Essex County Council and Essex CCGs Medicines Standards for Providers

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Relevance: The standards are mainly developed for nursing and residential care providers but have relevance to other providers as noted below:

Care and Nursing home providers

(separate standards are available for domiciliary care and personal care providers)

Whole document

ECC Public Health Services:

Substance Misuse Smoking Cessation Sexual Health

2.1.2 4.1 5.1 6.1

2.1.3 4.2.1 6.2

2.1.4 4.2.2 6.3

2.1.7 4.3 6.4

2.2 4.4 6.5

2.3 4.5.1 6.6

2.4 4.5.2

4.6.1

4.6.2

4.6.3

4.6.4

4.6.10

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REVIEW DATE APRIL 2017

DEVELOPMENT GROUP AND

CONTACT NAME

ORGANISATION REPRESENTED

ANURITA ROHILLA

CHIEF PHARMACIST

WEST ESSEX CCG

PAULA WILKINSON

CHIEF PHARMACIST

MID ESSEX CCG

SHEILA BALDWIN

CHIEF PHARMACIST

NORTH EAST ESSEX CCG

SIMON WILLIAMS

CHIEF PHARMACIST

CASTLE POINT AND ROCHFORD CCG

MARY TOMPKINS

CHIEF PHARMACIST

BASILDON AND BRENTWOOD CCG

DIPTI PATEL

PHARMACY LEAD

ESSEX COUNTY COUNCIL

Essex County Council and Essex CCGs Medicines Standards for Providers

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Contents

Page

1. Introduction 4

2. Handling Medicines 2.1 Handling medicines – additional points 2.2 The Mental Capacity Act 2.3 The Equality Act 2.4 Controlled Drugs

6 6 8 8 8

3. Medicines Policy 9

4. Prescribing 4.1 Prescription forms 4.2 Supply arrangements 4.3 Medication review 4.4 Duration of treatment 4.5 Prescribers 4.6 Formulary

16 17 18 19 20 20 21

5. Advice to Patients 5.1 Promotion of self care

23 23

6. Governance 6.1 Standard Operating Procedures 6.2 Working with industry 6.3 Near miss errors and medication incidents 6.4 Adverse reactions 6.5 Medicines Safety alerts 6.6 Audit

23 24 24 24 24 24 24

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1 Introduction The Commissioner requires that organisations establish, document and maintain an effective system to ensure that medicines are handled in a safe and secure manner. This standards document forms part of the contract for any organisation or contractor commissioned to provide services which include pharmaceutical or medicines management activities such as purchasing, storing, transporting, prescribing, dispensing, administering and disposal of medication. Adherence to the standards is monitored via the Quality and Clinical Governance processes and Contract monitoring processes. Organisations will need to develop local policies and procedures to ensure that medicines are handled safely, securely and in accordance with the legislation, professional standards and best practice guidance that applies to their activities. Links to the relevant documentation are given for convenience and are not exhaustive but providers are responsible for ensuring that they refer to the current version. Providers are expected to have a formal arrangement in place for access to pharmaceutical advice to ensure there are robust governance processes in place for medication management and to support them in achieving these standards – this may be from an employed pharmacist or through an agreement with an organisation or individual. To ensure independent appraisal and monitoring of the pharmacy supply service, advice should be separately obtained and not come from the supplier of medication. Individuals procuring their own medication can obtain advice from their Community Pharmacist. Prescribing advice may only be given by a pharmacy professional or prescriber and will be in line with the Commissioners policies and guidelines. Advice provided by other healthcare professionals e.g. pharmacists, nurse practitioners, nurses, dieticians, physiotherapists and others must be within agreed the Commissioners guidelines and any recommendations to patients or other clinicians that may affect prescribing should be within these parameters. For many Customers taking medication and being assisted with related tasks is an everyday but essential aspect of their life. Regardless of how the support is arranged, or who is providing it, the Customer can reasonably expect that the people who support them understand good practice, follow guidance and have demonstrated an ability to meet required standards to ensure their support is compliant, safe, appropriate and that they will have their medication and related tasks at the times they need them. This includes support commissioned by Essex County Council or a Customer (The Commissioners) and provided by an Agency Care Worker or a Personal Assistant. Each Customer must be enabled to take their own medication as fully as their understanding and physical abilities allow, therefore the Customer has the right to administer their own medication without assistance from a Care Worker/Personal Assistant. The assessment should include the Customer’s ability to manage medication and related tasks, and this should be clarified and detailed in the Support Plan and/or Support Plan Summary and form part of the ongoing risk assessment. Employers have a responsibility to ensure Care Workers/Personal Assistants have an appropriate level of knowledge and ability to undertake the work safely and competently. Training can be sourced from accredited providers on the Royal Pharmaceutical Society (RPS) or CQC website.

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Care Workers will only be able to prompt, assist or administer medication and carry out related tasks once they have completed training and are assessed as competent. A record must be kept of training and competence. The Commissioner must complete a Commissioning Document to inform the Provider of all essential aspects of the medication support required, including the level of support and details of the medication management. A detailed plan will be developed for each Customer which will specify the approach for supporting the individual. This will include support around medication and related tasks. The roles and responsibilities of key people involved in the Customer’s medication support should be documented in the Support Plan/Support Plan Summary and the Information to Service Provider. Prior to completing any Core or Specialist Competencies, all Care Workers/Personal Assistants must be assessed as competent and this should be evidenced in their training/personal development record.

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2 Handling medicines The Commissioner expects providers to meet the standards of the relevant legislation and local and national guidance for the processes of ordering, storing, transport, supply, administration and disposal of medicines, including but not limited to those in the table below.

