Safe and secure handling of medicines manual

Rotherham, Doncaster and South Humber NHS foundation Trust manual for safe and secure handling of medicines.

This is the working manual for safe and secure handling of medicines policy and standards. This webpage content is the overarching policy content with each numbered section having a hyperlink (underlined text) to the detail. Section 5 lists the individual standards which are accessed via the named hyperlink. Please use these hyperlinks to go to the appropriate section detail or standard.

1 Introduction

In the trust the principles which govern the management of medicines must be applied to all the activities in which medicines or their administrative and legal control is concerned.

The key principles are:

compliance with current legislation
adherence to guidance issued by the Health Departments for England, Wales, Scotland and Northern Ireland and other national guidance, for example, National Prescribing Centre (NPC) Guide, Medicines and Healthcare products Regulatory Agency (MHRA) alerts
management of the risks to patients and staff arising from the use of medicines

These principles will be applied to the management and physical handling processes involved in the initiation of treatment, prescribing, procurement, production, acquisition, storage, distribution, dispensing, preparation, administration to patients and the safe handling and disposal of any residual medicinal product.

Medicines management focuses on optimizing the use of medicines and is defined in the audit commission’s report ‘A Spoonful of Sugar’ as ‘encompassing the entire way that medicines are selected, procured, delivered, prescribed, administered and reviewed to optimize the contribution that medicines make to produce informed and desired outcomes of care’.

Aspects of medicines management run throughout the trust, across all localities and service areas, and comprehensive medicines’ management is crucial to the achievement of the trust strategic and operation objective. Medicines management involves patients, carers, and all pharmacy services within the trust.

2 Purpose

The Department of Health requires that NHS Trusts establish and maintain an effective system to ensure that medicines are handled in a safe and secure manner.

The purpose of this policy is that it overarches the safe and secure handling of medicines manual including all the standards contained therein. It sets out the arrangements for managing the risks associated with medicines in all care environments; and, to enhance standards of professional practice in the safe prescribing, dispensing and administration of medicines by:

providing a procedural framework supporting the safe and secure use of medicines across all trust activities. This framework is to be used to support the development of ward, department, and base point specific standard operating procedures
ensuring that the handling and storage of medicines within the trust meets legal requirements
creating a robust audit trail that will be monitored in line with the trust audit programme
defining the roles and limitations of staff working within the trust in relation to medicines
detailing the lines of responsibility for the investigation of medicines related incidents

Additionally, the aims of this policy are to ensure that:

all patients receiving treatment and requiring medication do so in the correct and proper manner
all precautions have been taken to ensure that the proper procedures have been followed in providing that treatment
proper procedures have been followed such that all medicines have been stored and transported to ensure that their integrity has been maintained and to minimize risks to staff, patients, and the public

The result of using this policy (in conjunction with any other appropriate local policies) should be that the right patient receives:

the correct medication
in the correct dosage
by the correct route
at the right time
for the right duration however, medicines management should not be viewed as a mechanistic task, which becomes routine, as it requires thought and the exercise of professional judgment with each practitioner being accountable for their actions and omissions

3 Scope

This policy applies to those members of staff that are directly employed by the trust and for whom the trust has legal responsibility who are involved with the use of medicines. For those staff covered by a letter of authority or honorary contract or work experience this policy is also applicable whilst undertaking duties on behalf of the trust or whilst working on trust premises and forms part of their arrangements with our organisation.

As part of good employment practice, agency workers are also required to abide by the trusts policies and procedures, as appropriate, to ensure their health, safety, and welfare.

All staff contracted to work within the trust who are involved with the use of medicines must familiarise themselves with the correct procedures contained within this policy. Those in charge of wards, units and clinics are responsible for ensuring that their staff, (especially new and locum staff), follow procedures in this policy, which may differ from procedures used elsewhere. The policy will be available at all inpatient and outpatient sites on the trust’s website.

If situations occur that may require staff to go outside of policy, then the chief pharmacist must be contacted who will decide whether the course of action is appropriate, and whether they can continue, or it needs further agreement. Following this the chief pharmacist will then consult with the team manager and head of professional service for agreement and document the decision, this will then be taken to medicines management for ratification.

