Benacort Hayfever Relief reclassified from POM to GSL

 

The Medicine Healthcare and Regulatory Authority (MHRA) has taken the decision to reclassify the legal status for Benacort Hayfever Relief for Adults 64 micrograms nasal spray from POM to GSL. The MHRA has made this decision with the following terms of reclassification:

 

  1. For use in the nose in the form of a nasal spray.
  2. For the treatment of seasonal allergic rhinitis (hayfever).
  3. Maximum strength: 64 micrograms per actuation (spray).
  4. Maximum dose: 132 micrograms per nostril (264 micrograms).
  5. Maximum daily dose: 132 micrograms per nostril (264 micrograms).
  6. Maximum duration of treatment: 1 month.
  7. Maximum pack size: 10 mls (60 actuations).

 

Commenting on their website the MHRA have said the following:

 

“The MHRA considers that there is no reason to believe that there is a higher risk of misuse for Benacort Hayfever Relief compared to other corticosteroid nasal sprays that are already classified as GSL. There is no evidence of abuse of these products since they were reclassified to GSL.

“GSL medicines for the treatment of hayfever have been available for decades. Therefore, a patient’s ability to self-diagnose hayfever has already been established.

 

“Instructions about who should not use the product, and warnings and precautions for when using it are on the label and PIL. The maximum duration of continuous use before seeking medical advice has been limited to one month, which has been emphasised clearly on the product information. Patients are advised to seek professional advice if symptoms are not controlled or persist for longer than 7 days. These limitations on use are considered safe enough for users to self-treat their condition without masking any underlying serious conditions or delaying the amount of time it takes for them to seek further advice from a healthcare professional. They are also consistent with the limitations on use for other GSL corticosteroid nasal sprays.

“The 60-actuation (spray) pack size provides a maximum of 30 days treatment (at the minimum daily dose), which is not greater than the maximum length of treatment of other GSL corticosteroid nasal sprays and aligns with the maximum recommended length of continuous treatment (at minimum dose) before seeking medical advice.

 

“No major issues have been identified in the assessment of this application for Benacort Hayfever Relief as a GSL medicine based on the following reasons:

 

  • The treatment of hayfever is very common with two other intranasal corticosteroids available to treat this condition in the GSL setting. Non-sedating antihistamine tablets and liquids are also available. Patients can self-diagnose hayfever when purchasing these products so it would be considered reasonable that patients who wish to purchase Benacort Hayfever Relief can correctly diagnose themselves with hayfever.
  • The proposed indication, route of administration, duration of treatment and maximum pack size are in line with the two GSL intranasal corticosteroids currently available.
  • Since the reclassification of other corticosteroid nasal sprays, no additional safety concerns have been raised as a result of their availability as GSL products.

 

“The treatment of hayfever is a well-established GSL indication within the UK environment. Consumers are used to buying hayfever treatments including nasal sprays on self-selection in a general retail outlet. The MHRA accepts that the wider availability of Benacort Hayfever Relief would be beneficial to patients as it would allow access to another corticosteroid nasal spray in the GSL setting.”

 

You can read about further details of this POM to GSL reclassification here.

 

This circular is being shared under the Open Government Copyright licence.

 

 

What is it like to depend on medicine to treat endometriosis?

 

I have endometriosis.

 

I was diagnosed when I was 16. In the ten years since diagnosis, I have taken Loestrin 20 tablets. Over the years the doctors looking after me have tried three different medicines but to no avail. I have tried mild painkillers, lifestyle and dietary changes too. These were largely experimental medication changes. Together we made various attempts to make things better for me but this inconsistency in my medicines resulted in significant negative changes to my health.

 

I kept coming back to Loestrin 20.

 

And that’s fine because it works. It has been the only medicine that I have taken for endometriosis that has helped me to continue daily life.

 

You probably think I’m making a meal of this or overreacting but please believe me that this medicine helps me to stay well both mentally and physically. The thought of not being able to access it anymore would be terrifying.

 

And that’s what brings me to my story that happened in November 2019. The day everything changed and my life took a seismic hit below the waterline.

 

This was the day that I found out after attempting to collect my prescription from my local pharmacy that I can no longer receive my treatment for endometriosis.

 

At that time I had my last pill and that was it. I was devastated, anxious and uncertain about how the future would unfold. This situation was such a travesty because my health prospects were looking really good.

 

So, of course, I asked why?

 

Apparently, the medicine could not be sourced from anywhere because of ‘manufacturing’ issues or ‘undisclosed issues’ I was told by different places.

