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PROTOCOL FOR THE ADMINISTRATION OF DANGEROUS DEPOT DRUGS IN SOCIAL HEALTH CENTRES: ONE YEAR LATER (submitted in 2019)

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European Statement

Patient Safety and Quality Assurance

Author(s)

Arantxa Andújar-Mateos, José Manuel del Moral-Sánchez, Inmaculada Sánchez-Martínez, Francisco Valiente-Borrego, María Muros-Ortega, Andrés Navarro-Ruiz

Why was it done?

When the National Institute for Occupational Safety and Health (NIOSH) published a list that included drugs considered dangerous for general and reproductive health, we had to devise a protocol in our field so that parenteral drugs could be administered in a safe way for health personnel.

What was done?

The aim of our study is to determine the integration into clinical practice of a protocol for the administration of dangerous depot drugs in the social health field after a year has elapsed since its implementation.

How was it done?

The Depot Dangerous Drug Administration Protocol was intended to increase the safety of healthcare personnel in their preparation and administration. The recommendations contained therein, issued by official agencies and in force at the time, were transmitted by different means of communication: – Verbal: in a physical meeting with the nursing coordination of all the residences. – Written: through the distribution of the protocol via e-mail and in folders shared with the centers. – Audiovisual: elaboration and diffusion of a video explaining the preparation of the different drugs affected. For its implementation, the points mentioned in the previous section were implemented and a reference pharmacist was made available to each residence to resolve any doubts in this regard. Within a year of its implementation, from our socio-sanitary pharmacy service and in collaboration with the 16 residences specialising in geriatrics, disability and mental illness, the degree of adaptation to the protocol was measured.

What has been achieved?

In December 2017, the aforementioned protocol was implemented in the 16 residences. Within a year, more than half of the residences, 9 of the 16, acknowledged not taking any of the precautions indicated in the protocol. Of the rest of the residences, 4 stated that they have adopted all the recommendations in each preparation and administration of dangerous drugs and the remaining 3 placed their adaptation to the protocol at between 25% and 50%.

What next?

We believe it is necessary to reinforce the information contained in the protocol every 1−2 months in person. It is also necessary to keep the protocol continuously updated to detect changes in it.

DESIGN AND ELABORATION OF AN INTELLIGENT INTRAVENOUS INFUSION PUMPS GUIDE FOR THE INTENSIVE CARE UNIT (submitted in 2019)

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European Statement

Clinical Pharmacy Services

Author(s)

MARTA VALERA-RUBIO, MARIA ISABEL SIERRA-TORRES, ELENA SÁNCHEZ-YAÑEZ, JOSE LUIS ORTIZ-LATORRE, ISABEL MOYA-CARMONA

Why was it done?

Critically ill patients often require the administration of several intravenous drugs and that includes infusion pumps. New infusion pumps offer the ability to build a drug library within the infusion system itself. This allows intravenous infusion medication safety to be improved. Because of that, it is highly important to have an updated administration guide and an IV smarts pumps library for the everyday clinical practice. This guide was developed in order to help ICU staff to practice safe prescribing and managing of medicines and to reduce the incidence of adverse drug events and administration errors.

What was done?

We developed an updated guide on intravenous drug administration including infusion parameters for intelligent intravenous infusion pumps, so called “IV smarts pumps”, used in the intensive care unit (ICU).

How was it done?

A database with the most important intravenous drugs used was created by a multidisciplinary working team (pharmacists, physicians and nurses). The drugs included were divided into therapeutic groups and were distributed among the participating members for the drug information review process. The therapeutics groups included were: sedatives, analgesics, antihypertensives, vasopressors, anti-arrhythmics and others such as insulin, heparin, etc. For each drug, a bibliographic research was conducted, gathering information from manufacturers, intravenous drugs databases (Uptodate®, Micromedex®, Stabilis®) and other hospital guidelines. The data collected included: drug name, lower and upper hard limit, default dilution, flow rate, default rate, rate upper soft and hard limit, bolus default, flow rate and volume upper limit, loading dose, duration, dilution volume, default, and lower and upper hard limit.

