Effects of pharmaceutical care on adherence and persistence to bisphosphonates in postmenopausal osteoporotic women

What is known and Objective: Studies have shown that comprehensive interventions by pharmacists can improve adherence and persistence to osteoporosis therapy, but the association between adherence and bone turnover markers (BTMs) has never been studied. Therefore, the aim of this study was to evaluate the effects of pharmaceutical care on medication adherence (and its effects on BTMs), as well as persistence of postmenopausal osteoporotic women to prescribed bisphosphonates. Methods: A randomized controlled trial was conducted from 2005 to 2009 in the University Malaya Medical Centre, Malaysia. Inclusion criteria: postmenopausal osteoporotic women diagnosed with osteoporosis with a T‐score≤?2·5 or who had a low‐trauma fracture and prescribed weekly alendronate/risedronate. Intervention participants received counselling on osteoporosis, risk factors, lifestyle modifications, goals of therapy, side effects and the importance of adherence. Adherence was assessed at months 3, 6 and 12, and persistence at month 12. Feedback on BTMs was provided at months 4 and 7. The control group received no counselling. Two BTMs were used: serum C‐terminal cross‐linking telopeptide of type I collagen (CTX‐I) and serum osteocalcin (OC). Main outcomes measured: medication adherence, BTMs and persistence. Results and Discussion: Intervention participants who received pharmaceutical care reported significantly higher medication adherence at 6 (P = 0·015) and 12 months (P = 0·047) compared with the control group; but this effect was not shown by the BTMs. This is probably due to the long effect of bisphosphonates in bone. A significant difference was found between serum CTX‐I and OC in identifying non‐responders to anti‐resorptive therapy (P < 0·001), indicating the usefulness of BTMs as an objective marker. However, pharmaceutical care did not affect persistence to osteoporosis therapy within a 1‐year period [log rank (Mantel–Cox) χ² = 0·496, P = 0·481]. The proportion of participants who were persistent with bisphosphonate therapy after 12 months was 89·8% and 87·0% in the control and intervention group respectively. What is new and Conclusion: The provision of pharmaceutical care improved medication adherence but not persistence. BTMs were not appropriate objective measures for assessing adherence to weekly bisphosphonates but were useful for identifying non‐responders to treatment within 3–6 months, much earlier than using bone mineral density. The study indicates that pharmacists have a role in improving medication adherence, but its long‐term effect on persistence warrants further studies with longer duration.     

Factors related to medication non-adherence for patients with hypertension in Taiwan

Aims and objective. To characterise a Taiwanese population and to examine the prevalence of antihypertensive medication non‐adherence and how the cultural/clinical factors were associated with non‐adherence in Taiwan. Background. Antihypertensive medication non‐adherence is a significant clinical issue in the United States. However, little is known about hypertension (HTN) control and cultural/clinical factors related to non‐adherence in Taiwan. Design. A convenience sample survey design was used. Method. Data were gathered from a convenience sample of 200 subjects recruited from a large teaching hospital. Medication non‐adherence and cultural/clinical factors were recorded using various self‐administered questionnaires, and blood pressure was taken twice for each participant. Results. The mean age of the participants was 60·4 (SD 11·5 years) including 62% men. Two‐thirds had less than a high school education (64·5%), and the majority of them were married (86·0%) and lived with family or close friends (93·5%). The average length of HTN diagnosis was 8·6 years (SD 9·0 years). Medication non‐adherence rate was 47·5%, and uncontrolled HTN rate was 49·0%. Some participants (17·0%) used Chinese herbs for treating their disease (e.g. cough) and promoting health in addition to their regular antihypertensive medications. Two factors were found to be statistically significant for predicting medication non‐adherence: Lower Perceived Susceptibility to Specific Diseases [OR = 1·15 (95%CI, 1·01–1·31)] and Longer Length of HTN Diagnosis [OR = 1·06 (95%CI, 1·01–1·12)]. Conclusions. Taiwanese at risk of non‐adherence included those who perceived lower susceptibility to specific diseases and had been diagnosed with HTN for a longer time. Those using herbs need to be studied for an impact of herbs on their adherence behaviour. Relevance to clinical practice. These findings can help guide the development of culturally sensitive and clinically appropriate nursing interventions for HTN management in Taiwan.     

