At least 450 patients are thought to have died after the administration of inappropriately high doses of opioids between 1988 and 2000 at Gosport War Memorial Hospital. In June 2018, the report of the Gosport Independent Panel into failures of care was published. The report found no evidence that the pharmacists providing services to the hospital, or the Portsmouth Hospitals NHS trust drug and therapeutics committee which covered the Gosport War Memorial Hospital had challenged prescribing practices.
That such prescribing practice remained unchallenged for a prolonged period of time despite initial concerns being raised by nursing staff raises concerns for current providers of pharmacy services. These providers include the traditional hospital pharmacy services as well as newer service models that include outsourced and alternative service providers.
In November 2018, the Government responded to the report of the Gosport Independent Panel. This discussion paper focuses on pharmacy services and was developed primarily from the views of the Royal Pharmaceutical Society’s Hospital Expert Advisory Group. It discusses the issues the Gosport report raises for providers of pharmacy services and lessons to be learnt.
Whilst practice has improved and there are now professional standards for hospital pharmacy services, pharmacy teams are urged to continue to be medicine safety advocates for the public and support a culture of listening, speaking up and being heard.
2. How pharmacy services have developed since Gosport
Since the events at Gosport War Memorial Hospital, person-centred pharmacy practice in the hospital setting has undergone significant change. In 2018, in most areas of clinical practice in secondary care, pharmacists have become key members of multi-disciplinary teams and are better placed to challenge inappropriate prescribing practice.
Assurance processes for the safe use of opioid medicines have strengthened. The legal requirement to appoint Controlled Drugs Accountable Officers (CDAOs) with responsibility for all aspects of controlled drug management within their organisation has increased the focus on safe and secure handling of controlled drugs. To share concerns and good practice initiatives across local areas, Controlled Drugs Local Intelligence Networks (CD LINs) have been established and CDAOs are required to submit quarterly occurrence reports of incidents.
As well as CDAOs, since 2014, organisations in England have medicines safety officers , with networks across organisations, their focus is medicines safety and promoting shared learning and best practice.In Scotland, the Scottish Patient Safety Programme is well established in acute care and is now delivering programmes in primary care; it includes a specific work programme around medicines.
Add to this the introduction of electronic tools which enable review of medicines usage patterns and comparisons with peers, and there are now more mechanisms in place assure the safe use of opioids and a different culture around this.
The General Pharmaceutical Council (GPhC) was established in 2010 as the regulator for pharmacists, pharmacy technicians and pharmacy premises. GPhC standards for pharmacy professionals, place a responsibility on individuals to speak up when they have concerns or when things go wrong, even when it is not easy to do so. The introduction of revalidation for both professions further encourages this behaviour.
In addition, systems regulators monitor the quality of health and care providers and pharmacy services are part of that overall picture. The systems regulators look to professional standards and guidance to inform their work.
3. The RPS professional standards for hospital pharmacy services
Chief pharmacists* and the boards of their organisations will want to assure themselves and the public that the events of Gosport cannot be repeated.
*Whilst not all organisations will employ a ‘chief pharmacist’ they will have an equivalent individual with a significant role in making decisions about the safe and effective use of medicines and running of the pharmacy service.
The RPS is the GB leadership body for pharmacists and since 2012 has provided professional standards for hospital pharmacy services that describe what good looks like. The standards for hospital pharmacy services are applicable in or to acute, mental health, private, community service, prison, hospice and ambulance settings.
The standards provide a framework for all providers of pharmacy services (NHS or independent sector) whether provided in-house or outsourced. They describe what is expected of a quality pharmacy service. Organisations delivering or commissioning services in line with the standards will have a level of assurance that the services are safe, effective and patient-focused.
The standards can be used as a framework for organisations to consider actions that they need to take in light of Gosport. By way of illustration, some key standards are highlighted below with a description of how they relate to the events at Gosport War Memorial Hospital.