3.1 Medicines which fall within this policy

Medicines, whether for internal or external use, will be regarded, for the purpose of the policy, as comprising the following categories:

controlled drugs controlled under the provisions of the misuse of Drugs Act 1971, with stringent requirement for supply, storage, and administration
all other medicines and medicinal products prepared for administration to patients, and which are controlled by the Medicines Act 1968. This also includes many diagnostic agents, x-ray contrast agents and medical gases. Whilst less stringent regulations apply than in the case of controlled drugs, they must be treated with equal care
all complementary medicines, for example, aromatherapy, herbal or homeopathic remedies. These products are used for therapeutic purposes and require the same safeguards as other medicines
other pharmaceutical preparations such as disinfectants, reagents and other preparations are not used directly to treat patients. However, the use of these products must still be subject to agreed and approved procedures. Full attention must also be given to the requirements of current Control of Substances Hazardous to Health (COSHH) Regulations
it is important to understand that procedures listed in this document apply to all medicines used in the trust. These include topical lotions, applications, injectable fluids, medicated dressings, dietary products, and complementary medicines
standard operating procedures (SOPs) must be followed, new SOP’s must be developed in conjunction with the Medicines Management team

4 Responsibilities, accountabilities and duties

The duties and responsibilities for medicines procedures that may be held by various grades of practitioners are shown below. However, all grades of practitioners must:

be aware of the tasks they may or may not perform
identify their training needs making their manager aware of any training deficit
maintain a personal record of all competency-based assessments
report near-misses, clinical incidents and serious incidents regarding their prescribing, dispensing, storage, and administration of medicines

4.1 The board of directors (including medical director)

The board of directors through the executive medical director and the chief pharmacist is responsible for medicines management within the trust.

4.2 Quality Committee

The Quality Committee is responsible for:

establishing, auditing, and maintaining effective processes for medicines management
to receive audit results and ensure action plans are appropriate and robust in relation to the audit results
receiving, debating, and acting on as appropriate the annual report of the accountable officer for controlled drugs

4.3. Clinical policy review and approval group (CPRAG)

The clinical policy review and approval group is responsible for:

receiving, discussing, and ratifying proposed medicines related policies and suggested amendments to existing policies

4.4 The Medicines Management Committee (MMC)

The Medicines Management Committee is responsible for:

developing effective medicines management policies which supports compliance with medicines legislation and good professional practice in prescribing, supplying, administering, and monitoring of medicines
ratifying and registering all unlicensed medicinal products supplied or administered through the trust
promoting safe medication practice by the systematic review of medication errors
recommending to CPRAG all documentation associated with the prescribing and administration of medicines
recommending to the CPRAG protocols which enable non-medical practitioners to supply and administer medicines
audit medicines policies and procedures and the administration of medicines as part of the annual clinical audit program

4.5 Chief pharmacist (accountable officer for controlled drugs and medication safety officer)

The chief pharmacist is responsible and accountable to the trust board for:

pharmacy services
medicines management throughout the trust, ensuring timely reporting against the monitoring requirements of this policy
ensuring processes are in place supporting the appropriate acquisition, storage, usage, and disposal of medicines across the trust
providing a monthly report from the MMC to the clinical governance group
providing an annual report to the clinical governance group in their capacity as accountable officer for controlled drugs
providing an annual report to the trust board from the controlled drug local intelligence network (LIN)
providing a monthly report on medication related errors to the MMC
signatory to trust patient group directions
providing advice on the medicines management element of the trusts clinical audit programme

4.6 Trust pharmacists

Trust medicines are supplied through either service level agreements with acute hospitals within the localities or via a contract with local pharmacies.

Trust employed pharmacists are responsible for supporting the best use of medicines throughout the trust including:

the safe, effective, and economical use of medicines
appropriate storage of medicines in clinical area
supporting the trust’s clinical audit programme in relation to medicines management
appropriate investigation of medicines related incidents
support staff training in relation to medicines management
monitor prescription cards in line with the 10 point plan

4.7 Pharmacy technician

These staff offer a service trust-wide but are based within the Doncaster locality and will inspect the stocks of medicines held on the wards or in departments at any time to ensure the medicines are in date and stored or disposed of under the proper legal and environmental conditions. Provide assurance to the trust regarding medication storage and security.