Standards

Human Medicines Regulations 2012

Controlled Drugs (Supervision of Management and Use) Regulations 2013

Misuse of Drugs Act 1971

Misuse of Drugs Regulations 2001

Misuse of Drugs (Safe Custody) Regulations 1973

The Health Act 2006

Health and Social Care Act 2008

The Equality Act 2010

European Community Directive 2001/83/EC

Environment Agency T28 – Sorting and Denaturing Controlled Drugs for Disposal

Royal Pharmaceutical Society Medicines, Ethics and Practice

Nursing & Midwifery Council Standards for Medicines Management

Good Practice in Prescribing and Managing Medicines and Devices GMC 2013

DH Protocol for ordering, storing and handling vaccines

Control of Substances Hazardous to Health (COSHH) Guidance

Current good practice guidance issued by organisations including RPS, GPhC, MHRA, DoH, NICE, Home Office, NHS Patient Safety etc.

The Safe and Secure Handling of Medicines: a team approach (Royal Pharmaceutical Society)

A Guide to Good Practice in the Management of Controlled Drugs in Primary Care (National Prescribing Centre)

CQC Standards for Medicines Management Outcome 9

A Guide to Good Practice in the Management of Controlled drugs in Primary Care (National Prescribing Centre)

NICE Clinical Guideline (SC1) Managing Medicines in Care Homes

2.1 Handling medicines – additional points

2.1.1 Purchasing ‘special order’ products Contractors will consider the cost to the NHS when purchasing ‘special order’ products which are not listed in the Drug Tariff and:

Advise the prescriber of the cost and discuss alternatives

Ensure that the quantity prescribed and ordered minimises waste

Purchase from a supplier offering best value to the NHS. It may be quicker and cheaper to order directly from the manufacturer rather than via a wholesaler / distributor. Information is available from the Medicines Management team.

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2.1.2 Dispensing Medication will be supplied on a named patient basis whenever possible (except where

‘bulk-prescribing arrangements are in place), and patients who wish to self-administer their medication will be supported to do so when it can be done safely. Patient specific prescriptions will not be used to top up stock.

It is up to the patient or their representative to choose where their prescriptions are dispensed. Health professionals may provide signposting information on services and opening times but will not direct prescriptions to a particular supplier.

Original pack dispensing should be routine and is preferred. Each patient should be assessed for self administration. The need for monitored dosage systems (MDS) should be reviewed on an individual basis taking into consideration the stability and suitability of individual medicines and not be used routinely for the benefit of the organisation.

2.1.3 Prescription charges Providers who supply medication which attracts a prescription charge will meet the requirements for collecting the appropriate charges or confirming exemption. This applies to medication supplied via Patient Group Direction (PGD) as well as on FP10.

2.1.4 Emergency Medicines In settings where it is recommended that medication is held in case of medical emergency, there will be procedures in place to ensure safe and secure storage, and regular recorded checks on expiry dates. Staff will be trained in the use of the medication and be aware of the location. There will be protocols on the use of the medication.

2.1.5 Transfer of medicines Green self-sealing plastic bags will be made available for patients, whether in care homes or

in their own homes ,to use to hold their medication when going into hospital or moving between care settings

Providers will use the bags or equivalent packaging when they need to send medication anywhere with patients to identify patients own drugs, support medicines reconciliation and minimise loss.

2.1.6 Patient’s own drugs in compliance aids Compliance aids which have been filled by a community pharmacist or dispensing doctor

and o allow identification of individual products o are fully labelled o are assessed as suitable by a suitably trained member of staff. o do not contain schedule 2 or 3 controlled drugs

should be treated as all other patient’s own medication in line with local policy.

Compliance aids which have been filled by the patient or a family member will not be fully labelled to allow identification of the medicines. They may be used for self-administration after risk assessment, but medicines from them cannot be administered by a nurse or carer.

Self-administration by patients should be encouraged where appropriate to ensure that these skills are not lost during their stay.

If a patient is admitted using a compliance aid they should be discharged with the same, unless a pharmaceutical assessment has been made and an alternative is in the interest of and agreed with the patient / carer.

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2.1.7 Illegal substances Providers will have in place a procedure for dealing with potential illegal substances and prescription drugs liable to abuse brought in to their premises by service users or other visitors.

2.2 The Mental Capacity Act

Assessment of the Customer’s capacity to give their consent is vital. If the Customer’s capacity is being challenged, an assessment must take place under the Mental Capacity Act. People with capacity must give consent each time medication is given. The Support Plan Summary should clearly state action to be taken if circumstances change, and any specific preferences that have been identified relating to equality and diversity.

A Customer may have certain preferences relating to equality and diversity. These should be recognised at the assessment stage, arrangements made to accommodate them and relevant details recorded in the Support Plan and/or Support Plan Summary and Information to Service Provider form

2.3 The Equality Act Providers are expected to meet the requirements of The Equality Act 2010 by assessing

patients and making appropriate adjustments to their services. Where this involves the provision of medicines compliance aids by community pharmacy contractors and dispensing doctors:

Patient assessment and the selection of appropriate compliance aids (which include monitored dosage systems, reminder charts, easy open containers and large print labels) is a decision for the contractor who dispenses that patient’s prescriptions.

The duration of the prescription is a decision for the prescriber and where a prescriber considers that there is a clinical risk in a patient having more than a certain amount of medication in the house at any one time, they will issue prescriptions of the appropriate duration

The requirement is to support the patient in managing their own medication. There is no obligation to provide compliance aids where the patient is not self-medicating, although a private service may be offered (to individuals, care homes or care agencies). Patients with a learning disability, who are training to self-medicate but who currently have a carer, may be an exception to this.

Stability of the products within the compliance aid will be a factor in the decision

2.4 Controlled Drugs The Provider shall ensure it has robust arrangements for the safe and secure use and handling of controlled drugs in line with legislation, national regulations and guidance. Additionally the provider will allow the Commissioner and the NHS England Area Team Controlled Drugs Accountable Officer (CDAO) to access premises to conduct audits, inspections and investigations. General

Care homes should have a Controlled Drugs (CD) lead who will be expected to act in the same way as a CDAO.

It is the legal responsibility of the provider to acquire and evidence to the commissioner and Area Team CDAO that the necessary Home Office CD Licences are in place where stocks of Controlled Drugs are held.

