PROMOTING THE USE OF SAFER INJECTABLE MEDICINES USING A NOVEL METRIC
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European Statement
Patient Safety and Quality Assurance
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.
IMPLEMENTING THE PRODUCTION OF STERILISED SYRINGES IN THE HOSPITAL: IMPROVING MEDICATION SAFETY AND SAVING HEALTHCARE COSTS
Pdf
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.
HOSPITAL PHARMACY UNIFIES ELECTRONIC STANDARD PRESCRIPTION THROUGHOUT THE REGION
Pdf
European Statement
Patient Safety and Quality Assurance
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.
PREPARATION OF A CYTOSTATIC STABILITY GUIDE AFTER RECONSTITUTION AND DILUTION
European Statement
Patient Safety and Quality Assurance
Author(s)
Gregorio Romero Candel, Paula Ruiz Belda, Maria del Carmen Caballero Requejo, Maria Jesus Sanchez Cuenca, Jose Marco del Rio , Julian Castillo Sanchez, Luna Carratala Herrera
Why was it done?
In common clinical practice, the stability of medications is an area of interest to obtain maximum security and efficiency. After reconstitution and dilution, knowing the validity period is very important for the effectiveness and safety of the treatment, since it must be administered to the patient under the appropriate conditions. In recent years, a large number of high-impact cytostatic medicines with limited stability data have been registered and incorporated into clinical practice. Frequently, the stability data results are contradictory or insufficient. The main goal is to make a reliable quick guide of reference with the validity periods of the reconstituted and diluted active principles according to physicochemical stability, therefore increasing safety, reducing queries for these doubts and improving the management of unused remains that have high economic impact.
What was done?
A cytostatic stability guide after reconstitution and dilution has been made. The active principles and commercial presentations that are used in the intravenous mixtures area were reviewed.
How was it done?
The obtaining of the physical-chemical stability data has been done by reviewing the information available in Stabilis, Pubmed, Lexicomp and technical data sheets.
What has been achieved?
Fifty-four pharmaceutical specialities from 44 active principles, all in the cytostatic group, were checked. Tables of reference for the elaboration sites were made for consultation. It has reduced the number of consultations conducted and improved the time of preparation of these products. The rest of the elaborations for other administrations have been taken advantage of, making a better use of the pharmacotherapeutic resources.
What next?
The next step is to keep developing consultation tools that improve the safety and management of hospital drugs.
A SET OF QUALITY IMPROVEMENT INTERVENTIONS TO INCREASE THE PERCENTAGE OF STAT IV MEDICINES, MEETING THE GOAL OF BEING READY WITHIN 30 MINUTES
Pdf
European Statement
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.
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.
SAFER DRUGS WITH AWARD-WINNING DATABASE
European Statement
Patient Safety and Quality Assurance
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.
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.
OPIOID ROTATION IN PEDIATRICS: A CONVERSION CHART FOR CHILDREN OLDER THAN 1 YEAR
Pdf
European Statement
Clinical Pharmacy Services
Author(s)
Sabina Hiltbrunner, Dalibor Panis, Jörg Thomas, Eva Bergsträsser, Angela Caduff Good
Why was it done?
Opioids are widely used for acute pain management in pediatrics after surgery, for sedation on the intensive care unit, and chronic pain management in palliative care and many other conditions. In some patients, it is necessary to change the opioid during therapy, due to tolerance development or due to side effects. Although conversion tables for adults are well established, they are not readily available for pediatric use.
What was done?
To simplify the process of opioid rotation in pediatrics, an opioid conversion chart with easily memorable conversion factors was generated.
How was it done?
A literature search was performed to collect conversion factors and equivalent doses of opioids with different application routes. We searched specifically for conversion factors in pediatrics. Except for Oxycodone and Remifentanil, for all other opioids in our chart conversion factors for pediatric patients were found. Data for adults were used for these two substances. For all conversion factors experts confirmed their adequacy for clinical use in pediatrics. The conversion factors were rounded up to whole numbers, which was considered reasonably based on long-term experience in pediatric pain manage-ment.
What has been achieved?
This conversion chart is now part of a drug information document about opioid dosing in children older than 1 year in our hospital. For every substance, starting doses were set according to www.pediatric-dosages.ch and based on clinical experience. When necessary, details about the therapy with the indi-vidual substance were added. For illustration purposes, a sample calculation of the change from oral Morphine to oral Oxycodone was included.
The immature metabolism in children younger than 1 year makes the opioid action often unpredictable. Therefore we restrict the use of the chart for children older than 1 year and in younger children specialists in pain management should be consulted.
What next?
Our opioid conversion chart, with easily memorable conversion factors and starting doses, supports all healthcare professionals in pediatric pain management and may also help to reduce critical incidences due to mistakes in calculation. This is the first time an opioid conversion chart is established for pediatric purpose. Its impact on patient safety has to be shown in the future.
IMPLEMENTATION OF INDIVIDUAL, HOSPITAL PHARMACY-COMPOUNDED NEONATAL TPN
Pdf
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.