A systematic review of pharmacists performing obstructive sleep apnea screening services

Background Obstructive sleep apnea (OSA) is a chronic sleep disorder associated with a varying degree of upper airway collapse during sleep. Left untreated, OSA can lead to the development of cardiovascular disease including risk of stroke and increased mortality. Pharmacists are the most accessible and underutilized healthcare resource in the community and can have a significant role in screening patients for OSA. The result may include an expedited referral to the patient’s general practitioners or sleep disorder specialists for further diagnostic assessment and therapeutic intervention. Aim of the review The primary aim of this review was to identify the current published evidence of pharmacists providing OSA screening services in a community pharmacy setting. Methods A literature search was conducted to identify evidence of pharmacists providing OSA screening services. The literature search including five databases [PubMed, (1946-January 2015), Cumulative Index of Nursing and Allied Health Literature, International Pharmaceutical Abstracts (1970 to January 2015), Cochrane Database of Systematic Reviews and Google Scholar] with search terms of (“pharmacist or pharmacy”) AND (“obstructive sleep apnea”) AND (“sleep disorders”) AND (“continuous positive airway pressure—CPAP”) were used. Articles were limited to English and reported in humans. Results A total of seven publications (four Australia, two Switzerland and one France) were selected and evaluated. Pharmacists utilized validated screening tools in 6/7 (86 %) of clinical studies to assist in the identification of patients with sleep disorders in community pharmacies. A total of 1701 pharmacies encompassing 9177 patients were screened in the clinical studies. Pharmacists were able to identify between 21.4 and 67 % of patients that were at risk for developing OSA or required a referral to a general practitioner or sleep disorder specialist for further diagnostic testing. Conclusion Studies assessing the role of pharmacists performing OSA screening services remains limited due to the small number of studies available and differences in methodological assessment. More qualitative studies including randomized controlled trials are needed to better identify the value of pharmacists providing this novel service.     

Sleep health management in community pharmacy: Where are we and where should we be heading?

BackgroundPoor sleep health is now recognised as a significant risk factor for chronic diseases and is associated with considerable comorbidity and mortality. Community pharmacists are primary care clinicians with an integral role in sleep health promotion and chronic sleep disorder management; however, it is unclear to what extent this is currently being undertaken or what the perspectives of Australian community pharmacists regarding their role in sleep health are.ObjectivesTo explore community pharmacists’ current sleep health practice and perspectives on the potential future of sleep health care in community pharmacy.MethodsQualitative semi-structured interviews were carried out with a maximally varied, convenience-based purposive sample of community pharmacists. Interviews were audio-recorded, transcribed verbatim and subjected to, in sequence; an inductive analysis followed by a deductive approach where the inductively derived thematic structure was used as a framework.ResultsTwenty-five community pharmacists from two Australian states were interviewed. Insomnia and obstructive sleep apnea (OSA) were the most frequently encountered sleep disorders in community pharmacy presentations. Four key themes were derived from the data: 1) Preparedness, 2) Approach, 3) Capabilities and 4) What needs to change? All participants reported that their sleep health knowledge was insufficient and emphasized the need for more education and training. Although some were engaged in providing OSA services, none of the participants offered services for insomnia or other sleep disorders. Time/task pressures, low health system/health care professional sleep health recognition/awareness and the lack of standardised pharmacy-specific sleep health management guidelines were commonly cited barriers for sleep health service provision.ConclusionCommunity pharmacists commonly manage day-to-day sleep health; however, most expressed a need for increased sleep health recognition/awareness by the health system, targeted education/training for pharmacists and support for the future provision of community pharmacy-delivered sleep health services. With the appropriate implementation strategies, community pharmacists could utilise their availability and accessibility to improve the future of primary care sleep health management.     

