VENOUS THROMBOEMBOLISM PREVENTION MEASURES FOR WOMEN IN PREGNANCY AND THE PUERPERIUM (submitted in 2019)
Pdf
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)
Pdf
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
Pdf
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
Pdf
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
Pdf
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
Pdf
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.
COMPUTERIZED QUALITY CONTROL OF THE TABLET SPLITTING PROCESS
Pdf
European Statement
Production and Compounding
Author(s)
María Lourdes Recio Blázquez, Alberto Pérez Morales
Why was it done?
It was necessary to establish a quality control of this pharmaceutical process.
What was done?
A computer method of gravimetric quality control of the tablet splitting process was designed.
How was it done?
The procedure consists on a precision scale connected to a computer in which, according to the uniformity of mass assay of the European Pharmacopoeia, the weights of 20% of a batch of whole tablets destined to be split are automatically recorded in a spreadsheet, carrying out the following formulas:
=AVERAGE: provides the average weight of the sample of whole tablets.
=MAX and =MIN: selects respectively the largest and the smallest of the weights.
=STDEV: calculates the standard deviation of the sample weights.
With the average weight of the whole tablets, the theoretical weight of the half-tablets is calculated, establishing a maximum and a minimum admissible limit with the following formulas:
=AVERAGE(whole tablets)/2: determines the theoretical average weight of each half-tablet.
=AVERAGE(whole tablets)/2 ± 7.5%: establishes upper and lower gravimetric limits that cannot be exceeded by any half-tablet.
All the half-tablets need to be weighted, as the tablet-splitting process is carried out tablet-by-tablet and this modus operandi is not reproducible enough. In case of non-compliance with maximum and minimum weight criteria, the half-tablet must be discarded.
Conditional functions were established such that the spreadsheet itself reflects the half-tablet acceptance/rejection decision.
Basic technical computer skills, training in the technique of tablet splitting, appropriate clothing and environmental measures to avoid risks to the operator and the medications are required.
What has been achieved?
Since 2015, two different medicinal products were subjected to the tablet splitting technique. A total of 10,536 halves of suitable tablets were obtained, which permitted safe dosing at lower doses than commercialized, and also generated a financial asset of 101,724 Euros. 566 halves were discarded. The splitting efficiency was of 94.9%.
What next?
This quality control procedure is applicable to all divisible solid oral dosage forms. The standardization of the technique and the quality controls will allow to extend it to other medicinal products with dosing and economic purposes.
A 72 hours training program for pharmacy residents to perform secure, optimized and standardized medication review orders: a proof of concept
European Statement
Education and Research
Author(s)
Sophie Renet, Florian Le seigneur, Ratiba Haddad, Andre Rieutord, Marie Camille Chaumais
Why was it done?
The high turn over rate of medical and pharmacy residents (every 6 months) could jeopardize the patient’s care management as they generally lack of appropriate skills upon arrival. Our former process medication review was relying on individual and heterogeneous competencies of pharmacy residents likely to lead to sub-optimal medication review and treatment optimisation. We had to design a training program for residents according to the constraints of time and characteristics of related treatment of the considered clinical ward recruited patients.
What was done?
A training program for pharmacy residents was developed and implemented. The aim was to develop the skills of the residents to allow them to perform, after 72 hours, a secure, optimized and standardized (SOS) medication review orders, according to the specificities and the “real-life practice” of the clinical department.
How was it done?
Through a collaborative approach (residents and seniors pharmacists, physicians, PhD student in education sciences), ADDIE (Analyse, Design, Development, Implantation, Evaluation) method was used. First, the most frequent pathologies and drugs prescribed in the cardiology department were identified to define specificities and thus custom the educational needs and skills that residents have to acquire to ensure a SOS medication review orders. The program included a 3 steps process over 3 days: (1) recognize the organisation and learning tools; (2) practice 3 clinical medication review orders simulation; (4) assess and feed-back with a senior clinical pharmacist. Some learning tools were developed: a training tool kit to guide the learners ; an aid kit, including a SOS medication review orders algorithm to follow throughout the whole process. Two years after implementation, 4 pharmacy residents have used this training program.
What has been achieved?
Our 72-hours-training program is routinely used for new pharmacy residents. It has been implemented successfully with a high acceptance. They also felt more comfortable to suggest therapeutic advices to the physicians.
What next?
The proof of concept of SOS was successfully done. We are currently extending it for 5th year pharmacy students and develop similar training program for other clinical wards (Surgery, oncology, immunology). In 2017, we expect to share it with our pharmacist colleagues working in the two closest hospitals.