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Blackburn with Darwen Primary Care Trust - About Us
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'Specially' Manufactured Medicines

For 'Specially' Manufactured Medicines Database - Click Here

 

For the New Drug Tariff Unlicensed Specials Tariff - Click here and then select Part VIIIB - Basic Price of Unlicensed Medicines

 

Introduction

Where possible commercially available formulations of medicines should be used over crushing tablets/opening capsules or the prescribing of unlicensed specials. If a patient does require a liquid preparation of a medication and there is none available commercially, the medication should be reviewed in the first instance - is the medication necessary, is there an alternative route the medication can be given by e.g. rectal or is there an alternative medication that does have a commerically available liquid. If none of these are an option, the database below offers alternatives to prescribing a specially manufactured liquid e.g. tablets that can be crushed etc. Specials are often very expensive and their use should be restricted.

 

Background to Enteral Tube Administration

Administration of medication to patients with enteral feeding tubes or swallowing difficulties presents a number of problems:

  • may cause the enteral feed to precipitate
  • drugs may bind to the enteral feeding tube reducing drug absorption
  • nutrients and electrolytes in the enteral feeding solution may affect drug absorption
  • positioning of the tube may also lead to changes in bioavailability of preparations e.g. nasogastric versus jejunostomy, this is because the medicine is delivered to a different part of the gastrointestinal tract and absorption may be altered
  • liquid or soluble formulations are not always available.

 

To minimise potential problems all prescriptions must be reviewed to reduce the number of medications to a minimum.

 

Always check with the prescriber to seek alternative preparations before crushing tablets or opening capsules as this may alter drug bioavailability resulting in unpredictable serum concentrations or tube occlusion.

 

Alternative routes which may be considered:

  • rectal
  • parenteral
  • transdermal
  • sublingual/buccal

 

Certain solid dosage forms present a significant health risk to the patient/carer when crushed or opened.

 

It is good practice for the clinical staff to discuss with the patient/carer that medication may be administered via the enteral feeding tube.

 

Prescribing Issues

There are several issues surrounding the practice of crushing tablets or opening capsules:

  1. The "opening" of a capsule or "crushing" or a tablet will (in the majority of cases) make its use "unlicensed". Consequently the manufacturer assumes NO LIABILITY for any harm that may occur to the patient or person administering the medication.
  2. Before considering opening capsules/crushing tablets the medication should be reviewed and changed to the most appropriate formulation, which may mean changing medication if necessary.
  3. According to the "Medicines Act 1968" only medical and dental practitioners can authorise the use of unlicensed medicines in humans.
  4. Authorisation for unlicensed medication administration (i.e. crushing tablets or opening capsules) must therefore ALWAYS be obtained in writing and not accepted verbally. For the purposes of this procedure we assume that the responsible prescriber is aware of the patients swallowing/feeding status and by signing the prescription is authorising medication to be administered in this way.

 

Information for Prescribers

When medication is administered via an enteral feeding tube or the patient has swallowing difficulties please note the following:

  1. change to syrup where possible e.g. metoclopramide tablets to syrup, ferrous sulphate tablets 200mg to sodium feredate e.t.c
  2. liquid medicines must be prescribed in "milligrams" and not "mls" - there may be several strengths available which may lead to potential for error
  3. The following should not be crushed:
    1. Enteric Coated Tablets: Enteric coated tablets are designed to prevent drug dissolution in the stomach and promote absorption in the small intestine. Crushing may produce undesirable side effects or decrease drug effectiveness.
    2. Buccal or Sublingual Formulations: Drugs formulated in these dosage forms are designed to diffuse through the blood vessel wall under the tongue or cheek pouch in order to avoid first pass metabolism effects via the liver. These tablets should not be crushed.
    3. Modified Release Dosage Forms: These dosage forms are formulated to result in slow dissolution and release of the drug. Crushing the tablet may result in higher than expected peak dose initially and sub-therapeutic drug concentrations later in the dosing interval. This is especially important for drugs with a narrow therapeutic range e.g. theophylline. Generally these tablets should not be crushed - but there may be exceptions e.g. MR formulation designed to be given more than twice daily.
    4. Film Coated Tablets: Film coated tablets are not ideal for crushing, where there is no alternative there may be crushed with care NB. film coating may block the tube.
    5. Cytotoxic tablets: Special precautions are required with these drugs to ensure patients/carers avoid contact with them.

 

Disclaimer: The information contained within the following database is for guidance only and was considered correct at the time of publication. The East Lancashire Medicines Management Board accepts no liability and the responsibility of its use rests soley with the prescriber.

 

'Specially' Manufactured Medicines Database

NB. The following database is not exhaustive, it is based on specials prescribed within the health economy and will be updated accordingly. 

Aknowledgement: All information gathered from UKMI, NEWT Guidelines and Handbook of Drug Administration via Enteral Feeding Tubes (2007).

 

Academic detail aid on 'specials' - from UKMi

An academic detail aid has been prepared to accompany the recent Medicines Q&A on choosing medicines for patients unable to take solid oral dosage forms. The detail aid highlights the message that licensed medicines should be used in preference to special-order products where possible. It includes practical information on giving medicines in food or via feeding tubes so that prescribers can give directions to care staff. The detail aid can be adapted for local use - Click Here.

 

The Medicines Q&A has been partly revised to provide clarification regarding manufacturers specials licences: Click Here.

 

All material in this section is aimed at health professionals, but is information currently held within the public domain.   Members of the public seeking advice on medicine-related matters are encouraged to speak with their GP, pharmacist or nurse, or contact NHS Direct on 0845 46 47.  

Richard Lee, East Lancashire Health Economy New Drugs Pharmacist.

Email: Interface@bwd.nhs.uk

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