PGD templates from PHE updated

Yesterday Public Health England published updated templates for the PGDs for Hepatitis A, combined hepatitis A+B and Revaxis for use in England.  See the full list of PGDs here.  These new documents (found under the section 'individuals at increased risk') will be valid until 31st October 2021 for these specific travel vaccines we provide in an NHS travel service in primary care.  Remember though, they cannot be used until signed off (in Section 2, usually found on page 4) by your organisation that has the legal authority to authorise the PGD. To remind you, NHS England has five regional teams as follows and I've hopefully identified the page on the websites where access to the PGDs are found:

North regional team

Midlands and East regional team

London regional team

South East regional team

South West regional team 

Some points of interest within the new PGD for combination hep A + B vaccine

The PGD for Twinrix, Twinrix Paediatric and Ambirix says

Inclusion for use within a travel context: are individuals over 1 year of age requiring Hepatitis A and Hepatitis B pre-exposure prophylaxis where hepatitis A and hepatitis B vaccination is currently recommended for travel by NaTHNaC (see the Travel Health Pro website for country-specific advice on hepatitis A and hepatitis B vaccine recommendations).

Criteria for exclusion

require solely hepatitis B vaccination for overseas travel purposes

Action to be taken if the patient is excluded
Individuals requiring solely hepatitis B vaccination for overseas travel purposes should be administered hepatitis B in accordance with local policy. However, hepatitis B vaccination for travel is not remunerated by the NHS as part of additional services and is therefore not covered by this PGD unless hepatitis A vaccination is also indicated, and a combined HepA/B vaccine is used.

Off-label use
The Twinrix® Adult schedule given at 0, 7 and 21 days is licensed for adults (that is those from 18 years of age) but may be used off-label in those from 16 to 18 years of age where it is important to provide rapid protection and to maximise compliance (this includes PWID) in accordance with Chapter 18 of ‘The Green Book’.

COMMENT 

• Were you aware the PGD specifies you need to use TravelHealthPro within your travel risk assessment when identifying the vaccine recommendation? 
• It's very useful that the off-label use of of Twinrix Adult for the 0, 7 and 21 day schedule and a 4th dose 12 months after the first dose can be provided under the PGD where insufficient time is available to allow the standard 0, 1, 6 month schedule to be completed.  
• The PGD says (under the section 'Dose and frequency of administration'): For travellers, vaccine should preferably be given at least two weeks before departure but can be given up to the day of departure. 
• Reference to the new Vaccine Incidence Guidance document republished on 19 September was also included 

Falsified Medicines Directive

Substandard and Falsified (SF) Medical Products represent a dangerous global problem.  There is quite a good video explaining the problem and the World Health Organization have a factsheet and links to further resources here.

A Falsified Medicines Directive (FMD) was adopted in 2011, aiming at guaranteeing the safety and quality of medicines sold in the European Union (EU).  The final stage of this initiative was adopted on 9 February 2019 when new rules on safety features for prescription medicines sold in the EU were applied.  This link will also provides information about global falsified medicines directives in progress around the world, this is certainly not just a UK or EU issue.  

The UK is governed by the EU directive just now and these rules mean that the industry has to affix a 2-D barcode and an anti-tampering device on the box of prescription medicines.  The EU published a video to explain the safety features.  An explanation has been published on the GOV.UK website regarding 'How the Falsified Directive Works'.  NHS Digital has a great deal of information - Falsified Medicine Directive implementation toolkits here  PHE have also published a document 'FMD guidance for recipients of PHE supplied vaccines here.  

This blog is aiming to provide basic information about the FMD - I have found it a complex subject and am no expert.  I hope the links provided will give you additional resources to research and understand the subject.

Information about this development was published in the April edition of Vaccine Update (page 11).  It said that vaccines used in the National immunisation programme would come under this new regulation and in practice this means that at the end of the supply chain before a vaccine is administered to a patient, the integrity of the product seal should be checked and the barcode on the packaging should be scanned to verify authenticity and register the removal of the product from the supply chain on a central database - this is the process of decommissioning.

The database for the UK is called the National Medicines Verification System (NMVS), supplied by a company called SecurMed UK, which comprises bodies representing manufacturers, importers, wholesalers and pharmacies.  Community pharmacy is represented on SecurMed UK jointly by the National Pharmacy Association and the Company Chemists' Association.  The SecurMed website has helpful information as does the ABPI.

