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IMPLEMENTING THE PRODUCTION OF STERILISED SYRINGES IN THE HOSPITAL: IMPROVING MEDICATION SAFETY AND SAVING HEALTHCARE COSTS

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European Statement

Patient Safety and Quality Assurance

Author(s)

Karin Larmene-Beld, Rommert Wijnsma, Gerrit de Weerd, Maarten Postma, Erik Frijlink, Katja Taxis

Why was it done?

Medication administration errors are common in hospital practice. Meta-analyses suggest that about 10% of administrations are erroneous, with much higher error rates occurring during intravenous drug administrations. It has been demonstrated that 21% of the errors can be eliminated when prepared syringes are used. Many countries struggle with the problem of optimising the process of safe parenteral medication in hospitals. Different guidelines across countries outline how preparation of parenteral medication in the clinical environment should be done. Recently the Council of Europe published a resolution about preparation of medication which encourage the supply of ready-to-administer products by the pharmacy. Moving the activities of preparation of medication from the clinical environment to the pharmacy requires investments in pharmacy equipment but will result in efficacy, better quality and reduction in preparation medication errors in the hospital.

What was done?

Development and implementation of sterilisable plastic syringes produced in the hospital pharmacy for large-scale production of ready-to-administer products.

How was it done?

A new development in this area are ready-to-administer pre-filled sterilised syringes (PFSS) produced by the pharmacy. PFSS are produced on stock under GMP conditions by the hospital pharmacy using (semi) automatic filling and closing machines whereby quality and safety are embedded in the whole process of manufacturing. A total cost of ownership analysis is performed showing PFSS prepared in the hospital pharmacy yielded cost savings compared to conventional preparation on the ward. The process of production, filling, closing and sterilisation has been validated using newly acquired equipment. With the introduction of the cyclic olefin polymer (COP) syringes a new type of primary container is implemented in the pharmacy. To ensure patient safety and product quality a science- and risk-based strategy has been developed for testing extractables and leachables to qualify the new container as primary packaging material.

What has been achieved?

Introducing PFSS is cost saving for the healthcare system:– COP syringes are suitable as primary packaging material; –enhancement styles for better readability of labels are established; and – already, 15 products are validated and available for use in the hospital.

1. KHM Larmené-Beld KHM, Touwen-Spronk J, Luttjeboer J, et al. A cost minimization analysis of ready-to-administer pre-filled sterilized syringes in a Dutch hospital.. Submitted for publication in Clinical Therapeutics.
2. Larmené-Beld K, Kuiper A, van Berkel S, et al. A science- and risk-based strategy to qualify sterilized prefilled syringes as primary packaging material in a hospital pharmacy. Abstract submitted for 24th EAHP Congress.
3. Larmené-Beld KHM, Kim Alting E, Taxis K. A systematic literature review on strategies to avoid look-alike errors of labels. Eur J Clin Pharmacol 2018 74:985–93.

What next?

Introducing more drugs as ready-to-administer products. Optimising the label of ready-to-administer syringes to avoid look-alike errors based on the results of the review.

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.

HOSPITAL PHARMACY UNIFIES ELECTRONIC STANDARD PRESCRIPTION THROUGHOUT THE REGION

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European Statement

Patient Safety and Quality Assurance

Author(s)

Linda Jeffery

Why was it done?

The primary aim was to increase patient safety by quality-assuring ESPs and guiding clinicians to rational and safe prescribing. The Central Denmark Region (1.3 million citizens) has five hospitals, each with their own hospital and ward management. ESPs were previously set up and maintained locally, often by clinicians at ward level, resulting in several thousand, and a huge variety of ESPs for the same indication/treatment. Often only small differences separated these, but larger differences were also observed. Both patients and clinicians move around hospitals within the region. Varying ESPs from hospital to hospital confused clinicians and compromised patient safety.

What was done?

The regional Drug and Therapeutics Committee (DTC) commissioned the Hospital Pharmacy, Central Denmark Region to take over management of electronic standard prescriptions (ESP) in the shared Electronic Prescribing System (EPS). The pharmacy was also commissioned to lead the unification of local to regional ESPs, in collaboration with clinical specialists. ESPs are electronic ‘packages’ of one or more prescriptions, set up for treatment of defined conditions/procedures e.g. knee-replacement. When the clinician prescribes an ESP, the predefined prescriptions appear automatically in the patient’s medicines list.

How was it done?

