Understanding the Drug Tariff - medicinal products and medical devices

Pharmacists

Understanding the Drug Tariff - medicinal products and medical devices

The Drug Tariff (DT) is the definitive guide to how a pharmacy will be reimbursed for supplying products to patients; it is an essential document but one that strikes fear into pharmacists and technicians alike. Questions on whether a product is allowed on prescription rank in the top three of all queries received by Information Services, making up 15-20% of our workload. While a CPD article such as this cannot hope to cover all the intricacies of supply and reimbursement, we can give you hints and tips on how to interpret the information in the Drug Tariff, helping you to decide if a product can be dispensed or not.

This article will describe the Drug Tariff as used in England and Wales. The Drug Tariffs used in Scotland and Northern Ireland are laid out slightly differently, for example with different names for the various sections and some rules over reimbursement are different. However, the concepts described here, namely deciding whether a product in allowed on the NHS, are the same for all four countries. We therefore ask pharmacists and technicians in Scotland and Northern Ireland to forgive us the bias towards England's terminology and rest assured that this learning remains relevant to you.

The DT contains two main categories of product; medicinal products and medical devices. In simple terms the pharmacy will be paid for supplying any medicinal product as long as it is not in part XVIII the 'blacklist' and will be paid for supplying a medical device as long as it is named in part IX A, B, C or R (Parts 2-6 & 9 in Scotland). Difficulties arise when deciding if an item is a medicine or a device.

Let's look at medical devices first.

The easiest way to tell the difference between medicinal products and medical devices is to look for a CE mark which signifies that the item is registered as a device. The CE mark can normally be found on the packaging of a device, on the instruction leaflet and sometimes on the device itself.

CE or not CE, that is the question!

What is the CE mark and how does it affect us in pharmacy?

A CE mark needs to be applied to a medical device so that it can be marketed in Europe. The mark is applied by the manufacturer. The CE mark itself means numerous things.

It means firstly that the device itself has met the required standards; it is safe and works as it should do. This is verified by an Independent Certification body (Notified Body). The MHRA is responsible for appointing the UK Notified Bodies and to make sure they perform to high standards. The MHRA regularly audits these notified bodies to make sure that this is the case.

So how does the CE mark affect us?

The CE mark denotes that the product is a registered medical advice and devices can only be supplied if they are specifically named, including the pack size, in the appliance sections of the Drug Tariff, parts IX A, B, C and R.

If you have the product in stock, you can easily check the packaging to see if it has a CE mark – but what to do if you do not have sight of the product itself? There are a number of ways to check if a product is registered as a device:

  • Check the Dictionary of Medicines and Devices (DMD): this online resource gives details of the vast majority of healthcare products and will specify if a product is registered as a device or a medicine.
  • Check the manufacturer’s product website or contact the manufacturer for clarification.
  • Contact Numark Information Services on 0800 783 5709 option 2.

Examples of common appliances with a CE mark and listed in the Drug Tariff are:

  • Micropore Tape
  • Aknicare Lotion and Aknicare Cream
  • Bug Buster Kit
  • Appeel Medical Adhesive Remover

 

Examples of appliances with a CE mark and not listed in the Drug Tariff are:

  • IPhone 4s (CE mark clearly marked on the back, other smart phones are available)
  • NeilMed Sinus Rinse
  • Tena Pad

Never assume that a product is a medicine: you may think it is a medicine – but it could be a device.

A good example of this is sodium bicarbonate 5% ear drops - you may automatically think of this as a medicine but it is not, it is a device and is listed in part IXA of the Drug Tariff. Carmellose 0.5% unit dose vials, sodium chloride 5% eye drops, and Lumecare Advance 0.5% eye drops, are all similar examples of items classed as devices rather than as medicinal products.

Dressings are another good example where you must take care before dispensing. Dressings are classed as appliances and so to be dispensed must be listed in Part IXA. However, not every size of dressing that is manufactured will be listed in the DT. For dressings then, both the product and the size must be listed in order to dispense it.

A useful resource for checking if you will be paid for an appliance is the PSNC's "Dispensing on an FP10 database". This provides information on commonly queried medicinal products and appliances, as well as some supplements, foods, toiletries and cosmetics.

Finally, if a product does not have a CE mark then it is either a medicinal product, a food/nutritional supplement or a cosmetic/toiletry. These are discussed below.

Let's take a look at medicinal products

The Drug Tariff contains an extensive list of medicines along with the price that a pharmacy will be paid for dispensing on prescription. This list is called Part VIIIA and the medicines are split up into different categories based on availability. The categories are not important for our purposes; the point is that if a drug is listed in the DT then you will be reimbursed the set price for dispensing it.

So what if the drug isn’t listed in Part VIIIA? Does that mean it can't be prescribed?

No. Any drug, cosmetic or food can be prescribed on an NHS prescription unless it is named in part XVIIIB – affectionately known as "the blacklist". Technically, this means that a GP could prescribe a Mars Bar if they wanted to – it is a food and it is not on the blacklist – and a pharmacy would (with an appropriate endorsement) be paid for dispensing it. In this case, the local health authority would be asking the GP to justify their prescribing and of course the pharmacist would be likely to query the prescription rather than dispense it.

