Gemma Donovan

Special unlicensed medicines: what we do and do not know about them

A special unlicensed medicine is one that is manufactured without a marketing authorisation (MA) from the Medicines and Healthcare products Regulatory Agency (MHRA). An MA (or product licence) is granted by the MHRA only once a medicinal product has been proven to be safe and effective. Prescribed products that do not hold an MA include those prepared on an individual basis by ‘special order’ manufacturers (for example liquid preparations), products classed as ‘food supplements’ (such as vitamin D preparations), and medicines that are licensed abroad but which do not hold a UK MA.1 The MHRA recommends that unlicensed medicines should only be used when existing licensed medicinal products are not appropriate to meet patient needs2 and this is also echoed in guidance from the General Medical Council.3 An example of this situation often arises in paediatric medicine due to smaller or unusual doses being required, which cannot normally be administered using standard solid oral dosage forms. Other examples include patients with difficulty swallowing solid oral dosage forms and patients needing to receive medicines through enteral feeding tubes. Medicines that have received marketing authorisations in countries other than the UK are another example of unlicensed medicines that may be employed where licensed preparations have been unsuccessful or unsuitable.4 Midodrine tablets for example, which are licensed in the US but not in the UK, may be used for the treatment of orthostatic hypotension where treatment with fludrocortisone has been unsuccessful, or use of a steroid is unsuitable for the patient. There is also significant prescribing of products classed as ‘food supplements’ that do not hold a marketing authorisation.5 Prescribing and dispensing of unlicensed medicines comes with additional professional responsibilities for both the prescriber and the dispensing pharmacist.6 Without a marketing authorisation, there is no MA holder …

Unlicensed medicines use: A UK guideline analysis using AGREE II

There is widespread use of unlicensed medicines within primary and secondary care but little information is available around how these medicines are used. This analysis examines and evaluates the content and quality of relevant guidance documentation currently in use within the UK.

Attitudes and perceptions of health professionals towards management of hypothyroidism in general practice: a qualitative interview study

Objective To explore the attitudes and perceptions of health professionals towards management of hypothyroidism that contributes to the suboptimal treatment of hypothyroidism in general practice. Design A qualitative interview study using semistructured interviews. Participants Sixteen participants were interviewed between March and August 2016 comprising nine general practitioners (GPs), four pharmacists, two practice nurses and one nurse practitioner. Setting General practice and community pharmacies in the counties of Northumberland, Tyne and Wear, Stockton-on-Tees and North Cumbria, North of England, UK. Method A grounded-theory approach was used to generate themes from interviews, which were underpinned by the theory of planned behaviour to give explanation to the data. Results Although health professionals felt that hypothyroidism was easy to manage, GPs and nurses generally revealed inadequate knowledge of medication interactions and levothyroxine pharmacokinetics. Pharmacists felt limited in the advice that they provide to patients due to lack of access to patient records. Most GPs and nurses followed local guidelines, and relied on blood tests over clinical symptoms to adjust levothyroxine dose. The information exchanged between professional and patient was usually restricted by time and often centred on symptoms rather than patient education. Health professionals felt that incorrect levothyroxine adherence was the main reason behind suboptimal treatment, although other factors such as comorbidity and concomitant medication were mentioned. Enablers perceived by health professionals to improve the management of hypothyroidism included continuity of care, blood test reminders, system alerts for interfering medications and prescription renewal, and accessible blood tests and levothyroxine prescriptions for patients. Conclusion There is a significant health professional behavioural component to the management of hypothyroidism. Addressing the differences in patient and professional knowledge and perceptions could reduce the barriers to optimal treatment, while continuity of care and increased involvement of pharmacists and practice nurses would help to promote optimal thyroid replacement.

46 An integrated pathway to access medicines for the palliative care patient in crisis in the out-of-hours period

Introduction It is recognised that community rapid response services can face difficulties in sourcing medicines to support end-of-life care (Butler and Holdsworth, 2013). Medicines used in the out-of-hours (OOH) period cannot usually be dispensed directly to the patient due to community pharmacies being closed. This can prevent the setup of syringe drivers and/or administration of prescribed stat doses. Here, an on-call pharmacy service was commissioned but not well integrated into pathways of care. Aim To optimise the treatment of palliative care patients in crisis, using an integrated pathway. Method A Rapid Process Improvement Workshop (RPIW) was used to map the process of managing a patient in crisis, and plan a more efficient pathway to access medicines across nursing, medical and pharmacy services. Results An integrated pathway was developed to facilitate best use of healthcare professional time to deliver palliative care (see below). An on-call pharmacy service is key to its delivery. In 2015/16, palliative care nurses were coordinating medicines supply for 95% pharmacy call-outs (n=38), since implementation of the new pathway in 2016/17 this has reduced to 42% (n=31). At baseline, it was estimated that sourcing medicines by nurses took four to five hours, the new service takes an average 49 min from call-out to patient delivery of required medicines. Conclusion Commissioning an on-call pharmacy service using an integrated pathway for patients in crisis enables efficient supply of medicines during the OOH period, optimising use of nursing, pharmacist and medical time to facilitate timely access to medicines for symptom management. Reference . Butler, C. and Holdsworth, L. (2013) ‘Setting up a new evidence-based hospice-at-home service in England’, International Journal of Palliative Nursing, 19(7), pp. 355–359