Guest post - Social media and blogs

I've not blogged for a while, so to kick things off here's a guest post written by a pharmacist whose identity I know but who wishes their post to be anonymous.

Social media and blogs are just what the internet was designed for.  The ability for anyone who has access to a computer anywhere to find out what someone is thinking on the other side of the world - in “real time”.

Just let that sink in. In Real Time.

Not 3 weeks later when a copy of a news paper or a journal lands on your mat.  But instantly. And it’s the views of a “small person” (in relation to a world leader).  And what’s even more amazing is that you can reply back, in real time....

Just take a moment to let that sink in.......

You can instantly communicate with someone, articulate your thoughts - disseminate ideas - discuss and learn.....all in the time it takes for a few key strokes to happen.

I would argue that this has been the greatest achievement of the late 20th/early 21st century...and...its greatest negative.

Take for instance right now.  I’m sat at a table, with my ear phones in, typing this into my phone whilst two men have a face to face conversation about all sorts whilst drinking tea or coffee.

I am totally disconnected from “reality” as I’m immersing myself about a blog to do with the digital world.

And there is one of the, if not the biggest drawback of being connected/being online. 

We lead so much of our lives online now, the lines blur and merge.  For youngsters it may even be able to not differentiate - to them it’s just life.

As more people go online - so it therefore means their work follows.  This is all good....but also bad.

People spend what seems like every waking moment cataloguing, replying, posting, liking, disagreeing, re-posting.  

There never seems to be a switch off.  Even on holiday - there seems to be an intrinsic need to take a selfie from a far flung shore or a picture of a relaxing alcoholic drink somewhere warm.

I’m just as guilty of all of the above.  I’ve been involved in the digital world from the early 1990’s, I’ve seen the evolution from message boards to social media platforms and have been involved in them all.

And whilst I still have “e-friends” from the very beginning on IRC (internet relay chat)....I’ve still not met some, across the various platforms, in real life. 

I do wonder looking back at nearly 25 years of internet connectivity and contrast to today - are we spending too much time online?

Everything is online in one form or another. 

But is this a good thing for us?

I am starting to feel that for professionals it isn’t.  We need a break from being online for our own sanity.  People seem to just live and breathe work online from the moment they turn their phone on/wake up until they go to bed/turn their phone off.

It’s instant gratification.

By that I mean you’re always checking to see what people have said, have people replied to something you posted or replied to something you have replied to.....it is extremely addictive and also very destructive.....

Instagram, snap chat (snap chat filters), Twitter, LinkedIn, Facebook; where does it end????

So whilst you read this, smile at the irony of me saying “disconnect more”.......

And then disconnect - have a day off, go for a walk in the woods, go swimming, read a book and listen to the radio or your favourite music, talk to someone random. Revel in human-human interaction!

The author is a practising community pharmacist who has been qualified for 20 years.

Administration of prescription only medicines - settling a dispute, the final part

Further scrutiny of the Human Medicines Regulations 2012 and discussion yesterday with expert colleagues has brought me to the conclusion that I was wrong.  This causes me much distress.  Not that I could be wrong, I sometimes am though not that often, but because the Regs leave the administration of non-parenteral POMs effectively unregulated.

In most healthcare settings additional governance is delivered by treating non-parenteral POMs in the same way as parenteral POMs, so administered by health professionals and prescribed or authorised under PGD.  Ambulance services appear to be the only health sector allowing unregistered staff to administer non-parenteral POMs under a local protocol.

Hmm.

Administration of prescription only medicines - settling a dispute: part 2

Ah well, my initial idea didn't stand up in court.  I accept @aptaim's comment that 'administration' inherently contains an element of supply and 'supply' (as defined in the Regs) does not apply.

I'm reviewing the other relevant Provisions of the Regs to see if anything negates the interpretation used by ambulance services.  I've not found anything yet...

If this interpretation is not negated then it opens up a spectrum of opportunities for administration of non-parenteral POMs by a range of persons operating within a regulated service under local protocol.

Hmm

Administration of prescription only medicines - settling a dispute

It's common practice in ambulance services for staff members, both registered and unregistered, to administer non-parenteral Prescription Only Medicines to patients under the 'authority' of locally drawn up organisational guidelines.  The argument is that anyone can legally administer a non-parenteral POM and the ambulance service can 'possess' the POMs so no further legal authority is required to administer them.  This article in the Journal of Paramedic Practice covers the rationale.

I dispute that this is a correct interpretation of the Human Medicines Regulations 2012, as if this were the case there would be limited need for the exemptions in Part 12 Chapter 3 - for instance why do other healthcare services bother using Patient Group Directions for administration of non-parenteral POMs if a local protocol would do?

So I refreshed my memory of the HMR and gave it some thought.  Here is my understanding of the Regs.