Under agreement administer medication in line with trust policy and competency.

4.8 Prescribing responsibilities of all staff, practitioners with prescribing, ordering, storing, and administering of medicines responsibilities

4.8.1 Staff definitions

Throughout the policy, certain specialist titles describe healthcare staff that have defined responsibilities regarding the management of medicines. In general, only staff with contracts (including honorary contracts) of employment to work within the trust are assessed as having any involvement with medicines. All nurses or practitioners who are either new or unsure about certain practices should administer in pairs, one of which should be competent in the given task.

4.8.2 Independent prescribers

Independent prescribers may include medics, dentists, nurses, pharmacists or physiotherapists. Independent prescribers are responsible for prescribing medicines for patients. They, and any other authorized prescribers, must comply with current legislation, national guidance and the safe and secure handling of medicines policy, when performing these duties.

Except Clozapine, which can only be initiated by a consultant psychiatrist, who in turn must be registered with Zaponex treatment access system (ZTAS). All qualified doctors may prescribe licensed medication on inpatient charts, leave prescriptions To Take Out (TTOs) and outpatient prescriptions.

Off-licence prescribing must be consultant-led, unless supported by the trust formulary or national or local guidance such as NICE and should be recorded in the patient’s clinical record.

4.8.3 Independent prescribing

Non-medical prescribers must not prescribe unlicensed medicines. However, medication which is licensed, but outside its licensed indications may be in exceptional circumstances prescribed by an independent nonmedical prescriber, if such use is justified by current best practice (for example, national NHS guidance or local trust guidance). Prescribing medicines outside the terms of the product licence must accept professional, clinical, and legal responsibility for that prescribing. This prescribing must be carried out within their professional competence.

4.8.4 Supplementary prescribing

Supplementary prescribing with the agreement of patients enables nurses, pharmacists, and allied health professionals (AHP) previously identified, to make adjustments to medication based on agreed clinical management plans, thus facilitating a more flexible approach to care delivery and the development of new professional roles.

The Department of Health (2004) defines supplementary prescribing as “a voluntary partnership between an independent prescriber (a doctor or dentist) and a supplementary prescriber to implement an agreed patient specific clinical management plan (CMP) with the Patient’s agreement”.

4.8.5 Non-medical prescribers (NMPs)

NMPs are nurses, pharmacists, or certain AHPs who have satisfactorily completed the supplementary and independent prescribing course. They should only prescribe within their agreed area of expertise and competence, please refer to the trust’s non-medical prescribing policy.

4.8.6 Prescribers responsibility

It is the responsibility of any authorised prescriber to:

ensure the intent in regard to the pharmacological management plan is clear
write the prescription legibly and correctly
include all relevant details of the patient on the prescription
prescribe medication in accordance with the standards in the safe and secure handling of medicines policy
check the patient’s medical record prior to writing any new prescription
follow local and national prescribing standards
pay particular attention to the accuracy of complex drug calculations
discuss the proposed treatment plan with the patient and their carer or relatives (subject to the patient’s agreement) and record a summary of this discussion in the patient’s records stating clearly:
- what medication is to be prescribed?
- the aims of the treatment plan
- how long the medication should be taken for?
- what alternative treatment plans have been discussed?
- review date and monitoring

4.8.7 Informed prescribing

The trust appreciates that face to face assessment, by the prescriber, of a patient prior to any prescribing decision is the ideal situation. However, the reality is that in many instances this is simply not possible or in the patient’s best interest, most notably in out of hours situations, community teams where patient assessment may be by another health care professional (HCP) or occasions where a patient receives a repeat prescription from us as part of their ongoing care.

In such instances the trust supports national and professional guidance which requires prescribers to work within their competencies and assure themselves of the patient’s health and their need for the medication prior to prescribing. This assurance may be informed by:

phone conversation with the patient or their carer
the patient’s clinical notes or care plan
referral letters from other HCPs
adequate feedback from other HCPs who have assessed the patient
other sources that are considered reliable

When making such prescribing decisions, due regard should be given to the prescriber’s experience, the seriousness of the patient’s clinical condition and specific drug considerations such as potency, monitoring requirements and abuse potential.

