ANNEX 2

NHS Eastern and Coastal Kent

Key Performance Indicators for Anticoagulant Supply Services.

This document applies to staff working within or on behalf of NHS Eastern and Coastal Kent. It is also regarded as providing good practice guidance to independent contractor organisations.

This document provides commissioners and service providers with:

  • A framework to ensure compliance with NPSA safety indicators for anticoagulant supply services.
  • The PCT key performance indicators relating to the provision of anticoagulant supply services.
  • The agreed care pathway for patients requiring anticoagulation therapy.
  • The PCT policy on local and national reporting mechanisms.

Written by: Jo-Ann Lodge, Provider Development Pharmacist.

Valid from: 1st January 2011

Review Date:31st March 2012

Lead Manager / Director:Sarah Andrews

Agreed by:Patient Safety Sub-committee

NHS Eastern and Coastal Kent actively challenges discrimination and actively promotes equality. We will not restrict assessment, treatment, therapy or care on the basis of age, disability, gender, ethnic group, religion or belief, sexual orientation or any other irrelevant consideration.

1.Introduction.

1.1Anticoagulants are one of the classes of medicines most frequently identified as causing preventable harm and admission to hospital (NPSA 2007).

1.2This document is the agreed NHS Eastern and Coastal Kenthealth economy care pathway, for community pharmacy providers who are supplying anticoagulants against patient group direction (PGD).

1.3This policy applies to all providers of anticoagulant supply services under PGD for NHS Eastern and Coastal Kent.

1.4This document was reviewed and updated via the Anti-coagulation Working Group, sub-group of the CVD Service Improvement Group from April-September 2010.

2.NPSA Patient Safety Alert

2.1This document is based on the most recent evidence and best practice recommendations described in the 2007 Patient Safety Alert from the National Patient Safety Agency (NPSA), “Actions that can make anticoagulant therapy safer”.

2.2In primary care, anticoagulants are one of the classes of medicines most commonly associated with fatal medication errors. In secondary care Warfarin is one of the ten drugs most frequently associated with prescribing/dispensing errors. The NHS Litigation Authority has reported that anticoagulants are one of the ten most common drugs involved in errors resulting in claims against NHS Trusts.

2.3 The following pages describe the safety indicators from the NPSA alert that relate to anticoagulant supply. These must be followed by all pharmacy providers who are supplying patients with anticoagulants.

The policy is set out as a series of measurable objectives and benchmarks.

For NPSA links see appendix 1.

3.Benchmarks and expected best practice.

Objective 1 – To ensure that there is a robust mechanism in place to ensure that all staff caring for patients on anticoagulant therapy have the necessary work competencies.

Benchmark of expected best practice – There are processes in place,to ensure that all staff have required work competencies.

To demonstrate standards of best practice for objective 1 the PCT, organisations, practitioners, managers and staff should ensure that:

  • All services commissioned and provided by and on behalf of the PCT and by independent contractors have arrangements in place to identify the required work competencies for staff.
  • Any gaps in competence must be addressed through training to ensure that all staff undertake their duties safely.

Actions that anticoagulant supply providers should be taking to make sure best practice is achieved:
1.1. / It is compulsory for the pharmacist(s) undertaking anticoagulation supply under the PGD to be accredited by successfully completing the following training:
Either
1) the CPPE open learning module “Anticoagulation: managing patients, prescribing and problems”, including CPPE on line “Anticoagulants – supporting patients and ensuring safety” examination
OR
2) the BMJ module “maintaining patients on anticoagulants : how to do it”.
The latter is most useful to pharmacists wishing to offer anticoagulation monitoring and supply services.
Medicines use review (MUR) accreditation.
Copies of completion certificates must be sent to Contracting Team, Eastern and Coastal Kent PCT, Templar House, Tannery Lane, Ashford, KentTN23 1PL and originals retained on file as evidence.
In addition, pharmacists must understand and comply with the contents of Service Specification
Signed documents must be returned to : Contracting Team, Eastern and Coastal Kent PCT, Templar House, Tannery Lane, Ashford, KentTN23 1PL
Pharmacists must be reaccredited every two years.
For information relating to training and to access the PGDs for anticoagulation monitoring and dispensing, please use the link below:

1.2. / Identification of any gaps in training or resource requirements to ensure compliance.