The Hospital Pharmacy highlighted clinical areas/treatments with several variations of the same ESP. The DTC appointed relevant clinicians to work with a pharmacist on unifying these, to one (or more) standardised ESPs, to be used in the whole region. The pharmacist was coordinator for the ad-hoc working groups. After approval by the DTC, these ESPs replaced the existing. If a department wanted an ESP that differed from the regional ESP, this had to be approved by the DTC.

What has been achieved?

Regional ESPs have been approved for:
• Abortion (reduced from 17 to six).
• Helicobacter pylori eradication (reduced from 28 to two).
• Treatment of paracetamol-overdosage.
Many new ESPs have been approved, promoting:
• Safe prescribing of complicated regimes e.g. fosphenytoin loading/maintenance.
• Use of regional formulary drugs e.g. antibiotics for pneumonia/urosepsis.

What next?

We continue to work on other regimes that can be unified e.g. treatment of Wernickes prophylaxis/syndrome and parenteral nutrition. We recently met with pharmacists from two other regions that use the same EPS as us – maybe we can share ESPs nationwide in future.

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

PHARMACISTS IMPROVE DOCUMENTATION OF DRUG ALLERGIES

European Statement

Patient Safety and Quality Assurance

Author(s)

Mohammed Almeziny, Fahad Alkharji , Ali Alkhudair , Jameel Al Mutairi

Why was it done?

Poor allergies’ documentation may cause harm to the patients, if the concerned medication reaches them. The hospital is planning to implement a new Health Information System, which includes a Computerised Provider Order Entry. However, this is a long-term project, so in order to minimise that risk, the hospital administration gave the pharmacists the privilege to do so. The percentage of documented drug allergies was 14%. The issue of compliance from the medical, nursing and pharmacy staff was a major obstacle in allergies’ documentation. For that reason, the pharmaceutical services initiated an improvement project to enhance allergies’ documentation. it is the responsibility of the physician to document any allergy on the inpatient prescription form (IPPF). On the other hand, it is the responsibility of the nurse to ensure that all information is completed on the IPPF before it is sent to the pharmacy. The role of the pharmacist is to document the patient’s allergy in the pharmacy system.

What was done?

Increase the allergy documentation from 14% to 96%.

How was it done?

The FOCUS PDCA was adopted. Find: It was found that the compliance rate was not satisfactory. Patients might receive a medication that is known to cause an allergic reaction, because the allergy was not documented and communicated with other healthcare providers. Organise: The team consisted of all involved departments. Clarify: Some IPPF may not contain allergies and some pharmacy staff do not document the allergy in the pharmacy system. Understand: The factors that may influence the process were identified, although some healthcare professionals consider the documentation as a time-consuming process. The pharmacy system is an old system which does not support enforcing function. Select: The targeted outcome was 90% within 1 year of its inception, July 2017 to July 2018. Plan: All allergies MUST be assisted, and the pharmacy will act as the enforcing body. Do the plan: All pharmacists were reminded to enforce hospital policies by not accepting any incomplete prescription and document all drug allergies in the pharmacy system. Check: Statistics regarding compliance were presented in monthly meetings to highlight the challenges, difficulty or any serious issue. It is a proactive meeting and members can freely suggest any tools required to improve the situation.

What has been achieved?

There was a significant improvement from 14% to 96%.

What next?

Start e-prescription to enforce the documentation of allergies.

OPTIMIZATION OF INTRANET COMMUNICATION TO THE CLINIC

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European Statement

Education and Research

Author(s)

Nina Kærgaard Hansen

Why was it done?

The initiative was performed to investigate the accessibility and usability of the current intranet in order to improve intranet information and communication from the hospital pharmacy to the clinic.

What was done?

Workshops with usability tests were performed with four different professions who are expected to use the intranet information and communication from the hospital pharmacy.

How was it done?

Workshops for selected professionals including pharmacists, pharmaconomists and nurses were held. The workshops consisted of four parts:
1. Video capture and recording test: Participants were asked to find specific information on the intranet. Comments, clicks and movements of the mouse were recorded during the task.
2. Sorting and prioritization the pages: Participants were given screen shots of 57 pages from the intranet. The participants were asked to sort the pages in three categories: need to know, nice to know and insignificant.
3. Evaluation of selected texts: Participants were given 5 examples of texts from the intranet and asked to assess if the text was relevant and understandable.
4. Structured focus group interview: Using a structured interviewguide the use and challenges experienced by the participants were explored.

What has been achieved?

