Medicines information for healthcare professionals
How a healthcare professional's question about a medicine becomes an evaluated written answer they can act on, and how the service that produces such answers is run, are one set of questions whether the service sits in a health service, in a pharmaceutical company's medical information department, or behind the community pharmacist at the counter. Promotional material about a product is in medical advertising, the in-house function that writes for both a company's science and its marketing in medical affairs writing, information written for patients rather than clinicians is in patient education materials, and appraising the studies an answer rests on is in critical appraisal.
Know which service is answering
Medicines information turns a question and evaluated evidence into an answer that a healthcare professional can use. Most of the advice on answering enquiries and running a service comes from a 2007 book chapter on writing medicines information for healthcare professionals, in The Complete Guide to Medical Writing. The chapter writes from UK National Health Service practice of that period, so the services, websites, software, training packages, incident-reporting scheme and legislation it names illustrate functions rather than describe current arrangements, and their availability and legal force need checking before they are relied on. The Complete Guide to Medical Writing is held as a conversion of an incomplete copy of the 2007 book, with numerous internal pages missing and their boundaries marked as gaps, figures represented as text, and no full page-by-page proofread of the conversion, so its marked gaps cannot be read as continuous prose.
The accounts agree on what the work is. In the chapter, UK Medicines Information (UKMI) pharmacists provide medicines information services for the NHS under a strategy and framework that oversees their development, and the kinds of medicines information it lists run from enquiry answering and frequently asked questions through the development of local services and decision-making, news and newsletters, to critical appraisals and drug reviews. A medicines information pharmacist writing in December 2013 describes the same function: medicines information services aim to support the safe and efficient use of medicines by providing evidence-based information and advice on their use, may be publicly or privately funded, and in the UK the publicly funded ones are organised into a three-tier virtual network, UKMi, which ensures ready access for all National Health Service health professionals. Their core work is enquiry answering for healthcare professionals and in some cases patients, researched by staff who have a wide range of resources and are specially trained in the retrieval, interpretation and appraisal of information; they may also provide information proactively in newsletters and publications, and take part in training, formulary work and a wide range of other activities. The issues of EMWA's Medical Writing of December 2013 (volume 22, number 4, Good Pharma) and September 2017 (volume 26, number 3, Observational Studies) were admitted from an existing Markdown conversion without content repair; their known limitations are broken ligatures, mangled multi-column tables, interleaved page headers and footers, and figure text represented as marked text.
A pharmaceutical company runs the same service for its own products. The goal of its medical information department is to respond to unsolicited requests on a broad range of topics about a product or a disease state, and the standard response letter is its most used form of response. An article in the same December 2013 issue on launching products in emerging markets describes the team a company needs following a launch: dedicated medical information scientists answering unsolicited enquiries from healthcare professionals, through standardised or customised responses, about labelled or off-label use and the product's efficacy and safety. The AMWA Journal issues of 2008 (volume 23, number 1), carrying the news of a proposed pharmacist-counselled class of medicines, 2009 (volume 24, number 3), carrying one department's guidance on standard response letters, and 2012 (volume 27, number 4), carrying the report on the US regulator's off-label policy, came through layout-aware Poppler XML conversion from their PDFs without content repair, so figure labels can be inlined into prose, cover and contents columns can interleave and reference URLs can be malformed or truncated. What the promotional side of a launch in a new market needs, as distinct from this service, is in what a promotional campaign is made of, and how such a function is staffed and located is in building writing capability in emerging markets.
Establish the question and the service's capacity
The writer should know what the enquirer wants and needs and how they work, and match the work to clinical urgency and current workload, and to available staff, expertise, information resources, and technology. Suitable training, standard search strategies, checklists, and templates help deliver quality information, while any search depends on the complexity of the enquiry and the needs of the enquirer. The writer should also recognise when specialist referral is necessary.
A search should follow a strategy. The chapter asks for an organised and systematic search strategy so that no important information source is missed, with a clear plan of how and when to use each resource , and the emerging-markets article describes each company response in the same terms, as requiring a strategy-based search of peer-reviewed literature databases to identify the relevant articles from which the customised response is built.