What has been achieved?

This guideline promotes, mainly, the safe use of drugs usually administered in critically ill patients, and is available for all the staff in this unit. Its elaboration has made it possible to avoid medication errors and to establish a narrower bound between the pharmacy service and the critical care unit, developing new partnerships which could lead to new projects.

What next?

We are still working on improving this guide, making it easier to understand and with a unified vocabulary. We will update it periodically in order to include new evidence and new drugs if necessary.

DESIGN OF AN ANTI-HAEMORRHAGIC AGENTS PROTOCOL FOR AN INTENSIVE CARE UNIT (submitted in 2019)

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Clinical Pharmacy Services

Author(s)

Mercedes Gómez-Delgado, Marta Valera-Rubio, Margarita Carballo-Ruiz, José Luis Ortiz-Latorre, Isabel Moya-Carmona

Why was it done?

Blood coagulation factors and their adequate use can be of particular importance in the treatment of massive haemorrhage, especially in the ICU. This initiative was taken in order to improve uptake and to avoid errors in the administration, which can be difficult in emergency situations.

What was done?

To define an emergency procedure that ensures correct management in cases of massive bleeding in an intensive care unit (ICU).

How was it done?

The development of drug use protocols for emergency situations is a simple task that facilitates health workers to manage them. Prioritising the drugs to be included in a protocol by a previous survey in a multidisciplinary setting is important to consider the different points of view. We carried out a review of the pharmacy service to the ICU needs of antihaemorrhagic drugs. ICU staff (doctors and nurses) were informed to reach an agreement about eligible drugs for being included in the protocol. ICU staff requested the inclusion of four drugs in the protocol according to the prevalence of use and the difficulty of administration: human fibrinogen, tranexamic acid, eptacog alfa and human prothrombin complex. We created a protocol with four information sheets, one of each drug, made of schematic information about: 1. Physical location (fridge or room temperature, number of shelf) and minimum safety stock (3 units of human fibrinogen, 4 units of tranexamic acid and 3 units of human prothrombin complex). 2. Indications and dosage according to the clinical situation and the patient characteristics (dosage adjustment according to renal or hepatic impairment, weight or age when applicable). 3. Recommendations for intravenous administration (flow rate, bolus, loading dose, dilution, mixture stability).

What has been achieved?

Mapping the information and dividing it into sections is essential for its rapid understanding in a high-stress work environment. The implementation of this protocol was well embraced by all the staff involved, since it allowed a more efficient health care circuit for the ICU staff. It also optimises the consumption of this type of more monitored drugs.

What next?

We will monitor the compliance with this protocol, as well as possible updates that may be beneficial for a better understanding of the forms of administration.

A NOVEL CLOSED SYSTEM DRUG-TRANSFER DEVICE FOR ORAL DOSAGE FORM HELPING PATIENTS WHO CANNOT SWALLOW SOLIDS (submitted in 2019)

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European Statement

Patient Safety and Quality Assurance

Author(s)

SALIM HADAD

Why was it done?

It remains that new solutions to increasing the safety of handling Solid Dosage Form hazardous drugs have to be developed. Conceptually, through operating in a closed system, CSTDs should significantly reduce the risks to pharmacists and nurses There are two main drawbacks of the known solutions:
1. The crushing and dilution of the solid dosage form medicine is done with an open vessel to the environment, such as a porcelain crater, which may cause the work environment to be contaminated with carcinogenic or teratogenic substances, that could expose and endanger the medical staff to hazardous substances in the course of their duties as providers of medical care.
2. The tools available today are reusable, requiring a thorough cleaning process between different materials (drugs), which can lead to cross-contamination between different doses of drugs, which are crushed one after the other with the same instrument.

What was done?

