COVID-19 has moved at such a fast pace, travel medicine seems a very low priority and I struggle to find much news to put on my FaceBook page about it really. I also realise that this is the only subject I've blogged about this year. I've now created a webpage of resources to take you to key sites for information, but to be honest, it's very hard to keep up with it all and I've reduced the time I listen to the news - I was finding it detrimental to sleeping well and coping with day to day work.
So although I'm fully aware of the situation, my usual news sources have changed. I wake to the headlines on Radio 4 at 6.30am each day, continue to refer to the Government resources, watch the daily Goverment briefings if possible and if not, catch a summary on the 6pm news.
I'm still blogging every two weeks (althugh as time progressed, they became a little less frequent) for the Royal College of Physicians and Surgeons of Glasgow in my role as Dean of the Faculty of Travel Medicine. They have a great COVID-19 landing page of resources here and my blogs can be found as follows: 31st January 2020, 14th February 2020, 28th February 2020, 13th March 2020 27th March 2020 10th April 2020 24th April 2020 15th May 2020 8th June 2020
Click the image below ot access the COVID-19 resources page on my website or here.
Tuesday, 31 March 2020
Saturday, 29 February 2020
COVID-19 Update
In just one month so much has happened and it's a challenge to keep up to speed. I've been writing a regular blog in my position as Dean of the Faculty of Travel Medicine of the Royal College of Physicians and Surgeons of Glasgow so I'm going to defer you to these and then below itemise some of the the most useful resources for us in our day to day jobs. The clear messages from the Government right now are correct hand washing hygiene and etiquette around coughing and sneezing.
here are a few key or interesting resources for COVID-19 - but not an exhaustive list!
For children
Here are the blogs from
here are a few key or interesting resources for COVID-19 - but not an exhaustive list!
- PHE & DHSC COVID-19: guidance for health professionals This includes guidance for primary care and travel advice.
- Public Health Matters Q&A webpage. Coronavirus – what you need to know here
- NHS page designed to help clinicians- doctors, nurses, dentists, opticians and other healthcare colleagues – deal with coronavirus (COVID-19) here
- WHO collection of resources here
- WHO Coronavirus disease (COVID-2019) situation reports here
- CDC collection of resources here
- Very interesting series of presentations - Royal College of Physicians COVID-19: An expert update for doctors on 12th February here
- NHS Overview Coronavirus (COVID-19) for the public here
- NHS resource: How to wash your hands here
- PHE Coronavirus (COVID-19) resources here
For children
- CDC collection of handwashing posters including some for children here
- The CBBC Newsround has published a short video with Dr Chris and Dr Xand - Coronavirus: Why it might not be as scary as it sounds I think we should all adopt the elbow shake!
Friday, 31 January 2020
Novel Coronavirus (2019-nCoV)
The purpose of this (rather long sorry!) blog is to lead you to key resources as the developments of novel coronavirus (2019-nCoV) unfold. Please note, as new resources become available I will post these updates right at the bottom of the page under the heading, Update on New Resources.
Background
On 31 December 2019, the World Health Organization (WHO) was
informed of a cluster of cases of pneumonia of unknown cause detected in Wuhan
City, Hubei Province, China. A novel coronovirus was identified as the cause
and was named Coronovirus (2019-nCoV).
Coronaviruses are a large family of viruses, some cause mild
illness, such as the common cold but others can result in more severe disease
such as Middle East respiratory syndrome (MERS) and Severe Acute Respiratory
Syndrome (SARS). Generally, coronavirus
can cause more severe symptoms in people with weakened immune systems, older
people, and those with long term conditions like diabetes, cancer and chronic
lung disease. The main symptoms reported for novel coronovirus (2019n-CoV) have
been fever, cough or chest tightness, and dyspnoea. While most cases report a
mild illness, severe cases are also being reported, some of whom require intensive
care and some deaths have occurred.
World Health Organization updates
The WHO publish a daily situation report and on 30th January 2020 recommended that the interim name of the disease
causing the current outbreak should be “2019-nCoV acute respiratory disease”
(where ‘n’ is for novel and ‘CoV’ is for coronavirus). At this time there were 7818 cases confirmed
globally of which 7736 were confirmed in China.
