EU MONITOR - Contribute to EAHP’s ePI survey by the 30th of April!

 The EAHP EU Monitor is a regular round up of news relevant to hospital pharmacy in Europe.

 

EAHP celebrates its 25th Anniversary Congress

From the 23rd to 28th of March, the annual congress of the European Association of Hospital Pharmacists (EAHP) gathered more than 2200 participants from over 60 different countries. This year’s anniversary edition focused on the future of the hospital pharmacy profession by touching on subjects like 3D printing, artificial intelligence, pharmacy prescribing and telepharmacy. 

The programme put together by EAHP’s Scientific Committee for this first virtual edition of EAHP’s annual congress encompassed inspiring keynotes, trailblazing Synergy Satellites, engaging workshops and lively interactive sessions centred around the theme “Hospital Pharmacy 5.0 - the future of patient care”. If you missed this year’s edition or want to think back to what you experienced while attending have a look at our latest press release

For next year, please circle the 23rd to 25th of March in your calendar. In 2022, EAHP is inviting you all to Vienna, Austria to experience the 26th annual congress focusing on “Hospital pharmacists – changing roles in a changing world”.

 

Results of EAHP’s Survey on the future crisis preparedness of hospital pharmacies are out 

To better understand the impact that the first wave of the COVID-19 pandemic has had on the profession, EAHP collected input from its members via the Survey on the future crisis preparedness of

hospital pharmacies. Between 16 September and 23 December 2020, the survey gathered on the one hand details on the medicines for which shortages were experienced. On the other hand, it took into account the experiences made in hospital pharmacies and the approaches for crisis management and preparedness. 1664 hospital pharmacists from all across Europe participated and shared their lessons learned from the COVID-19 pandemic.

Compared to other survey activities of EAHP linked to the topic of medicines shortages the feedback received for the survey on the future crisis preparedness was a bit more diverse with 59% of respondents experiencing problems, compared to 38% that did not. This might be attributed to the fact that not only hospital pharmacists working at hospitals that exclusively catered to COVID-19 patients participated but also those that continued to provide care to other patients. The most common types of medicines in shortage included those used in intensive care units, such as anaesthetics (46%) and muscle relaxants (29%). But also antibiotics (37%) ranked among the top three like in EAHP’s previous shortage surveys. 

Cooperation, including collaboration with other healthcare professionals, was one of the reoccurring themes of the feedback received from this survey. Hospital pharmacists supported their colleagues through the production of disinfectants and sourcing medicines that were in shortage. Besides, they valued discussions with other healthcare professionals supporting the quest for treatment options and finding solutions to other problems that occurred during the pandemic. Room for improvement was found in relation to preparedness. More work in the field of risk assessments is needed but also communication with others could be further enhanced. 

Find the survey results HERE

 

EAHP’s ePI – contribute by the end of April 

Earlier this month, EAHP launched its newest survey targeting hospital pharmacists analysing the use of (electronic) patient leaflets and the future potential of electronic product information (ePI). Until the 30th of April, EAHP’s ePI survey seeks to collect information on both the use of printed package leaflets and the prevalence of the application of product information in a digital format. Also, the future use of ePI in European hospitals will be looked at. You can contribute by replying to one of the twenty-one different language versions. 

Access EAHP’s ePI survey HERE

 

Read EAHP’s 2020 Annual Report

2020 was undoubtedly a challenging year for hospital pharmacists. In its newest Annual Report, EAHP outlines how hospital pharmacists rose to the challenges posed to them by the COVID-19 pandemic and how the Association supported them throughout the last year. 

The 2020 Annual Report shares information about EAHP’s projects, educational and policy activities as well as the work centred around COVID-19. Members were supported by the COVID-19 resource centre and new ways to engage with them were found through for example a virtual general assembly and EAHP’s open learning courses that were already in place before the start of the pandemic. Also, EAHP joined forces with other organisations to hold webinars discussing potential solutions for addressing the medicine shortage problem and best practices by clinical and hospital pharmacists for dealing with SARS-CoV2. 

