Public Health Wales Medicines Management Policy and Code of Practice Final

Medicines management policy and code of practice
Policy type: Public Health Wales wide
Policy reference number:PHW26
Policy classification:Clinical Governance
Author:Karen Fitzgerald, Consultant in PharmaceuticalPublic Health
Policy lead: Lead Consultant in Pharmaceutical Public Health
Executive lead: Director of Public Health Services
Date:04 March 2013 / Version:V1
Publication/ Distribution: Public (Internet)
Review date: 31 January 2016 / Approval date:31 January 2013
Approving body:Quality and Safety Committee
Purpose and Summary of Document:
This document sets out the medicines management responsibilities of clinical staff and divisional leads across Public Health Wales involved in the direct prescribing, supply and administration of medicines.
Public Health Wales does not have routine responsibility for patient care and has very limited direct medicines involvement. Consequently it does not have the routine clinical governance infrastructures for medicines established within other healthcare organisations. However there are scenarios that require or potentially require Public Health Wales staff to supply or administer medicines to members of the public.
This policy sets out the arrangements to ensure that if and when medicines are supplied or administered by Public Health Wales staff that they are administered safely in accordance with current legislation and professional competence.
Intended audience:Executive Directors,Divisional Directors,medical, pharmaceutical, nursing and other health professional staff involved in the supply or administration of medicines.
Interdependencies with other policies:Waste management, incident reporting, record keeping, information governance
Standards for Health Services in Wales:Standard 15 – Medicines Management

Policy consultation circulation list

Group/Lead / Date Circulated
Information Governance Leads / 07.12.12
Risk Management Group / 07.12.12
Health and Safety Group / 07.12.12
Infection control Group / 16.04.12 (Meeting)
Staff consultation / 16.11.12-28.12.12
Senior Management Forum / 16.11.12
Equality Impact Assessment / 16.11.12
Policy workshop / 18.02.13
Partnership Forum / 01.03.13

Contents

1Introduction

2Policy aims and objectives

3Scope

4Legislative and national initiatives

5Roles and responsibilities

6Control of prescribing

7Patient Group Directions (PGD)

8Ordering stock drugs and pharmaceuticals

9Storage of medicinal products

10Administration

11Incident reporting

12Disposal

13Reporting defects

14Pharmaceutical public health links (hazard warning)

15Unlicensed medicines

16Prescribing for members of staff and families

17Training and/or Communication with Staff

18Monitoring and auditing

19Information Governance Statement

Appendix A Public Health Wales PGD template

1Introduction

This policy and code of practice describes the responsibilities of Medical, Pharmacy, Nursing staff and other Health Professionals to ensure that all medicines are supplied or administered safely and according to current legislation and relevant health professions Codes of Professional Conduct.

This policy is not a detailed procedure for any aspect of Medicines Management. Divisional procedures must be drawn up where necessary to supplement this Policy, providing specific detail on medicines management relevant to each service provided.

2Policy aims and objectives

The main aim of this policy is to ensure that all medicines supplied or administered by Public Health Wales staff are appropriate, safeand in accordance with current legislation and relevant health professions Codes of Professional Conduct.

It aims to protect service users by ensuring the control of medicines through safe prescribing, administration, storage, disposal and through the reporting, monitoring and review of any incidents.

3Scope

This policy applies to all medical, pharmaceutical, nursing staff and other health professional staff involved in the supply or administration of medicines.

4Legislative and national initiatives

  • Medicines, Ethics and Practice, A guide for pharmacists, Royal Pharmaceutical Society, July 2012
  • Human Medicines Regulations 2012
  • Misuse of Drugs Regulations 1971 (as amended)
  • Welsh Health Circular WHC(2000) 116, Patients Group Directions - Review of Prescribing, Supply and Administration of Medicines December 2000

5Roles and responsibilities

5.1Board & Executive Directors

The Chief Executive has ultimate responsibility for medicines management in Public Health Wales and delegates this responsibility to an Executive Director lead. The Director of Public Health Services is the Board lead for Medicines Management.

