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.
THE EFFECT OF A PRESCRIBER TRAINING INTERVENTION ON THE PREVALENCE OF PRESCRIBING ERRORS FOUND IN A ELECTRONIC PRESCRIBING SYSTEM
Pdf
European Statement
Education and Research
Author(s)
Fionnuala Nevin, Gail Melanophy, Aisling Collins, Miriam Moriarty, Grainne Courtney, Tamasine Grimes, Gaye Stephens
Why was it done?
The available literature strongly advocates the importance of training for users of electronic prescribing systems to ensure their safe and effective use. However, there is a lack of evidence to demonstrate the effect that ongoing training has on the use and impact of these systems. This study was carried out to strengthen the case for staff training resources for electronic prescribing systems.
What was done?
A study was carried out to investigate the effect of a training intervention on the prevalence of prescribing errors found in an outpatient electronic prescribing system currently in use. Audit and feedback methods were used. Prescription audits were carried out before and after the delivery of a classroom-based training intervention. The audits were used to measure and analyse the effect of the intervention on prescribing errors found in the electronic prescribing system. A questionnaire and clinician observations were carried out with prescribers. The pre-intervention audit results, questionnaire, and clinician observations were used to inform the prescriber training intervention.
How was it done?
Key stakeholders were recruited and assisted in the planning and delivery of the study methods. This was to ensure participate buy-in and study success. The audit tools and questionnaire were initially piloted to test their design, and allow adjustments to be made based on feedback received.
What has been achieved?
The prevalence of prescribing errors was significantly reduced, following the delivery of the training intervention. Statistically significantly more medications prescribed during the pre-intervention audit contained one or more errors when compared with the post-intervention audit (28.6% versus 9.2%, p < 0.05). Most errors found were deemed to be system-related errors.
What next?
The study demonstrates the positive impact that ongoing training can have on users’ interactions with an electronic prescribing system. Electronic prescribing systems are being increasingly considered and implemented in healthcare settings internationally. The results of this study could be used to inform the planning for training interventions to be delivered as part of ongoing system maintenance. The study stands to inform those managing electronic prescribing projects that, despite initial training, errors can still occur and must be addressed. This study supports the need to provide adequate training resources for users of electronic prescribing systems.
TRAINING NURSING STAFF ON SAFE DRUG ADMINISTRATION IN THE EMERGENCY DEPARTMENT
Pdf
European Statement
Patient Safety and Quality Assurance
Author(s)
Gregorio Romero Candel, Esther Domingo Chiva, Nuria Martinez Monteagudo, Jose Marco del Rio, Marca Diaz Rangel, Francisca Sanchez Rubio, Ismael Perez Alpuente, Eva Garcia Martinez, Ana Valladolid Wals
Why was it done?
The ED is an area where medication errors are common given it´s complexity, the large number of patients with different pathologies, having to make quick decisions with little clinical information and the coexistence of professionals with different training.
The use of intravenous (IV) and high risk drugs, as well as the mixture of two or more intravenous drugs in the same diluent are usual and can lead to medication errors.
We designed an educational program based on a session for nurses of the ED to standardize the use of the most commonly administered drugs and improve patient safety
What was done?
A training session for nursing staff on safe drug administration in the emergency department (ED) was performed
How was it done?
A training session was conducted by the fourth year resident during a two month rotation period in this area. The most common mistakes were presented to nurses based on national studies, as well as techniques for safe administration of drugs. Guides on parenteral administration of the hospital were reviewed with special emphasis on high risk drugs and how to manage them according to the Institute for Safe Medication Practices. We also developed a guide including the most frequent drug incompatibilities and direct intravenous administration of drugs for the ED.
What has been achieved?
The aim of the session was to train personnel at the ED in order to reduce medication errors and promote a safety culture. In turn, the development of guidelines to standardize clinical practice are useful, making information accessible and easy to use. Clinical sessions between departments allow the integration of the pharmacist in other areas.
What next?
We are still working with the ED to increase safety in drug therapy by developing new pharmacotherapeutic protocols (high risk medications protocols, perfusion protocols and new safety guidelines and training sessions). We are also working with more departments at our hospital with the experienced gained
PATIENT SAFETY: INTERVENTIONS TO REDUCE RISKS IN MEDICATION USE PROCESSES
Pdf
European Statement
Patient Safety and Quality Assurance
Author(s)
Nadia El Hilali Masó, Elvira Ramió Montero, Gemma Baronet Jordana, Marina De temple Pla, Paula Montoliu Alcon, Maria Jaume Gaya, Núria Pi Sala, Joan Altimiras Ruiz, Montserrat Pons Busoms
Why was it done?