 

I sought help from my Doctor, from NHS 24 and other pharmacies. It is a birth control pill for the general population so I was told that my Doctor can simply put me on another pill and I can get on with life as normal. It didn’t seem to be considered a drastic change with challenging knock-on effects.

 

Well, this is the problem you see because Health Professionals often see these things in a binary way and don’t consider fully the impact on us patients.

 

It is quite frankly not the case that this was a minor problem with an easy fix for women with endometriosis. I was upset about the undermining of the severity of endometriosis and changes like this to treatment.

 

I was absolutely terrified tonight about what was going to happen to my health. If I was to be placed on a new pill to ‘test the waters’ for the subsequent for next 3-6 months I would once again be playing another game of risk with my physical and mental health.

 

The times in the past this was attempted my life was turned upside down. I was not ready for this again. I felt sick. Gobsmacked. And angry.

 

I wasn’t informed by my doctor who signed off on the prescription. I didn’t hear from anyone until I went to the pharmacy and searched online.

 

What was going on? Why were patients on this medication not informed?

 

No letters, emails or phone call.

 

I was very disappointed about this on behalf of all women with endometriosis, especially those like me who have been given no warning of these supply problems.

 

Even though these events happened some time ago I have some questions for pharmacists reading this blog that I really hope they can answer:

 

Can anyone shed light on this situation?

 

What’s the plan ahead for changes to medication supplies for chronic conditions like endometriosis?

 

How are medication shortages communicated with Doctors?

 

Who or what is to blame for these shortages of essential medication?

 

I hope this blog triggers at the very least a conversation about this issue and that we can begin to work towards a solution. Obviously, my medication is extremely important to me but I cannot imagine how frightening it must be if my example involved a life-saving medicine.

 

The author of this article wishes to remain anonymous. 

 

 

Urgent action required on medicine shortages

 

 

Medicines shortages are a growing problem across Europe, not just in the UK, according to a new report by the Pharmaceutical Group of the European Union (PGEU).

 

All responding countries experienced medicine shortages in community pharmacies in the past 12 months, and the vast majority (87%) of respondents indicated that the situation got worse compared to 2018. All classes of medicines are affected by medicine shortages in community pharmacies.

 

In the majority of responding countries (67%), over 200 medicines were listed as in short supply at the time of completing the survey.

 

All responding countries indicated that they believe medicine shortages cause distress and inconvenience to patients. Interruption of treatments (75% of countries), increased copayments as a result of more expensive/non-reimbursed alternatives (58%) and suboptimal treatment/inferior efficacy (42%) are also perceived as negative consequences of medicine shortages on patients.

 

Medicine shortages are believed to affect community pharmacy businesses in most countries by a reduced level of patient trust (92% of countries), financial loss due to time invested in mitigating shortages (82%) and reduced employee satisfaction (79%).

 

Across European countries, strong differences exist in terms of legal solutions community pharmacists can offer in case of a shortage. Generic substitution (79 % of countries), sourcing the same medicine from alternative authorised sources (such as other pharmacies) (63%), and importing the medicine from a country where it is available (46%) are the solutions which can be provided in most of the European countries.

 

The time pharmacy staff have to spent on dealing with medicine shortages has increased from 5,6 hours per week (2018) to 6,6 hours per week on average.

 

25% of responding countries indicated that there is still no reporting system for shortages in place which can be used by community pharmacists in their country, despite that pharmacists often experience or foresee supply difficulties before the industry or wholesalers are aware that there is, or will be, a problem.

 

Community pharmacists receive the needed information on shortages in most countries from wholesalers (71%), medicines agencies (67%) and pharmacy organisations (42%).

 

The 2019 PGEU Medicine Shortages Survey Results cover the responses from 24 European countries and is created from the perspective of community pharmacists across Europe.

 

Pharmacy associations from all the countries in the PGEU survey said they had experienced medicines shortages in 2019.  Of the 24 countries, 21 said the situation had got worse in the last 12 months.  In the majority of counties, over 200 medicines were listed as being in short supply at the time of completing the survey, which was carried out in November and December 2019.  The most widespread shortages were medications affecting the central nervous system, respiratory medicines and cardiovascular medicines.

 

The shortages were reported to have caused distress and sometimes serious harm.

 

National Pharmacy Association Policy Manager Helga Mangion said:

 

“This data is further evidence of a widespread problem in this country and across Europe.

 

“Because of heroic efforts by pharmacists, patients usually get their medicines when and where they need them, but longstanding faults in the medicines supply chain too often leave patients waiting. It’s time for urgent action, to reduce the risk of harm and to allow pharmacists to spend more time with patients instead of hunting for stock.”

