HOSPITAL PHARMACY CONTRIBUTION TO CLINICAL TRIALS: TYPIFICATION OF MEDICATION INCIDENTS AND PHARMACEUTICAL INTERVENTIONS IN A CLINICAL TRIAL UNIT
Pdf
European Statement
Patient Safety and Quality Assurance
Author(s)
Paula Arrabal-Durán, Carmen Herrero-Domínguez-Berrueta, María Norberta Sánchez-Fresneda, Ana Mur-Mur, Ana Herranz-Alonso, María Sanjurjo-Sáez
Why was it done?
MI and PI are normally recorded in Hospital Pharmacy Services as a method for evaluating safety. Nevertheless, classical methods for reporting MI do not allow for a correct classification in the field of clinical trials. The reason is their more complex processes involving drugs compared to the processes in daily clinical practice. If there are no specific categories, the information obtained by recording usually gets lost and could not reflect exactly what occurred. In September 2016, a clinical tool to notify MI and PI was implemented in the Pharmacy Service, with the aim of unifying their classification criteria and gathering complete information for analysis and further implementation of improvement measures.
What was done?
A database to notify medication incidents (MI) and pharmaceutical interventions (PI) in the Clinical Trials Unit was developed in the Pharmacy Service of a tertiary hospital.
How was it done?
All the processes involving drugs in clinical trials were evaluated by a Failure Mode and Effects Analysis (FMEA). For each process, the possible incidents and their resulting effects on the patient were recorded. After that, a database was designed in Microsoft® Access with defined lists of choices to allow pharmacists notify both MI and PI that occur in the Clinical Trials Unit.
What has been achieved?
A database with the following information has been implemented:
a) Identification of the MI:
1. Date of the MI.
2. Number of patient.
3. Clinical Trial protocol.
4. Investigational product.
b) Process in which the MI took place (16 options).
c) Process in which the MI was detected (16 options).
d) Process that caused the MI (24 options).
e) Person who detected the MI (9 options).
f) Did any PI take place? (Yes/No).
g) PI performed (12 options).
h) Did the MI reach the patient? (Yes/No).
i) MI that reached the patient (21 options).
j) Patient outcome (8 options).
k) Effect in the clinical trial (4 options).
What next?
The implemented notification system will be further expanded and adapted over time.
Future aim is to analyse MI for establishing improvement measures and checking their results.
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
LEARNING FROM RETURN: HOW RETURNS CAN HELP TO IMPROVE THE PROCESS OF DISTRIBUTION
Pdf
European Statement
Selection, Procurement and Distribution
Author(s)
Claudia Wunder, Szabolcs Tobi
Why was it done?
To introduce returns to supply chain is a critical process in distribution of medicinal products, as non-compliance with storage conditions or inappropriate handling can impair the quality and hence endangers patient safety. In terms of a continous improvement process we considered a standardization and a supervision of this field as mandatory.
What was done?
A standard form for handling of returns was developed. It was designed to ensure that important process steps are done and documented. Furthermore it should offer the opportunity to learn about the reasons why users return medicinal goods to the pharmacy. After one year of usage (2015) the forms were evaluated with the objective of validation and improving the process. According to PDCA-cycle measures were deduced based on the results.
How was it done?
The standard form guides the process and assures
– that medicinal products are stored under quarantine until approval by pharmacist,
– that storage conditions are proved for the time the goods were out of pharmacy,
– that the quality of each returned medicinal product is checked carefully and
– that the reason for return is documented.
The standard forms were collected and evaluated concerning
– number of returns,
– reasons for returns,
– value of returns.
What has been achieved?
The standard form proved to be a useful tool to gain information about gaps in the process of distribution. The evaluation demonstrated that users had problems with ordering due to article changes and unclear names in the warehouse management system. It showed the need for education of trainees and pointed out lacks of communication between pharmacy and wards. The analysis also presented the money-saving potential of re-utilization of returns. What was achieved is an improvement of distribution process by
– implementing an intensive and standardized education for trainees,
– optimizing main data in warehouse management system,
– sensitizing the responsible persons and
– getting in closer communication with nurses on wards.
Besides that the economic benefit of the process could be proved.
What next?
At the end of 2016 the impact of the measures shall be reviewed. Benchmarks shall be deduced to audit the functionality of the process in future.
