We wish to highlight to readers of Clinical Pharmacist, the results of a recent survey of oncology healthcare professionals (HCPs) which demonstrated that inadequate and potentially out-of-date sources of information may be used as reference sources for prescribing medicines in oncology. Use of outdated reference sources has implications for patient safety, potentially exposing patients to risk.
The definitive data source for a marketed medicine is the ‘summary of product characteristics’ (SPC) document
. From the SPC, a number of other, derived sources also exist; including the British National Formulary/British National Formulary for Children; abbreviated prescribing information (PI); indication-specific apps; local guidance and national guidance in the UK
The BNF is published twice a year, with local and national guidance generally updated on an ad hoc basis
. A print BNF, published bi-annually is insufficient. Chemotherapy Peer Review Measure states that prescribing of systemic anti-cancer therapy should follow agreed treatment protocols, with details not typically found in the BNF
Prescribing information (PI) is a one-page document abbreviated from a significantly larger and more detailed SPC
. The ABPI code of practice states that PI must be provided in a clear and legible manner on all promotional materials provided by pharmaceutical companies in the UK
. PI must be updated immediately when the SPC undergoes changes
. Companies must then withdraw printed materials with the superseded PI. Retrieval of old materials is not required, and therefore there is a risk that materials with out-of-date PI remain in the hands of prescribers.
A questionnaire was distributed to pharmacists via the British Oncology Pharmacy Association and to oncologists via the Association of Cancer Physicians; a total of 103 responses were received.
While the SPC was the most frequently used source of information for prescribing among respondents, almost a third of oncologists surveyed did not use this source despite it being the most up-to-date and complete source of information for prescribing. Of those surveyed, 74% used the BNF as a regular reference source; however, outdated print copies of the BNF could be used as a prescribing source, as 73% of respondents used the BNF in print. Agreeing with a survey completed in 2003, which found that the HCPs check the BNF rather than other, more definitive and up-to-date sources (including the SPC), when uncertain about an aspect of drug treatment for prescribing
PI attached to pharmaceutical materials is rarely used by oncology HCPs; almost 60% of respondents do not currently use printed PI for prescribing. However, when printed materials are used, version control is an issue and a potential safety risk to patients, if prescribing decisions are based on out-of-date information. Nearly one-third of the oncology HCPs surveyed do not check whether the most up-to-date PI is used for prescribing. To check for PI version control, the prescriber must go onto the EMC/SPC website and compare the date of revision on the PI with that on the SPC, taking the prescriber directly to the SPC, which should have been used as a reference in the first place. A study completed in 2004 observed this in action, reporting that different doctors have different versions of PI available
In summary, it could be inferred that the production of further derived sources of information, including the BNF and PI could add to confusion and the potential use of outdated information for prescribing, allowing the industry to miss an opportunity to refer HCPs to the SPC as the definitive data source. On promotional materials, it is clear that the industry could move to a link to the SPC on electronic materials, but also on printed materials (including possibly QR codes or similar) to encourage use of the definitive data source and ensure all prescribing is undertaken based on the most up-to-date guidance in the SPC. This would ensure prescribing is based on current information, improving patient safety.
The authors would like to request that the Medicines and Healthcare products Regulatory Agency (MHRA) consider the use of current SPC and abolish the requirement for PI on promotional materials.
Rosanne J Bruggink
University of Sussex and Pfizer Ltd.
On behalf of the co-authors listed:
Rebecca J Thorne, Aston University and Pfizer Ltd, and Stephen J Kelly, Sarah JL Payne, Simon J Purcell, David A Montgomery, Pfizer Ltd.
We thank the authors of this letter for sharing the results of their survey.
BNF Publications provide practical, evidence-based information for healthcare professionals who prescribe, dispense or administer medicines. They are designed as digests for rapid reference and should be interpreted in the light of professional knowledge and supplemented as necessary by specialised publications and by reference to the product literature.
We support fully the notion that all HCPs should use the most up-to-date reference source available. We also acknowledge the varying needs of our users and, as such, provide BNF content on multiple platforms. Online, BNF publications are updated monthly. Our print publications are published biannually (BNF) and yearly (BNFC).
For the most up-to-date information we recommend viewing BNF content online via MedicinesComplete or the mobile app.
Head of Content
 European Medicines Agency. How to prepare and review a summary of product characteristics, 2017. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000357.jsp&. (accessed November 2017)
 Prescription Medicines Code of Practice Authority. Prescribing Information. Available at: http://www.pmcpa.org.uk/advice/promotional%20material/Pages/Keep-prescribing-information-up-to-date.aspx (accessed November 2017)
 NHS England. Manual for cancer services chemotherapy measures version 1.0, 2014. Available at: http://www.cquins.nhs.uk/download.php?d=resources/measures/Chemotherapy_April2014.pdf (accessed November 2017)
 Prescription Medicines Code of Practice Authority. ABPI Code of practice for the pharmaceutical industry, 2016. Available at: http://www.pmcpa.org.uk/thecode/Documents/Code%20of%20Practice%202016%20.pdf (accessed November 2017)
 Watkins C, Harvey I, Carthy P et al. Attitudes and behaviour of general practitioners and their prescribing costs: a national cross sectional survey. BMJ Quality & Safety 2003;12(1):29–34. doi: 10.1136/qhc.12.1.29
 Hopwood P, Wonderling D, Watson M et al. A randomised comparison of UK genetic risk counselling services for familial cancer: psychosocial outcomes. Br J Cancer 2004;91(5):884–892. doi: 10.1038/sj.bjc.6602081