ABSTRACT
The inhaled route of medicines delivery has been heralded as a major development in respiratory therapeutics. Drug delivery via inhalation offers significant advantages such as greater efficacy and reduced side effects, as compared to the oral route of drug administration. Consequently, several innovative drug delivery devices have been developed for manufacturers of drugs used in respiratory conditions. Asthma therapy is now largely available in the inhaled form, with devices ranging from conventional nebulisers to the more contemporary dry powder inhalers. Dry powder inhaler devices include devices with discrete multi dose units (eg the Accuhaler), or a reservoir with a mechanism for metering dose amounts (eg the Turbuhaler), with the patients inspiratory flow generating targeted drug delivery. Whilst quite evolutionary in design and concept, a major limitation to the effective use of inhaled medication is the inability of patients to use these devices correctly as high rates of incorrect device technique (28-68%), with pressurised metered dose inhalers and dry powder inhalers, have been reported. In turn, incorrect device usage defeats the purpose of therapy, and has been shown to lead to poor control and outcomes in those using inhaled corticosteroids for prevention of asthma symptoms.
Pharmacists are in an excellent position to educate patients about appropriate inhaler technique, as they are the last health care professionals seen by patients before an inhaled medication is used. International asthma guidelines recommend that pharmacists should form part of a team approach to patient education about use of inhalers. In addition, current evidence suggests that pharmacists' interventions can lead to a positive impact on the management of many chronic diseases including asthma. However, pharmacists are not currently fulfilling their responsibilities regarding educating patients on correct inhaler technique. Studies have revealed an alarming lack of knowledge regarding the correct use of inhaler devices among community pharmacists.
With these issues in focus, this project aimed to determine the effect of a specialised counselling service delivered by specially trained community pharmacists to asthma patients on dry powder inhaler technique, and to assess patients’ resultant clinical and humanistic health outcomes. In addition, a subsequent aim was to develop a module for asthma educators to use in training pharmacists on correct inhaler technique, so they could in turn deliver appropriate inhaler technique education to their asthma patients. This module could then be used to sustain the inhaler technique education service in community practice.
To meet these aims, the study was undertaken in stages. The first stage was to conduct an interactive device-training workshop that followed the "train the trainer" approach, based on adult learning principles, including physical demonstration, hands-on training with inhalers, peer assessment and instant feedback. In this workshop, pharmacists were randomly assigned to Active and Control groups. Pharmacists in the Active group were trained on device technique and lung function assessment (Peak Flow Meter (PFM) use) in order to be able to deliver an intervention targeting inhaler technique, while pharmacists in the Control group were trained in lung function assessment (PFM use) only, in order to deliver standard care. The training workshops lasted 3 and 2 hours for Active and Control groups respectively.
The project then moved into the second stage, where a blinded cluster randomised study was conducted to investigate the effect of a simple pharmacist delivered educational intervention, targeting inhaler technique, on patients' clinical and humanistic outcomes.
The pharmacists approached every second asthmatic patient who presented a prescription for an inhaled corticosteroid contained in a TH or ACC device at their pharmacy. Following a 2 week run-in period, where PFM readings were recorded, patients in the Active group presented at the pharmacy for 5 visits (time = 0,1,2,3,6 months), at which times the intervention was delivered. The intervention included a specialised "Show-and-Tell" Inhaler Technique counselling service, with augmented verbal counselling and physical demonstration using a placebo inhaler, addressing all steps in the inhaler technique checklist. Active pharmacists highlighted any incorrect steps initially performed by the patients on a custom-designed "Inhaler Technique Label" which was pre-printed with the items from the technique checklists. At the completion of counselling, the pharmacist attached the highlighted Inhaler Technique Label to the patient's own inhaler. At each subsequent visit, inhaler technique assessment and education were repeated. Patients in the Control group visited the pharmacy for assessment at the same intervals and received standard care. Both groups also performed 2 weeks of peak flow monitoring before visits at 3 and 6 months. Asthma severity was assessed at every visit, while reliever use was assessed at baseline, 3 and 6 months from baseline. Data for humanistic outcomes (Asthma-related Quality of Life (AQOL) and Perceived Control (PC)) were collected at baseline, 3 and 6 months from baseline.