CSTD – for oral dosage form new device of its kind, combines the act of crushing the various drugs, dissolve in liquid and give to a patient who cannot swallow for various reasons, that mechanically prohibits the transfer of environmental contaminants into the system and the escape of hazardous drug or vapor concentrations outside the system.

How was it done?

We designed the device with 3D software (solid wark). It consists of a number of functional parts. The main ones are: a 20 ml barrel, a top part of which is a piston with a bottom basket loaded with the solid medicine; this part is sealed as a barrel from above. With the help of mechanical rotation, the drug breaks down into small particles that fall into the inner space of the barrel. Adding the liquid through a fluid port disposed on the bottom barrel which it is completely sealed. The removal of the liquid drug through a unique adapter which at its end is adapted to the gastric tube or oral administration to the patient,

What has been achieved?

1. The complete process of crushing and liquefying of the solid drugs is carried out under sealed conditions to the immediate environment and without fear of exposure to residues of toxic substances to the medical caregiver. 2. A one-time use system saves complex cleaning process. 3. There is no risk of cross-contamination between different drugs. 4. Saving personal protective equipment such as gloves, masks, lab coats clean rooms, etc. which is necessary for protection and for the safety of the caregiver team.

What next?

Applied research will be carried out by pharmacists and nurses to test the efficiency of the new device (as a basic prototype). These experiments will take various non-cytotoxic pills, will be dummy operations, in which the crushing and liquefying will be performed, and the solution or suspension will be transferred through the gastric tube, according to an approved research protocol.

STANDARDISATION OF DILUTED POTASSIUM INTRAVENOUS SOLUTIONS IN NEONATAL CARE UNITS (submitted in 2019)

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European Statement

Patient Safety and Quality Assurance

Author(s)

Luis Pérez de Amezaga Tomás, María Magdalena Parera Pascual, Mónica Sanz Muñoz, Catalina March Frontera, Gonzalo González Morcillo, Alejandra Mandilego Garcia, Álvaro Medina Guerrero, Ana Filgueira Posse, Montserrat Vilanova Boltó

Why was it done?

Administration of intravenous KCl produces hyperkalaemia and this can result in cardiac arrest and death. The Institute for Safe Medication Practices (ISMP) as well as other security agencies have recommended the withdrawal of KCl 2M from ward stock. This project was born as a response to these recommendations. We focused on a group of patients where these practices have not been extensively implemented. The aim of the protocol was to standardise the prescription, preparation, dispensation and administration of KCl to neonates in our hospital.

What was done?

Development of a protocol that standardises diluted potassium intravenous solutions for neonates (including those preterm over 28 weeks of gestation). This allowed us to remove concentrated potassium chloride (KCl) 2M from neonatal care units in our hospital. For this purpose, the hospital pharmacy centralised the preparation and distribution of KCl ready-to-use infusions.

How was it done?

The elaboration of the protocol took place as follows: • A multidisciplinary team designed KCl ready-to-use solutions that met the requirements of the newborn: – Glucose 10% 250mL with 5 mEq KCl (20mEq/L solution) – Glucose 10% 250mL with 10 mEq KCl (40mEq/L solution). • The hospital pharmacy centralised the preparation of these solutions. A risk assessment was performed and determined an expiration date of 7 days. • These solutions were stocked at all neonatal care units: Intensive Care Unit, Hospitalized Paediatric Unit and Paediatric Emergency Unit. • Weekly, the hospital pharmacy distributes these solutions and disposes of the expired ones. • Only ready-to-use KCl solutions were able to prescribe at the electronic prescription programme. • A formation plan was implemented to train all the professionals involved in neonatal care.

What has been achieved?

The protocol was implemented in November 2016. Since then, 65 patients have been treated with 20mEq/L solution and only 1 patient with 40mEq/L solution. No remarkable imbalances in electrolytes have been detected resulting from the standardisation of the fluid therapy with KCl. Only 3 incidents have been registered. All of them were prescription errors (solution selection); they reached the patient but without damage.