Prochlorperazine tablets repackaged into dose administration aids: can the patient be assured of quality?

Background and objective: Patients are increasingly requiring their medications to be repackaged into dose administration aids because of the positive outcomes associated with reduction in medication related hospitalization and adverse effects due to improved medicines management. Since the stability of these repackaged medications is not the responsibility of manufacturer, it is important that drug substances with potential stability issues be identified. Thus the objective of this study was to evaluate the stability of prochlorperazine, a light sensitive drug repackaged into dose administration aids (DAAs), in order to provide guidelines to the pharmacist and advice to the patient on appropriate storage. Methods: Prochlorperazine tablets were stored repackaged in DAAs and in their original packaging for 8 weeks at ambient (25 ± 1 °C; 60 ± 1·5% RH), accelerated (40 ± 1 °C; 75 ± 1·5% RH) and in‐use conditions encountered in situ both in a pharmacy and the patients’ home. They were assessed for both chemical (using a validated HPLC method) and physical stability according to British Pharmacopoeial (BP) standards. In addition, photostability testing was undertaken under ICH conditions. Results and discussion: Chemical and physical stability was confirmed to be within BP Limits.
There were, however, noticeable organoleptic changes in the tablets stored under in‐use conditions with a progressive grey discolouration over the 8 weeks, starting in week 2. Conclusion: Despite the confirmation of physical and chemical stability within BP limits, the discoloration and the potential for photodegradants to cause adverse effects in patients must lead us to draw the conclusion that the quality of this medication has been compromised. Pharmacists thus need to take this into account in repackaging and storage of prochlorperazine in DAAs and advise patients to store their DAA protected from light, heat and humidity.     

Interventions to reduce vasovagal reactions in blood donors: a systematic review and meta‐analysis

Vasovagal reactions (VVRs) in blood donors have significant implications for the welfare of donors, donor retention and the management of donor sessions. We present a systematic review of interventions designed to prevent or reduce VVRs in blood donors. Electronic databases were searched for eligible randomised trials to March 2015. Data on study design and outcomes were extracted and pooled using random effects meta‐analyses. Sixteen trials met the inclusion criteria: five trials (12 042 participants) of pre‐donation water, eight trials (3500 participants) of applied muscle tension (AMT) and one trial each of AMT combined with water, caffeine, audio‐visual distraction and/or social support. In donors receiving pre‐donation water, the relative risk (RR) compared with controls for VVRs was 0·79 [95% confidence interval (CI) 0·70–0·89, P < 0·0001] and the mean difference (MD) in severity of VVRs measured with the Blood Donation Reactions Inventory (BDRI) score was ?0·32 (95% CI ?0·51 to ?0·12, P < 0·0001). Excluding trials with a high risk of selection bias, the RR for VVRs was 0·70 (95% CI 0·45–1·11, P = 0·13). In donors who received AMT, there was no difference in the risk of chair recline in response to donor distress from controls (RR 0·76, 95% CI 0·53–1·10, P = 0·15), although the MD in BDRI score was ?0·07 (95% CI ?0·11 to ?0·03, P = 0·0005). There was insufficient data to perform meta‐analysis for other interventions. Current evidence on interventions to prevent or reduce VVRs in blood donors is indeed limited and does not provide strong support for the administration of pre‐donation water or AMT during donation. Further large trials are required to reliably evaluate the effect of these and other interventions in the prevention of VVRs.     

Using snowball sampling method with nurses to understand medication administration errors