Of these, 1370 were severe and 170 deaths had occurred. Outside of China there were 82 cases in 18
countries. The report provides a global
map of the countries, territories or areas with reported confirmed cases of 2019-nCoV
and a surveillance table of the numbers within each location.
However, this is a rapidly changing picture and on 30th
January 2020 the WHO convened the second International Health Regulations (IHR) Emergency
Committee on novel coronavirus in China.
The Committee stated they believed that ‘it is still possible to interrupt
virus spread, provided that countries put in place strong measures to detect
disease early, isolate and treat cases, trace contacts, and promote social
distancing measures commensurate with the risk. It is important to note that as
the situation continues to evolve, so will the strategic goals and measures to
prevent and reduce spread of the infection’. As a result the
Director-General declared that the outbreak of 2019-nCoV constitutes a Public Health
Emergency of International Concern (PHEIC) and accepted the Committee’s advice
and issued advice as Temporary Recommendations under the IHR to the People’s
Republic of China, to all countries and then to the global community – full
details can be viewed here
A key page of very helpful resources from the WHO provides advice on protecting yourself,
travel advice, myth-busters, situation reports and technical guidance. It is suggested users visit it daily. The image below is one of the mythbusters, click on this image to view more.
News from the United Kingdom
In the UK our four Chief Medical Officers issued a press
release on 30th January 2020 explaining in light of the current situation they
considered it prudent for their governments to escalate planning and
preparation in case of a more widespread outbreak. For that reason, they advised an increase of
the UK risk level from low to moderate clarifying that this didn’t mean they
thought the risk to individuals in the UK had changed at this stage, but that
government should plan for all eventualities. To read in full see here
On the morning of 31st January 2020, the Department of
Health and Social Care (DHSC) announced two patients in England who were members of the same family had tested positive for coronavirus and were
receiving specialist NHS care, using tried and tested infection control
procedures to prevent further spread of the virus. These are the first cases identified in the
UK, but a very interesting blog prepared by Public Health England (PHE) explains
the NHS is extremely well-prepared and used to managing infections. PHE is a world leader in developing
techniques to aid the public health investigation of infectious disease and the
UK is one of the countries outside China to have an assured testing capability
for this disease. It is a complex test
which can differentiate this type of coronavirus from any other coronavirus.
Health Protection Scotland (HPS) have published resources including a comprehensive document on Wuhan novel coronavirus (WN-CoV) Guidance for Primary Care: Management of patients presenting to primary care
PHE have published a collection of helpful resources including guidance on aspects such as
initial investigation of possible cases, self-isolation for patients under going testing, infection prevention and control, guidance for primary care. This page also contains links to news and announcements All resources are reviewed and updated regularly. Also look at the PHE data on Novel coronavirus (2019-nCoV):epidemiology, virology and clinical features
UK Travel advice
Regarding travel advice, the Foreign and Commonwealth Office
(FCO) advise against all travel to Hubei Province due to the ongoing novel
coronavirus outbreak and against all but essential travel to the rest of
mainland China (not including Hong Kong and Macao). More details are found here, including a downloadable map. PHE were advising that anyone who had visited Wuhan in the
last 14 days, should stay indoors and avoid contact with others where possible,
and call NHS 111 informing them of your symptoms and recent travel to the city.
Individuals in Northern Ireland, should call their GP
However in a CMO alert sent on 31st January 2020,
(Alert Reference: CEM/CMO/2020/002) it was recommended that all travellers who
develop relevant symptoms, however mild, within 14 days of returning from
mainland China, should self-isolate at home immediately and call NHS 111. This document is essential information of
all clinical staff encountering patients with respiratory infections arrived
from overseas and can be accessed within in the attachments at the bottom of the page here or directly on the image left below. This page also provides a flowchart for
use in the Management of a suspected case of 2019-nCoV acute respiratory
disease or access directly on the image below right .
