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DRAFT MEDICINES POLICY

1 POLICY DRAFTED BY: HEAD OF MEDICINES MANAGEMENTPRESCRIBING ADVISERS

2 ACCOUNTABLE DIRECTOR: DIRECTOR OF COMMISSIONING

3 APPLIES TO:ALL GP PRACTICESALL ISLINGTON CCG COMMISSIONED SERVICES

4 COMMITTEE& DATE APPROVED:

5 VERSION: 1.1

6 RELATED DOCUMENTS:

7 DATE OF IMPLEMENTATION: FEBRUARY 2015

8 DATE OF NEXT REVIEW: FEBRUARY 2017

DOCUMENT CONTROL

Date Version Action Amendments19 September 2013

1.0 First version Draft

15 May 2014

1.1 Revised first version Updated draft with comments included and incident reporting refined. Cross-references added to NHS England policies where appropriate.

31 December 2014

1.1 Revised first version – final updates

Updated hyperlinks, addition of Medicines Safety Officer details, rebate schemes details and minor amendments to guidance.

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1. Introduction

The term ‘medicines’ embraces all products for the purpose of treating or preventing disease, diagnosing disease or determining the extent of a physiological condition, contraception, inducing anaesthesia, or otherwise preventing or interfering with the normal operation of a physiological function. Medical gases, immunisations/ vaccines and pharmaceutical preparations such as medicated or interactive dressings, disinfectants, reagents and similar products, and all medicinal products covered by the European Directive on Medicines are included.

This policy will ensure high quality Clinical Commissioning Group (CCG)-commissioned services through the safe, effective, economic and patient-centred use of medicines.

Medicines optimisation encompasses a whole systems approach to ensure the NHS is achieving maximum health gain and least harm from all medicines. It involves maximising the use of medicines in preventing disease or the progression of disease and in improving patient outcomes from the use of medicines.

This approach will be used to develop medicines services within Islington CCG through application of the Royal Pharmaceutical Society’s four principles of medicines optimisation:

i) Aim to understand the patient’s experienceii) Evidence-based choice of medicinesiii) Ensure medicines use is as safe as possibleiv) Make medicines optimisation part of everyday practice

The key areas of legislation underpinning this policy include:

The Medicines Act 1968, as amended, which regulates the manufacture, distribution, import, export, sale and supply of medicinal products

The Misuse of Drugs Act 1971 as modified, which controls the availability of drugs liable for misuse

The Misuse of Drugs Regulations 2001, as amended, which enable specified health care professionals to possess, supply, prescribe and/or administer controlled drugs in the sphere of their practice.

The Misuse of Drugs Regulations 2005, which sets out arrangements for the safer management of controlled drugs

Health and Social Care Act 2012, which sets out the statutory functions of Clinical Commissioning Groups and new NHS organisational structures within which they will function.

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2. Policies statement

Islington CCG’s policies set out the organisation’s standards and intentions, and are written with the aim of being as clear and comprehensive as possible. However, we operate in a dynamic and evolving work environment and attention should be paid to the spirit of the policy as well as the letter. Policies by themselves cannot guarantee effective behaviour or the delivery of key objectives. While they are designed to support the CCG, and the people working within it, our success depends on continuous, high quality effort by everyone the policy covers. Therefore thought must be given to good practice when applying or interpreting any of the CCG’s policies, and you should read any guidance or supporting documentation that relates to this policy to help you do this.

3. Purpose and Scope of the Policy

This policy has been developed to summarise legislative requirements and best practice relating to the safe and secure handling of medicines, including Controlled Drugs and is intended for use by all staff commissioning services which include medicines components in Islington CCG. It includes guidance on the ordering, storage, prescribing, administration, disposal and optimisation of medicines.

The objectives of the policy are to provide organisation-wide assurance that:

Safe and appropriate arrangements for the use of medicines are in place in all CCG-commissioned services and within CCG GP practices, complying with legislation, regulators’ (e.g. CQC, NHS England, GMC, GPhC) requirements and good practice guidance.

Patients have access to the medicines they require in line with the NHS Constitution.

Medicines are correctly and appropriately prescribed by an authorised prescriber.

Medicines are accurately and appropriately administered by authorised staff.

Recording and safe and secure handling of medicines is correctly performed to prevent harm, loss or inappropriate access.

Staff are accountable for their actions in relation to use of medicines and adherence to this policy.

Staff are supported in working to the highest standards when involved in the prescribing, dispensing, handling, storing, administration and optimisation of medicines.

This policy replaces the former Islington PCT Medicines Policy.

4. Who this policy applies to

The policy applies to all GP practices within Islington CCG, employees and staff of Islington CCG and to all services commissioned by Islington CCG.

5. Medicines Guide

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The full guidance to support this policy is set out in Appendix 1 below.

6. Roles and Responsibilities

Responsibility of Commissioners

To ensure a copy of the policy is accessible to all commissioned services and that service provider policies comply with this policy.Prescribing and medicines should always be considered when commissioning or redesigning services. Commissioners should contact the Medicines Management team at the earliest opportunity to discuss medicines aspects of new or changed services.

