P.A.G.M. de Smet

Prevalence and determinants of pharmacy shopping behaviour.

Background and objective:  Discontinuity of care bears the risk of medication errors and poor clinical outcomes. Little is known about the continuity of care related to pharmacies. Therefore, we studied the prevalence and determinants of pharmacy shopping behaviour in the Netherlands.

Risk of Lactic Acidosis or Elevated Lactate Concentrations in Metformin Users With Renal Impairment: A Population-Based Cohort Study

OBJECTIVE The objective of this study was to determine whether treatment with metformin in patients with renal impairment is associated with a higher risk of lactic acidosis or elevated lactate concentrations compared with users of a noninsulin antidiabetic drug (NIAD) who had never used metformin. RESEARCH DESIGN AND METHODS A cohort of 223,968 metformin users and 34,571 diabetic patients who had never used metformin were identified from the Clinical Practice Research Datalink (CPRD).The primary outcome was defined as either a CPRD READ code lactic acidosis or a record of a plasma lactate concentration >5 mmol/L. The associations between renal impairment, dose of metformin, and the risk of lactic acidosis or elevated lactate concentrations were determined with time-dependent Cox models and expressed as hazard ratios (HRs). RESULTS The crude incidence of lactic acidosis or elevated lactate concentrations in current metformin users was 7.4 per 100,000 person-years (vs. 2.2 per 100,000 person-years in nonusers). Compared with nonusers, risk of lactic acidosis or elevated lactate concentrations in current metformin users was significantly associated with a renal function <60 mL/min/1.73 m2 (adjusted HR 6.37 [95% CI 1.48–27.5]). The increased risk among patients with impaired renal function was further increased in users of ≥730 g of metformin in the preceding year (adjusted HR 11.8 [95% CI 2.27–61.5]) and in users of a recent high daily dose (>2 g) of metformin (adjusted HR 13.0 [95% CI 2.36–72.0]). CONCLUSIONS Our study is consistent with current recommendations that the renal function of metformin users should be adequately monitored and that the dose of metformin should be adjusted, if necessary, if renal function falls below 60 mL/min/1.73 m2.

Reporting Format for Economic Evaluation: Part II: Focus on Modelling Studies

This article presents the first version of a reporting format for modelling studies which is based on a general reporting format by our taskforce, which was published in the previous issue of this journal. The use of decision-analytical models for economic evaluations is increasing because, in practice, it is not always possible to derive information from prospective studies. However, the acceptance of modelling studies is generally lower than prospective studies not only because of the use of secondary data, but also because the reports of modelling studies do not always have sufficient transparency. Hence, a standardised reporting format may improve the transparency and, consequently, the acceptance of modelling studies. This article presents an example of a reporting format for economic evaluation based on modelling studies, which may facilitate the development of future guidelines for modelling studies. The format consists of a number of headings, which are followed by a brief recommendation on the content. This format does not deal with methodology and data management, but especially addresses validation and quality assurance, which may increase the transparency of the report.

User-related pharmaceutical care problems and factors affecting them: the importance of clinical relevance.

Background and objectives:  Many studies determined the number and nature of user‐related Pharmaceutical Care Problems (PCP) and factors affecting them, but none considered the inclusion of clinical relevance.

Reporting Format for Economic Evaluation: Part I: Application to the Dutch Healthcare System

SummaryThis article presents the first version of the reporting format for economic valuation that was created in 1995 by a multidisciplinary taskforce. The members of this taskforce come from a broad spectrum of backgrounds within the healthcare field and participated in the exercise voluntarily. The format presented should be understood as the preferred Dutch structure for the reporting of any study on economic evaluation. In view of the many areas of contention that exist within the field, this format only gives normative directions in those areas in which consensus exists, as evidenced by the current published international guidelines. A regular review and adaptation of this format will be needed to reflect advances in the field.

Instructions on laboratory monitoring in 200 drug labels.