How do pharmacists respond to complaints of acute insomnia? A simulated patient study

Objective It is known that many people with insomnia choose to self medicate and present at community pharmacies, particularly in cases of acute insomnia. The objective of this study is to investigate how community pharmacists respond to complaints of acute insomnia from people who seek self treatment and determine the factors affecting this response. Setting Community pharmacies in New South Wales, Australia. Method A simulated patient study was conducted in 100 randomly selected pharmacies located in Newcastle and Sydney, Australia. A standardized scenario of acute sleep onset insomnia and a scoring system was used in each pharmacy. Main outcome measures Main outcome measures included supply/non supply of an over the counter sleep aid to the simulated patient, and scores for pharmacists for skills in eliciting information prior to supply of medication (Pre Supply Score), counseling about medication (Supply Score), or about sleep (Sleep Score). Results Of the 100 pharmacies, upon simulated patient presentation, 96% supplied a product, the remaining 4% referred to a physician. Non-pharmacological advice was provided in 42%. Pharmacists scored highly on advice provided with supply of a medication (Supply scores/4, 3.1 ± 0.9), but lower on skills in eliciting information prior to supply (Pre-supply score/8, 3.6 ± 1.9) and sleep related counselling (Sleep Score/9, 2.1 ± 1.7). Lower estimated pharmacist age, being in a chain type pharmacy, and having a visible symbol of quality accreditation were found to significantly improve (P < 0.05 the Sleep Score outcome. Lower estimated pharmacist age as also significantly associated with higher Supply Score (P < 0.05); whilst both lower estimated age an visible quality assurance signage were associated with higher Pre-Supply scores (P < 0.05). Conclusion The results of this study suggest that many pharmacists are responding appropriately to complaints of sleeplessness in terms of eliciting insomnia type and counseling about medicines use. However more education for pharmacists would help to further promote good sleep health, and address behaviors including reliance on medicines taking that can progressively worsen insomnia.     

A polysomnography study of eszopiclone in elderly patients with insomnia

ABSTRACT

Objective: To evaluate the safety and efficacy of eszopiclone 2?mg in elderly patients (aged 64-86 years) with chronic insomnia.

Methods: This was a randomized, double-blind, placebo-controlled 2‐week study. Patients meeting DSM-IV criteria for primary insomnia and screening polysomnography criteria (wakefulness after sleep onset [WASO] ≥ 20?min and latency to persistent sleep ≥ 20?min) were randomized to 2 weeks of nightly treatment with eszopiclone 2?mg (n = 136) or placebo (n = 128). Efficacy was assessed using polysomnography (Nights 1, 2, 13, and 14) and patient reports (Nights 1–14); safety was assessed using adverse events, clinical labs, physical examination, and vital signs. The mean of all efficacy results during the double-blind period was used for the efficacy analysis.

Results: Results indicated that eszopiclone was associated with significantly shorter sleep onset, less WASO, higher sleep efficiency, more total sleep time, and greater patient-reported quality and depth of sleep scores than placebo (?p < 0.05 for all) with a trend in patient-reported morning sleepiness (?p = 0.07). Other measures of daytime functioning (ability to function, daytime alertness, and sense of well-being) were not significantly different between the two treatment groups. Among patients who napped, eszopiclone patients reported fewer naps (?p = 0.03) and less cumulative naptime (median: 98?min placebo, 70?min eszopiclone, p = 0.07). Unpleasant taste, dry mouth, somnolence, and dizziness were higher in the eszopiclone group (12.5%, 8.8%, 6.6%, and 6.6%, respectively) than in the placebo group (0%, 1.6%, 5.5%, and 1.6%, respectively).

Conclusion: In this study, eszopiclone was well tolerated and produced significant improvements in both polysomnographic and patient-reported measures of sleep maintenance, sleep induction, and sleep duration in elderly patients with chronic primary insomnia.     

Evaluation of a training and communication-network nephrology program for community pharmacists