With regards to the pharmacists' own inhaler technique following the workshop, inhaler technique of Active pharmacists was later re-assessed at 3 and 6 months. Both pharmacist groups were reassessed 12 months after study completion i.e. 2 years post-initial training at the workshop. After the final assessment, Control group pharmacists were delivered the Active group inhaler technique education.
One hundred and sixteen patients were screened by the 31 pharmacists recruited and commenced two weeks of Peak Expiratory Flow (PEF) monitoring, with 97 (84%) returning to complete enrolment at visit 2. Inhaler technique education took an average of 2.5 minutes/patient/visit. With completion of data record forms, the total visit time per patient (including 6 visits) was approximately one hour.
At baseline, patients in all groups demonstrated poor inhaler technique, with Correct Technique observed in 9% Active and 5% Control TH users, and in 10% Active and 17% Control ACC users. At 3 months, Correct Technique was demonstrated by 85% Active TH and 96% Active ACC users (Control group was not assessed). At 6 months, Correct Technique was significantly better in Active than Control patients (TH: 10/20 (50%) vs. 2/14 (14%), p=0.032; ACC: 23/29 (79%) vs. 3/21 (14%), p<0.001). In the TH Active group, there was a significantly greater proportion of patients demonstrating Correct Technique at each visit compared with baseline, with a slight trend to decrease between 3 months and 6 months (p=0.531). Results were similar for the ACC group.
Improvements in TH and ACC technique were reflected in improved clinical outcomes. Min%Max (index of PEF variability) at 3 months and 6 months, adjusted for baseline, was significantly higher (indicating less variability) for the Active compared with the Control patients (3 months: 83.8±8.3% (mean±SD) vs. 77.6±9.2%, p<0.001; 6 months: 78.9 ± 9.7% vs. 74.4±8.9%, p=0.002, One-way ANCOVA). When TH and ACC data were analyzed separately, both device groups showed a significant improvement in Min%Max (reduced variability) between the Active and Control groups at 3 months (TH: 86.2±7.0% vs. 76.8±9.8, p=0.005; ACC: 82.1±8.8% vs. 78.5±8.9%, p<0.001), with a significant difference at 6 months only for ACC (78.3±7.9% vs. 75.2±8.8, p=0.005).
With both inhaler types combined, the Active group showed a trend towards lower reliever use over time, which was not significantly different to the Control group when adjusted for baseline.
At 2, 3 and 6 months, there were significant differences in the distribution of asthma severity between Active and Control groups. For TH users, significant differences were seen in the distribution of asthma severity between Active and Control groups at 2 and 3 months, and for ACC users, at 3 months only.
For both inhaler groups combined, there were statistically significant and clinically-important differences in AQOL and PC between Active and Control groups at 3 months (AQOL: 0.8±0.5 vs. 1.35±0.6; PC: 44.0±5.7 vs. 39.5±4.4) and 6 months (AQOL: 0.8±0.6 vs. 1.3±0.6; PC: 43.8±4.9 vs. 39.8±4.0, p<0.001 for each, One-way ANCOVA). Similar results were seen in the TH and ACC groups separately.
Twenty seven pharmacists completed the study. Correct Technique for both inhalers was maintained by all Active pharmacists at 3 and 6 months, except for one pharmacist at 6 months. One year after study completion (2 years after the training workshop), Correct Technique was demonstrated on TH by 10/12 (83%) Active and 1/9 (11%) Control pharmacists, and on ACC by 9/12 (75%) Active and 1/9 (11%) Control pharmacists.
Following the success of the intervention, an Inhaler Technique Educational Module was designed based on the findings of the preceding clinical study, to offer an evidence based educational tool, capable of optimising community pharmacists' inhaler technique and providing them with the required skills to review and educate asthma patients on correct inhaler technique. This module has been presented to the Pharmaceutical Society of Australia, a major national body, with a proposal to implement the project nationally.
In summary, this study demonstrated that a simple educational intervention taking only 2.5 minutes, targeting inhaler technique, was feasible for delivery by community pharmacists, and resulted in improved clinical and humanistic outcomes for patients with asthma. This study also highlights the critical role of face-to-face pharmacist-patient interactions about inhaled medications. The study processes and results have led to the development of an Inhaler Technique Educational Module, whose feasibility and effectiveness have been demonstrated. This module offers a solution to the ongoing problem of inhaler technique training and provides a sustainable training model that can be offered to the profession.