How Pharmaceutical Press ensures content is evidence-based
Faye Gardner is a clinical writer at Pharmaceutical Press. With a background working as a hospital antimicrobial pharmacist, she draws on her experience to evaluate how information may be used by health professionals to inform and guide decision-making.
Her work at Pharmaceutical Press involves authoring and approving content for publication in British National Formulary (BNF) and BNF for Children (BNFC), as well as working on the content creation process for Martindale: The Complete Drug Reference.
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Talk us through how Pharmaceutical Press develops its evidence-based content, including the main processes used to ensure accuracy and clinical relevance?
For BNF, we follow a rigorous content creation process, which also includes what we would consider or use as sources for our content.
Main sources of our content for BNF +BNFC include the Summary of Product Characteristics (SPC) and patient information leaflets, both of which are produced by manufacturers.
We also use other sources such as emerging evidence, best-practice guidelines, and even advice from our expert advisors. We critically assess sources and evidence-grade our clinical advice, so that clinicians can be assured that our recommendations are sound.
We can also conduct an extensive literature search ourselves, again guided by our internal governance process. The findings from the literature search can then be incorporated into a proposal. At this point we may contact our expert advisors, who are often working in the field, for their input and expertise. Our expert advisors are from a wide range of well-respected organisations and bodies.
Once we receive input from our expert advisors, we can then take our suggestions to our clinical governance committees, which are the Joint Formulary Committee for BNF or the Paediatric Formulary Committee for BNFC. At these committees we present our findings and the information we have gathered to receive their input as well.
Official product literature is only one source of medicines information. Some people may not realise how it fits into the wider evidence base. How does Pharmaceutical Press assess and use product literature alongside other trusted sources, and what steps do you take to ensure that content remains independent, evidence-based, and focused on patient safety?
Product information can be used as a starting point for our content. Specific information, such as doses for new drugs, is typically only found in official product literature. There will not be any more information available about using other doses.
It might come in time, but we use the manufacturer’s information at that point.
The use of medicines, however, do not always follow product information, and lots of medicines are used differently to how they are licensed. So, in these circumstances, we delve much deeper.
This is generally done through our governance process. For example, when proposing an unlicensed dose or indication, we perform additional research such as extensive literature searches, checking respected guidelines, such as NICE guidelines, and potentially discussing with our expert advisors, with our clinical governance boards (JFC and PFC) acting as our final sign off.
When considering the use of a drug in certain populations such as pregnant or breastfeeding females, we also consult other specialist sources alongside licensed product information, to ensure that the most accurate, evidence-based information is available to clinicians.
Finally, we always consider any safety aspects of a drug and therefore take into consideration any MHRA drug safety updates, or indeed, any safety alerts from other organisations such as HSSIB, on top of information provided in licenced literature.
And of course, regardless of the source of information, we are always utilising our clinical and editorial expertise to ensure that our content supports the safe and effective use of medicines.
Product literature is regulated by bodies such as the Medicines and Healthcare products Regulatory Agency (MHRA) and the European Medicines Agency (EMA), but it is also prepared by pharmaceutical companies. How does Pharmaceutical Press critically evaluate that information, and what checks are in place before it is incorporated into our content?
Product literature is critically evaluated and checked against the wider evidence base. If further clarification is needed, we can contact the manufacturers directly for advice.
We ensure that we use the most up-to-date product information available and have a robust sources processing procedure to ensure that updates in product information are reviewed by our editorial team, so any resulting content updates can be planned.
As mentioned, although product literature is a very useful source, we do consider a wide range of sources for our content.
Evidence grading is an important part of utilising the information we collect. Can you explain to readers what evidence grading is and outline its benefits?
Evidence grading is a simple way for health professionals to understand the basis of our advice. We use a five-level grading system, from A to E.
Grade A represents a high-strength recommendation based on high-quality sources, such as NICE guidance or other trusted bodies.
Grade B indicates a moderate-strength recommendation, Grade C a low-strength recommendation, and Grade D a very low-strength recommendation, where the supporting evidence is limited or of poorer quality.
Grade E is used for practice points. These are suggestions about best practice in clinical practice, rather than recommendations based directly on evidence.
We also use an evidence grade M. When an M appears next to highlighted content in BNF, it means the advice comes directly from the manufacturer. This helps readers clearly identify when information is based on manufacturer guidance.
We also have other ways of showing health professionals where our information comes from. For example, in our pregnancy and breastfeeding sections of BNF, we often highlight when recommendations are based on specialist or tertiary sources. This helps show that we have carried out thorough background work and reviewed a wide range of evidence and sources before making recommendations to the public and clinicians.
What role do you think Pharmaceutical Press can play in preventing misinformation within the medical and health communications sector and how does your work support that goal?
I think Pharmaceutical Press has a really important role to play here.
We are a trusted resource for health professionals and are synonymous with healthcare. We are also well-known, particularly for our BNF + BNFC products; our readers rely on us to provide high-quality, evidence-based information.
By maintaining those standards, we help ensure that readers can continue to trust what we publish and know that our content is not influenced by misinformation due to the rigorous standards we maintain.
A recent example was misinformation surrounding the use of paracetamol in pregnant women, which could result in patient harm if paracetamol was avoided. Pharmaceutical Press, through the BNF newsletter, was in a great position to publish the MHRA’s reassurance on the safety of paracetamol during pregnancy.
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How can health professionals stay up to date with your work?
The BNF newsletter is a great way to stay up to date with BNF + BNFC. Every month we publish a list of significant changes to our content, including any new drugs, new indications, safety warnings, and even discontinued drugs which we remove from content.
We also provide an insight into some of our larger projects when we publish, explaining what the change is, and why it was necessary; while our core content is factual and evidence-based, the newsletter provides a useful space for us to share additional context and information.