Objectives To assess the feasibility and impact of implementing ProFiL program to optimize community-pharmacist management of drug-related problems among chronic kidney disease patients followed in a predialysis clinic. The program comprises a training workshop, communication-network program and consultation service. Setting Forty-two community pharmacies, 101 pharmacists, and 90 chronic kidney disease patients attending a predialysis clinic in Laval (Canada). Patients were followed-up for 6 months. Method In a six-month, pilot, open, cluster-randomized controlled trial, community pharmacies were assigned to ProFiL or the usual care. Chronic kidney disease patients of these pharmacies attending a predialysis clinic were recruited. ProFiL pharmacists attended a workshop, received patient information (diagnoses, medications, and laboratory-test results) and had access to a consultation service. Their knowledge and satisfaction were measured before and after the workshop. The mean numbers of pharmacists’ written recommendations to physicians (pharmaceutical opinions) and refusals to dispense a medication were computed. Results Of the ProFiL pharmacists, 84% attended the workshop; their knowledge increased from 52% to 88% (95% CI: 29–40%). Most ProFiL pharmacists rated workshop (95%), communication program (82%) and consultation service (59%) as “excellent” or “very good”; 82% said the program improved the quality of their follow-up. The consultation service received 21 requests. ProFiL and usual care pharmacists issued a mean of 0.50 and 0.02 opinion/patient, respectively, (95% CI of the adjusted difference: 0.28–1.01 opinion/patient). Conclusion The results of this pilot study suggest that ProFiL can be implemented and may help community pharmacists intervene more frequently to manage drug-related problems. However, a larger-scale study with longer follow-up is necessary to evaluate the impact of the program on management of drug-related problems and its clinical relevance. Institution where the study was conducted: Centre ambulatoire, Centre de santé et de services sociaux de Laval. Information about presentation of the work as an abstract or poster: Abstracts of this study have been published in the proceedings of the 3rd Canadian Joint Therapeutics Congress of the Canadian Society for Clinical Pharmacology—Canadian Association for Population Therapeutics—Canadian College of Clinical Pharmacy (Toronto, Canada, May 2006), the Colloque 2006 of the Réseau québécois de recherche sur l’usage des médicaments (Quebec, Canada, June 2006), the 22nd International Conference of the International Society of Pharmacoepidemiology (Lisbon, Portugal, August 2006), and the North American Primary Care Research Group (NAPCRG) annual meeting (Vancouver, Canada, October 2007).     

The knowledge and attitude of the Turkish community pharmacists toward pharmacovigilance in the Kadikoy district of Istanbul

Objective We investigated the knowledge and attitudes of community pharmacists towards pharmacovigilance and adverse drug reactions (ADRs) in Kadık?y district of Istanbul (Turkey). Setting The community pharmacies in Kadikoy. Kadikoy is one of the biggest districts of Istanbul and has the largest number of pharmacies. Kadikoy district was divided into two regions, the central and the peripheral. Method Between December 2005 and June 2006 we conducted a survey about the knowledge and attitude of community pharmacists (n = 219) using a face-to-face questionnaire. The questionnaire consisted of questions about the sociodemographic characteristics of the pharmacists, their knowledge of pharmacovigilance and their attitudes towards ADR reporting. Main outcomes measured The knowledge of pharmacovigilance practice, ADR reporting compliance rates, reasons for not reporting ADR and perceptions of the Turkish community pharmacists on pharmacovigilance practice were evaluated. Results Although all 411 pharmacies in the Kadikoy district were visited, only 53% of the community pharmacists (n = 219) consented to participate in the study. Of those that did respond, only 17.2% of the pharmacists had any knowledge about ‘pharmacovigilance’. Sixty-five percent of the pharmacists stated that patients reported an ADR to them during the previous 12 months, and 21% of pharmacists reported to the concerned organizations. Our survey showed that only 7% actually reported an ADR to the national pharmacovigilance center. On the other hand, 89% of the pharmacists believed that the role of the pharmacist in ADR reporting was essential. Conclusion The results show that Turkish community pharmacists have poor knowledge about pharmacovigilance. There is an urgent need for educational programs to train them about pharmacovigilance and ADR reporting.     

