The names of some medicinal substances changed in 2003/04. This was to reduce the risk of error in the prescribing and dispensing of some medicines arising from their availability in the UK under two different names. This means that for some medicines, the names used on prescriptions, dispensing labels and manufacturers' packaging changed.
In this section...
The action taken was based on the advice of the Medicines Commission, the Government's principal advisory body on medicines, and follows consultation with stakeholder groups, including professional bodies, retail pharmacists and medical software providers.
Substances affected by the change
A complete list of substances affected by the change and a list of the most commonly used names are available:
Complete list - pdf format (35Kb)
Complete list - Word format (50Kb)
There is a requirement in both European and UK legislation to use recommended International Non-Proprietary Names (rINNs) in the packaging and labelling of medicinal substances. This is the naming system used internationally, co-ordinated by the World Health Organisation. Until now this requirement had not been fully applied in the UK because of the well-established national naming system, British Approved Names (BANs). In particular, there were concerns about the possibility of medication errors that might result from a switch to the use of rINNs for certain substances, where healthcare professionals might be unfamiliar with the names. In many cases, the BAN and the rINN were identical. In a number of other cases, however, there were differences between them varying from the minor, for example, amoxycillin and amoxicillin respectively, and, in a relatively limited number of cases, those where it is difficult to relate the names, for example, benzhexol and trihexyphenidyl.
The continued use of BANs which differ from rINNs had, however, itself led to a great deal of confusion on the part of healthcare professionals and patients. Many products accepted onto the UK market from other EU Member States use rINNs where other products containing the same substance used BANs. There was an ongoing risk that these inconsistencies could potentially contribute to medication errors.
Action by manufacturers of medicinal substances
The name changes were published in the 'British Pharmacopoeia 2003' which became effective on 1 December 2003. From December 2003, industry had twelve months to make the necessary changes to licences and product labelling to reflect the name changes. In cases where the rINN is not the active substance of the product, two years from December 2003 will be allowed for the changes to be made. Industry is moving towards comprehensive use of rINNs.
Action by healthcare professionals
Healthcare professionals were advised to:
- familiarise themselves, as appropriate to their circumstances, with the name changes and in particular those rINNs that differ significantly from the BAN;
prescribe and dispense using only rINNs by 30 June 2004;
- continue to use the BANs only for adrenaline and noradrenaline;
- be aware that there may be some new names which are unfamiliar, but perceived as alphabetically similar to established names, and employ extra care to ensure the correct medicine is selected; and
inform patients when the names of the medicine on their prescription and dispensed medicine changes;
- refer to the attached leaflet produced by the National Patient Safety Agency (NPSA) on how to minimise the risks arising from the name changes. (48Kb)
Healthcare professionals were asked to use rINNs by 30 June 2004 and software providers agreed to change over to the new names by 30 April 2004.
Communication regarding the change has emphasised the need for vigilance on the part of healthcare professionals to guard against medication errors and the importance of thoroughly assessing and managing risks. The main areas of risk during the changeover period included the possibility of the wrong medicine being prescribed, dispensed or administered; and the patient delaying or not taking the correct medicine as a result of uncertainty over whether the correct medicine has been supplied or taking a double dose. The risk may be compounded where the new rINN is similar in name to another medicine.
Care needed prescribing and dispensing mercaptamine and mercaptopurine
We have received reports of medication incidents involving confusion between the substances mercaptamine (previously known as cysteamine) and mercaptopurine, due to their alphabetical similarity and the fact that both are available as 50 mg solid oral dose presentations. Healthcare professionals should take extra care when prescribing or dispensing these substances. Mercaptamine is used in the treatment of the rare condition nephropathic cystinosis. This condition is diagnosed and treated by hospital specialists, but maintenance therapy may be prescribed by some GPs and dispensed by some community pharmacists. It is important that professionals dispensing these products for patients confirm the diagnosis with the patient and/or prescriber before initiating a new supply. The attached drug safety information message was issued to healthcare professionals. (122Kb)
Adrenaline, noradrenaline and lidocaine
Adrenaline and noradrenaline
In line with the Medicines Commission's advice, healthcare professionals should treat these two substances as exceptions and continue to use the BANs. This reflects widespread familiarity with the BANs on the part of healthcare professionals and the wide usage of these substances in emergency medicine. Marketing authorisation (MA) holders for these substances will be encouraged to use both names on product packaging and product information literature. Recommendations were sent to MA holders in April 2004:
Lidocaine was also subject to a targeted exercise to update the product particulars and the following recommendations were sent to MA holders in April 2004:
A comprehensive communication programme was co-ordinated by the MHRA and supported by the National Patient Safety Agency (NPSA).
- A Department of Health press release announcing the programme of action was issued on 2 March 2004.
- The Chief Medical Officer, Chief Pharmaceutical Officer and Chief Nursing Officer issued a professional letter to healthcare professionals on 17 March 2004 telling them about the name changes and the related implications. Similar communications have been sent to professionals in Scotland, Wales and Northern Ireland.
- Adverts were placed in the professional journals to raise awareness of the name changes among healthcare professionals.
- A laminated list of commonly used substances* affected by the name changes were distributed through the professional journals and to community and hospital pharmacies and nursing and care homes.
- Posters* weredistributed to: GP surgeries, prison and Armed Forces' medical centres, community and hospital pharmacies and nursing and care homes.
- A patient information leaflet has been produced by the NPSA and the MHRA; this is available on the MHRA website and may be reproduced by healthcare organisations for educational use. (431Kb)
- A leaflet for healthcare professionals giving tips on how to minimise the risk of medication errors was produced by the NPSA. (48Kb)
The Pharmacy Department at Wrexham Maelor Hospital, North East Wales NHS Trust, have also issued a 'quick aide-memoire to commonly used drugs for healthcare professionals' (45Kb) ; we commend this innovative approach.
* Copies of the laminated list of commonly used substances and the posters are available from the MHRA Information Centre, telephone 020 7084 6000, email firstname.lastname@example.org