Planned implementation procedures for replacement of devices for patients with asthma will enable GPs to spread the workload and maintain care, says Mr Andrew Martin


  • This working party guideline was developed during a one-day meeting
  • The development of this guidance was supported by an educational grant from Teva UK Ltd
  • The content of the working party guideline and this article is independent of and not influenced by the commercial sponsorship
Since Health Service Circular 180 was issued in 1998,1 the message has been that when there are two chlorofluorocarbon (CFC)-free versions of an inhaled drug, then the CFC-containing variant should be phased out in order to meet the requirements of the Montreal Protocol.2 A second CFC-free beclometasone dipropionate (BDP) inhaler is finally now available, and with the availability of two CFC-free BDP devices, forecasts suggest that CFC-containing inhalers will probably disappear by mid-2008. This projection is based on:
  • CFC stocks
  • availability of components for CFC-containing inhalers
  • news that manufacturers are discontinuing production of CFC-containing BDP devices.

Need for the guideline

With less than a year in which to manage the change, a consensus guideline for all healthcare professionals involved in the management of patients with asthma was developed.3 Although the guideline discusses the phasing out of all CFC-containing inhalers, it focuses mainly on devices containing BDP as these will soon be unavailable.

The working party for developing the new guideline has laid out useful information on how to manage the change, and it is hoped this will stimulate a desire in practices to plan ahead and administer the transfer effectively.3 The guideline emphasises that this should be a managed process, and highlights dosage equivalence as something healthcare professionals must consider when transferring patients to a new regimen; the two CFC-free BDP products are not both equivalent.

Impact on the practice

When switching a patient from a CFC-containing inhaler to another device, it is also an ideal opportunity to review his or her asthma treatment. However, as there is still some time in which to effect the change, the process need not create a significant additional workload and it should be possible to do the bulk of the work alongside routine clinic activity.

The Prescription Cost Analysis for England for 20064 indicates that over 4.2 million CFC-containing BDP inhalers were dispensed, which implies that if each patient used seven inhalers per year, then over 600,000 patients in England would be affected by this change. These figures suggest that this will have a significant workload impact on every practice in England.

There may also be financial consequences arising from:3

  • increased administrative and staff costs of patient reviews
  • a rise in indirect costs if the patient is not offered sufficient support during the transfer to the CFC-free inhaler, which could result in a deterioration in asthma control and subsequent increased costs of care.

These costs can be minimised by implementing a planned review and transfer to a new inhaler. Planning should take into account financial, administrative, and clinical concerns.

Managing the transfer

The guideline outlines strategies that may be employed to manage the changeover. Adjustments to medication should be effected with minimal disruption in order to avoid loss of asthma control and its consequent potential for adverse effects on patients and costs.3 The algorithm in Figure 1 contains a scheme for managing the change. The strategies are discussed below.

Figure 1: Managing the transfer to CFC-free ICS inhalers for patients currently using CFC-containing BDP devices

Managing the transfer to CFC-free ICS inhalers for patients currently using CFC-containing BDP devices
CFC=chlorofluorocarbon; ICS=inhaled corticosteroid; BDP=beclometasone dipropionate; pMDI= pressurised metered-dose inhaler; DPI=dry powder inhaler

Patient review

It is preferable to see every patient individually to discuss the change in medication, and this also provides an opportunity to check his or her inhaler technique. By combining this with the annual review, the additional workload associated with the change can be minimised. Asthma control can be reviewed and any step up or down of the inhaled corticosteroid dose can be implemented.

Computerised searches at practices can be used to identify patients due for review and their notes can be flagged. If the patient attends for another reason, there may be an opportunity to review their treatment and prescribe a CFC-free inhaler.

Quality and outcomes framework annual asthma reviews may present an opportunity to switch if these are being carried out over the next few months. I recommend that practices estimate how much work is involved and plan according to their own workload profiles.

Targeted patients

A significant number of patients will not attend for review in any 12-month period, and it may be appropriate to offer them individual appointments or to discuss the change over the phone. It may be useful to consider whether extra clinics need to be offered during this changeover period.

The consensus guideline also defines a list of patients considered to be at high risk from a change of inhaler (see Box 1).3 These patients may be targeted for individual appointments if a decision is made not to see all patients.