Cardiovascular risk screening program in Australian community pharmacies

Objective To assess the suitability of Australian community pharmacies as cardiovascular disease risk profile screening centres and evaluate whether community pharmacists can play an important role in detecting, educating and referring screened individuals at high risk of cardiovascular disease. Setting 14 Australian community pharmacies. Method Opportunistic cardiovascular disease risk profiling for members of the public aged greater than 30 years with no existing cardiovascular diseases was performed. All major cardiovascular risk factors were measured. Exercise habits, existing conditions and therapy, and family history were also assessed. The results were used to calculate each subject’s 10-year risk of developing cardiovascular events, based on Framingham Risk Equations (New Zealand tables). Each subject’s knowledge of cardiovascular risk factors was assessed using a multiple-choice questionnaire. Written educational materials and verbal counselling were provided. Referral to a doctor for further assessment was recommended as appropriate. The screened individuals were followed up via mailed out questionnaire. A random sample of individuals at elevated risk was phoned to assess for outcomes of the screening and referral process. Main outcome measures Risk of developing cardiovascular disease and knowledge of cardiovascular risk factors. Results A total of 655 individuals (71.4% female) were screened for cardiovascular disease risk factors. Ages ranged from 30 to 90 years (median: 54 years) and 14.2% were smokers. Of the individuals screened, 28.1% had a 10-year risk of developing cardiovascular disease greater than 15%, including 6.9% who had a 10-year risk above 30%. The median calculated 10-year risk of developing cardiovascular disease was 9.5%. Approximately one-third of the individuals had elevated blood pressure, and almost two-thirds were either overweight or obese. The mean total serum cholesterol was 5.31 mmol/l, with 40% of individuals having a level above 5.5 mmol/l and 20% having a high-density lipoprotein cholesterol level below 1.0 mmol/l. There was a statistically significant improvement in the knowledge of cardiovascular disease risk factors at follow-up. Almost half of the contacted high-risk subjects reported lifestyle changes or started drug therapy following re-testing by their general practitioner. Conclusion A pharmacy-based cardiovascular disease risk profile screening and education program has the potential to identify and refer many undiagnosed individuals at high risk of cardiovascular events, and help contain the burden of heart disease.     

Mg2+ reduces ACTH secretion and enhances spindle power without changing delta power during sleep in men – possible therapeutic implications

Disturbances of Mg²⁺ metabolism have been reported in association with affective disorders, seizures in eclampsia, and alcohol withdrawal. Mg²⁺ has been reported to have N-methyl-D-aspartate (NMDA)-antagonistic and gamma-aminobutyric acid (GABA)-agonistic properties and modulation of GABA_A- and NMDA-dependent systems is involved in pharmacological treatment of affective disorders and seizures. We studied the effect of Mg²⁺ on sleep electroencephalogram (EEG) and nocturnal hormonal secretion in men. Ten normal controls were given MgSO₄ (3 g MgSO₄ between 2030 hours and 2100 hours, followed by 0.5 g MgSO₄ per hour until 0700 hours) or placebo IV according to a randomized schedule. The sleep EEG was recorded from 2300 hours to 0700 hours. Blood samples were taken from 2000 hours to 0700 hours for analysis of plasma corticotropin (ACTH), cortisol, growth hormone, prolactin and melatonin. The sleep-EEG power within the spindle frequency range (11.0–12.9 Hz) showed a significant increase in the third sleep cycle, but delta power was unchanged throughout the night. ACTH concentration was suppressed between 2200 hours and 0700 hours. No changes in cortisol, growth hormone prolactin or melatonin release were found. The findings are consistent with the assumption that Mg²⁺ has GABA_A-agonistic or NMDA-antagonistic effects on sleep and nocturnal hormonal secretion and hence may be useful in controlling depressive symptoms and seizures. Received: 24 June 1997/Final version: 29 October 1997     

Change of body weight and lifestyle of persons at risk for diabetes after screening and counselling in pharmacies

Objective To investigate the effects of pharmacy based counselling on changes in lifestyle and body weight. Methods Three months after screening a stratified sample of 3,800 randomly chosen overweight persons were addressed with questionnaires. Half a year and 1 year later the assessment was repeated. Standard counselling (SC; non-specific recommendations towards lifestyle), intensive counselling (IC; additional advice to reduce body weight) and counselling for persons at high risk for type 2 diabetes (HRC; recommendation to contact a physician) were compared. Results All counselling groups (SC; n = 557, IC; n = 568, HRC; n = 245) showed significant weight loss three months after screening (0.6–1.9 kg). A further weight reduction was observed at 1 year follow up (1.1–2.4 kg). The HRC group showed a higher percentage of weight loss than the IC or SC group after 3 months (−2.25% vs. −1.20% and −0.67%; P < 0.001) and at 1 year of follow-up (−2.74% vs. −1.54% and −1.29%; P < 0.01). Lifestyle changes in physical activity and/or nutrition were reported by 81.2% in the HRC group, 74.1% in the IC group and 67.0% in the SC group. Conclusion Immediate counselling in community pharmacies after screening for type 2 diabetes can result in significant lifestyle changes and weight loss in overweight individuals.     