Objective 2 - To ensure that there are written procedures and clinical protocolsin place thatreflect safe practice.

Benchmark of expected best practice – Healthcare organisations should have clinical policies and clinical protocols for the safe use of oral anticoagulant therapy.

To demonstrate best practice for objective 2 the PCT, organisations, practitioners, managers and staff should ensure:

  • The PCT, organisations and services willhavewritten procedures and protocols in place.
  • There must be a structured process in place to review and update polices – local policies should be amended to standardise the range of anticoagulant products used, incorporating characteristics identified by patients as promoting safer use.
  • Staff must be trained in, and work to theseprocedures and protocols.

Actions that anticoagulant supply providers should be taking to make sure best practice is achieved:
2.1. / Evidence of written, agreed protocols for the following:
Evidencethat INR levelsarewithin appropriate range before issuing or dispensing oral anticoagulants;
Identifying patients who have been discontinued on therapy;
Ensuring the dose of Anticoagulant tablets is described in mg NOT number of tablets;
Have access to the following locally agreed policies for the following:
Dosage recommendations; guidance for anticoagulation;
The agreed checks required to safely dispense oral anticoagulants in a dispensing setting (pages 12 and 13 at the end of the Dispensing Specification);
Standard INR checking frequency (appendix 2);
Identify stable and unstable, to ensure patient safety throughout the pathway (appendix 3).
2.2. / A process is in place to ensure documents are reviewed yearly and disseminated to all staff as appropriate.

Objective 3 – To ensure that patients prescribed anticoagulants receive appropriate verbal and written information at the start of therapy, at hospital discharge, at the first anticoagulant appointment, and when necessary throughout the course of their treatment.

Benchmark of expected best practice – To ensure that there are processes in place to ensure patients receive information throughout the care pathway.

To demonstrate best practice for objective 3 the PCT, organisations, practitioners, managers and staff should ensure:

  • Organisations, services and practices will have processes in place to ensure provision of information to patients
  • Organisations, services and practices will have processes in place to ensure that patient receipt of information is recorded.

Actions that anticoagulant supply providers should be taking to make sure best practice is achieved:
3.1. / Evidence that a range of patient information is available (i.e. a selection of documentation from the Patient and Carers section on the NPSA webite
3.2. / Documentedthat patient has been given information and advice.

Objective 4 – To ensure that there is a structured auditprogram in place.

Benchmark of expected best practice – Annualdocumented audit.

To demonstrate best practice for objective 4 the PCT, organisations, practitioners, managers and staff should ensure:

  • Audit of safety indicators for patients starting oral anticoagulant treatment.
  • Audit of safety indicators for patients established on oral anticoagulant treatment.
  • Recommendations and action planning based on results of audits.

Actions that anticoagulant supply providers should be taking to make sure best practice is achieved:
4.1. / Audit supply service yearly against KPI document.
4.2. / The audit programme will include audits that ensure compliance with National Patient Safety Agency (NPSA) alerts and Work competence statement for dispensing, Standards for Better Health (SfBH), NHS Litigation Authority (NHSLA), where required,.
4.3. / Documented audit of safety indicators:
  • % of supplies made when the INR Record book was not seen.
  • % of supplies made when the patient’s last INR recorded was 0.5 units away from their target INR (ie. Outside of therapeutic range).
  • % of supplies made when full details were not entered into the supply forms.

4.4. / The audit results are used to make recommendations for continuous quality improvements to the services, evidenced by action planning and implementation of the same.

Objective 5 – Promotion of the use of safe procedures in social care settings and domiciliary visits.

Benchmark of expected best practice – There are written safe practice procedures for the administration of anticoagulants in social care settings and domiciliary visits.

To demonstrate best practice for objective 5 the PCT, organisations, practitioners, managers and staff should ensure:

  • Social care settings (e.g. care homes; day centres; support living centres), should have written procedures for administering anticoagulants.
  • Dosage changes to be confirmed in writing by the provider.
  • The use of monitored dosage systems should be individually risk assessed and other means of administration sought where possible.
  • All providers must undertake domiciliary visits and must have written procedures for administering anticoagulants.

