Effect of a spacer on total systemic and lung bioavailability in healthy volunteers and in vitro performance of the Symbicort® (budesonide/formoterol) pressurized metered dose inhaler.

INTRODUCTION: Many patients with chronic obstructive pulmonary disease or asthma experience difficulties in coordinating inhalation with pressurized metered-dose inhaler (pMDI) actuation. The use of a spacer device can improve drug delivery in these patients. The aim of this study was to establish the relative bioavailability of single doses of Symbicort® (budesonide/formoterol) pMDI 160/4.5 µg/actuation (2 actuations) used with and without a spacer device. In addition, an in vitro study was conducted to characterize performance of the inhaler when used in conjunction with a spacer device. METHODS: A Phase I, randomized, open-label, single-dose, single-center, crossover study in 50 healthy volunteers (NCT02934607) assessed the relative bioavailability of single-dose Symbicort® pMDI 160/4.5 µg/actuation (2 actuations) with and without a spacer (AeroChamber Plus® Flow-Vu®). Inhaled doses were administered without or with activated charcoal (taken orally) to estimate total systemic exposure and exposure through the lung, respectively. The in vitro study characterized the effect of the spacer with respect to delivered dose, fine particle dose, and dose during simulated breathing of budesonide and formoterol. RESULTS: In terms of total systemic exposure, use of the spacer increased the relative bioavailability determined by AUC(0-last) and Cmax by 68% (spacer:no spacer treatment ratio, 167.9%; 90% CI, 144.1 to 195.6) and 99% (ratio, 198.7%; 90% CI, 164.4 to 240.2) for budesonide, and 77% (ratio, 176.6%; 90% CI, 145.1 to 215.0) and 124% (ratio, 223.6%; 90% CI, 189.9 to 263.3) for formoterol, respectively, compared with pMDI alone. Similarly, the lung exposure of budesonide and formoterol increased (AUC(0-last) and Cmax by 146% [ratio, 246.0%; 90% CI, 200.7 to 301.6] and 127% [ratio, 226.5%; 90% CI, 186.4 to 275.4] for budesonide, and 173% [ratio, 272.8%; 90% CI, 202.5 to 367.4] and 136% [ratio, 236.2%; 90% CI, 192.6 to 289.6] for formoterol, respectively) when the pMDI was administered through the spacer. When assessed by AUC(0-last) quartile without spacer, subjects in the lowest exposure quartile (indicating poor inhalation technique) with Symbicort® pMDI 160/4.5 µg/actuation (2 actuations) had markedly increased total systemic and lung exposure when the same dose was administered with the spacer. In contrast, for subjects in the highest exposure quartile with pMDI alone, total systemic and lung exposure of formoterol and budesonide was similar with and without the spacer. In the in vitro study, the fine particle dose (<5 µm) of both budesonide and formoterol from the spacer at delay time (i.e. pause period after actuation) = 0 s (instantaneous) after actuation was similar to the fine particle dose when not using the spacer. The delivered doses of budesonide and formoterol from the spacer were both lower compared with the doses administered without the spacer. There was also a decrease in delivered dose with increasing delay time. CONCLUSIONS: The clinical study demonstrated that in subjects with poor inhalation technique the use of the AeroChamber Plus® Flow-Vu® spacer increased the bioavailability of Symbicort® pMDI to a level observed in subjects with good inhalation technique without a spacer. The findings from the in vitro study support the fine particle dose characteristics of Symbicort® pMDI with the AeroChamber Plus® Flow-Vu® spacer.

Supplementary nurse prescribing for patients with skin conditions: a national questionnaire survey.

