Allowed / Disallowed Items
What can be prescribed on NHS Prescriptions?
The Drug Tariff is structured so that medicinal products and medical devices are treated in different ways. Pharmacies will always be paid for supplying a medicinal product on an FP10 prescription unless it is blacklisted (listed in Part XVIIIA of the Drug Tariff) and pharmacies will only be paid for supplying a medical device if it is listed in the Drug Tariff (Part IX).
The easiest way to tell the difference between medicinal products and medical devices is to look for a mark which signifies that the item is a medical device. The CE mark can normally be found on the packaging of a device, on the instruction leaflet and on the device itself (where practical).
Subject to the prescriber having the appropriate prescribing rights, any food, drug, toiletry or cosmetic may be prescribed on an NHS prescription unless the product is listed in Part XVIIIA of the Drug Tariff (the ‘Blacklist’) or the criteria set out in the Tariff for prescribing products listed in Part XVIIIB of the Drug Tariff (the Selected List) is not met. To download a quick reference guide on how to determine whether a medicinal product can be prescribed at NHS expense, click here.
The ‘Blacklist’ can be found in Schedule 1 to the NHS (General Medical Services Contracts) (Prescription of Drugs etc.) Regulations 2004 which is reproduced in Part XVIIIA of the Drug Tariff.
Any food, drug, toiletry or cosmetic may be prescribed on an NHS prescription unless the product is listed in Part XVIIIA of the Drug Tariff. For example, whisky is not on the blacklist, so a prescription for this item would be passed for payment by the NHSBSA Prescription Services. The prescriber may however be questioned by their Primary Care Trust (PCT) about the appropriateness of prescribing this item at NHS expense.
As a general rule, if a proprietary (branded) product is listed in ‘the blacklist’, it can not be prescribed on the NHS. The only exception to this is:
If the prescription has been written generically AND the generic product is not blacklisted AND if the generic name has an 'Official Title', that is, the drug appears as the head of a monograph in the European Pharmacopoeia (EP), the British Pharmacopoeia (BP), the British National Formulary (BNF), the International Pharmacopoeia, the Dental Practitioners' Formulary or is included in the Cumulative List of Recommended International Non-proprietary Names.
In cases where a blacklisted proprietary product contains more than one ingredient, the combination product must have an official title.
Laxoberal appears in the blacklist. The product’s generic name, Sodium Picosulphate has a Recommended International Non-proprietary Name (RiNN) and is not blacklisted, therefore Laxoberal could be dispensed if the prescription was written generically.
Regaine and its generic name, Minoxidil (RiNN) both appear in the blacklist so this product cannot be prescribed either generically or by brand name.
Paramol tablets appear in the blacklist. The ingredients, Paracetamol 500mg and Dihydrocodeine 7.46mg do not have an official title (with this particular ratio of ingredients) so Paramol tablets can not be dispensed on the NHS.
When a prescription for a blacklisted product is received, pharmacy staff have a number of options open to them, the prescription could be returned to the prescriber so that an alternative product can be prescribed or a private prescription issued or if the item has GSL or P status, the product could be sold to the patient over the counter.
The Selected List
The ‘Selected List’ can be found in Schedule 2 to the NHS (General Medical Services Contracts) (Prescription of Drugs etc.) Regulations 2004 which is reproduced in Part XVIIIB of the Drug Tariff. The items included on the list may only be prescribed for the patient groups and for the purpose listed in the Tariff. For example, ‘Niferex Elixir 30ml Paediatric Dropper Bottle’ can only be prescribed to infants born prematurely for prophylaxis in the treatment of iron deficiency.
Prescribers must endorse prescriptions for these products ‘SLS’. If the ‘SLS’ endorsement is missing, the prescription should not be dispensed and will not be passed for payment by the NHSBSA Prescription Services. Pharmacy staff can not make the SLS endorsement.
FAQ. I have received an FP10 prescription for Viagra tablets which doesn’t have the letters ‘SLS’ on it, can I still dispense the item?
Viagra is one of the products on the list of drugs only to be ordered in certain circumstances (see Part XVIIIB of the Drug Tariff ), which means the prescriber has to write the letters SLS on the prescription as authorisation. If the ‘SLS’ endorsement is missing, the prescription should not be dispensed and will not be passed for payment by the NHS BSA Prescription Services. Pharmacy staff cannot make the SLS endorsement.
Borderline Substances List
Part XV of the Drug Tariff is known as the ‘Borderline Substances’ list. In certain conditions, some foods and toiletry preparations have the characteristics of drugs. A board known as the Advisory Committee on Borderline Substances (ACBS) advises on the circumstances in which these products may be regarded as drugs. Part XV of the Drug Tariff is split into two lists:
List A is an alphabetical index of the approved borderline products and the conditions they may be prescribed for.