When dispensing a medicine that is not listed in the DT you must endorse the prescription with manufacturer, pack size and price. Failure to do so will result in the prescription being sent back for clarification. If the medicine is specially manufactured or imported then there are additional endorsing requirements.

The blacklist

The underlying principle of the blacklist is to try and prevent expensive over-the-counter products being prescribed at the expense of the NHS. This proves very difficult to achieve, particularly when the blacklist does not keep pace with new and amended OTC products. The result is a historical document replete with quirks and anomalies which we have to make sense of.

So how does the blacklist work? If a given product is named in the blacklist then it cannot be prescribed using that exact description. If dispensed, the item will be disallowed and the pharmacy will not be reimbursed for it. The key here is that it is the 'exact description' that is blacklisted. If an alternative description is used, for example the generic name of the product and that description is not in the blacklist then the pharmacy will be reimbursed for dispensing it. It is the product name on the prescription that is important, not the name on the packaging!

Let's look at a few examples of items in the blacklist:

The description Fiery Jack ointment, a medicinal product, is in the blacklist and therefore cannot be prescribed. However, its generic name of Capsicum 2.466% ointment is not blacklisted – if a GP prescribed generically then the pharmacy could dispense Fiery Jack and get reimbursed.

Complan is blacklisted and so the product cannot be prescribed. But the full product description (as given in the DMD) Complan Shake oral powder 57g sachets is not blacklisted and therefore can be prescribed.

Benerva 100mg tablets are blacklisted under their brand name of Benerva but can be prescribed generically as thiamine 100mg tablets. In this case, the GP cannot insist that Benerva is dispensed. You should choose the cheapest product available to you which may or may not be Benerva.

Daktarin 2% cream 15g is in the blacklist so it cannot be prescribed. But again, it could be prescribed using its generic name of miconazole 2% cream 15g which is not in the blacklist.

Selected List Scheme

There are some medicines that are only allowed to be prescribed on the NHS for certain patients or certain medical conditions. The classic example of this is the supply of Viagra (sildenafil) for the treatment of erectile dysfunction. Other examples include clobazam for the treatment of epilepsy and Nizoral cream (ketoconazole) for seborrhoeic dermatitis.

Full details are given in Part XVIIIB Drugs, Medicines and other Substances that may be ordered only in certain circumstances (Part 12 in Scotland). When using this list drugs in column 1 may be prescribed for persons mentioned in column 2, only for the purpose specified in column 3. It is for the prescriber to determine if the patient has the listed medical condition and they must endorse the prescription with "SLS". Where SLS is missing the prescription cannot be dispensed and must be returned for amendment.

Foods and nutritional supplements

There are many food products used to treat or manage various medical conditions; gluten-free foods, total meal replacements (e.g. Fortisip/FortiJuice), some baby milks and so on. Where foods are used in this way they are considered by the Advisory Committee on Borderline Substances and this is discussed below.

Nutritional supplements cover the whole range of vitamin and mineral products from vitamin A to zinc. Most vitamin or mineral products are not licensed as medicines (there are exceptions e.g. Fultium D3) but are allowed to be prescribed provided the description is not in the blacklist. In most cases, provided a generic description is used rather than a brand name or manufacturer then the item will be allowed on prescription.

Borderline substances

Some foods and toiletry preparations have the properties of drugs when used to treat a medical condition. These products are assessed by a committee, known as the Advisory Committee on Borderline Substances (ACBS), to decide if they are appropriate to prescribe on the NHS. If they are approved they are given the designation 'borderline substance' and listed in Part XV of the Drug Tariff. Where a borderline substance is prescribed, the prescriber should endorse the prescription "ACBS" – however, if the endorsement is missing the item can still be dispensed.

Part XV is split into three lists; A, B and C.

List A is an alphabetical list of products which have been approved by the ACBS committee. They are listed with the conditions that they may be prescribed for. In other words, for a borderline substance to be prescribed it must be intended to treat the specified medical conditions.

List B is a list of medical conditions combined with the products that can be prescribed for that condition.

List C no longer has any products on it but still exists in the DT. It was a list of products which have been considered by the ACBS but may not be prescribed on Form FP10. These are now included in the blacklist rather than List C.

Let’s have a look at some examples:

List A

Product: E45 EMOLLIENT BATH OIL

Conditions: Endogenous and exogenous eczema, xeroderma, ichthyosis and senile pruritus associated with dry skin.

Product: SMA LF

Conditions: Proven lactose intolerance.

List B

PROPIONIC ACIDAEMIA

  • MMA/PA Anamix Infant
  • XMTVI Asadon

GALACTOKINASE DEFICIENCY AND GALACTOSAEMIA

  • Galactomin 17
  • Prosobee Liquid and Powder
  • Wysoy

Actions and further reading

So, deciding if an item is allowed on prescription can be a complicated business, but is essential to your business – if you dispense an item and it is disallowed you will be out of pocket for the full cost, as well as your time and effort. The hope is that this CPD article raises your awareness of some of the issues and provides solutions to aid your decisions.

But, if in doubt – ask! The Information Services team is here to take your calls on all aspects of pharmacy practice, including the Drug Tariff. Our knowledge and experience of the Drug Tariff and related resources can be utilised to save you time and money – both precious resources.

Record my learning outcomes

Pharmacists