Intern pharmacists as change agents to improve the practice of nonprescription medication supply: provision of salbutamol to patients with asthma

BACKGROUND: Earlier work established an evidence practice gap during provision of nonprescription salbutamol (albuterol). Pharmacist interns are hypothesized to be in a position to improve professional practice in the community pharmacy setting. OBJECTIVE: To explore the potential of intern pharmacists to improve the professional practice of community pharmacy staff in the provision of nonprescription salbutamol. METHODS: Intern pharmacists (n = 157) delivered an asthma intervention in 136 pharmacies consisting of an educational activity to pharmacy staff and a health promotion campaign to consumers. Post-intervention, simulated patients presented to 100 intervention and 100 control community pharmacies with a request for salbutamol. The appropriate outcome was medical referral for poor asthma control and correction of poor inhaler technique. Incidence and quantity of patient assessment and counseling provided during the visit were also assessed. Logistic regression was used to determine the predictors of medical referral. RESULTS: A doubling in the rate of medical referral was seen in the intervention group (19% vs 40%; p = 0.001). Assessment of reliever use frequency was the main predictor of medical referral (OR = 22.7; 95% CI 9.06 to 56.9). Correction of poor inhaler technique did not improve; however, a reduction in salbutamol supplied without patient assessment (23% vs 8%; p = 0.009) or counseling (75% vs 48%; p < 0.001) was noted. CONCLUSIONS: A doubling in the rate of medical referral showed a clear improvement in professional practice during the provision of nonprescription salbutamol. The improved patient outcome in the intervention group was due to increased assessment of reliever use frequency. Identification of poor inhaler technique remained near zero in both groups, which suggests that intern pharmacists were able to improve the current practice of community pharmacies yet were unable to establish a new practice behavior. This study provides evidence that intern pharmacists can act as change agents to improve pharmacy practice.

Measuring the assessment and counselling provided with the supply of non-prescription asthma reliever medication: a simulated patient study

BACKGROUND: Over one quarter of asthma reliever medications are provided without prescription by community pharmacies in Australia. Evidence that community pharmacies provide these medications with sufficient patient assessment and medication counseling to ensure compliance with the government's Quality Use of Medicines principles is currently lacking. OBJECTIVE: To assess current practice when asthma reliever medication is provided in the community pharmacy setting and to identify factors that correlate with assessment of asthma control. METHODS: Researchers posing as patients visited a sample of Perth metropolitan community pharmacies in May 2007. During the visit, the simulated patient enacted a standardized scenario of someone with moderately controlled asthma who wished to purchase a salbutamol (albuterol) inhaler without prescription. Results of the encounter were recorded immediately after the visit. Regression analysis was performed, with medication use frequency (a marker of asthma control) as the dependent variable. RESULTS: One hundred sixty community pharmacies in the Perth metropolitan area were visited in May 2007. Pharmacists and/or pharmacy assistants provided some form of assessment in 84% of the visits. Counseling was provided to the simulated patients in 24% of the visits. Only 4 pharmacy staff members asked whether the simulated patient knew how to use the inhaler. Significant correlation was found between assessment and/or counseling of reliever use frequency and 3 independent variables: visit length (p < 0.001), number of assessment questions asked (p < 0.001), and the simulated patient who conducted the visit (p < 0.02). CONCLUSIONS: Both patient assessment and medication counseling were suboptimal compared with recommended practice when nonprescription asthma reliever medication was supplied in the community pharmacy setting. Pharmacy and pharmacist demographic variables do not appear to affect assessment of asthma control. This research indicates the need for substantial improvements in practice in order to provide reliever medication in line with Quality Use of Medication principles of ensuring safe and effective use of medication.