Article 23 of the Directive found on page 28 provides Member States with legal flexibility regarding their respective supply chains about where the decommissioning process should take place.  Additional guidance on 'Article 23 providers', 'Healthcare Institutions' and 'Article 26 exemption' was published by the Medicines & Healthcare products Regulatory Agency (MHRA) in December 2018 - see here.

Within this document is says the UK has classed General Practitioners (GPs) as health centres and therefore healthcare institutions - that includes both dispensing and non-dispensing GPs.  Therefore GP surgeries must decommission medicines.   Here is a toolkit which has been produced for General Practice. 

Travel clinics are not defined in the further guidance about Article 23.  So the first thing is to assess the supply of the vaccines to the clinic whether directly from a manufacturer, wholesaler or pharmacy.  Article 23 then raises the question if they are regarded as a healthcare institution or pharmacy.  What is unclear is if the determination of a healthcare institution covers private travel clinics.  I've been discussing with colleagues and have made some further enquiries.  If and when I find out more I'll update this blog.  The general feeling just now from these discussions is that private travel clinics would probably need to decommission the vaccines and any other drugs administered or supplied to travellers they see in a consultation.

Having searched the online FaceBook forums for 'discussion' on this subject, there was limited information but what seems clear is that GP surgeries have nothing implemented as yet and little to no information has been forthcoming from their CCGs (from those that commented).  Private travel clinics also seem in a state of flux as to what should happen, but some clinics and community pharmacies have scanners already in place.

And then of course the chaotic developments regarding Brexit create another big question since this is an EU Directive.  But whatever happens on that in the future, the UK has and must continue to have a process in place on this important aspect of patient care.  The government updated a page on 'How we propose to regulate medicines if there is a no-deal Brexit' yesterday here but I didn't read anything further on FMD.  

I’m guessing for now the next thing is to continue to increase your knowledge of this important initiative, watch out for news from your CCG or Health Board or private travel clinic owners and eventually we will hear what exactly is to happen!  

Saving time recording your travel consultation!

Back in the summer of 2018 I had an EMIS template built which followed the lines of my travel risk management form found at item no. 2 here.  I put it out there for some of you to trial and it generally received great feedback.  The travel consultation is complex, but sometimes writing up the information to provide evidence of all you covered and advised takes huge effort and significant time.  However in my opinion this is essential not only as best practice, but to also protect the practitioner.

The template is divided into three sections - the tabs are at the top on the left hand side as you look at the screen.  As many answers as possible have been populated into the template so that you need to write very little, but of course the beauty of EMIS is that you can simply add in extra detail if you need to.  The original template had drop down menus.

However we have a wonderful new nurse at the surgery (David Piercy) who is an absolute wizard at EMIS templates.  David has altered the format so that instead of all the information being in a drop down menu template, it's now in a list so you can read it easily and check the box of the answer that suits the best.  It possibly makes the information on the template much longer but on the other hand acts as a great prompt within your consultation.

Added to this wizardry, David has now made it SNOMED ready.  I'm told that all EMIS users will be switched to SNOMED coding so the template has had the adjustments made in readiness.  Now this last sentence is all non-sensical to me but I thought I would add it because if you've used the template in the past and it's working you may still need this new version as the other one may not!

Anyway I hope this helps.  I've put the file into a 'space' you can download it from but it will only work when you import it into your EMIS software.  I have no knowledge about  this aspect (so please don't ask me questions about it), but hopefully someone in your surgery will be able to help.  Or you could Google 'How to import a clinical template into EMIS' because leaflets will certainly come up

SO TO DOWNLOAD THE NEW TRAVEL RISK TEMPLATE 
CLICK HERE! 

and then RIGHT click on the screen and do a 'save as' 

...... all I have left to say is 

And a plea from me - I'd really appreciate you completing a short survey after using the template for evidence that the work, effort and funding put in was all worthwhile (and it would then make a really different reflective account for my revalidation!)  

The survey is HERE.

p.s. I'm not sure such templates can be built in SystmOne but if anyone out there has the skills I'm very happy to work with you from the content perspective.  Please contact me via my website.  

For the FOURTH time - Indemnity cover for the private travel vaccines - but GOOD NEWS!

