East & South East England Specialist Pharmacy Services East of England, London, South Central & South East Coast

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Medicines in Commissioning Checklist

Medicines • are the most common treatment intervention • are used in most care pathways • expenditure in the NHS is expected to reach £15.6 billion by 2015

This checklist supports a resource entitled ‘Optimising medicines use in care pathways’ Link

Version 5.1 published November 2014 © East and South East England Specialist Pharmacy Services

Commissioning for medicines safety, effectiveness and improved patient

outcomes

Commissioners are responsible for ensuring services and pathways in which medicines are used are commissioned to standards that deliver cost effective use of resources, reduced risks associated with medicines use, improved patient outcomes and experience with medicines

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Who is this checklist for? This checklist has been developed by senior pharmacists to support those responsible for commissioning services that include the use of medicines. It is intended to help plan, secure and monitor aspects of services that involve medicines. It may be used by commissioners and service providers, to assist them in identifying and addressing medicines-related issues in pathways and service specifications to ensure compliance with both legal and quality standards such as Care Quality Commission (CQC) Standards The checklist supports the components of the commissioning cycle (Appendix 1). Potential applications include development of service specifications for service contract tenders, patient pathway or service redesign.

Why is the checklist needed? To ‘get medicines use right’ all aspects need to be addressed early in the commissioning process. Below are some examples where this did not happen with the resulting consequences:

Service provision delayed because of failure to allocate time for the development of Patient Group Directions Service provision delayed because the service did not comply with the National Patent Safety Agency requirements for delivery of

Anticoagulant Services Service had to be withdrawn from a provider who was found to be operating illegally.

Using the checklist The checklist should be used early in the early stages of service or pathway commissioning to ensure critical factors and action points related to

medicines are identified and addressed in good time to ensure accurate service specifications to be developed. Section 1 is designed for Commissioning Managers to identify the extent to which medicines are involved in the service or pathway and the need to seek advice from a Medicines Management Lead to help work through the considerations in Section 2. The high level questions in Section 2 help Medicines Management Leads and Commissioners consider all potential aspects of medicines use and ensure they have been addressed. If necessary, the questions and considerations may help commissioners develop specific standards for inclusion in service specifications. Note: For ease of completion, an excel version is also available.

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Medicines in Commissioning Checklist

Section 1:Initial Questions for Commissioners

Will the proposed service/pathway involve:

Treatment with medicines? Yes/No If the answer is Yes to any of these questions seek assistance from Medicines Management Lead with Section 2

Prescribing of medicines? Yes/No

Supply/dispensing of medicines? Yes/No

Procurement of medicines? Yes/No

Administration of medicines to patients? Yes/No

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Section 2: Medicines Management Lead & Commissioners to consider

Will the proposed service/pathway: Notes & action required

Comply with current legislation and NHS regulations?

Consider:

Yes/No

Licences required for manufacturing, packaging & supply of medicines

Compliance with NHS and non-NHS provider regulations

Compliance with CQC Standards

Assessment of provider’s quality assurance processes

Need for Medicines policy, SOPs and processes

Need for PGDs

CD regulations if CDs involved including Accountable Officer role

Waste regulations

VAT regulations

Safe handling requirements for hazardous substances e.g. cytotoxic drugs

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Comply with current evidence and best practice guidance?

Consider:

Yes/No

Compliance with RPS standards

National guidance including NICE

Local guidance from prescribing or priorities committees, including medicines formularies

Requirement for maintaining active risk register that includes risks with medicines

Need for Medication Safety Officer to review, monitor & ensure medication errors reported to NRLS

Process for reviewing & reporting adverse reactions and events to MHRA

Processes for safer transfer of care at healthcare interfaces including medicines reconciliation

Result in a need to decommission services?

Consider

Yes/No

Arrangements during transition period

Provisions relating to staff transfer (TUPE)

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Have cost implications for the way in which medicines are used compared to current arrangements?

Consider:

Yes/No

Source of supply: Community Pharmacy, Secondary Care, Homecare, PGDs

Requirement for enhanced services

Payment & collection of prescription charges

Procurement issues; access to Regional/National prices, VAT, prepacks, specials

Prescribing responsibility, including clinical governance arrangements

Infrastructure & support costs

Consumables and equipment costs (including maintenance)

Staff training costs

Medicines storage- need for cold chain

Medicines transportation costs

Handling & disposal of medicines waste

Current cost & volumes vs future predicted cost & volumes

Collection of medicines prior to administration (eg Home IV)

Implementation of new NICE approved technologies

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Require new funding streams for medicines to be identified?

Consider:

Yes/No

Mechanisms for transferring funding

Cost-effectiveness of options

Primary or secondary care prescribing, including clinical responsibility

Tariff payments to secondary care

Responsible Commissioner CCG or NHSE

Methodology for calculating funding needed

Mechanisms for transferring funding

Be provided by staff adequately trained in the activities required?

Consider:

Yes/No

Professional registration requirements & revalidation

Need for a designated person with overall responsibility for the safe use of medicines

Clinical governance framework for prescribers including non-medical prescribers

Competency frameworks for relevant staff groups

Systems for appraisal, CPD and supervision

Workforce & succession planning

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Enhance patient safety, understanding of medicines & overall experience?