STANDARD 2: EPISODE OF CARE
Patients’ medicines requirements are regularly assessed and responded to in order to keep patients safe and to optimise their outcomes from medicines.
2.2a. Treatment requirements are clinically reviewed to optimise outcomes from any medicines prescribed; frequency and level of review adjusted according to patient need.
The professional standards highlight the need for pharmacists and pharmacy technicians to assess a patient’s medicines needs and validate that those are met through their medicines. This requirement exists seven days a week and across all hours of the day. The review of a patient’s medicines includes a conversation with the patient or carer in order for the pharmacy professional to meet that patient’s needs (including, for example, pain relief). Pharmacists also need to have relevant conversations with nursing and medical staff.
Organisations need a robust reporting culture so that any concerns about overuse of opioids are investigated by the chief pharmacist (or equivalent) and the Controlled Drug Accountable Officer. The connectivity between the chief pharmacist and other healthcare professionals but in particular nursing staff is critically important in ensuring safe care of vulnerable patients. The routine reporting by the chief pharmacist to the Executive Team/ Board is one element of good assurance, enabling concerns about potentially inappropriate use of medicines to be brought to the attention of the Chief Medical Officer, Chief Nursing Officer and Chief Executive within an organisation.
STANDARD 4: MEDICINES GOVERNANCE
Pharmacy expertise is available seven days a week to support the safe and effective use of medicines. The pharmacy team leads a multidisciplinary approach to safe medication practices.
4.5f. The pharmacy team actively works with, and where necessary intervenes with prescribers, patients and other healthcare professionals to ensure medicines are safe and effective
Medicines governance includes a strategic overview of the use of medicines within an organisation. Patient safety is of the utmost priority. Good medicines governance requires that the pharmacy service is aware of all near misses and incidents causing harm with medicines, and ensures that learning and practice changes occur to seek to prevent incidents recurring. In addition all medicines incidents are routinely reviewed and an understanding of root causes used to prevent future incidents. In organisations that have one, the Medication Safety Officer is responsible for leading this programme of work.
The routine and regular review of the cause of patients’ deaths and the impact of the use of opioids on these was absent in Gosport. Pharmacy (and wider organisational) leadership must learn from this. The use of opioids in all organisations should be subject to peer review to ensure that poor custom and practice is not established as the norm.
STANDARD 6: LEADERSHIP
Pharmacy has strong professional leadership, a clear strategic vision and the governance and controls assurance necessary to ensure patients are safe and get the best from their medicines.
6.1f. All members of the pharmacy team are encouraged and supported to raise any professional concerns they may have both from within the pharmacy service, and from other parts of the organisation.
Chief pharmacists (or equivalent) share responsibility for safe use of medicines within an organisation alongside their medical and nursing colleagues. The chief pharmacist, through membership of relevant Board Committees, reports on the use of the medicines within the organisation and raises concerns where practices are divergent from what could be expected.
The Controlled Drugs Accountable Officer must ensure that all matters of controlled drug handling, including safe prescribing are regularly audited, and listen to concerns raised. Incidents and concerns must be recorded and acted upon, and relevant information shared with the CD Local Intelligence Networks.
Person-centred, safe care needs to be at the heart of organisational culture. Within the Gosport Memorial Hospital during 1988-2000 even where concerns were raised by nursing staff and the families of patients they were not acted upon. The importance of listening to patients and families, raising concerns and the culture necessary to allow that to happen cannot be overstated.
4. Areas for action
Each organisation providing or contracting pharmacy services will want to review the recommendations of the Gosport Independent Panel and develop their own organisational action plans. The areas for action highlighted here for consideration have been identified by RPS HEAG members and by individuals attending a Medicines Safety Event held at the RPS in December 2018.
4.1 Listening, speaking up and being heard
Organisations need a culture where all health professionals are expected to challenge and be challenged to ensure safe practice, and to listen to and act upon the concerns of patients, carers and families.