 

The NPA is part of the UK’s delegation to PGEU, alongside the Royal Pharmaceutical Society and the Pharmaceutical Society of Northern Ireland.

 

You can view the survey results below.

 

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For more information on this story click here.

 

Free alcohol reduction service package launched for UK pharmacies

 

Pharmadoctor has announced that it has launched a new free Alcohol Reduction clinical service package for pharmacists.

 

It’s reported that 1 in every 100 people in the UK are alcohol dependent but only 18% of these are currently accessing treatment. With one of the highest rates of alcohol dependency in Europe, alcohol-related health issues in the UK cost the NHS ~£3.5 billion annually1. By running an alcohol reduction service, Community Pharmacy can help tackle this problem.

 

In support of the Public Health England backed Dry January campaign managed by the charity Alcohol Change, Pharmadoctor is offering every pharmacy in the UK a free Alcohol Reduction pharmacy service package so that they can offer their patients more than just advice to help them reduce their consumption of alcohol.

 

The Pharmadoctor free package includes an Alcohol Reduction eTool which seamlessly guides pharmacists through patient consultations for alcohol consumption, then fully supports them to provide the required behaviour support to help patients reduce their harmful drinking. Integrated within the eTool, the PGD, which if suitable, enables pharmacists to dispense nalmefene hydrochloride dihydrate Selincro® which is a NICE approved once-daily/on-demand treatment for the reduction of alcohol.

 

To support the new pharmacy service, Pharmadoctor is also providing a CPD training module and is investing in a nationwide service promotional campaign across social media, radio and TV to signpost patients to the pharmacies offering the new service via the Pharmadoctor patient website. Launched 1st January, the campaign has already reached over 1 million people across the UK.

 

Commenting on the launch of the new package, Pharmadoctor CEO Graham Thoms said “Our new Alcohol Reduction package supports pharmacists to offer more than advice during Dry January and beyond, so it’s encouraging to see that over 120 pharmacies have already signed-up and are providing the service”. He goes on to say “for those patients who need additional support to reduce their alcohol consumption, pharmacies can now offer their patients the service with treatment for the equivalent of £4 per day. This is less than the cost of a pint of beer or a large glass of wine, so it’s affordable for patients who require additional support to reduce their drinking”.

 

Pharmacists can sign-up to the Pharmadoctor Alcohol Reduction Package for free by clicking here.

 

References

 

  1. The staggering cost of NHS alcohol report available here.

Australian community pharmacy minor ailment success

 

An Australian study has demonstrated both economic and clinical benefits to community pharmacist running a minor ailment service.

 

The consultation service was evaluated in a cluster randomised controlled trial conducted over eight months in Western Sydney Primary Health Network (WSPHN), compared with usual pharmacist care. Fifty-five community pharmacists from 30 community pharmacies, 150 GPs from 27 general practices and 894 patients were recruited into the study. 

 

The recommendations published demonstrate a ‘significant opportunity’ for pharmacists, GPs and other health professionals to operate in a collaborative professional capacity to best meet the healthcare needs of their patients while delivering care at the appropriate level.

 

The service supports a structured and integrated approach to consultation, seeks to standardise practice, focuses on increasing the quality and safe use of medicines and encourages patients to seek care at the appropriate level with greater accessibility. The evaluation of the service demonstrated ‘extremely positive’ results at both the patient and economic level, and the potential impact if the consultation service is implemented on a larger national scale.

 

The service was co-designed to complement general practice and promotes collaboration between professions. Stakeholders involved in co-design included GPs involved in WSPHN clinical governance, community pharmacists, management leaders from WSPHN, patients and representatives from the Pharmaceutical Society of Australia.

 

The key elements of the service, included standardised triage consultation pre-agreed with GPs, integrated IT platforms pre-agreed with GPs, upskilling community pharmacists and change facilitation support.

 

The clinical evaluation demonstrated the effectiveness of the service, compared with usual pharmacist care. As follows:

 

  • Pharmacists were 2.6 times more likely to perform a clinical intervention and recommended a more appropriate medicine for the patient. This occurred in 21% of all direct product requests.
  • 91% of nonprescription medicine recommendations met pre-agreed protocols, compared to 79% in usual pharmacist care.
  • Patients were 1.5 times more likely to receive an appropriate referral by their pharmacist and were 5 times more likely to adhere to that referral advice and seek medical practitioner care within an appropriate timeframe (20% of all patients were referred).
  • Pharmacists identified 2% of patients with ‘red flag’ clinical features. No patients with red flag symptoms were identified in the usual care arm.
  • Pharmacists provided self-care advice in almost all consultations (98%), compared to 62% of patients receiving usual pharmacist care.
  • 94% of patients achieved symptom resolution or improvement within two weeks, while this was 88% in the usual care arm.

