EAHP EU Monitor - 26 January 2018
The EAHP EU Monitor is a regular round up of news relevant to hospital pharmacy in Europe.
You can subscribe to receive the EAHP EU Monitor by email HERE.
EAHP: Hospital Pharmacists - Show us what you can do!
The 23rd Congress of EAHP is fast approaching, with the reduced rate registration open until the 31st of January.This coming 21-23 March, the Annual Congress will be held in Gothenburg, Sweden, featuring keynote speakers, satellite symposia, exhibitors and much more!
Three keynote speeches are awaiting hospital pharmacists from all over the world which come together to meet, network and share expertise and best practice with colleagues. Dr Helena Nordensted will present a fact-based view on global health and infectious diseases during the first Keynote on Wednesday 21st March. During her presentation, she will discuss demographic trends in the world, underlying reasons and the global disease panorama shift.
On Thursday 22nd March, there will be the second keynote titled ‘We have a dream!’. Cheryl McKay and Jonathan Underhill will take their audience on a journey covering the value of hospital pharmacy history and its effect on the future, the potential opportunities for hospital pharmacy practice, and self-awareness on the role of hospital pharmacists.
The third and final keynote, to be held on Friday 23rd March, is titled ‘Marketing the hospital pharmacy profession’. As many people are only seldom aware of the work and contributions of hospital pharmacist, this keynote will equip congress participants with practical and creative approaches to marketing and communication for the promotion of the hospital pharmacist profession.
Don’t forget the reduced rate registration deadline: 31 January 2018
For more information, please send an e-mail to congress[at]eahp[dot]eu
EMA survey focusing on product information for EU medicines
The European Medicines Agency (EMA) seeks information on initiatives on electronic/digital formats for product information that are currently being undertaken in the EU. This follows an EMA action plan to improve the product information for EU medicines.
One of the key areas of this plan is to explore how electronic or digital means can be used to improve accessibility to medicines’ information by patients and healthcare professionals. As a mapping exercise prior to a multi-stakeholder workshop planned for the third quarter of 2018, EMA invites all stakeholders (patients and consumers, healthcare professionals, pharmaceutical industry and national competent authorities) to send an overview of electronic and digital initiatives regarding product information they are using or aware of.
Access to the survey
Press release and information on this topic HERE.
WHO/Europe and ECDC intensify collaboration on infectious diseases and health emergencies
Dr Zsuzsanna Jakab, WHO Regional Director for Europe, and Dr Andrea Ammon, Director of the European Centre for Disease Prevention and Control (ECDC), met at the WHO Regional Office in Copenhagen, where they expressed their commitment to strengthen collaboration on infectious diseases and disease outbreaks by establishing operational guidelines on collaborative actions. This will support European countries in reaching the Sustainable Development Goals through addressing communicable diseases and antimicrobial resistance and strengthening immunization.
WHO/Europe and ECDC have been collaborating on public health development in Europe via a memorandum of understanding (2005) and an administrative agreement (2011), focusing on communicable diseases surveillance, prevention and control, risk assessment and communication, health emergencies and the use of International Health Regulations to prevent and respond to health threats.
A joint Coordination Group of WHO/Europe and ECDC has been set up, with annual joint activity plans, information-sharing and regular interaction by staff in activity implementation.
EMA: Defect with Buccolam plastic syringes and PRAC recommended suspension for hydroxyethyl-starch (HES) solutions
The European Medicines Agency (EMA) has reported a defect with Buccolam plastic syringes, urging parents and carers to carefully inspect the syringes before giving the medicine to children.
There have been a few cases in which the syringe cap didn’t come off completely, leaving a translucent tip-cap which stopped the medicine from leaving the syringe. This has sometimes resulted in the tip-cap coming off inside the patient’s mouth and being inhaled or ingested. A letter will be sent alerting doctors and pharmacists who prescribe and dispense Buccolam. The company marketing Buccolam is resolving the issue for new syringes, but syringes already on the market and those already dispensed to patients need to be carefully checked before use.
The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has recommended the suspension for hydroxyethyl-starch (HES) solutions for infusion, following a review initiated on 17 October 2017.
These products are used as plasma volume replacement following acute blood loss, where treatment with alternative products known as ‘crystalloids’ alone is not considered to be sufficient. The review was triggered after use of HES solutions in critically ill patients and those with sepsis and kidney injury, despite restrictions introduced in 2013 to reduce the risks of kidney problems and deaths. The PRAC recommendation has been sent to the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) for consideration at its meeting on 22-25 January 2018.