The prescriber is responsible for any prescription they sign, including repeat prescriptions for medicines initiated by colleagues; therefore, prescribers must make sure that any prescription that is signed is safe and appropriate.

4.8.8 Appointed practitioner in charge or responsible person (service manager or ward manager)

This is the senior practitioner appointed to take charge of a ward or department, for example, ward manager or team leader. In the event that the person in charge is not from a professional nursing background appropriate to take on the duties and responsibilities within this policy (for example, community team leader with a social work background), another senior member of the nursing team will undertake the role of appointed practitioner in charge with respect to controlled drugs and may take the role of appointed practitioner in relation to all medicines’ management issues.

This appointed practitioner or staff member has ultimate responsibility for:

ensuring that this policy and other associated procedures in relation to medicines administration are being followed correctly
the safekeeping of medicines on the ward, department or base point and will ensure their safe and appropriate storage at all times
ensuring that SOPs are relevant to their area of practice, are consistent with the standards of this policy and that all staff have read and signed SOPs appropriate to their role
ensuring that the staff performing physical security checks and stock reconciliation is appropriately rotated to ensure secure delegation is maintained
arranging for an appropriate investigation to take place if there are any exceptions or discrepancies
ensuring that unwanted medicines are disposed of in appropriate pharmaceutical waste bin prior to collection
ensuring that all controlled stationery on the ward, department or base point is held securely. Where a department is closed for any reason for up to 7 days the responsible person will ensure that all medicines are stored in cupboards as specified in section 5.17
signing for receipt of any medicines delivered to the ward or department. This process will involve checking the received stock against requisition, and patients own medication against the prescription, as well as ensuring security of storage through transit has been maintained
ensuring that access to medicines is restricted, by control of keys to the medicine cupboards and refrigerators, or other alternative approved storage areas. This responsibility remains with the responsible person even if they decide to delegate this duty
checking stock levels at least once every six months when a ward or department is not served by a pharmacy top-up service
ensuring that a running balance of controlled drugs is recorded after each transaction and recorded under the last entry for each medicine in the controlled drug register
administration of medicines. This duty may be delegated to another practitioner, but the appointed practitioner or responsible person in charge must exercise supervision as necessary and be satisfied that the staff member to whom they have delegated the task has received relevant training
if a situation arises where medication, which has been prescribed has not been written in accordance with the standards in this policy, the practitioner may still administer the medication provided they are satisfied the prescription is legible and safe, and that any delay in administration would be detrimental to the patient. The prescriber must be contacted immediately and informed of the deficiencies with the prescription being re-written correctly within 24 hours

4.8.9 Assigned practitioner in charge

This is the senior practitioner on duty (for example, team manager) who in the absence of the appointed practitioner in charge or responsible person has been rostered as the professional in charge for that shift. Whilst in charge this person is responsible for all the duties as set out above in section 5.9.3.

4.8.10 Non-registered healthcare staff

These are clinical support workers, trainee and assistant practitioners, healthcare workers, support workers and nursing assistants who assist in medication duties. These staff must have the relevant training or trust approved training, allowing them to undertake certain functions with respect to assisting with medicines administration, or administering medication in agreed circumstances, such as community homes and other community settings. Prior to administering medication, the staff must be deemed competent by the lead clinician to carry out the task, and where appropriate receive approved training.

The following situations are suitable for support staff to administer or aid in the administration, provided the task has been delegated to them as an individual authorised for that level of administration.

They must administer medication in line with trust policy following appropriate training and assessment of competence. For example, this may include:

administration of oral medication, such as in a community home or supported living
the application or insertion of creams, ointments or drops
nursing a child who is using a nebulizer
the supervision of a dependent patient to ensure their medicines are taken effectively
simple eye care
simple dressings
suitably trained health care assistants may administer insulin

The individual authorised to administer medicines retains the responsibility to ensure that a medicine has been administered correctly; and that responsibility cannot be delegated. In line with this the individual authorised to administer will identify the correct medicine and correct patient to whom the medicine is to be administered.

