Medicines formularies: And your point is?

Introduction

Search the internet for ‘hospital drug formularies’; the return is an extensive list from healthcare organisations with a number listed as joint formulary publications for the local healthcare economy.

The purpose of the formulary is to promote evidence based, safe, clinically effective and cost-effective prescribing; however, if that is the case, why do all formularies not contain the same medicines for treating the same conditions? Does this mean that, instead of increasing rational prescribing, formularies promote variation?

The processes leading to formulary inclusion usually require a consideration of the evidence supporting a medicine’s use and the associated financial consequences. This process is potentially repeated many times over by different local formulary committees which can result in different decisions, leaving significant duplication of effort. The uptake of new medicines within the UK is significantly slower than in healthcare systems in other developed countries. Do formulary processes impede the earlier use of new medicines?

What happens when the formularies of primary and secondary care organisations within the same healthcare economy differ? Or the patient sits between two healthcare economies or receives elements of care from different healthcare economies?

With the growth of NICE, the emergence of regional medicines optimisation committees, commissioning on a national level and perhaps most important of all patient choice, do formularies still fulfil their original purpose or are they simply lists of medicines which the hospital keeps in stock and the Clinical Commissioning Group is happy to pay for?

What are the some of the risks associated with local formularies?

What is the purpose of a formulary?

The 1986 Nuffield Report ¹ gave positive reinforcement to the need for pharmacy and was keen to see full use of pharmacists' education and training by their making the most effective contribution to healthcare. This has developed in to the idea of proactively embedding pharmaceutical advice into a localised medicines formulary, refining the British National Formulary into something manageable within a defined care setting.

In 1995, The WHO Expert Committee on the Use of Essential Drugs recommended that WHO develop a Model Formulary to complement the Model List of Essential Drugs. ² The purpose was to promote a rational approach to therapeutics.

The 2014 National Institute of Health and Clinical Effectiveness (NICE) guidelines ³ on developing and updating local formularies identifies that there is variation in such formularies across the range of medicines included, and the processes for developing and updating the formulary.

So do formularies achieve their purpose?

The stated purpose of many formularies is to support the safe, clinically effective and cost-effective use of medicines; however, there is limited published evidence to support these assertions. Similar to the adage “you would not jump out of a plane without a parachute” for many the benefits of formularies just make sense and do not require evidence to prove their usefulness.

Improving medication safety

Risks associated with medication do not only arise from the potential adverse effects of the drugs themselves, prescribing and administering medicines is the most common therapeutic intervention within modern healthcare, and the possibility of human error is ever present throughout the associated processes:

Prescribing the incorrect medicine

Prior to formulary inclusion, medicines undergo critical review of published evidence to understand the clinical efficacy, tolerability and safety profile of the requested medicine. In conjunction with the published literature review, many formulary committees in the United Kingdom undertake additional risk assessments for local implementation related to purchasing, dispensing, preparation, storage, administration and prescribing.

The potential for look-alike and sound-alike medication errors is well known ⁴ ; this coupled with ‘brand consistent’ product packaging needs to be considered when adding new medicines to the formulary or changing preferred suppliers of medication. Where medicines present a significant risk of confusion in prescribing, dispensing and administration strategies such as the following should be considered to minimise error and potential for harm:

Restricting prescribing rights to individuals or departments

Consideration will be given to the setting in which the medicine is to be prescribed, whether this will be a hospital only medication or will there be prescribing in primary care. An essential element of this decision will be the level of knowledge and experience required by the prescriber in relation to the drug or disease, any therapeutic drug monitoring and the systems in place to support such activities.

In addition to the medicine specific safety questions, formularies develop familiarity with medications and treatments at a local level. Through reducing the number of medications available, knowledge of dosing and administration requirements is increased within the healthcare professionals (HCPs) prescribing and administering.

This promise of reduced risk through familiarity holds true for a stable staffing model where HCPs have the time to invest in developing a working understanding of formulary, but a significant proportion of the workforce will be rotational (junior doctors) or of a flexible nature (agency and locum staff). For this staffing group initial intensive support can be provided through induction or education, but what about on-going need?

Advances in information technology have made it possible to expand the information which is contained within the formulary to include additional information such as dosing in renal failure, local protocols or reconstitution and administration advice. The IT advance has led to the development of local formulary apps to support prescribing choice at the bedside.

