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NPA and Day Lewis defend PGD as DH and GPs raise concerns

Practice Pharmacy leaders have defended a patient group direction that allows the dispensing of 16 POMs – including antibiotics and inhalers – without a prescription, after the DH called a summit to discuss safety concerns.

Pharmacy leaders have defended an NPA scheme that allows the dispensing of 16 prescription-only medicines (POMs) without a prescription after the Department of Health (DH) and GPs raised concerns over the safety of the service.

The NPA, which developed the private patient group direction (PGD) service with Day Lewis, said it was "confident" that its "protocols improve access for people genuinely in need", after the DH requested a meeting to discuss the scheme.

Day Lewis, which has been piloting the scheme in pharmacies since October, also said it was confident that it was "both accessible and robust". 

The DH has requested a meeting with the NPA and Day Lewis to ensure patient safety was "not compromised" by the PGD

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The comments came after the DH said last week that chief pharmaceutical officer Keith Ridge had requested a meeting with the NPA and Day Lewis to discuss the PGD scheme.

It was important to ensure patient safety was "not compromised" by "getting medicines from other sources", a DH spokesperson said.

And "particular caution should be exercised in the use of antibiotics," the DH added. "Pharmacists should consider whether their inclusion in a patient group direction is absolutely necessary. This will make sure strategies to combat increasing antibiotic resistance are not put at risk."

But NPA director of pharmacy Deborah Evans said the scheme was "minimising" the risk of patients over-using antibiotics and patient feedback had so far been good.

She told C+D that the DH had requested further information about the four antibiotics featured in the PGD service and therefore, "as courtesy to the DH", participating pharmacies are not for now supplying trimethoprim, Zithromax, doxycycline and Ciproxin.

The British Medical Association's General Practitioners Committee (GPC) also raised concerns about the inclusion of asthma inhalers in the scheme. Chair of GPC's clincial and prescribing committee, Dr Bill Beeby said asthma patients could "run into trouble" if they weren't given the correct medical advice. 

"It's about being able to access appropriate medical advice, which is prevention rather than just [access to] a reliever. This is not an idle concern," he told C+D. 

But the NPA said it was about "emergency supply only". 

"This service helps to ensure patnnets have access to an important medicine for their symptom control, but they must have already been taking ventolin to qualify," Ms Evans said.   

Do you think the DH's concerns about the PGD are justified?

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S S Locum, Locum pharmacist

well said Rajiv. all comments fair and valid.Just one Q - where do u get the time??

Neil G, Locum pharmacist

Hmmm..interesting debate.

I think Rajive, its all good to be supporting the DH and the GPs. But I think your personal views are slightly mis-aligned with your proffession and slightly niave.

I do agree that pharmacists main priority should be looking after the patients and secondly trying to earn a living!

If you take the commercial aspect out of the equation for a moment and look at the concept, i think you'll agree its a great idea.

PGD's are formed with GP guidance. If they didn't think it was a good idea they wouldn't allow a PGD to be put into practice. Thats one check.

The risk assessment is a second check.

And the decision that the pharmacist makes is the 3rd check. I believe in my ability as a pharmacist to give out AB's for an obvious acute infection, i think you should too.

If you want to make it more stringent, then perhaps the e-learning should be more comprehensive and a test should be put into place to complete the understanding.

As pharmacists we must think outside the box. And our profession needs to be more respected by Primary Care and DH! What better way then to give us more responsibility! With the responsibility it is up to us to make sure we proove our worth by providing a great service to our patients!


Rajive Patel, Community pharmacist

"I think your personal views are slightly mis-aligned with your proffession" - well I hope so! This is what allows a debate to flourish. I have a point of view and it seems the majority of commentators have the opposed view. To go and say my views are naive, is a bit poor, but hey, you are entitled to your opinion.

Anyway you say:

"I believe in my ability as a pharmacist to give out AB's for an obvious acute infection, i think you should too."

Well this is fine. However, the DH and GPC are questioning the design of the PGD to see if it includes and respects Public Health Strategies relating to Antimicrobial prescribing. If you are up to date with Public Health agendas, you will be very aware of its importance at the moment. The GPC has raised issues around how diagnosis is made and that the correct AB is prescribed. These are very fair issues these bodies, quite correctly, make. In fact, the DH has a legal right to raise these points. This is what I support, the PGD's are scrutinized.