Box 1: Asthma patients considered to be at high risk from an unsupervised

change in medication

Patients considered to be at high risk are those who:

  • use ?2 bronchodilator inhalers per month
  • have received a course of oral corticosteroids in the previous 12 months
  • do not attend routine asthma reviews
  • have been hospitalised or who have required out of hours asthma care over the past 2 years
  • use >800 ?g/day BDP or equivalent
  • require three or more classes of asthma medication
 
BDP=beclometasone dipropionate

Basic healthcare provision

The working party spent some time debating the minimum level of effort that would effect the change. This situation is likely to arise towards the middle of next year, when CFC-containing BDP inhalers become increasingly difficult to obtain. In order to avoid multiple calls from community pharmacists seeking permission to supply alternatives, practices may bulk change repeat prescriptions by computer, and letters could be sent to patients informing them of the change. These letters should offer an invitation to contact the GP or asthma nurse if there are any concerns. This approach has been used in some areas, but the guideline stresses that this method should only be used if unavoidable. Patients such as those detailed in Box 1 would be particularly put at risk by this policy.3

Children

Children are another group who should be monitored carefully during the changeover. However, with only one CFC-free BDP preparation licensed for under 12 year olds (i.e. Clenil Modulite®Triangle),5 there is little choice and some drift towards dry powder devices may result, particularly as Clenil Modulite®Triangle is required to be prescribed with a Volumatic® spacer.

Review of the asthma regimen in children is an opportunity to check that dosages are within recommended limits, and to ensure that parents/carers and children understand the new dosage and know not to exceed it.

Implementing the change

If the changeover is planned and managed, it can be done with support from local hospitals and community pharmacies. Here in the North West, the latest NHS Purchasing and Supply Agency contract contains details of alternative hydrofluoroalkane-containing inhalers, meaning that hospitalised patients will soon receive a CFC-free inhaler. It is important they continue to use the same device on discharge and that their old one is removed from their usual repeat medications. This will reduce the likelihood of multiple changes. Community pharmacies should also be informed of planned changes so that they can provide timely advice at the changeover, and so that they may manage their stocks appropriately.

All patients will probably now be familiar with CFC-free bronchodilators and the ‘warmer’, softer spray from their new BDP inhaler should not come as a surprise. However, it will be worth reminding them that this change is not for reasons of safety but from environmental concerns, so their old inhaler can be used up. However, it is important that these patients understand any differences when starting the new one.

The Medicines and Healthcare Products Regulatory Agency has already recommended the prescribing of CFC-free BDP inhalers by brand name in view of the increased potency of Qvar® compared with Clenil Modulite®Triangle and CFC-containing inhalers.6 Dispensing pharmacists are advised to check with the prescriber if a CFC-free product is required but not named.6 The changeover to CFC-free salbutamol seemed to happen smoothly and, with no differences in doses, could have happened in the pharmacy or the GP practice. However, the change of steroid inhaler is not likely to be so straightforward as there is a choice of two, non-bioequivalent products. Table 1 lists possible alternative ICS inhalers

Table 1: Possible alternative ICS inhalers for patients currently using CFC-containing BDP inhalers3

Product* Active ingredient Dose equivalence (HFA:CFC BDP device) Licensed recommended dosage for adults Licensed for children?
Qvar®† BDP 1:2 (i.e. dose is halved) 50–200 µg b.i.d., max 400 µg b.i.d. (i.e. 800 µg b.i.d. CFC-containing BDP equivalent) Age ?12 years
Clenil Modulite®Triangle BDP 1:1 200 µg b.i.d. (in more severe cases initially 600–800 µg daily),
max 2000 µg daily
50–100 µg 2–4 times daily
Alvesco®Triangle Ciclesonide Not known 160 µg once daily, reducing to 80 µg if control maintained Age ?12 years
Flixotide Evohaler®† Fluticasone propionate 1:2 Age ?16 years: 100–250 µg b.i.d., max 1 mg
b.i.d.
Age 4–16 years: 50–100 µg b.i.d., max 200 µg b.i.d.
(NB 125 µg and 250 µg are not indicated for children)
Breath-actuated pMDIs Except for AeroBec® and Beclazone Easi-Breathe®, all ICS breath-actuated pMDIs are CFC-free. Several products are available.
DPIs DPIs do not contain propellants. Several products are available.
*This is not an exhaustive list of steroids available; †metered dose inhalers
ICS=inhaled corticosteroids; CFC=chlorofluorocarbon; BDP=beclometasone dipropionate; HFA=hydrofluoroalkane; b.i.d.=twice daily; pMDI=pressurised metered-dose inhaler; DPI=dry powder inhaler

Prescribing costs

From October 2007, there has been an increase in the price of CFC-containing BDP in the Drug Tariff,7 where it has increased by between 38% (50 ?g inhaler) and 92% (250 ?g inhaler). This now makes it dearer than equivalent CFC-free pMDIs and, therefore, on purely prescribing cost grounds, a switch to CFC-free inhalers sooner rather than later could actually reduce costs. Costs of selected ICS pMDIs and BAIs are shown in Table 2.

