Tuesday, 19 April 2016

A community pharmacist's ethical dilemma

How it all began

Not so long ago, a group of pharmacists and I were discussing on Facebook a scenario where a GP tells a patient to buy some 0.5% hydrocortisone ointment from the community pharmacy to treat their blepharitis.  The discussion flagged up that 0.5% ointment is POM (Prescription Only Medicine) but the 1% ointment/cream is available OTC (over the counter) and then progressed to whether we would sell a product outside of it's licence, with a range of views being expressed.

A:  "But OTC hydrocortisone 1% not licensed for use on face...?"

B:  "I'd still sell off licence, but I guess that comes with experience?"

C:  "Sell off licence and record on PMR.  Not saying I would do that every time.  Case by case basis."

A:  "I'm experienced and know it can be used on face but are you covered to sell out of licensing?"

D:  "I wouldn't sell it off licence, and that's come with a lot of experience.  Pharmacist is then responsible for any adverse outcomes."

B:  "I guess it comes down to what people are comfortable with."

D:  "Interesting to see what your indemnity insurance covers..."

A:  "So would you sell chloramphenicol eye drops for anything other than conjunctivitis?"

D:  "No.  There's no point."

A:  "Licensing of products are there for a reason right?..."

B:  "No, because my ability to diagnose complex eye conditions is limited and it wouldn't £$**%& work [...] But if a patient came to me with a script for 1% hydro for use on face 15g, and they paid, I'd sell it to them, and be able to fully justify my decision."

The conversation continued and got me thinking.  I asked a random selection of pharmacists I came across what they would do and the outcome of combining the views of the two groups was that there was a roughly equal split between those who believe it appropriate for a pharmacist to recommend a product outside of its licence and those who think it would be problematic.
One comment relevant to the scenario above: "Makes it difficult if one pharmacist refuses due to licensing - patient goes elsewhere and they get the product."

I was interested in getting some more views, so...

The Twitter poll

I ran a poll on Twitter, and this is the result:

There were a few Tweet comments (including the use of Independent Prescribing, an alternative means of supply, which I'll pick up below.)  Here is a selection:

The result of the Twitter poll corresponded to the previous discussion with a spread of views from 'no' through 'it would depend on the circumstances' to 'yes'.

Regulation and professional guidance

Every pharmacist must be able to justify their actions and when considering what those would be they should take into account regulatory requirements and any professional guidance relevant to them.  I looked at the following sources for information relevant to the sale of a product ouside it's manufacturing authorisation (product licence).
  • Human Medicines Regulations 2012
  • General Pharmaceutical Council: Standards of Conduct, Ethics and Performance
  • Royal Pharmaceutical Society: Medicines, Ethics and Practice 
  • Medicines and Healthcare products Regulatory Agency (MHRA): Medicines and Medical Devices Regulation Guidance - How to change the legal classification of a medicine in the UK

Human Medicines Regulations 2012

I could see nothing within the Regulations specifically relating to this topic.

General Pharmaceutical Council: Standards

The second principle is relevant here:
2.  Use your professional judgement in the interests of patients and the public.
You must:
     2.1  Consider and act in the best interests of individual patients and the public.

Royal Pharmaceutical Society: MEP

Section 3.2.6 Reclassified Medicines states:
'It is appropriate that pharmacists involved in the sale of reclassified medicines are appropriately trained on relevant clinical and best practice aspects of the medicines [...] This is particularly relevant to newly reclassified POM to P medicines but also applies to all reclassifications and P medicines generally.'

The RPS website has a number of guidance documents.  Most of the documents follow the same layout and do not mention marketing authorisation (product licence) with the exception of the 'Quick reference guide for chloramphenicol 0.5%w/v eye drops/ 1%w/v ointment P medicine' which states:
'Pharmacists need to be satisfied when making a supply of chloramphenical P medicine that it is in line with its marketing authorisation...'

MHRA: Medicines and Medical Devices Regulation Guidance - How to change the legal classification of a medicine in the UK

Information from this guidance is relevant as it explains the procedures needed to be followed by a manufacturer.

'Following reclassification from POM to P or P to GSL, some products may be limited to specific indications with appropriate restrictions on strength, dose and pack size.'

Applicants are required to thoroughly evaluate potential switch candidates before intitiating with the MHRA.  An evaluation of the benefit : risk profile takes into account all data available.  The MHRA requires that the following benefits and risks are considered:

  • Improved access
  • Improved clinical outcomes
  • Improved public health
  • Enhanced customer involvement
  • Economic benefits
  • Inherent risks (e.g. safety/ADR profile)
  • Unintended misuse
  • Intentional misuse with therapeutic intent
  • Accidental ingestion
  • Intentional overdose
  • Worsened outcome due to self-management 
If potential risks are identified then this allows evaluation of risk minimisation proposals such as reduced indications, pack size, target population, dose etc.  Additional measures such as pharmacy training and educational materials may be required.

Independent prescribing

As mentioned above, some pharmacists who are independent prescribers indicated that they would consider prescribing if a suitably licensed product were not available OTC.  This is of course a separate legal activity that would require gaining consent from the patient to prescribe for them, dispensing and labelling an appropriate product if necessary, and the completion of a record.


Let's take a hypothetical scenario to explore the issues with some questions to stimulate thought.

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?

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?

What could be the reason(s) that use on the face is not included in the marketing authorisation? 

What is the impact on Mrs A of a delay in starting treatment by refusing to sell and referring her back to the GP?  Would this make any difference to your decision?

How do you think advising a use not included in the product's Patient Information Leaflet could influence Mrs A's approach to instructions of OTC medicines she purchases in the future?

Does your professional indemnity insurance cover the additional risk involved when selling a product outside of its marketing authorisation?

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? 

I shan't state my views now, but I may do so in a follow on blog...

What are yours?


  1. This comment has been removed by the author.

  2. The GP has prescribed 0.5% where I to sell 1% not only would I be fully responsible I would have to justify the sale of a stronger product. Supply outside the licensed indications requires the prescriber and supplier to take joint responsibility for any adverse effects in this case I as the pharmacist would be both thus being solely responsible, even if such adverse effects are accepted by manufacturer they are not recommending it for this indication thus can deny responsibility. As I understand it professional indemnity insurance does cover such supplies but would require me to justify supplying a stronger product, and TBH I suspect I'd have a hard time in absence of evidence. Personally I would and have referred patients back to prescribers in such situations, hopefully with a phone call or note to explain the situation to mitigate any delay in starting treatment.

  3. Thanks Ghostofcain, good points.