What next?

Nowadays, we are developing a stability study of the KCl solutions in order to assess the appropriateness of the expiration date.

THE OPIOID WORKING GROUP: AN INTERDISCIPLINARY WORKING GROUP TO IMPROVE THE CORRECT PRESCRIPTION AND APPLICATION OF OPIOIDS IN THE HOSPITAL SETTING (submitted in 2019)

European Statement

Patient Safety and Quality Assurance

Author(s)

Imke Willrodt, Delia Bornand, Jimena Ramos, Stojan Petkovic, Giulia Mohr, Anne Leuppi-Taegtmeyer

Why was it done?

Due to critical incidents involving opioids reported internally at the University Hospital Basel in 2018, there was an urgent need to evaluate underlying reasons for these events. The Opioid AG was established with the aim to mitigate risks for the correct prescription and application of opioids, and therefore to improve patient safety.

What was done?

The Opioid Working Group at the University Hospital Basel is an interdisciplinary working group including representatives from different professions (physicians, nurses, pharmacists) and departments (medical, surgery, gynaecology, emergency, pain therapy, palliative care, pharmacology and toxicology, patient safety and information technology).

How was it done?

The thorough analysis of root causes for the critical incidents revealed prescribing and application errors, such as non-observance of kidney failure, pharmacodynamic interactions of opioids with other prescribed drugs, inadvertent overdosing – in particular with liquid drug formulations, or patient mix-ups.

What has been achieved?

Consequently, the following steps are being taken to address these risks: 1. Optimisation of the prescribing software including opioid prescription templates, links to existing opioid unit conversion tables for liquid forms of diamorphine, morphine, hydrocodone and oxycodone (milligrams to millilitres) as well as clearer display of “as required” opioid prescriptions on the patients’ electronic drug charts. 2. Preparation of Standard Medication Preparation Schemes for nursing staff of the emergency department. 3. Development of an additional label (concentration, patient initials, date of reconstitution, date of expiry of reconstituted solution) for parenteral diamorphine. 4. Improvement in detailed written instructions for the correct preparation, labelling, application and disposal of intravenous and oral drugs (to include opioids). 5. Evaluation of a hospital opioid safety self-assessment tracking tool.

What next?

A comprehensive evaluation will take place, 6 months after the implementation of all measures. We will use the number of naloxone prescriptions on the wards as a key performance indicator to measure the success of this project. The reported critical incidents involving opioids will also be assessed before and after the implementation of all measures.

This evaluation will help to identify open questions, potential gaps and further needs for improvement to be addressed by the interdisciplinary team.

MICROBIOLOGICAL CLEANLINESS IN A CHEMOTHERAPY ROBOT DEPENDING ON DIFFERENT INTERVALS OF INTENSIVE CLEANING IN THE WORKING AREA (submitted in 2019)

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European Statement

Production and Compounding

Author(s)

Jannik Almasi, Irene Krämer

Why was it done?

Aim of the study was to evaluate if the microbiological cleanliness of the working area of APOTECAchemo® is affected by extending the interval of intensive cleaning from biweekly to monthly cleaning intervals.

What was done?

Automated preparation of ready-to-administer chemotherapy products with the APOTECAchemo® robot is well established in a number of pharmacy departments. One of the few disadvantages is the time-consuming, intensive cleaning and disinfection of the working area (clean room class A) by wiping with cleaning and disinfection solutions.

How was it done?