5.2Chief Pharmacist

Public Health Wales’ lead Consultant in Pharmaceutical Public Health is responsible for advising on effective medicines’ management, its systems and procedures and is Public Health Wales medicines management lead for Standard 15 of the Welsh Government’s Doing Well, Doing Better: Standards for Health Services in Wales.

5.3Operational responsibilities

5.3.1Divisional Directors

Divisional Directors must ensure a nominated Senior Health Professional (e.g. Senior Nurse) has professional responsibility, and this responsibility is included in their job description, for the following:

Ensuring that there are appropriate systems in place for the following:

  • The ordering, in-date checkingand stock rotation of drugs;
  • The storage (physical & environmental conditionsof drugs);
  • The administration of drugs (other than that done by a doctor);
  • The recording of administration including dosage and batch numbers;
  • The security of drugs and prescription forms;
  • The supply of drugs to patients/users in accordance with Patient Group Directions/Patient Specific Directions;
  • The reporting of drugs-related incidents and errors via the incident reporting system;
  • The safe and proper disposal of unused/unwanted drugs and pharmaceuticals;
  • The retention of documents relating to the ordering, storage and administration and supply of drugs;
  • The induction of new staff with respect to this policy & code of practice and any local supporting procedures;
  • The education and training required to enable health professionals to comply with this policy & code of practice and for ensuring a copy is readily available to staff;
  • The auditing of compliance with this policy & code of practice and the implementation of remedial action.

5.3.2All Healthcare Professionals

All healthcare professionals involved in any aspect of medicines management (e.g. nurses, radiographers etc) are responsible for:

  • Reading and understanding this policy & code of practice;
  • Complying with this Code of Practice and their professional Code of Practice (e.g.NMC guidance);
  • Not undertaking tasks beyond their qualifications, competency or authorisation

5.3.3Doctors

The Director of Public Health Services, in their role as Board lead for Medicines Management, will devolve the operational management responsibility to consultants who will ensure that doctors under their supervision are aware of and comply with the Code of Practice.

5.3.4Chief Pharmacist

The Lead Consultant in Pharmaceutical Public Health (CPPH) is responsible for providing advice to all service divisions of Public Health Wales on request on the following issues:

  • Safe, effective and secure systems for drug procurement and distribution
  • Systems for monitoring departmental drug usage and advising on appropriate stock range and stock holding levels
  • Drug security
  • Appropriate environmental storage conditions
  • Safe and proper means of disposal of unwanted/unused drugs
  • Safe and effective systems and arrangements for drug administration (including commenting & advising on drug administration errors and near misses reported via Public Health Wales’ incident reporting system.)
  • Transportation of drugs & other pharmaceuticals
  • Systems for access to emergency drugs out of hours

6Control of prescribing

Any prescribing, supply or administration of medicineswithin Public Health Wales should adhere to policies and guidelines approved by the Quality and Safety Committee. These will be developed by working groups including senior medical, pharmaceutical and healthcare professional and management staff that is appropriate to the range of prescribing undertaken.

6.1Prescribing medicinal products – Who may prescribe?

Medicinal products may only be prescribed by persons who are legally qualified to do so. Prescribers must be currently registered with the appropriate professional body. They must be employed and authorised by Public Health Wales to prescribe, and have the appropriate knowledge and experience to prescribe e.g. a doctor, a dentist, or an appropriately accredited practitioner e.g. a Nurse or Pharmacist Independent Prescriber. Prescribers may only prescribe from the appropriate list of medicinal products accorded to their profession.

7Patient Group Directions (PGD)

Patient Group Directions (PGDs) were introduced in August 2000 to provide a legal framework to enable certain healthcare professionals to supply and/or administer Prescription Only Medicines directly to a patient without the need for a prescription or an instruction from a prescriber. The original guidance from the Welsh Assembly Government, WHC (2000) 116, placed a responsibility on Chief Executives of authorising NHS bodies to ensure that any current or new PGDs comply with the legislation. It also stated that:

The majority of clinical care should be provided on an individual patient-specific basis. The supply and administration of medicines under PGDs should be reserved for those limited situation where this offers an advantage for patient care without compromising patient safety, and where it is consistent with appropriate professional relationships and accountability.

