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IMPLANTATION OF A COMMUNICATION CIRCUIT OF ALERTS AND SAFETY NOTES RELATED TO DRUGS FROM THE PHARMACY DEPARTMENT (submitted in 2019)

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European Statement

Patient Safety and Quality Assurance

Author(s)

Ignacio García Giménez, Natalia Martín Fernández, Olalla Montero Pérez, Ernesto Sánchez Gómez, Isabel María Carrión Madroñal

Why was it done?

The aim is to implement a protocol to follow when these safety notes/alerts are released from the AEMPS. It comprehends the reception of the information, its registration and its communication, when needed, to the rest of the healthcare professionals.

What was done?

A communication circuit of alerts and safety notes related to drugs coming from the “Agencia Española de Medicamentos y Productos Sanitarios (AEMPS)”.

How was it done?

At the reception of an alert from the AEMPS, the first step is to check if the drug has been acquired by the Pharmacy, and then act in accordance with the recommendations, informing the Departments in which the medication had been dispensed. If a drug must be retired and a stock break is generated, the healthcare professionals must be informed as well. Security notes from the AEMPS are published in the local hospital website, where the documents sent by the AEMPS can be found. If this medication is included in the Pharmacotherapeutic guide, a notification is shown when it is prescribed. Finally, all alerts and security notes, with the pharmacist intervention, are registered in a database.

What has been achieved?

Since the implementation of the circuit, 14 alerts and 9 security notes were sent from the AEMPS in a period of 6 months. No interventions regarding the alerts were needed. Healthcare professionals were informed when the security notes were released, pointing to the patients at risk, the precautions required and the alternative therapies available.

What next?

To incorporate it as an indicator of quality of care within the procedures performed by the pharmacy department and detect areas of improvement.

SAFE PRESCRIBING METRICS FOR HOSPITAL PHARMACY (submitted in 2019)

European Statement

Patient Safety and Quality Assurance

Author(s)

Oran Quinn, Anna Marzec

Why was it done?

Errors of miscalculation, doses inappropriate for renal function and at extremes of weight were reported when doses of medication were written as ‘mg/kg’ without stating the dose to be given e.g. Gentamicin 5mg/kg, Vancomycin 15mg/kg and Enoxaparin 1.5mg/kg.

What was done?

A quality improvement initiative to resolve issues with prescribing medications dosed by weight. Nursing staff were identified as ‘gate-keepers’ who could refuse to administer medication inappropriately prescribed. Identification, agreement, education and feedback were necessary to change prescribing practice and support nursing staff. Hospital doctors were required to calculate and prescribe the total dose to be given. Feedback was given by monthly bulletin.

How was it done?

Support from key stakeholders was sought to endorse the initiative. Verbal and written education was given to nursing, medical and pharmacy staff to implement the initiative on an agreed date. Refusal to administer medication unsafely prescribed was key to successful implementation. Patient’s weight was not always available and additional equipment was provided to overcome this problem. The risk of withholding treatment was considered and an escalating referral process was recommended contacting the Senior House Officer, then Registrar and ultimately the patients Consultant to avoid lengthy delays to patient treatment. Nurses felt supported in refusing to administer medication.

What has been achieved?

A point prevalence study of all inpatients was carried out monthly to ascertain the level of compliance Mar-19 Apr-19 May-19 Jun-19 Jul-19 Aug-19 % of patients with total dose prescribed correctly 67.0 86.7 96.7 100.0 100.0 88.9 87.5. Results showed overall improvement from March to August and full compliance in May and June. Success was achieved through a multidisciplinary approach involving all key stakeholders, a forcing function and support from and for front line staff.

 

What next?

This initiative has been further developed to become ‘Monthly Safe Prescribing Metrics’.
Other prescribing metrics such as using ‘iu’ dosing for Insulin, prescribing appropriately for patients at extremes of weight and using the abbreviation ‘mcg’ for medications dosed in ‘micrograms’ were included. Initiatives to improve all metrics are ongoing.
Safe prescribing metrics could help to positively influence prescribing culture in other healthcare settings.

HERA – A NEW TOOL FOR THE QUALITATIVE AND PHARMACOECONOMICAL EVALUATION OF GENERIC DRUG PRODUCTS BEFORE CHANGING BRANDS (submitted in 2019)

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European Statement

Selection, Procurement and Distribution

Author(s)

Steffen Amann, Rudolf Bernard, Georg Berndt , Meike Bindemann, Myga Brakebusch, Jörg Brüggmann, Frank Dörje, Miriam Gyalrong-Steur, Anita Kellermann, Markus Müller, Elfriede Nusser-Rothermundt, Rainer Riedel, Eva Tydecks

Why was it done?