CDAOs and CD leads will, within the framework of the NHS England CD Local Intelligence Network, share information regarding the management of CDs

Organisations will have procedures in place to ensure that complaints, incidents and concerns relating to Controlled Drugs are brought to the attention of the appropriate CDAO

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and the commissioner. For designated bodies this will be their own CDAO, for others this will be the specified NHS England Area Team CDAO.

Serious concerns about any element of the management and use of controlled drugs should be reported to the Area team CDAO, the police, the Local Intelligence Network, the local Clinical Performance or equivalent group, the commissioner and / or the relevant regulatory body.

Destruction of out of date and unwanted stock CDs will be witnessed by one of the groups listed in the regulations.

Providers who administer CDs will have a procedure in place to cover the arrangements for the disposal of any unused portion of an injection. Where possible there should be a witness to this procedure.

Care home staff will not order stock CDs (i.e. not dispensed for an individual resident) unless they have a Home Office license

Care homes will have Standard Operating Procedures in place to cover the handling of CDs

Providers will have procedures in place to monitor inappropriate, unusual or excessive prescribing and report this to the commissioner and Area Team CDAO.

The Area Team CDAO and commissioner will monitor inappropriate, unusual or excessive CD prescribing by prescribers (including non-practice prescribers, non-medical prescribers and private prescribers). Providers will respond promptly to requests for information or clarification and requests for self-assessments.

Providers will allow access on request from the Area team CDAO to check physical arrangements for storage, record keeping and management of CDs.

3 Medicines Policy The Provider will have a medicines policy which complies with the following NICE Guideline recommendations:

Include a process for managing personal and sensitive information covering the 5 rules set out in ‘A guide to confidentiality in health and social care’. See recommendation 1.3.1

Set out the training needed by care home staff who are managing information, and how their skills will be assessed. See recommendation 1.3.1.

Give details of the information about medicines that should be transferred when a resident moves from one care setting to another. Includes details of who is responsible for this during ‘out-of-hours’ periods. See recommendation 1.7.3.

Give details of the information about medicines that should be checked and the process to be followed when a resident moves into a care home. Includes details of who is responsible for this during ‘out-of-hours’ periods. See recommendation 1.3.3.

Give details of how changes to a resident’s medicines should be communicated between care home staff at shift changes. See recommendation 1.3.7.

Give details of the information about a resident’s medicines that should be available when a resident attends appointments outside the care home. See recommendation 1.3.4.

Give details of agreed processes for the secure sharing of data.

Give details of how processes for sharing and transferring information about a resident’s medicines will be monitored and audited.

Include a process for ensuring that everyone involved in a resident's care knows when medicines have been started, stopped or changed. See recommendation 1.9.3. Ensuring that records are accurate and up-to-date

Include a process for ensuring that records about medicines are accurate and up-to-date. The process covers the recording of information See recommendation 1.4.1.:

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o in the resident’s care plan o in the resident’s medicines administration record o from correspondence and messages about medicines o in transfer of care letters and summaries about medicines when the resident is away

from the home for a short time. o Gives details of what to do with copies of prescriptions and any records of medicines

ordered for residents.

Give details of: o how to store records about medicines securely o how long to store the records o how to destroy records securely.

See recommendation 1.4.2.

Give details of how processes for record-keeping will be monitored and audited.

Identifying, reporting and reviewing medicines-related problems

Include a process for reporting all suspected adverse effects from medicines. The process includes:

o how to report o who to report to during normal working hours (for example, the GP) o who to report to out-of-hours (for example, the out-of-hours service) o what to record in the resident’s care plan o who to feedback to (for example, the resident and/or their family or carers, and the

supplying pharmacy).

Include a process for recording all medicines-related safety incidents, including all ‘near misses’ and incidents that do not cause any harm. The process requires that any notifiable safeguarding concerns are reported to the Care Quality Commission (CQC) and the Commissioner. See recommendation 1.6.5.

Include a process for managing medicines-related errors or incidents, which gives details of: o how to identify them (include actual errors or incidents and ‘near misses’) o how to report them o who to report to (the process follows any local reporting processes). o what to record o how the incident will be investigated (including how to find the root cause) o who will investigate o the time scale for investigation o how the results of the investigation and any lessons learnt will be shared, both with

the staff of the care home and more widely (local shared learning) o how the incident will be reported to the resident and/or their family or carers. See recommendation 1.5.1, recommendation 1.6.5 and recommendation 1.6.8.

Include a process for managing medicines-related safeguarding incidents, which gives details of:

o how to identify them (include actual incidents and concerns) o how to report them o who to notify (for example, the CQC or other appropriate regulator) o what to record (as soon as possible) o how to investigate incidents (including how to find the root cause) o who will investigate o the time scale for investigation o how to share the results of the investigation and any lessons learnt with the staff

of the care home and more widely (local shared learning) o how to report incidents to residents and/or their families or carers.

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The process follows local safeguarding processes. See recommendation 1.6.2 and recommendation 1.6.8.

Include a process for providing information to residents and/or their families or carers about:

o how to report a medicines-related safety incident o how to report a medicines-related safeguarding incident or concern o how to discuss their concerns about medicines o how to use the care home provider's complaints process, local authority (or local

safeguarding) processes and/or a regulator's complaints process o how to use advocacy and independent complaints services.

See recommendation 1.6.10 and recommendation 1.6.11.

Include a process for identifying any training needed by care home staff who are responsible for managing and administering medicines. The process notes that if there is a medicines-related safety incident, review may need to be more frequent to identify support; learning and development needs. See recommendation 1.17.4.