5. / Actions that anticoagulant supply providers should be taking to make sure best practice is achieved:
5.1. / The use of monitored dosage systems for anticoagulants should be minimised as dosage changes using these systems are difficult.
5.2. / Anticoagulation therapy services have processes in place to ensure risk assessments are undertaken on the use of monitored dosage systems for individual patients.

Objective 6 – Recording of patient safety incidents and near miss reporting.

Benchmark of expected best practice – That there is a robust procedure in place to record patient safety incidents and near miss reporting involving anticoagulants.

To demonstrate best practice for objective 6 the PCT, organisations, practitioners, managers and staff should ensure:

  • Incidents involving anticoagulants are reported via the organisations risk management process (e.g. PCT Incident Reporting System).
  • A record of all incidents, actual and potential, is maintained. (see Enhanced services contract).

6. / Actions that anticoagulant supply providers should be taking to make sure best practice is achieved:
6.1. / A process is in place to ensure all incidents and near misses are reported to the PCT (e.g. Incident Reporting System).
6.2. / A record of all incidents, near misses and potential incidents is maintained by the pharmacy. This information should include those areas required by the NPSA (see appendix 4).

Objective 7 – Interactions and dental treatment.

Benchmark of expected best practice – That there are robust procedures in place to manage interacting medicines and dental treatment.

To demonstrate best practice for objective 7 the PCT, organisations, practitioners, managers and staff should ensure:

  • Promotion of safe practice for prescribers co-prescribing one or more significantly interacting medicines.
  • Patients should be advised to inform their dentists that they are taking Anticoagulation Medication.

7. / Actions that anticoagulant supply providers should be taking to make sure best practice is achieved:
7.1 / A process will be in place to check at supply of oral anticoagulants for any co-prescribed significantly interacting medicines having being started or dosages changed, or for significant lifestyle changes, so that the anticoagulation service can be informed if required and arrangements for additional INR blood tests made.

Objective 8 – Quality control

Benchmark of expected best practice – There are robust procedures in place to manage stable and unstable patients; INR checking frequency, choice of systems; calibration of equipment; waste disposal; discontinuation of patients on anticoagulation treatment.

To demonstrate best practice for objective 8 the PCT, organisations, practitioners, managers and staff should ensure:

  • Organisations, services and practices must include the agreed health economy definition of stable and unstable patients, within their protocols – see appendix 3 for definition.
  • DAWN is the preferred system of choice. INR Star is the ONLY other acceptable system.
  • Organisations, services and practices must use the agreed health economy INR checking frequency – see appendix 2.
  • All providers MUST be registered with UK NEQAS.
  • Coaguchek machines to be calibrated in line with manufacturer’s recommendations.
  • All providers must have a policy in place for disposal of clinical waste.
  • The preferred length of treatment is to be written in the patient’s yellow book by the clinician initiating treatment.
  • Providers make use of the nursing helpline – numbers in appendix 7.

8. / Actions that anticoagulant supply providers should be taking to make sure best practice is achieved:
8.1 / Evidence that dispensing anticoagulant protocols and procedures comply with the NPSA Work Competence statement for Dispensing anticoagulants (appendix 1).
8.2 / A written waste disposal policy is in place.

Objective 9 – Supply and/or administration

Benchmark of expected best practice – There is a PGD in place for supply and/or administration.

To demonstrate best practice for objective 9 the PCT, organisations, practitioners, managers and staff should ensure:

  • There is a PGD in place for the supply of anticoagulants and the administration of Phytomenadione. Information can be accessed via:
9. / Actions that anticoagulant supply providers should be taking to make sure best practice is achieved:
9.1 / Each pharmacist must sign a copy of the currently dated PGD for supply and return to the PCT, to be covered to supply the anticoagulants under the PGD.
9.2 / A responsible pharmacist for the premises must sign a copy of the currently dated SLA agreement for the premises and return to the PCT, to be allowed as a site for the supply of anticoagulants under PGD.

