Medicines Q&As

Q&A 121.2

What practical issues need to be considered for the use and care of spacer devices?

Prepared by UK Medicines Information (UKMi) pharmacists for NHS healthcare professionals Date prepared: 22/11/12

Background

Spacer devices are chamber devices that remove the need for co-ordination between actuation of a pressurised metered-dose inhaler (pMDI) and inhalation. The spacer device reduces the velocity of the aerosol and subsequent impaction on the oropharynx and allows more time for evaporation of the propellant so that a larger proportion of the particles can be inhaled and deposited in the lungs (1). They are useful for patients with poor inhalation technique, for children, for patients requiring higher doses of inhaled corticosteroids, for nocturnal asthma, for patients with coordination problems and for patients prone to oral candidiasis with inhaled corticosteroids (1, 2).

There are various spacer devices available on the market. The size of the spacer is important, the larger spacers with a one-way valve (Volumatic®) being most effective (1). Changing a patient's spacer device may affect adherence to a regimen and should be resisted. There is evidence to suggest different spacers may also deliver different amounts of medication (2). It is important to prescribe a spacer device that is compatible with the pMDI prescribed (see individual Summary of Product Characteristics) (3).

There are no official guidelines or general consensus on the practical issues of using spacer devices. This FAQ will attempt to summarise the findings on the following issues:

 Should a new spacer device be primed before first use?  Should a new spacer device be washed before first use?  How should a spacer device be washed?  How often should a spacer device be washed?  How frequently should a spacer device be replaced?

Answer

Anecdotal evidence from the BNF and Martindale suggests that spacer devices should be cleansed once a month by washing in mild detergent and then allowed to dry in air without rinsing; the mouthpiece should be wiped clean of detergent before use. More frequent cleaning should be avoided since any electrostatic charge may affect drug delivery (1, 4). Spacer devices should be replaced every 6–12 months (1).

NICE, in its appraisal of inhaler devices for children, also recognised the problem of electrostatic discharge with spacer devices. To reduce this problem it suggests careful washing with household detergent and air-drying (i.e. leaving to dry) of spacers at appropriate intervals. If there are concerns about the possibility of contact dermatitis using this method, the mouthpiece of facemask should be rinsed in water and dried. It suggests the use of metal spacer devices to avoid problems with electrostatic discharge (5, 6).

Joint guidelines for asthma from the British Thoracic Society and Scottish Intercollegiate Guidelines Network recommend that spacer devices should be cleaned monthly rather than weekly as per manufacturer’s recommendations. They should be washed in detergent and allowed to dry in air. The mouthpiece should be wiped clean of detergent before use. Plastic spacers should be replaced at least every 12 months but some may need changing at six months (7).

From the National Electronic Library for Medicines. www.nelm.nhs.uk 1

Medicines Q&As

An expert in inhalation therapy makes the following recommendations (2):  It is not known whether a spacer device needs to be washed before use. There is theoretical evidence to support the for and against reason but with little supportive evidence either way.  A spacer device should be washed when there are visible deposits on the spacer wall since this could affect dose reproducibility. If these deposits can not be removed by non-ionic detergent and rinsing, the device should be replaced.  Spacer devices should not be dried after washing since this may introduce electrostatic charge to the spacer device; they are best left to dry in natural air.  Bacterial growth may be a problem with spacer devices. Because of the risk of cross infection they should not be shared with other patients. Gentle washing and rinsing is by no means sterilisation..  The spacer device probably needs replacing when the integrity of the device is compromised, usually when the rubber seals at either end of the spacer device have become worn down with wear and tear.

Summary

Overall, the following is a summary of the issues raised in this FAQ:

 A spacer device does not need to be primed with the first dose from a pMDI

 It is not known whether a spacer device should be pre-washed before first use.

 The spacer device should be washed with a non-ionic detergent eg washing up liquid and left to air-dry without rinsing or wiping. The mouthpiece should be wiped clean of detergent before use.

