Hospital pharmacists gather at EAHP 2022 Congress

Hospital Pharmacists gather for 26th EAHP Congress in Vienna

Written by Gonzalo Marzal López EAHP Project Portfolio Manager and Joan Peppard, Past President, EAHP

Dr. András Süle, EAHP President

The EAHP Congress is a great opportunity to meet one’s friends and colleagues from across Europe and in 2022 this was a special occasion. This was the first EAHP in person Congress since the COVID-19 pandemic started in 2020 (EAHP held a virtual Congress in March 2021). The 26th EAHP Congress was held in Vienna from 23rd to 25th of March 2022. Around 2000 participants from 50 different countries participated at this Congress. All COVID-19 protocols were followed, and the organisation made sure that all participants enjoyed this in person event while staying safe. “Hospital pharmacists – changing roles in a changing world” was the theme of this Congress. The presentations aimed to explore and further expand on the changing roles of hospital pharmacists in this evolving scene. The theme of the congress was an inspiration to prepare for this changing world and provide tools to hospitals pharmacists to embrace the opportunities to guarantee optimal patient care within the available resources, and it admirably succeeded in these goals. Lecture theatres were full and many smaller meeting rooms had full signs including the presentation by a well-known lecturer from the ‘real’ Irish capital, Stephen – take a bow! As the EAHP President Andras Süle and EAHP Scientific Chairman Thomas Derijt explained during the opening ceremony, the era in which hospital pharmacists were just box movers triggered by a medical prescription is part of the past. Thomas described the evolution of the hospital pharmacy professions as following a steep curve and still to reach the summit. The quick changing scene creates the opportunity to embrace new challenges and responsibilities for our profession. The three keynotes presentations were focussed on the future of hospital pharmacy. The first Keynote presentation “Value based healthcare – hospital pharmacists should claim their sea” was dedicated to valuebased healthcare as a possible financing model to keep healthcare affordable in the future. Keynote 2 – “What people want from their medicines – Making shared decisions” focused on what really matters to the patients and the importance of putting the patient

at the centre of medication management. The keynote 3 “The

era of cell and gene therapies in oncology – Fiction, poetry,

or science?” provided intriguing insights on the science and the processes of these new therapies and gave an outlook on what to expect in the near future. Besides the keynotes, the Congress held more than 30 sessions and workshops linked with the changing roles theme as well as lessons learned from the pandemic. This EAHP Congress also marked the 50th anniversary of EAHP and some surprises linked with the anniversary were prepared. A history walk with 30 posters was set up in the exhibition area that led participants through the history of EAHP since its foundation in 1972. In addition, the anniversary marked the creation of a new EAHP award: the “EAHP Board of Directors Professional Excellence Award”. This award is for individuals that have made a significant contribution in making EAHP’s vision and mission a reality. The first award was given to Dr. Leonidas Tzimis from Greece, an experienced hospital pharmacist who has collaborated with EAHP for many years. Leonidas has worked for 40 years as a hospital pharmacist in Greece and has supported the transition of an old-fashioned hospital to a digital one, authored more than 130 publications and presentations for national and international congresses, shared expertise on hospitals’ integrated health information systems and represented the EAHP Greek delegation for almost 20 years. The 26th EAHP Congress was also an opportunity to showcase and launch the outcomes of the EAHP Special Interest Group (SIG) on Hazardous Medicinal Products. The EAHP SIGs are a new initiative launched in 2021 that build on the knowledge and experience of European hospital pharmacists to focus on specific topics. The speakers for this session described the different classification systems for hazardous medicinal products in Europe, best practices identified, outcomes of the survey initiatives and the recommendations for improving the current landscape. Finally, more than 400 posters and 70 Good Practice initiatives were accepted by the EAHP Scientific Committee and included in the poster area for participants to see and to consider for application to their own practice areas. Once again, this in-person Congress was indeed a perfect opportunity to network and meet face to face, an opportunity we really missed in 2020 and 2021. Well done to all involved.

News

HIQA Publishes Annual Report

The Health Information and Quality Authority (HIQA) has published its annual report for 2021, outlining its role in working to improve the quality and safety of Ireland’s health and social care services.