As the situation unfolds, ongoing updates will be available
by checking out the resources above but if an individual is planning travel
abroad then excellent travel advice is available from fitfortravel There is also a specific leaflet entitled
Novel Coronavirus (Wuhan, China) Infection
TravelHealthPro from NaTHNaC have advice for Coronavirus (2019-nCoV)
This current information for travellers
advises the following:
To reduce the risk of coronavirus infection all
travellers should:
- Maintain good hand and personal hygiene. Wash hands regularly with soap and water or a disinfectant before handling or consuming food.
- Avoid visiting live bird and animal markets, backyard or commercial poultry farms and do not touch wild or domestic birds (alive or dead).
- Avoid any contact with animals, birds or surfaces that may be contaminated with animal or bird dropping.
- Avoid eating or handling undercooked or raw meat including poultry, egg or duck dishes.
- Avoid close contact with anyone with cold or flu-like symptoms, or who appears unwell.Avoid sharing personal items.
To reduce the risk of passing coronavirus to others,
anyone with respiratory symptoms should:
- Cover the nose and mouth when coughing and sneezing with a tissue or flexed elbow
- Use paper tissues only once and dispose of them carefully
- Should a mask be worn, all the recommended precautions in order to minimise the risk of transmission should still be used
There is currently no preventive vaccine or specific treatment for Coronavirus (2019-nCoV).
- The WHO posted a great information video late on 31st January
- On 1st February PHE published a new page 'Guidance to assist professionals in advising the general public'
- On 2nd February the DHSC launched a Coronavirus public information campaign across the UK
- On 3rd February PHE published new information on Novel coronavirus (2019-nCoV): guidance for healthcare providers with staff who have travelled to China
- The CBBC Newsround has published a short video with Dr Chris and Dr Xand - Coronavirus: Why it might not be as scary as it sounds A great little clip particularly for children.
- BMJ Coronavirus resources here
- The Lancet 2019-nCoV Resource Centre here
- BMJ Best Practice COVID-19 here
Saturday, 28 December 2019
Polio Update
I continue to get many questions about polio and although I've written a couple of blogs about it in the past, here is a fresh one with the latest information. Some detail is taken from the previous blogs....
Here are the topics covered:
1. Explanation of the PHEIC for Polio and the latest news
A Public Health Emergency of International Concern (PHEIC) is a formal declaration made by the World Health Organization and one was called regarding polio in May 2014. As a result, the Emergency Committee (EC) meets every three months under the International Health Regulations (2005) (IHR) to review the situation regarding the international spread of polio virus. The intent is to stop polio being exported from these countries.
Polio will eventually be eradicated, but for now it's about controlling numbers of cases of wild polio virus (WPV) and also circulating vaccine derived polio virus (CVDPV). There's a map which illustrates the progress although in 2019, numbers increased rather than declined. This data is on the Polio Global Eradication Initiative site which has some excellent information explaining the situation, so maybe take the opportunity to look around.
The EC meets every 3 months. The latest meeting was held on the 11th December 2019, then posted on the WHO website on 20th December. Updates are then subsequently put onto the NaTHNaC (TravelHealthPro) and TRAVAX websites to inform you about this and any other polio information such as cases of CVDPV occurring in other countries.
2. Detail about the temporary recommendations and what your travellers need to know
This latest meeting named the following countries where implementation of the WHO Temporary Recommendations regulation are currently required. These are Afghanistan, Angola, Benin, Central African Republic (CAR), Chad, Cote d’Ivoire, Democratic Republic of Congo (DR Congo), Ethiopia, Ghana, Nigeria, Pakistan, Philippines, Togo and Zambia.
Please note the countries involved often change from one meeting to another so this is the situation at the time of writing this blog.
So what do you need to do as a travel health advisor seeing a traveller going to one of these countries?
3. Details about the ICVP and how to obtain them - this is guidance if working in England
Here are the topics covered:
- Explanation of the PHEIC for Polio and the latest news
- Detail about the temporary recommendations and what your travellers need to know
- Details about the ICVP and how to obtain them
- Details about who to charge for a polio containing vaccine
1. Explanation of the PHEIC for Polio and the latest news
A Public Health Emergency of International Concern (PHEIC) is a formal declaration made by the World Health Organization and one was called regarding polio in May 2014. As a result, the Emergency Committee (EC) meets every three months under the International Health Regulations (2005) (IHR) to review the situation regarding the international spread of polio virus. The intent is to stop polio being exported from these countries.