Aims and objectives. We aimed to encourage nurses to release information about drug administration errors to increase understanding of error‐related circumstances and to identify high‐alert situations. Background. Drug administration errors represent the majority of medication errors, but errors are underreported. Effective ways are lacking to encourage nurses to actively report errors. Methods. Snowball sampling was conducted to recruit participants. A semi‐structured questionnaire was used to record types of error, hospital and nurse backgrounds, patient consequences, error discovery mechanisms and reporting rates. Results. Eighty‐five nurses participated, reporting 328 administration errors (259 actual, 69 near misses). Most errors occurred in medical surgical wards of teaching hospitals, during day shifts, committed by nurses working fewer than two years. Leading errors were wrong drugs and doses, each accounting for about one‐third of total errors. Among 259 actual errors, 83·8% resulted in no adverse effects; among remaining 16·2%, 6·6% had mild consequences and 9·6% had serious consequences (severe reaction, coma, death). Actual errors and near misses were discovered mainly through double‐check procedures by colleagues and nurses responsible for errors; reporting rates were 62·5% (162/259) vs. 50·7% (35/69) and only 3·5% (9/259) vs. 0% (0/69) were disclosed to patients and families. High‐alert situations included administration of 15% KCl, insulin and Pitocin; using intravenous pumps; and implementation of cardiopulmonary resuscitation (CPR). Conclusions. Snowball sampling proved to be an effective way to encourage nurses to release details concerning medication errors. Using empirical data, we identified high‐alert situations. Strategies for reducing drug administration errors by nurses are suggested. Relevance to clinical practice. Survey results suggest that nurses should double check medication administration in known high‐alert situations. Nursing management can use snowball sampling to gather error details from nurses in a non‐reprimanding atmosphere, helping to establish standard operational procedures for known high‐alert situations.     

Intravenous bisphosphonates for post-menopausal osteoporosis: adherence to a network guideline

What is known and Objective: An evidence‐based guideline on the use of intravenous (i.v.) bisphosphonates in post‐menopausal osteoporosis was developed across a healthcare system and approved by clinical experts and Pharmacy and Therapeutics Committees. The objective of the study was to evaluate adherence to the guideline at hospitals in the healthcare system. Methods: Post‐menopausal women who received i.v. zoledronic acid or i.v. ibandronate for osteoporosis between September 2007 and October 2008 were identified through a data repository that provides patient‐level longitudinal information on diagnoses, medications and laboratory tests. Manual review of electronic medical records supplemented the data capture. The guideline recommends use of i.v. bisphosphonates in patients: (i) who have had a recent vertebral or hip fracture; (ii) who cannot stand or sit upright for 30–60 min; (iii) who have oesophageal dysmotility or varices; (iv) who have documented adherence issues or, (v) who failed to tolerate oral bisphosphonates after 12 months. In addition, specific monitoring tests are recommended prior to administration. Results and Discussion: Among the 220 women that received an i.v. bisphosphonate (hospitals A/B: n = 92 vs. hospital C: n = 128), 72% met the criteria for use. The results were similar when examined by institution (hospitals A/B 66% vs. hospital C 77%; P = 0·094). On review of the electronic medical records, an additional reason for using i.v. bisphosphonates was identified: persistent bone loss despite oral bisphosphonate therapy. When this criterion for use was included, the adherence rate increased to 80% (hospitals A/B 72% vs. hospital C 86%; P = 0·009). Serum calcium and 25‐OH vitamin D were performed in 75% (hospitals A/B 77% vs. hospital C 73%; P = 0·53), and 86% (hospitals A/B 84% vs. hospital C 87%; P = 0·53) of patients respectively. What is new and Conclusion: Adherence to an i.v. bisphosphonates evidence‐based guideline was adequate (defined as at least 80%) although room for improvement in meeting the criteria for use at one hospital and for conducting baseline serum calcium levels was noted. A future project is warranted to re‐assesses adherence after the measures to improve guideline adherence are implemented.     

Inappropriate prescribing in older residents of Australian care homes

What is known and objective: The incidence of inappropriate prescribing is higher amongst the older age group than the younger population. Inappropriate prescribing potentially leads to drug‐related problems such as adverse drug reactions. We aimed to determine the prevalence of inappropriate prescribing in residents of Tasmanian (Australia) residential care homes using Beers and McLeod criteria. Methods: Patient demographics, medical conditions and medications were collected from medical records. The patients who fulfilled either Beers or McLeod criteria were identified and the characteristics of these patients were then compared. Results: Data for 2345 residents were collected between 2006 and 2007. There were 1027 (43·8%) patients prescribed at least one inappropriate medication. Beers criteria identified more patients (828 patients, 35·3%) as being prescribed inappropriate medication compared with McLeod criteria (438 patients, 18·7%). Patients taking psychotropic medication/s, more than six medications or diagnosed with five or more medical conditions were more likely to be prescribed an inappropriate medication (P < 0·001). The most frequently identified inappropriate medications included benzodiazepines, amitriptyline, oxybutynin and non‐steroidal anti‐inflammatory drugs. What is new and conclusion: Inappropriate prescribing, as defined by either Beers criteria or McLeod criteria, is relatively common in Australian nursing homes. The prevalence of inappropriate prescribing, and factors influencing it, are consistent with other countries. Both Beers and McLeod criteria are a general guide to prescribing, and do not substitute for professional judgment.     