合肥市856名学龄前儿童睡眠问题分析

目的 分析合肥市学龄前儿童睡眠问题,为改善儿童睡眠健康提供依据。方法 合肥市妇幼保健计划生育服务中心于2018年4～6月采用儿童睡眠习惯问卷对合肥市瑶海区、新站区856名3～6岁儿童家长进行调查,观察比较学龄前儿童就寝时间及夜间睡眠时间,分析学龄前儿童睡眠问题及其危险因素。结果 合肥市学龄前儿童平均每日就寝时间为21：39,夜间睡眠时间为（9.72±0.62）h。23.01%儿童就寝时间晚于22：00,61.45%儿童夜间睡眠时间<10 h。总体睡眠问题发生率为790名（92.29%）,以睡眠焦虑774名（90.42%）、就寝习惯不良757名（88.43%）、睡眠持续时间不规律580名（67.76%）、白天嗜睡576名（67.29%）最常见,儿童与家人同床睡眠率高达667名（77.92%）。同床睡眠是儿童睡眠质量不良的独立危险因素（OR=11.288,P<0.001）。结论 合肥市学龄前儿童睡眠习惯不良较为普遍,应引起家长和社会重视。     

Opinion comparison concerning future information technology in Finnish community pharmacies

Objective To compare the opinions of community pharmacy owners, managers and personnel concerning the key features of the future information technology system needed in Finnish community pharmacies. Setting The study was targeted to the pharmacists working in community pharmacies as managers (owners and staff pharmacists with M.Sc. degree) or personnel responsible for dispensing and patient counselling (pharmacists with B.Sc. degree). Method A national cross-sectional survey to all of Finnish community pharmacy owners (n = 580) and staff pharmacists (B.Sc. and M.Sc. degrees, n = 1709) working in community pharmacies, was conducted in order to determine differences in opinions between these occupation groups with different professional duties. The response rates were 53% for pharmacy owners (n = 308) and 22% for staff pharmacists (n = 373). Main outcome measure The main outcome measure was the perceived importance of 89 potential features for a new IT system ranked by using a five-point Likert scale. Results The responding community pharmacy managers and staff pharmacists had differences in their ranking of more than half (52%) of the potential features listed in the survey questionnaire. The features related to the pharmacy’s internal processes, such as financial management, sales and marketing management and stock holding, were ranked significantly higher by the managers, while the personnel prioritized the features supporting pharmaceutical service provision and personnel management. The managers and personnel shared their opinion on the importance of features supporting drug information and patient counselling, medication safety and interprofessional collaboration. Conclusion The managers and staff pharmacists have different views of the importance of IT features, reflecting their different professional duties in the community pharmacy. A high priority was given for the features familiar to the users and needed in their daily practice. This indicates the need for involving different occupation groups in planning the new IT systems for community pharmacies.     

Decline in prolonged hormone replacement therapy in women aged 45 years or more,and impact of a centralised database tool