Polio will eventually be eradicated, but for now it's about controlling numbers of cases of wild polio virus (WPV) and also circulating vaccine derived polio virus (CVDPV). There's a map which illustrates the progress although in 2019, numbers increased rather than declined. This data is on the Polio Global Eradication Initiative site which has some excellent information explaining the situation, so maybe take the opportunity to look around.
The EC meets every 3 months. The latest meeting was held on the 11th December 2019, then posted on the WHO website on 20th December. Updates are then subsequently put onto the NaTHNaC (TravelHealthPro) and TRAVAX websites to inform you about this and any other polio information such as cases of CVDPV occurring in other countries.
2. Detail about the temporary recommendations and what your travellers need to know
This latest meeting named the following countries where implementation of the WHO Temporary Recommendations regulation are currently required. These are Afghanistan, Angola, Benin, Central African Republic (CAR), Chad, Cote d’Ivoire, Democratic Republic of Congo (DR Congo), Ethiopia, Ghana, Nigeria, Pakistan, Philippines, Togo and Zambia.
Please note the countries involved often change from one meeting to another so this is the situation at the time of writing this blog.
So what do you need to do as a travel health advisor seeing a traveller going to one of these countries?
- If your traveller is going to one of the destinations for LONGER THAN 4 WEEKS they should be asked to provide evidence of having received polio vaccine IN THE LAST 12 MONTHS when they leave the country
- This evidence has to be produced on an International Certificate of Vaccination or Prophylaxis (ICVP).
- If they can't provide this, they may be given oral polio vaccine immediately on exit and provided with a certificate - all free of charge.
- For most travellers this is FINE but because the vaccine given will be oral polio vaccine (OPV) which is a live vaccine, we wouldn't want certain groups to have it e.g. a pregnant woman, someone who is immunosuppressed (see more detail below).
- Therefore certain groups are advised to be vaccinated prior to departure.
3. Details about the ICVP and how to obtain them - this is guidance if working in England
These need to be obtained by telephoning Communisis on 0191 201 50126 because the online provision via NaTHNaC is no longer available. See the poster below. Or you could order them from the WHO online shop here.
- Guidance on how to complete the certificate is on NaTHNaC here
- You are able to charge for just the certificate in a GP setting - the certificate booklet costs just over £1 per unit so could add on a modest amount to allow for the work involved
- NaTHNaC does not advise writing yellow fever and poliomyelitis on the same certificate - one ICVP per disease should be given - reference on the guidance page here
4. Details about who to charge for a polio containing vaccine
If you work in Scotland then the advice on TRAVAX allows anyone who needs the vaccine and ICVP for this situation to have it on the NHS if they live in Scotland and the Scottish Government funds it.
If you work in England the guidance is different and you must follow the information on NaTHNaC. This information will be found in the vaccine advice for polio in the relevant country page information. Polio vaccine will need to be given within Revaxis or Repevax (depending on age of traveller) but NOT ALL travellers can have this on the NHS.
If working in England, therefore following the NaTHNaC advice, who can you provide the vaccine to as an NHS provision?
- A person who hasn't yet completed their UK schedule and doesn't have 5 doses recorded
- A person who hasn't had a Revaxis booster in the last 10 years for travel purposes
- A pregnant woman
- A person who is immunosuppressed and their household contacts
- A person travelling to a setting with extremely poor hygiene (e.g. refugee camps) or likely to be in close proximity with cases (e.g. healthcare workers)
- A traveller visiting for 6 months or more
All other travellers seen in a GP surgery in England would NOT be entitled to vaccine as an NHS provision but receiving oral polio vaccine on exit from the country should present no problem.
If a traveller is unhappy with this advice, then they could access a polio containing vaccine, but need to obtain this from a private travel clinic and pay for both the vaccine and the ICVP. A GP surgery cannot provide this privately and charge for the vaccine.