7.1Definition of a Patient Group Direction

A patient group direction is a specific written instruction for the supply and administration, or administration, of a named medicine in an identified clinical situation. It applies to groups of patients who may not be individually identified before presenting for treatment.

The use of a PGD does not constitute a form of prescribing. A PGD must not be confused with a patient-specific written direction.

7.2Healthcare Professions able to operate under a PGD

The following categories of healthcare professionals are able to supply or administer medicines under a patient group direction:

  • Pharmacists.
  • Registered chiropodists and podiatrists.
  • Registered dental hygienist.
  • Registered dental therapist.
  • Registered dieticians.
  • Registered midwives.
  • Registered nurses.
  • Registered occupational therapists.
  • Registered optometrists.
  • Registered orthoptists.
  • Registered orthotists and prosthetists.
  • Registered paramedics.
  • Registered physiotherapists.
  • Registered radiographers.
  • Registered speech and language therapists.

NB: Practitioners may only operate under a PGD as named individuals.

A senior person in each profession should be designated with the responsibility to ensure that only fully competent, qualified and trained professionals are authorised to operate within the PGD directions.

7.3Circumstances under which PGDs are permissible within Public Health Wales

To authorise the supply or administration of medicines by Public Health Wales employed staff where Public Health Wales is directly responsible for the care of patients or group of individuals.

7.4Criteria required to ensure valid PGD within Public Health Wales

The legislation specifies the information that each PGD must contain. Within Public Health Wales the following criteria must apply when developing and authorising a PGD:

  • The PGD must comply with the approved PGD template (Appendix A)
  • It should be drawn up by a multi disciplinary group involving a doctor, a pharmacist and a representative of any professional group expected to supply and/or administer medicines under the PGD
  • It must be signed by a senior doctor involved in the preparation of the PGD
  • It must be signed by a senior pharmacist involved in the preparation of the PGD
  • It must be signed by the relevant healthcare professionals involved in the preparation of the PGD
  • It must be signed by the Divisional Director responsible for the delivery of the service
  • It must be authorised on behalf of Public Health Wales by the Director of Public Health Services
  • A senior person in each profession should be designated with the responsibility to ensure that only fully competent, fully qualified and trained professionals operate within directions.
  • The Lead Consultant in Pharmaceutical Public Health on behalf of Public Health Wales should maintain a record of the designated senior person within each professional group authorised to approve PGDs.
  • All professionals must act within their code of professional conduct
  • It must be signed by the individual or individuals that may supply or administer medicines under the PGD, who must belong to one of the classes of person specified above
  • It must relate to medicines that have a marketing authorisation or a homeopathic certificate of registration
  • Be in effect at the time of administration or supply
  • The PGD must be reviewed every two years.

7.5Drugs requiring special consideration

7.5.1Controlled drugs

Controlled drugs can only be supplied and administered in accordance with the requirements of the Misuse of Drugs Regulations 2001. No circumstances have been identified where a controlled drug should be permitted to be supplied or administered within Public Health Wales. Consequently a Controlled Drug Accountable Officer has not been appointed by Public Health Wales. This position will be reviewed if the situation changes.

7.5.2Medicines not considered appropriate for inclusion in a PGD

Medicines without an UK marketing authorisation and those used outside the terms of the Summary of Product Characteristics (SPC) are not considered appropriate for inclusion in a PGD. The regulations specifically state that a medicine can only be included if it has a current UK marketing authorisation or a homeopathic certificate of registration. Only medicines with a marketing authorisation can have guarantees of safety, quality and efficacy.

7.5.3Exceptional Circumstances

In certain exceptional circumstances, medicines with a marketing authorisation may be used outside the summary of product characteristics e.g. in paediatrics where no licensed drug exists.This includes vaccines used according to Joint Committee on Vaccination and Immunisation (JCVI) advice.Any National Institute for Health and Clinical Excellence (NICE) guidance should be followed to ensure that a medicine used in this way is justified. The PGD must clearly state that the product is being used outside the terms of the SPC, state the reasons why its use is necessary and ideally a gold standard reference in support of its use e.g. JCVI, NICE or British National Formulary guidance. Where the medicine is for children, particular attention will be needed to specify any restrictions on the age, size and the maturity of the child and the need for consent.