Effectiveness of a community pharmacist intervention in diabetes care: a randomized controlled trial

What is known and Objective: There is little evidence from well‐designed randomized controlled trials of the impact of community pharmacist intervention on the clinical management of patients with type 2 diabetes. It is also not known how sustainable any observed effects on glycaemic control are, over time. This study was initiated to address both these issues. Methods: A 6‐month, randomized, controlled parallel‐group trial in 66 community pharmacies was conducted in Belgium. Patients were randomly assigned to receive usual pharmacist care (n = 135) or a predefined pharmacist intervention (n = 153). The intervention mainly focused on correct medication use, medication adherence and healthy lifestyle promotion. Primary outcome was glycaemic control, as measured by fasting plasma glucose and HbA1c. Sustainability of changes in glycaemic control was assessed by additional glucose measurements 18 months after the end of the study. Results and Discussion: The intervention significantly reduced HbA1c (between‐group difference: 0·5%, P = 0.009). The largest impact on HbA1c was observed when pharmacotherapy changes (i.e., type and/or dose of hypoglycaemic agents) initiated by the physician were sustained with pharmaceutical care: HbA1c was reduced by 1·05% in the intervention group, whose medication was changed, compared with a reduction of 0·02% in the therapy‐modification only, group. It was also found that the diabetes education program resulted in improved self‐management and better knowledge of diabetes. Eighteen months after the end of the formal study period, the mean HbA1c of the intervention group did not differ significantly from the control group (7·4% vs. 7·2%). What is new and Conclusion: This study provides new evidence, from a randomized controlled trial, of the beneficial effect of community pharmacist intervention in the clinical management of type 2 diabetic patients. However, questions remain about the sustainability of the observed improvements.     

A training package for primary care nurses in conducting medication reviews: their views and the resultant outputs

Aims. To ascertain nurses’ views about training in and undertaking of medication reviews and to analyse documented pharmaceutical care issues (PCI) and outputs from nurse reviews. Background. Primary‐care nurses in the UK are increasingly expected to contribute effectively to chronic disease management for example by undertaking medication reviews. There are concerns that nurse education is inadequate for these new roles. Little research is published about nurse medication reviews. A pilot study in one Scottish medical practice demonstrated that, after training in systematic medication review, practice‐based nurses could identify medication‐related problems. The training, consisting of reading material, including self‐assessment questions and a training event, was subsequently offered to all practice‐based nurses in the Community Health Partnership (CHP); participants then undertook six reviews to achieve CHP accreditation. Design. Survey of participant nurses and analysis of completed documentation from reviews. Methods. A self‐completion, postal questionnaire distributed three months post‐training. Analysis of documentation from reviews for PCI and outputs. Results. Eighty‐one nurses were offered training: 64 (79%) participated; 38 (59%) returned questionnaires. Low confidence levels before training (0, very confident; 6, 16% confident) rose afterwards (8, 21% very confident; 19, 50% confident). Thirty‐two (84%) nurses indicated the training had completely or mostly met their needs. A total of 120 nurse reviews were analysed and 188 PCI documented, mean 1·6/patient, with 117 outputs, mean 1·0/patient. Twenty‐seven outputs (23%) involved prescribed medicine changes. Conclusions. A pharmacist‐supported training package in medication reviews for primary‐care nurses is feasible and generally welcome. The training met the needs of most respondents although concerns were expressed regarding time pressures and knowledge base for extended roles. Relevance to clinical practice. Medication reviews are vitally important for both patients and the NHS; this approach may be useful for nurse prescribers and non‐prescribers alike although concerns expressed will require attention.     