I'm sorry I don't know the charging situation in Wales and Northern Ireland - if you do, perhaps you could e mail me to let me know and I'll update the blog.
To see the FAQ on charging for travel vaccines on my website - see here.
Sunday, 24 November 2019
IMPORTANT YELLOW FEVER UPDATE
Recent very important news has been published on yellow fever vaccine.
What is this news all about?
Back in April 2019, the Medicines and Healthcare Regulatory Agency (MHRA) published a Drug Safety Update 'Yellow fever vaccine (Stamaril) and fatal adverse reactions: extreme caution needed in people who may be immunosuppressed and those 60 years and older' found here.
It is strongly advised that you read this page in full, but some of the lead up to this was the fact that in recent months, they had been notified of 2 fatal adverse reactions to yellow fever vaccine. In one case, the vaccine was given to a person with a history of thymectomy following a thymoma (a contraindication in the product information). In another case, the vaccine was given to a 67-year-old with no other known risk factors. Both patients died shortly after vaccination due to suspected yellow fever vaccine-associated viscerotropic disease (YEL-AVD).
The guidance went on to explain they were in the process of reviewing the benefit-risk balance of yellow fever vaccine and measures to minimise risks in the light of these cases and the latest scientific data. The Commission on Human Medicines has convened an Expert Working Group, which will make recommendations. We will update guidance, as necessary.
The Green Book at the time (updated in January 2019) provided clarity over individuals who had had an incidental removal of their thymus gland including the following details:
* To date there is no evidence of increased risk of yellow fever vaccine–associated serious adverse events in people who have undergone incidental surgical removal of their thymus (e.g. during cardiac surgery) or have had indirect radiation therapy in the distant past. People who had incidental removal of their thymus after the age of one year may therefore receive a yellow fever vaccine following a detailed risk assessment. A cautious approach is recommended for those who had incidental removal of their thymus before the age of one year. In these cases further advice should be sought.
Here is some of the important information
What is this news all about?
Back in April 2019, the Medicines and Healthcare Regulatory Agency (MHRA) published a Drug Safety Update 'Yellow fever vaccine (Stamaril) and fatal adverse reactions: extreme caution needed in people who may be immunosuppressed and those 60 years and older' found here.
It is strongly advised that you read this page in full, but some of the lead up to this was the fact that in recent months, they had been notified of 2 fatal adverse reactions to yellow fever vaccine. In one case, the vaccine was given to a person with a history of thymectomy following a thymoma (a contraindication in the product information). In another case, the vaccine was given to a 67-year-old with no other known risk factors. Both patients died shortly after vaccination due to suspected yellow fever vaccine-associated viscerotropic disease (YEL-AVD).
The guidance went on to explain they were in the process of reviewing the benefit-risk balance of yellow fever vaccine and measures to minimise risks in the light of these cases and the latest scientific data. The Commission on Human Medicines has convened an Expert Working Group, which will make recommendations. We will update guidance, as necessary.
A summary box was included:
The Green Book at the time (updated in January 2019) provided clarity over individuals who had had an incidental removal of their thymus gland including the following details:
* To date there is no evidence of increased risk of yellow fever vaccine–associated serious adverse events in people who have undergone incidental surgical removal of their thymus (e.g. during cardiac surgery) or have had indirect radiation therapy in the distant past. People who had incidental removal of their thymus after the age of one year may therefore receive a yellow fever vaccine following a detailed risk assessment. A cautious approach is recommended for those who had incidental removal of their thymus before the age of one year. In these cases further advice should be sought.
In addition the NaTHNaC YF Factsheet on TravelHealthPro also provided the same message.
So this is what I have been teaching this year....
BUT PLEASE NOTE THIS GUIDANCE HAS CHANGED,
even though the Green Book from January 2019 remains
online at the current moment.
So what has happened recently?
On 21st November NaTHNaC posted an update on TravelHealthPro entitled REVIEW OF SERIOUS ADVERSE EVENTS FOLLOWING YELLOW FEVER VACCINATION and on 22nd November TRAVAX posted a similar update entitled Strengthened Recommendations to Minimise Risk of Serious and Fatal Reactions to Yellow Fever Vaccination (password required for the latter link).