DEVELOPING A PROJECT FOR BROADCASTING INFORMATION ABOUT MEDICATION ERRORS
Pdf
European Statement
Patient Safety and Quality Assurance
Author(s)
Sergio Plata-Paniagua, Alfredo Montero-Delgado, Jose Javier Arenas-Villafranca
Why was it done?
Currently, with the extended use of social-networks (SN), information related to medication errors can be disseminated quickly and directly, and also provide interaction with professionals enhancing the information. This is very important to promote safety culture among health professionals to prevent medication errors.
What was done?
Two hospital pharmacy specialists from two spanish hospitals created a project based on web 2.0 to broadcast information about medication errors and how to prevent them.
How was it done?
First step was to create a website in which we could post information related to medication errors. The main part of the website is the blog, where we develop all information that we consider interesting. The website also has other sections containing useful resources: photo gallery with examples of look/sound-alike drugs, infographics, educational information, information about the authors and a section where readers can share content with the authors.
Second step was to create accounts on SN to spread the information posted in the website and also for sharing original content. We chose Twitter and Facebook as ideal SN. Twitter allows sharing information quickly and concisely and also is used by a different groups of healthcare providers by allowing us a wide spread. On the other hand, Facebook allows us to reach to a different audience, especially patients.
What has been achieved?
-Currently we have more than 16.000 followers on Facebook, 5.500 on Twitter and the website receives more than 3.500 monthly visits.
-Because of the multiple warnings that we have carried out about Look-Alike/Sound-Alike drugs, some pharmaceutical companies have considered changing the packaging of their drugs.
-We have achieved more than 70.000 signatures on change.org website requesting Spanish healthcare authorities to develop guidelines for the proper packaging and labeling of drugs. Because of this initiative, the Spanish press became interested in this problem and our project and the problem of drug packaging was mentioned in multiple media.
What next?
Currently, we have included another pharmacist in our project in order to enhance the quality and periodicity of our publications. On the other hand, we are trying to work together with institutions dedicated to preventing medication errors to carry out joint projects in order to improve patient safety.
NEW ORAL ANTICOAGULANTS – HOSPITAL PHARMACISTS IMPROVING THE SAFETY OF PATIENTS PRESCRIBED THESE AGENTS
Pdf
European Statement
Patient Safety and Quality Assurance
Author(s)
D. Lenehan, C. Meegan
Why was it done?
Due to the high risk nature of the NOACs, the PD has throughout 2014 and 2015 been committed to a comprehensive NOAC risk minimisation strategy, targeting all points of care to address the various safety concerns with these medicines.
What was done?
The following suite of activities were introduced in a drive to improve understanding, familiarity and awareness of new oral anticoagulant (NOAC) therapy.
1 – Medication Safety Alert – Outlines the relevant background information, risks and safety tips for prescribing and administering NOACs.
2 – Quiz – a novel and fun method to ascertain the level of knowledge staff had on NOACs by incentivising participation.
3 – Prescribing information sheet – summarises all the pertinent prescribing information on NOACs to aid selection and detail the relevant clinical cautions and risks.
4 – Point prevalence study (PPS) – captured data on all NOAC patients in the hospital to identify prescribing trends and appropriateness of prescribing.
5 – Clinical checklist algorithm – identifies the key prescribing decisions and risks when admitting a patient on a NOAC.
6 – Staff educational drive – a major innovative roll-out of education sessions to medical and nursing staff.
7 – Patient education – pharmacists now educate all patients newly started on NOAC therapy.
How was it done?
Introduction of this comprehensive suite of activities required collaboration and communication with our nursing and medical colleagues in the hospital.
What has been achieved?
Knowledge and awareness of NOAC therapy has improved significantly among clinical staff and this has been reflected in medication variance reporting. The safe use of this high risk group of medicines is of paramount importance in order to minimise patient risk with these agents.
What next?
The appropriateness of NOAC prescribing will continue to be assessed through the medication variance reporting process and a follow-up PPS will be completed. Rationalisation of NOAC therapies will be considered through the formulary process and the education of staff and patients will remain a priority.