To full appreciate PGD's, you need to understand them. The law is clear that the majority of care should be provided on an individual, patient-specific basis, and that the supply and administration of medicines under PGDs should be reserved for those situations where this offers an advantage for patient care (without compromising safety), and where it is consistent with appropriate professional relationships and accountability. In determining the suitability of a PGD in meeting care needs, consider whether the patient’s needs can be dealt with as part of a homogeneous group or if they require an individual prescription to meet their specific needs.

Now a lot of the above is very subjective and open to interpretation. This is why we should welcome further interest from the DH and GPC. I am not here to say we cannot deliver PGD's, far from it. I am merely saying that we need to engage with healthcare stakeholders and understand their concerns. It would be NAIVE, if we simply went in as a PROFESSION and implemented PGD's wholesale and unilaterally.

This is not about proving to yourself weather you can complete a PGD, but how you implement it in your locality. You would be naive to pick it up from the NPA and implement it without discussing it with other local key stakeholders, including your patients/clients. I am merely saying, listen to the people who have concerns, engage with them and then set out your stall of being a "pharmacy champion".

Sachin Badiani, Pharmacy owner/ Proprietor

"With the responsibility it is up to us to make sure we proove our worth by providing a great service to our patients!"

Exactly. We need to prove that if there is a demand and evidence is recorded that patients want to get medicines through a private PGD, then where there is a local health need, the new commissioners will then commission the PGD through NHS via pharmacy.

The pharmacist and pharmacy staff, through training, are more than capable of providing these extra "private" services.

Secondly, this will make us more respected because of the responsibility providing PGDs entails. Pharmacy is not only where labels are stuck on boxes.

Rajive Patel, Community pharmacist

The DH and GPC are not kicking up a stink for nothing, they obviously have very real concerns about the execution and management of these PDG's in relation to provision of certain POM's.

At a time when Pharmacist's should be encouraged to work in alliance with other healthcare professionals to build and design collaborative care pathways, well this type of "opportunistic commercialism" just smacks in the face of this approach.

I certainly would approach PGD's with caution, and if I did employ them, I would thoroughly discuss implementation with all local stakeholders including GP's.

Davesh Patel, Locum pharmacist

I think you should be confident that you are a competent pharmacist to prescribe the POMs. Why do you want to be a cap in hand pharmacist ?

Gerry Diamond, Primary care pharmacist

Equally, it has raised the issue at DH level that pharmacists can offer these services privately and it is about patient choice and access.

Given the push for 'any suitable provider' why should not community pharmacists extend their expertise to provision of POMs on PGDs.

GPs are just as equally commercial with private and NHS income streams actively practiced. Clearly community pharmacy cannot solely depend on the PSNC and NHS to deliver a living wage.

I say good luck Day Lewis and hope it works out..

Rajive Patel, Community pharmacist

You seem to missing the point, Gerry. This is not about commercial opportunity, but rather patient safety. There are valid and very serious concerns, especially relating to Antibiotic PDG's which could quite rightly affect and risk overall strategies to combat increasing antibiotic resistance. In addition where is the rationale where a specialised asthma nurse cannot give out a salbutamol inhaler, despite extensive clinical training and how can it be safe for pharmacies to sell them after completing an e-learning module. Add further, that despite promised of safeguards, what prevents asthma suffers to move from pharmacy to pharmacy to "buy" salbutamol inhalers and by doing so, fall outside the scope of GP managed healthcare. As the DH has quite rightly pointed out: "It is important that if getting medicines from other sources, patient safety is not compromised.".

Gerry Diamond, Primary care pharmacist

Did not say it was about money. I said it was about patient choice and access and if people want to pay for it then let them.

Rajive Patel, Community pharmacist

For reference, MHRA guidelines on drawing up PGD for anitmicrobials. As you will read, this is not a straight forward matter of simply drawing up PDG's and executing, but there needs to be not only patient safeguards but also consideration of public health policy. Therefore, it is very appropriate that the DH look into these PDG's extremely thoroughly to assess patient safety and that the PDG's are in line broad public health strategies.