Responsibilities of commissioned organisations

Commissioned service providers will ensure they have an operational medicines policy in place and that this is available for review by Islington CCG staff when required. Provider units shall ensure that processes are in place covering (but not limited to) ordering and receipt of medicines, prescribing and administration of medicine, destruction of medicines, storage of medicines and medicines monitoring and review.

Commissioned organisations should also adhere to the North Central London Prescribing Guidance.

Responsibilities of GP practices

GP practices are accountable for their medicines arrangements to the Care Quality Commission (CQC) under Outcome 9 –Management of Medicines. GP practices are also contractually accountable to NHS England. The CCG Medicines Management team can provide support and help practices with enquiries in relation to the safe and appropriate use of medicines.

Responsibilities of community pharmacies

Community pharmacies are contractually accountable to NHS England and professionally accountable to the General Pharmaceutical Council. Where Community pharmacies are providing CCG commissioned services they should adhere to the terms of their NHS contract and the requirements of this policy.

Responsibilities of nursing staff

All registered nurses, midwives and health visitors are accountable for their practice and shall adhere to the current Nursing & Midwifery Council (NMC) guidelinesEach individual nurse has a responsibility for storing, handling, administering and recording of medicines and disposal in a safe, correct and appropriate manner and must be prepared to be accountable for his/her actions.

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7. Breaches of Policy

Any breaches of this policy must be reported as an incident to the NEL Commissioning Support Unit incident reporting service or in accordance with a commissioned service provider’s incident reporting policy.

All incidents will be reviewed by the Medicines Optimisation Group for trends and organisational learning and policy change and development.

8. References

References are provided as hyperlinks throughout the policy to ensure links to the most up-to-date versions of guidance and provide ease of reference. The policy will be reviewed annually and the hyperlinks updated. If a hyperlink has expired, please search for the item or contact your prescribing adviser.

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Appendix 1

MEDICINES GUIDE

This guidance applies to all staff in Islington CCG who are involved in any aspect of the use of medicines including locum and agency staff.

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Contents

1. Introduction....................................................................................................................91.1 Staff Training............................................................................................................101.2 The Pharmaceutical Industry....................................................................................101.3 Clinical Trials............................................................................................................111.4 Medicines adherence................................................................................................11

2. Prescribing...................................................................................................................122.1 General guidance.....................................................................................................122.2 NICE guidance..........................................................................................................122.3 Formulary..................................................................................................................132.4 Guidelines and pathways..........................................................................................132.5 Off-Label/Unlicensed Prescribing.............................................................................132.6 Prescription forms.....................................................................................................142.7 Non-Medical Prescribing...........................................................................................142.8 Communications on transfer of care (Medicines Reconciliation)..............................15

3. Safe and secure handling of medicines.......................................................................163.1 Administration of medicines......................................................................................163.2 Authorisation to Administer Medicines..................................................................173.3 Administration of Medicines via the Intravenous Route........................................183.4 Vaccine Administration..........................................................................................193.5 Administration by Nurses in Training.....................................................................203.6 Supervision and Assessment of staff....................................................................203.7 Responsibilities of Registered Nurses...................................................................203.8 Consent.................................................................................................................203.9 Self-Administration of Medicines...........................................................................203.10 Patient Group Directions....................................................................................213.11 Patient Specific Directions.................................................................................213.12 Emergency drugs....................................................................................................21

4. Medicines safety..........................................................................................................214.1 Medicines information...........................................................................................214.2 NHS England, Patient Safety function (formerly National Patient Safety Agency) 224.3 Incident reporting......................................................................................................224.4 Alerts.........................................................................................................................23

5 Controlled Drugs.............................................................................................................235.1 Accountable Officer..................................................................................................245.2 Prescribing of controlled drugs Schedule 2 and 3....................................................245.3 Prescription forms in use..........................................................................................24

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5.4 Monitoring of patterns of CD prescribing..................................................................245.5 CD Declarations........................................................................................................255.6 Prescribing of controlled drugs via a syringe driver..................................................255.7 Prescribing high doses of CDs.................................................................................255.8 Reducing dosing errors with opioid medicines..........................................................255.9 Advice regarding the safe administration of naloxone..............................................255.10 Reducing dosing errors with midazolam.................................................................25

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1. Introduction

The term ‘medicines’ embraces all products for the purpose of treating or preventing disease, diagnosing disease or determining the extent of a physiological condition,contraception, inducing anaesthesia, orotherwise preventing or interfering with the normal operation of a physiologicalfunction. Medical gases, immunisations/ vaccines and pharmaceutical preparations such as medicated or interactive dressings, disinfectants, reagents and similar products, and all medicinalproducts covered by the European Directive on Medicines are included.

The Medicines Policy will ensure high quality Clinical Commissioning Group (CCG)-commissioned services through the safe, effective, economic and patient-centred use of medicines.

Medicines optimisation encompasses a whole systems approach to ensure the NHS is achieving maximum health gain and least harm from all medicines. It involves maximising the use of medicines in preventing disease or the progression of disease and in improving patient outcomes from the use of medicines.

