: The pharmacists had positive attitudes towards pharmacovigilance, but very little experience with reporting. The educational programme clarified their role and increased their knowledge about the reporting requirements.

Characteristics and quality of adverse drug reaction reports by pharmacists in Norway.

PURPOSE: To evaluate the characteristics and quality of adverse drug reaction (ADR) reports submitted by pharmacists, and thereby assess the possible contribution of pharmacists to the spontaneous reporting system for ADRs in Norway. METHODS: An open, prospective study was conducted where dispensing pharmacists from 39 pharmacies were encouraged to report ADRs over a 3-month period. The submitted ADR reports were compared to reports by physicians from the same time period. All reports were evaluated for selected characteristics, that is distribution of Anatomical Therapeutic Chemical (ATC) classification codes of suspected drugs, distribution of ADRs according to system-organ classes and the quality of the reports. RESULTS: A total of 118 reports covering 274 ADRs received from the pharmacists were compared to 109 ADR reports with 304 ADRs submitted by physicians. Pharmacists more often reported ADRs related to cardiovascular drugs, alimentary tract and metabolism drugs and respiratory drugs, whereas physicians more frequently reported ADRs related to musculoskeletal drugs and antineoplastic and immunomodulating agents. ADRs reported by pharmacists more frequently described gastrointestinal reactions while physicians reported more ADRs in relation to the cardiovascular and blood system. Whereas 68% of the physicians' reports were classified as serious, only 5% of the pharmacists' reports were serious. More than 50% of the reports submitted by pharmacists concerned ADRs following a generic substitution, in contrast to only 2% of the physicians' reports. The pharmacists' reports were found to be of a lower documentation grade. However, there was no substantial difference in a subjective assessment of the quality of information in the reports submitted by the two categories of health professionals. CONCLUSIONS: Pharmacists submit valuable ADR reports which provide information complimentary to physicians' reports. This emphasises that pharmacist ADR reporting might constitute an important addition to the spontaneous reporting system.