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Certain drugs not suitable for pharmacists' emergency shortage powers

Leyla Hannbeck: Patients receiving medicines under a protocol would be closely monitored
Leyla Hannbeck: Patients receiving medicines under a protocol would be closely monitored

It would be unsuitable for pharmacists to dispense alternatives to certain drugs under the upcoming shortages regulations, the NPA's director of pharmacy has confirmed.

The Human Medicines (Amendment) Regulations 2019 order – which is scheduled to come into force next week (February 9) – includes provisions to allow pharmacists to dispense an alternative in accordance with a “serious shortage protocol”, rather than the prescription, without contacting the GP, in the event of a national medicines shortage.

In its explanatory note published alongside the order, the Department of Health and Social Care (DH) stressed that “protocols for therapeutic or generic equivalents will not be suitable for all medicines and patients”. It gave the examples of “epilepsy or treatments requiring biological products, where the medicines...need to be prescribed by brand for clinical reasons”.

“In these cases, patients would always be referred back to the prescriber for any decision about their treatment, before any therapeutic or generic equivalent is supplied,” the DH added.

Based on the DH’s guidance, National Pharmacy Association (NPA) director of pharmacy Leyla Hannbeck suggested other medicines that may not be covered by a “serious shortage protocol” could include “those with a narrow therapeutic index”, such as warfarin and methotrexate.

“Drugs that have to be brand-prescribed, or insulins with different strengths, may be difficult to substitute,” she told C+D last week (January 23).

It would also be “unsuitable” for pharmacists to dispense alternatives to “anti-rejection drugs used in transplant patients”, such as mycophenolate or ciclosporin, “certain modified-release preparations that are not interchangeable” and “controlled drugs, especially those in schedules 2, 3 and 4”, Ms Hannbeck said.

“Medicines where patient familiarity with a specific brand is important and instruction for use may vary between brands” may also be unsuitable for any DH protocol, she added.

“However, in the event of the complete unavailability of a medicine, the DH may choose to initiate a [protocol] for a medicine that would have previously been considered unsuitable, to ensure that affected patients are not left without medication,” she added.

While the sector awaits further details on how the protocols will work in practice, Ms Hannbeck said “it would be expected” that any patients receiving medicines under a protocol would be closely monitored.

The DH stressed earlier this month that “any protocol would be developed with and signed off centrally by clinicians” before it is implemented.

Medicines stockpiling ahead of Brexit

As the Guardian reports some patients are stockpiling medicines in fear of disrupted medicines supplies after Brexit, C+D wants to know if you've seen any evidence of this. Vote in C+D's poll below and contact us anonymously with more details at [email protected]


Have you seen or heard any evidence of patients stockpiling medicines ahead of Brexit?
Total votes: 128
What do you make of the DH's "serious shortage protocols"?

C A, Community pharmacist

“Drugs that have to be brand-prescribed, or insulins with different strengths, may be difficult to substitute,” 

Reminds me of a conversation I had with out of hours doctors - Doctor "What do you suggest I prescribe, I'm not very good with insulin" - Yes really!

Leon The Apothecary, Student

That's fine. Doctors are human too, and they are clearly respecting your specialist knowledge.

C A, Community pharmacist

It's hard to convey in text, not really wanting to complain, but it felt like I substituted/prescribed a insulin at the time, as there wasn't the option to dispense the patients regular insulin as they didn't use our pharmacy, and I phoned around to see if anyone else did before contacting out of hours on the patients behalf. 

Looking at your more optimistic take - yes the patient got sorted and yes they got counselling before leaving on a different insulin, and yes they were fine when I phoned later to check. 

In closing my ramble there maybe circumstances when the right thing to do is substitute, even if it is difficult drug, and maybe a pharmacist could help?

Really? Wow, Superintendent Pharmacist

This is another article in stating the obvious.... !

What has not been mentioned anywhere is how we get paid for supplying said alternatives? 

Sam Pharmacist, Community pharmacist

My moto is taking something is better than taking nothing at all. I have changed all my Adalat patients to Adipine over the past few weeks due to unavailability and no doctor resisted my suggestions. Epilim to generic sodium valp and now sno-tears to liquifilm. I waste most my day suggesting alternative to receptionists (not doctors) who seem to go with the flow.

Paul Dishman, Pharmaceutical Adviser

I've now retired, but I wouldn't suggest an Epilim to generic valproate switch. That's one that would need careful individual consideration by the GP on a patient by patient basis

Richard Binns, Primary care pharmacist

have you referred to the MHRA guidance with regards to changing brands of epilepsy meds? my concern with changing epilim to generic sod valp is what happens if a stable patient then has a seizure and looses their driving license resulting in a loss of earnings? I think unless an explicitly documented conversation detailing the potential risks of switiching has been recorded in the patient notes, stating the patient acknowledges the risks and wishes to proceed, you could find yourself in a very vulnerable postition here.

If this is not in place, and the patient is unwilling to accept the risks (which most young, stable patients who drive, are not) I would be seeking advice from a neurologist.

Obviously this is in relation to sod valp in epilepsy, its use as a mood stabiliser is not such an issue with switching between brands.

Be careful with this one

Chris Locum, Locum pharmacist

I agree. Caution is called for in certain clinical circumstances. Good intentions can have consequences and legal action. Pharmacists have made enough suggestions to DOH over the years. They were ignored unless saving money was the outcome. I won't be acting on any such 'powers' when' we have the (potentially dangerous) working environment of community pharmacy as it currently stands: Poorly staffed, chaotic, bureaucratic, and high work-volumes.

Soon-To-Be Ex-Pharmacist, Superintendent Pharmacist

Shan't be using them. I'm not paid enough to do a doctor's job.

Leon The Apothecary, Student

I'm finding a lot of the time I spend talking to a receptionist, which for all the good they do, are not a suitable person for prescription management.

Soon-To-Be Ex-Pharmacist, Superintendent Pharmacist

True enough but once referred on it becomes an SEP. Cynical I know, but I've been in this sad trade for too long not to be.

Leon The Apothecary, Student

I'd love to see surgery pharmacy dispensers/technicians as the norm - I'd much rather talk to someone who understands why I want twelve months of the regular medications in sync on eRd for everyone's benefit.

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