Include a process for accurately listing a resident’s medicines (medicines reconciliation), which covers: o who is responsible for coordinating medicines reconciliation (the person who is

responsible for the resident’s transfer into the care home) o who to involve (including the resident and/or their family or carers, a pharmacist, other

health and social care staff) o the information that should be available for medicines reconciliation on the day that a

resident transfers into or from a care home: o resident's details, including full name, date of birth, NHS number, address and weight

(for those under 16 or where appropriate, for example, frail older residents) GP's details

o details of other contacts defined by the resident and/or their family or carers (for example, consultant, regular pharmacist, specialist nurse)

o known allergies and reactions to medicines or ingredients, and the type of reaction experienced

o medicines the resident is currently taking, including name, strength, form, dose, timing and frequency, how the medicine is taken (route of administration) and what for (indication), if known

o changes to medicines, including medicines started, stopped or dosage changed, and reason for change

o date and time of the last dose of any 'when required' medicine or any medicine given less often than once a day (weekly or monthly)

o other information, including when the medicine should be reviewed or monitored, and any support the resident needs (adherence support)

o what information has been given to the resident and/or family or carers. o the training and skills needed for medicines reconciliation (for example, effective

communication skills, technical knowledge of relevant medicines management systems and evidence-based therapeutics).

See recommendation 1.7.1, recommendation 1.7.2, recommendation 1.7.3.

Include a process for medication review, which covers: o a GP documenting in each resident’s care record which named health professional is

responsible for that resident’s planned multidisciplinary medication review o who may be involved in the review and how to ensure that they have appropriate

involvement; this may include: the resident and/or their family or carers, and

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a pharmacist, community matron or specialist nurse, GP, member of care home staff, practice nurse, social care practitioner

documenting in each resident’s care record the agreed frequency of planned multidisciplinary medication review based on:

the resident’s safety (the most important factor when deciding how often to do the review)

the health and care needs of the resident an interval between reviews of no more than 1 year

o how care home staff should identify residents who may need more frequent review of their medicines and highlighting this to the GP; for example, residents: entering the end-of-life phase with a recent diagnosis of a long-term condition needing frequent or complex monitoring who have been transferred to the care home (for example, after hospital discharge).

See recommendation 1.8.2, recommendation 1.8.3 and recommendation 1.8.4

Include a process for ordering medicines, which ensures that medicines prescribed for a resident are not used by other residents. See recommendation 1.10.1. The process covers:

o protecting time for ordering and checking medicines delivered to the home the home having at least 2 members of staff who are competent to order medicines, although at any one time ordering can be carried out by 1 member of staff

o how to order repeat, acute and ‘when required’ medicines from the GP practice (and during out-of-hours)

o which records to make when ordering medicines (for example, a copy of the prescription, stock order or requisition note)

o how to inform the supplying pharmacy (with the resident’s consent) of any changes to medicines (including when medicines are stopped).

See recommendation 1.10.2, recommendation 1.10.3, recommendation 1.10.4 and recommendation 1.10.5.

Include a process for determining the best system for supplying medicines (original packs or monitored dosage systems) for each resident based on the resident’s health and care needs and the aim of maintaining the resident’s independence wherever possible. The process indicates that care home staff should seek the support of health and social care staff if needed. See recommendation 1.11.2.

Include a process for anticipatory medicines (for example, those used in end-of-life care) when these are used by a care home. See recommendation 1.9.5.

Include a process for the safe storage of medicines, which gives details of: o how to store controlled drugs o how and where to store medicines, including medicines supplied in monitored dosage

systems, medicines to be taken and looked after by residents themselves, medicines to be stored in the refrigerator, skin creams, oral nutritional supplements and appliances

o how to ensure secure storage with only authorised care home staff having access o the temperatures for storing medicines o how the storage conditions should be monitored o how to assess each resident's needs for storing their medicines (taking into account the

resident's choices, risk assessment and type of medicines system they are using) o who care home staff should contact should a storage problem occur o how to dispose of medicines, including: controlled drugs, and medicines classed as clinical

waste

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o how to store medicines awaiting disposal, including the use of tamper-proof sealed containers locked in storage cupboards until collection for disposal

o keeping records of medicines (including controlled drugs) that have been disposed of, or are awaiting disposal.

See recommendation 1.12.1, recommendation 1.12.3, recommendation 1.12.4, recommendation 1.12.5, recommendation 1.12.6, recommendation 1.13.2 and recommendation 1.13.6.

Include a process for self-administration of medicines, which gives details of: o when and how to carry out an individual risk assessment to find out how much support a

resident needs to carry on taking and looking after their medicines themselves o who may be involved in the risk assessment in addition to the resident and/or their

family or carers o how medicines for self-administration will be stored (for example, in a lockable

cupboard or drawer in a resident's room), including controlled drugs. In adult care homes, the process includes: o recording any medicines supplied to the resident for self-administration o recording when a resident has been reminded to take their medicine themselves. In children’s homes, the process includes: o making and keeping records for children who self-administer their medicines.

See recommendation 1.13.2, recommendation 1.13.3, recommendation 1.13.4, recommendation 1.13.5, recommendation 1.13.6, and recommendation 1.13.7.

Include a process for medicines administration by care home staff, which follows a person-centred approach and specifies that only trained and competent staff should administer medicines.

The process details: • the 6 R's of administration:

o right resident o right medicine o right route o right dose o right time o resident's right to refuse

• that records should: o be legible o be signed by the care home staff o be clear and accurate o be factual o have the correct date and time o be completed as soon as possible after administration o avoid jargon and abbreviations o be easily understood by the resident, their family and carers.