Every two weeks (period 1: 07-12/2018) or every four weeks (period 2: 01-06/2019) all surfaces in the working area of APOTECAchemo® were wiped with ethanolic NaOH solution in order to inactivate or remove cytotoxic spillages. In a second work step all surfaces are disinfected by wiping with spore-free alcohol. The procedure lasts about one hour. The working area is at the end of each working session irradiated with UV light for 4 hours. Microbiological monitoring of the working area is done weekly in operation by passive air sampling (2 settle plates at predefined locations S1, S2) and surface sampling (3 contact plates at predefined locations O1, O2, O3) and colony-forming units (CFU) are counted after incubation. Results of the microbiological samples (CFU ± standard deviation) were compared for period 1 and 2. On average, 0 CFU (n=52) were detected (period 1) and 0.04±0.2 CFU (n=44) (period 2) on settle plates. During period 1 on average 0.04±0.19 CFU were found at O1, 0 CFU on O2, and 0.81 CFU±4.23 at O3 (n=27 each). During period 2, 0 CFU were detected at O1, O2 and 0.04±0.2 CFU at O3 (n=25 each). The extended interval for the intensive cleaning process did not affect the microbiological cleanliness. The CFU limits set for clean room class A were met.

What has been achieved?

Maintaining the daily cleaning procedure, the interval of intensive cleaning can be extended to one month without increasing the microbiological contamination risk and saving two hours of cleaning.

What next?

Monthly intensive cleaning will be attended by trending the microbiological results.

PROMOTING THE USE OF SAFER INJECTABLE MEDICINES USING A NOVEL METRIC

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European Statement

Patient Safety and Quality Assurance

Author(s)

Gillian Cavell

Why was it done?

Despite the availability of RTU and RTA formulations of high-risk injectable medicines they were not always used. We developed the metric, to compare the use of RTU and RTA injectable medicines with the use of concentrates requiring further dilution or manipulation prior to administration e.g. dilution of morphine 10 mg/ml to 10 mg/10 ml prior to intravenous administration, e.g. withdrawal of 5 x 10 ml fentanyl 500 mcg/10 ml into a 50 ml syringe for continuous infusion, and identify areas for improvement.

What was done?

We have developed a series of metrics to measure compliance with national guidance for the safe use of injectable medicines. The guidance recommends use of ready-to-use (RTU) or ready-to-administer (RTA) injectable products, where these are available, to reduce the risk of patient harm from errors in the preparation of injections and infusions on hospital wards.

How was it done?

The metric utilises pharmacy-issue data to compare the number of units of RTU or RTA formulations issued to wards and clinical areas with the numbers of units of alternative products of the same drug entity. Expressed as a percentage the metric informs the organisation of the extent to which safer injectable medicines are being used, providing a baseline against which to review practice and reinforce the need to use alternative, safer formulations. A high percentage indicates good compliance.

What has been achieved?

The metrics have been used to successfully maximise the use of a range of safer formulations including RTA potassium chloride, RTU fentanyl 2500 mcg/50 ml vials for critical care infusion, 100 mg/10 ml paracetamol in neonatal units and RTU magnesium sulphate 20% (50 ml vials) for obstetric emergencies. Since the introduction of the metrics in 2016 a monthly scorecard of performance is reviewed by the Hospital Medication Safety Committee to identify and account for deviations.

What next?

The metrics are being shared with other organisations to benchmark performance. Ideas to promote implementation and business cases can be shared between organisations who may find implementing RTA and RTU injectable medicines challenging, especially where these are more expensive than formulations in established use.

A SET OF QUALITY IMPROVEMENT INTERVENTIONS TO INCREASE THE PERCENTAGE OF STAT IV MEDICINES, MEETING THE GOAL OF BEING READY WITHIN 30 MINUTES

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Patient Safety and Quality Assurance

Author(s)

MELINDA LITAO, HANY ELATROUSH , KHATHLEEN ESER, ARWA AFANA, AHMED BAIBRAHIM, JAYSON DE JUZMAN, BAYAN RAMBO, DERI PASCUAL, MA ENCARNACION DELOS ANGELES, MANAL SALLAM, MALIK KHUWAJA

Why was it done?

STAT orders have always been a priority, however there are some areas which require some modification in the workflow to attain higher efficiency and to increase the percentage of STAT IV medicines, meeting the goal of being ready within 30 minutes.