More on Buccolam defect HERE
More about HES available HERE
Survey focusing on emergency and disaster pharmacy
In 2016, the International Pharmaceutical Federation (FIP) published pharmacy guidelines for responding to natural disasters which aims at helping pharmacists to prepare and manage natural disasters situations. Moreover, FIP has issued a policy statement about the role of the pharmacist in disaster management. Also, a survey is being conducted to determine how hospital pharmacies in Europe are prepared for a natural or manmade disaster and whether they have specifically followed these guidelines since their publication. The survey tries to make an inventory of hospital pharmacies that already faced disaster situations and to collect information on how these hospital pharmacies have managed the disaster situation.
This survey was initiated by Prof Pascal Bonnabry (Chief-pharmacist at the pharmacy of Geneva University Hospitals) and Dr Nicolas Widmer (Chief-pharmacist at the pharmacy of Eastern Vaud Hospitals), who have been mandated by the Swiss Confederation to develop a Centre for Emergency and Disaster Pharmacy at the University of Geneva, Switzerland. Its objectives are to offer research and teaching in this field.
Participation in the survey should not take more than 10-15 minutes to fill in case major events were not experienced in the last 5 years. For hospital pharmacies that were faced with a disaster situation the completion of the survey will take less than 30-40 minutes. All answers are welcome even if your hospital pharmacy doesn't have any special preparedness plan, since every answer is important.
Answers should be submitted by 23rd February 2018.
The survey can be accessed HERE
For any questions you can contact the Centre (info[at]disaster-pharmacy[dot]ch)
EJHP: Content analysis of Twitter in relation to biological treatments for chronic inflammatory arthropathies
The online first edition of the European Journal of Hospital Pharmacy (EJHP) has published an article analysing the volume and content of tweets in relation to biological treatments for chronic inflammatory arthropathies. This study hand-coded tweets and filtered content from English and Spanish tweets, highlighting that Twitter is widely used to search for health information, in this case biological treatments for chronic arthropathies. The most searched terms in relation to therapies dealt with safety aspects such as adverse events related to drug administration, infections or general adverse effects. It concludes by indicating the use of the study in understanding the areas of greater interest among patients, as well as the potential for patient-focused strategies.
EMA – Reflection paper on the pharmaceutical development of medicines for use in the older population
The reflection paper describes aspects that medicines developers may consider when designing medicines for older people, such as selecting appropriate routes of administration and dosage forms, dosing frequency, excipients, container closure systems, devices and technologies, and user instructions in the product information. It is intended to communicate the current status of discussions on the pharmaceutical development of medicines that may be used in the older population.
Deadline – 31st January 2018
More information HERE
EMA – Concept paper on the need for a paediatric addendum of the guideline on clinical investigation of medicinal products for the treatment and prophylaxis of venous thromboembolic disease
A number of new EMA guidelines related to clinical investigation of medicinal products for the treatment and prophylaxis of venous thromboembolism (VTE) are already available, but recommendations are applicable only to adults. In contrast to adults, VTE in children is a rare event, but represents a significant management dilemma that requires therapeutic intervention. The concept paper thus has been drafted since a paediatric addendum to the guidelines on clinical investigation of medicinal products for the treatment and prophylaxis of VTE is considered necessary to discuss and make methodological recommendations adapted to children.
Deadline – 31st January 2018
More information HERE
Commission – Public consultation on pharmaceuticals in the environment
The consultation by the European Commission seeks views on possible actions to address the risks from pharmaceuticals in the environment. Its overall aim is to obtain views and information to support the development of the European Commission's strategic approach to pharmaceuticals in the environment.
Deadline – 21st February 2018
Access survey HERE
Commission – Public consultation on strengthened cooperation against vaccine preventable diseases
Due to the cross-border nature of vaccine preventable diseases and the challenges to national vaccination programmes, the European Commission saw the need to look into common EU actions and an increase of coordination. The information collected via the public consultation is intended to feed into the adoption of a proposal of a Council Recommendation on Strengthened Cooperation against Vaccine Preventable Diseases.
Deadline – 15th March 2018
More information HERE
EMA- Concept paper on the development of a reflection paper on new analytical methods/ technologies in the quality control of herbal medicinal products
Quality control is a prerequisite to assure safe and effective use of (traditional) herbal medicinal products, which are complex mixtures of numerous phytochemical constituents. For the majority of herbal substances, herbal preparations and (traditional) herbal medicinal products the active constituents are not known or are only partly understood. Consequently, EMA is planning to develop a reflection paper that addresses new analytical methods and technologies for the quality control of herbal medicinal products.
Deadline – 30th April 2018
More information HERE