Given rising cost-pressure and increasing numbers of supply shortages, changes between generics have become daily practice in hospital pharmacies. To ensure constant treatment quality and patient safety, the equivalence of a potential new product with the current one must be guaranteed before changing brands. So far there has been no transparent, standardised tool for the comparison of generics workable in everyday clinical practice. Developing such a tool was our project’s aim.

What was done?

We developed an Excel-based tool for the qualitative and pharmacoeconomical evaluation of generics before changing brands (aut-idem substitution) in hospitals.

How was it done?

A working-group of pharmacists from seven hospitals developed the “HERA” tool (HTA-evaluation of geneReric phArmaceuticals). Starting from a base version, 22 generic products were assessed with the tool during five evaluation rounds. Based on these results the instrument was gradually refined. Within HERA‘s Excel matrix a potentially to-be-used generic is compared with the current one. The economic evaluation is based on unit prices and prescription volumes, but also includes process costs associated with the product change. The assessment of pharmaceutical quality is based on 34 criteria from six areas (licensed uses, drug substance, dosage form and excipients, handling, safe design, packaging and storage). The objective quality evaluation is complemented by the assessment of hospital-specific features. Complex substitutions – e.g. associated with a handling change – require involvement of the medical staff using the product. The purchasing decision is taken based on the synopsis of pharmaceutical quality and economic evaluation.

What has been achieved?

The standardised evaluation of product differences before substitutions allows for the early identification of potential problems of brand changes and helps avoiding them for the benefit of patient safety. HERA also guarantees reproducibility and transparent, QM-compliant documentation of product changes. The pharmacies of our purchasing group now routinely use HERA for the assessment of generics before intended brand substitutions. Each evaluation is conducted in one pharmacy and shared with the others via data-cloud.

What next?

We have published a paper on HERA and presented it at the German Hospital Pharmacists congress in 2018. Our aim is to create a network of colleagues with shared access to all colleagues’ HERA product evaluations to reduce the workload for the individual pharmacies.

THE IMPACT OF A WARD SATELLITE PHARMACY ON CLINICAL PHARMACY SERVICES AND POTENTIAL COST BENEFIET (submitted in 2019)

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European Statement

Patient Safety and Quality Assurance

Author(s)

Thewodros Leka, iun Grayston, Mashal Kamran, Biljana Markovic

Why was it done?

The Carter report recommended that about 80% of hospital pharmacist time should be spent on the wards to provide clinical pharmacy services. However, in our hospital’s surgical specialty at the time of this report, it was found that only 33% of pharmacist’s time was spent on clinical pharmacy services. This had a negative impact on:
• rate of medication errors and near misses
• supply of critical medicines
• pharmacist participation in productive ward rounds
• timely discharge of patients home

What was done?

The Pharmacy department made a successful business case to the Hospital executives to open a Satellite pharmacy to serve 4 surgical wards. The proposal was to recruit a dedicated clinical pharmacist and Medicines Management Technician, and set-up a dispensing satellite pharmacy.

How was it done?

The business case indicated that if funded, the new satellite pharmacy team would: • improve clinical pharmacy key performance indicators • improve patient safety • deliver a potential cost benefit Funding limitation was an obstacle and we have to convince the board.

What has been achieved?

We achieved 60−90% improvement in the objectives set in the business case as illustrated in Table 1 and 2. The pharmacy team won the annual quality improvement award of 2018. Table 1: Clinical Pharmacy Service improvement Clinical pharmacy services Service rate pre-satellite pharmacy Service rate post satellite pharmacy % of service improvement Medication errors 16/month 6/month 63% Pharmacist interventions 20/month 80/month 75% Pharmacist participation in ward round 6/month 50/month 88% Time to dispense discharge summaries 90 minutes/discharge summary 20 minutes/discharge summary 77% Number of patients counselled 15/month 75/month 80% Pharmacist available in the ward 1.5 hrs/day 7.5 hrs/day 80% Time taken to supply critical medicines 1 hour 5 minutes 91% Table 2: Potential Cost-benefit savings achieved Activities Cost-benefit savings/year (€) Reducing length of stay of patients €17,000 Reducing repeat dispensing €16,000 Effective use of nursing time €11,000 Reducing prescribing errors €103,000 Total Savings €147,000.

What next?

• Weekend working.
• Service improvements can be transferred to acute medical units and downstream medical wards. Reference Carter report.