The incorporation of formularies within electronic prescribing systems offers the potential to bring the formulary to the forefront in prescribing decisions with software providing at the point of decision support in selecting the most appropriate treatment within the local context.

Within the hospital setting, medicines stocked within the Pharmacy department will be closely aligned with the formulary, which presents a physical barrier to access of non-formulary medicines, ensuring that all medicines available for use within the hospital will undergo a review of safety and efficacy.

The potential lack of access to medicines can in itself present a safety risk to patients admitted on one or more non-formulary agents. Omitted doses of medications can lead to serious adverse effects for patients, as highlighted in the National Patient Safety Agency Rapid Response Alert in 2010. ⁵

The possibility of patients experiencing the unintended omission of medicines, when admitted to hospital, can be reduced through the following actions:

Develop and manage a joint formulary between all care settings within a healthcare economy.

Clinically effective

To establish clinical efficacy local formulary committees undertake a critical review of medicines prior to formulary inclusion. This critical review of published literature is to ensure that patients are not exposed to potentially harmful effects of medications where evidence of efficacy is questionable or lacking.

Local formulary committees will review evidence from the same pool of published literature; however, decisions may vary between centres or healthcare economies, in whether medications are listed as formulary or where in the formulary they sit. In February 2009, The National Prescribing Centre (NPC) published “Supporting rational local decision making about medicines (and treatments)”, ⁶ to provide a standard for the Primary Care Trusts and Area Prescribing Committees of the time, against which formulary processes can be assessed and gives a model of best practice to provide consistency within the decision process itself.

The first source for variation in formulary status of medicines lies in the process of identifying the need for the medicine. Medicines review processes within local formulary committees, particularly those within provider organisations, are likely to be triggered by a request from a clinical champion. The timeliness with which the request for review occurs is therefore dependant on the services provided and the specialist interest of the consultant body working within. Delays in requests for review of new medications may mean patients are not being treated with newer therapies which may be advantageous from an efficacy or safety point of view.

The 2009, NPC document highlights the need to undertake proactive review of new and emerging therapies, however, without a clinical champion to set the evidence within the context of local populations or changing epidemiology, these reviews can be unproductive producing a formulary status which identifies that the formulary committee is aware of the medicine but provides no firm decision on place in treatment.

The potential for variation on formulary inclusion leads to potential risk to patients in continuity of care. Patients living in border areas of healthcare economies may have GPs and provider organisations working with significantly different medicines formularies. In moving between care settings, the patient may be subject to unnecessary formulary substitutions or medicines omissions. Substitutions of medicines mean that patients may have to undergo extended periods of monitoring as the effects of medicines, even when in the same therapeutic class, are not always equivalent or predictable.

Formularies may contain a number of agents within the same therapeutic class, listing a medicine within a formulary does not necessarily provide adequate information or guidance to ensure that it is the most appropriate treatment for the patient nor does it support optimal therapy. Formulary committees should look to identify the place in therapy. First or second line? For specific patient groups? Such information should be included within the formulary or in some cases developed as treatment pathways. These pathways are most commonly found when treatment is complex or expensive.

In delivering the clinical efficacy agenda, formulary committees look to minimise unwarranted clinical variation through a restricted choice of medication and a semi-structured approach to the use of these medicines. Although based on published evidence, the extrapolation of data from the clinical trial settings to real patients is not always black and white. In reducing variations in prescribing, formularies naturally introduce limitations to clinical freedom and choice, the evolution of the classic formulary list into a clinical pathway can provide appropriate clinical choices to prescribers to better suit individual patient need.

Cost effective

In the financial year 2014/2015, the NHS in England spent £15.5 billion on medicines. ⁷ Given the finite and challenged financial resources within the NHS, it is vital that formulary committees ensure that approved medicines are cost effective.

When safety and clinical value are equal formularies list medicines with the lowest acquisition costs as preferred agents. Through this type of formulary management and therapeutic substitution as medications have lost patent protection, significant savings have been realised with minimal disruption to patients.

The intent to guide prescribers to make cost-effective choices and optimise value from medicines requires supervision of prescribing within the bounds of the formulary. This activity is generally provided by the hospital pharmacy or the primary care medicines management teams, but supervision can easily be circumvented, deliberately or without intention, FP10 prescriptions are portable and are dispensed without reference to local or regional formularies.

