The Irish Medicines Board has recently authorised the following combination products containing perindopril arginine and amlodipine (Acerycal) for the Irish market.
Four different strengths of this combination product have been authorised:
5mg perindopril arginine + 5mg amlodipine (Acerycal 5mg/5mg)
5mg perindopril arginine + 10mg amlodipine (Acerycal 5mg/10mg)
10mg perindopril arginine + 5mg amlodipine (Acerycal 10mg/5mg)
10mg perindopril arginine + 10mg amlodipine (Acerycal 10mg/10mg)
Prescribing Convention for accurate prescribing and dispensing
This is a unique situation as the two possible strengths of each of the active substances are identical. Therefore the IMB considers that it is necessary to establish a formal prescribing convention to ensure that patients receive the correct strength of the combination product when the ‘5mg/10mg’ or ‘10mg/ 5mg’ product strengths are prescribed.
Prescribing Convention for risk minimisation
• To ensure that patients receive the intended dose of each drug the following prescribing convention has been established: the dose of the ACE inhibitor perindopril arginine should be written as the first strength on the prescription, followed by the dose of the calcium channel blocker amlodipine as the second strength. For example ‘Brand X 5mg/ 10mg Tablets’ will always mean 5mg perindopril arginine and 10mg amlodipine and never vice versa (i.e. never 5mg amlodipine and 10mg perindopril arginine).
• All subsequently licensed perindopril arginine/ amlodipine combination products will be authorised and must be prescribed and dispensed using this same established convention for the order in which the strength of each active substance is listed in the product name.
• Prescribers and pharmacists are both requested to ensure that the convention outlined above is followed in order to minimise the risk of medication errors. Particular care should be taken when considering the intended posology both when prescribing and dispensing these products.
Healthcare professionals are requested to monitor use of these products and to report any adverse reactions in the usual way, particularly any associated with possible medication errors.
Adverse reactions may be reported to the Irish Medicines Board via the on-line reporting system (www.imb.ie), or using the downloadable or post-paid yellow card system.
Medication errors can also be reported using the same options.