Provision 214 states:
(1) A person may not sell or supply a prescription only medicine except in accordance with a prescription given by an appropriate practitioner.
(2) A person may not parenterally administer (otherwise than to himself or herself) a prescription only medicine unless the person is - 
     (a) an appropriate practitioner other than an EEA health professional; or
     (b) acting in accordance with the directions of such an appropriate practitioner.

• From 214-2 it can be deduced that a person MAY administer a non-parenteral POM without being either an appropriate practitioner or acting in accordance with the directions of one.  
• Sale, supply and administer are three distinct activities, defined in the Regs. 
• A person could administer a POM to a patient, with no additional authority, providing the patient legally possessed the POM. 
• If the patient didn't possess the POM, the person would need to SUPPLY the POM to the patient prior to administering it.  Supply is not permitted under 214-1. 

 I rest my case...

A community pharmacist's ethical dilemma - the sequel

When I posted my last blog 'The community pharmacist's ethical dilemma' I said that I may share my views in a future blog.  So here they are.  I waited a while as I was asked by one of the pharmacy schools if they could use my blog as a discussion tool for their students and didn't want anything I posted to influence people forming their own opinion.

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.

 

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

• 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).

 

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

• 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.

 

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?

• 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.

 

Do you agree?

These are my personal views based on the regulation and professional guidance information I described in my previous blog.  Do you agree?

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:

Benefits

• Improved access
• Improved clinical outcomes
• Improved public health
• Enhanced customer involvement
• Economic benefits

Risks

• 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.

Discussion

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?

Police custody healthcare - models of service

Historically, police custody healthcare provision in the UK had been provided by the police surgeon (also known as forensic medical examiner FME).  In recent years there has been a move to include other healthcare professionals (HCPs) such as nurses and paramedics, with the current preferred model as nurse-led.  (Paramedics can have a role in provision of urgent care but as their training is specifically targeted and far narrower than that of a general nurse they are not widely employed).  This model is appropriate as many detainees will present with minor injuries or conditions which can be ably managed by a nurse with the relevant experience and training.  However, practical implementation of the model can provide areas of weak governance unless the risks are identified and managed.

It is commonplace for Patient Group Directions (PGDs) to be used as a means of providing timely access to prescription only medicines without the need for assessment and authorisation by an appropriate prescriber.  A PGD is a legal instruction that must include specified information to give defined categories of HCPs the authority to administer or supply the medicine.  They are intended to be specific and clear regarding inclusion and exclusion criteria to support permitted HCPs who do not have the skills and competence of a prescriber.  PGDs were introduced into police custody in 2003 with Home Office Circular 026/2003:

'The extension of PGDs to police station custody suites will allow named healthcare professionals, other than medical practitioners, to supply and/or administer (but not prescribe) medication for minor ailments and injuries without having to call upon the police surgeon to prescribe medication in each individual case. PGDs will therefore assist in improving the delivery of treatment to detainees by shortening response times and will ensure that treatment for minor ailments in police custody suites parallels that provided in the NHS.'

An increasingly common model of healthcare provision is for the nurse-led service to be supported by one or two FMEs covering the police force area.  This will usually mean that the majority of advice consultations between nurse and FME will be by phone and the FME will only be able to attend to a limited number of detainees if required to do so.  Providing advice to another HCP regarding a patient you have not seen based on the HCP's assessment constitutes an area of high risk for a clinician.

Healthcare providers are also now commonly using PGDs for treating the symptoms of opiate and alcohol withdrawal.  It can be seem from the HO circular mentioned above that this area of treatment was not authorised in the original circular.  In 2010 I contacted the HO to ask if they had subsequently authorised use of PGDs in this clinical treatment area and received a response that they now looked to the Department of Health for clinical policy guidance.  Following contact with the DH, a pharmacist advisor and I drafted a brief policy statement, which unfortunately coincided with a change of government and is yet to be issued.

The Medicines and Healthcare products Regulatory Agency on PGDs states:

'The majority of clinical care should be provided on an individual, patient-specific basis.  The supply and administration of medicines under PGDs should be reserved for those limited situations where this offers an advantage for patient care without compromising patient safety, and where it is consistent with appropriate professional relationships and accountability.'

It is clear that PGDs should not provide the main vehicle for provision of medicines, particularly in non-minor conditions such as substance misuse, where they can provide prompt initial treatment until the detainee can be seen by a clinician with the expertise and ability to prescribe individualised care for the patient.  It is important that PGDs have clearly defined treatment periods as, although periods of detention are usually very short, they may be longer and clear referral criteria must be set.

Any service model must be assessed and demonstrable as able to provide a good standard of clinical governance.  Expert advisors must have professional expertise in this sector and be able to demonstrate their competence for the protection of providers, staff and patients.  Staff must possess the identified clinical and professional skills necessary to practice at the level required.  Medicines policies must be robust and comprehensive.  Anything less than excellence is not good enough.