Views from our Partners: Medicinal product or molecule?

The views expressed in this blog are the author’s own and do not represent the views of the PRSB.

Medicinal product or molecule? – The challenge for medicines interoperability

Summary

For medicines interoperability to work across our healthcare system, standards are essential. But complying with these standards can often be harder than it seems. The PRSB information standards have the potential to make medicines data truly interoperable – but interoperability will also require a change in the way we prescribe medicines in secondary care. Molecule based prescribing (prescribing just the name of the active ingredient) is helpful in many ways – but for interoperability to work, we need to document the actual medicinal products a patient leaves hospital with, or there will always be a need for humans to clear up the ambiguity.

Product vs Molecule

There are two ways of thinking about a therapeutic medicine – and while both are valid, they are at times, unhelpfully incompatible – or should I say un-interoperable.

The first concept is the Product.

A pharmaceutical organisation develops, tests and trials a medicinal product. The product is a ‘preparation’ of (one or more) active ingredients and if present, excipients that give the product its form.

 The product has a form, a weight a manufacturer and a price. The product is ‘licenced for use’ in certain situations for specific clinical indications. It is sold to healthcare organisations who may use it for a licenced indication or (at their own risk) for an unlicenced indication.

For the avoidance of doubt, it is the product that the pharmaceutical organisation has tested, the product that has undergone a clinical trial, the product that has the clinical indication for use.

The second concept is the Molecule.

The molecule is the active ingredient. It is the actor within a biological process; the subject of academic research. Supporting evidence for the molecule is generalised from the clinical trials of actual medicinal products. The molecule is considered in the abstract. It is independent of any product. It does not have a form, a weight a manufacturer or a price.

Secondary care prescribing

In secondary care, the prescribing preference has been to use molecule-based prescribing. To use the correct jargon, hospital prescribers tend to prescribe Virtual Therapeutic Moieties (VTMs). The VTM is just the name of the active ingredient and a VTM prescription includes the dose and posology – for example: ‘Paracetamol – 500mg – 4 times a day until stopped’.

The VTM prescription provides several advantages:

  • A single VTM prescription can cover multiple different medicinal products and formulations so the prescriber can leave, to their pharmacy and nursing colleagues, more options as to what to actually give the patient:
    • Options related to what is in stock
    • Options related to which brand is the most cost effective
    • Options related to the specific form/formulation
    • Options related to the route of administration (prescribing for multiple routes: Oral, Intravenous etc)
  • The prescriber only needs to remember the dose of the active ingredient and the posology
  • It is faster to prescribe (on paper)
  • Your prescription must be reviewed by pharmacy/nursing staff – who may correct prescribing errors

But there are disadvantages:

  • The options leave open significant ambiguity:
    • Ambiguity between different potential preparations
      • e.g. Lithium is available as two salts, lithium carbonate and lithium citrate, which are not dose equivalent.
    • Ambiguity between forms
      • Did the prescriber want the patient to have a liquid, a tablet or a capsule?
    • Ambiguity between formulations
      • Did the prescriber want the patient to have a gastro-resistant or modified release formulation?
  • Unintended over/under dose when multiple routes are prescribed
    • Some medicines are far more potent when given intravenously than orally
  • Habitual prescribing errors
    • VTM prescribing for multi-ingredient drugs
      • e.g. Prescribing 500 mg of Co-codamol is not a valid prescription. Co-codamol consists of two active ingredients with different doses e.g. 15 mg of Codeine phosphate and 500mg paracetamol. Prescribing 500mg of ‘Co-codamol’ is not a valid prescription.
    • Error correction by pharmacy not feeding back to prescribers
      • Where prescribers rely on pharmacy to correct errors and do not get adequate feedback – prescribing errors will continue.
  • Pharmacy dispensing cannot be automated as there are too many potential products that could match a VTM prescription.

Primary care prescribing

Primary care providers, who sometimes have their own on-site pharmacy, have long understood the practical and financial benefits of prescribing products in primary care. The vast majority of primary care prescription are simple formulations (tablets, inhalers, creams) and their product based prescriptions do not require further interpretation before dispensing.

Digital Inter-operability

Our problem occurs when medicines data is transmitted between secondary and primary care. When a patient is admitted it is easy for a clinician (or computer) to ‘convert’ a medicinal product prescription to a VTM prescription. But when a patient is discharged, automatically ‘converting’ a VTM to a medicinal product is almost always impossible – there are just too many options, too much ambiguity.

In the world of medicines digital interoperability, it would be a lot easier if everyone just prescribed medicinal products. If actual products are documented, data is easily shared. There would be no ambiguity, and digital systems could interoperate without the need for human intervention.

So what’s the solution?

In my opinion, the solution is to ensure that when a patient is discharged from hospital, the discharge prescription only contains medicinal products. During the inpatient stay, hospital prescribers should be free to use VTM prescriptions on the inpatient drug chart, and work with their pharmacy and nursing colleagues to ensure safe and cost-effective dispensing and administration. But when a patient leaves hospital, if we want medicines interoperability, we need to prescribe products to remove the ambiguity.

