EU Monitor – 18/09/2018 - Submit your abstract for #EAHP2019
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 2019 – 1 month left to submit your abstract
The abstract submission deadline for the 24thCongress of the European Association of Hospital Pharmacists (EAHP) is less than 4 weeks away. EAHP’s Scientific Committee encourages all hospital pharmacists, other health care professionals and interested scientists to submit their work for consideration leading to acceptance and display at the upcoming EAHP congress. Submissions need to be provided to EAHP by Monday 15th October 2018.
The upcoming congress of EAHP will take place in Barcelona, Spain from 27thto 29thMarch 2019. The theme of the Congress "Personalised Hospital Pharmacy – meeting the needs of every patient" will explore the role of hospital pharmacists in personalised medication. Different seminars, workshops and keynotes will serve as a source of knowledge and inspiration to prepare the profession for future advances and engagement in the field of personalised medication.
Contributors are kindly reminded to carefully read and comply with the guidelines presented on EAHP's website which outline the abstract review process, provide guidance to those submitting abstracts for the first time and list tips on avoiding abstract rejection. Submissions of abstracts from all disciplines of hospital pharmacy or related areas are encouraged, provided that they can be linked to one of the 44 European Statements of Hospital Pharmacy.
Abstracts must be structured and written in five paragraphs (Background, Purpose, Materials and Methods, Results, Conclusions) and they should not exceed the limit of 350 words. The online submission system will guide you through the process. In case you still have questions concerning the abstract submission process, please send an email to abstract[at]eahp[dot]eu
The best abstracts/posters, with regards to aspects like originality, scientific quality and practical applicability, will be awarded with 3 prizes amounting to 750 euro, 500 euro and 250 euro.
More information HERE
FIP – Analysis predicts growth of pharmacy workforce
In early September during its 78th World Congress of Pharmacy and Pharmaceutical Sciences, the International Pharmaceutical Federation (FIP) released the results from the largest retrospective study on pharmaceutical workforce capacity. The publication describes trends of the workforce relating to gender distribution and capacity growth by taking into account figures from 2006 to 2016.
Overall, the analysis suggests an increase in the global capacity of pharmacists by 40% in the coming 12 years. The WHO Europe and Eastern Mediterranean regions displayed the highest absolute changes over the 10-year period assessed in the report. Growth appears to be slower in low-income countries. Other key trends described in the report include a steady increase in the proportion of women in the pharmacy workforce. Due to the growth of the workforce until 2030, the report highlights the need for further investigation to inform national strategic pharmacy workforce planning.
Read more HERE
EC – Paper on the obligation of continuous supply to tackle the problem of shortages of medicines
In response to a call from the Council and European Parliament, the European Commission collected evidence from 27 EU Member States and Norway to monitor the obligation of marketing authorisation holders to ensure continuous supply of medicines laid down in EU legislation. The paper on the obligation of continuous supply to tackle the problem of shortages of medicines summarises the findings of this exercise. It addresses the responsibilities of both manufacturers and wholesalers and bases itself on Member State responses to a questionnaire on measures implemented in the Member States territories in the context of Article 81 of Directive 2001/83/EC which was launched in autumn 2017.
Marketing authorisation holders are obliged to ensure supply sufficiently in advance and in adequate quantities to cover demand from patients. Vigilance is needed for products whose manufacturing is dependent on a single facility and for which no or only limited alternatives are available. For products whose discontinuation of supply poses a potential risk for public health, Member States may require the development of shortage prevention plans by marketing authorisation holders. In relation to wholesalers their obligation to continuously supply pharmacists was highlighted in the paper. In addition to the responsibilities the paper also outlines limitations and provides information on the possibility of Member States to introduce restrictions on the supply of medicines to other operators in the EU. These restrictions should aim at mitigating the risk of shortages of medicines.
Read the paper HERE
In relation to the shortage problem, it should be noted that EAHP will be sharing the results of its 2018 Medicines Shortage Survey at the launch event of the report on 7th November 2018. Registration will open in October. For more information, please regularly check updates published on our website and social media accounts.
COST Action CA 15105 – Survey on patients opinion about drug shortages
COST Action CA 15105 on medicines shortages invites you to participate in a qualitative study regarding patients’ perspective about medicine shortages during hospital stay. Drug shortages are a global problem which can result in significant implications for the patient. Despite the importance of the problem, no objective data is available on patient impact. This survey aims at quantifying the impact of drug shortages at patient level in the hospital environment.