This approach will be used to develop medicines services within Islington CCG through application of the Royal Pharmaceutical Society’s four principles of medicines optimisation:

v) Aim to understand the patient’s experiencevi) Evidence-based choice of medicinesvii) Ensure medicines use is as safe as possibleviii) Make medicines optimisation part of everyday practice

The key areas of legislation underpinning this policy include:

The Medicines Act 1968, as amended, which regulates the manufacture, distribution, import, export sale and supply of medicinal products

The Misuse of Drugs Act 1971 as modified, which controls the availability of drugs liable for misuse

The Misuse of Drugs Regulations 2001, as amended, which enable specified health care professionals to possess, supply, prescribe and/or administer controlled drugs in the sphere of their practice.

The Misuse of Drugs Regulations 2005, which sets out arrangements for the safer management of controlled drugs

Health and Social Care Act 2012, which sets out the statutory functions of Clinical Commissioning Groups and new NHS organisational structures within which they will function.

1.1 Staff Training

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All staff involved in the prescribing, administration and/or handling of medicines should be appropriately trained with regard to safety and storage of medicines and with regard to safeguarding themselves and those under their supervision from any risks posed by products (e.g. cytotoxics, sensitising, flammable or corrosive items).

Such training should include training and education about locally agreed procedures as well as defining lines of responsibility and secure methods of handling both medicines and controlled stationery.

All staff should understand their scope of practice and work within it, and must be clearly instructed as to what documentation they may or may not complete.

Personnel involved in handling medicines should be trained to ensure understanding of the need for risk management in relation to drug products and procedures.

1.2 The Pharmaceutical Industry

Contact with the Pharmaceutical Industry must be in accordance with the CCG Gifts and hospitality and declarations of interest policy and Anti-bribery policy.

GP Practices are advised to have their own policies in place for contact with the pharmaceutical industry.

Pharmaceutical Industry representatives who wish to discuss products with the CCG are advised to contact the CCG Head of Medicines Management. Appointments are limited.

Samples should not be left with CCG staff without agreement by the Head of Medicines Management.

Pharmaceutical industry representatives are requested not to make direct approaches to CCG Board members.

Participation of the CCG in pharmaceutical industry price rebate schemes will be considered in line with guidance from the London Procurement Programme and is at the discretion of the CCG.

Participation of CCG staff in advisory boards or surveys is at the discretion of the CCG. All participation will be declared and recorded in the CCG register of interests.

All CCG staff must declare any competing interests when involved in decision-making for medicines or providing medicines advice.

All pharmaceutical industry staff should declare any competing interests when involved in NHS-related meetings, e.g. Healthwatch.

1.3 Clinical Trials

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By law, all clinical trials must have prior approval of the necessary ethics committees and research governance processes. See also North Central London, Prescribing Guidance.

1.4 Medicines adherence

It is estimated that between a third and a half of all medicines prescribed for long-term conditions are not taken as recommended. NICE Clinical Guideline 76 provides full detail on how to improve and support medicines adherence. Key components are:

o Healthcare professionals have a duty to help patients make informed decisions about treatment and use appropriately prescribed medicines to best effect.

o Unintentional non˗adherence occurs when the patient wants to follow the agreed treatment but is prevented from doing so by barriers that are beyond their control. Examples include poor recall or difficulties in understanding the instructions, problems with using the treatment, inability to pay for the treatment, or simply forgetting to take it.

o Intentional non˗adherence occurs when the patient decides not to follow the treatment recommendations. This is best understood in terms of the beliefs and preferences that influence the person's perceptions of the treatment and their motivation to start and continue with it.

o To understand adherence to treatment we need to consider the perceptual factors (for example, beliefs and preferences) that influence motivation to start and continue with treatment, as well as the practical factors that influence patients' ability to adhere to the agreed treatment. Applying this approach in practice requires:

a frank and open approach which recognises that non˗adherence may be the norm (or is at least very common) and takes a no˗blame approach, encouraging patients to discuss non˗adherence and any doubts or concerns they have about treatment

a patient˗centred approach that encourages informed adherence

identification of specific perceptual and practical barriers to adherence for each individual, both at the time of prescribing and during regular review, because perceptions, practical problems and adherence may change over time.

Cultural and religious issues

Healthcare professionals need to be aware of the impact of a patient’s cultural and religious beliefs on medicines adherence (e.g. consideration to gelatin, alcohol and animal-derived products). Opportunity should be given to patients to discuss their

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concerns and appropriate and suitable medication and regimens should be considered. Please contact the medicines management team for advice.

2. Prescribing

2.1 General guidance

Comprehensive guidance on prescribing is available in the British National Formulary and British National Formulary for Children. All prescribers are expected to follow this guidance where appropriate and are recommended to document reasons for prescribing outside the guidance, following discussion and agreement with the patient.

Prescribers should also follow the guidance set out by their professional regulator (see appendices for guidance).