List B is an alphabetical index of medical conditions and related approved products for managing those conditions.
Prescribers should endorse prescriptions with the endorsement ‘ACBS’ if they are issuing the prescription in accordance with the Committee’s advice.
If the ACBS endorsement is missing for a product on the borderline substances list, pharmacy contractors can still dispense the prescription and it will be passed for payment by the NHSBSA Prescription Services. However the prescriber may be asked by their PCT to justify why the product has been dispensed at NHS expense. Pharmacy staff should not add the ACBS endorsement.
As a rule, products are regulated either as medical devices (by the Medical Devices Regulations SI 2002 No 618) or as medicinal products (by the Medicinal Products Directive 65/65/EEC). There are some exceptions to this (eg. unlicensed medicines).
The Medical Device Directives
Within Europe, the EU passed a set of directives to introduce legal controls that regulate the safety and performance of devices across the European Union. The Directives replaced any existing national systems in EU Member States and included provisions for the mandatory CE marking of products, except for certain specific exclusions. The European Medical Devices Directives were implemented into UK legislation by the Medical Devices Regulations 2002, which came into force on the 13th June 2002.
The introduction of the new regulations resulted in a range of products being removed from medicines control and transferred to control under the medical devices regulations. The products affected included wound dressings, some dental products, absorbable surgical materials, non-hormonal contraceptive devices, some contact lens products and irrigation solutions intended for mechanical rinsing.
The CE mark means that a manufacturer is satisfied that his product conforms with the relevant medical device directives and that it is fit for its intended purpose. It is a self-regulatory scheme and once a device has a CE mark, it can be freely marketed anywhere in the EU without further control.
The CE mark can normally be found on the packaging of a device, on the instruction leaflet and on the device itself (where practical). There are some exceptions to this.
Medical Device or Medicinal Product?
Medical devices (appliances) can only be prescribed on NHS prescriptions if the product is listed in Part IX (Appliances section) of the Drug Tariff. To download a quick reference guide on how to determine whether a medical device can be prescribed at NHS expense, click here.
Over the past couple of years, pharmacists have experienced problems where products were changed from being medicinal products to medical devices (eg. Sterile Water for Irrigation) or where new devices have been introduced to the market that at first glance appear to be medicinal products. The situation has been greatly complicated by the fact that there is no central European Database of registered devices so problems have been experienced with devices that have been licensed/CE marked in another EU state but then introduced to the UK Market.
If you receive a prescription for a new product or an unusual item, you may wish to check the packaging to see whether the product bears a ‘CE' mark (indicating that it is a device) or if you are in any doubt, contact the PSNC Information Team and they will be able to find this out for you.
Once it has been established that a product is a medical device, the next step is confirming whether the product is listed in the Drug Tariff as only medical devices listed in Part IX of the Tariff can be prescribed on an NHS prescription. Key points to consider are:
• Check that the prescribed appliance is an exact match for the listing in the Drug Tariff; for example is the type and pack size the same? Particular care needs to be taken with dressings where only certain sizes of the dressing may be listed.
• If there is internet access in the pharmacy, the Drug Tariff can be viewed online at www.nhsbsa.nhs.uk/prescriptions. If the appliance has been ordered by code number or brand name, use the search functionality on the online Tariff to quickly locate the product.
• A list of common ‘disallowed appliances’ can be found here. This can be a useful reference to double-check that a device is not prescribable.
• Watch out for ‘restricted availability appliances’ (e.g. vacuum pumps and constrictor rings for erectile dysfunction). Details of restricted availability appliances can be found in Part IX of the Drug Tariff beside the listing for the relevant appliance. In a similar way to medicines on the selected list, these appliances may only be ordered on an NHS prescription for the patient groups and for the purpose listed in Part IX of the Tariff, and the prescriber must endorse the prescription ‘SLS’. If the ‘SLS’ endorsement is missing, the prescription should not be dispensed and will not be passed for payment by NHS Prescription services. Pharmacy staff cannot make the SLS endorsement.
• Care also needs to be taken with ‘dual listed’ products. When the name of an item listed in Part IX of the Drug Tariff changes, prescribers have time to change their prescribing habits from using the old name to the new one. This period of grace, when both the old and new name for a product will be passed for payment by NHS Prescription Services, usually lasts for 12 months. When the dual listing is removed, only prescriptions using the new name as it appears in the Tariff will be passed for payment.
• Finally, although medical devices can only be prescribed on an NHS prescription if the product is listed in Part IX of the Drug Tariff, there is an exception that allows some, ‘drugs packed with non-Drug Tariff appliances’ to be prescribed where the appliance is used to administer the drug, for example metered aerosols packed with refills, nicotine inhalation cartridges packed with the device etc.
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