Table 2: Costs of selected ICS pMDIs and BAIs8

Inhaler

Cost per unit* (£)

Dose (?g)

Number of doses

Qvar®†pMDI

 

Qvar Autohaler® BAI

 

Qvar Easi-Breathe® pMDI

7.87

17.21

7.87

17.21

7.74

16.95

50

100

50

100

50

100

200

200

200

200

200

200

Clenil Modulite®Triangle

pMDI

3.85

7.72

16.83

16.95

50

100

200

250

200

200

200

200

Alvesco®Triangle pMDI

28.56

16.80

33.60

80

160

160

120

60

120

Flixotide Evohaler® BAI

5.44

21.26

36.14

50

125

250

120

120

120

*Prices correct as of 1 December 2007 and subject to change; Qvar® is prescribed at half the dose

ICS=inhaled corticosteroids; pMDI=pressurised metered-dose inhaler; BAI=breath-actuated inhaler

Summary

In summary, the consensus guideline advises that the change needs to be planned now, to allow for decisions about the CFC-free BDP alternatives to be made, with special considerations applying for each of the two options (Clenil Modulite®Triangle or Qvar®). If planned and managed over a period of time, the change need not create significant additional workload for prescribers and dispensers.

 

Practice-based commissioning take-home messages

written by Dr David Jenner, NHS Alliance PBC Lead

  • Currently, CFC-free BDP inhalers are cheaper than old generic CFC-containing BDP inhalers, so it is time to change now
  • Prices:
      • Generic CFC-containing BDP 100 µg inhaler = £9.65a
      • Clenil Modulite®Triangle 100 µg = £7.72b
      • Qvar® 50 µg (dose equivalent) = £7.87a
  • Clenil Modulite®Triangle is the only CFC-free BDP preparation licensed for use in patients under 12 years of age
  • The switch is ideally achieved at a face-to-face asthma review, which includes a review of current therapy
  • The change from CFC-based inhalers could save prescribing costs if therapy can be stepped down
  • Asthma reviews attract remuneration from the QOF
  • Community pharmacists are well placed to inform patients about the change with a medicine use review. Plan the switch with them!
 
CFC=chlorofluorocarbon; BDP=beclometasone dipropionate; QOF=quality and outcomes framework
awww.ppa.org.uk
bBritish National Formulary September 2007. London: BMJ Publishing Group Ltd, Royal Pharmaceutical Society, 2007

References

  1. Department of Health. Health Service Circular HSC 1998/180: Phase out of CFC-containing metered dose inhalers for the treatment of asthma and COPD. London: DH, 1998.
  2. United Nations Environment Programme. Handbook for the Montreal Protocol on Substances that Deplete the Ozone Layer. Nairobi: Secretariat of the Vienna Convention for the Protection of the Ozone Layer and the Montreal Protocol on Substances that Deplete the Ozone Layer, 2006.
  3. Thomas M, Angus R, Fehrenbach C et al. Consensus guideline on phasing out CFC-containing inhalers in asthma. Berkhamsted: MGP Ltd, 2007.
  4. Prescription Cost Analysis. The Information Centre. www.ic.nhs.uk/webfiles/publications/pca2006/PCA_2006.pdf, page 83.
  5. Trinity Chiesi Pharmaceuticals Ltd. Clenil Modulite® Summary of Product Characteristics. Cheadle: Trinity Chiesi Pharmaceuticals Ltd, 2006.
  6. Medicines and Healthcare Products Regulatory Agency. Beclometasone dipropionate pressurised metered dose inhaler: important information. London: MHRA, 2006. www.mhra.gov.uk/home/idcplg?IdcService=GET_FILE&dDocName=CON2024433&RevisionSelectionMethod=LatestReleased accessed 31/10/2007
  7. National Health Service Business Services Authority. Prescription Pricing Division. Drug Tariff October 2007. www.ppa.org.uk/ppa/edt_intro.htm accessed 31/10/2007.
  8. Respiratory system: asthma, COPD. In: Gowans J, editor. MIMS. London: Haymarket Medical Media Ltd, December 2007.G