From the present initiative it was found that the structure of the intranet was not optimal and did not reflect the daily needs from the users. The results from the workshops provided a clear guideline on how to restructure the intranet. It is important to make short cuts and optimize search function.
In addition, the initiative revealed how to improve texts:
– Write shortly, concisely and action oriented: “Tell us what to do”.
– Write the most important first, then elaborate and insert links to learn more.
– Use subheadings for skimming the text.

What next?

A campaign is planned to advertise the new intranet structure. Number of users and subscribers on the intranet pages is followed to see if the activity increases. Editors have been educated to write texts that are short, concise and written in an action oriented language

ANTIMICROBIAL STEWARDSHIP ALERTS SYSTEM

European Statement

Patient Safety and Quality Assurance

Author(s)

Emma Ramos Santana, Enrique Tevar Alfonso, Maria Jose Castillos Mendez, Maria Luz Padilla Salazar, Lucy Abella Vazquez, Jesus Ode Febles, Marcelino Hayek Peraza, Javier Merino Alonso

Why was it done?

The implementation of an antimicrobial stewardship program (AMS) is very important, but it has to be accompanied by personal resources. It is therefore necessary to effectively use the time spent in the AMS.

What was done?

We have worked with the Information Technology Service to develop an “Intelligent Antimicrobial Screening Program” (IASP).

How was it done?

Using the information available in Electronic Health Record (EHR) and in pharmacy and microbiology applications we have developed a computer tool that analyze hundreds of situations through pre-established conditions

What has been achieved?

Currently the system analyzes more than 40 conditions related to the correct use of antimicrobials based on antibiotic characteristics, patient situation and microbiological data.
Some of the most relevant conditions are:
●Antibiotic prescribed more than 6 days.
●Patient with parenteral antibiotic for more than 3 days and with other oral medicines.
●Antibiotic that must be adjusted in patients with renal impairment prescribed in patients with glomerular filtration rate (GFR)65 years old, GFR5 days prescribed or other nephrotoxic prescribed.
●Patients with linezolid and thrombocytopenia or anemia or without an hemogram in the last week.
●Patients with daptomicyn and high creatininkinase (CK) or without a recent determination.

What next?

This software allows to collect information contained in different systems and displays it in an organized view to the user. This makes it an easily system that can be exported to other hospitals.
Our next objective is to consult the microbiological information. Therefore the system will be able to recommend about the optimal antimicrobial treatment, detecting situations in which the treatment can be de-escalated or alerting in case of resistance.

IMPLEMENTING NEW CHEMOTHERAPY COMPOUNDING WORKFLOW USING SEQUENTIAL PDSA CYCLES TO INCREASE PRODUCTION CAPACITY, REDUCE WAITING TIME, IMPROVE RESOURCES UTILIZATION, AND MINIMIZE THE RISK OF ERRORS

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European Statement

Production and Compounding

Author(s)

A Elsheashaey, A Elshishiny, A Orabi, A Almutairi, A Aboulwafa, H Alobaid, F Dashti, D Saeed, R Yassin, M Salama

Why was it done?

Kuwait Cancer Control Center (KCCC) is the only oncology hospital in Kuwait. Chemotherapy Preparation Unit (CTPU) was unable to meet the increased orders; causing delivery delay and more patients’ waiting time. Moreover; rework and more waste due to defective and faulty processes of current workflow resulting in frequent incident reports of wrong final products dispatched.

What was done?

Shifting to a systematic multi-step production workflow to increase compounding capacity, minimize risk of errors, reduce processing time, and maximize utilization of integrated technological resources.

How was it done?

Using multiple PDSA cycles, a comprehensive educational and practical training was conducted, proceeded by staff rotation with newly trained team. Every three weeks a new pharmacist trained and assigned to CTPU. Raw materials stores were rearranged for better accessibility and diminishing unnecessary staff movement. A staging step as the first independent double-check before the start of compounding, and for assembly of raw materials and supplies required for compounding. A verification Step as the second independent double-check upon compounding, using bar-code scanners, touchscreens and cross-checking with the chemotherapy order to assure the quality and integrity of the finished product. Production workload were restructured over three parallel line of manual stations and one automated preparation unit. Pharmacy Information System (PIS) screens were customized to give a first and second audio-visual alarms after 30 and 45 minutes of transcription time respectively. Chemotherapy sessions appointment system were established to assess the daily chemotherapy compounding needs from CTPU in advance with an incremental increase of production capacity to reach 100~120 patients/day or 180~200 preparations/day.

What has been achieved?