THE RISK MANAGEMENT OF THE PHARMACY PREPARATIONS IN THE HOSPITAL PHARMACIES (submitted in 2019)

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European Statement

Production and Compounding

Author(s)

ADRIANA DURCANSKA

Why was it done?

The quality and safety standards of pharmacy preparations are not harmonised throughout Europe. They fall under the national competencies of individual European countries.

What was done?

The quantitative risk assessment of the pharmacy preparations for stock in hospital pharmacies (HPs) in accordance with Resolution EDQM CM / Res (2016) 1; to specify the decision criteria for the risk assessment; the risk management of the pharmacy preparations for stock in the country; to design a check list of the risk assessment for extempore preparations.

How was it done?

Out of the total number of 53 hospital pharmacies contacted, 5 pharmacies sent a suitable file.

What has been achieved?

A total of 170 types of medicines are being prepared in HPs. One HP  had the result of the risk ≥ 100 when preparing ophthalmic medicines. Annex A is a check list designed to assess the risk of extempore preparations.

What next?

The management is and will be forced to consider its introduction or to use another model: hospital – GMP / outsourcing / central pharmacy preparing and distributing. The aim of using the document in hospital pharmacies of the country.

IMPLEMENTATION OF A MEDICATION SAFETY AGENDA AT TWO HOSPITAL SITES IN RESPONSE TO WORLD HEALTH ORGANISATION (WHO) PATIENT SAFETY CHALLENGE ‘MEDICATION WITHOUT HARM’ (submitted in 2019)

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European Statement

Patient Safety and Quality Assurance

Author(s)

Meenal Patel, Sheena Patel, Peta Longstaff

Why was it done?

• Initiative introduced and on-going since 2017
• To increase and embed medication safety awareness
• To address under-reporting of medication-related incidents, with feedback
• To embed medication safety in education programmes and clinical practice

What was done?

A local medication safety agenda implemented across two hospital sites in response to World Health Organisation (WHO) patient safety challenge ‘Medication without Harm’.

How was it done?

• Medication safety group (MSG) introduced with local strategy, involving junior medical staff for frontline feedback • Medication safety metrics changed to allow benchmarking with peers as per NHS Improvement’s Model Hospital data • ‘Plan, Do, Study, Act’ model applied to improve transfer of care from hospital to rehabilitation unit following external incidents • Monthly analysis of incidents with harm, exploring reasons for under-reporting • Optimisation of incident reporting system to improve staff feedback following investigations • Near miss error log introduced in pharmacy with shared learning • Mitigation of medication-related risks e.g. medications safe storage action plan • Medication safety bulletins, patient safety newsletters and top tips guide introduced covering focal themes • ‘Safe prescribing’ mandatory induction training for junior doctors to support prescribing of high risk medicines and compliance to patient safety alerts • Hospital-wide education on lessons learnt from incidents • Medication safety resources for staff to access • Nursing quality round on medication safety • Electronic missed doses realtime report developed to tackle omitted/delayed critical medication doses • Medication safety awareness (MSA) week held to increase awareness on focal themes

What has been achieved?

• Multidisciplinary MSG with assurance on meeting WHO global challenge. • Monthly analysis of medication safety data to allow learning, collaboration and benchmarking against peers. • Positive staff feedback on bulletins/newsletters with staff involvement/engagement. • Training programmes embedded with safe prescribing education. • Improved hospital safety metrics: Following MSA week, a 5% and 21% increase in medication-related incident reporting occurred at each site which has been sustained. Reporting rates doubled at one site following success of MSA week. • In 2018-19, local target achieved for reported medication-related incidents per 100,000 finished consultant episodes and medication-related incidents with harm

What next?

• Collaborative multidisciplinary working raising the profile of pharmacists acting as medication safety officers
• Implementing medication safety measures from NHS Patient Safety Strategy 2019
• Initiatives for safer culture, safer systems and safer patients

VENOUS THROMBOEMBOLISM PREVENTION MEASURES FOR WOMEN IN PREGNANCY AND THE PUERPERIUM (submitted in 2019)

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European Statement

Patient Safety and Quality Assurance

Author(s)

Sheena Patel, Sima Purohit, Jennifer Hanna

Why was it done?

• VTE remains the leading cause of direct maternal death, with no evidence of a consistent decrease in mortality over the past 20 years.
• Alongside changes in national guidelines, the maternity population and interventions are changing e.g. women giving birth are now older with more risk factors for thrombosis e.g. obesity. More interventions e.g. caesarean section are undertaken placing women at higher risk of VTE.
• VTE prevention measures were introduced in 2010, and nearly 10 years on further changes were implemented to reduce mortality and morbidity.

