Prescribing and Dispensing
New Pharmaceutical Regulations came into force on 1st September 2012, and replaces the 2005 regulations and its many amendments. The regulations comprise 186 pages and includes ten pages of Amendments, Revocations and Explanatory Notes.
One of the amendments removes the 100-hour pharmacy exemptions by virtue of the fact that there are no exemptions in the new regs and all applications have to satisfy the needs of the Pharmaceutical Needs Assessment (PNA).
These regulations also remove the paragraphs in the GMS and PMS regulations that allowed GP in rural areas to apply to dispense under the GMS/PMS regulations, instead of under the Pharmaceutical Services regulations. In fact, no practice in England ever applied under those regulations and the commissioners always considered applications under the Pharmaceutical Services regulations.
Guidance for dispensing doctors is available at chapter 15 of the NHS pharmaceutical services regulations document.
Dispensing Doctors' Association
The Dispensing Doctors’ Asociation is concerned with promoting the interests of Dispensing Doctors and the excellence of doctor dispensing for the benefit of patients
Dispensing Doctor Feescale Changes 2013-14
An agreement has been reached between the GPC, the Dispensing Doctors Association, NHS England, the Welsh Government and NHS Employers around the changes for the dispensing doctors feescales from 1 October 2013 and onwards.
The agreement is outlined below and is effective from 1 October 2013:
- an envelope of £172.3m for dispensing fees
For the 'underspend' in 2010-11 and 2011-12 England and Wales received a one off payment. In England this equates to £10m and £700,000 in Wales. Last year's agreement also included an updated methodology which more accurately remunerates dispensing doctors for the medicines they dispense. The new methodology includes changes year on year to take into account increases in GP pay and changes in the volume of medicines dispensed. It also sets out an agreed way forward, should there be an over or underspend. Dispensing doctors will also receive £20 for each 'special' they dispense.
A new feescale to deliver the agreed envelope has been calculated and was implemented on 1 October 2013. This feescale will deliver the total funding envelope for 2013-2014. More information is availabel form the BMA website under dispensing doctors.
Dispensing and Sale of Goodwill
Where the dispensing rights have been granted to a GMS or PMS practice and form part of the NHS core services, they are intrinsically linked to the practice then the practice cannot sell goodwill – it would be illegal according to the NHS Act 2006. Breaching the Goodwill rules could ultimately result in a criminal offence.
There are some circumstances where a practice has set up a pharmacy as a separate business (which may run from practice premises). It is not linked to the GMS or PMS agreement and can therefore be sold independently. In these cases it is thought that the Goodwill rules most probably do not apply. We would always advise practices who are unsure whether the goodwill rules apply, to seek further clarification – please contact the office. The BMA has provided soem helpful clarification on this issue
Medicines for Export
This Trading Medicines for Export paper sets out the key legal and ethical obligations on manufacturers, wholesalers, NHS Trusts, registered pharmacies and dispensing doctors in relation to the supply and trading of medicines. Recent increases in the export of medicines are a major contributor to supply problems and risk jeopardising patient care. This guidance is relevant to market authorisation holders, manufacturers, pre-wholesalers, full-line wholesalers, short-line wholesalers, brokers, traders, dispensing doctors, registered pharmacies and NHS Trusts.
The Medicines Act 1968 and its supporting Statutory Instruments, provide that those who wholesale deal any medicinal product for human use are required to hold the necessary licence, unless an exemption applies. Conducting any of the specified activities listed in the Medicines Act, without the necessary licence or outside the conditions of an exemption, constitutes a criminal offence. Article 81 of European Directive 2001/83, requires the maintenance of appropriate and continued supply of medicinal products by marketing authorisation holders and distributors. In 2005 two UK Statutory Instruments were introduced which implemented this Article.
What else can I offer and charge patients for?
A common question in times when we are seeking to maximise the services we are able to offer patients – read this article to find out the regulations. The following question was posed to the office from a Dispensing GP
Can I confirm with you, that the only items we can sell through our practice dispensary to our NHS patients are travel kits? Can I assume that OTC products such as plasters, BP machines etc cannot be sold by the dispensary?"
The regulations on what you can charge for in this context are as follows:
- For treatment consisting of an immunisation for which no remuneration is payable by the Primary Care Trust and which is requested in connection with travel abroad.
- For prescribing or providing drugs, medicines or appliances (including a collection of such drugs, medicines or appliances in the form of a travel kit) which a patient requires to have in his possession solely in anticipation of the onset of an ailment or occurrence of an injury while he is outside the United Kingdom but for which he is not requiring treatment when the medicine is prescribed.
- For prescribing or providing drugs or medicines for malaria chemoprophylaxis.
Point (2) above mentiones appliances:
which a patient requires to have in his possession solely in anticipation of the onset of an ailment or occurrence of an injury’.
There is no list or guidance to define this further. Most of us would agree that such appliances could include anything related to first aid. I do not think this should include a BP machine but it could include a nebuliser. You can, therefore, include some non drug items but you need to be able to justify doing so in terms of the above sentence of the regulations.
Dispensing Services Quality Scheme
Dispensing doctors are general practitioners (GPs) who provide primary healthcare to over nine million UK rural patients. Nearly 3.8 million of these patients live remotely from a community pharmacy; at the patient's request dispensing doctors are allowed to dispense the medicines they prescribe for these patients. Only certain patients are eligible to receive dispensing services from a dispensing doctor; in total, around 7% of all prescription items are dispensed by doctors.
The Dispensary Services Quality Scheme (DSQS) supplementary guidance for revisions to the GMS (General Medical Services) contract 2006 – 2007 specifies the requirements for receiving dispensary services quality payments.
Please note: From 1 April 2013 the responsibility for overseeing the Dispensary Services Quality Scheme (DSQS) has been passed to the Area Teams of NHS England. Although, NHS England has not yet established a single operating policy for DSQS, in some local areas the Area Team has agreed to use the procedures and documentation from the previous PCTs to manage the DSQS process for 2013 – 2014.
Specials are sometimes used when licensed products are not available e.g. dermatological preparations, eye drops or liquids for children. The safety of these and the cost are sometimes inkown to the prescriber. This useful document guides prescribers through the principals of safe and cost effective prescribing of specials.
(e.g. liquid omeprazole for paeds cost range £100-over £1000, hypromellose drops range £30 - £3000 !)
 SI 2005/2759 which amended the Medicines for Human Use (Marketing Authorisations Etc) Regulations 1994 (SI 1994/3144) and The Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005 (SI 2005/2789).
Prescription Codes - GP's working in different places
Please click here to access the NHS Business Services Authority (BSA) hints & tips (prescription information services) recent newsletter.
The article of particular interest is on page 9, entitled 'Medical Prescriber Codes'. With all the integrated working, semi informal mergers, federation support etc, it causes huge issues if a GP starts having prescriptions generated at another practice, before the formal changes have been made by PCSE.
- GPs working in two different practices must use a different code at each practice.
- If a GP is moving from one practice to another, the authorised signatory at the CCG (or CCGs if they are moving out of the area) must inform NHS Prescription Services. This is so that the BSA can remove them from their original practice in their records and add them to the new practice.