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Policy responses and statements
- Name of organisation:
- Medicines and Healthcare Products Regulatory Agency
- Name of policy document:
- MLX 331: Proposals for Amendments to the Range of Medicines which can be Sold, Supplied or Administered by Podiatrists
- Deadline for response:
- 20 January 2006
Background: The MHRA is consulting on proposals to amend the range of medicines which can be sold, supplied or administered by registered podiatrists. The proposals are intended to enhance patient care by offering timely access to treatment and updating the range of medicines available to podiatrists to reflect modern practice. The proposed changes to legislation would apply throughout the UK.
Under the Medicines Act 1968, medicines classed as prescription only (POM) and pharmacy (P) medicines may only be sold or supplied through registered pharmacy premises by or under the supervision of a pharmacist. POMs are subject to the additional requirement that they may only be sold or supplied against an appropriate practitioners' prescription. An appropriate practitioner is a doctor, dentist and, within the terms of the legislation covering their prescribing, a supplementary prescriber or independent nurse prescriber.
The law also restricts the administration of parenteral medicines. Unless self-administered, they may only be administered by an appropriate practitioner or by anyone acting in accordance with the directions of an appropriate practitioner.
There are exemptions from these restrictions for registered podiatrists which allow them to sell or supply specified lists of POM and P medicines in the course of their professional practice. In the case of POM products, this is subject to the condition that they hold a certificate of competence in the use of the medicines. In addition, podiatrists who hold a certificate of competence in the use of analgesics are allowed to administer certain parenteral medicines. Both are recorded in the certificates of registration issued by the podiatrists' regulatory body, the Health Professions Council.
It has been more than 7 years since the last review of the podiatrists' exemptions and the current arrangements do not reflect developments in practice. The proposals for updating the exemptions have been put forward by the Society of Chiropodists and Podiatrists which is one of the profession's representative bodies.
COMMENTS ON
MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY MLX 331: PROPOSALS FOR AMENDMENTS TO THE RANGE OF MEDICINES WHICH CAN BE SOLD, SUPPLIED OR ADMINISTERED BY PODIATRISTS
The Royal College of Physicians of Edinburgh is pleased to respond to the Medicines and Healthcare Products Regulatory Agency on Consultation MLX 331: Proposals for Amendments to the Range of Medicines which can be Sold, Supplied or Administered by Podiatrists.
The College has the following specific comments relating to these proposals
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Parenteral administration (local injection) of methyl prednisolone acetate for plantar saciitis
The diagnosis of plantar fasciitis is simple, but injection treatment is uncomfortable and the technique requires tuition. The evidence base for effectiveness is weak. The diagnosis and injection are within the professional capacity of a podiatrist.
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Local anaesthesia with levobupivacaine hydrochloride and ropivacaine hydrochloride
Bupivacaine and lignocaine administration are already accessible by prescription to podiatrists, and it is logical that the two longer acting agents be added to the list.
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Adrenaline for anaphylaxis
Every practitioner administering parenteral drugs should have on site an anaphylaxis emergency kit containing ready to administer adrenaline, hydrocortisone and antihistamine. The list should be checked and replaced regularly. All practitioners should have training in immediate life support.
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Silver sulfadiazine for local application
This is used by dermatologists and is safe. It could have limited application for podiatrists.
- Amoxicillin, erythromycin, flucloxacillin
The diagnosis of local infection, the distinction from tendonitis, gout and mechanical causes of inflammation, the recognition of osteomyelitis and the indications for intravenous antibiotics and surgical referral normally fall within the province of medically qualified practitioners. However, these conditions could be diagnosed and treated by podiatrists following appropriate training and ongoing assessment of competence.
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Ticonazole 28%, terbinafine 1%, clotrimazole 1% for topical use
These anti-fungal and antimicrobial preparations can be safely administered, but not all podiatrists will have had training in skin biopsy and skin scrapings and/or access to laboratory support facilities to be secure in establishing a diagnosis of onychomycosis and pityriasis versicolor.
Copies of this response are available from:
Lesley Lockhart,
Royal College of Physicians of Edinburgh,
9 Queen Street,
Edinburgh,
EH2 1JQ.
Tel: 0131 225 7324 ext 608
Fax: 0131 220 3939
[23 January 2006] |