 Most sources recommend monthly washing of spacer devices although this may differ from manufacturer’s instructions. Alternatively the spacer device should be washed when there are visible deposits on the spacer wall.

 The general consensus is that spacer devices should be replaced every 6-12 months. Replacement may be required earlier if the integrity of the spacer device is compromised or if visible deposits on the spacer cannot be removed by washing with a non-ionic detergent and rinsing.

Limitations  No published evidence was found to address this question; content is based on consensus viewpoints.  The information contained in this FAQ may differ from individual manufacturer’s instructions.  This FAQ does not review how spacer devices should be used.

Disclaimer  Medicines Q&As are intended for healthcare professionals and reflect UK practice.  Each Q&A relates only to the clinical scenario described.  Q&As are believed to accurately reflect the medical literature at the time of writing.  The authors of Medicines Q&As are not responsible for the content of external websites and links are made available solely to indicate their potential usefulness to users of NeLM. You must use your judgement to determine the accuracy and relevance of the information they contain.  This document is intended for use by NHS healthcare professionals and cannot be used for commercial or marketing purposes.  See NeLM for full disclaimer.

From the National Electronic Library for Medicines. www.nelm.nhs.uk 2

Medicines Q&As

References 1. British National Formulary. Sept 2012 online, accessed on 22/11/12 via Medicines Complete. http://www.medicinescomplete.com/mc/bnf/current/PHP18646-a2a-spacer.htm? q=spacer&t=search&ss=text&p=1#PHP18646-a2a-spacer 2. Dr Tristan Learoyd, Senior Lecturer, Respiratory Education UK: www.respiratoryeduk.com 3. Anon. Inhaled products that contain corticosteroids. MHRA Drug Safety Update July 2008; vo1 1, issue 12: p6-7. http://www.mhra.gov.uk/home/groups/pl- p/documents/publication/con020567.pdf 4. Martindale: the complete drug reference accessed on 22/11/12 via Medicines Complete. Inhalational therapy (last reviewed 04/08/2010) 5. NICE. Inhaler devices for routine treatment of chronic asthma in older children (5-15 years). (TA38; March 2002). http://www.nice.org.uk/Guidance/TA38 6. NICE. Inhaler devices for children under 5 (TA10: September 2000). http://guidance.nice.org.uk/TA10 7. BTS British Guideline on the Management of Asthma: Revised January 2012. http://www.brit- thoracic.org.uk/Portals/0/Guidelines/AsthmaGuidelines/sign101%20Jan%202012.pdf

Quality Assurance

Prepared by Sheetal Ladva, Medicines Information Pharmacist, Regional Medicines Information, London and South-East

Date Prepared Original version:11/12/2008. Updated version 22/11/12

Checked by Yuet wan, Medicines Information Pharmacist, Regional Medicines Information, London and South- East

Date of check Original version: 23/12/2008. Updated version 3/12/12

Search strategy Original search strategy (11/12/2008)

 In-house database/ resources (BNF, Martindale, CKS, NICE, Cochrane, NLH, NeLM, MHRA)  Embase: *INHALATION SPACER/ OR (spacer AND device).ti,ab  Medline: *INHALATION SPACERS/  Pharmline: spacers  Dr Tristan P. Learoyd, Senior Lecturer in Clinical Pharmaceutics, Inhalation Technology Research, School of Pharmacy, University of Hertfordshire (personal communication)

Updated search strategy (22/11/2012)  In-house database/ resources (BNF, Martindale, CKS, NICE, Cochrane, NLH, NeLM, MHRA, NHS Evidence  Embase: *INHALATION DRUG ADMINISTRATION/ OR (spacer AND device).AND (ASTHMA/drug therapy  Medline: (spacer AND device) AND (ASTHMA)  CINAHL: (spacer AND device)  Dr Tristan P. Learoyd, Dr Tristan Learoyd, Senior Lecturer, Respiratory Education UK. www.respiratoryeduk.com (personal communication)

From the National Electronic Library for Medicines. www.nelm.nhs.uk 3