Consider:

Yes/No

Assessment of provider’s capacity & capability to deliver

Public/service user engagement in service design

Provider’s processes for dealing with complaints

Responsibility for checking patients’ understanding of their medicines & adherence to treatment

Availability of systems to support self-administration

Contact point for patients to receive information about their medicines

Requirement for patient held information and responsibility for completing records

Require KPIs and outcome measures to monitor performance?

Consider:

Yes/No

Activity measures

Performance against budget

Audit vs agreed national or local standards

Quality measures including patient safety, experience & outcome

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Require access to or advice from a specialist pharmacist?

Consider:

Yes/No

Degree of complexity or specialist nature of medicines involved e.g. biologicals

Vulnerability of patients involved

Access to pharmaceutical advice and medicines information services

Require clear lines of responsibility & accountability to be defined?

Consider:

Yes/No

Legal liability

Clinical governance

Financial governance

Professional ethics & codes of practice

Employment contracts

Inter- organisation responsibilities

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Useful Web sites

NICE

http://www.nice.org.uk

Department of Health

https://www.gov.uk/government/organisations/department-of-health

Care Quality Commission

http://www.cqc.org.uk/

Medicines & Healthcare Products Regulatory Agency (MHRA)

http://www.mhra.gov.uk/index.htm

National Patient Safety Agency (now disbanded but useful

patient safety resources remain at the site) http://www.npsa.nhs.uk

Nursing & Midwifery Council (NMC)

http://www.nmc-uk.org/

Royal Pharmaceutical Society (RPS) (most material members only)

http://www.rpharms.com/home/home.asp

Patient Group Directions (part of NELM)

https://www.sps.nhs.uk/category/services/guidance-and-governance/patient-group-directions/

NHS Prescription services

http://www.nhsbsa.nhs.uk/prescriptions

Health Professions Council

http://www.hpc-uk.org/aboutregistration/

Specialist Pharmacy Service

https://www.sps.nhs.uk/

Primary Care Commissioning http://www.pcc-cic.org.uk/

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Appendix 1: Medicines aspects within the Commissioning Cycle

Strategy Planning Assess Needs and Provision Review Impact on local Pharmaceutical Needs Assessment Deciding Priorities and Investments What are the risks if current services are to be de-commissioned? Patient Safety and Governance Are key performance indicators & outcome measures that support the governance of medicines built into the specification? Funding Aspects Has funding been identified for medicines, supply & storage systems, and any training needs for staff? Legal Aspects Would the service comply with NHS regulations? Patient Experience How will choice, information needs and access to medicines be addressed?

Procuring Services Assess Needs and Provision Review Have all aspects of medicines use been addressed in the service specification?

Patient Safety and Governance Is there a designated person with lead responsibility for the safe and cost effective use of medicines?

Funding Aspects Has funding been identified for all aspects of medicines use?

Legal Aspects Should any other legislation be considered e.g. VAT, Human Rights, Waste Regulations?

Service Delivery Will medicines be administered as part of the service and how will they be sourced?

Staff training and competency Are there enough staff to deliver the service?

Patients and the Public Assess Needs and Provision Review Who are the potential providers?

Patient Safety and Governance Is there a clear communication process about current medication & recent changes to medication wherever care is delivered to the patient

Legal Aspects Are the staff that will be employed to provide the service appropriately qualified, competent, and registered for the activity being commissioned?

Service Delivery How will patients access medicines?

Patient Experience Do patients and/or their carers have their medicines explained to them? Do they know how to access advice and information after they have left the care setting?

Monitoring and Evaluation Patient Safety and Governance Is there a robust Medicine Policy and are Standard Operating Procedures or protocols in place for all processes involving medicines?

Legal Aspects Are the arrangements for prescription, supply and administration of medicines within the law?

Staff training and competency What training and competencies are required for staff who will be delivering the service?

Funding Aspects Has funding been identified to ensure the service has safe systems & equipment for optimal medicines management?

Patient Experience Are medicines prescribed for which regular monitoring is essential for patient safety?

Copyright © 2010. Re-used with the permission of the Health and Social Care Information Centre. All rights reserved.

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Membership of the working group Version 1 (June 2008) was developed by a working group from the Clinical, Community Health, Community Pharmacy and Medicines Information Specialists of East and South East England, Specialist Pharmacy Services covering East of England, London, South Central and South East Coast. Versions 2-4 (August 2009, Sept 2010, August 2012 ) were revised by a working group from the above service to reflect the changes in NHS provision brought about by ‘Equity and Excellence: Liberating the NHS’. Version 5 (November 2014) was revised by Julia Wright and Tracy Rogers with assistance from Kay Scott, South East CSU.

Acknowledgements The working group extends thanks to the many colleagues who gave their useful comments and suggestions during the development and updating of this resource. The NHS Institute for Innovation & Improvement gave permission for the use of the commissioning cycle diagram.

If you have further questions or wish to discuss this document please contact: Julia.wright2@nhs.net Tracy.Rogers@nhs.net