Layer 1

The 'exceptional' factors needed to grant pharmacists shortages powers

The DH would not confirm whether naproxen could be subject to a protocol

The government has shed more light on the “exceptional” circumstances required for it to empower pharmacists to dispense an alternative without first consulting a GP.

The Human Medicines (Amendment) Regulations 2019 order – which came into force on February 9 – includes provisions to allow pharmacists to dispense an alternative in accordance with a “serious shortage protocol” that could be announced by the government – rather than the prescription and without contacting the GP – in the event of a national medicines shortage.

The Department of Health and Social Care (DH) would only announce a protocol in an “exceptional and rare situation”, when other measures taken “behind the scenes” have been “exhausted or are likely to be ineffective”, it told C+D last week (March 22).

These measures include working with the Medicines and Healthcare products Regulatory Agency to “expedite regulatory procedures”, working with manufacturers to manage remaining supplies and “facilitating the import of medicines from other global markets”.

Unclear which drugs could be affected

However, the DH would not confirm whether it expects certain medicines – such as naproxen, which C+D readers have complained has been plagued by shortages for months – to be subject to a protocol.

It pointed out that since January it has been mandatory for manufacturers to report “information that may potentially interrupt the supply of medicines to us in a timely manner”.

“The DH also has close links with NHS networks, [which] are able to notify us about any supply disruption the NHS is experiencing.”

“Several steps will need to be undergone before a protocol is issued, such as exploring all other options to mitigate a supply issue, considering whether a protocol is appropriate, and securing the expertise from clinicians in the relevant area to provide the clinical content for any protocol,” it added.

The DH said it was unable to respond to C+D’s request for the specific job titles of the clinically-chaired governance group, which is developing the framework to consider the suitability of a protocol.

Legal challenge

Not-for-profit organisation the Good Law Project launched legal proceedings against the DH last month, arguing the government had pushed through the regulatory changes “without proper consultation with patient and clinical groups”. 

An oral hearing took place yesterday (March 26) at the Royal Courts of Justice in London and the decision is expected on Friday.

Result

Would you be happy to dispense an alternative under a government 'serious shortage protocol'?
Not sure. It would depend on the specific protocol
41%
Yes, I would be confident dispensing an alternative (quantity/dose/form/therapeutic equivalent) as designated by the government
48%
No. I would never be comfortable dispensing an alternative (quantity/dose/form/therapeutic equivalent) without consulting the GP
11%
Total votes: 118
6 Comments
Question: 
Would you be happy to dispense an alternative under a government 'serious shortage protocol'?

N O, Pharmaceutical Adviser

Keith, your reply point by point looks fantastic (in theory and on paper) But practically, I don't think what you are proposing make a comfortable transaction for anyone.

1. If what you said is right, then, why have a special legislation, why not incorporate these in the main law to allow a Pharmacist to sustitute medicines they cannot get hold of??? 

2. We all do let them know about allergies and side effects when they are started on a new medicine. I'm sure you have heard of NMS. But the problem is, when the patient is already stressed that the regular drug is not available, what do you think goes in their minds when you replace their medicines withou being approved by their GP? Any thoughts ????

3. """Errors - you will be accountable for - just as you would if you supply the wrong thing on the Rx in the first place.  Thats why prescription medicines aren't supplied by the local pound store.""" --- Surprising to see such a kind of response from the Chief Pharmacist (if you are, going by the name) Does the legislation cover for any evntuality after the sustitution without a prescription?? Who pays for the indemnity?? As you rightly pointed, the POMs are what they are and are not sold in a £££ shop, but they also carry a huge legal burden on the Pharmacists' actions in dealing with them. As long as you and your colleagues in the Ivory Tower promise us that no Legal action would be taken against us if things wrong, then we will be more than happy to follow your instructions.

4. """How does the GP know what is available?  What you have on the shelf?  They don't.""" Can I ask -- How do I know which medication is going to be out of stock every DAY?? What if I gave an item from my shelf and informed the GP and in the subsequent month even that Item went out of stock, should I replace with a 3rd medicine and let the viceous cycle play around?? If the GPs act quick when the first referral was made, there won't be a problem. They or their staff (your own CLINICAL PHARMACISTS) can pick up the phone and speak to the Pharmacist referring to decide what is best for the future for the patient and not for US. Also, have you given a thought about what if the GP does not agree with our sustitution ?? Will they put the blame back on to us for any ups/downs with patient's medical condition?? Do you think we have so much time in community to be spending on without being paid for, when it can be dealt with at the surgery where you have placed the novel CLINICAL PHARMACISTS.

5. I can go on and on, but finally as mentioned above WHO IS GOING TO PAY FOR ALL THIS. HOW WILL WE GET RE-IMBURSED FOR THE ALTERNATIVE WE HAVE SUPPLIED?????

Please look in to the actual troubles we face than just ranting about your theoritical proposals.

Keith Ridge, Pharmaceutical Adviser

Why have legislation?  Because the DH is preparing for Brexit.  Thats not to say there aren't potential uses elsewhere.  Why not have it all the time? Because the DH is preparing for unprecidented levels of problems.  If it works - maybe it should become part of norm.