The confusion between drug names represents a common cause of medication errors due to similarities between trade names and active ingredients or vice versa. Very new drugs coexisting with others that are very well known can easily induce errors in wards, unclear prescription may lead to misunderstanding of prescription.
What was done?
Development and implementation of measures to improve patient’s safety from purchase to drug prescription and administration.When we switch to a new provider maybe forced by drug shortage, we perform a review to avoid medication errors in all dosage forms.If needed, we elaborated alerts (pharmalerts) and newsletters. We applied Tall Man letters (TML) method to manage look-alike and sound-alike drugs, and to reduce prescription errors we elaborated a “Best practices on drug prescription” validated by Commission of pharmacy.
How was it done?
We prepared a formulary online on the intranet where pharmacist introduces relevant drug information as composition (i.e, excipients, contents latex or not, etc.), dilution, stability, source of errors (name, brand name,etc) among others. We compare them with existing ones to take an action, if necessary, that will be spread to all professionals. To implement TML method we followed the ISMP recommendations. First, we selected 3 antibiotics: cefOTAXime, cefAZOLin, cefTRIAXone. We changed these names in the prescription program so that the differentiation is reflected when drugs are prescribed, dispensed and administered. The implementation was explained to pharmacy, nursery and medical staff.After a month, we evaluated its acceptance.
What has been achieved?
We reviewed 61 new products: 50 trademarks, 14 new drugs and 7 dosage forms. 70.48% of products, acquired temporally or permanently, were new trademarks; 19.71% new drugs and 9.81% new dosage forms. The review is a good tool for a safe use of drugs and improves communication between healthcare providers. To evaluate TML implementation 240 questionnaires were completed: Acceptance was 92.05% (nursery and medical staff). 91.17% thought that it is possible to make a mistake with look-alike or sound-alike drugs and 68.72% that TML is useful to minimise medication errors.
What next?
The huge acceptance of TML encourages us to select other drugs from ISMP list. We have 6 pairs of drugs. We are planning to extend its use to storage shelves on wards.
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.
SIMULATION LEARNING PROGRAMME FOR NURSES: A WAY TO SECURE THE PILLBOXES PREPARATION IN THE CARE UNITS
Pdf
European Statement
Patient Safety and Quality Assurance
Author(s)
Charlotte Ménage, Mickaël Le Barbu, Adrien Borowik, Christine Housset, Sandrine Voisin, Florence Lémann, Jean-Michel Descoutures
Why was it done?
An audit of the medication storage cabinets was performed in 2015 in 19 care units. Over a three month period, more than 5000 inappropriate medecines were found which are likely to alter the process of pillboxes prepation by the nurses. Our objective was to develop a training program for nurses to identify and avoid near miss events during the medication administration process.
What was done?
A simulation learning program for nurses was implemented to secure the drug pillboxes preparation.
How was it done?
A multiprofessional team (i.e., pharmacist, physician, pharmacist resident, head nurse, risk manager, hospital hygienist) collaboratively developed a simulation-based workshop. Two mobile cabinets were designed. They were composed of 28 medicine boxes, a patient pillbox and a laptop with a mock prescription. They included the use of a simulation scenario with errors (e.g., expired tablets, damaged blister packs, mixed pharmaceutical forms or dosages, non-formulary drugs). The nurses had to prepare the patient’s pillbox for one day and then were asked to solve five questions about good practices. A validated assessment grid was filled in by two team members, and finally discussed with the nurse about the successes and pitfalls as an education purpose. At the end of the simulation program, nurses had to answer a satisfaction survey.
What has been achieved?
47 nurses experienced the simulation-based workshop. It took 40 min for each nurse on the same week. 89% removed the deteriorated tablets remaining in the pillbox and did not unpack any unit dose. However, 81% were unable to prepare the right medicine, the right dose, the right route for the right patient at the right time, because of a lack of patient identification on the pillbox. Some critical procedures were considered not appropriately followed: i.e., detecting acetaminophen prescription duplicate (only 26%), throwing away medicines in the right disposable bin (21%), checking the tablet expiry dates (70%), using a drug for which the patient was not allergic (62%). The 47 nurses were all together satisfied (100%) with this workshop.
What next?
The simulation based program was adopted by the hospital department of nurse care. It is now integrated in the yearly re-assessment skills program of all nurses.