Prescribers have a responsibility when prescribing to inform the patient about the medicines being prescribed and to discuss with the patient the risks and benefits of treatment so that the patient may make an informed decision about their treatment. This should include the aims of treatment and possible common side-effects. Prescribers should monitor and document in the patients’ notes any side-effects of treatment and take appropriate action if causing any concern e.g. reduce dose, change medicine.If there is a suspected adverse reaction to a medication a report should be made in accordance with the MHRA’s Yellow Card Scheme.

It is the prescriber’s responsibility to ensure all prescriptions are accurate and comply with these requirements

The ICCG mission statement states that Islington practices are “committed to working together as a Clinical Commissioning Group to ensure our communities receive the best evidence based care possible within the available resources.” Prescribers must consider the evidence base of any treatment and its effect on resources of any prescription they issue. 

Wherever possible self-care should be promoted and patients encouraged make use of over-the-counter products for minor ailments available from local pharmacies. The GMS contract requires a doctor to prescribe any medicines necessary where there is a clinical need and the treatment is available on the NHS. If the treatment is not available on the NHS a prescriber may issue a private prescription.

2.2 NICE guidance

All NICE guidance for medicines will be reviewed by the Islington Medicines Optimisation Group (IMOG) at the meeting following publication. IMOG will make recommendations for implementation of guidance when required to inform local commissioning arrangements.

The guidance represents the views of NICE and was arrived at after careful consideration of the evidence available. Healthcare professionals are expected to take it fully into account when exercising their clinical judgement. However, the

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guidance does not override the individual responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.

IMOG will adhere to NICE guidance unless there is clear justification for local deviation from the guidance.

Providers of Islington CCG-commissioned services should inform their commissioner and turn, IMOG, in writing if their service will deviate from NICE guidance clearly explaining their reasons.

2.3 Formulary

ICCG does not operate an independent formulary. ICCG expects all providers to adhere to national formulary guidance in line with the NHS Standard Contract and ICCG will publish local formularies on its website. ICCG expects that all medicines (including herbal medicines, homoeopathic preparations etc.) requested by secondary or tertiary care providers to be prescribed by Islington GPs on an NHS prescription should have been assessed by their local formulary committee or the Joint Formulary Committee.

Clinicians from providers should not ask GPs or other primary care prescribers to prescribe medications which have not been accepted for use on their local formulary. All these requests should be rejected by primary care prescribers and the relevant formulary committee made aware of the request. In exceptional circumstances providers may make a request for a non-formulary item to be prescribed in primary care but prior approval should be sought from the ICCG medicines management team.

2.4 Guidelines and pathways

All guidelines and pathways containing references to medicines which affect primary care within Islington must be reviewed and approved by IMOG.

Groups developing pathways or guidelines should seek to involve IMOG at the earliest possible point to ensure no delays in development.

All guidelines and pathways will be published on the Medicines Optimisation pages on Map of Medicine (password required, available from ICCG Map of Medicine team) and in other relevant communications from ICCG e.g. GP bulletins.

2.5 Off-Label/Unlicensed Prescribing

Off-label prescribing refers to prescribing of a UK licensed medicine outside the terms of its Marketing Authorisation.

Unlicensed prescribing refers to prescribing of a medicine that does not have a UK Marketing Authorisation.

Licensed medicines used within the terms of its Marketing Authorisation for licensed indications should be prescribed routinely wherever possible.

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However in certain situations it may be necessary to prescribe an unlicensed medication.

The GMC advice is summarised below:You can prescribe unlicensed medicines but, if you decide to do so, you must:

Be satisfied that an alternative, licensed medicine would not meet the patient's needs

Be satisfied that there is a sufficient evidence base and/or experience of using the medicine to demonstrate its safety and efficacy

Take responsibility for prescribing the unlicensed medicine and for overseeing the patient's care, including monitoring and any follow up treatment

Record the medicine prescribed and, where you are not following common practice, the reasons for choosing this medicine in the patient's notes.

Information for patients about the license of their medicines You must give patients (or their parents or carers) sufficient information

about the medicines you propose to prescribe to allow them to make an informed decision.

Some medicines are routinely used outside the terms of their licence, for example in treating children. In emergencies or where there is no realistic alternative treatment and such information is likely to cause distress, it may not be practical or necessary to draw attention to the licence. The GMC guidance gives further information and links to patient information leaflets designed for use with paediatric medicines. The BNF for Children also provides helpful prescribing advice.

Prescribers should refer to the Prescribers’ Guide – Introduction to Specials and Prescribing Dilemmas – A guide for Islington Prescribers for more detailed advice.

2.6 Prescription forms

Prescriptions should be generated electronically wherever possible. If it is necessary to handwrite a prescription (e.g. on a home visit) care should be taken to make sure the prescription is written legibly. Details of handwritten prescriptions should be added to the patient’s records by the prescriber within 24 hours.

All NHS prescriptions are controlled stationary and must be stored in a locked cupboard and their use accounted for. ICCG recommends that all practices have procedures in place for the management of NHS prescription forms within their practice and clear advice on what to do if forms are stolen or lost. Further detailed guidance is available here.

2.7 Non-Medical Prescribing

Evidence shows that non-medical prescribing can lead to improved patient care and satisfaction, increased access to medicines, reduction in waiting times and delivery of high quality care.