An authoritative reference summary can provide orientation before a more detailed search. Bibliographic indexes should be used to locate relevant reports, and the underlying evidence evaluated when the question requires it. Summaries can introduce author bias, miss important detail, and become out of date quickly. The chapter's primary/secondary/tertiary terminology follows medicines-information practice and includes systematic reviews among primary resources; original studies should be distinguished from syntheses when the actual evidence is described.
Write the answer the enquirer needs
The request should be acknowledged at once, with an estimated timeframe and an agreed deadline, and the question answered, with a summary of the question at the beginning of a written reply. The response should be impartial, evaluated, accurate, and timely, with references, and should say what any limits on the answer are. Any opinion of the writer's own should be marked as such and supported. It can be useful to support an answer given over the telephone or in person with a written response, which allows a fully referenced, evidence-based answer, and a written answer can also avoid misinterpretation or carry a large amount of information.
A letter should have a subject heading and a header that identifies what it concerns, present arguments and facts in a logical order, and summarise the conclusion. A very short answer may need neither headings and bullets nor a closing summary. A letter should also include the writer's job title and contact details and offer further support, and its clarity, readability, and overall presentation should be checked.
The chapter's paired letters show how a response can fail despite containing relevant facts: it may not answer the question, explain why a mechanism matters, provide references, or separate distinct ideas. The revision restores context, a reasoned conclusion, attribution, and a usable letter structure. Its pharmacological statements are historical illustrative content and should not be used to answer a clinical or legal enquiry.
Turn recurring questions into standard answers
Recurring questions can become reviewed FAQs that preserve qualifications, references, limitations, and review or expiry dates. Where there is no answer, the FAQ should say so and explain why. Looking back at a previous enquiry can give a head start when someone presents a similar one.
The standard response letter is the company department's form of that reuse, summarising information from the published literature, internal data and the prescribing information. As part of a departmental excellence initiative, one company's medical information department created a guidance document intended to give a structural foundation that would facilitate consistency while leaving enough flexibility for the unique needs of each letter.
Several samples of letters for each product were reviewed to establish which resource documents were most heavily used and whether the responses could be categorised by the kind of inquiry; a representative letter from each resulting category was then dissected to record which additional elements it contained. Six categories fell out of that analysis, along with seven core elements common to all of them and five category-specific ones.
The guidance document then fixed several things. An outline established which elements were required for each category. Section headings were specified for each category, for clarity. Standardised text was written for many elements, and for the elements that did not warrant fixed wording, general guidelines were given instead. And it gave guidance on creating a letter in response to an inquiry about disease-state information, and supplied a composed response to inquiries on which no data are available.
Two effects are reported. New department members found the guidance a comprehensive learning tool, so the document doubled as training material. And implementing it provided an opportunity to review each existing letter critically and fostered an intensive revision process that updated and standardised the letter databases.
Answer an unsolicited request for off-label information privately and without promotion
The US Food and Drug Administration's policy on unsolicited requests for off-label information is known from a report, published in 2012, of a conference session at which an official of its Office of Prescription Drug Promotion set it out. The agency defined an unsolicited request as one initiated by a person or entity completely independent of the firm and not prompted in any way by the manufacturer or its representatives. Such a request could be non-public, directed privately to the firm in a one-to-one communication, or public, made in a public forum, and whichever it was, a firm that chose to respond was to send the response as a private, one-to-one communication only to the individual who asked.
A response to a non-public request was to be tailored to answer only the specific question asked. The information in it had to be truthful, non-misleading, accurate, balanced, scientific and not promotional in nature, and generated by medical or scientific personnel, and the response was to be accompanied by the FDA-required labelling. Prominent statements in it were to explain that the FDA had not approved or cleared the product for the use addressed, disclose the FDA-approved indications, provide all important safety information including any boxed warning, and provide a complete list of references for all of the information.