Actions for consideration:
- Review the GPhC, RPS and APTUK slide set to refresh knowledge of existing guidance and support available (including Just Culture and Right Culture).
- Review training for pharmacy team members in how to respond when patients, carers or their families raise concerns directly.
- Review training needs for all those in supervisory roles to ensure focus on human factors and behaving with empathy when concerns and complaints are raised.
- Review and re-launch of Raising Your Concerns Policies and re-promote the role and contact numbers of the Freedom to Speak Up Guardians.
- Review induction processes to include a briefing from the Freedom to Speak Up Guardian to stress the importance of speaking up and how to do that.
- Triangulate data from annual staff surveys, trainee surveys, patient feedback and other feedback mechanisms about raising concerns and being heard.
- Refresh learning by reviewing 2014 Trusted to Care and 2013 A Promise to Learn – a commitment to act.
- Promote the CDAO and (where it exists) the MSO role throughout the organisation so that healthcare professions know who they are / how to report concerns and the importance of reporting, investigating and sharing concerns.
- Reinforce with the multidisciplinary team the importance of a culture that encourages challenge of unsafe practice.
4.2 Medicines governance
Medicines governance arrangements provide a mechanism to ensure that reporting is transparent and effective. Boards and the leadership of organisations need to be confidently and competently using data and other intelligence about medicines to ensure safety and improve quality.
Actions for consideration:
- Table and discuss actions and outcomes to be taken as a result of the Gosport Independent Panel report at a high level within the organisation (for example the organisation’s Executive Quality Committee).
- Review against national best practice the organisation’s pain guidelines, palliative care and anticipatory prescribing guidelines; consider review and rationalisation of opioid formulations used within the organisation.
- Ensure all pharmacy team members are aware of the details and recommendations from the Gosport Independent Panel report. Including the teams providing outsourced services.
- Reinforce with all the pharmacy team the organisation’s pain, palliative care and anticipatory prescribing guidelines in order to facilitate monitoring of opioid use.
- Review implementation of the National Patient Safety Agency guidance – specifically those that concern opioids (e.g. high dose morphine/diamorphine).
- Introduce regular multidisciplinary formal education events, for example mandatory training and induction training in the use of strong opioids and syringe drivers.
- Challenge any use of as required opioids without fixed maximum dosing schedules.
- Review controls in place for controlled drugs and medicines of abuse to prevent multiple ordering routes. Include how pharmacy team members identify and challenge changes in usage.
- Review governance arrangements in settings with more complex/less robust pharmacy service provision.
- Benchmark across a region (or wider) using IT that provides an overview of opioid use assessed by Defined Daily Dose or quantity to bed number. This enables an average to be identified so that an organisation’s use can be considered.
- Consider how to benchmark data on reporting and incidents, and share learning across wider networks (linked to CD Local Intelligence Networks).
- Peer review usage of opioids between organisations to ensure that activity in drug choice and dose range is consistent.
4.3 Use of data and benchmarking
Electronic prescribing can provide the key to more rapid overview of prescriptions and enables prioritisation of pharmacist review activities. With electronic prescribing the use of opioids in Gosport would have been more visible to scrutiny. Digitalisation, improved provision of information about medicines and automation of stock supplies could potentially have challenged the care of these patients – making what was happening more visible to a broader group of people.
Actions for consideration
- Prioritise the development of digital systems that support the safe and effective handling of medicines (linked to the World Health Organisation Patient Safety Challenge: Medication Without Harm).
- Utilise business intelligence and analytic tools that include commercially available products to enable the review of quantities of opioids supplied to clinical areas. Determine how data from these tools are analysed and acted upon.
4.4 Clinical Audits
Pharmacist validation of prescribed medication to ensure that medicine choice, dose and route of administration are appropriate, with knowledge of the patient’s medication history and concurrent conditions should be routine.