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All nurses who wish to prescribe must undertake a recognised Non-Medical Prescribing Course and must have recorded their prescriber qualification on the Nursing & Midwifery Council (NMC) register and adhere to the NMC Standards of proficiency for nurse and midwife prescribers http://www.nmc-uk.org/Documents/NMC-Publications/NMC-Standards-proficiency-nurse-and-midwife-prescribers.pdf . Before prescribing, individual non-medical Independent Prescribers (NMIPs) must also be registered with the NHS Business Services Authority. This process is managed locally by the Nursing and Organisational Development Manager and Head of Medicines Management.

Nurses employed by GP practices who either wish to undertake non-medical prescribing training or register as an Islington prescriber need to contact the Nursing & Organisational Development Manager at the CCG for advice. Further information for non-medical prescribers in Islington GP practices is provided in the Islington CCG Non-Medical Prescribing Guidelines.

Provider organisations will have their own guidelines in place. Individual practices that employ NMIPs, must ensure guidance is incorporated into their policies.

Community pharmacists wishing to undertake non-medical Independent Prescribing should contact the Head of Medicines Management.

2.8 Communications on transfer of care (Medicines Reconciliation)

Efficient communication between different care settings is paramount to the safe and effective use of medicines. When a patient is admitted to an in-patient setting it is essential that a medicines reconciliation process takes place in line with NICE/ NPSA guidance. It is important that clinicians provide any information requested in a timely manner.

Clinicians discharging patients from hospital settings shall communicate the patient‘s drug regimen to GPs/carers in a timely and reliable way. Discharge information shall be provided simultaneously to care homes and GPs. Providing a copy to the patient’s community pharmacist can also significantly reduce errors. Staff shall ensure that patients/carers understand their discharge medicines.

For some patients, referral to the community pharmacist for a Medicines Use Review or New Medicines Service support would be beneficial and may reduce drug related admissions.

Inpatients identified as requiring help with medication following discharge from Whittington Health will be seen by the re-ablement pharmacist, for a post-discharge domiciliary medicines use review. Information from the review will be communicated to the patient’s GP and if necessary, other relevant healthcare professionals.

Patients with a diagnosed global learning disability can be referred to the learning disabilities pharmacist.

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Contact Details: Islington Learning Disabilities Partnership52D Drayton ParkLondonN5 1NSTel: 0207 527 6600

The learning disabilities pharmacist can provide accessible information on medication, support patients on discharge and to manage their medication at home and work with carers to ensure that medicines are being administered according to medication policies and specific guidance.

3. Safe and secure handling of medicines

All staff, Islington CCG-commissioned services and GP practices involved in the preparation, handling, ordering, storage, supply or administration of medicines should do so in line with the CQC’s Essential Standards of Quality and Safety Outcome 9: Management of Medicines.

3.1 Administration of medicines

General guidance

It is the responsibility of the member of staff administering a medicine to ensure that the correct medicine is administered to the correct patient, in the correct form, by the correct route, at the correct dose at the time specified by the prescriber.

The practitioner administering must always check for allergies before administering a medicine.

Commissioned Service specific Standard Operating Procedures (SOPs) will describe the process for:

Checking current prescribed medicines and doses. Checking accuracy of prescription charts or transcribed Medication

Administration Record charts (describing which type is used within the specific care environment).

Incident reporting involving medicines, (see section 4.3) Administering medicines

Where there is any doubt as to the accuracy, completeness or appropriateness of an individual prescription, or to the quality of the medicine, it is the responsibility of the member of staff to confirm the details with the prescriber and/or a pharmacist as well as their line manager before administering the medicine. Any concerns and details must be recorded in the nursing record or case notes.

Documentation completed at the time of administration will be in accordance with the “service specific SOPs for medicines”. Signatures and initials must be legible. See also, NMC guidance.

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The practitioner should discuss the medicines with patients or carers at the time of administration, involving them in checking where appropriate. They should provide patients or carers with the opportunity to ask questions about their medicines.

3.2 Authorisation to Administer Medicines

The Medicines Act (1968) states that any person may legally administer a prescription-only medicine provided that this is done in accordance with the written directions of the prescriber (see additional information about injections below). The written direction may take the form of a prescription, or patient specific direction (PSD). This task is therefore not legally restricted to medical and nursing staff, although this has been the practice in most hospital services.

Individual services will need to decide through local policies which grades of staff may administer medication, and their training requirements. There may therefore be some variation as to which staff will undertake this duty.

All medical and dental practitioners and registered nurses can perform full administration of medicines. Other staff may only administer medicines after receiving appropriate training and assessment at local level in relation to the task to be performed.

Healthcare Assistants/support workers may administer medicines in accordance with the guidance in the SOP for administering medicines – Community and District Nursing Services, or other approved policies/procedures relevant to the specified service, which should include training, competencies, assessment, documentation and supervision. Registered staff must ensure the HCA/support worker has been trained according to national minimum standards and are competent to do so before delegating and that they follow guidance on delegation as laid out by their professional registration body. The law does not permit them to work to Patient Group Directions.

