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Patients and their medicines In hospital: a joint report from the National Pharmaceutical Forum and the Scottish Medical and Scientific Advisory Committee

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3 PATIENT SAFETY AND CLINICAL GOVERNANCE

3.1 INTRODUCTION

Estimates from work in Scotland suggest that in a typical 400-bed district general hospital as many as 5,000 individual doses are administered daily. The vast majority of these doses will be given without incident. However some patients may experience medicine-related problems due to the nature of the medicine, patient factors or the systems through which medicines are prescribed, supplied or administered.

The consequences of medicine-related problems for patients, relatives and carers can result in a sub-optimal outcome from treatment and delay in discharge from hospital. 2 Adverse incidents and events (see footnote below) engender a lack of public confidence in the competence of healthcare practitioners and can be devastating for the patient.

Adverse incident is defined as 'any event or circumstance that could have, or did, lead to unintended or unnecessary harm, loss or damage to patient, public, staff or organisation.'
Adverse event is 'an incident which did lead to harm'.

The policy context for Clinical Governance in Scotland was first set out in NHSMEL (1998)75. 3 Further guidance was issued between 2000 and 2002 4-6 and the Scottish Executive has consulted on How to Improve Safety for Patients in Scotland. 7

A UK review of prescribing, supply and administration of medicines reported in 1998 and 1999. The review set out a new framework for the prescribing, supply and administration of medicines inside and outwith the NHS.

This chapter provides a governance framework for the use of medicines in hospital to support patient safety. It sets out the standard and criteria that will support the development of local policy and procedures in response to changes in legislation, national guidance and best practice.

3.2 THE STANDARD

The NHS in Scotland must have systems in place to support the safe and secure prescribing, supply and administration of medicines in accordance with legislative requirements, national guidance and best practice.

3.3 THE CRITERIA

Criterion 1
Prescribing, supply and administration of medicines conforms to legislative requirements, national guidance and best practice.

Rationale

There is a wide range of legislation, guidance and best practice associated with the prescribing, supply and administration of medicines.

The Chief Executive of the organisation has statutory responsibility for corporate and clinical governance. The Chief Pharmacist working within a multidisciplinary team is responsible for ensuring that systems are in place to appropriately address all aspects of the safe and secure handling of medicines. The complexity of medicines and the issues around their safe use including their potential for misdirection requires the Chief Pharmacist to be recognised as a senior member of the management team within the organisation.

There are a number of local committees including Area Drug and Therapeutics Committees ( ADTCs) who include in their remit the safe and effective use of medicines. There is a need to review the remits, accountability and reporting arrangements of such committees to avoid duplication of work and engender commitment.

Recommendations

NHS Boards* must assure prescribing, supply and administration of medicines meets legislative requirements, national guidance and best practice. The Chief Pharmacist should have the authority associated with Clinical Director status.

NHS Boards should review those committees charged with the safe and effective use of medicines.

* NHS Boards comprises the Board and divisional operational units within each Health Board area.

References

The main legislative framework is provided by:

  • The Medicines Act 1968 (as amended). London,
    The Stationery Office.
  • The Misuse of Drugs Act, 1971, London,
    The Stationery Office.
  • Health and Social Care Act 2001.
  • Misuse of Drug (Safe Custody) Regulations 1973, London, The Stationery Office.
  • The Misuse of Drugs Regulations 1985, London,
    The Stationery Office.
  • Health Act 1999, London, The Stationery Office.
  • EEC Directive (92/27/EEC).
  • Control of Substances Hazardous to Health ( COSHH) Regulations 1999, London, The Stationery Office.
  • Safe Administration of Intrathecal Cytotoxic Chemotherapy. NHSHDL (2004)30 Scottish Executive Health Department.
  • Aseptic Dispensing for NHS Patients, 1995, Department of Health.
  • Medicines Ethics and Practice, July 2002, Royal Pharmaceutical Society of Great Britain.
  • Review of Prescribing Supply and Administration of Medicines, Final Report (Dr June Crown), Department of Health, March 1999.
  • Report on the Supply and Administration of Medicines Under Patient Group Protocols (Dr June Crown), Department of Health, 1998.
  • The National Health Service (Pharmaceutical Services) (Scotland) Regulations 1995.
  • Medicines The Prescription Only Medicines (Human Use) Amendment Order 2003.
  • The National Health Service (Scotland) Act 1978.

Other important legislation includes:

  • Data Protection Act (1998) London HMSO.
  • Consumer Protection Act (1987).