After responding, a firm was to keep records of the nature of the request, including the requester's name, address and affiliation, the information provided, and any follow-up inquiries or questions. A firm was to respond to a public request only where it concerned its own product and not solely a competitor's, and the response was to be limited to the firm's contact information and carry no off-label information, so that the individual could follow up independently through a non-public channel. A representative giving a public response had to disclose their relationship with the firm clearly, and the response was not to be promotional.
Publish for a readership as well as an enquirer
Newsletters can combine brief news, evaluated research, guidelines, service changes, product or authorization updates, and relevant questions. Their frequency and length should balance the needs of the audience against the ability to stay in regular production. Short summaries orient readers, while links or references lead to the full evidence. The seasonal bulletin example combines treatment information, practical resources, and fuller sources; its damaged clinical text is not a basis for current advice.
A service should work with local providers to identify information needs. Medicines information skills can provide evaluated information for local decision-makers and commissioners, and formulary management involves economic evaluation, including cost implications for the local health economy, as well as clinical effectiveness. A newsletter can publicise changes or developments in formulary choice or policies.
A guide can also be written for a whole professional audience rather than for an individual enquiry, as one published in May 2017 was. The European Medicines Agency and the European Commission published an information guide on biosimilar medicines for healthcare professionals — biosimilars being biological medicines highly similar in all essential aspects to a biological medicine already authorised — whose objective is to give healthcare professionals reference information on both the science and the regulation underpinning their use. It was a joint initiative of the agency and the Commission. It was developed in collaboration with scientific experts across the Union and in response to requests from healthcare professionals, and organisations from across the Union representing doctors, nurses, pharmacists and patients shared views on it, to ensure it addressed questions relevant to healthcare professionals. It was launched at a stakeholder event on biosimilar medicines bringing together healthcare professionals, patients, payers, regulators and industry. The announcement adds that since the first biosimilar was approved in the Union in 2006, clinical experience shows that biosimilars approved there are as safe and effective in all their approved indications as other biological medicines, and by that date 28 had been recommended for use.
Maintain an accountable service
The standard follows from the stakes. Poorly presented medicines information can cost the writer professional credibility and lead the recipient to ignore the advice, and more seriously could result in clinical error and patient harm; medical information services require high-quality standards because even small errors could have serious consequences for patients.
To present medicines information effectively, a writer needs planning, prioritisation and time management; to know the audience and their own limits; use of resources and search strategies; accurate, up-to-date information from reputable evidence-based sources; and suitable skills and knowledge. A writer who is not a pharmacist should always involve one, both for the expertise and to ensure clinical accuracy.
A service should define its scope, procedures, competence, resources, and quality standards, and review its performance through audit, peer review, user feedback, and incident learning, including near misses. Records support continuity, complaint investigation, training, workload assessment, and improvement. The chapter illustrates these with UKMI's quality-assurance and incident-reporting arrangements.
The record should document the enquirer, question, urgency, relevant background, search and sources, answer, responsible reviewers, and any unresolved issue or delay, in a retrievable system with appropriate access and retention arrangements. The chapter's example enquiry form ends with a section recording why an enquiry is pending, with the date and initials. Shared records and reusable answers can support training as well as service delivery.
Handle limits and sensitive enquiries explicitly
Where a question is outside scope or cannot appropriately be answered, the answer should explain the limit and refer to a suitable service where possible. Faced with an ethical dilemma, the writer should take time to think before replying, consider consulting colleagues or managers, and document carefully everything done. For third-party questions, identity, purpose, and the implications for confidentiality should be established. No guidance covers every ethical dilemma; each needs professional judgment, discretion, and experience.
Enquiries connected to legal proceedings should follow an organisational policy. An answer should state expertise and resource limits and distinguish opinion from fact, and its basis should be retained. Information handling and access rights depend on the applicable law; the chapter refers to the UK Data Protection Act 1998 and related legislation.
Specialist services, competency materials, completed enquiries used as training examples, and structured learning packages can support staff development. The chapter's named UK services, libraries, software, and training packages illustrate these functions.
