The Discussion
Mrs A comes into the pharmacy and tells you that her GP has recommended hydrocortisone 0.5% ointment for her face and said it can be bought over the counter. The 0.5% product is POM but the 1% product is P and could be supplied, although the product licence excludes use on the face.As the GP has diagnosed the condition and recommended the treatment, does that make the pharmacist any less professionally accountable for the sale?
- I don't think so. The GP has diagnosed the condition but has recommended to Mrs A to purchase the medicine over the counter so the GP is not involved in the transaction. The transaction is between Mrs A and the pharmacist so the pharmacist is entirely responsible professionally for satisfying themselves that the medicine is suitable for the intended condition as described by the purchaser. In addition to professional considerations of appropriateness, under The Consumer Rights Act 2015, the purchaser has the right to expect that 'the goods should be fit for the purpose they are supplied for, as well as any specific purpose you made known to the retailer before you agreed to buy the goods.'
What if the pharmacist sold the 1% ointment and advised Mrs A to use a very small amount, is that equivalent to supplying the 0.5% product? And why or why not?
- No. The 1% is double the concentration so the chances of being able to spread a 1% ointment to half the thickness of what Mrs A theoretically may have done for a 0.5% ointment is slim. It's hard to spread thinner than 'spread thinly' and there's no guarantee that Mrs A won't use too high a dose in these circumstances.
- Regular use of topical steroids can cause skin damage, such as thinning, changes in pigmentation, redness and dilated blood vessels. Although over the counter hydrocortisone 1% ointment should be used for no more than seven days, because of the 'inherent risks' of adverse effects coupled with 'inherent misuse with therapeutic intent' (using a larger dose than advised and/or using for longer than the recommended period of treatment) I believe that the MHRA would have required that facial use be excluded from the indication for the marketing authorisation (MA).
- Mrs A would experience a delay in starting treatment but I would make this as short as possible. I would explain why I could not sell the item, with Mrs A's permission I would contact her GP surgery and advise that I was referring Mrs A back for a prescription for the item and the reason. I would provide Mrs A with a written referral note as confirmation, with contact details should the GP wish to discuss the matter with me. No, it wouldn't make a difference to my decision as I consider I am acting in the patient's best interest overall.
- As a pharmacist I would be wary of telling a person that although it says something in the PIL it is ok to ignore it. This goes against the safety messages we regularly give to take medicines as directed. There is a risk that Mrs A may in the future decide that other medicines may be safe to use differently from the directions provided. People's approach to and beliefs about medicines vary considerably and it cannot be assumed that everyone would respond in the same way.
Does your professional indemnity insurance cover the additional risk involved when selling a product outside of its marketing authorisation?
- This will be for each pharmacist to check. I'm not currently practising as a community pharmacist so my indemnity insurance doesn't cover community practice.
As P medicines are awarded a marketing authorisation so that they are sold under the supervision of a pharmacist, if a pharmacist sells outside of the MA under what authority are they doing this?
- None. The award of P status will be dependent on the specific indications, strength and dose specified in the MA. As pharmacists must supervise the sale of a P medicine to ensure it is appropriate, there is no authority that permits them to advise on a different indication or dose. The RPS MEP mentions in its guidance on over the counter supply of chloramphenical eye drops/ointment that pharmacists should be satisfied that the supply is in line with the MA. I can't see any reason that this product should be particularly singled out , so consider the advice applicable to other reclassified medicines.