Particular caution should be exercised in any decision to draw up PGDs relating to antibiotics. Microbial resistance is a public health matter of major importance and great care should be taken to ensure that their inclusion in a direction is absolutely necessary and will not jeopardise strategies to combat increasing resistance. A local microbiologist should be involved in drawing up the PGD. The local Drug and Therapeutics Committee or Area Prescribing Committee, where they exist, should ensure that any such directions are consistent with local policies and subject to regular external audit.

Davesh Patel, Locum pharmacist

Do you think your local GPs are really bothered about the theoretical aspects of bacterial resistance ? And do you seriously think that repeat prescriptions for salbutamols are MONITORED ?

Rajive Patel, Community pharmacist

Davesh, it is precisely these views that tarnish pharmacists as "shop-keepers" rather than serious healthcare professionals that can influence local healthcare provision. I would say if GP's dont take aspects of public health seriously then they are falling foul of standards of healthcare delivery, however, from my experience GP colleagues are more than adequate in their current knowledge of public health and local health strategies.

Ramesh Menon, Community pharmacist

I am not sure who is sounding more like a shop-keeper. Anyhow if we do what we have been doing then obviously we would be called 'shop-keeper'. I am with day lewis, a image makeover is needed and i am sure PGD's can help.

Rajive Patel, Community pharmacist

I would also express opposition to the scheme for community pharmacists to supply beta-agonist inhalers on a PGD. The rate of patient usage of these inhalers can be the clearest indicator of over-use either because of deteriorating control or poor inhaler technique. In either case, this needs to be checked out by a competent practitioner with access to monitoring equipment such as spirometers.

Davesh Patel, Locum pharmacist

Yes , I am also against us supplying salbutamol inhalers except under REAL emergencies which in my extensive experience is extremely rare. Patients know it is quicker and painless to obtain one from a pharmacy and there is nothing stopping them from going to multiple outlets. Why the PSNC or our "professional" body did not make it mandotary to notify the patient's GP via suitable prescription forms for ALL supplies for any condition or reason and attrack proper fee is regretably incomprehensive and may be reprehensive.

David Lewis, Community pharmacist

Didn't notice the DH or BMA creating a fuss when the big companies started their own PGD's for inhalers etc.

Paul Thomas, Other GP

How about letting GPs (as a suitable provider) supply these and other medicines privately?

No PGD needed!

Sam Somewhere, Pharmacy Area manager/ Operations Manager

I rarely comment however :

Assuming the consultation time of the GP has not been paid for by the NHS or the time any staff involved in the service (assuming they have been trained and not just sold from the receptionists desk ) that then dispense the item to the patient concerned. That space in the building is accounted for and deducted from NHS reimbursement including the stock storage space. Dispensing premises registered and meeting good dispensing practice etc and inspected in the same way?

That the sale of the private item is handled correctly for VAT

And of course if the patient can walk in without an appointment to get the service during the surgeries normal opening hours

If they did call in to see their GP on a moments notice on this basis and the GP willing to provide it most likely they would expect to receive an NHS service - and not expect to pay - would GP's want to send such mixed messages to their patients. Slippery road to I cant get an NHS appointment but i can get a private one ?

Pharmacy PGD's are not replacing an NHS service they are intended to extend access for example Travel Meds , where previously a GP wrote a private prescription . Other medicines can clearly fall into this space with the right protocols --- but the limiting aspect to this would always be the end user chooses to pay for such a service rather than to seek the free NHS service through GP appointment.

Gerry Diamond, Primary care pharmacist

Why not maybe getting a GP appointment, access and cost of the consultation?

Rajive Patel, Community pharmacist

The only valid points I can see from your position is choice and access for those that can afford it, therefore, this creates inequalities. On balance, these things may work in affluent areas, however, I doubt they would work in socioeconomically deprived areas.

In any event, I fully stand by the inquiries that the DH are making, and the issues raised by the GPC. Afterall, our ultimate goal is not the £, but patient healthcare.