The use of absorption enhancers to enhance the despersibility of spray-dried powders for pulmonary gene therapy

Background: Pulmonary gene therapy requires aerosolisation of the gene vectors to the target region of the lower respiratory tract. Pulmonary absorption enhancers have been shown to improve the penetration of pharmaceutically active ingredients in the airway. In this study, we investigate whether certain absorption enhancers may also enhance the aerosolisation properties of spray-dried powders containing non-viral gene vectors. Methods: Spray-drying was used to prepare potentially respirable trehalose-based dry powders containing lipid-polycation-pDNA (LPD) vectors and absorption enhancers. Powder morphology and particle size were characterised using scanning electron microscopy and laser diffraction, respectively, with gel electrophoresis used to assess the structural integrity of the pDNA. The biological functionality of the powders was quantified using in vitro cell (A549) transfection. Aerosolisation from a Spinhaler® dry powder inhaler into a multistage liquid impinger (MSLI) was used to assess the in vitro dispersibility and deposition of the powders. Results: Spray-dried powder containing dimethyl-β-cyclodextrin (DMC) demonstrated substantially altered particle morphology and an optimal particle size distribution for pulmonary delivery. The inclusion of DMC did not adversely affect the structural integrity of the LPD complex and the powder displayed significantly greater transfection efficiency as compared to unmodified powder. All absorption enhancers proffered enhanced powder deposition characteristics, with the DMC-modified powder facilitating high deposition in the lower stages of the MSLI. Conclusions: Incorporation of absorption enhancers into non-viral gene therapy formulations prior to spray-drying can significantly enhance the aerosolisation properties of the resultant powder and increase biological functionality at the site of deposition in an in vitro model. Copyright © 2005 John Wiley & Sons, Ltd.

Selection and education of patients for inhaled insulin

Inhaled insulin is a recent advance in insulin delivery that promises to be an effective alternative to subcutaneous insulin. Several insulin delivery systems are currently in development and the first of these has been approved for clinical use. Inhaled insulin offers greater flexibility and convenience for patients with diabetes and may be particularly useful in those who are reluctant to initiate or intensify insulin treatment. Although promising, potential concerns remain regarding its long-term effects on lungs. Also, excluding certain groups of patients such as smokers and those with respiratory illnesses will restrict its use at present. Lack of familiarity with the technology, especially relating to dose adjustments and inhaler device, is also likely to present fresh challenges. But, careful selection of patients, education, and continued support from health professionals is vital to ensure success with this new technology.

Spray drying lactoferrin produces inhalable antimicrobial particles

The use of antimicrobial peptides and proteins as potential therapeutic agents in the management of multi-drug resistant infections is considered an attractive concept especially since such compounds should theoretically have low immunogenicity, high bioavailability with negligible toxicity. In this study we investigated the potential of developing a dry powder inhaler formulation of lactoferrin (a multifunctional iron binding protein). To achieve this, the protein was spray dried from a water only feedstock with suitably adjusted spray drying parameters. The particle size, degree of crystallinity, moisture content and yield of the spray dried powders along with the minimum bactericidal concentration (MBC) against Pseudomonas aeruginosa strain PAO1, were assessed. Dry powder inhaler formulations were prepared, and in vitro assessment studies using the multistage impinger were carried out to assess the aerosolisation performance of the formulations. Data obtained indicate that spray dried lactoferrin retains activity against biofilms and may be successfully employed in the treatment of chronic airway infections.

The use of sodium carboxymethylcellulose in the preparation of spray-dried proteins for pulmonary drug delivery

The use of sodium carboxymethylcellulose (NaCMC) as a spray-drying excipient in the preparation of inhalable formulations of proteins was investigated, using alkaline phosphatase as a model functional protein. Two spray-dried powders were investigated: a control powder comprising 100% (w/w) alkaline phosphatase and a test powder comprising 67% (w/w) NaCMC and 33% (w/w) alkaline phosphatase. Following physicochemical characterisation, the powders were prepared as both dry powder inhaler (DPI) and pressurised metered dose inhaler (pMDI) formulations. The aerosolisation performance of the formulations was assessed using a Multi-Stage Liquid Impinger, both immediately after preparation and over a 16-week storage period. Formulating the control powder as a DPI resulted in a poor fine particle fraction (FPF: 10%), whereas the FPF of the NaCMC-modified DPI formulation was significantly greater (47%). When the powders were formulated as pMDI systems, the control and NaCMC-modified powders demonstrated FPFs of 52% and 55%, respectively. Following storage, reduced FPF was observed for all formulations except the NaCMC-modified pMDI system; the performance of this formulation following storage was statistically equivalent to that immediately following preparation. Co-spray-drying proteins and peptides with NaCMC may therefore offer an alternative method for the preparation of stable and respirable pMDI formulations for pulmonary delivery. © 2010 Elsevier B.V.