The administration of medicine by injection may only be carried out by;

a medical or dental practitioner,

a competent registered nurse,

Therapist/other grades of staff who have been authorised to administer specific named medicines e.g. specific vaccines

Health care assistants/support workers who have been trained to administer a specified medicine to a specified patient in line with service specific SOP for medicines. This is a delegated task, and the delegating Registered Nurse retains responsibility for the patient.

See National Patient Safety agency (NPSA) Alerts and Rapid Response Reports - summary of requirements for provider services” for safer practice requirements from the NPSA alert "safer practice with injectable medicines”.

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A second authorised person must be involved with administration of all blood and blood products, unless service specific SOPs direct otherwise, and demonstrate risk management processes.

Community Nursing Services should adhere to the “Protocol for the recording of medication changes to be acted upon by nursing staff working in the community”. This includes guidance on the use of verbal instructions in exceptional circumstances only.

3.3 Administration of Medicines via the Intravenous Route

Medicines shall only be administered intravenously in the following circumstances: if there is no alternative route of administration that is suitable for the patient where there is a clear clinical advantage to the patient over other routes, where the medication is only licensed for intravenous use and there is no

suitable alternative.

Prescriptions for intravenous medicines must comply with general policies and procedures on prescription writing and must include all relevant details. Compatible diluents and flushes will also be prescribed, and checked by the administering practitioner, as will rate of administration.

Prescriptions for intravenous medicines shall be reviewed regularly according to the regime.

Practitioners authorised to administer intravenous medicines: all medical and dental practitioners Qualified nurses who are recognised as professionally competent through

authorised training, and appropriate experience.

Nurses should follow their operational policy for the administration of intravenous medicines and any service specific SOPs or where appropriate, following agreement with their line manager, written guidelines from the hospital that prescribed the Intravenous medication. Wherever possible, two registrants should check medication to be administered intravenously, one of whom should also be the registrant who then administers the intravenous (IV) medication.

The UCL hospitals "Injectable Drug Administration Guide" current edition is a suitable additional reference book for practitioners. The on-line NHS Injectable Medicines Guide (registration required), is a further resource.

In community settings, the following must also be in place:

GP informed in advance, of IV administration details. Clear pathway of clinical responsibility for prescribing, and named contact

should any problems or adverse reactions occur. Sufficient trained nursing cover available, and frequency of IV administration

suits patient and community nurse schedules. Monitoring requirements documented and potential adverse reactions/ drug

interactions identified.

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Clear, timely arrangements for supply of drugs/appliances by referring hospital.

“Shared care guidelines” available, where GPs are requested to prescribe. Confirmation in advance with pharmacy, that drugs/diluents/infusion bags are

available on FP10 prescription, and whether required appliances are available via FP10 (check Drug Tariff) or via NHS supply chain for community nursing.

Guidelines/shared care guidelines for community prescribing of specific IV drugs to be approved by Medicines Committee, in liaison with Trust Commissioning.

Suitable arrangements for safe reconstitution (consider COSHH and infection control) and for clinical waste disposal.

3.4 Vaccine Administration

The nurse should:

Have undertaken training in vaccine administration, and have achieved the competencies required under any PGD arrangements or operational policies.

Attend CPR/anaphylaxis training annually, and be competent in the recognition and treatment of anaphylaxis.

Have an in-date anaphylaxis kit. Be conversant with and have signed the PGD for the relevant vaccines, or

follow the written patient specific direction of a doctor or other authorised independent prescriber.

Refer to the current copy of the Immunisation Against Infectious Diseases “Green Book”;

Have access to relevant Department of Health advice – e.g. Chief Medical Officer (CMO) letters

Have access to a working telephone Have patient consent Check that the vaccines conform to the cold chain

The above guidelines also apply to vaccine administration by other authorised practitioners, in accordance with “service specific SOP for medicines”. PGDs can only be signed and used by certain registered professionals, including nurses, pharmacists, podiatrists, physiotherapists.

See separate “service specific SOP for medicines” for childhood immunisations, and handling and storage of vaccines.

Health Care Assistants who have been trained to at least minimum national standards, to administer a specified vaccine to a specified patient in line with service specific SOP for vaccinations, may administer influenza and pneumococcal vaccines as part of seasonal immunisation programmes. This is a delegated task, and the delegating Registered Nurse retains responsibility for the patient. Minimal National Standards and Core Curriculum for Immunisation Training of Healthcare Support Workers must be adhered to.

3.5 Administration by Nurses in Training

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For learning purposes, a nurse in training may be involved with an authorised nurse, in the administration of medicines that have been prescribed for a named patient by an authorised registered independent or supplementary prescriber. However the responsibility for the administration of the medicines still attaches to the authorised nurse, who should clearly countersign any signature of the student. Students must never administer or supply medicinal products without direct supervision.

3.6 Supervision and Assessment of staff

Supervision for newly qualified staff should be carried out by the preceptor. When the individual and preceptor feel that the nurse is competent, they should be assessed by a qualified assessor and cover all aspects of administration of medicines.