What was done?

Venous thromboembolism (VTE) prevention measures introduced and embedded for women in pregnancy and the puerperium, with an aim to reduce potentially preventable hospital-associated events

How was it done?

• Electronic VTE risk assessment introduced with mandatory alerts at relevant time-points e.g. at booking, on admission, post-delivery • Simplification of the national VTE risk scoring system to ensure accurate completion of assessment and user-ability • Clear hospital guidance on VTE prevention for pregnant women, including a pocket guide covering risk assessment and thromboprophylaxis • Staff education on mechanical thromboprophylaxis for correct use and monitoring to avoid adverse effects • VTE patient information leaflet covering signs and symptoms of VTE and when to seek urgent medical attention • Introduction of a ‘mum and baby’ app with information during pregnancy and postpartum • Root cause analysis performed on hospital associated VTE events, with shared learning of root causes and actions to prevent recurrence to multidisciplinary teams • VTE education introduced in medical, midwifery and pharmacy staff training programmes, with regular updates in the maternity risk newsletter

What has been achieved?

• Over 95% of women with VTE risk assessments on admission, with weekly and monthly performance reports for local monitoring • Pharmacy staff perform quarterly audits on appropriate thromboprophylaxis. 97% inpatients received pharmacological thromboprophylaxis, and 88% inpatients were wearing anti-embolism stockings • Pre-printed VTE management plan in maternity documentation to assist with transfer of care • Development of an ‘app’ to provide patient information • Patients counselled on anticoagulant therapy to support medication compliance • VTE education embedded in training programmes • VTE ward rounds for ongoing stewardship

What next?

• Staff engagement to embed VTE prevention measures in practice
• Increasing patient education on VTE prevention
• Robust and sustainable interventions improving patient outcomes

COMPENDIUM OF POST-GRADUATE ITALIAN HOSPITAL PHARMACY SCHOOLS: AN INFORMATIONAL GUIDE OF ReNaSFO ASSOCIATION – NATIONAL NETWORK OF ITALIAN HOSPITAL PHARMACY SCHOOL STUDENTS (submitted in 2019)

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European Statement

Education and Research

Author(s)

ANTONIO PIRRONE, FEDERICA MILANI, LUCA CANCANELLI, VALENTINA MARINI , DANIELE MENGATO , ROBERTO LANGELLA , NICOLA REALDON

Why was it done?

On October 5, 2017 the National Network of Italian Hospital Pharmacy School Students (ReNaSFO) was born with the aim to face the various critical aspects of post-graduate Hospital Pharmacy School (SHP), such as the need to make the different paths homogenous among regional SHPs, improve dialogue between colleagues and encourage a more informed approach focused to the training pathway for specialisation. In particular, little official information is available and hard to find about the different realities present in Italy.

What was done?

“Compendium” project is designed to fill this lack and to gather information on post-graduate SHPs operating in Italy. In addition to outlining a summary description of the SHPs, the Compendium is configured as an official tool to respond and provide targeted information to near-graduates and graduates in Pharmacy (who often contact ReNaSFO) interested to approach the SHPs path.

How was it done?

Two project coordinators prepared a list of items submitted to representative ReNaSFO student in every 21 operating SHPs. The items refer to: available places and admission requirements, type of entry test, organisation of didactic lessons, exams and residency training, health facilities affiliated with SHP, potential availability of scholarships, useful links of the SHP or university. The help of universities was fundamental, in particular the helpfulness of SHP directors to collaborate with students.

What has been achieved?

As many as 18 SHPs out of 21 (85.71%) have joined the project: Bari, Bologna, Catania, Catanzaro, Camerino, Genoa, Florence, Milan, Modena and Reggio Emilia, Messina, Naples, Padua, Parma, Pisa, Rome, Siena, Turin and Sassari; of these, 14 schools have already sent their finished “Compendium” form.

What next?

Thanks to the widespread presence of associated ReNaSFO students, the initiative has immediately found interest and participation, reconfirming once again the active and unconditional collaboration between SHP students throughout Italy. Despite a heterogeneous situation between different SHPs, we keep working together hopeful to achieve national uniformity of SHPs and to improve educational objectives and training pathways.

PROTOCOL IMPLEMENTATION FOR PRESCRIBING AND DISPENSING POSTEXPOSURE PROPHYLAXIS KITS FOR HUMAN IMMUNODEFICIENCY VIRUS IN A THIRD-LEVEL HOSPITAL

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European Statement

Patient Safety and Quality Assurance

Author(s)

Clara Estaún-Martínez, Isabel Moya-Carmona, Laila Dani-Ben Abdel-lah, Jose Manuel Fernández-Ovies

Why was it done?