'The Commission on Human Medicines (CHM) has recommended strengthened measures to minimise the potential risk of rare but serious and fatal adverse events associated with yellow fever vaccination in those with weakened immune systems, and in particular those aged 60 years or older and anyone who has had their thymus removed.
A joint letter from the MHRA, PHE, HPS and NaTHNaC gives further detail viewed HERE.
So although the Green Book chapter (35) on Yellow Fever is currently still up online as the January 2019 chapter, the GUIDANCE HAS CHANGED. An update notice has been put on the landing page for this chapter which says 'The Commission on Human Measures (CHM) has recommended strengthened measures to minimise the potential risk of rare but serious and fatal adverse events associated with yellow fever vaccination in those with weakened immune systems, and in particular those aged 60 years or older and anyone who has had their thymus removed.
The Green Book chapter will be updated accordingly but for now, please see a joint letter issued by the MHRA, PHE, HPS and NaTHNaC which gives further detail'. See the image below as the page appears today.
WHAT ARE THE KEY POINTS?
I have copied and pasted the information from the letter in the text below, but please make sure you click on the link and read it in full.
Here is some of the important information
- In people aged 60 years or older, due to a higher risk of life-threatening side effects, the vaccine should be given only when there is a significant and unavoidable risk of acquiring yellow fever infection, such as travel to an area where there is a current or periodic risk of yellow fever transmission - this would exclude travel to areas in which vaccination is ‘generally not recommended’ by WHO
- Only healthcare professionals specifically trained in benefit-risk evaluation of yellow fever vaccine should administer the vaccine, following their individualised assessment of a person’s travel itinerary and suitability to receive the vaccine
- Do not administer the vaccine to people:
- who have had their thymus gland removed for any reason
- who are taking biological drugs that are immunosuppressive or immunomodulating
- who have a first-degree family history of YEL-AVD or YEL-AND following vaccination that was not related to a known medical risk factor (i.e. in case of an unidentified geneticpredisposition).
Thoroughly inform vaccinees about the early signs and symptoms of these side effects and to urgently seek medical attention if these side effects are suspected – this will support rapid identification and referral for treatment of YEL-AND and YEL-AVD. The manufacturer’s patient information leaflet should be given to everyone receiving a yellow fever vaccine as part of the travel consultation.
The letter goes on to let readers know that
The above recommendations are in addition to the full list of contraindications and precautions described in the current Summary of Product Characteristics and patient information leaflet, which will be updated in due course. Standardised pre-vaccination screening checklists are also being produced, along with a patient group direction (PGD) template. A further communication will be issued when these are ready to ensure they are implemented in clinical practice. An article will be published in the MHRA’s Drug Safety Update (https://www.gov.uk/drug-safety-update) with a detailed assessment report and more information about the risks and manifestation of YEL-AVD and YEL-AND.
The Report of the Commission on Human Medicine’s Expert Working Group on benefit-risk and risk minimisation measures of the yellow fever vaccine can be found HERE
This post and links to more resources will be updated as they become available.
To download the current Yellow Fever Vaccine: Traveller Checklist from NaTHNaC - see here (published 10.07.19)
Latest News from NaTHNaC - Yellow fever vaccination recommendations: persons aged 60 years or older posted 25.11.19 here
NaTHNaC Yellow fever: Information for Travellers Leaflet here
To view the CQC Mythbuster no. 91 on Patient Safety Alerts see here
To sign up for MHRA Patient Safety Alerts see here
This post and links to more resources will be updated as they become available.
To download the current Yellow Fever Vaccine: Traveller Checklist from NaTHNaC - see here (published 10.07.19)
Latest News from NaTHNaC - Yellow fever vaccination recommendations: persons aged 60 years or older posted 25.11.19 here
NaTHNaC Yellow fever: Information for Travellers Leaflet here
To view the CQC Mythbuster no. 91 on Patient Safety Alerts see here
To sign up for MHRA Patient Safety Alerts see here
Tuesday, 1 October 2019
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:
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
Some points of interest within the new PGD for combination hep A + B vaccine
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
Monday, 2 September 2019
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!
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