• the information a medicines administration record should include: o the full name, date of birth and weight (for those under 16 or where appropriate, for

example, frail older residents) of the resident o details of any medicines the resident is taking, including the name of the medicine and its

strength, form, dose, how often it is given and where it is given (route of administration) o known allergies and reactions to medicines or their ingredients, and the type of reaction

experienced (this will require liaison between the care home and the resident’s GP) o when the medicine should be reviewed or monitored (as appropriate) o any support the resident may need to carry on taking the medicine (adherence support)

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o any special instructions about how the medicine should be taken (such as before, with or after food, or whether the medicine could be crushed)

• who will produce the medicines administration records • how to record medicines administration (including medicines administered by visiting health

professionals) • how to cross-reference administration records (for example, 'see warfarin administration

record') when a medicine has a separate administration record • what to do if the resident is having a meal • what to do if the resident is asleep • how to administer specific medicines such as patches, creams, inhalers, eye drops and

liquids • using the correct equipment depending on the formulation (for example, using oral syringes

for small doses of liquid medicines) • how to record and report administration errors and reactions to medicines • how to record and report a resident's refusal to take a medicine(s) • how to manage medicines that are prescribed 'when required' • how to manage medicines when the resident is away from the care home for a short time

(for example, visiting relatives) • monitoring and evaluating the effects of medicines, including reactions to medicines • agreeing with the resident, prescriber and pharmacist the timing for administration of

medicines • how to reduce interruptions during medicines administration rounds • the training and skills needed by care home staff to use system(s) adopted in the care home

for administering medicines • how to ensure information on the medicines administration record is accurate and up-to-

date • how to access appropriate medicines information and resources. See recommendation 1.11.3, recommendation 1.14.1, recommendation 1.14.4, recommendation 1.14.5, recommendation 1.14.10, recommendation 1.14.13, recommendation 1.14.14, recommendation 1.14.15 and recommendation 1.14.19. For ‘when required’ medicines, the process includes: • the reasons for giving the 'when required' medicine • how much to give if a variable dose has been prescribed • what the medicine is expected to do • the minimum time between doses if the first dose has not worked • offering the medicine when needed and not just during 'medication rounds' • when to check with the prescriber any confusion about which medicines or doses are to be

given • recording 'when required' medicines in the resident's care plan. The process specifies that medicines prescribed as ‘when required’ are kept in their original packs and not monitored dosage systems. See recommendation 1.14.3. For controlled drugs, the process includes: • how to make appropriate records of controlled drugs that have been administered to

residents • the requirement for signing the controlled drugs register and the medicines administration

record. See recommendation 1.14.16. The process includes the following information about producing new, hand-written medicines administration records: • the training, skills and designated responsibility required by the care home staff

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• checking accuracy and signing by a second trained and skilled member of staff before first use. See recommendation 1.14.9.

Include a process for when a resident is temporarily absent from the care home that details giving the following information to the resident and/or their family or carers:

o the medicines taken with the resident o clear directions and advice on how, when and how much of the medicines the resident

should take o time of the last and next dose of each medicine o a contact for queries about the resident's medicines, such as the care home, supplying

pharmacy or GP. See recommendation 1.14.17 and recommendation 1.14.18.

Include a process for care home staff (registered nurses and social care practitioners working in care homes) updating records of medicines administration with accurate information about any changes to medicines. See recommendation 1.9.4.

Include a process for recording prescribing instructions given remotely, which gives details of: o how care home staff should record instructions given by telephone, video link, online or, in

exceptional circumstances only, text message o how care home staff should make sure that the health professional using remote prescribing

changes the prescription o the training and skills required by care home staff to assist with the assessment and

discussion of a resident’s clinical needs o how the medicines administration record should be updated o recording the information in the resident’s care plan (usually within 24 hours) o how staff should make sure that the resident’s confidentiality is maintained.

For care homes with nursing, the process incorporates the Nursing and Midwifery Council Standards for medicines management (2010) for remote prescribing. See recommendation 1.9.7and recommendation 1.9.8.

Include details of the training and skills required by care home staff, as follows: o induction training relevant to the type of home care home staff are working in (adult care

homes or children's homes) o training and competency assessment for staff designated to administer medicines, including

the learning and development requirements for this role o internal or external learning and development programmes for the skills needed to manage

and administer medicines o annual review of the knowledge, skills and competencies relating to managing and

administering medicines o a requirement that staff who do not have the skills to administer medicines, despite

completing the required training, are not allowed to administer medicines to residents o a requirement for all health professionals employed by the care home to be professionally

qualified and registered with the appropriate professional body, and continue to meet the professional registration requirements, if applicable (for example the post-registration education and practice (Prep) standards set by the Nursing and Midwifery Council).

See recommendation 1.17.1, recommendation 1.17.2 and recommendation 1.17.3. Include a process for the covert administration of medicines.

For adult care homes, the process includes: • when to consider covert administration of medicines • how to undertake an assessment of the resident’s mental capacity • how and when to hold a best interest meeting • recording the reasons for presuming mental incapacity and the proposed management plan • a plan of how medicines will be administered without the resident knowing • how to regularly review whether covert administration is still needed.

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See recommendation 1.15.1, recommendation 1.15.3 and recommendation 1.15.4. The process specifies that covert administration should only take place in the context of existing legal and good practice frameworks to protect both the resident who is receiving the medicine(s) and the care home staff involved in administering the medicines. See recommendation 1.15.2.

Include a process for managing and administering non-prescription medicines and other over-the-counter-products (homely remedies) for treating minor ailments when providers (care homes) offer these to residents.

The process includes: • naming care home staff who give homely remedies to residents • ensuring that named staff sign the process to confirm they have the skills to administer the homely remedy and acknowledge that they will be accountable for their actions • how and when care home staff should take advice on the use of homely remedies from a health professional, such as a GP or pharmacist • regular stock checking of homely remedies to ensure that they are within their expiry date • keeping homely medicines in their original packaging together with any information supplied with the medicine about its use. See recommendation 1.16.1 and recommendation 1.16.2

4 Prescribing The Commissioner expects providers to meet the standards of the relevant legislation and local and national guidance for prescribing including but not limited to those in the table below.