Make the evidence usable at the counter
The pharmacist's December 2013 account of community pharmacy explains why evidence-based medicine is not often used at the counter. Products sold over the counter may traditionally have been guided more by commercial gain than by evidence, and even licensed products may lack a robust evidence base: irrational combination products, cough medicines and unproven complementary medicines line the shelves of most stores, which is what led prominent promoters of good science to call pharmacy a quack trade. Distancing the profession from quackery and embracing evidence-based medicine is becoming more and more imperative, particularly with the deregulation of prescription-only medicines, the potential for patients to self-select pharmacy medicines, and a public increasingly willing to take responsibility for its own healthcare. The cornerstone of evidence-based practice is the ability to locate, appraise, understand and communicate clinical evidence, and pharmacists — often the front-line interface between patient and health service — need the skills to translate complex statistical health information into language patients will understand and engage with.
The pharmacist sees clear opportunities to use clinical trial evidence in daily community pharmacy. An over-the-counter consultation is a stepwise process of elimination: structured questions, usually following a mnemonic such as WWHAM — who is it for, what are the symptoms, how long have they been present, what action has been taken, what medication is being taken — or the longer ASMETHOD, to establish symptoms and check the diagnosis and to identify symptoms requiring referral; then the range of available products for that diagnosis, narrowed by medical and drug history for cautions, contraindications and interactions; then a recommendation and counselling on safe and effective use. Pharmacists are among the most accessible healthcare professionals and routinely field questions prompted by sensationalist media reporting or by information from friends, family or the Internet.
The surveys the account cites suggest a profession broadly in favour of evidence-based medicine whose ability to use it in everyday work is limited. A 2005 survey of pharmacists across all sectors in Illinois by Burkiewicz and Zgarrick found 90% of 323 respondents holding positive attitudes towards evidence-based medicine, and a later survey of community pharmacists in Northern Ireland by Hanna and Hughes found 88.3% of 205 respondents familiar with the concept of evidence-based practice. The same Northern Ireland work found that the overriding concern when selecting a product was patient safety, with 91.8% agreeing or strongly agreeing, effectiveness coming second, and the most common methods of judging effectiveness being patient and colleague feedback and personal or family use, with clinical trial data a less important consideration; over 60% agreed that evidence-based practice is more difficult for community pharmacists than for other healthcare professionals. The account is explicit that this evidence base is itself thin — there is an overall lack of robust evidence on pharmacists' attitudes and uptake, and the published work is limited by small sample sizes and methodological flaws — so the percentages indicate a pattern rather than measure a profession.
An undercover investigation adds a consumer-side figure with the same caveat attached. In May 2013 the UK magazine Which? visited a sample of 122 community pharmacies and found unsatisfactory advice given by pharmacy staff in 43% of visits; the report was widely criticised for its small sample, and the pharmacist suggests it may be indicative of a wider problem that increased uptake of evidence-based medicine may improve. The same magazine published a list of ten popular and widely available pharmacy products for which no good evidence of benefit exists.
The account identifies several barriers. Lack of time was cited by 45% of pharmacists in the 2005 study as the main factor limiting their ability to practise evidence-based medicine, and the fast-paced, unpredictable retail environment — constant interruptions, many tasks, an open appointment-free approach — makes the proportion likely higher in community settings. Trusted resources such as the major commercial medicines compendia may be too expensive for an average community pharmacy and hard to navigate in that environment, while advanced clinical services and a rising dispensing workload compete for the same time. Training is skewed: over-the-counter training tends to take the form of industry-sponsored packs aimed at enabling staff to sell new products, which in the pharmacist's experience focus on practical selling points rather than addressing shortcomings in clinical evidence or proof of benefit, and may be adequate for safe sale but do not always include enough information for an unbiased evidence-based assessment. And the skill itself is thin — only 38% of community pharmacists in the Hanna and Hughes study agreed that they knew how to perform a literature review and critically appraise research papers, despite critical appraisal being covered in degree courses and pre-registration training, because it may not be used often enough in everyday practice to be maintained.