Interneuron are delighted to be working with the PRSB to ensure the discharge summary standard supports medicines digital interoperability, and look forward to seeing the impact of this and other PRSB standards as they are adopted across the NHS.

Author information

Joel Ratnasothy, CEO,  Interneuron

Joel is CEO of Interneuron a community interest healthcare IT company. Joel has previously worked as an executive for global technology companies, as an NHS surgeon and as an academic at Imperial College London. He co-founded Interneuron in 2017 to change the way healthcare software was designed developed and supported. He is passionate about co-design and has placed this at the heart of Interneuron’s Modular Care Record. He has a particular interest in Electronic Prescribing and Medicines Administration and Interneuron are currently developing their own EPMA and medicines formulary management solution.

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Personalised care and support planning for people with severe mental illness

A review of a sample of current care plans, and the way they have been developed, may be helpful in identifying the priorities for this improvement. The PRSB Implementation Guide provides more detailed explanations about each element of the plan, including advice on how the planning process might be best conducted.
These questions might form a checklist for current plans to be compared with. 

1. Does the plan include an About Me section in which the service user, in their own words, can indicate the information they want to be available about their lives, their values, their interests, and priorities, available for all those who may care for them?
2. Is the approach to developing a care plan patient centred and engaging, allowing plans to be based on patient priorities goals, and aspirations, along with the actions they plan to take and the support that they will receive?
3. Is there space for a “formulation” to be recorded in which the person receiving care and the professionals who provide it, share and record the personal meaning and the origins of the person’s difficulties?
4. Are relevant procedures and therapies recorded?
5. Where relevant, are one or more contingency plans included for anticipatable disruptions, exacerbations, or deterioration, and do they include advice on what to do and points of contact for those called upon to respond?
6. Where relevant are additional supporting plans incorporated, (an example being an “educational and health plan” for someone with a neurodevelopment disorder)
7. Is a version of the plan available to a service user (if they wish to have it) in a form and format that they can understand and find to be of value?
8. How is a version of the plan available to the GP and other key parts of the health and care system?

Work conducted by PRSB and partners recently has looked specifically at the suitability of this approach to the development and documentation of care and support plans for people with Severe Mental Illness. This resulted in an updated version of the standard (v1.4), for use by any service and for any group of service users, but with some modifications to ensure that it meets the needs of this community. The approach to a patient centred process of identifying goals, hopes, and values, and the support needed to achieve them, is fully compatible with and can be conducted using, specific tools in use in mental health, such as DIALOG, DIALOG+, and ReQoL, for example. 

Where analysis indicates the need for improvement in the content and process of personalised care and support planning for patients with Severe Mental Illness, specific improvement projects should be instituted to co-design with service users and their representatives, and the relevant staff groups, new approaches, and documentation that would be of value in delivering improvement. The toolkit includes a range of existing resources that could be used to engage in this improvement work, including signposting to relevant existing approaches informed by patient experience-based design.

Moving to a single holistic plan

A review of a sample of current care plans, and the way they have been developed, may be helpful in identifying the priorities for this improvement. The PRSB Implementation Guide provides A key development, consistent with national policy on support for Personalised Care across all health and care sectors, is the move towards an individual with complex needs having a single, integrated, care plan, rather than a series of plans developed by different parts of the health and social care system in isolation of one another. For a patient with severe mental illness, the related concerns and challenges might form a very prominent part of such an integrated plan; many will also have concurrent health challenges and needs. The intention is that the relevant services work together to plan and wrap support around the patient and their family in an integrated way, rather than as a series of sequential or disconnected encounters in which the service user or their friends and family have to adopt the role of the integrator.

A starting point would be to agree priority groups of service users who may already have more than one care plan because they need care from more than one part of the system of health and social care. This could be initiated by looking at service users registered with some sentinel practices or PCNs. Alternatively, the approach might focus initially on people with defined co-morbidity or risk that entails collaborative care with agencies beyond specialist mental health services.

The focus here is on the process of care planning and agreement on what should be shared, rather than solely on the technology used;

1. What is the process to agree which professional will initiate care planning and act as the “lead point of contact” for the service user?
2. Will initial plans be agreed with the service user in joint consultations or sequentially? Where and how will they be conducted?
3. What will be the process to agree the elements of the plans which should be available to professionals and potential authorised users beyond the immediate care teams, (A&E services, Ambulance Services, Social services, etc.) with the service user’s consent?
4. How will elements of the plan be updated following consultations in a way which is proportionate, to allow contact and progress notes to be maintained by the service conducting the consultation, whilst avoiding unnecessary work for partners in care if there is no significant change to the personalised care and support plan?
5. What are the implications for workload, logistics, and administration arising out of these decisions?

The answers to these questions and others will best be elicited through focused joint working, grounded in real, or at least realistic examples. This will entail process mapping, and co-design with a range of professionals, service users, and families. Resources from the toolkit and outputs from the Simulation element of this project will be valuable. Some organisations would adopt an approach such as a Rapid Process Improvement Workshop, planned over several weeks and conducted over a number of sequential days, to develop prototype ways of working that could be tested in the field.