Having written three time now about this in March and then May and June  (the latter two blogs I have left up for now so click on the links) this time I'm writing with good news!

This is the detail from the RCN

"In April, a new state-backed indemnity scheme for general practice (GP) staff was introduced in England. The Clinical Negligence Scheme for General Practice (CNSGP) is operated by NHS Resolution. It automatically provides cover to nursing staff working in NHS GP services. It includes self-employed workers and covers all clinical negligence claims that arise from an act (or omission to act) on the part of someone providing a GP service that is NHS-funded in England. In Wales, a similar scheme, General Medical Practice Indemnity (GMPI), was introduced at the same time. Both schemes include travel vaccinations given in GP surgeries except for where vaccinations are paid for by the patient.

The RCN is now extending its indemnity scheme to cover this gap. This means both employed and self-employed RCN members who are providing any paid-for travel vaccinations from GP practices not included in CNSGP in England and GMPI in Wales will be covered by the RCN indemnity scheme".

There was a news item on the RCN website, but this has now disappeared (update on 12.03.22) but this is a useful podcast to help you here and well worth listening to.  Details about the RCN indemnity scheme are here

I've been a member of the RCN since I qualified and am delighted about this news - the provision will be very helpful for General Practice Nurses giving the private travel vaccines going forward. 

Clinical Negligence Scheme for General Practice - a THIRD time

Having written twice now about this in March and then May (the latter blog I have left up for now so click on the link) I am astonished to be writing yet again.

NHS Resolution have now posted a FURTHER update to the document called the Scheme Scope document posted  last month that informed us the CNSGP did cover us for the private travel vaccines given in General Practice.

This new document  dated 12 JUNE 2019 now overturns that advice and it says:

• Travel vaccinations and immunisations funded by the NHS are covered under CNSGP
• Travel vaccinations and immunisations for which patients have to pay a charge are not NHS services and therefore not covered under CNSGP   
• NB. The Department of Health and Social Care (DHSC) had understood that all vaccinations and immunisations, paid for or not, were NHS services. This was based on an understanding that these services were included in the Part 4 GMS contract as an additional service and so were to be regarded as primary medical services. 
• NHS England has clarified that whilst GMS and PMS contracts allow GP practices to administer and charge for certain vaccinations, when the patient pays for the vaccine or immunisation they are considered private health services, not NHS services.  
• DHSC has taken further legal advice and considered this issue carefully. Having done so it has concluded the administration of paid for vaccinations and immunisations are not NHS services so cannot be in-scope of CNSGP. 
• These vaccinations and immunisations are covered under MDO policies.

The document is found here and directly here - see pages 7/8 in the table of information.  So it would seem that if you give private travel vaccines you do need to ensure you have additional indemnity cover from a provider such as the MDU, MPAS etc.

Whilst there is a frustration over the mixed messages we have received to date, I think the important aspect here at the present time is to ensure you are covered if you are working in General Practice and giving any private travel vaccines (and I am guessing involved in malaria chemoprophylaxis as well).  Please make sure you sort this out and share the update with colleagues.

Indemnity in General Practice AGAIN

Back in March there were a number of queries on forums  about the Clinical Negligence Scheme for General Practice (CNSGP) in relation to the private vaccines we may give in General Practice (yellow fever, rabies, meningititis ACWY for travel purposes, tick borne encephalitits and Japanese encephalitis PLUS malaria chemoprophylaxis prescriptions.

The history

From 1st April 2019 NHS Resolution started operating a new state-backed indemnity scheme for general practice in England called the Clinical Negligence Scheme for General Practice (CNSGP).

The website describes what is and isn't covered.

It appeared at the time from enquiries to different medical defence organisations that the private travel vaccines weren't covered.  HOWEVER IT SEEMS THIS TURNS OUT NOT TO BE TRUE!

NHS Resolution have now posted a document dated MAY 2019 called the Scheme Scope document or found directly here.  It's a very useful document so please read.  

It says Travel vaccinations are covered by the CNSGP as long as these vaccinations are delivered under a GMS/PMS/APMS contract or under a sub-contract for the GMS/PMS/APMS services.  In practice, most travel vaccinations will be provided by general practice under a GMS/PMS/APMS contract. The costs of some are reimbursed to the GP practice in the usual manner under the GP contract terms but the costs of some travel vaccinations may not be reimbursable under the contract. For such vaccinations, legislation permits general practice to charge patients directly. This is still an NHS charge and an NHS service so is covered by the CNSGP. 