Standards

Human Medicines Regulations 2012

Controlled Drugs (Supervision of Management and Use) Regulations 2013

Misuse of Drugs Act 1971

Misuse of Drugs Regulations 2001

Misuse of Drugs (Safe Custody) Regulations 1973

The Health Act 2006

Health and Social Care Act 2008

The Equality Act 2010

European Community Directive 2001/83/EC

Royal Pharmaceutical Society Medicines, Ethics and Practice 36

Nursing & Midwifery Council Standards for Medicines Management

Good Practice in Prescribing and Managing Medicines and Devices GMC 2013

Guide to Medication Review (National Prescribing Centre, 2008)

Current good practice guidance issued by organisations including RPS, GPhC, MHRA, DoH, NICE, Home Office, NHS Patient Safety etc

CCG prescribing policies, guidelines, formularies

BNF guidance and individual product SPCs

A Guide to Good Practice in the Management of Controlled Drugs in Primary Care (National Prescribing Centre)

CQC Standards for Medicines Management Outcome 9

NICE PSG001 Technical patient safety solutions for medicines reconciliation on admission of adults to hospital 2007

Drug Misuse and Dependence: UK Guidelines on Clinical Management (DH September 2007)

Handling Medicines in Social Care (Royal Pharmaceutical Society)

CQC Standards for Medicines Management Outcome 9

National Prescribing Centre. (2004). Good Practice Guide to Quality Repeat Prescribing

National Prescribing Centre. (2008). Medicines Reconciliation; A Guide to Implementation

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Standards

A Guide to Good Practice in the Management of Controlled Drugs in Primary Care (National Prescribing Centre)

The arrangements for prescribing to patients of each service will be defined within the contractual framework for that service. Generally where a consultant / specialist initiates a new medication, s/he will generally provide the first prescription in accordance with local agreements. Transfer of care, shared care and sharing information with colleagues should follow the the GMC Guidance: Good practice in prescribing and managing medicines and devices, February 2013, paragraphs 30 to 43. Failure to do so will result in an incident form being completed and the Commissioner requesting a full investigation. The Provider will have a Commissioner agreed process including timescales for response and resolution for dealing with prescribing queries. It is imperative, that patient care does not suffer and is not interrupted or delayed due to insufficient / inaccurate information being communicated and the patient and the GP are communicated to. The query will be acknowledged within 24 hours of sending and an estimated time provided for resolution depending on the complexity of the query. The resolution time will not exceed 28 days and the Patient and GP will be advised by the provider of what action to take to keep the patient clinically and medically safe.

4.1 Prescription forms Providers who use individual prescription forms will have Standard Operating Procedures in

place which ensure that prescription stationery is handled to the standards specified in “Security of Prescription Forms Guidance” (NHS Security Management, 2013).

Providers who use prescriptions sheets (e.g. Prescription and Medication Administration Records) and charts (e.g. for syringe drivers) will give consideration to the security of blank sheets.

If the CCG commissions a service which requires the use of NHS prescriptions, arrangements for the purchase and administration of prescription forms will be included in the contract.

Providers will have a process in place to manage incidents involving lost, stolen or forged prescriptions. If there is a need to notify local pharmacies to prevent fraudulent prescriptions being dispensed, the provider will notify the NHS England area team who will issue an alert to the relevant contractors. CCG Commissioners should also be informed.

Providers using FP10s are responsible for the secure destruction of any unused prescriptions when prescribers leave their organisation

Prescriptions will be written or computer-generated in line with guidance in the current BNF, and include dose and frequency.

Prescriptions will include contact details which allow the prescriber to be contacted by the dispensing pharmacist if necessary.

The process for handing out prescription forms to patients, their representatives or healthcare staff will take into account prescription security and patient confidentiality. Consent must be obtained before handing a prescription to anyone other than the patient.

Legal responsibility for prescribing lies with the prescriber who signs the prescription.

Where the following activities are carried out there will be Standard Operating Procedures in place to ensure legal, safe and accurate prescribing:

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o The use of prescription sheets (e.g. Prescription and Medication Administration Records) and charts (e.g. for syringe drivers) to include the management of multiple sheets

o Transcribing prescriptions previously prescribed by a registered prescriber o Amending prescriptions o Bulk prescribing* o Verbal orders o Prescribing for discharge

Prescribing will be by generic name except where clinically inappropriate or when branded prescribing is specified in the area formulary or by the medicines management team

Blank green prescriptions generated as the left hand side of a repeat request slip or private prescription will be removed

Provider clinicians and staff should only recommend or prescribe medicines from the CCG Essex Locality formulary/guidelines except when variance has been agreed with the Commissioner medicines management team.

Robust, reliable and secure communication systems should be in place to ensure accurate and timely information about an individual patient's medication is available to the appropriate professionals responsible for his/her care.

*Bulk Prescribing-A "Bulk" prescription is an order for two or more patients, bearing the name of a school or institution in which at least 20 persons normally reside, for the treatment of at least 10 of whom a particular doctor is responsible. Such a prescription must be an order for a drug which is prescribable under the NHS and which is not designated a "Prescription Only Medicine" (POM) under Section 58(1) of the Medicines Act 1968, or for a prescribable dressing which does not contain a product which is designated POM. (Drug Tariff Part VIIIA, Note 9).

4.2 Supply arrangements All prescriptions must be requested in writing allowing 48 hours’ notice (or longer on bank

holidays or weekend).

The provider must have in place robust ordering systems to ensure continuity of supply and to avoid requesting urgent repeat prescriptions.

Must ensure where it is not possible for a GP to indicate an exact dose on a prescription for medication that is to be administered, for example insulin, they are provided with written instructions by the GP. Indication for use and maximum doses must be stated for "as needed" prescriptions

The arrangements for supplying medication to patients of each service will be defined within the contractual framework for that service. In order to comply with European Community directive 92/27/EEC on pharmaceutical labelling, and the provision of information to patients, providers will normally be expected to dispense medicines in patient packs.

Where patient packs are not clinically appropriate (e.g. short-term leave for patients, risk of self harm, continuing dose adjustment) providers will make alternative arrangements to ensure patients receive information as required by the directive 92/27 EEC.

4.2.1 Patient Group Directions Providers who are commissioned to deliver a service using PGDs will develop and operate

those PGDs in accordance with current legislation, and the NICE Good Practice Guidance

Organisations which are listed in legislation as able to authorise their own PGDs will do so

Those organisations which are not listed in legislation as able to authorise their own PGDs will arrange authorisation by the Commissioner. Providers will submit PGDs in draft form

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for review by members of the Commissioning medicines management team before final approval within their own organisation

PGDs will only be used where there is no opportunity for assessment by a prescriber who could issue a Patient Specific Direction.