 

The economic evaluation demonstrated the service to be highly cost-effective and provides evidence of significant savings for the Australian health system if implemented nationally. As follows:

 

  • The cost-utility analysis revealed the service as highly cost-effective, compared with usual pharmacist care.
  • Nationally, 2.9 to 11.5% of ED services and 7.0 to 21.2% of GP services can be safely transferred to a structured service in community pharmacy.
  • These services (9 million to 27.5 million ED and GP services) currently represent a cost to the Australian health system from $511 million to $1.67 billion per annum.
  • The transfer of these services to pharmacy would save the Australian government between $380 million and $1.3 billion per annum, based on remuneration of $14.50 per pharmacist consultation as determined by the average duration of the service.

 

The service model provides a solid framework for national rollout. IT infrastructure, change facilitation processes and agreed protocols have already been established. A number of recommendations are presented in the evaluation report for consideration by federal and state policymakers, primary health networks, professional organisations, the pharmaceutical industry and practitioners.

 

Sarah Dineen-Griffin, and the UTS research team, Dr Victoria Garcia Cardenas, Prof Kylie Williams, Emeritus Prof Charlie Benrimoj, in collaboration with WSPHN have evaluated a consultation service for community pharmacists to triage, manage and appropriately refer patients to general practitioners (GPs) for minor ailments through agreed referral pathways for the first time in Australia.

 

Click here to read the full evaluation report.

 

 

 

Community pharmacy team writes an open letter to Matt Hancock MP

 

Dear Mr Hancock,

 

I am writing this letter as I am seriously concerned about the future of Community Pharmacy.

 

I have worked as a Community Pharmacist for 22 years and I can honestly say that I have enjoyed all of those years. I love my job. I love the interaction with patients and the bond formed with my team as we strive every day to provide an efficient and caring service to our community. Unfortunately, I feel that this has started to change in the last few years since the funding to Community Pharmacy was drastically reduced.

 

All Community Pharmacies have been put under pressure due to the desire of the Government to force some to close. Pharmacies have had no choice but to respond by slashing staff hours and cutting services in an effort to ensure businesses can continue to function and serve their population. We care about our patients and we do not want to let them down but we are all reaching the limit of what we can provide.

 

In the past week, I have spoken to two young Community Pharmacists who have reached out on social media for help as they are at the end of their tether and don’t know where else to turn. I only know them through interaction online and I and other experienced pharmacists have done our best to offer help and advice but we can only do so much. How many other Community Pharmacists and their teams are suffering in silence and just trying to get through the day?

 

If the Government wants to close some Community Pharmacies then that is fair enough. I don’t think anyone would argue with the fact that there are some locations where there are too many, but why not target those locations and work with the pharmacies there to solve the problem? Why make all pharmacies suffer and reduce the quality of care in all of them?

 

Many people see the dispensing of prescriptions as being merely a supply function. Unless you have worked in Community Pharmacy it is difficult to appreciate the subtle nuances involved in the provision of a quality dispensing service. The casual conversation with the patient whilst they are waiting for their prescription that picks up on a health issue. The discrepancy in the patient records that prompts a conversation about their treatment and picks up on another issue. The years and years of interaction with a patient that isn’t recorded on a computer but plays a huge part in forming a bond of trust between us. All of these things and more are taken into consideration when we dispense a prescription. It is not merely a supply function.

 

Mr Hancock, you are so lucky. You have an amazing resource at your fingertips. You have a network of highly skilled healthcare professionals in Community Pharmacy who you can use to improve the health of the nation. I know that you want us to do more and we would love to, but we need the resources to do that. The Government needs to look again at how they are going to decide which pharmacies they would like to close because at the moment there is no plan and it could be any of us.

 

Community Pharmacy cannot continue to function under this pressure. Valued and highly trained staff are leaving to work in other, less pressured jobs. If you do not act now the Community Pharmacy network may soon be beyond repair.

 

A pharmacy is just a building. It is the people who work in that building that make it a Community Pharmacy and it those people that make a difference to patients lives every day. I know we don’t shout about it much but please do not underestimate the impact that Community Pharmacy has and how valued we are by our patients.

 

You would be very welcome to come and spend some time with us and see for yourself.

 

Yours sincerely,

 

Amanda Smith

 

(This letter is my own personal view and is independent of any organisation I may be associated with)

 

Heath Pharmacy

96 Free School Lane

Halifax

HX1 2YF