Staff who are not newly qualified should be assessed by an appropriate preceptor, against locally agreed competencies, through clinical supervision.

The Royal Marsden NHS Trust Manual of Clinical Nursing procedures (latest edition) is a useful reference. See also Skills for Health website and NPSA website.

3.7 Responsibilities of Registered Nurses

In addition to the above criteria, the registered nurse should:

Be aware of their accountability Be aware of the responsibilities associated with delegation Have read the medicines policies and procedures Comply with The Code: Standards of conduct, performance and ethics for

nurses and midwives. NMC Have read the NMC documents:

o Standards for Medicines Managemento The Code: Guidelines for records and record keeping

3.8 Consent

Refer to the service specific policy on consent to treatment and the NMC advice sheet on the covert administration of medicines

3.9 Self-Administration of Medicines

Patients are encouraged to self-medicate, where appropriate and facilities are available, to increase their capability for independent living. See “service specific SOP for medicines” to safely facilitate this and self-medication policies.

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3.10 Patient Group Directions

Refer to CCG Patient Group Direction policy, NHS England policy and Memorandum of Understanding with CCGs, local Memorandum of Understanding with Camden and Islington Local Authorities and MPC guidance.

3.11 Patient Specific Directions

Refer to MPC guidance

3.12 Emergency drugs

Refer to CQC advice available here.

4. Medicines safety

4.1Medicines information

Lack of information about medicines can lead to medication errors. All staff should have access to this policy and to supporting medicines information available from the following websites:

GP Extranet Map of medicine CCG website Joint Formulary Committee

Healthcare professionals, patients and carers can access medicines information and advice from a variety of sources including:

Islington CCG Prescribing Advisers Community pharmacists A printed copy of the BNF is sent annually to every GP principal and non-

medical prescriber and is available online in a version that is updated monthly. Smartphone and tablet application versions that are updated monthly are available free of charge to Athens account holders. All prescribers and health care professionals are advised to refer only to online/application versions of the BNF as these are updated monthly.

Regional specialist medicines information centres are listed in the BNF Medicines information websites including:

o Summaries of product characteristics www.emc.medicines.org.uko National Institute for Clinical Excellence (NICE) www.nice.org.uk

NICE Medicines and Prescribing Centre www.nice.org.uk/mpc NICE Evidence Search www.evidence.nhs.uk NICE Clinical Knowledge Systems cks.nice.org.uk

o BNF https://www.evidence.nhs.uk/formulary/bnf/current o NPSA www.npsa.nhs.uk (now part of NHS England)

Islington CCG’s Medicines Management team offers “prescribing induction” sessions for GPs, GP Registrars and non-medical prescribers new to the area. An induction summary is available from the Map of Medicine page.

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A newsletter for GP practices and community pharmacies is produced bi-monthly and copies are available here.

4.2NHS England, Patient Safety function (formerly National Patient Safety Agency)

The NPSA produced patient safety alerts on specific medicine related problems (and also on non-medicine related alerts). Each alert contains information on risks, solutions (e.g. operating procedures, training, competencies), and audits required to check compliance. All alerts must be implemented within the required timescales. Important alerts with respect to improving medicines safety including anticoagulation, methotrexate, insulin and oral anti-cancer drugs are available here.

In January 2014, a new alert system, the National Patient Safety Alert System (NPSAS) was introduced with three stages of alert:

Stage One Alert: WarningThis stage ‘warns’ organisations of emerging risk. It can be issued very quickly once a new risk has been identified to allow rapid dissemination of information.

Stage Two Alert: ResourceThis alert may be issued some weeks or months after the stage one alert, and could consist of: sharing of relevant local information identified by providers following a stage one

alert; sharing of examples of local good practice that mitigates the risk identified in the

stage one alert; access to tools and resources that help providers implement solutions to the

stage one alert; and access to learning resources that are relevant to all healthcare workers and can

be used as evidence of continued professional development.

Stage Three Alert: DirectiveWhen this stage of alert is issued, organisations will be required to confirm they have implemented specific solutions or actions to mitigate the risk. A checklist will be issued of required actions to be signed-off in a set timeframe. These actions will be tailored to the patient safety issue.

All staff must ensure that they are up-to-date with recommended best practice set out by the alerts. Where actions can be applied corporately across all services, these actions may be included on CCG Medicines Optimisation guidance documents or incorporated within SLAs or Locally Commissioned Service specifications.

A directory of all alerts issued is available from the Controls Assurance Service (CAS).

4.3 Incident reporting

After taking any immediate steps within their ability to prevent patient harm, the person discovering the incident should make a report of the incident. This should be notified to the commissioner of the relevant service. Incident reporting processes

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are provided here (local, see Appendix 6 for reporting form) and here (national guidance).

The Clinical Director fulfils the role of Medicines Safety Officer and Medical Devices Officer for Islington CCG.

4.4 Alerts

www.mhra.gov.ukThe reporting and re-call of medicines which are known or suspected to be defective must be carefully and promptly controlled, documented and carried out to ensure that patients are not put at risk. This responsibility lies with the person responsible for cascading recall information (unless delegated to another staff within the team) which are as follows:

Read the alert. Assess for whom it is intended. If it is a specialist product, it may only need to be cascaded to a limited number of recipients.