Supply or administration of the medication must be carried out by the professional who is operating the PGD, it cannot be delegated to another member of the team

Providers are expected to consider the arrangements for the purchase, storage and supply of medication packs as specified in PGDs for take away medication. Packaging and labelling will meet regulatory requirements.

Providers will ensure staff who operate the PGDs are competent and trained

Prescription charges will be collected where applicable.

Where a provider adopts a PGD written by another organisation, for example a GP practice or community pharmacy adopts a PGD written by the Commissioner, the PGD will be signed by a governance lead or manager on behalf of the contractor. That person is responsible for the governance arrangements for the use of the PGD within their organisation, and ensuring that each practitioner who operates the PGD is suitably qualified and signed up to it individually at that organisation.

4.2.2 Verbal orders Providers who administer medication will assess the risks associated with verbal orders,

issued in an emergency to authorise the administration or discontinuation of a prescribed medication, and when they are used, have a governance framework in place to manage those risks.

Where verbal orders are used, providers will have a procedure in place to ensure that they are issued by a prescriber, and received, recorded and acted on by a designated practitioner.

The procedure will specify the duration for which a verbal order will apply, and the process for obtaining the prescriber’s written instructions

The procedure will cover other methods of receiving remote instructions such as fax, email and text if applicable.

Controlled drug orders should not be accepted verbally or by fax.

4.3 Medication review and Medicines Reconciliation Medication reviews take place in many settings and providers are encouraged to work together to provide a complimentary service.

For all types of review there will be a procedure in place which complies with the principles of medication review outlined in the Guide to Medication Review (National Prescribing Centre, 2008). The document “Polypharmacy Guidance” published by NHS Scotland is also useful.

The review will include considering the discontinuation of medication which is no longer effective or adhered to

4.3.1 Clinical medication reviews in primary care (GP practices) Practices will ensure that their policy includes the identification of patients for review based

on risk factors such as number of medications, repeat medications, long term conditions and others in line with national service frameworks and best practice guidance.

The policy will include how patients who do not present for review are managed

The policy will include how the results of MURs and DRUMs and NMS are used to trigger clinical medication reviews, and how patients are referred for MURs, DRUMs and NMS

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4.3.2 Community Pharmacy Medicines Use Review (MUR) Pharmacy contractors meeting the conditions of the national Advanced Service may offer MURs. The service is monitored and funded by NHS England. The service can be offered to any patient who will benefit from the review, but at least 70% should be offered to patients in the national target groups:

patients taking high risk medicines;

patients recently discharged from hospital who had changes made to their medicines while they were in hospital. Ideally patients discharged from hospital with receive an MUR within four weeks of discharge but in certain circumstances the MUR can take place within eight weeks of discharge;

patients with respiratory disease; and

patients at risk of or diagnosed with cardiovascular disease and regularly being prescribed at least four medicines.

4.3.3 Appliance Use Review (AUR) -Community Pharmacy and Dispensing Appliance Contractors

Pharmacy contractors meeting the conditions of the national Advanced Service may offer AURs. The service is monitored and funded by the NHS England.

4.3.4 Dispensing Review of Use of Medicines (DRUM) (Dispensing practices) The service forms part of the Dispensary Services Quality Scheme monitored and funded by

NHS England

4.3.5 Community Pharmacy New Medicines Service (NMS) Pharmacy contractors meeting the conditions of the national Advanced Service may offer

NMS. The service is monitored and funded by NHS England.

4.3.6 Medicines Reconciliation Providers should establish communication links with other providers including, general

practitioners, care homes, and community pharmacies to ensure that adequate information about a patients medicines arrangements, (including any supplies of medicines) are transferred with the patient. Information from ‘Medicine Use Reviews’ (provided by community pharmacists) should be used where appropriate.

There should be a policy for medicines management arrangements on admission including:

Medicines Reconciliation policy in line with NICE/NPSA requirements.

Arrangements for medicines history taking and medication review

Communication with general practice.

Arrangements for medicines supply for emergencies.

4.4 Duration of treatment Prescriptions will be written for the duration that meets the patient’s need and must not exceed 28 days (unless otherwise agreed locally with the CCG).

4.5 Prescribers

4.5.1 General Providers will ensure that their prescribers have access to clinical supervision, Continuing

Professional Development, up to date information sources, relevant information about prescribing policies and practice

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Providers will have robust governance arrangements for assuring safe and effective prescribing and a Commissioner agreed process for the Commissioner to raise concerns.

Providers will ensure that prescribers are registered as prescribers with the relevant governing body, and that any restrictions on their prescribing are adhered to

Providers will maintain a list of current prescribers with specimen signatures (which will be provided to the Commissioner if requested)

Prescribers are responsible for ensuring that arrangements are in place for disease and drug monitoring when required.

4.5.2 Non-medical prescribers Providers will have a policy to cover the activities of non-medical prescribing. The policy will

include: o The governance arrangements for assuring safe and effective non-medical

prescribing o Employer liability o Professional indemnity o CRB checks o Prescribing for self, family and friends o Repeat prescriptions o Off-label prescribing and unlicensed medicines o Regular reviews of prescribing and identification of CPD needs

Non-medical prescribers will: o Be registered as prescribers with the relevant governing body and comply with their

code of practice o Act as prescribers only when formally contracted to do so o Only issue prescriptions bearing their own name and professional registration

number o Agree a scope of practice with their employer and prescribe within this scope only o Ensure that they are remain up to date with current legislation on prescribing and

the safe management of Controlled Drugs

4.6 Formulary Organisations will ensure that staff are aware of the CCG’s formulary, policies and prescribing guidelines and that they prescribe and advise within these parameters.

4.6.1 Area Prescribing Committees Organisations with prescribing responsibilities are expected to participate in and abide by

the decision making processes of the Essex CCG Prescribing Committees, which develop prescribing guidelines and manages the entry of new drugs into the local health economy.