Practitioners in training must be given every opportunity to become proficient in medicines related activities under appropriate supervision. The supervising practitioner always has responsibility for such medicine procedures.

4.8.11 Bank or agency nursing staff

Before administering medication, agency or bank staff should have received appropriate guidance on local practices, this includes the use of the electronic prescribing system. Regular bank or agency registered nursing staff confident in trust practices may administer medicines with approval of the appointed practitioner in charge. It is the responsibility of the registered nurse to report any issues regarding their competence.

4.8.12 Staff who administer medication

The individual authorised to administer medicines will be responsible for:

ensuring they have an understanding of the use, action, usual dose, side effects and handling hazards of the medicine(s) being administered
ensuring they are certain of the identity of the patient to whom the medicine is to be administered before initiating any administration activity
retaining the responsibility to ensure that a medicine has been administered correctly; this cannot be delegated. However, in certain circumstances support staff may aid in the administration of medicines. In these circumstances the administrator will ensure that the support staff has sufficient training and information to aid the administration of the medicines safely
they have received appropriate training to administer medication, especially when given parenterally or via enteral feeding tubes

4.8.13 Supplying pharmacist (community or hospital)

Supplying pharmacists are responsible for ensuring they comply with the service level agreement.

5 Standards

6 Standing operating procedure

Please see the pharmacy’s SOP page on the staff intranet (staff access only) (opens in new window) for standard operating procedures:

inpatient standard operating procedures
- medicines reconciliation
- medicines prescription
- medicines ordering
- medicines receiving and storage
- medicines administration
- medicines disposal
- network unavailable
controlled drug standard operating procedures:
- controlled drug prescribing aspire drug and alcohol service Doncaster care group
- controlled drugs (RDaSH care groups community services (physical health))
- controlled drugs (except St John’s hospice and RDaSH community services (physical health))
- controlled drugs St John’s hospice
- destruction of controlled drugs:
destruction of controlled drugs and unknown substances by pharmacy services staff
- community inpatient services:
- management of medicines on Hazel, Hawthorn and Magnolia wards and Evergreen day services
adult community mental health:
- management of medicines on RDaSH adult mental health community services
- community team drug chart, short, exemplar
- community team drug chart, short
- community team drug chart, long
- stock medicines reconciliation form
- stock medicines reconciliation form, exemplar
- record of removal of medicines from a community patient
- record of removal of medicines from a community patient, exemplar
- patient medicines reconciliation form
guideline for the administration of adrenaline for the emergency management of anaphylaxis
omitted doses:
- omitted medication guidance
minor ailments:
- guidelines for the supply and administration of medicines for minor ailments by registered nurses within Doncaster Deaf Trust
- guidelines for the supply and administration of medicines for minor ailments by registered nurses within inpatient services
local working Instructions:
- the safe administration of Dalteparin (Fragmin), Tinzaparin (Innohep) and Enoxaparin (Clexane) in the community
- standard operating procedure for the emergency supply of clozapine to an acute hospital by the Mental Health Hospital Liaison team
guidelines:
- guidance on missed doses of depots long-acting injections
- licensed injection sites for depot antipsychotics
- guidelines for the management of QTc prolongation in adults prescribed antipsychotics

7 Training implications

The training needs analysis for this policy can be found in the training needs analysis which is part of the trust’s mandatory and statutory training policy.

8 Equality impact assessment screening

To access the equality impact assessment for this policy, please email rdash.equalityanddiversity@nhs.net to request the document.

8.1 Privacy, dignity and respect

The NHS Constitution states that all patients should feel that their privacy and dignity are respected while they are in hospital. High Quality Care for All (2008), Lord Darzi’s review of the NHS, identifies the need to organise care around the individual, “not just clinically but in terms of dignity and respect”.

As a consequence the trust is required to articulate its intent to deliver care with privacy and dignity that treats all service users with respect. Therefore, all procedural documents will be considered, if relevant, to reflect the requirement to treat everyone with privacy, dignity and respect, (when appropriate this should also include how same sex accommodation is provided).

8.1.1 How this will be met

No issues have been identified in relation to this policy.