INTEGRATION OF A PHARMACIST INTO THE EMERGENCY DEPARTMENT
European Statement
Patient Safety and Quality Assurance
Author(s)
PALOMA CRESPO-ROBLEDO, MARIA SEGURA BEDMAR, IRENE ESCRIBANO VALENCIANO, NURIA BLAZQUEZ-RAMOS, BEATRIZ MARTIN CRUZ, CARMEN MORIEL SANCHEZ
Why was it done?
Patient safety is an essential component of quality care. It’s known that EDs are an element of risk for the onset of adverse events due to conditions related to patients’ comorbidity, communication problems, medication errors and working conditions like limited information about the patient, workload, interruptions, shifts, etc. It was detected that reconciliation of medication was not performed; neither validation of the medication prescribed and medications were stocked with no order and control.
What was done?
A project was developed to increase patient safety in the Emergency Department (ED) based on the presence of a hospital pharmacist in the team.
How was it done?
First thing was to review and validate the medication prescribed in patients who were under observation, at the same time performing a reconciliation given their acute situation. This way a relationship between nurses, physicians, patients and pharmacist was established.
Then, electronic prescription software was integrated within the automated dispensing cabinet (ADC), eliminating potential errors choosing the right drug. Only when a pharmacist has checked the medication, the list appears in the display and can be taken out all at once. The main problem has been to agree the stocks and how nurses can return easily and operatively the medication in order to not accumulate it out of the ADC.
What has been achieved?
Pharmacists’ clinical figure is being disclosed in a country where Hospital Pharmacy is a central and close department. In 43 days, 428 patients got their prescription checked in the ED, 346 pharmaceutical interventions were made in 198 patients, a median (IQR) average of 1 (1,2) interventions per patient. The main reason for an intervention was the adequacy to pharmaceutical forms included in the Hospital(n=130), followed by reconciliation interventions(n=77). Category of errors detected were mostly B (NCC MERP), showing pharmacists can detect an error occurred but that did not reach the patient
What next?
Hospital pharmacists should show their clinical and logistic potential, fighting with other health professionals to increase safety and care in patients. ED is the entrance of patients into the health system and where more errors can be committed, the work of a pharmacist should start at ED to prevent errors and give support and be part of the team.
MAKING CLINICAL PHARMACY ESSENTIAL IN A LARGE UNIVERSITY HOSPITAL
Pdf
European Statement
Clinical Pharmacy Services
Author(s)
Janne Kutschera Sund, Martin Grotnes, Ingvild Klevan, Lene Lilleaas, Johan Fredrik Skomsvoll
Why was it done?
Lack of comprehensive strategies and funding has made it difficult to develop and implement extensive clinical pharmacy services in our hospital. It has been challenging to secure hospital involvement. A new financial model securing funding from the regional health authority made way for a new joint approach.
What was done?
A dialog based process involving hospital management, clinicians and the pharmacy led to a large increase in clinical pharmacy services in our university hospital.
How was it done?
A literature review was conducted. Based on this, a multidisciplinary project group decided that all clinics and wards were eligible for clinical pharmacy services and should receive extensive information on the topic. As there were limited resources allocated, all clinics were asked to apply for the service. The hospital management received applications three times the number of funded clinical pharmacists.
Prioritizing was based on the following criteria; use of the Integrated Medicines Management (IMM)-method, patient flow, evaluation and research, in- or out –patient clinics, continuation of established services, localization and time schedules on the wards.
What has been achieved?
The long term funding of clinical pharmacy in the health region enabled the hospital pharmacy to recruit and educate highly competent clinical pharmacists.
In less than a year, the number of clinical pharmacists has increased from three to twelve. The number of wards receiving clinical pharmacy services has also grown from three to twelve and there are still plans for further implementation.
The hospital and the ward managements are much more involved in evolving a common patient safety strategy with focus on medication. Specific quality indicators for each patient population and ward are being developed, and clinical pharmacists are now important members of multidisciplinary teams all over the hospital. Pharmacists are integrated in ongoing clinical research projects and publishing.
User surveys show that clinical pharmacy is assessed as a highly beneficial service by both nurses and physicians.
What next?
Develop the IMM-model to include the clinical pharmacists in standard patient care in every clinic and department. We plan to perform follow-up studies on the effects of clinical pharmacy services in different settings.