INFLUENCE OF INTEGRATION OF A PHARMACIST IN MEDICATION ERRORS IN CRITICALLY ILL PATIENTS
Pdf
European Statement
Patient Safety and Quality Assurance
Author(s)
A. Valladolid-Walsh, E. Domingo-Chiva, P. Cuesta-Montero, J.A. Monsalve-Naharro, E.M. García-Martínez, S. Plata-Paniagua, M.D. Pardo-Ibañez, G. Romero-Candel, J.M. Jiménez-Vizuete, R. Peyró-García
Why was it done?
To determine the incidence of medication errors in our environment and implement enhancement systems to prevent them, which is a priority for the improvement of the drug treatment process in critically ill patients.
What was done?
A clinical pharmacist was integrated on a full time basis into the multidisciplinary team of an anaesthesia intensive care unit (ICU).
How was it done?
The project was carried out in 3 different stages:
– First stage: a prospective observational study was carried out over 1 month to detect medication errors in anaesthesia ICU and to determine the baseline situation before the pharmacist´s intervention. During this stage, 36.27% errors were detected in overall treatments.
– Second stage (intervention stage): Over 10 months, the pharmacist reviewed the prescriptions of all patients admitted to the anaesthesia ICU, performing the appropriate interventions regarding medications. Furthermore, to educate physicians and nursing staff, we organised educational meetings, and also pharmacotherapeutic protocols and guidelines of medication administration were created to standarise clinical practice. Finally, a system for reporting medication errors was introduced.
– Third stage: a prospective observational study was carried out for 1 month to detect medication errors after the pharmacist’s intervention. During this stage, 5.9% of errors were detected in overall treatments.
What has been achieved?
– Medication errors were reduced by more than 30%.
– A pharmacist is now part of the multidisciplinary team in the ICU.
– The experience has been broadcast to the national level to promote the implementation of clinical pharmacist activities in our environment.
What next?
We are still working on the same areas to improve safety in drug therapy in critically ill patients. Currently, improvement measures that are being developed are: new pharmacotherapeutic protocols specifically for this unit; drugs and drug-diluent compatibility guidelines; new training sessions; standarised medication kits in operating rooms and implementation of the computerised prescription; and a new labelling system for syringes.
BREAKING BARRIERS: MEDICATION SAFETY IN TRANSITIONS OF CARE
Pdf
European Statement
Clinical Pharmacy Services
Author(s)
M. Cabré Serres, T. Aguilella Vicente, E. Julián Avila, D. Rodríguez Cumplido, J.M. Pepió Vilaubí, M. Muñoz-García
Why was it done?
As a part of a multicentric medication reconciliation (MR) study in the fragile patient, one of the phases of the project included primary care reconciliation so we had to create alliances and enable effective communication channels between the two levels of care.
What was done?
During 2015, we started using direct messaging between hospital pharmacist (HP) and primary care physician. The messaging tool, which is available in SIRE and ECAP programs, allows you to send messages to all physicians caring for the patient. It also allows you to contact the usual pharmacy of the patient. Physicians receive messages automatically during the patient’s clinical course.
How was it done?
When patients were medically discharged, the HP performed MR. The HP contacted the next provider to inform them of changes in the medication list and safety alerts. When the patient visited the doctor, he already had the pharmacotherapy summary and pharmaceutical recommendations in the patient’s electronic clinical course. Afterwards, the HP assessed if the pharmaceutical interventions (PIs) had been accepted.
What has been achieved?
We started using the tool in January 2015. We performed 205 discharge reconciliations and have sent 143 messages. This would be 0.7 PIs/patient. PIs have been: 26.6% (n=38) remove medication, 21.0% (n=30) monitor treatment, 21.0% (n=30) increase adherence, 11.2% (n=16) modify dose, 8.4% (n=12) add medication, 6.3%(n=9) modify posology and 5.6% (n=8) replace medication. Finally, 72.7% (n=104) of PIs have been accepted and 27.3% (n=39) rejected. We can also analyse population characteristics and the drugs involved in the PIs.
What next?
We are breaking barriers between hospital and primary care with nexus of the HP, who has begun to be part of the medical team. We want to continue in this direction to improve the results of our PIs. We want to determine if our PIs improve health outcomes. Another current problem in the transition of care is hyperprescription treatments with proton pump inhibitors or benzodiazepines. A de-prescription programme could be the next step.
