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Legal Exemptions

Legislation has provided a number of exemptions to the POM order for named groups of healthcare professionals in order that they can sell, supply or administer to patients named medicinal products within the scope of their clinical practice

Each healthcare professional ought to act in accordance with the code of professional conduct and standards as set by their professional body. The healthcare professional must also act in accordance with the policies and standards defined within their organisation. 

When a medicine is covered in the legislation by an exemption then the health professional does not need a Patient Group Direction (PGD), Patient Specific Direction (PSD) nor a prescription from an authorised prescriber.  Any administration, sale or supply under the Exemptions Order (Ref:http://www.mhra.gov.uk/Howweregulate/Medicines/Availabilityprescribingsellingandsupplyingofmedicines/ExemptionsfromMedicinesActrestrictions/index.htm    must be in the course of professional practice. Individual Health Boards may have local protocols in place to support healthcare professionals covered under the exemptions. These should provide dosing instructions and define the circumstances in which the medication should be administered (e.g. phytomenadione administration doses for premature neonates by midwives).

Healthcare professionals should provide evidence based care. This may result in "off-license" use which means a medicine is sold, supplied or administered outside the marketing authorisation. The legislation does not define the appropriate use of the medicinal product and therefore it can be used "off-license".  The healthcare professional must be satisfied that there is sufficient evidence and / or experience of using the medicine to demonstrate its safety and efficacy. (Ref: NMC standards and Medicines, Ethics & Practice No 33 July 2009). Patients should be advised of the 'off-license' use, consent obtained and noted. Consent does not need to be signed or written, it can be implied or verbal. Consent is then documented in the patient's medical record. 

The following tables have been drawn together to simplify and clarify the exemptions, to whom they apply, how they apply and what drugs are covered, for each group. 

Care should be exercised due to possible name changes of drug nomenclature. i.e BAN & rINN (Ref: BNF,   http://www.mhra.gov.uk/Howweregulate/Medicines/Namingofmedicines/ChangestomedicinesnamesBANstorINNs/index.htm)

Emergency Exemptions

The following list of medicines for use by parenteral administration, are exempt from PGDs,  prescriptions or  PSDs when administered for the purpose of saving life in an emergency:

Medicines for use in an emergency to save life
Doses are not specified in the legislation

• Adrenaline 1:1000 up to 1mg for intramuscular use in anaphylaxis
• Atropine sulphate and obidoxime chloride injection
• Atropine sulphate and pralidoxime chloride injection
• Atropine sulphate injection
• Atropine sulphate, pralidoxime mesilate and avizafone injection
• Chlorphenamine injection
• Dicobalt edetate injection
• Glucagon injection
• Glucose injection
• Hydrocortisone injection
• Naloxone hydrochloride
• Pralidoxime chloride injection
• Pralidoxime mesilate injection
• Promethazine hydrochloride injection
• Snake venom antiserum
• Sodium nitrate injection
• Sodium thiosulphate injection
• Sterile pralidoxime

Reference:  http://www.legislation.gov.uk/ukpga/1968/67

 

Midwives

Following the consultation on midwives exemptions the legislation has changed and a number of medicines have been removed from the list and a number have been added.  The restrictions on the sale and supply of GSL and Pharmacy medicines has remained unchanged. 

Please see the Midwives Exemptions circular link: http://www.nmc-uk.org/Documents/Circulars/2011Circulars/1/nmccircular07-2011-Midwives-Exemptions.pdf

Ophthalmic Opticians and Optometrists

Optometrists' sale or supply

Registered optometrists may sell or supply certain medicinal products provided it is in the course of their professional practice. The medicinal products, the categories and the circumstances in which they can be sold, supplied or administered are listed in   https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency (external link).

Information for pharmascists dispensing optometry orders can be found at:

https://www.nicpld.org/courses/assets/PreRegLeaflet_2014.pdf (external link)


Chiropodists and Podiatrists

Chiropodists and podiatrists who are appropriately qualified can administer local anaesthetic and supply certain prescription only medicines in the course of their practice.


Some restrictions apply and these are indicated on the Exemptions site of the MHRA. Chiropodists and Podiatrists should be aware of their entitlements and these can be checked on the Health and Care Professionals Council at the following page: http://www.hpc-uk.org

Occupational Health

An Occupational Health Scheme is a scheme in which a person, in the course of the business carried on by him or her, for their employees provides facilities for the treatment or prevention of disease. The supply of pharmacy and prescription only medicines must be made in the course of the business of the scheme. (Ref: Statutory Instruments 1980 no.1924 and 1997 no 1830). The person supplying or administering POMs in the course of the scheme must be a doctor, or a registered nurse. The nurse acting in accordance with the written instructions of a doctor as to the circumstances in which the POM is to be used in the course of the occupational health scheme. (http://www.legislation.gov.uk/uksi/2012/1916/schedule/17/made?view=plain) (external link)

Occupational Health Schemes do not require PGDs in order to supply or administer medicines to employees. If, however, the scheme treats non employees or employee relatives, then a PGD or PSD is required as with any other healthcare professional supply or administering to patients/clients.