Number of preparation compounded by CTPU was increase by 8%, where more than 43% of preparations were validated to release in less than 30 minutes and approximately 88% of preparations were delivered in less than 45 minutes. Number of preparation by automation was increased by 82%, Furthermore, all production incidences has been completely eliminated after full implementation of final verification and validation step.

What next?

The new workflow has increase the workload capacity with less production errors and zero incident reports. Patient experience was improved by comparable preparation time to other international Pharmacy Workload Unit and average time required per patient visit.

INVOLVING PATIENTS IN A WORKSHOP FOCUSED ON COMMUNICATION SKILLS: A PROOF OF CONCEPT OF EXPERIENTIAL TRAINING FOR RESIDENTS IN HOSPITAL PHARMACY

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European Statement

Education and Research

Author(s)

Caroline Hache, Stéphane Honoré, Guillaume Hache

Why was it done?

The development of clinical pharmacy allows pharmacists to take patient-centered roles and responsibilities. However, patient-centered care requires a specific set of skills and training, such as patient-focused communication and conducting structured interviews. Thus, improvement of pharmacist-patient communication may lead to better clinical outcomes.

What was done?

We developed a workshop involving patients within the training programme of residents in hospital pharmacy. The workshop focused on communication skills needed to improve the quality and effectiveness of a pharmaceutical interview.

How was it done?

The workshop was developed jointly by two senior clinical pharmacists and a lecturer in education and communication science. The learning process integrated: working on participants’ perception of pharmacists-patient communication, didactic learning, training activities and evaluation. The assessment of the learning effect was performed by self-, peers-, and patient-scored charts. Patients’ feedback during the training activities and assessments was highlighted as the cornerstone of the learning process.

What has been achieved?

First, we built a competency chart on communication skills needed to perform a structured pharmaceutical interview. This tool has been validated by the patients and well accepted by the learners. It was used to assess the learning effect of the workshop, and may serve as a guide for the continuous development of junior practitioners. Secondly, the workshop has actually been implemented, with both the learners and patients expressing a high general acceptance and satisfaction. Finally, preliminary results show a learning effect assessed by both peers and patients.

What next?

The involvement of patients needs to be further expanded to the training programmes of undergraduate students, residents and clinical pharmacists. A future action planned is to develop a model with the French Society of Clinical Pharmacy (SFPC) for a national systematic training module: “Improving pharmaceutical interviews’ performance through effective communication”, involving patients.

IMPLEMENTATION OF INDIVIDUAL, HOSPITAL PHARMACY-COMPOUNDED NEONATAL TPN

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European Statement

Production and Compounding

Why was it done?

Individual total parenteral nutrition (TPN) for neonates was originally compounded by nursing staff on the respective wards. This process of TPN compounding was error-prone. Documentation and traceability was inadequate. Clean room conditions were absent. By transferring the compounding of TPN from the ward to the pharmacy level, several aims were accomplished. Time of nursing staff was released and the highest quality standards for compounding were implemented. By doing so, several types of errors (e.g. overdosing, wrong additives) were eliminated.

What was done?

Development and implementation of nutrition support protocols by using an electronic prescribing and compounding software (catoPAN™) to address the special needs of neonates and ensure a high level of individualized care.

How was it done?

In cooperation with neonatologists, nutrition protocols were developed. Furthermore, a TPN compounding process was implemented and validated, including the validation of catoPAN™ software and compounding pumps. An integrated risk analysis was performed, stability data to allow TPN supply for weekends were generated and fail-safe procedures were determined. To finally succeed, various process and organizational changes concerning the wards, the production and the QC department of the hospital pharmacy were required.

What has been achieved?

Compounding of individualized nutrition solutions within defined standards, predetermined specifications and quality attributes is implemented. The production process is continuously monitored, including complete traceability. A strong interprofessional collaboration between physicians, nurses and pharmacists was established, ultimately leading to a high level of confidence among all members. Workload of nurses in terms of compounding medicines was dramatically reduced.
Currently, we provide nutrition bags for four wards (24 ICU- and 30 intermediate care beds), equaling an average production of 50 bags per day. In 2016, a total of 11.126 bags were supplied, implying an increase of 75% compared to 2015. We expect an increase of around 30% in 2017 due to rising demand.

What next?

With the expansion of TPN compounding to further pediatric wards, new nutrition protocols addressing other requirements have to be developed. Process changes are likely to follow. Further support can be provided by pharmacy-based IV admixture service. Additionally, due to current software updates, the prescribing and compounding software catoPAN™ must continually be revalidated.

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