Appendix 1

NPSA links

Appendix 2

Standard INR checking frequency

Appendix 3

Stable and unstable

Appendix 4

Patient safety incidents – information required by the NPSA

Appendix 5

Patient care pathway algorithm

Appendix 6

Audit Tool

Appendix 7

Medical and nursing support for primary care anticoagulant clinics

Appendix 1

NPSA links:

Web link to NPSA site:

NPSA Patient Safety Alert (NPSA/2007/18):

Template Service Audit Form:

Risk Assessment Grid:

Appendix 2

Standard INR checking frequency

After 1 result in range recheck after 1 week

After 2 results in range recheck after 2 weeks

After 3 results in range recheck after 3 weeks

After 4 results in range recheck after 5 weeks

After five results in range recheck after 8 weeks

Then to 12 weeks

Mechanical Valve Patients should have a maximum of 8 weeks between INR tests.

Providers should check that their systems are programmes to use this schedule. They may need to reprogramme this schedule into their software as the software ships with a different standard schedule.

Appendix 3

Stable and Unstable

Stable: If there are more INR readings in range than out of range over an 8 week period, then a patient may be considered to be stable on anticoagulation therapy.

Unstable: If there are more INR readings out of range than in range over an 8 week period, then a patient may be considered to be unstable on anticoagulation therapy and advice should be sought.

Appendix 4

Patient safety incidents – information required by the NPSA

Clinical outcome:

Death;

Severe (permanent harm);

Moderate (significant, but not permanent harm, requiring increase in treatment);

Low (temporary harm, requiring extra observation or minor treatment);

No harm.

Type of report:

Prescribing;

Dispensing/medicine preparation;

Administration;

Monitoring.

Type of incident:

Wrong dose;

Wrong frequency;

Omitted medicine/dose;

Wrong drug;

Wrong quantity;

Mismatching of patient and their medicine;

Wrong/transposed/omitted medicine label;

Wrong/omitted/passed expiry date;

Wrong storage;

Wrong route;

Contraindication;

Patient allergic to treatment;

Wrong formulation;

Wrong method of preparation/supply;

Adverse drug reaction – when used as intended;

Wrong or omitted verbal directions;

Other.

PATIENT CARE PATHWAYAppendix 5

Algorithm for Initiating, Maintaining, Referring and Discontinuing Patients on Anticoagulants

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ANNEX 2

Appendix 6

Audit Checklist

1. Ensure all staff caring for patients on anticoagulant therapy have the necessary work competencies. Any gaps in competence must be addressed through training to ensure that all staff may undertake their duties safely.

Recommended action / Evidence/Examples / Compliance (Yes/No) / Comment/further action required
Sign and date
Evidence of individual competence. / Copy of:
  • Accredited training programme completed by pharmacists - certificates required.

  1. Protocols and procedures

Recommended action / Evidence/Examples / Compliance (Yes/No/N/a) / Comment/further action required
Sign and date
Access to the local Healthcare organisations’ written clinical policies and protocols for the safe use of oral anticoagulant therapy. These procedures should include guidance on the following:
Initiation; monitoring; documentation of processes; dental treatment; discontinuation; protocol to manage over-coagulation. / Copies of written policies/protocolsavailable in the pharmacy– some of this information can be found in Dr Winter’s “Protocol for the management of patients on anticoagulant therapy”.
INR is monitored regularly and level is safe before issuing or dispensing repeat prescriptions for oral anticoagulants. / Copy of anticoagulant supply SOP which fulfils the NPSA work competence statement for dispensing oral anticoagulants and includes the following:
  • Checking for changes in drug therapy and lifestyle which may interact with the anticoagulant therapy
  • Checking duration of therapy and identifying stopped patients or patients due to stop.

All staff are aware of their responsibilities and actions if a request is made for the supply of Anticoagulants under PGD. / SOPs are included in the SOP folder for the pharmacy and reviewed yearly.
A record made detailing that each staff member is aware of their responsibilities regarding this service.
Locum packs should include guidance on how to deal with patients requesting this service.

3. Patient information