8.2 Mental Capacity Act (2005)

Central to any aspect of care delivered to adults and young people aged 16 years or over will be the consideration of the individuals’ capacity to participate in the decision-making process. Consequently, no intervention should be carried out without either the individual’s informed consent, or the powers included in a legal framework, or by order of the court.

Therefore, the trust is required to make sure that all staff working with individuals who use our service are familiar with the provisions within the Mental Capacity Act (2005). For this reason all procedural documents will be considered, if relevant to reflect the provisions of the Mental Capacity Act (2005) to ensure that the rights of individual are protected and they are supported to make their own decisions where possible and that any decisions made on their behalf when they lack capacity are made in their best interests and least restrictive of their rights and freedoms.

8.2.1 How this will be met

All individuals involved in the implementation of this policy should do so in accordance with the guiding principles of the Mental Capacity Act 2005 (section 1).

9 Links to any other associated documents

10 References

Audit Commission Report (2001) A Spoonful of Sugar, Medicines Management in NHS Hospitals.
British Medical Association, Royal Pharmaceutical Society of Great Britain (most recent edition) British National Formulary.
Care Quality Commission (2010) Essential standards of quality and safety.
Consumer Protection Act of (1987).
Control of Substances Hazardous to Health Regulations (2002). Crown Report (1998).
Department of Health (1999) Review of Prescribing, Supply and Administration of Medicines.
Department of Health (2004) Mechanisms for Nurse and Pharmacist Prescribing and Supply of Medicines.
Department of Health (2007) Safer Management of Controlled Drugs: A Guide to Good Practice in Secondary Care.
Department of Health (2015) Code of Practice Mental Health Act 1983.
Department of Health (2015) Reference Guide to the Mental Health Act 1983.
General Medical Council (2013) Good Practice in managing medicines and devices.
Manchester Mental Health and Social Care Trust (2008) Medicines Policy 4th Edition.
Medicines for Human Use (Clinical Trials) Regulations (2004).
Mental Capacity Act (2005).
Misuse of Drugs Regulations (2001).
National Institute for Health and Clinical Excellence (2013) MPG 2 Patient Group directions.
National Institute for Health and Clinical Excellence (2014) CG183 Allergy.
National Institute for Health and Clinical Excellence (2015) NG15 Antimicrobial Stewardship.
National Institute for Health and Clinical Excellence (2015) NG5 Medicines Optimisation.
National Patient Safety Agency (2007) Promoting Safer Use of Injectable Medicines.
Nursing and Midwifery Council (2008) Mental Health Act Manual Eleventh Edition.
Nursing and Midwifery Council (2015) Standards of Proficiency for Nurse and Midwife Prescribers.
Nursing and Midwifery Council (2015) The Code: standards of conduct, performance and ethics for Nurses and Midwives.
Nursing and Midwifery Council 2015 Standards for Medicines Management.
Royal College of Psychiatrists (2007) Use of Licensed Medicines for Unlicensed applications in Psychiatric Practice.
Royal Pharmaceutical Society of Great Britain (2008) Medicines Ethics and Practice, A Guide for Pharmacists and Pharmacy Technicians.
The Association of the British Pharmaceutical Industry Code of Practice (2006).
The Duthie Report (1988).
The Human Medicines Regulations (2012).
The Medicines Act (1968).
The Misuse of Drugs Act (1971).
The Royal Marsden NHS Foundation Trust (2004) Clinical Nursing Procedures 6th Edition.
The Stationery Office (2007) Mental Capacity Act (2005) Code of Practice.
Waddell L. and Taylor M. A new self-rating scale for detecting atypical or second-generation antipsychotic side effects, Psychopharmacol 2008.

11 Appendices

11.1 Appendix A Accepted Abbreviations that may be used when prescribing

The following abbreviations may be used when describing medication route of administration or strength.

With respect to tablet and capsule release characteristics only the following abbreviations may be used with in the trust:

Abbreviations
Acronym	Long form
EC	Enteric coated
MR	Modified release
LA	Long acting
SR	Sustained release
LAI	Long acting injection

11.1.1 Combination products

For oral medications containing more than one drug, write the approved name followed by the strength of each component, then the number of dose units, for example, Co-amilofruse 5/40 i od.

