pharmacists have been given powers to change prescriptions in new Regulations

[holyshedballs]

From Medscape January 31, 2019

in short, a pharmacist can a prescription in the event of serious shortage. the government will issue a "serious shortage protocol" to allow pharmacists to swap the prescription for some thing else.

Although the regulations are specifically about serious shortages, I think that we have look out for PrescQipp et al advising the ministers that T3 should be included as a drug that in serious shortage due to the price.

Ironically , if local chemists and the NHS were allowed to buy T3 fro Europe, the price would come down.

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medscape.com/viewarticle/90...

The British Medical Association (BMA) has objected to new powers granted to pharmacists to change GP patient prescriptions to alternatives in the event of a 'no-deal' Brexit.

From the 9th February 2019, pharmacists would be able to alter the strength, quantity or type of drug, without a GP's permission - as long as it has a similar effect as the original.

The measures were contained in the Human Medicines (Amendment) Regulations 2019, presented to Parliament almost 2 weeks ago. legislation.gov.uk/uksi/201...

The BMA said it was not appropriate for pharmacists to switch drugs without authorisation from an independent prescriber.

Amendments to the legislation followed discussions between the Department of Health and Social Care (DHSC) and pharmacists, doctor, and patient representative bodies. It came as a new general practice contract gave a greater role for pharmacists to alleviate pressure on primary care.

No-deal Brexit Preparations

The change to the powers was given fresh impetus with the possibility of a 'no-deal' Brexit in March. Last year, the Government said it was putting in place additional contingency plans for if the UK left the European Union without a deal.

Pharmaceutical companies who supplied NHS patients with medicines from, or via, the EU or EEA, had been asked to ensure they had a minimum of 6 weeks' additional supply in the UK, over and above their business-as-usual buffer stocks.

In a letter to pharmacists earlier this month, Dr Keith Ridge, chief pharmaceutical officer at NHS England, said that new powers would "enable community pharmacies to dispense against a protocol instead of a prescription without going back to the prescriber first".

'Not Appropriate': BMA

Commenting on the legislation, a spokesperson from the BMA said: "GPs and their teams have to contend with medicine shortages on a daily basis, much to the frustration of staff and their patients, and there are obvious concerns that a no-deal Brexit could exacerbate existing issues.

"This legislation is intended to minimise disruption to patients, GPs and pharmacists in the event of a serious shortage, building on how GPs and pharmacists are already working together locally to deal with current issues.

"However, we do not believe that it is appropriate for pharmacists to change patients from one drug to a different one without authorisation from an independent prescriber.

"Crucially, it is imperative that the specific details of the new rules and their practical application are developed by clinicians, and clearly communicated to doctors, patients and pharmacies."

Pharmacist Concerns

The Pharmacy Defence Association (PDA) said that while pharmacists were keen to ensure that patients would continue to receive their medicines, it had concerns about the impact on pharmacists at work.

In particular it was concerned that pharmacists would have to spend time explaining to patients and carers what alternative options existed in the event of a medicines shortage crisis.

"Employers need to make sure pharmacists are given the extra time, clearly agreed processes and appropriate supporting communications," it said in a statement.

"They must protect their employees and locums from any aggressive behaviour that could come from frustrated and concerned members of the public.

"The government has the responsibility to support employers in this, but if the government fails to do so, this in no way removes the obligation on employers to look after each employee or locum for whom they are responsible."

medscape.com/viewarticle/90...

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[Aurealis]

Thanks holyshedballs.

I despair. The country is run by lunatics (sorry lunatics out there, I mean no disrespect to you ... or me)

The NHS is not run. We have the jokers in charge. Oh dear. Hope we all have plenty of supplies or a flight out booked.

I’m sure there are pharmacists who aspired to be a pharmacist, but I assume many of these aspired to work in a technical back room environment not in a customer facing position. Many pharmacists are people who aspired to be doctors but didn’t make the grade - yes let’s give them the right to lord it over doctors and poor patients. Our society could turn uglier still very quickly

[bantam12 in reply to Aurealis]

That's quite disrespectful to Pharmacists, my sister has been a senior hospital Pharmacist for many years, she has far more knowledge about medications than Drs and in fact gives lectures to hospital Consultants about meds, doses and contraindications.

I would have no problem having my meds changed by an experienced Pharmacist, I trust them more than my GP's any day !!

[Aurealis in reply to bantam12]

It isnt enough to be an expert about medication, that is exactly the problem. Medicine is about treating PATIENTS and getting them well, not giving out MEDICINES and making changes with no reference to the individuals needs. Its a different skill set, the difference between knowledge and applied knowledge. There’s a lot of blagging going on by pharmacists making decisions about prescription drugs in CCG, way beyond their area of expertise. There is no point in spending all the money that is on training doctors if a pharmacist with less expertise comes along and makes a swap.

[SilverAvocado]

Thanks for this great information!

[RedApple]

holyshedballs , Thank you for frequently posting very interesting and important information.

It would be much appreciated if you would also remember to include a link to your source, and to clarify which part of your post is your own commenting/opinions, and which part is a direct copy and paste from the article.

I have edited this particular post to add the link and to separate what appears to be your comment, from the article text.