The report details the organisation’s work to regulate and monitor services, develop national standards and guidance, provide evidence synthesis and health technology assessments to support key policy decisionmaking, and to further develop health information in Ireland. The report also includes the Report of the Chief Inspector of Social Services, and details a summary of over 1,800 inspections of services during the year. HIQA’s Chief Executive, Angela Fitzgerald, said: “In 2021, HIQA continued to place a focus on safeguarding and human rights, including in the national standards and guidance we develop, and in how services are regulated. As the regulator, we continued to monitor the safety and quality of health and social care services, responding to risk as appropriate. We commenced work in the area of homecare, calling for the reform and regulation of such services to better safeguard the people receiving care and support in their own homes. We also launched an online learning course to support front-line staff to implement a human rights-based approach to their work in services.

“Collaboration with other bodies also remains a key area of focus for HIQA. For example, we worked with the Department of Health and HSE on the National Care Experience Programme, including the rollout of the 2021 National Inpatient Experience Survey which asked patients about the impact of COVID-19 on their care. HIQA published 113 evidence synthesis reviews or advice on COVID-19 for the Minister for Health, Department of Health and National Public Health Emergency Team. This work shows the value and importance of using scientific evidence to shape the public health decision-making process.” During the year, HIQA highlighted how reform is urgently needed in the regulation of social care services, and in Ireland’s health information system to better serve the needs of people using health and social care services. as highlighted in this report. As we prepare to take on new roles and responsibilities in a number of new areas — including through the commencement of the Patient Safety Bill and the inspection of International Protection Accommodation Services — we remain committed to protecting and upholding the human rights of all people using health and social care services in Ireland.”

HIQA Chief Executive, Angela Fitzgerald

The Value of Value Added Medicines

A new report, which focuses on the benefits of using Value Added Medicines in an EU context, has been published by Medicines for Ireland. ‘Value Added Medicines: Advancing Medicine Repurposing in the EU’ builds on the 2021 published report ‘Discussion Document on the Contribution of Value Added Medicines (VAMs) in Ireland’. It has been produced in conjunction with sister organisation, Medicines for Europe. Value Added Medicines (VAMs) are medicines based on known molecules that address healthcare needs and deliver relevant improvements for patients and healthcare professionals. VAMs are key drivers for access to medicines and are increasing patient quality of life for chronic diseases, while offering significant benefits to the healthcare community. VAMs offer a wide range of benefits from ensuring better adherence and compliance, to keeping healthcare costs down by reducing the need for patients to be moved to expensive next line therapies. The importance of using VAMs to address unmet medical needs in a timely and cost-effective manner has been highlighted during the Covid 19 pandemic. The 2022 report stresses that in order to make medicine repurposing a success on an EU level we need to employ all resources at hand to connect different actors. One such connection which can uniquely be addressed by the EU is to assist academia and non-commercial stakeholders in conducting research, as well as facilitating their partnering with the industry in making repurposed medicines available to patients. The early involvement of industry in repurposing projects opens a range of opportunities like new indications, different/adjusted delivery forms, changing dosage and combining different therapies to meet the needs of the patient community and to bring to market new treatment options in an accessible and affordable way. Furthermore, for more repurposing projects to come to fruition, we need to adapt the EU pharmaceutical ecosystem, starting with recognising the need for a tailored development approach for VAMs, including repurposed medicines. VAMs should be acknowledged as a separate group of medicines in EU legislation. “Ireland can learn a lot from our EU peers. The industry needs to continually innovate, meanwhile, the state and regulators still have an important role to play,” said Padraic O’Brien, Chairperson of MFI. “We need a system that rewards innovation with appropriate incentives, whilst recognising the potential longterm value and savings that VAMs can bring to the State.” “At MFI, we are committed to improving patient care and delivering value to the HSE and are proud to drive stakeholder engagement on this important topic,” said Clodagh Kevans, Chair of the MFI VAM Committee. “We believe that we need a new and simplified regulatory pathway for VAMs in Ireland, which would bring us into line with other major European countries to ensure that our patients and healthcare system is not left behind. “We also need a shift in mindset from one that focuses purely on cost to an outlook that is centred around better outcomes for patients taking a holistic look at the whole patient journey,” she continued.

Code of Practice Published

Medicines for Ireland have announced the publication of the MFI, Code of Practice V2.0.

