Legal Issues
What are the legal issues?
There are other considerations to take into account when crushing tablets or capsules. There are legal implications when the form of a medicine is changed and it can render the person administering the medicine liable for any damage that is caused to the patient's health.
Tablet crushing is commonplace and dangerous
If tablets are crushed this may influence the way the chemicals work and, as a result, the clinical outcome of the medicine may change. In these circumstances the safety and effectiveness of the treatment cannot be guaranteed by the manufacturer and the medicine becomes unlicenced.
"Pharmacists.... must consider whether alternative licensed products are available, such as the same drug with a different formulation"
"Pharmacists should be aware that if a formulation is crushed, dissolved or otherwise tampered with then the product will be rendered unlicensed."
Royal Pharmaceutical Society, Professional Standards Directorate
The legal implications of dysphagia
Changing the state of medication removes the protection afforded by the Consumer Protection Act 1987 and renders the person altering the medication personally liable for any harm caused. Under the Medicines Act 1968 only medical and dental practitioners can authorise the use of unlicensed medicines in people.
It is, therefore, strictly illegal to open a capsule or crush a tablet before administration
without proper authorisation1.
"You are personally accountable for your practice. This means that you are answerable for your actions and omissions, regardless of advice or directions from another professional."
Nursing & Midwifery Council - Code of Professional Conduct 2001
How healthcare professionals are helping the situation
The New Pharmacy Contract means that pharmacists will now be encouraged to expand upon their advisory role and initiate intervention of treatment where appropriate. This means that it is possible to visit a local pharmacy and make enquiries about the appropriate way to take a medicine and to highlight any problems that may be experienced when tablets or capsules are taken.
1 Wright D (2002) Swallowing difficulties protocol: medication administration.
www.swallowingdifficulties.com |