Other relevant guidance includes:

  • Department of Health. Guidelines for the Safe and Secure Handling of Medicines (Duthie Report) London: 1988. [This document is currently under review by the Royal Pharmaceutical Society.]
  • Good Clinical Practice for Trials on Medicinal Products in the European Community, 111/3976/88 - EN Final. Office for Publications for the European Community.
  • Nursing & Midwifery Council ( NMC). Guidelines for the Administration of Medicines. London: 2002.
  • Isolators for Pharmaceutical Application, 1994.
  • Guidelines for the Disposal of Pharmaceutical Waste, NHSQC Committee, 1998.
  • Scottish Executive Health Department. Clinical Governance NHSMEL (2000)29 (2 June 2000).
  • Scottish Executive Health Department. Clinical Governance Arrangements. NHSHDL(2001)74
    (9 October 2001).
  • Scottish Executive Health Department. Corporate Governance: Statement on Internal Control ( SIC) NHSHDL(2002)11 (1 March 2002).
  • The British National Formulary, ( BNF).
  • Safe Administration of Intrathecal Cytotoxic Chemotherapy. NHSHDL (2004)30 Scottish Executive Health Department.
  • CRAG, Good Practice Statement for the Preparation of Injections in Near Patient Areas, including in Clinical and Home Environments, 2002, Scottish Executive Health Department.

Criterion 2
The system used for the prescribing, supply and administration of medicines maintains patient confidentiality.

Rationale

Medicine prescribing, supply and administration systems hold sensitive information relating to individuals and must comply with the Data Protection Act and satisfy the arrangements overseen by the Caldicott Guardian in each organisation.

Recommendations

NHS Boards must ensure that those staff prescribing, supplying and administering medicines comply with the Data Protection Act.

NHS Boards should ensure that staff are aware of the Scottish Executive Confidentiality and Security Advisory Group for Scotland ( CSAGS) report, which outlines both the principles of confidentiality (section 12) and the importance of consent in data processing (section 7).

References

The main legislative framework is provided by:

  • Data Protection Act (1998).

Other relevant guidance includes:

  • NHS Executive. Protecting and Using Patient Information: A Manual for Caldicott Guardians.
    London: 2000.
  • Confidentiality and Security Advisory Group for Scotland ( CSAGS). Protecting Patient Confidentiality:
    A Consultation Paper. SEHD, Edinburgh: 2001 [and SEHD response.

Criterion 3
The system used for the prescribing of medicines in hospitals accommodates all categories of prescriber.

Rationale

The Health and Social Care Act 2001 enabled the introduction of different types of prescriber and extended prescribing rights to healthcare professionals other than medical, dental and certain nurse practitioners. These new prescribers need to be registered on the local system for the prescribing of medicines in hospital.

Recommendation

NHS Boards must have systems in place to ensure that prescribing is undertaken by approved staff who are registered within the local healthcare system to undertake this role and that the system allows the status and authority of each prescriber to be identified.

References

The main legislative framework is provided by:

  • Scottish Executive Health Department. Extension of Nurse Prescribing in NHSScotland: Introduction of the Nurse Prescribers' Extended Formulary. NHSHDL (2002) 56. (5 July 2002).
  • Scottish Executive Health Department. Patient Group Directions. NHSHDL (2001)7. (January 2001).
  • The Health and Social Care Act 2001.
  • Medicines Control Agency ( MCA). Proposals for Supplementary Prescribing and Pharmacists and Proposed Amendments to the Prescription Only Medicines (Human Use) Order 1997. Consultation Paper MLX284. London: MCA, (16 April 2002).
  • The National Health Service (Pharmaceutical Services) (Scotland) Regulations 1995.
  • The National Health Service (General Medical Services) (Scotland) Regulations 1995.
  • Medicines The Prescription Only Medicines (Human Use) Amendment Order 2003.
  • The National Health Service (Scotland) Act 1978.

Criterion 4
The prescribing, supply and administration of medicines is undertaken by appropriate healthcare staff.

Rationale

A range of NHS staff groups are involved in the prescribing, supply and administration of medicines in hospital. Competent staff are at the centre of safe systems of work. There is a need to ensure staff within an NHS organisation understand and can use the local system.

Recommendations

Medical Directors, Directors of Nursing and Chief Pharmacists must ensure that all staff involved in the prescribing, supply and administration of medicines receive sufficient formal competency-based training. This should accommodate new staff, employees moving within the organisation and the introduction of new systems of work. Monitoring of competencies in the prescribing, supply and administration of medicines should be given a high priority.

NHS Education Scotland should facilitate the development of generic core competencies for staff involved in the prescribing, supply and administration of medicines through inter-professional collaboration for inclusion in appropriate educational programmes.

Pre-registration training programmes for staff involved in the prescribing, supply and administration of medicines should include the generic core competencies.

References

The main legislative framework is provided by:

  • The Medicines Act 1968 (as amended). London,
    The Stationery Office.
  • Control of Substances Hazardous to Health Regulations ( COSSH) 1999.
  • NHSHDL (2001)7: Patient Group Directions.