Formulary committees which lack the ability to allocate or agree financial implications may approve medicines for formulary inclusion which may experience delays in implementation or never used at all due to budgetary processes. Realising cost savings arising from medicines use may not be easy or even possible; newer agents may reduce the requirement for blood monitoring or transition care from an inpatient to outpatient care setting; however, changes in activity, acuity of patients or marginal gains in capacity in services may mask underlying cost savings. This can be a dilemma as the medicines may offer improvements in safety, clinical efficacy or patient experience.

Non-formulary prescribing

It is unavoidable that within a care setting a proportion of patients will be prescribed a non-formulary medicine and as formularies within hospitals tend to be more limited, this is a more commonly observed in secondary care.

Patients should be encouraged to bring with them supplies of medicines from home, which can be continued and reused within the hospital, reducing the likelihood that alterations to therapy will be required.

Substitution policies can be used to provide guidance to prescribers or empower pharmacists to change non-critical therapies to formulary alternatives. Changes to therapies should always be discussed with patients to minimise the risk of inappropriate therapeutic duplication once the patient returns home.

It may not be desirable therapeutically to change certain medicines, either for patient response, tolerability or monitoring reasons. In these circumstances, most care organisations will have a non-formulary prescribing process to support continuation of therapy and provide access to the required medicine.

Across the boundaries

Ideally, commissioners and providers within the same healthcare economy will work together and operate a joint or aligned formulary model, and although minor differences will arise in some of the more specialist aspects of their operations, the fundamental principals will be established to ensure continuity of care. Joint formulary committees provide an opportunity for specialist and commissioners to engage and develop effective treatment algorithms.

In recent times, many primary care formularies have evolved to utilise traffic light status to denote suitability for prescribing by GPs. Starting with the intention of being simple three status lists, some have extended the rating system to have five or more status leading to confusion and disengagement amongst many users.

The original purpose of the traffic light status was to support GPs in the multitude of requests for prescribing that they receive from local hospital specialists through to tertiary centres. GPs should be able to access the traffic light status of the medicine to identify if it is suitable for prescribing by GPs, suitable for prescribing with the support of shared care arrangements or have ongoing prescribing provided by the hospital.

There are possible unintended consequences of traffic light status:

The primary and secondary care organisations may not agree on the traffic light status leaving the patient unclear about where continuing therapy will come from.

Shared care prescribing

Shared care prescribing protocols offer a way to mitigate risks in the prescribing of drugs which require complex titration or safety monitoring, across care boundaries, and have been utilised within rheumatology for over two decades to effectively support the prescribing of some of the most toxic medicines in common use.

The shared care prescribing protocol defines the responsibilities of specialists, GPs and patients during the initiation and continuation of treatment and provides a detailed schedule for efficacy and safety monitoring as well as dose adjustments within specific circumstances. Such arrangements enable the patient’s GP to continue chronic therapies in a safe and effective manner, meaning that the GP is fully informed when making ongoing care decisions.

What is the future for formularies?

The NHS constitution mandates that all NHS organisations in England must provide access to NICE approved therapies, which has led to a considerable reduction in variation of access to these medicines. This has eliminated the need for local formulary groups to undertake the critical review of clinical and cost effectiveness, leaving only the safe implementation to be considered.

In February 2016, a letter from the Chief Pharmaceutical Officer NHS England outlined plans for the creation of four regional Medicines Optimisation Committees which will assume many of the responsibilities and activities currently delivered by local formulary groups in an effort to:

Support the delivery of the medicines optimisation agenda at local level

These groups will focus on medicines outside of the NICE programme, leaving local formulary groups to focus on implementation and achieving best value.

Clarity is required on how these groups will link with local formulary groups or whether this will further reduce the variation in formularies between healthcare economies. However, the refocusing of local formulary committee time to implementation will provide an opportunity to build on the strengths of current formularies and eliminate some of the weaknesses.

In doing so, formulary committees should look to strengthen:

Alignment of formularies within local healthcare economies

Formularies need to move from lists, prioritised lists and traffic light lists to cohesive medicines policies and pathways, which describe the What, When, Where, How and by Whom to improve medicines optimisation and patient safety. Pathways which are useful to the full range of prescribers and pharmacy staff that the patient encounters and outline specific goals of treatment.

Formularies need to be enlivened and transitioned from lists of medications to tools which support prescribers in choice of therapies, not a framework by which to grade prescribing.