Objective Evaluation of discontinuation in prolonged use of menopausal and post‐menopausal hormone replacement therapy (HRT) in The Netherlands after the publication of the Million Women Study in The Lancet of August 9, 2003. Furthermore estimation of the contribution of a centralised database tool on this decline, supplying community pharmacists with their patients on prolonged HRT therapy. Setting Dispensing data of more than 90% of Dutch community pharmacies were collected in a centralised database. Shortly after the publication of the Million Women Study, this database was used to offer community pharmacists online access to a listing of their patients with prolonged HRT use. Methods In August 2003 all women who had used HRT for at least one year were selected as long‐term users. This cohort was followed until April 2004. The proportion of patients who had stopped their prolonged HRT in this cohort was calculated. This decline was also measured according to the use of a database tool. For this purpose community pharmacies were divided into pharmacies who had repeatedly consulted the centralised database tool (T pharmacies; n = 343) and control pharmacies who had evidently not consulted the tool (C pharmacies; n =490). The two groups of pharmacies were compared according to characteristics of the pharmacy on which information was available in the centralised database. They were also compared for patient characteristics that were routinely collected in the database. Differences between the two groups for averages of these parameters were tested with a chi square test and with a chi square test for trend for ordinal variables with more categories. The proportion of patients who stopped their prolonged HRT was calculated for each of the two groups of pharmacies. These proportions were compared with a Z test for proportions. The two groups of pharmacies were compared for cessation of HRT treatment and for ceasing treatment earlier by a Kaplan‐Meier survival curve. Cox survival analyses was used to estimate the chances for discontinuation of HRT for patients within the two pharmacy groups with the possibility to adjust for possible confounders such as patient's age and type of HRT medication. Key findings After publication of the Million Women Study in The Lancet of August 9, 2003, 63% of the women in The Netherlands who had used HRT for more than one year in August 2003 had stopped their prolonged use in April 2004. A centralised database tool supplying community pharmacists with a list of their patients on prolonged HRT therapy caused a significantly higher proportion of cessation in the T group of pharmacies than in the C group (65% versus 62%; P < 0.05). Furthermore, the time needed for halving the number of patients on prolonged HRT was significantly shorter in T pharmacies than in C pharmacies (187 days versus 202 days; P < 0.05). Patients in T pharmacies had a significantly increased chance of 7.6% (95% confidence interval: 1.05–1.10) of discontinuing their HRT and of doing so earlier. Conclusions The results of the Million Women Study had a major impact on prolonged HRT use in The Netherlands. A centralised database tool for prolonged use of HRT could have a modest but significant impact on dispensing patterns.     

Short-term treatment with gaboxadol improves sleep maintenance and enhances slow wave sleep in adult patients with primary insomnia

Rationale Gaboxadol is a selective extrasynaptic GABA_A agonist, previously in development for the treatment of insomniac patients. Objective To evaluate the acute efficacy and safety of gaboxadol in primary insomnia (PI). Methods This was a randomised, double-blind, four-way crossover, polysomnograph study comparing gaboxadol 10 and 20 mg (GBX20) to placebo in 40 adults with the Diagnostic and Statistical Manual of Mental Disorders, 4th edition, criteria for PI. Zolpidem 10 mg was used as an active reference. Treatment was administered on two consecutive nights in each treatment session. Next-day residual effects were evaluated 2 and 9 h after lights on. Results Efficacy analysis included the per-protocol population (n = 38) from night 2. GBX20 reduced wake after sleep onset (p < 0.01). Both doses of gaboxadol, but not zolpidem, reduced the number of night awakenings (p < 0.001). GBX20 and zolpidem increased total sleep time (p < 0.05). Neither dose of gaboxadol nor zolpidem significantly reduced sleep onset latency, although a trend was seen for zolpidem. Gaboxadol enhanced slow wave sleep (SWS) dose-dependently (gaboxadol 10 mg: p < 0.01, GBX20: p < 0.001). Patients reported improved sleep quality following GBX20 (p < 0.05). Both doses of gaboxadol were generally well tolerated with almost exclusively mild to moderately severe adverse events (AEs). More frequent and severe AEs followed GBX20. No serious AEs were reported. No drug treatment was associated with next-day residual effects. Conclusion Acute administration of gaboxadol improves sleep maintenance and enhances SWS in a dose-dependent manner in adult patients with PI. Gaboxadol was not associated with next-day residual effects. Gaboxadol was generally well tolerated, although gaboxadol showed a dose-dependent increase in incidence and severity of AEs. This study was funded by H. Lundbeck A/S.     

Relationship between drug-related problems and health outcomes: a cross-sectional study among cardiovascular patients