Medicines for Ireland are committed to ensure that all members advertising medicinal products aimed at both healthcare professionals and the public is conducted in a responsible, ethical, compliant and professional manner. The Codes set out specific standards for pharmaceutical companies with regard to ethical and regulatory advertising and promotional interactions with the Healthcare Community. The Codes are not intended to address or regulate commercial terms and conditions relating to the price, sale and distribution of medicines, which must always be in compliance with applicable rules and requirements. The principles set forth in the Codes are mandatory and shall be implemented by all Members. The organisation stated, “Medicines for Ireland and our parent association Medicines for Europe are committed to ensure that all members advertising medicinal products aimed at both healthcare professionals and the public is conducted in a responsible, ethical, compliant and professional manner. “As a member of Medicines for Europe, all Medicines for Ireland members are committed to the ethical standards set out in Medicines for Europe Code of Conduct (www.medicinesforeurope.com). Medicines for Ireland has developed this supplementary Code of Marketing Practice to outline Irish specific requirements additional to the parent Medicines for Europe Code of Conduct. Both Codes should be read in conjunction and are intended to be a self-regulatory standard and are without prejudice to any existing or future legislation. Where there is any gap or inconsistency between standards, the stricter requirement shall always apply.”

The full document can be viewed at: https://www.medicinesforireland.ie/wp-content/uploads/2022/05/Medicines-for-Ireland-Code-ofPractice-V2.0.pdf

FMD Use and Learn Ends

The Falsified Medicines Directive (2011/62/EU) ‘(FMD’) introduced new requirements from February 2019 for safety features on prescription medicines packaging, enabling the packs to be authenticated as genuine prior to supply to patients. FMD has been in a ‘use and learn’ phase in Ireland since February 2019 due, in part, to the impact of Covid-19 and Brexit. The use and learn phase ended for wholesalers on 9th May 2022 and for pharmacies and hospitals for 30th May 2022. After these dates, pharmacies, hospitals and wholesalers may not supply packs that generate alerts when scanned unless the alert has been fully investigated and a root cause has been found and falsification ruled out.

I haVe the will to work out eVery day. But I still need help to lose weight and keep it off.

Patient portrayal. ROBERTO, civil servant; Age: 48 BMI: 39

Your patients with obesity have the will. You can offer them the way.