What “class” is the alert? Class 1 are related to potentially serious or life threatening situations. The timescales on the Drug Recall indicates the priority with which actions should be taken. Additional consideration should be given to the mechanism of the cascade and the likely time for it to be received and acted on by the relevant healthcare professional.

Stock should be checked for the affected product using the information provided in the drug alert. The alert gives distribution dates as well as batch and expiry information. If, based on the information provided, it is unlikely that you have had any of the affected product you do not need to do anything else, e.g. if you have not had any deliveries since the date of the affected products, you are unlikely to have any stock.

If you may have had deliveries of the affected product, you should check your stock and quarantine any affected product. You should consider any outstanding orders and recent deliveries, as these may have been dispatched before the recall notice was issued.

If the alert specifies that relevant patients should be contacted (Patient Level Recall), ensure the specified investigations or actions are taken.

5 Controlled Drugs

Controlled Drugs (CDs) are subject to special legislative controls because there is a potential for them to be misused or diverted, causing possible harm. In response to the case of Dr Harold Shipman the government has introduced strengthened measures underpinned by The Health Act 2006, and Controlled Drugs (Supervision of Management and Use) Regulations 2006.

Prescribing, non-medical prescribing, dispensing, supply and administration, storage, safe custody, record-keeping and destruction issues must comply with the Misuse of Drugs Act 1971 and subsequent updates.

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Any service involving the use of CDs must include arrangements for their safe management within the service-specific Standard Operating Procedure (SOP).

5.1 Accountable Officer

All incidents and concerns relating to the use of CDs must be reported to the Accountable Officer. This can be done by completing an incident report (see section 4.3) and sending this to the Accountable Officer at england.londonaccountableoffice@nhs.net and copied to the incident reporting e-mail (ncl.incidents@nhs.net ).

The CCG has a statutory duty to support the Accountable Officer.

Details of NHS England CD processes and Memorandum of Understanding with CCGs can be found here.

5.2 Prescribing of controlled drugs Schedule 2 and 3

A quick reference guide for prescribing and writing prescriptions for CDs is laid out in the front of the BNF; section "Guidance for Prescribing; Controlled Drugs and drug dependence ".

All medical staff (except medical students, unregistered locums or doctors with restrictions placed on their prescribing by the GMC) may prescribe controlled drugs schedule 2 and 3. They may not prescribe diamorphine, dipipanone, or cocaine in the treatment of addicts unless they have a licence to do so. Independent nurse prescribers may prescribe CDs only in accordance with DH guidelines. The list of CDs and the indications, for which such nurses may prescribe them, is available in the BNF (appendix Nurse Prescribers Formulary) and in the Drug Tariff. Supplementary prescribers may prescribe CDs in accordance with a clinical management plan agreed with the doctor and patient.

5.3 Prescription forms in use.

Please refer to the legacy NPC guide to Controlled Drugs for the latest list of prescription forms and details of which practitioners may prescribe which CDs. Updated NICE Medicines and Prescribing guidance is expected in 2016.

Private prescriptions for CDs require the use of FP10(PCD)s. Please contact the Accountable Officer if you require a private prescription pad.

5.4 Monitoring of patterns of CD prescribing.

Prescribing advisers will monitor prescribing of CDs from e-PACT data by NHS GPs, and non-medical prescribers using FP10 prescriptions.

NHS England will monitor private controlled drugs prescribing.

5.5 CD Declarations

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Periodic declarations are required from all services using CDs to record that CDs are being safely managed. Declarations must be completed, signed and returned within the required timescales. NHS England Area Team will co-ordinate this function.

5.6 Prescribing of controlled drugs via a syringe driver

Additional care must be taken when prescribing CDs via a syringe driver. Please refer to palliative care guidance and NPSA guidance.

5.7 Prescribing high doses of CDs

Where prescribers are prescribing high doses of CDs for palliative care, it is recommended that the specialist palliative care teams are contacted for advice and support, wherever feasible. Any actions resulting from such contact should be recorded in the patient's notes.

If the prescriber is prescribing high doses of CDs for a patient, and where prolonged use is expected, this should be reported to the Trust (prescribing adviser) to aid the interpretation of e-PACT data.

5.8 Reducing dosing errors with opioid medicines.

See “National Patient Safety agency (NPSA) Alerts and Rapid Response Reports - summary of requirements for provider services”

5.9 Advice regarding the safe administration of naloxone

Naloxone must be given with great caution to patients who have received longer-term opioid/opiate treatment for pain control or who are physically dependent on opioids/opiates. Use of naloxone in patients where it is not indicated, or in larger than recommended doses, can cause a rapid reversal of the physiological effects for pain control, leading to intense pain and distress, and an increase in sympathetic nervous stimulation and cytokine release precipitating an acute withdrawal syndrome.

See NPSAS alert.

5.10 Reducing dosing errors with midazolam

See “National Patient Safety Agency (NPSA) Alerts and Rapid Response Reports - summary of requirements for provider services”

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