ELECTRONIC RECORDING OF MEDICATION RECONCILIATION AS A RELIABLE REFERENCE FOR MULTIDISCIPLINARY CARE
Pdf
European Statement
Clinical Pharmacy Services
Author(s)
C. Bilbao Gómez-Martino, M.I. Borrego Hernando, A. Santiago Pérez, M.P. Pacheco Ramos, A.E. Arenaza Peña, L. Zamora Barrios, E. Rodríguez del Río, J.C. Tallón Martínez, Á. Nieto Sánchez, M.L. Arias Fernández
Why was it done?
MR has been proven to reduce medication errors at admission. If there are no electronic records of PCM, the information obtained by MR usually gets lost and could lead to repetition of errors.
What was done?
We provided electronic updated reports of patients’ current medications (PCM) after performing medication reconciliation (MR) at admission, although the electronic medical record (EMR) is not yet developed in our hospital.
How was it done?
The procedure, designed in the framework of a pilot MR programme, was gradually implemented in three hospitalisation units: internal medicine, geriatrics and oncology.
In order to make the medication reconciliation reports (MRR) reliable, the pharmacist consulted primary care prescriptions and at least two other independent sources of information, such as: emergency department’s admission report, previous clinical reports, self-reported medication list or the medication itself, if possible. The information was confirmed by a standardised clinical interview. Medication discrepancies were clarified by specific closed ended questions. The rest of treatment was investigated by open ended questions.
MRR included current chronic medication, relevant medications administered on demand, herbal medicines used for therapeutic purposes and other relevant data (inappropriate medications, interactions, dysphagia, adherence). Sources of information were also detailed.
MRR were integrated within the electronic hospitalisation reports, which were easily accessible via the hospital intranet.
At discharge, printed copies of reports were handled to patients.
What has been achieved?
99 MRR were recorded. 751 PCM were registered and 183 MR errors (MRE) were detected.
We contribute to the ‘best possible medication history’ of patients. This initiative might have improved patient safety by reducing discharge and readmission MRE, although it has not yet been measured.
We enhanced the pharmacist’s role in the multidisciplinary team.
What next?
This model of electronic MRR could become a useful reference for healthcare professionals, until the EMR is implemented. The next aim is to register MRR and all pharmaceutical care information in the EMR to improve our patients’ healthcare.
PHARMACEUTICAL INITIATIVE FOR APPROPRIATE HANDLING WITH CYTOTOXIC DRUG ON NON-ONCOLOGY DEPARTMENT AT OUR CLINICAL HOSPITAL
Pdf
European Statement
Introductory Statements and Governance
Author(s)
T. DIMITROVSKA MANOJLOVIKJ
Why was it done?
To highlight the classification of this drug, its dangerous side effects even to those patients not receiving it, due to intoxication when handled inappropriate, and the precautions and measures that should be undertaken to minimise the risk/danger of occupational exposure and environmental pollution with inappropriate managing of the waste and spill.
What was done?
These 4 written statements were created: (1) Notification/instructions for handling cytotoxic agentS, (2) instructions for hygienic use of the toilets by patients receiving cytotoxic therapy and disposal of toxic waste on gynaecology and obstetrics wards, (3) instructions for a woman receiving methotrexate injection and (4) standard operating procedure for intramuscular application of methotrexate for nurses in the gynaecology-obstetric ward.
All statement were copied and disseminated to all departments on the ward. In November 2014 during verification of daily drug supplies to the gynaecology-obstetrics ward, I detected a package of methotrexate injections in the transporting container together with other drugs. I immediately contacted the head ward nurse and took control of the handling of the drugs on the ward, especially in the department for pathological pregnancy. The young departmental nurse responsible nurse was not aware of the classification of nethotrexate as a hazardous cytotoxic drug that should be handled with special care. Even though a drug is not given for cancer, it should still be treated as hazardous. Explanations were given to all those present at the time: nurses, gynaecologists and hygiene maintenance staff in the department.
How was it done?
Difficulties in persuading departmental staff of the occupational hazard, intoxication by other patients not receiving the drug and environmental pollution, particularly the danger of extravasation in this class of drugs when handled inappropriately, were overcome by repeating the explanations several times and disseminating the 4 statements.
What has been achieved?
Appropriate handling of cytotoxic drugs, improvement in patient care and protection from pollution of the environment.
What next?
Frequent controls on drug handling on all hospital wards for prevention of irregularities and to ensure safe medicines application.