The Medicines and HealthCare Products Regulatory Agency is currently consulting on a major review and consolidation of the Medicines Act and associated legislation. One of the proposed changes is to allow dental practices and clinics, registered with the Care Quality Commission to supply and administer medicines to private patients by way of a private group direction (PGO).
Ordinarily, the retail sale, supply or administration of a prescription only medicine, in the absence of a prescription, or the direction of an appropriate practitioner, is a criminal offence. However, under a PGD, a health professional who is not a doctor or a dentist is allowed to supply or administer a specific prescription only medicine to a patient, legally, without a prescription or direction.
Since June 2010 dental therapists and hygienists have been allowed to supply and administer certain medicine in order to assist a dentist with the provision of NHS dental services, provided the supply or administration is carried out in accordance with a PGD which satisfies various requirements. These include:
- The PGO has been signed by the dentist.
- The PGO has been signed on behalf of the Primary Care Trust.
- The person who is making the supply, or administering the medication has been named in the PGD.
- The clinical criteria which must be met before the medicine can be supplied or administered,
- The prescription only medicine which is to be supplied or administered has been specified in the PGD, as have the strength and frequency of the dose, and the circumstances in which the medication is to be provided,
- Any circumstances under which further advice should be obtained from the Dentist have been identified in the PGD, as has whether there should be any follow up.
Whilst medicine can be provided through a PGO to NHS patients. at present, the same medicine cannot be provided through a PGD to private patients ~ even though they are being treated by the same practice, This anomaly has been recognised by the MHRA which notes in its consultation document. that as many practices currently treat both private and NHS patients, it does not make sense to draw a distinction between the two.
The MHRA suggests that PGDs developed in dental practices and clinics should be subject 10 the same authorisation requirements as those that apply to independent hospitals, clinics and medical agencies". These include a requirement that the PGD is signed by, or on behalf of the registered provider, and any relevant manager, and that those people have authorised. in writing, that a specific individual may supply or administer the medicine.
The formal consultation regarding the changes to the Medicines Act and associated legislation will come to an end on 17th January 2012, and it is anticipated that the new legislation will come into force in around July 2012. However, until the current legislation has been changed, it remains a criminal offence to sell, supply or administer a prescription only medicine to a private dental patient without a prescription or direction.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
