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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)
Correspondence to: info@clinicalhomecare.co.uk
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 info@clinicalhomecare.co.uk.
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.
21 June 2018
Carol J McCall
Senior Advisor
Susan Gibert, Alison Davis
NCHA Limited Registered Office: Ground Floor, 4 Victoria Square, St Albans, Hertfordshire, AL1 3TF
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) .
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)
Correspondence to: info@clinicalhomecare.co.uk
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 info@clinicalhomecare.co.uk. 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.