Learn more about EAHP’s activities in 2020 by reading the Annual Report HERE

 


Updates from the European Medicines agency

The European Medicines Agency (EMA) published a direct to healthcare professional communication for Vaxzevria (previously COVID-19 Vaccine AstraZeneca), a plain-language description of medical terms related to medicines use and a communication advising against the use of ivermectin for the prevention or treatment of COVID-19 outside randomised clinical trials.

COVID-19 Vaccine AstraZeneca – direct healthcare professional communication

EMA has released a direct healthcare professional communication (DHPC) on the risk of thrombocytopenia and coagulation disorders with the COVID-19 Vaccine AstraZeneca.  It contains important information for healthcare professionals prescribing, dispensing or administering this vaccine. As noted in the DHPC: 

  • Benefits of the COVID-19 Vaccine AstraZeneca outweigh the risks despite the possible link to very rare blood clots with low blood platelets. 
  • A combination of thrombosis and thrombocytopenia, in some cases accompanied by bleeding, has been observed very rarely following vaccination with COVID-19 Vaccine AstraZeneca. 
  • Healthcare professionals should be alert to the signs and symptoms of thromboembolism and or thrombocytopenia. 

 Those vaccinated should be instructed to seek immediate medical attention if they develop symptoms such as shortness of breath, chest pain, leg swelling, persistent abdominal pain following vaccination. Additionally, anyone with neurological symptoms including severe or persistent headaches and blurred vision after vaccination, or who experiences skin bruising (petechia) beyond the site of vaccination after a few days, should seek prompt medical attention.

You can find the full text of the DHPC in the following LINK 

EMA’s medical terms simplifier 

EMA has created a medical terms simplifier that provides public-friendly descriptions of medical terms used for side effects of medicines and mechanisms of action.  

The 'EMA medical terms simplifier' has been assembled over many years by EMA's medical writers, who use these plain-language descriptions to prepare public-friendly communications. Having become increasingly aware that there was no single resource for describing common medical terms found in medicines information, the team worked to produce a public-domain version of this resource.

Please note that the medical terms simplifier does not cover rarely used terms, most disease states, very specialised areas or the broader field of medical science.  EMA will continue to maintain and further develop this resource over time.

Access EMA’s medical terms simplifier HERE

EMA advises against use of ivermectin for the prevention or treatment of COVID-19 outside randomised clinical trials

EMA has reviewed the latest evidence on the use of ivermectin for the prevention and treatment of COVID-19 and concluded that the available data do not support its use for COVID-19 outside well-designed clinical trials.

In the EU, ivermectin tablets are approved for treating some parasitic worm infestations while ivermectin skin preparations are approved for treating skin conditions such as rosacea. Ivermectin is also authorised for veterinary use for a wide range of animal species for internal and external parasites.

Ivermectin medicines are not authorised for use in COVID-19 in the EU, and EMA has not received any application for such use (Czechia and Slovakia, have allowed the temporary use of the medicine for COVID-19 within the remit of their national legislation).

Following recent media reports and publications on the use of ivermectin, EMA reviewed the latest published evidence from laboratory studies, observational studies, clinical trials and meta-analyses. Laboratory studies found that ivermectin could block replication of SARS-CoV-2 (the virus that causes COVID-19), but at much higher ivermectin concentrations than those achieved with the currently authorised doses. Results from clinical studies were varied, with some studies showing no benefit and others reporting a potential benefit. Most studies EMA reviewed were small and had additional limitations, including different dosing regimens and use of concomitant medications. EMA therefore concluded that the currently available evidence is not sufficient to support the use of ivermectin in COVID-19 outside clinical trials.

Although ivermectin is generally well tolerated at doses authorised for other indications, side effects could increase with the much higher doses that would be needed to obtain concentrations of ivermectin in the lungs that are effective against the virus. Toxicity when ivermectin is used at higher than approved doses therefore cannot be excluded.

EMA therefore concluded that use of ivermectin for prevention or treatment of COVID-19 cannot currently be recommended outside controlled clinical trials. Further well-designed, randomised studies are needed to draw conclusions as to whether the product is effective and safe in the prevention and treatment of COVID-19.

This EMA public health statement has been endorsed by the COVID-19 EMA pandemic Task Force (COVID-ETF), in light of the ongoing discussions on the use of ivermectin in the prevention and treatment of COVID-19.

