NHS Greater Glasgow & Clyde Area Drug and Therapeutics Committee
Greater Glasgow and Clyde Medicines
Medicines Update Primary Care

Medicines Update Primary Care May 2015

Subcutaneous Fluids


Subcutaneous fluid administration of IV fluids is an unlicensed procedure (or being used “off-label”) which can be carried out in the care home setting for the subcutaneous replacement of fluids in mild to moderate dehydration. The fluids used for subcutaneous fluid replacement have a product specific licence for intravenous route only. Therefore the use of sterile fluids for subcutaneous use must be considered an unlicensed procedure (MHRA 2010), and therefore use must be in line with the principles of  the NHSGGC Unlicensed Medicine Policy. Risk assessment is an integral part of the approval process for the use of unlicensed medicines and off label medicines and is a fundamental part of the policy governance arrangements.

There is currently no NHSGGC guidance to support the administration of fluids by the subcutaneous route. Although not applicable in all cases, Scottish Palliative Care Guidelines
have guidance on the use of sub cut fluids in end of life care.

Due to the lack of any clear evidence decisions to initiate subcutaneous hydration rests with the individual clinician and will vary from patient to patient depending on the estimated burden to benefit balance. Treatment should always be in conjunction with other quality care.  Should the clinician decide to prescribe they should;
• be conversant with available evidence,
• inform the patient or welfare proxy is made aware of the off-license status of the treatment as it forms part of the consent required for the procedure,
• limit treatment to a temporary period of 48 to 72 h, to facilitate rehydration whilst the person has treatment and recovers from any intercurrent illness.

As with all prescribing, prescribers are responsible for the use of a medicine and the patient’s welfare and in the event of adverse reactions may be called upon to justify the decisions that they have made. In the case of unlicensed/ off label medicine prescribing it is important to be aware that information regarding efficacy and safety may be less robust and this should be considered where there is an alternative, more appropriate treatment option.

Obtaining Fluids
Where the decision is made to prescribe, fluids must be prescribed by a GP or competent non medical prescriber on appropriate form (GP10, GP10A, GP10N etc) and must be dispensed by a community pharmacy. This should be for a named patient for each episode of care as care homes cannot procure IV fluids to hold in stock as the fluids are prescription only medicines. Community Pharmacies may not hold stock of these fluids and may require ordering from wholesalers. Prescribers who wish to have stock on hand may obtain emergency stock via GP10A.

Obtaining sundries
Sundries cannot be prescribed and will be supplied to homes by Care Home Liaison Nurses.

Covert Medication


Covert medication is the administration of any medical treatment in a disguised form. As a result the person is unknowingly taking medication. This is only legally justifiable under conditions clearly defined in the Adults with Incapacity (Scotland) Act 2000 (AWIA) or The Mental Health (Care and Treatment) (Scotland) Act 2003 (MHA).

Covert medication must never be given to someone who is capable of making decisions about their medical treatment.

How does it work in practice?
1. AWIA documentation
A medical practitioner assesses the adult’s capacity in relation to the treatment decision in question. Where covert administration is being considered and there is a welfare attorney or guardian, that person must be consulted unless impracticable. Treatment cannot proceed if a welfare attorney or guardian objects. If the individual lacks capacity, a certificate of incapacity under section 47 of the Act is issued.  It is good practice for the certificate to mention “covert administration if necessary”. A certificate is normally valid for one year, but can be valid for up to three years in certain cases. Multiple interventions should be accompanied by a treatment plan. Only medicines which the patient is refusing that are considered so essential that they need to be given by deception should be considered for covert administration.

2. MHA Documentation
MHA legislation only covers treatment for mental disorder. For an individual who refuses medication in general, there is no distinction drawn between treatment for physical and mental disorders, so AWIA documentation is used as above. If the individual specifically accepts treatment for physical illness but refuses mental health treatment, consideration should be given to use of the MHA. In this case a psychiatrist will complete the required documentation.

3. Covert Medication Pathway documentation
The section 47 certificate or MHA documentation alone is not sufficient to authorise administration of medication by covert means. NHSGG&C has developed a local policy located on staffnet to comply with the legal and practical recommendations of the Mental Welfare Commission with regard to covert administration.  It is essential that the prescriber completes the Covert Medication Care Pathway documentation in the policy before medication can be administered covertly.

4. Reviews
It is the responsibility of the prescriber to ensure treatment plans are up to date and regularly reviewed (weekly initially and no less than four weekly thereafter).  A review form is included in the policy to document reviews. New prescriptions must be assessed individually for suitability for covert administration and added to the treatment plan.

What is the pharmacist’s role?
When covert administration is appropriate, pharmacist input is essential to specify the best method of achieving administration and identify any risks involved. It is not the role of the pharmacist to sanction the use of covert medication. However, suggesting stopping unnecessary medication may be appropriate. Where the formulation of a medicine is altered e.g. by crushing tablets or mixing with food or drink, the medicine is then being used outwith the product license.  Reliable sources of information such as the NEWT1 guidelines are used when giving advice on methods of administration. The resultant advice constitutes a ‘recipe’ for giving each medication safely in covert form.

What records should be kept?
The pharmacist will document pharmaceutical advice on the method of administration for each medicine to be given covertly on a locally developed template (or an alternative company template).  A copy should be retained by the pharmacist, GP practice and care home (where appropriate) to support an effective audit trail.

The information provided by the pharmacist should be added by the prescriber to the Covert Medication Care Pathway document for the individual patient before it is signed off.  This document should be filed in the main medical record. 
1JA Smyth (Ed). The NEWT Guidelines for Administration of Medication to Patients with Enteral Feeding Tubes or Swallowing Difficulties. . 2nd Edn.  Cardiff: North East Wales NHS Trust.  May 2010

SPC


Stands for Summary of Product Characteristics.
The SPC is used by healthcare professionals to explain how to use and prescribe a medicine.
SPC’s are written and updated by pharmaceutical companies based on their research and product knowledge. The SPC is then checked and approved by the UK or European medicines licensing agency. SPC’s can be found on the electronic medicines compendium or medicines.org.uk