AIM: To examine the prescribing practices of supplementary nurse prescribers (working in both primary and secondary care) who prescribe medicines for patients with skin conditions and the factors that facilitate or inhibit this mode of prescribing. BACKGROUND: Nurses work in a variety of roles, with varying levels of expertise, are involved in the treatment management of a broad range of skin diseases. Skin conditions are those for which independent nurse prescribers prescribe most frequently. The role of the nurse, limitations of the formulary and inter-professional relationships influence the prescribing practices of these nurses. There is no evidence currently available examining the impact and activity of supplementary nurse prescribing for patients with skin conditions. METHODS: A convenient sample of 580 nurses who prescribed for skin conditions and were qualified supplementary nurse prescriber, self-completed a written questionnaire. RESULTS: Five hundred and twenty (89.7%) nurses were based in primary care and worked in general practice. Four hundred and thirty-six (75%) held a degree level qualification or higher, 41 (7%) had specialist dermatology training and 512 (88.3%) had more than 10 years postregistration nursing experience. Supplementary prescribing was used by a minority of nurses. Nurses who had specialist dermatology training used this mode of prescribing most frequently. Doctor and pharmacists lack of understanding of supplementary prescribing, lack of peer support and clinical management plans prevented the implementation of this mode of prescribing. CONCLUSIONS: Supplementary prescribing is used by a minority of nurses to treat skin conditions. A number of factors prevent nurses from using this mode of prescribing including lack of specialist training and lack of support in practice. RELEVANCE TO CLINICAL PRACTICE: Specialist dermatology training, an understanding of supplementary prescribing by the members of the healthcare team, and support in practice are required if supplementary prescribing is to be implemented effectively for the treatment of skin conditions.

Independent extended nurse prescribing for patients with skin conditions: a national questionnaire survey.

AIM: To examine the prescribing practices of independent extended nurse prescribers for patients with skin conditions. BACKGROUND: Nurse-led services are one means of improving healthcare provision for dermatology patients. The advent of nurse prescribing should optimize the role of the nurse in these situations. Medicines for skin conditions constitute a significant category within the Nurse Prescribers Extended Formulary. The impact and activity of independent extended nurse prescribing for patients with skin disease has yet to be evaluated. METHODS: A convenience sample of 638 qualified independent extended nurse prescribers self completed a written questionnaire. spss and splus were used for data entry and analysis. RESULTS: The majority of nurses (89.7%) were based in primary care and worked in general practice. Four hundred and seventy-six (75%) participants held a degree level qualification or higher. Forty-four (6.9%) held a diploma, degree or master's level module/s in dermatology, 433 (67.9%) had undertaken study day/s in dermatology. Five hundred and sixty (87.8%) had more than 10 years postregistration nursing experience. A significantly broader range of skin conditions, and more items for these conditions, were prescribed by nurses with higher academic qualifications, nurses with specialist dermatology training (i.e. a diploma, degree or master's level module in dermatology or dermatology study days), nurses over 45 years and nurses in general practice. A small number of nurses felt unconfident in their prescribing practice. CONCLUSION: The majority of nurses treating skin conditions work in general practice, are highly qualified, and have a wealth of clinical experience. Nurses' dermatology training is inconsistent A small number of nurses feel unconfident in their prescribing practice. RELEVANCE TO CLINICAL PRACTICE: Nurses prescribing for skin conditions must be provided with appropriate dermatological training in order to treat the enormous numbers of patients with skin conditions treated in primary care.

Independent extended supplementary nurse prescribers, their prescribing practice and confidence to educate and assess prescribing students.

BACKGROUND: No other country in the world has such extended prescribing rights for nurses as the United Kingdom. Concerns surround the move of nursing towards a medical model of care, and the level of medical practice support required by trainee prescribers. AIM: To provide an overview of the nurses adopting the role of independent extended supplementary prescriber, their prescribing practice and confidence to educate and assess prescribing students. METHODS: A convenience sample of 1187 independent extended supplementary nurse prescribers were sent a questionnaire. Eight hundred and sixty eight completed questionnaires were returned. RESULTS: The majority (82%) of nurses worked in primary care. Eighty seven percent used independent extended prescribing and 35% supplementary prescribing. Most were qualified to degree level or higher and had over 10 years nursing experience. Seventy four percent felt confident to act as a mentor during the prescribing programme. More highly qualified nurses and those who had undertaken, or had access to continuing professional development, were statistically more likely to feel confident to adopt this role. CONCLUSION: Appropriately qualified nurse prescribers might be best placed to support trainee prescribers. Exploration of the low uptake of supplementary prescribing and access to continuing professional development is required.