Audit and peer review of prescribing practice has a key role to play in supporting quality patient care. For example, pain ladders are now in use in care settings and peer review of practice in adhering to the pain ladder would have supported challenges about medical prescribing practice.
Actions for consideration:
- Ensure audits reflect changes in service delivery, including changes to service providers, changes in the scope of independent prescribers and changes in the staff associated with administration of medicines.
- Audit retrospectively opioids prescribed in end of life care to ensure they are clinically appropriate and that the dose [and escalation] was appropriate for the indication.
- Review opioids administered by syringe drivers in the organisation in the past three months.
- Audit of all current patients on high dose / high potency analgesia to ensure appropriate pathways were followed, and a rational step-wise approach taken to progression up the analgesic ladder. Use NICE clinical guideline 140.
- Completion of the National Audit of Care at the End of Life (NACEL) 2018. Includes a case review of all the people that have died in the organisation in April 2018.
- Look at all hospital deaths were opioids were prescribed.
- Audits of practice against organisation guidelines for palliative care and pain guidelines.
- Audit of the volume of high strength opioid vials and limited stock availability in clinical areas.
- Annual review of patient safety incidents involving opioids to promote shared learning and identify trends.
Hospital pharmacy practice has moved on in the decades since 2000, and ever-increasing use of technology and data driven care mean that trends in medicines use and anomalies in prescribing can be identified more efficiently. Pharmacists are more integrated into multidisciplinary ward teams, making them better able to challenge when they think patient safety is compromised, and there is increased scrutiny of both medicines safety practices and the safe use of controlled drugs, largely due to measures introduced post-Shipman.
Today, the practices that survived in Gosport War Memorial Hospital would be unlikely to go undetected for so long. However, we still need to ensure that systems and ways of working are clearly focused on patient safety and that this remains a high priority for pharmacists and their teams.
Pharmacy teams have a crucial oversight role in the safe use of medicines within organisations.
The most sobering lesson from Gosport is that the practice of anticipatory prescribing continued long after initial concerns were raised by nursing staff. Patients and carers should expect pharmacy teams to provide information about medicines and to be their medicines safety advocates. If safety is compromised pharmacists and their teams must have the confidence to speak up and challenge. Unusual patterns of prescribing behaviour and unwarranted variations in clinical practice between individual prescribers cannot go unchallenged.
Senior leaders need to encourage a culture that encourages staff to speak up and challenge their organisations, a culture that enables all staff to raise concerns, encourage others to do so and to listen to – and act upon – the concerns of patients, carers and families.All staff need to set an example about how to respond positively to being challenged, as well as in challenging others.
QUOTES FROM THE PANEL REPORT
“If those responsible for the hospital had listened properly to what their own nurses said in 1991, and acted, the Panel is clear that the events described in this Report would not have followed the path they did. This should serve as a challenge to all those in positions of authority.”
Report of the Gosport Independent Panel, 2018
“There were no systems in place in 1998 for the routine review of pharmacy data which could have alerted the trust to any unusual or excessive patterns of prescribing although the prescribing data was available for analysis … it is clear that had adequate checking mechanisms existed in the trust, this level of prescribing would have been questioned.”
Report of the Gosport Independent Panel, 2018
“One of the most difficult things to understand about these events is why so many people were prescribed and administered drugs that were not clinically indicated, in quantities sufficient to shorten their lives.”
Report of the Gosport Independent Panel, 2018
“The practice of anticipatory prescribing, and of administering certain drugs in circumstances and doses beyond what would have been indicated or justified clinically, involved the consultants, the clinical assistant, the nurses and the pharmacists. It was a practice that built up and continued over many years, and lives were shortened before the pattern changed significantly from 2000”.
Report of the Gosport Independent Panel, 2018
 General Pharmaceutical Council, Royal Pharmaceutical Society, Association of Pharmacy Technicians UK. Learnings from Gosport. Sharing pharmacy themes, current practice and key resources. January 2019