What was done?

A set of quality improvement interventions to increase the percentage of STAT IV medicines, meeting the goal of being ready within 30 minutes.

How was it done?

This was a pre-post study in a government hospital between January and September 2018. LEAN and FOCUS-PDCA models were implemented to design the process of improvement. A medication-tracking system (MedBoard) was used to collect the data to measure the number of STAT IV medicines ready within 30 minutes. Data was also collected from the number of phone calls and faxes received from the day procedure unit (DPU) and home health care unit (HHC).

What has been achieved?

The cumulative data showed an increase in the percentage of STAT IV medicines being ready by 7%, equivalent to 707 orders per month (90% vs 97%), a reduction in the number of phone calls by 87.5% (48 vs six calls per day) and fax by 100% from the DPU and HHC units, which means that implementing the set of interventions were associated with an increase in percentage of STAT IV medicines being ready within 30 minutes. Additionally, there was a significant decrease in the number of phone calls and faxes, which allowed pharmacists to focus more on STAT IV orders.

What next?

Since the hospital pharmacy receives numerous orders on a day-to-day basis, this will facilitate prioritisation during the entire process. This aligns with the hospital goal of attaining ‘zero harm’, and is therefore a good example of good practice in a hospital setting. The use of Medboard in tracking medications and monitoring performance can be applied to allow any healthcare setting to ensure that goals are reached, and performance is maintained at the highest level. Designing a list of eligible medications that can be ordered as STAT can be used as a guide to avoid the abuse of STAT orders and can help in prioritising order preparation in the STAT IV room.

SAFER DRUGS WITH AWARD-WINNING DATABASE

European Statement

Patient Safety and Quality Assurance

Author(s)

Teimori Kaveh

Why was it done?

Hospitalised patients often need multiple IV drugs simultaneously which are commonly mixed in-line before entering the bloodstream. Physicochemically incompatible drugs cause reduced efficacy, clogged catheters and drug precipitation, which can be harmful or even fatal. The risks add uncertainty to the stressful working environment for clinical practitioners. According to a local 2012 survey 68% (n=44) of Sahlgrenska University Hospital (SUH) intensive care unit (ICU) nurses had co-administered drugs uncertain of their compatibility. Hospital pharmacists were hence asked for guidance to optimise compatibility and patient safety.

What was done?

Nurses, doctors and pharmacists were provided with accessible and evidence-based information on IV drug compatibility in order to improve drug therapy, working environment and patient safety.

How was it done?

Drug compatibility data was collected by hospital pharmacists who assessed its applicability to Swedish conditions. The results were documented in charts and procedure documents. A project for creating a database was initiated in collaboration with the IT organisation in Västra Götaland Region (VGR). A survey was designed to evaluate how the SUH’s ICU nurses experienced the database. Collaboration with nurses, doctors and clinical pharmacists helped to improve the quality of the database.

What has been achieved?

Drug compatibility lectures were given to nurses, doctors and pharmacists on a continuous basis. Procedure documents were implemented in eight clinics. A peer-reviewed workflow was established. The database contains over 2,500 assessed drug combinations. Over 700 nurses, doctors and pharmacists from 11 counties plus Norway and Denmark have requested access to the database. Clinics avoid drug mixing by choosing multi-lumen catheters with greater capacity. The 2016 survey showed that 88% (n=86) of SUH’s ICU nurses had co-administered drugs uncertain of their compatibility. The database affected their decisions in 93% (n=45) of the cases, 85% (n=34) found information easier and 88% (n=34) felt more certain when making decisions. A new pharmacist role – IV Compatibility Manager – was introduced and implemented in VGR. In 2016, this work received the national annual award Guldpillret (‘The Golden Pill’).

What next?

In the next years, the database will become nationally available and integrated into electronic journal systems. Compatibility issues may then be identified when prescribing, further improving patient safety.

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