4.6.2 Nice guidance Providers are expected to comply with NICE Technology Appraisals.

The Commissioner and provider will determine collaboratively when and how NICE Clinical Guidelines and Public Health guidance with medicines implications are to be implemented

4.6.3 Shared- and continuing- care agreements For drugs subject to a shared- or continuing-care protocol, specialists will continue

prescribing until a patient-specific agreement has been put in place with the GP

When a shared- or continuing-care agreement is in place, specialists and GPs will undertake the responsibilities outlined in the protocol

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The Provider shall have systems in place to ensure that patients transferred to other care settings have an uninterrupted supply of medicines, and that information is provided to the patient, their GP and their carer.

4.6.4 Unlicensed products Unlicensed drugs, or drugs used ‘off label’, will only be included in the formulary where

there is a substantial body of published evidence and support from local clinicians.

See MHRA current guidance.

4.6.5 Prescribing and administration for patients with swallowing difficulties / feeding tubes

Providers who are involved in prescribing medication for adult patients will have a policy in place to manage patients with swallowing difficulties or feeding tubes. The policy will take into account the fact that special order liquid medicines are unlicensed and can be expensive, and should adopt the following stepwise approach:

1. Check that the medication is still needed 2. Use a licensed preparation (eg liquid, dispersible tablet). Consider changing to a different

drug of the same class in order to use a licensed preparation 3. Use a licensed medicine in an unlicensed manner (disperse tablets in water, crush tablets,

open capsules). Guidance is available on the ways in which different preparations can be treated, their suitability for use with feeding tubes, and how they can be administered

4. Where no licensed option is suitable, consider an unlicensed liquid special The prescriber must give clear instructions in writing for inclusion in the care plan, and the same instructions should appear on the label, in order for staff to be able to administer a product in an unlicensed manner. Patients should be informed that an unlicensed preparation is being prescribed.

4.6.6 Prescribing for covert administration Providers who are involved in administering medication will consider current legal and best practice frameworks and make an assessment of the capacity of the patient to refuse their medication before undertaking covert administration.

4.6.7 Availability of NHS treatment GPs may not issue private prescriptions to their NHS patients unless the item is not available

to prescribe on the NHS.

Where an NHS doctor has referred a patient to a consultant for advice, privately or otherwise, the referring doctor should issue NHS prescriptions, from the current area formulary, for ongoing treatment.

NHS prescriptions are not available to patients who refer themselves for private assessment and need ongoing treatment as part of that care. Patients must be re-assessed under the current agreed NHS criteria before transferring to NHS Care and treatment

Travel and occupational health vaccines which are not included in the NHS contract may be prescribed privately

4.6.8 Homely remedies Providers of residential and domiciliary care will have a policy on the treatment of minor ailments and the use of homely remedies and self-purchased medicines by their service users.

4.6.9 Complementary medicines Complementary medicines, e.g. aromatherapy, herbal, homeopathic remedies, are used for therapeutic purposes and require the same safeguards as with other medicines. They will only be

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prescribed when included on the formulary. Providers will have in place a procedure for dealing with Complementary medicines brought in to their premises by service users or other visitors.

4.6.10 Medicines for clinical trials No clinical trial should be commenced until approval for the trial has been given by the Essex and Hertfordshire Comprehensive Local Research Network (CLRN). Providers will seek the appropriate ethics approval before undertaking clinical trials which should be conducted according to current Good Clinical Practice standards. Any trial which may result in additional activity or change to existing pathways will be agreed in advance with the commissioner. Informed consent should be obtained before patients are included in any trial. It is the responsibility of the trial organiser to ensure that this is obtained. Nursing and pharmacy staff should not administer or supply any trial material if this consent has not been given.

5 Advice to patients

5.1 Promotion of self care Providers will offer opportunistic brief interventions whenever appropriate to advice

patients and service users on lifestyle measures that will enable them to get the best from their medication.

6 Governance Providers are expected to have governance arrangements in place appropriate to the services they provide. The following governance arrangements are not specific to medicines management and are not covered in detail in these standards:

Information governance

Performance management

Complaints and incidents

Record keeping

Mental capacity

Business continuity

Safeguarding

Consent

Whistle-blowing

Bribery

Fraud

Theft Providers should have access to specialist pharmacy services including Education and Training, Medicines Information, Quality Assurance, Clinical Pharmacy, and Community and Primary Care, and Procurement and Purchasing. Hospital consultants have full clinical responsibility for in-patients under their care.

6.1 Standard Operating Procedures Providers will develop Standard Operating Procedures (SOPs) to describe the processes of

handling and managing medicines for the services commissioned

SOPs will be formally approved by the provider, and reviewed at least every 2 years

SOPs will indicate who is authorised to carry out each activity, what training is necessary, and what records will be kept

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6.2 Working with industry Providers will adhere to national guidelines on working with the Pharmaceutical Industry or

their own equivalent policy.

The policy will apply to all employees including non-medical prescribers and non-clinical staff

Samples of medicine will not be accepted by staff or made available to patients

6.3 Near miss errors and medication incidents Providers will maintain an error /medication incident log

The log will be reviewed regularly and providers will be able to provide evidence that they have identified and acted on trends and put corrective action in place to prevent recurrence of errors /medication incidents.

Number of medication incidents, trends and action plans should be shared with the Commissioner.

6.4 Adverse reactions Suspected adverse reactions to medicines, particularly black triangle medicines under

intensive monitoring, can be reported to the MHRA by anyone including non-clinical staff and patients.

Reports can be made online at www.yellowcard.gov.uk or using the form in the BNF

6.5 Medicines Safety alerts Providers will have a process for receiving, acknowledging and acting on medicines safety alerts,

including drug recalls, whether national or local and provide assurance of implementation to the commissioners if requested

6.6 Audit Providers will have a programme of audit in line with their organisation’s clinical governance

framework, their professional code of conduct, individual service specifications and their contractual requirements.