DISCHARGE MANAGEMENT: SAFER DISCHARGES AND IMPROVED INFORMATION TRANSFER METRICS
Pdf
European Statement
Clinical Pharmacy Services
Author(s)
Marie-Claire Jago-Byrne, Sinead McCool, Caroline Reidy, Stephen Byrne
Why was it done?
Published research had demonstrated that 50% of discharge prescriptions were non-reconciled(1). A recent study demonstrated that 43% of patients experienced post-discharge medication errors(2). The prevalence of polypharmacy (>5 medications) has increased over the 15 years to 2012, from 17.8% to 60.4% in people 65 years and older in Ireland(3).
What was done?
The aim of this project was to improve medication safety at the point of hospital discharge by using targeted medication reconciliation and producing a computer-generated prescription. This new model for discharge prescribing was introduced for patients who met both of the following criteria in two acute hospitals:
• Prescribed 9 or more medications, at the time of admission.
• Aged 70 years and over
How was it done?
The new model for discharge prescribing used collaborative medication reconciliation and the e-Discharge software to improve the quality of discharge prescriptions. The model was introduced in both hospitals and received support from community and hospital colleagues. Clinical pharmacists became the project champions and worked closely with medics during the change process. Key safety aspects were:
• Clinical double check for this high-risk process- the pharmacist and the doctor sign the prescription.
• Increased legibility
• Explanation for all prescription changes to community colleagues.
Phase 2: The software was further tested on 200 patients in a bench top exercise
What has been achieved?
Phase 1: The overall compliance with the national discharge prescription standards increased from 50.4% to 96.9% with the new model for discharge prescribing. The biggest change in compliance was observed in the three communication categories, which explain to community healthcare providers the rationale behind the medication changes made during the hospital stay. A user acceptability survey of HCP involved in the project demonstrated that all those involved had benefited from improved workflows in hospital and community settings, and more appropriate and efficient use of resources. All users requested expansion of this service.
Phase 2: This review allowed for the improvement of the e-Discharge Software using anonymised patient cases to test issues identified in Phase 1.
What next?
In Phase 3 the model will be introduced to a third hospital to evaluate transferability of the concept alongside current practice outlined above
DEVELOPMENT AND IMPLEMENTATION OF “CHECK OF TREATMENT APPROPRIATENESS” IN A LARGE TERTIARY CARE CENTRE
European Statement
Clinical Pharmacy Services
Author(s)
Tine Van Nieuwenhuyse, Sabrina De Winter, Isabel Spriet, Thomas De Rijdt
Why was it done?
During the last decade, healthcare shifted in many ways towards a more patient-focused rather than a disease-focused approach. Hospital pharmacy services experienced a similar development. Traditional drug-oriented services expanded towards patient-oriented services by imbedding computerized clinical decision support (CCDS) in the prescribing process and implementing bedside clinical pharmacy services, both leading to improved efficacy and safety of medication use. However, due to limited resources, clinical pharmacy services are not implemented on a hospital-wide basis in Belgian hospitals.
To guarantee patient safety throughout the hospital, emphasizing patients at risk, we started in March 2016 with the development and implementation of central check of medication appropriateness.
What was done?
Development and implementation of central check of medication appropriateness (COMA) in hospitalized patients in a 2000-bed academic hospital.
How was it done?
Based on a risk analysis, high risk prescriptions are checked by a hospital pharmacist for appropriateness. A daily check (0.5 FTE) of automatically generated queries is performed using standardized algorithms. The queries are a result of the screening of all new prescriptions in the electronic prescribing system of the last 24 hours. If an urgent intervention is necessary, in case of a serious adverse event, a phone call is carried out to the treating physician. In all other scenarios, interventions are performed via electronic warnings in the patient’s file.
What has been achieved?
– Development of 75 specific algorithms covering 5 pharmacotherapeutic areas of interest: drugs with restrictive indication, medication-related biochemical changes, evaluation of overruled interventions raised by CCDS, reimbursement of drugs, sequential therapy for bio-equivalent drugs.
– Education of 8 pharmacist involved in the COMA
– During a 6-month period, 19220 prescriptions were checked for which 8284 (43%) electronic warnings were sent and 224 (1%) phone calls were carried out. When analysed without automatic warnings for sequential therapy, 11751 prescriptions were checked for which 815 (7%) electronic warnings were sent and 224 (2%) phone calls were carried out.
What next?
For the future we obtain next goals:
• Evaluation of the current COMA, with emphasis on improving specificity
• Development of new algorithms , also expanding to other areas of interest
• Development of an easy access training tool for hospital pharmacist to perform COMA