Historical cohort study examining comparative effectiveness of albuterol inhalers with and without integrated dose counter for patients with asthma or chronic obstructive pulmonary disease

This study was supported financially by an unrestricted grant from Teva Pharmaceuticals, Frazer, PA, USA. The authors thank Jenny Fanstone of Fanstone Medical Communications Ltd., UK, and Elizabeth V Hillyer for medical writing support, funded by Research in Real-Life. We acknowledge with gratitude Dr Ruchir Parikh for his review of and contributions to the manuscript.

Supporting self-management: development and evaluation of a digital resource for adults with asthma

The problem: Around 300 million people worldwide have asthma and prevalence is increasing. Support for optimal self-management can be effective in improving a range of outcomes and is cost effective, but is underutilised as a treatment strategy. Supporting optimum self-management using digital technology shows promise, but how best to do this is not clear. Aim: The purpose of this project was to explore the potential role of a digital intervention in promoting optimum self-management in adults with asthma. Methods: Following the MRC Guidance on the Development and Evaluation of Complex Interventions which advocates using theory, evidence, user testing and appropriate modelling and piloting, this project had 3 phases. Phase 1: Examination of the literature to inform phases 2 and 3, using systematic review methods and focussed literature searching. Phase 2: Developing the Living Well with Asthma website. A prototype (paper-based) version of the website was developed iteratively with input from a multidisciplinary expert panel, empirical evidence from the literature (from phase 1), and potential end users via focus groups (adults with asthma and practice nurses). Implementation and behaviour change theories informed this process. The paper-based designs were converted to the website through an iterative user centred process (think aloud studies with adults with asthma). Participants considered contents, layout, and navigation. Development was agile using feedback from the think aloud sessions immediately to inform design and subsequent think aloud sessions. Phase 3: A pilot randomised controlled trial over 12 weeks to evaluate the feasibility of a Phase 3 trial of Living Well with Asthma to support self-management. Primary outcomes were 1) recruitment & retention; 2) website use; 3) Asthma Control Questionnaire (ACQ) score change from baseline; 4) Mini Asthma Quality of Life (AQLQ) score change from baseline. Secondary outcomes were patient activation, adherence, lung function, fractional exhaled nitric oxide (FeNO), generic quality of life measure (EQ-5D), medication use, prescribing and health services contacts. Results: Phase1: Demonstrated that while digital interventions show promise, with some evidence of effectiveness in certain outcomes, participants were poorly characterised, telling us little about the reach of these interventions. The interventions themselves were poorly described making drawing definitive conclusions about what worked and what did not impossible. Phase 2: The literature indicated that important aspects to cover in any self-management intervention (digital or not) included: asthma action plans, regular health professional review, trigger avoidance, psychological functioning, self-monitoring, inhaler technique, and goal setting. The website asked users to aim to be symptom free. Key behaviours targeted to achieve this include: optimising medication use (including inhaler technique); attending primary care asthma reviews; using asthma action plans; increasing physical activity levels; and stopping smoking. The website had 11 sections, plus email reminders, which promoted these behaviours. Feedback during think aloud studies was mainly positive with most changes focussing on clarification of language, order of pages and usability issues mainly relating to navigation difficulties. Phase 3: To achieve our recruitment target 5383 potential participants were invited, leading to 51 participants randomised (25 to intervention group). Age range 16-78 years; 75% female; 28% from most deprived quintile. Nineteen (76%) of the intervention group used the website for an average of 23 minutes. Non-significant improvements in favour of the intervention group observed in the ACQ score (-0.36; 95% confidence interval: -0.96, 0.23; p=0.225), and mini-AQLQ scores (0.38; -0.13, 0.89; p=0.136). A significant improvement was observed in the activity limitation domain of the mini-AQLQ (0.60; 0.05 to 1.15; p = 0.034). Secondary outcomes showed increased patient activation and reduced reliance on reliever medication. There was no significant difference in the remaining secondary outcomes. There were no adverse events. Conclusion: Living Well with Asthma has been shown to be acceptable to potential end users, and has potential for effectiveness. This intervention merits further development, and subsequent evaluation in a Phase III full scale RCT.