The last barrier is the customer. Patients appear more likely to rely on personal experience or anecdote than on trial evidence when choosing a product, and seem broadly ambivalent about the need for evidence of effectiveness; combined with advertising and a retail culture in which the customer is always right, that can make them unresponsive to a message about missing evidence. In an Australian qualitative study, pharmacists reported that advertisements for over-the-counter medicines opposed their professional advice and left them feeling disempowered, and the pharmacist observes that in the face of consistent rejection of evidence-based advice it may be understandable that many stop trying to convey it. What the surrounding public argument about the industry looks like is in writing where the pharmaceutical industry is distrusted.
In late 2007 the US Food and Drug Administration was considering, for the fourth time since the 1970s, a class of "behind-the-counter" medicines, available without a physician's prescription but only after the patient is counselled by a pharmacist. The category already existed in various forms in several other countries, and some US products such as emergency contraception and pseudoephedrine-containing cold remedies were already handled under it.
Proponents argued the class would improve access and continuity of care; opponents raised safety concerns including the possibility that people would skip routine check-ups, and argued that access might actually narrow if such products were sold through a limited number of stores, curbing competition and raising prices; whether insurers would reimburse was open. A hearing was held on 14 November with no deadline set for a decision. This is a 2007–2008 snapshot of a proposal rather than a description of a category in force.
Give the pharmacist evidence already appraised
Awareness of reliable sources is the first of the account's solutions: only 23.9% of community pharmacists in the Northern Ireland survey were familiar with the work of the Cochrane Collaboration, and improving awareness of and access to reliable medicines information is crucial, because pharmacists without the time or skills to interpret trial data need robust, concise resources from organisations skilled in interpreting evidence. Primary care resources such as the UK national institute's clinical knowledge summaries can help with minor ailments, but high-quality independent guidelines for over-the-counter medicines were lacking. Greater collaboration between the industry and accredited pharmacy training providers may be one route, with an independent review process similar to peer review but tailored to over-the-counter needs that could control bias in industry-sponsored training packs, and standardisation of those packs to include information on clinical data and its limitations, which may improve pharmacists' ability to make evidence-based decisions.
The second route is the medicines information service itself, seen from the customer's side rather than the provider's: greater awareness and use of such services among community pharmacists may be helpful, since they provide a rapid and efficient evidence-based enquiry-answering service that frees pharmacists' time for other work, with staff specially trained in retrieving, interpreting and appraising evidence acting as a go-between who applies trial data to a clinical situation. The third is independent training on critical thinking and appraisal skills tailored specifically to community pharmacists, for which the pharmacist sees a clear need, and the account calls the ability to disseminate complex safety and effectiveness data to patients a valuable skill the profession could focus on. The account leaves open how best to close the gap between patients' reliance on advertising and anecdote and more reliable evidence, and calls future research in the area valuable.
The pharmacist's own account describes doing it. Having worked in community pharmacy for many years, the pharmacist identifies with using patient feedback and personal use as the main means of choosing a product: bombardment with information about new products and the pressure of running a pharmacy day to day can make keeping up with emerging evidence virtually impossible, and passive methods of differentiating between products become easier than appraisal. After moving into medicines information the pharmacist became more skilled at finding, appraising and communicating trial information, and found that this in turn improved the over-the-counter advice given on locum shifts, making it possible to help an engaged patient make an informed choice. Reactions ranged from gratitude, satisfaction and engagement through impatience to, rarely, anger — and for the most part the pharmacist found that being honest about the lack of evidence for a product increases trust, because patients can see that the person advising them is not there primarily for commercial gain.
The account ends on a structural point. Community pharmacy has an inherent conflict of interest as both a retail outlet and a professional healthcare service, and commercial interests may traditionally have outweighed the need for evidence-based advice. Other parts of the healthcare system, and of pharmacy, were adopting evidence-based medicine, and there was increased focus on the importance of clinical trial data in the health and popular media following the campaign for all past and present trials to be registered and their results reported, which was exposing the gap between reliable evidence of benefit and how over-the-counter products are sold. The registration and reporting campaign itself is in registering a trial and posting its results.