Safety of medicines delivered by homecare companiesBMJ 2018; 361 doi: https://doi.org/10.1136/bmj.k2201 (Published 22 May 2018) Cite this as: BMJ 2018;361:k2201
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During the writing of this editorial, we asked the MHRA to provide us with information on the proportion of Yellow Card reports filled by homecare providers for drugs prescribed via the homecare route. However, they informed us that they are unable to reliably determine how many ADRs are reported by homecare providers as the Yellow Card Scheme does not collect information of the type of healthcare organisation a reporter may work for (it may be captured in the free text address field, but it is not a formal requirement). As independent researchers, we are therefore unable to assess the frequency at which commercial homecare providers submit Yellow Card reports. We understand that homecare providers may be fully aware of the necessity to report ADRs to the MHRA, but without complete reporting of the source of reports, we cannot show evidence that this is actually happening. There is no legal requirement in the UK (in contrast to some countries) to report suspected ADRs, and it is unknown if compulsory reporting actually improves reporting rate. However, in some senses, this is irrelevant, since we are not interested simply in detecting signals, but being able to carry out proper studies to determine if a signal is a real effect or not.
McCall et al clearly state that information on drugs provided via the homecare route is not available to independent researchers, which is the crux of our argument. Without allowing full access to these data, along with linkage to other electronic health records for the purposes of peer-reviewed scientific research, there will always be unanswered questions surrounding the safety of several of these drugs.
Finally, we welcome the invitation to include homecare providers in any future research. We did make many attempts to contact one of the large Homecare providers over a period of over 5 years, but they did not respond to our requests to know exactly what data they had, never mind allowing for data access for research purposes.
Our concern that GP records do not have the requisite information is confirmed by the audit carried out by Dr Randev and colleagues and we are grateful to them for confirming this. It is possible that even when letters are included within a patient’s notes, it is not possible to retrieve the fact of a prescription for these drugs for research purposes since the free text is not available for analysis.
We hope that the situation can be improved since as McCall, Ho and Randev said in 2011 in the response they cite, “Given the severity of potential adverse effects and interactions from anti-TNF treatment, strategies for improving GP recording and awareness should be put in place.” We go further and say that research on the effects of these drugs should be done in the UK and the potential to do so is severely limited currently, and the situation has not changed since 2011.
Competing interests: No competing interests
Patient safety and governance in Homecare Medicines supply Response to Editorial “Safety of medicines delivered by homecare companies - Inadequate surveillance threatens patient safety and public health”
Delivery of specialised medicines through homecare is performed with high governance standards and the supposition that there is inadequate surveillance and a “ticking time-bomb” threat to public health is not supported by the facts. A significant proportion of homecare services are funded by the pharmaceutical manufacturers who hold the homecare providers to account for high standards of pharmacovigilance (PV) reporting. In our experience, homecare providers are fully aware and comply with their responsibility to ensure Adverse Drug Reactions (ADRs) are reported directly to the MHRA (or indirectly via the marketing authorisation holder), including additional reporting for new medicines.
Royal Pharmaceutical Society Handbook for Homecare Services Appendix 19: Further guidance on managing complaints and incidents within homecare services (2016) was developed in consultation with NHS stakeholders, homecare providers, pharmaceutical companies and medicines regulators to clarify the reporting responsibilities of all organisations involved in the delivery of homecare. The guidance introduces joint processes between homecare providers and hospitals to avoid multiple reporting of individual incidents and therefore overstatement of potential risks. There are also national standards for reporting key performance indicators for patient safety and ensuring cross-organisational learning from complaints and incidents.
Whilst homecare information may not currently be available to independent researchers or commercial providers of health data, the responsibility for signal detection rests with the marketing authorisation holder and medicines regulators including MHRA. We would assert that the regulatory management of adverse drug reaction reports related to homecare medicines is more robust than for medicines delivered to patients via traditional primary and secondary care routes. In many cases, adverse drug events that do not meet the criteria for valid Adverse Drug Reactions (ADRs) are reported in addition to valid ADRs for homecare medicines. Patients can be confident that medicines regulators have the information they need to detect signals and ensure any safety issues relating to homecare medicines are identified at the earliest opportunity.
NCHA is actively seeking to increase the published evidence for homecare and are keen to invite the researcher (and others) to expand the scope of their work to include the homecare providers to give a well-rounded view of the homecare sector. Furthermore, NHMC and NCHA will continue to work with the DPSIMS team and MHRA to ensure all homecare organisations are able to learn from patient safety incidents and near misses relating to homecare medicines supply.
Authors Dr Carol McCall FFRPS FRPharmS, Susan Gibert MRPharmS Chair NHS National Homecare Medicines Committee (NHMC), Alison Davis RN Chair National Clinical Homecare Association (NCHA)
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Competing interests: The National Clinical Homecare Association (NCHA) is the trade body for the Clinical Homecare Industry representing the majority of organisations providing Clinical Homecare Services. There are approximately 310,000 patients in the UK receiving Clinical Homecare Services. Clinical Homecare patients receive consultant-led care in community settings. For more information visit clinicalhomecare.org or email email@example.com. The National Homecare Medicines Committee (NHMC) is a national committee comprising of NHS, Royal Pharmaceutical Society and Industry representatives. The key aim of the NHMC is to act as the national focus for developing and improving processes for homecare medicines services. It advises the NHS on all matters relating to homecare and collaboratively works with industry to support best practise. For more information visit https://www.sps.nhs.uk/networks/national-homecare-medicines-committee-nhmc/ Declarations of interest:- Dr Carol McCall is an Independent Homecare Consultant and Senior Governance Advisor to the Board of the National Clinical Homecare Association, Member of the Royal Pharmaceutical Society Faculty and Education Board and Non-executive Director of Bedford Hospital NHS Trust. Susan Gibert is Chair of NHS National Homecare Medicines Committee (NHMC), Member of NHS Pharmaceutical Market Support Group (PMSG) and Thames Valley & Wessex Regional Homecare Medicines Pharmacist Alison Davis is Chair of National Clinical Homecare Association (NCHA) and Managing Director of Pharmaxo Pharmacy Services Ltd.
The issues raised are worrying. The significance of GP recording of medication prescribed elsewhere has been been highlighted by myself and colleagues in the past https://www.bmj.com/rapid-response/2011/11/03/recording-biologic-therapy...
In our audit we found less than 10% of practices were recording etanercept or adalimumab prescribed by secondary care. A key point is that this needs to be recorded in the repeat prescribing section of the medical record.
Helpfully our local prescribing group has created a guide to the process (1) .
Competing interests: No competing interests