The efficacy and safety of vildagliptin in patients with type 2 diabetes: a meta-analysis of randomized clinical trials

What is known and Objective: Dipeptidyl peptidase‐4 (DPP‐4) inhibitors are a relatively new class of drugs for the management of type 2 diabetes (T2DM). Vildagliptin is an oral DPP‐4 inhibitor approved in more than 70 countries. The purpose of this meta‐analysis is to provide an update on the clinical efficacy and safety of vildagliptin in patients with T2DM. Methods: A literature search identified 30 randomized controlled trials comparing vildagliptin with comparators (placebo or other hypoglycaemic agents). Meta‐analyses were conducted for HbA1c, weight, fasting plasma glucose (FPG), hypoglycaemia and other adverse events. The outcomes of HbA1c, weight and FPG were analysed as weighted mean differences (WMD), and the number of ADRs events as relative risks (RR). Results: Compared with placebo, vildagliptin lowered HbA1c {WMD, ?0·77% [95% confidence interval (CI), ?0·96% to ?0·58%] for 100 mg/day of vildagliptin and ?0·58% [95% CI, ?0·72% to ?0·44%] for 50 mg/day of vildagliptin}. The effect was non‐inferior to thiazolidinediones, sulfonylureas and α‐glycosidase inhibitors, but inferior to metformin. Compared with placebo, treatment with 50 mg/day of vildagliptin caused neutral weight changes, while 100 mg/day of vildagliptin resulted in slight weight gain [0·95 kg (95% CI, 0·73–1·17 kg)]. In addition, compared to comparators, vildagliptin was not associated with an increase in overall risk for any adverse events [RR, 0·97 (95% CI, 0·94–0·99)]. The incidence of hypoglycaemia was low with vildagliptin, and the risk with vildagliptin was not significantly different from the comparators [0·85 (95% CI, 0·49–1·47)]. The use of vildagliptin did not display any increased risks of infection [1·03 (95% CI, 0·94–1·13) for nasopharyngitis and 1·07 (95% CI, 0·90–1·27) for upper respiratory tract infection]. What is new and Conclusion: Vildagliptin is effective in glycaemic control with a low risk of hypoglycaemia and other adverse reactions. This may have an important impact on patient adherence to this medication.     

Perceived adverse patient outcomes correlated to nurses’ workload in medical and surgical wards of selected hospitals in Kuwait

Aim. This study was carried out to identify the perceived adverse patient outcomes as related to nurses’ workload. It also assessed nurses’ perception of variables contributing to the workload and adverse patient outcomes. Background. Several studies have been published on adverse patient outcomes in which a correlation was found between nurses’ workload and some adverse patient outcomes. Design. A cross‐sectional survey was conducted between registered nurses (n = 780) working in medical and surgical wards of five general governmental hospitals in Kuwait. Data collection instruments. Data were collected using a self‐administered questionnaire consisting of three sections to elicit information about the sample characteristics, perception of workload and perceived adverse patient outcomes during the last shift and last working week. Results. The three major perceived adverse outcomes reported by the nurses while on duty during their last shift were: complaints from patients and families (2%), patients received a late dose or missed a dose of medication (1·8%) and occurrences of pressure ulcer (1·5%). Similarly, the reported adverse outcomes over the past week were complaints from patients and families (5%), patients received a late dose or missed a dose of medication (5·3%) and discovery of a urinary tract infection (3·7%). Increases in nurse‐patient load, bed occupancy rate, unstable patients’ condition, extra ordinary life support efforts and non‐nursing tasks; all correlated positively with perceived adverse patient outcomes. Conclusion. This study sheds light on an important issue affecting patient safety and quality of care as perceived by the nurses themselves as caregivers. Relevance to clinical practice. Nurses’ perception of variables contributing to adverse patient outcomes and their workload could significantly affect the provided nursing care and nursing care recipients. The findings could help in policy formulation and planning strategies to decrease adverse patient outcomes in many countries with a health care structure similar to that of Kuwait.     