11.1.2 Dose

The DOSE must be expressed in metric units. Quantities of less than 1 gram must be written as milligrams. Decimal points should not be used, for example 500mg not 0.5g to avoid confusion. Whenever a decimal point is necessary, the prescriber and the practitioner administering the drug must exercise great care. The terms microgram and nanogram must not be abbreviated but must be printed in full and used for quantities less than one milligram. Liquid preparations should show the dose in milligrams or micrograms or the strength of the preparation and the dose in millilitres.

In regard to the prescribing of insulin this must always be prescribed as units, and in line with the NPSA alert on insulin it must not be prescribed using the abbreviations U or IU.

11.1.3 Dosage forms

Dosage form abbreviations
Acronym	Long form
Cap	Capsule
Syr	Syrup
Susp	Suspension
Injection	Injection
Sup	Suppository
Gutt	Eye drops
Occ	Eye ointment
Tab	Tablet

Only the following abbreviations are acceptable within the trust:

Amount abbreviations
Acronym	Long form
Mg	Milligram
G	Gram
Kg	Kilogram
L	Litre
Ml	Millilitre
Mmol	Millimole

Microgram and nanogram must be written in full

11.1.4 Route of an administration

This must be stated for all prescriptions and only the following abbreviations are acceptable:

Route of an administration abbreviations
Acronym	Long form
IM	Intramuscular
v	Inhalation
IV	Intravenous
NEB	Nebulisation
PO	Oral
PR	Per rectum
PV	Per vagina
SC	Subcutaneous
SL	Sublingual
TOP	Topical
PEG	Percutaneous

All other routes of administration must be written out in full.

11.1.5 Directions

Directions abbreviations
Acronym	Long form
OD	Once a day
OM/mane	Each morning
ON/nocte	Each night
Bd	Twice daily
Tds	Three times a day
Qds	Four times a day
PRN	When required
STAT	Once only
AC	Before food
PC	After food
Q#h	Every number of hours like every 4 hours or every 8 hours

No other abbreviations are permitted when documenting medications.

11.5 Appendix E Adverse drug reporting

11.5.1 Adverse drug reaction reporting and yellow card scheme

The yellow card scheme for spontaneous reporting of suspected adverse drug reactions (ADRs) was introduced in 1964 after the thalidomide tragedy highlighted the urgent need for routine monitoring of medicines. Adverse Drug Reactions should be reported to the Medicines and Healthcare products Regulatory Agency (MHRA) by completing a yellow card.

11.5.1.1 Who Can Report?

Until recently adverse drug reaction reporting using the yellow card scheme was only available to healthcare professionals such as doctors, pharmacists, coroners and nurses. In October 2005 the yellow card scheme was opened up to service users and their carers.

11.5.1.2 What should be reported?

An adverse drug reaction (ADR) is an unwanted or harmful reaction experienced following the administration of a drug or combination of drugs under normal conditions of use that is suspected to be related to the drug.

For intensively monitored medicines (identified by ▼) report all suspected reactions.

For established drugs and herbal remedies report all serious adverse reactions in adults, report all serious and minor reactions in children (under 18).

Serious reactions include those that are:

fatal
life threatening
disabling
incapacitating
result in or prolonged hospitalisation
and or are medically significant
congenital abnormalities

If in doubt about the seriousness of a reaction please report it.

11.5.1.3 Areas of special interest

Although all adverse reactions with medicines are monitored there are a number of areas of particular interest, as listed below:

children
the elderly
delayed drug effects
congenital abnormalities
herbal remedies: it is important to monitor all herbal products to ensure their safety

It would be helpful to report the ingredients, source or supplier.

11.5.1.4 Where to find a yellow card

A paper version of the yellow card is included in:

British National Formulary
Nurse Prescriber Formulary
Monthly Index of Medical Specialties (MIMS)

Alternatively download a copy from the MHRA website.

11.5.1.5 Service user details

Provide one of the following, service user’s initials, age, sex, weight if known, local identifier.

Do not identify the service user by date of birth or name of patient. In order to help identify the Service user in any future correspondence also include their initials and a local identification number, which will identify them in the case of any future correspondence. This does not breach any confidentiality agreements between the health care professional and the service user.