Kevin Western, Community pharmacist

Anyone whop thinks that there is a thorough screening process before trimethprim is handed out at surgeries is deluding themselves so why shouldnt a well set up PGD service work at least as well if not better?. Chlamydia treatment is fixed - no matter where you go it is azithromycin or doxycycline once it is diagnosed by a lab so what is the difference if it comes via PGD (where was the objection to PCT provided PGDs?) or from a GP surgery? Ciprofloxacin for travellers diahrroea is arguable until you are abroad and get ithen off you go to your local (foreign0 pharmacy and buy whatever antibiotic is on offer effective or not - why not be prepared and use the reccomended antibiotic with some hope of treating it effectively? Oh by the way it put some much needed money in our coffers, raises our profile , reduces the workload of the poor overworked GPs, and the patients dont have to wait a fortnight for an appointment - who loses?

Rajive Patel, Community pharmacist

And herein lies the problem. By suggesting GP's do not have adequate screening procedures before antibiotic prescribing is not the basis to support antimicrobial PGS's. GP's are qualified to prescribe and also work as part of the wider public health strategy on microbial prescribing. Antimicrobial PGD's could be seen to be rogue procurement mechanisms if they are seen to fall outside of the scope of public health strategies.

In addition, to say that GP's dont follow antimicrobial prescribing protocols, is no better than a GP saying that all a pharmacist does is to stick labels on boxes. It is complete nonsense.

Stephen Eggleston, Community pharmacist

Rajive - all good & fair points. - But who's to say the pharmacists, after suitable training, can't/won't follow guidelines (whoever compiles them).
As for excessive supply of medications, how many asthma patients get a salbutamol inhaler even though they are due to be seen for review - this is not a criticism of the prescribers by the way - becuase the prescriber finds themself in a difficult position - do not supply until patients attend review and risk an excaserbation which lands the patient in hospital (at huge cost) or worse! - or supply and be haranged for not adequately overseeing prescribing?
I think we have a number of different issues all trying to be discussed at one time
As a PS to Paul Thomas - if you have time to see patients privately, why are there so many complaints (generally) about access to GP services and hence an opportunity
for PGDs - since PGDs are only there to increase access

Kevin Western, Community pharmacist

I'm sorry but if you havent come across a patient who has rung up a surgery to tell them they have cystitis and been issued with a script for trimethoprim then you have led a very sheltered life! I dont understand what the problem is - as long as we do them properly, there is little or no difference between a patient going into a surgery, being asked the relevant questions by a nurse and being issued with a script and us doing the same thing but charging for the convenience.

Rajive Patel, Community pharmacist

Look, lets get one thing straight, I am not against PGD's. My only point is that the GPC and DH have some very valid concerns. I agree with these concerns. The designers of the PGD's need to work to address these concerns. They will address these concerns by putting safeguards in place and also that the PGD fits in strategically with overall public health strategies, as relates to anti-microbial prescribing.

On a wider topic, PGD's do have a place in the primary care setting, so far as access is concerned. However, paying for access to POM's, via PGD's, creates inequalities. I have heard arguments, such as it will free up the doctor, it will mean patients can be seen without appointment...but what if the patient can not afford to pay??

Where I see real benefits of PGD's is if they are implemented where there are local access needs and it takes into account all local healthcare stakeholders. Not only is this collaborative, but it could ultimately be funded by local healthcare commissioners. It can address the issues of access and inequalities, since less well off patients would not be discriminated from a valuable service.

Perhaps service designers like the NPA, in this instance, should work alongside commissioners or nationally, through the NHS CB, to see if PGD's could be funded and delivered by the Pharmacy First Schemes, that operate very successfully to combat access issues and ultimately help reduce resource drain on the rest of the NHS, including A&E visits.

Gerry Diamond, Primary care pharmacist

Bit of back tracking Rajive dont you think. Glad to see that you can admit being wrong!

Rajive Patel, Community pharmacist

No I'm not back tracking. Please read my posts, far from it. I'm trying to engage in a debate, however, it is pointless when you get childish posts coming from the sorts like you. ;-)

Kevin Western, Community pharmacist

sorry I am losing the ability to type!

Rajive Patel, Community pharmacist

I would urge anyone looking to introduce PDG's to do so whilst respecting and being mindful of current local provision and also introducing other local healthcare stakeholders, such as GP's, into the implementation planing process. Acting unilaterally, may raise short term income, but possibly at the cost of ruffling the feathers of your local GP. It is essential that local services are planned and discussed with local stakeholders.

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