Clinical implementation of systematic medication reconciliation and review as part of the Lund Integrated Medicines Management model – impact on all‐cause emergency department revisits

What is known and objective: Interventions involving medication reconciliation and review by clinical pharmacists can reduce drug‐related problems and improve therapeutic outcomes. The objective of this study was to examine the impact of routine admission medication reconciliation and inpatient medication review on emergency department (ED) revisits after discharge. Secondary outcomes included the combined rate of post‐discharge hospital revisits or death. Methods: This prospective, controlled study included all patients hospitalized in three internal medicine wards in a university hospital, between 1 January 2006 and 31 May 2008. Medication reconciliation on admission and inpatient medication review, conducted by clinical pharmacists in a multiprofessional team, were implemented in these wards at different times during 2007 and 2008 (intervention periods). A discharge medication reconciliation was undertaken in all the study wards, during both control and intervention periods. Patients were included in the intervention group (n = 1216) if they attended a ward with medication reconciliation and review, whether they had received the intervention or not. Control patients (n = 2758) attended the wards before implementation of the intervention. Results and Discussion: No impact of medication reconciliation and reviews on ED revisits [hazard ratio (HR), 0·95; 95% confidence interval (CI), 0·86–1·04]or event‐free survival (HR, 0·96; 95% CI, 0·88–1·04) was demonstrated. In the intervention group, 594 patients (48·8%) visited the ED, compared with 1416 (51·3%) control patients. In total, 716 intervention (58·9%) and 1688 (61·2%) control patients experienced any event (ED visit, hospitalization or death). Because the time to a subsequent ED visit was longer for the control as well as the intervention groups in 2007 than in 2006 (P < 0·05), we re‐examined this cohort of patients; the proportion of patients revisiting the ED was similar in both groups in 2007 (P = 0·608). What is new and conclusion: Routine implementation of medication reconciliation and reviews on admission and during the hospital stay did not appear to have any impact on ED revisits, re‐hospitalizations or mortality over 6‐month follow‐up.     

Patient expectations of benefit from common interventions for low back pain and effects on outcome: secondary analysis of a clinical trial of manual therapy interventions

Abstract

Objectives: The purpose of this secondary analysis was 1) to examine patient expectations related to a variety of common interventions for low back pain (LBP) and 2) to determine the influence that specific expectations about spinal manipulation might have had on self‐report of disability.

Methods: We collected patients' expectations about the benefit of specific interventions for low back pain. We also collected patients' general expectations about treatment and tested the relationships among the expectation of benefit from an intervention, receiving that intervention and disability‐related outcomes.

Results: Patients expected exercise and manual therapy interventions to provide more benefit than surgery and medication. There was a statistical association between expecting relief from thrust techniques and receiving thrust techniques, related to meeting the general expectation for treatment (chi‐square: 15·5, P = 0·008). This was not the case for patients who expected relief from thrust techniques but did not receive it (chi‐square: 6·9, P =?0·4). Logistic regression modeling was used to predict change in disability at treatment visit 5. When controlling for whether the general expectations for treatment were met, intervention assignment and the interaction between intervention assignment and expectations regarding thrust techniques, the parsimonious model only included intervention as the significant contributor to the model (P < 0·001). The adjusted odds ratio of success comparing thrust techniques to non‐thrust in this study was 41·2 (11·0, 201·7).

Discussion: The findings of this secondary analysis indicate that patients seeking intervention for LBP expect active interventions and manual therapy to significantly help improve their pain more than interventions like traction, rest, surgery, or medication. Additionally, in patients who meet the clinical prediction rule for good prognosis when managed with thrust techniques, treating with thrust techniques is more important than matching treatment to patient expectation.     

Urinary incontinence prevalence and risk factors in women aged 20 and over in Malatya

The purpose of this population‐based cross‐sectional study is to determine the prevalence and risk factors of urinary incontinence (UI) in women over 20 years old. The study was conducted with 800 women and the participants were stratified by age and residence. The data obtained from the study revealed that prevalence of UI was 32·4%, while the most frequently encountered type of UI was mixed urinary incontinence (72·6%). Logistic regression analysis results demonstrated the most important risk factors for UI as aging [≥50, Odds ratio (OR) 2·94, 95% confidence interval (CI) 1·68–5·13], chronic obstructive pulmonary disease (OR 2·90, 95% CI 1·15–7·34) and recurrent urinary tract infections (OR 3·30, 95% CI 1·94–5·61).