11.5.1.6 Copy of yellow card in patients notes

It is vital that a copy of the Yellow Card Report is included in the service users clinical record. It is also recommended that a copy be sent to the GP for future

11.5.1.7 Drug alerts

Medicines and Healthcare Products Regulatory Agency (MHRA) Drug Alerts are cascaded directly to the trust pharmacists and they are responsible for ensuring that the advised action is taken, which may necessitate the removal of the affected pharmaceuticals from pharmacy stock.

11.6 Appendix F Allergy assessment

When assessing a potential allergy the following tool should be used (NICE CG183)

11.6.1 Signs and allergic patterns of suspected drug allergy with timing of onset after exposure to drug

When assessing a person presenting with possible drug allergy, take a history and undertake a clinical examination, use the following when deciding whether to suspect drug allergy:

11.6.1.1 Immediate, rapidly evolving reactions

Anaphylaxis: a severe multi-system reaction usually with erythema, urticaria or angioedema in combination with hypotension and bronchospasm
Urticaria or angioedema without systemic features
Exacerbation of asthma, for example with non-steroidal anti-inflammatory drugs (NSAIDs)

Onset usually under 1 hour, previous exposure not always confirmed.

11.6.1.2 Non-immediate reactions without systemic involvement

Widespread red macules or papules (exanthem-like)
Fixed drug eruption (localised inflamed skin)

Onset usually on day 6 to 10 of first drug exposure (reaction to first exposure may be more prolonged), or day 1 to 3 of second exposure.

11.6.1.3 Non-immediate reactions with systemic involvement

Widespread red macules, papules or erythroderma with systemic involvement. For example, drug reaction with eosinophilia and systemic symptoms (DRESS) or drug hypersensitivity syndrome (DHS), characterised by fever, lymphadenopathy, liver dysfunction and platelets below the laboratory limits. Onset usually 2 to 6 weeks after first drug exposure, or 24 to 48 hours after second exposure. Note, this list describes common and important presenting features of drug allergy, but other presentations are also recognised.
Toxic epidermal necrolysis or Stevens Johnson syndrome, characterised by mucosal or cutaneous erosions, vesicles, blistering or epidermal detachment, and red purpuric macules or erythema multiforme. Painful rash and fever are often early signs. Onset usually 7 to 14 days after first drug exposure, or 24 to 48 hours after second exposure.
Acute generalised exanthematous pustulosis: widespread pustules, usually with a fever and neutrophilia. Onset 3 to 5 days after first drug exposure.
Common disorders caused, rarely, by drug allergy (time of onset variable):
- eczema
- hepatitis
- photosensitivity
- vasculitis

Be aware that the person’s reaction is more likely to be caused by drug allergy if:

the reaction occurred while the person was being treated with the drug
the drug is known to cause that type of reaction
the person has had a similar reaction to that drug or class of drug in a previous exposure

Be aware that the person’s reaction is less likely to be caused by drug allergy if:

- there is a possible non-drug cause for the person’s symptoms, for example, they have had similar symptoms when not taking the drug
- the person has gastrointestinal symptoms only

Note, this list describes common and important presenting features of drug allergy, but other presentations are also recognised.

11.6.2 Serum tryptase

After a suspected drug-related anaphylactic reaction, take blood samples for mast cell tryptase in line with recommendations in Anaphylaxis (NICE clinical guideline 134).

Record in the person’s notes and on the pathology request form, the exact timing of both blood samples taken for mast cell tryptase after onset of suspected anaphylaxis.

Ensure that tryptase sampling tubes are included in emergency anaphylaxis kits.

11.6.3 Serum IgE

Do not use blood testing for specific IgE for diagnosing drug allergy in a non-specialist setting.

The full guideline can be viewed at the NICE website guidelines (opens in new window).

Document control

Version: 2.
Approved by: Director of corporate assurance (COVID-19 emergency measures).
Date approved: 4 July 2023.
Name of originator or author: Chief pharmacist.
Name of responsible committee or individual: Executive medical director.
Unique reference number: 547.
Date issued: 2 August 2023.
Review date: 31 August 2026.
Target audience: Trust wide.
Description of changes: Review.

Page last reviewed: November 19, 2024
Next review due: November 19, 2025

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