More information is available HERE

 

MDR infographic – identifying medical device software

Medical devices are an essential part of the delivery of high-quality healthcare and their procurement and management in the European hospital setting is often under the authority of hospital pharmacist. With the full application of the new Medical Device Regulation only weeks away and the one on InVitro Devices following in May 2022, the European Commission has released an infographic that helps you with determining if your software is a medical device.  

Access the infographic HERE

 

 

 

 

 

 

EJHP: Cost-effectiveness of two technology-assisted manual medication picking systems versus traditional manual picking in a hospital outpatient pharmacy

The original research published in the online edition of the European Journal of Hospital Pharmacy (EJHP) evaluates the cost-effectiveness of two technology-assisted manual medication picking systems vs traditional manual. The authors performed a retrospective observational study comparing three outpatient pharmacies of a tertiary referral hospital in Singapore, where a light-emitting diode (LED-guided) manual picking system, an LED-guided manual picking plus lockable drawer (LED-LD) system, and traditional manual picking were implemented, respectively.  In conclusion, the authors found that the LED-LD system is more cost-effective than both the LED-guided and manual medication picking systems in reducing medication picking near-misses. 

Read the article HERE

 

[COVID-19 Updates]

 


EAHP’s COVID-19 Resource Centre

To assist its member associations and individual hospital pharmacists in this critical time with the provision of the best possible care for patients, EAHP has decided to gather and make available information on COVID-19 relevant for the hospital pharmacy profession.

Access the Resource Centre HERE

Operational Coordination Epidemic and Biological Risk (COREB)  - COVID-19 Management and follow-up of the hospitalized patient

The information in the document is based on national recommendations to carry out the initial assessment, follow-up, treatment and organise the discharge of the hospitalised COVID patient. The document is only available in French.

Read the document HERE 

French Society of Pharmacology and Therapeutics  - Position of the French Society of Pharmacology and Therapeutics on the currently available clinical evaluation data of bamlanivimab as monotherapy at 700 mg

The position provides methodological insight by offering a commented reading of the available clinical evaluation data.

Read the position HERE

Spain - Recommendations for the safe use of vaccines against COVID-19

This document contains basic safety measures to avoid possible errors in vaccination practice, aimed at the institutions that are going to organize the vaccination programs and the professionals who are going to handle the vaccines. It is only available in Spanish. 

Read the recommendations HERE 

The Permanente Journal - Telehealth in Pediatric Gastroenterology Can Be a Sustainable Long-Term Option: A Single-Center Experience

The report presents a single-center experience from the past year where virtual care was already an integral part of clinical practice in pediatric gastroenterology and review satisfaction data and quality measures from the COVID-19 era. 

Read the report HERE

Statement Implementation award

  

The EAHP Board of Directors has decided to award the Statement Implementation award to a GPI that adds value to the Statement Implementation project and the promotion of the European Statements of Hospital Pharmacy. This GPI is an example on how to help other pharmacies to understand the work done around the European Statements and their implementation. Vito Ladisa won the Statement Implementation Award for his GIP titled “Multidisciplinary CAR-T team”. Read the awarded GPI here

 

 

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Consultations

 

EDQM – Pharmeuropa PaedForm, Issue 3

The European Directorate for the Quality of Medicines & HealthCare (EDQM) released Issue 3 of Pharmeuropa PaedForm, in which the draft text for Phosphate 60 mg/mL Oral Solution is published for public consultation prior to its inclusion in the European Paediatric Formulary. This is the fourth monograph elaborated by the PaedForm Working Party.

Deadline – 31st March 2021

Find more information HERE

 

European Commission – Public Consultation on Blood, tissues and cells for medical treatments & therapies

This consultation concerns an initiative for an improved EU legal framework for the safety and quality of blood, tissues and cells used in transfusion, transplantation and medically assisted reproduction. These are healthcare services that impact on the lives of millions of EU citizens, both as donors of essential substances or patients that need treatment with those substances. For this reason, this public consultation is collecting the views of all interested citizens and organisations.

Deadline – 15th April 2021

Access the consultation HERE