What do you think goes in their minds when you replace their medicines withou being approved by their GP? Any thoughts ???? I'm hoping they think "I'm really pleased the health professional who is an expert on medicines is sorting this out for me rather than bouncing me back to my GP who will send me back with a new prescription that is also out of stock"  

Errors - why would there be any difference between supply on a prescription or under a shortages protocol?  If the prescription asks for paracetamol tablets and they are out of stock but you intend to supply paracetamol capsules and somehow supply something else then why would the handling of that supply be any different in law?  The law does not say it is illegal to make a mistake it says it is illegal to supply a POM other than in accordance with a prescription and the The Pharmacy (Preparation and Dispensing Errors – Registered Pharmacies) Order 2018 provide a defense in certain circumstances for doing so. Either you are grossly negligent  or the The Pharmacy (Preparation and Dispensing Errors – Registered Pharmacies) Order 2018 applies.

How do I know which medication is going to be out of stock every day? Manufacturers, Wholesalers and Hospitals are supplying the DH with daily SitReps.  Since January this has been mandated for manufacturers.

Have you given a thought about what if the GP does not agree with our sustitution ?  The protocol for an individual substitution is likely to address some of those concerns.   Many of the substitutions are likely to be the same active ingredients but a different strength tablet. Or a capsule instead of a tablet. 

Will they put the blame back on to us for any ups/downs with patient's medical condition? The concept of blame suggests you need to work more with your multi-disciplinary teams. This should not be about blame, this should be about using the legislation as an enabler to allow you to supply alternatives without needing to cause the patient and the wider team unnecessary extra burden when the expertise already exists in the pharmacy.  When a pharmacist (or patient) has a clinical concern about the appopriateness of a substitution they can of course discuss it with the original prescriber.  If it is likely that the substitution might not be completely identical and could result in variation in a patient's condition - would you not discuss that with the patient and if they had a concern encourage them to return to their GP, not to get blame, but to ensure the treatment is optimised.

Who is going to pay for all this? Reimbursement arrangements will be part of the protocol. But most likely you'll endorse the FP10 and submit it for payment.  

Its time for community pharmacy to embrace opportunities to support patient care instead of throwing barriers in the way.  If community pharmacy is to survive the evolution of technology, the internet, hub and spoke dispensing etc - they need to leave the dispensing bench and talk to their patients.

PS Its as likely that the Chief Pharmaceutical Officer of the DH is engaging in discussions on this website as it is that the other posters on here are called: N O, Lucky or Locum

Lucky Ex-Locum, Superintendent Pharmacist

I'd be perfectly comfortable doing it because I know what I'm doing, like we all do. However, I won't be doing this in practice for two reasons - it won't encourage GPs to not prescribe items we can't get and what about liability for any errors, allergies, side effects etc? No, I'll be referring everyone back to the GP I'm afraid.

Chris Locum, Locum pharmacist

It would just be the endless assessment of risk, SOP formulation and filling forms on a computer. Another 'opportunity' for those in the community setting to demonstrate how they can get involved with the understaffing, and potentially dangerous working conditions some are enduring.

Keith Ridge, Pharmaceutical Adviser

"It would just be the endless assessment of risk,"

Do you not assess risk when you supply a prescription medicine anyway?  Is that not infact your job?

"SOP formulation"

You should be using clinical judgement, not working to an SOP and algorithm beyond what the DH will supply.  You are paid as a clinical professional - time to behave like a clinical professional and not hide behind SOPs.  SOPs are for counter staff.

"filling forms on a computer".

I expect there will be some documentation of what you've done, to share back to the GP practice.  Sounds very sensible.

"Another 'opportunity' for those in the community setting to demonstrate how they can get involved with the understaffing, and potentially dangerous working conditions some are enduring"

Only some say they are working in dangerous conditions.  As a professional, it is that professional's responsibility to stand up to those conditions.   You must ensure you are working in a safe environment.

"I'd be perfectly comfortable doing it because I know what I'm doing, like we all do."

Great.

"However, I won't be doing this in practice for two reasons - it won't encourage GPs to not prescribe items we can't get"

How does the GP know what is available?  What you have on the shelf?  They don't.  There are countless pieces of feedback from GPs of them being told "X out of stock - please prescribe alternative" only for the alternative to then come back "Y out of stock - please prescribe alternative"

Tell the GP what you supplied as an alternative and they can perhaps prescribe that next time?  You are part of a team - lets behave like it rather than simply pass everything on to someone else.

 "what about liability for any errors"

Errors - you will be accountable for - just as you would if you supply the wrong thing on the Rx in the first place.  Thats why prescription medicines aren't supplied by the local pound store.

"allergies, side effects etc"

How about we all get out from behind the dispensing bench and TALK to a the patient.  Ask them about alergies. Warn them about side effects. OFFER them an alternative OR the choice to return to the GP practice for a different Rx.  Its not rocket science.  If you've done that, and documented that you did that what are you worried about?  Do you never sell medicines over the counter?  Do none of them cause allergies? Do none of them cause side effects?  In many cases you might be supplying 2 x 250mg instead of 1 x 500mg, or a capsule instead of a tablet.  There will be times you might be changing active ingredient.  I'd only expect you to do that where you felt it was clinically appropriate.

"No, I'll be referring everyone back to the GP I'm afraid."

Disappointing.

Really? Wow, Superintendent Pharmacist

You should be using clinical judgement, not working to an SOP and algorithm beyond what the DH will supply. ----

Making a clinical judgement with little access to clinical information.... good luck!

Job of the week

Pharmacist Manager
Wellingborough, Northamptonshire
Competitive