Objective To describe drug-related problems (DRPs) and expense problems (EPs) identified by a standardised community pharmacist-based medication review (MR) program among Swiss cardiovascular outpatients (56–75 years old) and to evaluate the need for collaborative pharmacy practice to achieve economic, clinical and humanistic outcomes. Setting A pilot population of 85 cardiovascular outpatients who were customers of 14 community pharmacies (members of the pharmacieplus virtual chain) and insured with Groupe Mutuel health insurance. Method Cross-sectional study of a structured medication review program, conducted by 11 pharmacists in collaboration with 61 general practitioners (GPs), with patient interviews and access to medical data. Main outcome measure Numbers and types of DRPs and EPs within the study population and odds ratios between them, as well as economic, clinical and humanistic outcomes. Results Of the included patients, 91% had at least one DRP or EP. The odds ratios indicated that not being exposed to DRPs was associated with a higher chance of reaching the clinical target (OR: 3.4; IC95%:1.1–10.5; P = 0.01), of having a better physical quality of life than the median (OR: 2.5; IC95%:0.9–7.3; P = 0.05) and having lower total health care costs (OR: 3.2; IC95%:1.1–9.8; P = 0.02). Conclusions This cross-sectional study shows that the control of cardiovascular risk factors, quality of life and healthcare costs are statistically related to the presence of DRPs detected by a community pharmacist-based MR program.     

Efficacy of prolonged release melatonin in insomnia patients aged 55–80 years: quality of sleep and next-day alertness outcomes

ABSTRACT

Objective: Melatonin, the hormone produced nocturnally by the pineal gland, serves as a circadian time cue and sleep-anticipating signal in humans. With age, melatonin production declines and the prevalence of sleep disorders, particularly insomnia, increases. The efficacy and safety of a prolonged release melatonin formulation (PR-melatonin; Circadin 2?mg) were examined in insomnia patients aged 55 years and older.

Design: Randomised, double blind, placebo-controlled.

Setting: Primary care.

Methodology: From 1248 patients pre-screened and 523 attending visit 1, 354 males and females aged 55–80 years were admitted to the study, 177 to active medication and 177 to placebo. The study was conducted by primary care physicians in the West of Scotland and consisted of a 2‐week, single blind, placebo run-in period followed by a 3‐week double blind treatment period with PR-melatonin or placebo, one tablet per day at 2 hours before bedtime.

Main outcome measures: Responder rate (concomitant improvement in sleep quality and morning alertness on Leeds Sleep Evaluation Questionnaire [LSEQ]), other LSEQ assessments, Pittsburgh Sleep Quality Index (PSQI) global score, other PSQI assessments, Quality of Night and Quality of Day derived from a diary, Clinical Global Improvement scale (CGI) score and quality of life (WHO‐5 well being index).

Results: Of the 354 patients entering the active phase of the study, 20 failed to complete visit 3 (eight PR-melatonin; 12 Placebo). The principal reasons for drop-out were patient decision and lost to follow-up. Significant differences in favour of PR-melatonin vs. placebo treatment were found in concomitant and clinically relevant improvements in quality of sleep and morning alertness, demonstrated by responder analysis (26% vs. 15%; p = 0.014) as well as on each of these parameters separately. A significant and clinically relevant shortening of sleep latency to the same extent as most frequently used sleep medications was also found (–24.3 vs.–12.9 minutes; p = 0.028). Quality of life also improved significantly (?p = 0.034).

Conclusions: PR-melatonin results in significant and clinically meaningful improvements in sleep quality, morning alertness, sleep onset latency and quality of life in primary insomnia patients aged 55 years and over.

Trial registration: The trial was conducted prior to registration being introduced.     

Efficacy and safety of eszopiclone across 6-weeks of treatment for primary insomnia

SUMMARY

Objective: Eszopiclone is a new, single-isomer, non-benzodiazepine, cyclopyrrolone agent under investigation for the treatment of insomnia. The present study was a randomized, double-blind, multicenter, placebo-controlled trial conducted to assess the efficacy and safety of eszopiclone in adults with chronic primary insomnia.

Research design and methods: Patients (n = 308) were randomized to receive placebo or eszopiclone (2?mg or 3?mg) for 44 consecutive nights, followed by 2 nights of single-blind placebo. Efficacy was evaluated with polysomnography (Nights 1, 15 and 29) and patient-reports (Nights 1, 15, 29 and 43/44). Next-day residual effects were evaluated using the Digit-Symbol Substitution Test (DSST).