7.5.4Newly licensed drugs

Newly licensed drugs subject to special reporting arrangements, (“black triangle” drugs) should also only be considered in exceptional circumstances. Good clinical practice guidelines must be followed and the PGD must clearly state the status of the product and why a black triangle drug has been chosen. Black triangle vaccines used in immunisation programmes may be included in PGD’s provided they are in accordance with the schedules recommended by the JCVI and specified in the Green Book Immunisation against Infectious Disease published electronically by the Department of Health.

7.5.5Antimicrobial Resistance

Antimicrobial resistance is a major public health concern. The use of antibiotics in PGD’s must therefore be given careful consideration. Inclusion in a PGD can only be considered where absolutely necessary and justifiable and where measures to combat resistance will not be compromised. Any PGD involving antibiotics must have the involvement and authorisation of consultant microbiologists and be audited regularly.

7.5.6Pharmacy Medicines (P) and General Sales List Medicines (GSL)

Within Public Health Wales only named individuals who belong to one of the classes of persons specified above can supply or administer a P or GSL medicine under a PGD. All the requirements for a valid PGD, as detailed above, must be adhered to for clinical governance purposes.

7.6Additional Public Health Wales requirements

7.6.1Security, Storage and Audit

All medicines to be supplied in accordance with a PGD authorised by Public Health Wales must be supplied in original packs or pre-packs made up by a pharmacist. Pharmacists asked to supply pre-packs in this manner must have the appropriate licences to allow them to do so.

A proper audit trail must be in place. This requires a secure system for the recording of medicine use under the PGD. This will include the reconciliation of receipts and supplies of medicines on an individual patient by patient basis. It must be possible to identify what patient has had which medicine. The names of the health professionals providing treatment must also be recorded.

7.6.2Labelling and Patient Information Leaflets

It is a legal requirement that the manufacturer’s patient information leaflet (PIL) is provided each time a medicine is supplied. Specific labelling requirements apply equally to medicines supplied under PGD’s. The labelling requirements for medicines are reproduced in the Royal Pharmaceutical Society’s Medicines, Ethics and Practice: The professional guide for pharmacists.Divisions requiring further advice on labelling requirements should contact the Lead Consultant in Pharmaceutical Public Health.

7.6.3General Requirements for PGD’s

A medicine supplied under a PGD need not be handed to the patient in person. The medicine could, for instance, be handed to the patient’s representative or carer. However, the supply must be for a particular person. For instance, where a supply of meningococcal prophylaxis may be required for a family, a supply of ciprofloxacin could not be made under a PGD for use by any unspecified members of a family. Each individual member of the family must be assessed against the inclusion criteria and a supply made only to those members of the family who comply with the requirements of the PGD. In addition, the PGD need not relate to specific premises. All the requirements that have been set out above must be complied with, but the supply or administration could take place at locations including a patient’s home, a surgery or health centre, a pharmacy or other appropriate premises.

7.6.4Master Copies

A copy of all PGDs authorised by the Director of Public Health Services (Executive lead for medicines management) will be held by the LeadConsultant in Pharmaceutical Public Health. The master copy of any PGDs authorised by Public Health Waleswill be held by the Divisional lead responsible for the service delivery.

7.6.5PGD Advisory Functions

It should be noted that Public Health Wales has a dual role in relation to PGDs as follows:

i) the development and approval of a range of PGDs for use internally by Public Health Wales staff. This activity is covered by the policy document.

ii) the production and maintenance of an extended range of PGD template documents as advisory documents to support LHBs and Trusts in the implementation of their immunisation programmes and other infectious disease management campaigns. These are made available on the Public Health Walesweb-site. These documents are available as advisory documents only and must be checked and authorised by individual LHBs and Trusts. Public Health Wales accepts no responsibility for the secondary use of this information.

8Ordering stock drugs and pharmaceuticals