Independent extended and supplementary nurse prescribing practice in the UK: a national questionnaire survey.

BACKGROUND: Nurses are able to prescribe independently from a list of nearly 250 prescription only medicines for a range of over 100 medical conditions or, from the whole British National Formulary as a supplementary prescriber. There is some evidence available on the prescribing practices of district nurses and health visitors and early independent extended prescribers. Little or no attention has focussed on supplementary nurse prescribing. OBJECTIVE: To provide an overview of the prescribing practices of independent extended/supplementary nurse prescribers and the factors that facilitate or inhibit prescribing. DESIGN OF STUDY: National questionnaire survey. SETTING: United Kingdom. PARTICIPANTS AND METHOD: A convenience sample of 868 qualified independent extended/supplementary nurse prescribers self-completed a written questionnaire. RESULTS: A total of 756 (87%) used independent extended prescribing; 304 (35%) used supplementary prescribing to treat a range of chronic conditions (including asthma, diabetes and hypertension); 710 (82%) nurses worked in primary care. Nurses in general practice reported the largest number of reasons preventing prescribing. Reasons included the inability to computer generate prescriptions and to implement the Clinical Management Plan. Nurses in primary care reported more continuing professional development needs. These needs included update on prescribing policy and the treatment management of conditions. A total of 277 (32%) nurses were unable to access continuing professional development. CONCLUSION: Independent extended/supplementary nurse prescribers work predominantly in primary care and do prescribe medicines. These nurses are highly qualified and have many years clinical experience. Supplementary prescribing is used by a minority of nurses. Implementing the Clinical Management Plan is a barrier preventing the use of this mode of prescribing. The continuing professional development needs of independent extended/supplementary nurse prescribers are frequently unmet. It will become increasingly important that these needs are met once nurses are able to prescribe the full range of medicines included in the British National Formulary, limited only by their area of competence.

Preparing nurses to prescribe medicines for patients with dermatological conditions.

BACKGROUND: From Spring 2006, independent extended nurse prescribers in the United Kingdom will be able to prescribe any licensed medicines except controlled drugs. Supplementary nurse prescribers are currently able to prescribe any medication. No other country in the world has such extended prescribing rights for nurses. Aspects of prescribing viewed positively by nurses include continuity of care, increased satisfaction, and the belief that patients receive improved information about prescriptions. There is some evidence, however, that nurses feel ill-prepared to prescribe due to poor understanding of pharmacology, physical assessment and diagnosis. AIM: This paper reports a study assessing the extent to which independent extended supplementary nurse prescribers feel prepared to prescribe medicines for patients with dermatological conditions. METHODS: A convenience sample of 1187 qualified independent extended supplementary nurse prescribers was sent a postal questionnaire. A total of 868 completed questionnaires was returned, and 638 of these nurses prescribed medicines for skin conditions. The data were collected in 2005. RESULTS: A total of 605 (94.8%) participants used independent extended prescribing and 234 (36.7%) supplementary prescribing. The majority were highly experienced and worked in primary care. In general, their prescribing programme had met their needs when prescribing medicines for patients with dermatological conditions. However, the needs of those who had undertaken a diploma-level module in dermatology and/or dermatology study days, and those working in both primary and secondary care, were met to a statistically significantly greater extent during the programme than for those nurses without this preparation, or those working in either primary or secondary care. CONCLUSION: Independent extended supplementary prescribing has extended the role that nurses in the United Kingdom are able to play in the management of skin disease. Specialist dermatology training is a prerequisite for nurses adopting this role. Further evaluative work on patient-focused outcomes, i.e. accessibility and convenience of care, and satisfaction with quality of care, is required.