Results: Eszopiclone 3?mg had significantly less time to sleep onset (?p ≤ 0.0001), more total sleep time and sleep efficiency (?p ≤ 0.0001), better sleep maintenance (p ≤ 0.01), and enhanced quality and depth of sleep (?p < 0.05) across the double-blind period compared with placebo. Eszopiclone 2?mg had significantly less time to sleep onset (?p ≤ 0.001), more total sleep time (?p ≤ 0.01) and sleep efficiency (?p ≤ 0.001), and enhanced quality and depth of sleep (?p < 0.05) compared with placebo, but did not significantly improve sleep maintenance. There was no evidence of tolerance or rebound insomnia after therapy discontinuation. Median DSST scores showed no decrement in psychomotor performance relative to baseline and did not differ from placebo in either eszopiclone group. Treatment was well tolerated; the most common adverse event related to eszopiclone was unpleasant taste.

Conclusions: Patients treated with nightly eszopiclone 3?mg had better polysomnographic (through Night 29) and patient-reported measures (through Night 44) of sleep over the 6-week trial. There was no evidence of tolerance or rebound insomnia and no detrimental effects on next-day psychomotor performance using the DSST.     

Refinement of an osteoporosis risk‐assessment questionnaire for use in community pharmacy

Objective To explore the influence of bone mineral density (BMD) tests in osteoporosis risk categorisation in community pharmacies, and to develop a simple tool for pharmacists to use as a pre‐BMD test screen. Method A secondary data analysis was conducted on the responses of 193 participants to a risk‐assessment questionnaire, used in previous osteoporosis research that included a BMD test. To explore the impact of the BMD test on pharmacists' categorisation of risk, the researchers made an independent assessment based on responses of the questionnaire. The influence of risk factors on BMD scores/bone status was explored using multiple and logistic regression respectively. Key findings A total of responses of 193 participants were available for study, with 113 in the BMD group and 80 from the non‐BMD group. In the BMD group, both researchers and pharmacists identified a similar proportion of patients in the moderate/high‐risk category when BMD results were incorporated in the risk assessments (X² = 0.78, degrees of freedom (df) = 1, 0.3 < P < 0.5). A statistically significant difference in risk categorisation was found between the pharmacists and researchers in the non‐BMD group (X² = 23.9, df = 1, P < 0.001). Risk factors identified to be significantly affecting BMD and of use for identifying patients at high risk for osteopenia/osteoporosis were age, weight, postmenopause and absence of hormone replacement therapy (HRT). These four factors were used to construct a simple risk index to guide pharmacists' initial risk categorisation. Conclusion The findings of this study suggested that BMD testing may increase the effectiveness of risk assessments and enhance the screening procedures in the community pharmacy. The simple risk index could serve as a pre‐BMD test screen, with a BMD test recommended when necessary. A refined risk‐assessment questionnaire could serve to guide pharmacists in directing individualised counselling and advice for at‐risk patients, through identification of modifiable risk factors and conditions.     

Prescribing errors during hospital inpatient care: factors influencing identification by pharmacists

Objective: To investigate the prevalence of prescribing errors identified by pharmacists in hospital inpatients and the factors influencing error identification rates by pharmacists throughout hospital admission. Setting: 880-bed university teaching hospital in North-west England. Methods: Data about prescribing errors identified by pharmacists (median: 9 (range 4–17) collecting data per day) when conducting routine work were prospectively recorded on 38 randomly selected days over 18 months. Main outcome measures: Proportion of new medication orders in which an error was identified; predictors of error identification rate, adjusted for workload and seniority of pharmacist, day of week, type of ward or stage of patient admission. Results: 33,012 new medication orders were reviewed for 5,199 patients; 3,455 errors (in 10.5% of orders) were identified for 2,040 patients (39.2%; median 1, range 1–12). Most were problem orders (1,456, 42.1%) or potentially significant errors (1,748, 50.6%); 197 (5.7%) were potentially serious; 1.6% (n = 54) were potentially severe or fatal. Errors were 41% (CI: 28–56%) more likely to be identified at patient’s admission than at other times, independent of confounders. Workload was the strongest predictor of error identification rates, with 40% (33–46%) less errors identified on the busiest days than at other times. Errors identified fell by 1.9% (1.5–2.3%) for every additional chart checked, independent of confounders. Conclusions: Pharmacists routinely identify errors but increasing workload may reduce identification rates. Where resources are limited, they may be better spent on identifying and addressing errors immediately after admission to hospital.