Other relevant guidance includes:

  • Safe Administration of Intrathecal Cytotoxic Chemotherapy. NHSHDL (2004)30 Scottish Executive Health Department.
  • CRAG, Good Practice Statement for the Preparation of Injections in Near-Patient Areas, including in Clinical and Home Environments, 2002, Scottish Executive Health Department.
  • Nursing and Midwifery Council ( NMC) Guidelines for the administration of medicines.
  • Review of Prescribing Supply and Administration of Medicines, Final Report, Dr June Crown, March 1999.
  • Report on the Supply and Administration of Medicines Under Patient Group Protocols,
    Dr June Crown, 1998.
  • Aseptic Dispensing for NHS Patients, Department of Health, 1995.
  • Clinical Standards Board for Scotland. Clinical Standards: Generic. 2002 Edinburgh:
  • Extending Independent Nurse Prescribing within NHSScotland: A guide for implementation - September 2002.

Criterion 5
The system for the prescribing, supply and administration of medicines permits audit of personnel, procedures, policies, environments and facilities.

Rationale

Regular, planned audit of personnel, procedures, policies, environments and facilities supports the safe and effective use of medicines and management of resources. Systems must include a clear audit trail encompassing the procurement, ordering, delivery, storage, distribution, dispensing, administration and disposal of medicines. In addition, the requirements of local Standing Financial Instructions must be embraced to ensure that all Corporate Governance requirements are met.

Recommendation

NHS Boards must have systems in place to audit prescribing, supply and administration of medicines.

References

The main legislative framework is provided by:

  • The Medicines Act 1968.
  • Control of Substances Hazardous to Health Regulations ( COSSH) 1999.
  • Data Protection Act (1998).

Other relevant guidance includes:

  • Department of Health. Guidelines for the Safe and Secure Handling of Medicines (Duthie Report) London: 1988.
  • Nursing & Midwifery Council ( NMC). Guidelines for the Administration of Medicines. London: 2002.
  • Scottish Executive Health Department. Clinical Resources and Audit Group ( CRAG). Good Practice Statement for the preparation of Injections in Near-Patient Areas, Including Clinical and Home Environments. Astron. Edinburgh: 2002.
  • Safe Administration of Intrathecal Cytotoxic Chemotherapy. NHSHDL (2004)30 Scottish Executive Health Department.
  • Aseptic Dispensing for NHS Patients, Department of Health, 1995
  • Environmental Protection Act, 1990.
  • Health Services Advisory Committee ( HSAC) 'Safe disposal of clinical waste' 1992.
  • Scottish Hospital Technical Note 3 -'The Management and Disposal of Clinical Waste'.

Criterion 6
There is a medication incident recording system in place.

Rationale

Complications arising from medicines are the most common cause of adverse incidents in hospital patients. The majority of medicines will be given without incident. However some patients may experience medicine-related problems due to the nature of the medicine, patient factors or the systems through which medicines are prescribed, supplied or administered.

NHS organisations need to be able to record and learn from medication incidents through adoption of self-reporting schemes within a blame-free culture. Priority should be given to areas of high risk, which would include medicines for injection. A study in the BMJ8 reported a high error rate in the preparation and administration of intravenous drugs. The Scottish Executive CRAG document Good practice statement for the preparation of injections in near-patient areas, including clinical and home environments, contained guidance for NHS Operating Divisions for the standards of practice that should apply in the preparation of injections. Similar guidance for NHS organisations on standards of practice for the administration of injections is required.

Recommendations

NHS Boards should introduce recording systems to support the collection of information on medication incidents.

To determine the current situation NHSScotland should encourage base-line audits, using standard definitions and categories of medication incidents at a representative sample of hospitals. This will allow improvement targets to be set and their achievement monitored. Work should prioritise specialties with highest likely risk.

NHSScotland should explore with the pharmaceutical industry the provision of more medicines in a ready to administer form to reduce risk of medication errors.

References

The main legislative framework is provided by:

  • The Medicines Act 1968.
  • Control of Substances Hazardous to Health Regulations ( COSSH) 1999.
  • Data Protection Act (1998).

Other relevant guidance includes:

  • Department of Health. Guidelines for the Safe and Secure Handling of Medicines (Duthie Report) London: 1988.
  • Nursing & Midwifery Council ( NMC). Guidelines for the Administration of Medicines. London: 2002.
  • Scottish Executive Health Department. Clinical Resources and Audit Group ( CRAG). Good Practice Statement for the preparation of Injections in Near-patient Areas, Including Clinical and Home Environments. Astron. Edinburgh: 2002.
  • Safe Administration of Intrathecal Cytotoxic Chemotherapy. NHSHDL (2004)30 Scottish Executive Health Department.
  • Aseptic Dispensing for NHS Patients, Department of Health, 1995
  • Environmental Protection Act, 1990.
  • Health Services Advisory Committee ( HSAC) 'Safe disposal of clinical waste' 1992.
  • Scottish Hospital Technical Note 3 -'The Management and Disposal of Clinical Waste'.