This initiative was taken in order to improve uptake and completion rates of PEP, and to homogenise the healthcare circuit for these patients and the prescribed drugs.

What was done?

A protocol was implemented in order to standardise the prescription and dispensation of postexposure prophylaxis (PEP) after occupational or nonoccupational exposure to human immunodeficiency virus (HIV).

How was it done?

A multidisciplinary team including Infectious Diseases and Preventive Medicine (PM) doctors, pharmacists and Emergency Room (ER) staff developed the following protocol for PEP according to World Health Organisation and national guidelines: – standard three-drug regimen for PEP: Tenofovir disoproxil fumarate/Emtricitabine + Raltegravir for 28 days. The pharmacy service (PS) repackages kits for five, 23 or 28 days that include antiretroviral drugs (AD) and written information about the treatment (use, length of the treatment, main interactions and side effects, contact number). Only 5-day PEP kits will be located in the ER. – Twenty-four-hour access granted to PEP kits as it is strongly recommended to initiate PEP as early as possible (ideally within 72h). –
Established healthcare circuit for patients in the ER:
• Monday–Fridays (8h00–15h00): patients will be immediately referred to PM, then they will go the PS in order to receive a 28-day PEP kit and pharmaceutical care.
• Out of this schedule and bank holidays: ER doctors will give patients a 5-day PEP kit and they will be referred to PM the next working day. After visiting PM, the patient will go to the PS in order to receive the rest of PEP (23-day kit) and pharmaceutical care. –
Several meetings took place in order to explain this new circuit to the health professionals involved and written copies were available on the ER as well as on the intranet.

What has been achieved?

The implementation of this protocol was well embraced by all the staff involved, since it allowed a more efficient healthcare circuit for the patients. It also optimises the evaluation and monitoring of these patients by PM and the pharmacist, and grants prompt PEP initiation and 24h access to the AD. The 28 days (or 5+23 days) kits help to accomplish the proper length of treatment, without using the regular packages which include 30 days of treatment (saving €43.17 per treatment).

What next?

We will monitor the compliance with this protocol and the drugs prescribed for PEP.

DEVELOPMENT OF NEW PRODUCTION WHEN NEITHER PACKAGING NOR SOME OF THE RAW MATERIALS CONFORM TO EUROPEAN STANDARDS

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European Statement

Production and Compounding

Author(s)

Katrine Bødker Rubach-Larsen, Anne Rungø, Anette Eskildsen, Lone Skovhauge

Why was it done?

A research team at the MR Centre (MRC2) wished to set up the production of Pharmacy Kits, but had no prior experience of, or licence to, manufacture drugs. Thus, the hospital pharmacy was asked to participate in the development of such production.

What was done?

A new MR-scanning technology, hyperpolarisation, for the quantification of metabolic processes with an extremely high sensitivity enables physicians early detection of treatment effects in, for example, cancer and diabetes. A so-called Pharmacy Kit is used in the hyperpolarisation process and consists of a specially designed packaging with tubes, vessels and filters containing the contrast agent and buffer solutions. The objective for the hospital pharmacy1 was to manufacture Pharmacy Kits complying with Good Manufacturing Practice (GMP), though neither packaging nor two of the raw materials conformed to European standards.

How was it done?

The MRC research team presented the hospital pharmacy with the desired combination of compounds and the packaging required for Pharmacy Kit production. The task for the hospital pharmacy was then to set up a manufacturing process that met these requirements and complied with the guidelines for GMP. A production complying with GMP was developed in close collaboration with the MRC and an ongoing contact with the Danish Medicines Agency. During the process the hospital pharmacy carried out its own microbiology test in order to determine if, and for how long, the non-CE-marked packaging could store the contrast agent and buffer solutions. Risk assessment of the raw materials not found in the European Pharmacopeia were conducted. The method investigated by the MRC already takes place at a few other places in and outside of Europe. Experiences from these production sites were implemented and expanded with process optimisation, and specially designed equipment for the production.

What has been achieved?

Due to a strong inter-professional collaboration between the MRC and the hospital pharmacy and due to qualified risk assessments, it was possible to set up a production of Pharmacy Kits according to GMP.

What next?

When researchers contact hospital pharmacies with new ideas, we have to be willing to work with GMP in a different way by applying knowhow and risk assessments in order to ensure developments within the healthcare system.
1. Hospital Pharmacy Central Region, Production, Aarhus, Denmark.
2. MR Centre, Aarhus University Hospital, 8200 Aarhus N, Denmark

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