Abstract Background: Monitoring drug treatment is important to assess the therapeutic effects and to prevent adverse drug reactions. Unfortunately, the clinical evidence for monitoring is often missing. To attain evidence-based laboratory monitoring and to improve patient safety it is mandatory for the clinical chemist to develop effective and rational methods for monitoring. The legal source for this evidence-based information is the drug label. We analysed frequency, nature, and applicability of instructions on laboratory monitoring described in 200 drug labels. Methods: The applicability of instructions was assessed with an adapted Systematic Information for Monitoring score. Seven items of information were evaluated: why to monitor, what to monitor (essential), when to start or stop monitoring, how frequently to monitor, critical value (essential) and how to respond (essential). Each item scored one point when information was described specifically, otherwise the score was zero. Instructions were applicable if all three essential items scored. Results: In 131 drug labels, 566 instructions on laboratory monitoring were identified, an average of 2.8 per drug label. Kidney, liver, electrolyte, and drug monitoring were important biomarker categories (71%). The median applicability score was 2.1 (0–6) and 95 (17%) instructions were applicable. Six determinants were associated with applicable instructions: kidney (OR 7.0; 95% CI 4.4–11.3), creatine phosphokinase (4.5; 1.5–13.6), drug selection (6.8; 4.0–11.7), dose adjustments (2.4; 1.5–3.7), year on the market 2000–2007 (2.6; 1.1–6.1) and statins (4.8; 2.5–9.0). Conclusions: Drug labels frequently describe instructions on laboratory monitoring, but these are ambiguous and incomplete and clinical applicability for the professional is limited.

Cue-Responding Behaviors During Pharmacy Counseling Sessions With Patients With Asthma About Inhaled Corticosteroids: Potential Relations With Medication Beliefs and Self-Reported Adherence

ABSTRACT The aim of this study was to examine cue-responding behavior at the pharmacy while counseling about inhaled corticosteroids (ICS) in relation to medication adherence and medication beliefs. Patients with asthma aged ≥18 years using ICS were recruited from 12 pharmacies. Counseling sessions were video-recorded. Patients’ emotional and informational cues and pharmacists’ and pharmacy technicians’ cue-responding behaviors were coded using an expanded version of the Medical Interview Aural Rating Scale. The Beliefs about Medicines Questionnaire assessed patients’ ICS concern and necessity beliefs. Self-reported ICS adherence was measured by four questions. During the 86 sessions, patients expressed on average 2.3, mostly informational, cues (70.8%). In 26.7% of the sessions, no cues were expressed. Pharmacists’ and technicians’ responses to emotional cues (59.3%) were mostly inadequate, and to informational cues mostly appropriate (63.6%). Providing inappropriate information (20.3%) was related to higher concerns post session (p < .05), and cue exploration to higher self-reported adherence at 3 months (p < .05). Apparently, providers’ responses to patients’ cues might have therapeutic value. In addition, patients might need to be encouraged to ask questions and express their concerns.

South American ritual Anadenanthera enemas

Certain differences between the native and experimental administration of hallucinogens, such as another route of administration, should not be disregarded. To set an example, the ritual use ofAnadenanthera enemas by South American Indians is discussed. In pharmacological studiesAnadenanthera alkaloids have been found to produce the alleged effects of these dosage forms. However, in contrast with dimethyltryptamine and its 5-methoxyderivative, bufotenine is likely to have no or only a weak central activity. Up to now oral administration has not been demonstrated to be effective, although relatively large doses have been studied. As first-pass metabolism is a likely cause of this inactivity, it cannot be safely assumed that rectal administration will give better results than oral administration.SamenvattingBepaalde verschillen tussen de inheemse en experimentele toediening van hallucinogenen, zoals een andere toedieningsweg, mogen niet worden veronachtzaamd. Om een voorbeeld te geven wordt het rituele gebruik vanAnadenanthera klysmas door Zuidamerikaanse indianen besproken. In farmacologische onderzoekingen hebbenAnadenanthera-alkaloïden de werking die aan deze toedieningsvormen wordt toegeschreven. Het is evenwel aannemelijk dat bufotenine, in tegenstelling tot dimethyltryptamine en het 5-methoxyderivaat daarvan, geen of een slechts zwakke centrale werking heeft. Tot dusverre is niet aangetoond dat orale toediening effectief is, hoewel relatief hoge doses zijn onderzocht. Aangezien ‘first-pass’ metabolisme een aannemelijke oorzaak hiervan is, kan niet veilig worden aangenomen dat rectale toediening betere resultaten zal geven dan orale toediening.