Hospital pharmacist are encouraged to question interested patients who are willing to share their experience with medicines shortages. Feedback from patients should be submitted by completing the short questionnaire by 1st December 2018. Questions in relation to this survey activity can be address by email to Darija Kuruc Poje (darijakuruc21[at]gmail[dot]com). Patients can also respond to the survey themselves.
Access the survey HERE
More about COST Action CA 15105 HERE
EJHP – Study protocols are now accepted
The ‘Protocol’ section of the European Journal of Hospital Pharmacy (EJHP) aims at presenting planned and/or ongoing studies to the hospital pharmacy world. Publishing study protocols enables researchers and funding bodies to stay up to date in their fields by providing exposure to research activity that may not otherwise be widely publicised. This can help prevent unnecessary duplication of work and will hopefully enable collaboration.
Hospital pharmacists are encouraged to send submissions for this EJHP section. Protocols should cover the following aspects:
- Title: This should include the specific study type e.g. randomised controlled trial.
- Abstract: This should be structured into sections: Introduction; Methods and analysis; Ethics and dissemination. Registration details should be included as a final section, if appropriate.
- Introduction: Explain the rationale for the study and what evidence gap it may fill. Appropriate previous literature should be referenced, including relevant systematic reviews.
- Methods and analysis: Provide a full description of the study design, including how the sample will be selected; interventions to be measured; the sample size calculation (drawing on previous literature) with an estimate of how many participants will be needed for the primary outcome to be statistically, clinically and/or politically significant; what outcomes will be measured, when and how; a data analysis plan.
- Ethics and dissemination: Outline ethical and safety considerations and the dissemination plan (publications, data deposition and curation).
- Authors’ contributions: State how each author was involved in writing the protocol.
- Funding statement: Preferably worded as follows: ‘This work was supported by [name of funder] grant number [xxx]’ or ‘This research received no specific grant from any funding agency in the public, commercial or not-for-profit sectors’.
- Competing interests statement
They can be uploaded via the ‘submit a paper’ button on the EJHP website. For more information please refer to the authors section of the EJHP website.
EJHP: Special online issue
The September edition of the European Journal of Hospital Pharmacy (EJHP) is an special online-only issue focusing entirely on articles which provide valuable information on formulation, compatibility and stability issues of medicines often used in ways that go beyond the norm.
Read more HERE.
[EAHP Statement Corner]
EAHP SAT – have you started your own assessment?
Since its launch during the 23rd EAHP Congress in Gothenburg (21-23 March 2018), more than 90 hospitals have used the EAHP self-assessment tool to assess the level of Statement implementation within their hospitals. The tool, translated already to 9 different languages, not only allows pharmacies to assess the level of implementation of the European Statements of Hospital Pharmacy within their hospitals, but it also provides an action plan including evidence-based resources. The tool also gives hospitals the possibility of understanding where they stand in comparison to other hospitals in their own or other countries.
Visit our website to learn more about the self-assessment tool and don’t forget to check the video that EAHP presented in Gothenburg explaining how the tool can be used to improve outcomes for patients by moving towards implementation.
EMA- Draft guideline on clinical evaluation of vaccines
This guideline addresses the clinical evaluation of vaccines intended for the prevention of infectious diseases. It includes considerations for trials intended to document the safety, immunogenicity and efficacy of new candidate vaccines and to support changes in the prescribing information of licensed vaccines. It also considers the need for and use of vaccine effectiveness studies.
Deadline – 30th October 2018
More information HERE
EMA- Draft guideline on the use of minimal residual disease as a clinical endpoint in multiple myeloma studies
The guideline aims to address the use of undetectable minimal residual disease (MRD) as an intermediate efficacy endpoint in controlled randomised clinical studies in patients with multiple myeloma (MM), adequately designed to demonstrate efficacy by relevant hard endpoints. MRD as an endpoint in this context would allow earlier approval of new drugs pending final confirmatory data.
Deadline – 31st October 2018
More information HERE
EMA - Draft guideline on clinical investigation of medicinal products in the treatment of epileptic disorders
The present document is a third revision of the existing guideline. The main changes to the existing guideline include incorporation of the new classification / definitions of seizure types and epilepsies, the acceptance of add-on studies in support of a monotherapy claim on a case-by-case basis, the inclusion of new sections on neonates and status epilepticus and other changes related to paediatric developments. The scope of this document is restricted to treatment of seizures in epileptic disorder although there are some remarks concerning non-seizure features of epilepsy syndromes.
Deadline – 17th February 2019
More information HERE