Pharmacists need to manage stocks of peak flow meters as new European standard is introduced
Pharmacists need to be ready to manage the supply of peak flow meters
when a new European standard for their manufacture is introduced on 1
September.
What is changing and why
Hand-held peak flow meters manufactured to
a new European standard (EN 13826) are being introduced and will
replace the traditional
Wright scale meters currently listed in the Drug Tariff. The MHRA
notes that the Wright scale is non-linear and may over-estimate
peak flow in the mid-range by up to 30 per cent. “In some
cases the over-reading of the Wright scale may have falsely reassured
patients and their health care professionals, so that corticosteroid
therapy, while appropriate, was not prescribed. This has been the
main clinical driver behind the introduction of the new scales.” |
The Medicines and Healthcare products Regulatory Agency has
issued
a notice alerting pharmacists and other health care professionals
to the
proposed changes (see Panel). The new peak flow meters will be CE marked
and will be available on the Drug Tariff from September.
The MHRA does not make recommendations about how the change from traditional
Wright meters to the new CE marked meters should be managed but states: “It
is essential that the stocks of Wright and EN 13826 peak flow meters
are managed correctly to ensure continuity of supply.” It points
out that it can take six weeks for meters to reach pharmacies from manufacturers
via wholesalers.
However, it is not clear whether Wright meters will continue to be reimbursable
on NHS prescription after 1 September. The June Drug Tariff states that
the CE marked meters will replace the traditional meters in the tariff
from September. However, the MHRA is less clear and states: “Wright
peak flow meters may still be available after [1 September], but they
may not be reimbursable on NHS prescription.”
A spokesman for the Prescription Pricing Authority said he was unable
to comment on the statement put out by the MHRA and that resolution of
the matter was back in the hands of the Department of Health.
The MHRA points out that the results from new peak flow meters and traditional
Wright meters may be different. It suggests that peak flow readings are
reassessed for patients with personalised asthma action plans and that
action levels are recalculated. Although meters do not need to be changed
immediately, Wright meters should be replaced with the CE marked meters
over the next 12 months, it says. |