No Evidence for an Association Between Renal Function and Serious Bleeding Events in Patients Treated With Coumarins: A Population-Based Study

Background: Although anticoagulation therapy is closely monitored in the Netherlands, coumarin-induced serious bleeding events are still observed. Current literature suggests that renal impairment may contribute to this. Objective: To explore the association between renal function and bleeding events during coumarin treatment. Methods: A nested case-control study was conducted using data from the PHARMO Database Network. Patients hospitalized for a bleeding event during coumarin treatment were selected as cases and matched on sex, birth year, and geographic region to up to 2 controls using coumarins without hospitalization for bleeding. All values of estimated glomerular filtration rates (eGFRs) were selected in the year before index date (case hospitalization date) and compared between cases and controls using logistic regression analyses. Results: In total, 2224 cases were matched to 4398 controls (61% male; mean ± SD age 75 ± 11 and 78 ± 11 years among cases and controls, respectively). Availability of eGFR values was higher among cases compared with controls (mean ± SD eGFR values 4.5 ± 7.1 vs 3.2 ± 5.5), reflected in the significantly shorter time since last eGFR value (at index date, mean ± SD = 2.7 ± 3.0 vs 3.8 ± 3.1 months; odds ratio [OR] = 0.91, 95%CI = 0.89-0.92). No statistically significant difference was found for the mean eGFR value in the year before index date (mean ± SD 65.7 ± 22.8 vs 64.6 ± 20.9 mL/min/1.73 m2; OR per 10 units [95%CI] = 0.99 [0.96-1.02]). Conclusions: No association between renal function and serious bleeding events during coumarin treatment was observed.

Potential Medication Triggers Of Deteriorated Renal Function Among Patients With Type 2 Diabetes: Using Real World Data

(SR) was conducted using MEDLINE and EMBASE (1996-2017). Key terms included a combination of neurogenic bladder, treatment patterns and epidemiological study. The inclusion criteria for studies were: 1) published in English; 2) conducted in human subjects; 4) reporting the treatment patterns/use in NGB (any neurogenic condition listed in the EAU guidelines); 5) conducted in a real world setting. Articles were reviewed for inclusion by an independent reviewer (AJ) and 10% were cross examined by a second independent reviewer (FF). A narrative synthesis of results was conducted and percentage of treatment use was reported in ranges. Results: A total of eight studies met the inclusion criteria. Study designs, setting, and patient groups were notably heterogeneous and all data was collected before 2008. This SR found that the most commonly used management method amongst NGB patients was reflex voiding (RV) methods and catheterisation (CIC and IndUC). Data and commentary from three studies show that a notable amount of patients switched treatments. The most popular oral pharmacotherapies were alpha-blockers and antimuscarinics used for neurogenic detrusor overactivity (NDO) and detrusor sphincter dyssynergia (DSD). One study which focused on spina bifida reported that the majority of patients underwent surgery. ConClusions: With passing time, clinicians have moved away from techniques associated with higher rates of complications and mortality. This has meant that in recent years, the survival chances of patients with NGB have increased. This suggests that current treatment patterns will be different from what was uncovered in this review. Epidemiological studies using electronic healthcare records (EHRs) are necessary to advance our understanding in how NGB patients are managed in current practice, and how well patterns relate to practice guidelines.