I think the reference to link to this would be Schedule 5 of the GMS contract from 2004 where it says 'The contractor may demand or accept a fee or other remuneration' then look at section
(g) which says 'for treatment consisting of an immunisation for which no remuneration is payable by the Primary Care Trust and which is requested in connection with travel abroad'.

This new Scheme Scope document doesn't mention malaria chemoprophylaxis but again in the Schedule 5 as above, if you look at section (l) it says  'for prescribing or providing drugs or medicines for malaria chemoprophylaxis'.

What I would say is this has been extremely confusing but I hope this is resolved now!  I've left the rest of the original blog below for information but it's still important you check out you have insurance for your nursing activities outside your NHS care as described on the NHS Resolution website - linked above!

I am currently covered for my work in a GP practice by their group practice policy (because there are a number of GPs using it, the organisation provide additional cover for their practice nurses at no extra cost), BUT making enquiries to this company I was informed that because of the new NHS scheme and that the premiums paid by GPs will be lower, there will be a charge for nurses to be added on to an indemnity policy in the future.  I was told this was approximately £525 if working up to 24 hours a week and £695 if working up to 40 hours per week.  I understand that this will happen when your policy is due up.  

Some years ago now the RCN stopped providing indemnity to practice nurses employed by GPs.  I remained in the RCN though, not only for the professional side, but their indemnity covered me for my self employed work, and other voluntary roles - see the RCN scheme. The information on their website is very helpful about this new development - see here.   Interesting to read on there that “The RCN has heard from members and non-members alike that some GP employers have told them that  they will no longer be purchasing indemnity cover from their medical defence organisations (MDOs). As a result, the MDO will no longer provide them with support for their other legal issues like employment advice, NMC referrals, inquests and many other potential legal issues - please go to the article to read more.  

My understanding is that the principles around vicarious liability for employees remain unchanged. It is not appropriate for a GP employer to try to shift that responsibility onto their employees, so if you're employed in a GP practice you should not be required to purchase your own cover because of these changes. Your employer should take responsibility for professional indemnity cover.  You will need this in addition to the Clinical Negligence Scheme for General Practice 

MMR and travel

I did a blog on MMR and travel back in December 2017.  Measles risk continues not only now in Europe but in other parts of the world as well.  The latest measles data is published on the World Health Organization website here which also provides links to other information including the measles fact sheet.

Look at the latest information on measles from NaTHNaC on TravelHealthPro in relation to your travellers.

The Vaccination of individuals with uncertain or incomplete immunisation status flowchart published by Public Health England (most recent edition November 2017) has excellent guidance regarding your course of action if doses are missed, and one of the statements is ' Two doses of MMR should be given irrespective of history of measles, mumps or rubella infection and/or age'.

Dealing with people born before 1970 has historically caused a greater quandary, but while the Green Book acknowledges this cohort are more likely to have had all three natural infections and are less likely to be susceptible, it states MMR vaccine should be offered to those who request it or if they are considered to be at risk of high exposure (see page 219).

The December 2017 issue of Vaccine Update clarified that ImmForm stock can be used - the exact wording says Central MMR vaccine stock (ordered from Immform) can be used to catch-up anyone of any age – this also covers opportunistic catch-up prompted by travel.   Moreover, it says an item of service fee can be claimed manually via the CQRS MMR programme for each dose of MMR administered to patients aged 16 years or over. This includes patients born before 1970 who have no history of measles or MMR vaccination.  See page 5 of the Vaccine Update issue 273.

There was further excellent information on MMR in the July 2018 Vaccine Update (Issue no. 281) which asked if 'you were up to date with your MMR' on page 5. And the CQC wrote mythbuster no. 37 on Immunisation of healthcare staff which includes MMR.  The relevant information is as follows: Measles, mumps and rubella (MMR) is particularly important to avoid transmission to vulnerable groups. Evidence of satisfactory immunity to MMR is either:

• a positive antibody test to measles and rubella or
• having two doses of the MMR vaccine.

Public Health England have published new leaflets about MMR available in English, Polish, Romanian and Somali.   Order hard copy from here