[holyshedballs in reply to RedApple]

I’m off work with a terrible flu so I may have missed the quotes

I thought I had included the link to the article and the regulations so thanks for checking

[RedApple in reply to holyshedballs]

Rather than rely on quote marks, if you use a line separator like I have it's much clearer. Hope that flu makes a rapid departure

[Dinkers]

I can see this being a disaster. How do pharmacists know if have an allergic reaction to certain drugs there swapping you to without obtaining your medical records.

[bantam12 in reply to Dinkers]

Would you not tell them if you had an allergy !

[Dinkers in reply to bantam12]

I would, but some of things i have reactions i just cant pronounce which would mean a delay in getting my prescription while I contact my doctor to check.

[bantam12 in reply to Dinkers]

Perhaps make a note of them and keep it with you in case of emergencies and you can't contact your Dr.

[Dinkers in reply to bantam12]

While I have the greatest of respect for my local pharmacist who is always on hand if I need advice I think I'll have to.

[Hidden]

I do apologise for the length of the following reply. What comes to mind is

"Fiddling while Rome burns!"

Too many have forgotten the advice from 2004 & 2006--------

June 2004. A Joint Position Statement of the American Association of Clinical Endo-crinologists, The Endocrine Society, and American Thyroid Association, on the Use and Interchangeability of Thyroxine Products

aace.com/files/position-sta...

“Patients should be maintained on the same brand name levothyroxine product.”

Conclusion:

Best Physician Practices:

Patients should be maintained on the same brand name levothyroxine product. If the brand of levothyroxine medication is changed, either from one brand to another brand, from a brand to a generic product, or from a generic product to another generic product, patients should be retested by measuring serum TSH in six (6) weeks, and the drug reiterated as needed. Since small changes in levothyroxine administration can cause significant changes in TSH serum concentrations, precise and accurate TSH control is necessary to avoid potential adverse iatrogenic effects.

October 2006. Bioequivalence of Levothyroxine The ATA Unveils New Data to FDA On Bioequivalence of Levothyroxine.

October 4th 2006 James Hennessey MD representing the ATA revealed that a survey revealed significant adverse events in patients

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[holyshedballs in reply to Hidden]

Thanks for a good post, but the regulations are in force now, so a pharmacist can swap medications if a SSP is in place. A SSP is issued by the Ministers (either of them acting alone or both of them acting jointly) in circumstances where the United Kingdom or any part of the United Kingdom is, in the opinion of the Ministers (either of them forming the opinion alone or both of them forming the opinion jointly), experiencing or may experience a serious shortage of a prescription only medicine or prescription only medicines of a specified description.

What concerns me is: how do the ministers come to the conclusion that a drug is in serious short supply? I have read in your link to the Pharmaceutical Journal that the marketing authorisation holder informs the minister of the short supply. So for example, Concordia (as was) is under pressure from the CMA reading its price for T3.

PrescQIPP and the Southern RMOC (pharmacists) think that T4 is a substitute for T3.

if Concordia (or PrescQIPP or an RMOC) concoct a story that T3 is under short supply, that can lead ministers to implement a SSP

This then leaves pharmacists open to swapping T3 for T4 and facing patient wrath.

[Hidden in reply to holyshedballs]

A factual Explanatory Memorandum should dispel all or any hyperbole -----

EXPLANATORY MEMORANDUM TO THE HUMAN MEDICINES (AMENDMENT) REGULATIONS 2019 2019 No. 62

legislation.gov.uk/uksi/201...

2.2 The instrument also provides for the sale or supply of prescription only medicines by retail pharmacy businesses under a ‘serious shortage protocol’ where there is or may be a serious shortage of particular prescription only medicines. These protocols would allow for substitution, in restricted circumstances, of a different strength, quantity or pharmaceutical form of a prescription only medicine, or a different prescription only medicine, to that ordered by the prescriber.

7.10 The power to issue protocols is a reserve power that the Department anticipates would only be used in exceptional circumstances. Protocol s for either an alternative quantity, strength or pharmaceutical form are likely to be more common than protocols for a therapeutic or generic equivalent, which would only be used in very exceptional circumstances, where appropriate.

7.11 Protocols for therapeutic or generic equivalents will not be suitable for all medicines and patients. For example, those types of protocols would not be suitable for treatments for epilepsy or treatments requiring biological products where the medicines that are prescribed 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 alternative is supplied.

7.12 The serious shortage protocol provisions provide an additional tool to manage serious supply shortages. The Department will continue to work with the industry, the NHS and the Medicines and Healthcare Products Regulatory Agency to mitigate the impact of supply issues on patients as it does now. The Department would always endeavour to discuss with manufacturers the supply issues relating to a specific drug before including it in a serious shortage protocol.

[helvella in reply to Hidden]

I am afraid, I still do not understand the basis on which a ‘serious shortage protocol’ can or would be implemented.

Quite clearly, 7.10 will easily be met - our current and immediate future situations are already exceptional circumstances.

7.11 appears to offer special treatment for some medicines/disorders but if the shortage is serious, just how are the patients going to get the medicines they need?

7.12 seems only to say that whatever was done before the ‘serious shortage protocol’ was implemented won't stop just because it has been implemented. I don't see that it adds much.

[knitwitty]

Brexit - The gift that keeps on giving!

[Aurealis]

Once in place it’s in place forever. Hope pharmacists have good professional indemnity insurance as I suspect they’re going to need it. It may be brought in under Brexit cover but it’s policy change masquerading as due to Brexit. Just how low are standards going to slip.