Abbreviated Prescribing Information

Saxenda® Liraglutide injection 3 mg. Please refer to the full Summary of Product Characteristics (SmPC) before prescribing. Saxenda® 6 mg/ml solution for injection in a prefilled pen. One pre-filled pen contains 18 mg liraglutide in 3 ml. Indication: Adults: Saxenda® is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adult patients with an initial Body Mass Index (BMI) of ≥ 30 kg/m² (obesity) or ≥ 27 kg/m² to < 30 kg/ m² (overweight) in the presence of at least one weight-related comorbidity. Treatment with Saxenda® should be discontinued after 12 weeks on the 3.0 mg/day dose if patients have not lost at least 5% of their initial body weight. Adolescents (≥12 years): Saxenda® can be used as an adjunct to a healthy nutrition and increased physical activity for weight management in adolescent patients from the age of 12 years and above with obesity (BMI corresponding to ≥30 kg/m2 for adults by international cut-off points)* and body weight above 60 kg. Treatment with Saxenda should be discontinued and re-evaluated if patients have not lost at least 4% of their BMI or BMI z score after 12 weeks on the 3.0 mg/day or maximum tolerated dose. *See table 1 in SmPC. Posology and administration: Adults: The starting dose is 0.6 mg once daily. Dose should be increased to 3.0 mg once daily in increments of 0.6 mg with at least one-week intervals to improve gastro-intestinal (GI) tolerability. If escalation to the next dose step is not tolerated for two consecutive weeks, consider discontinuing treatment. Adolescents (≥12 years): A similar dose escalation schedule as for adults should be applied. The dose should be increased until 3.0 mg (maintenance dose) or maximum tolerated dose has been reached (see SmPC). Adults and Adolescents: Daily doses higher than 3.0 mg are not recommended. Saxenda® is administered once daily at any time, independent of meals, subcutaneously injected in the abdomen, thigh or upper arm, preferably around the same time of the day. Saxenda® must not be administered intravenously or intramuscularly. Saxenda® should not be used in combination with another GLP-1 receptor agonist. When initiating treatment in patients with type 2 diabetes mellitus, consider reducing the dose of concomitantly administered insulin or insulin secretagogues (such as sulfonylureas) to reduce risk of hypoglycaemia. Blood glucose self-monitoring is necessary to adjust the dose of insulin or insulin-secretagogues. The safety and efficacy of Saxenda in children below 12 years of age has not been established. Contraindications: Hypersensitivity to the active substance or to any of the excipients. Special warnings and precautions for use: Saxenda® must not be used as a substitute for insulin in patients with diabetes mellitus. Diabetic ketoacidosis has been reported after rapid discontinuation or dose reduction of insulin. There is no clinical experience in patients with congestive heart failure New York Heart Association (NYHA) class IV and therefore Saxenda® is not recommended for use in these patients. Saxenda® is not recommended in patients: aged 75 years or more, treated with other products for weight management, with obesity secondary to endocrinological or eating disorders or to treatment with medicinal products that may cause weight gain, with severe renal impairment including end-stage renal disease, with severe hepatic impairment. Saxenda® must be used with caution in patients with mild or moderate hepatic impairment. Saxenda® is not recommended in patients with inflammatory bowel disease and diabetic gastroparesis. Acute pancreatitis has been observed with the use of GLP-1 receptor agonists, patients should be informed of the characteristic symptoms. If pancreatitis is suspected, Saxenda® should be discontinued; if acute pancreatitis is confirmed, Saxenda® should not be restarted. In clinical trials for weight management, a higher rate of cholelithiasis and cholecystitis was observed in patients on Saxenda® than those on placebo, therefore inform patients of characteristic symptoms. Use with caution in patients with thyroid disease. An increase in heart rate was observed with liraglutide in clinical trials. Heart rate should be monitored at regular intervals and patients informed of the symptoms of increased heart rate. For patients who experience a clinically relevant sustained increase in resting heart rate, treatment with Saxenda® should be discontinued. Patients treated with Saxenda® should be advised of the potential risk of dehydration in relation to GI side effects and take precautions to avoid fluid depletion. Signs and symptoms of dehydration, including renal impairment and acute renal failure have been reported. Patients with type 2 diabetes mellitus receiving Saxenda® in combination with insulin and/or sulfonylurea may have an increased risk of hypoglycaemia. Dizziness can be experienced mainly during the first 3 months of treatment, therefore use caution when driving or using machines if dizziness occurs. Episodes of clinically significant hypoglycaemia have been reported in adolescents (≥12 years) treated with liraglutide; patients should be informed about characteristic symptoms of hypoglycaemia and appropriate actions. Fertility, pregnancy and lactation: Saxenda® should not be used during pregnancy or breastfeeding. If a patient wishes to become pregnant, or pregnancy occurs, treatment with Saxenda® should be discontinued. Undesirable effects: Very common (≥1/10): headache, nausea, vomiting, diarrhoea, constipation. Common (≥1/100 to <1/10): hypoglycaemia, insomnia, dizziness, dysgeusia, dry mouth, dyspepsia, gastritis, gastro-oesophageal reflux disease, abdominal pain upper, flatulence, eructation, abdominal distension, cholelithiasis, injection site reactions, asthenia, fatigue, increased lipase, increased amylase. Uncommon (≥1/1,000 to <1/100): dehydration, tachycardia, pancreatitis, delayed gastric emptying, cholecystitis, urticaria, malaise. Rare (≥1/10,000 to <1/1,000): anaphylactic reaction, acute renal failure, renal impairment. The SmPC should be consulted for a full list of side effects. Legal category: POM MA number: 5 x 3 ml pre-filled pens EU/1/15/992/003 For complete prescribing information, please refer to the SmPC which is available on www.medicines.ie or by email from infoireland@novonordisk.com or from the Clinical, Medical and Regulatory Department, Novo Nordisk Limited, 1st Floor, Block A, The Crescent Building, Northwood Business Park, Santry, Dublin 9, Ireland. Date last revised: November 2021.

Adverse events should be reported to the Health Products Regulatory Authority. Information about adverse event reporting is available at www hpra.ie. Adverse events should also be reported to Novo Nordisk on Tel: 1850 665 665 or complaintireland@novonordisk.com