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A PHARMACOGENETIC CLINICAL DECISION SUPPORT SYSTEM (CDSS)

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European Statement

Patient Safety and Quality Assurance

Author(s)

Xando Díaz-Villamarín, Ana Pozo-Agundo, Paloma García-Navas, Alba Antúnez-Rodríguez, Celia Castaño-Amores, Cristina Lucía Dávila-Fajardo

Why was it done?

Nowadays, it is known that at least 33% of patients show variable response to drugs. Of those, genetic polymorphisms explain around 15-30% of these cases, single nucleotide polymorphisms (SNP) being the genetic markers most clinically relevant. In 2013, 40 million SNPs were identified in humans and some have been observed to determine drug response. These observations lead to the incorporation of genotyping some of these SNPs as a recommendation in many drug labels before treatment initiation.
Since patient´s drug response may be determined by certain SNPs in different genes it is necessary to develop CDSS based on pharmacogenetic (PGx) information that makes feasible its application in clinical routine, translating genotypes into phenotypes and dosing recommendations.

What was done?

We have developed a local Clinical Decision Support Systems (CDSS) that informs the physician on the availability of a PGx test in our hospital for certain prescribing drugs. This system will also be able to translate the genetic information into dosing recommendations.

How was it done?

We selected all the SNPs affecting drug response for which there is already a PGx test available in our hospital. All of them have been previously validated, and, only genes/SNPs related to drug response with the highest level of evidence, available in the Dutch Pharmacogenomics Working Group (DPWG) and Clinical Pharmacogenetics Implementation Consortium (CPIC) dosing guidelines with a minor allele frequency higher than 0,1% in our population have been included. We have considered all the different genotypes according to the SNPs included and linked them to a phenotype and dossing recommendation according to CPIC/DPWG guidelines.

What has been achieved?

Our CDSS connects different drugs with available PGx test in our unit, showing which gene should be genotyped before prescription. It translates genotypes into phenotypes and also provides dosing recommendations once PGx results are received, according to the CPIC and/or DPWG guidelines. Nowadays, this system facilitates the workflow for the implementation of pharmacogenetic tests in our hospital.

What next?

We have developed a CDSS that manages PGx information facilitating the implementation of pharmacogenetics in daily clinical routine. It will also allow us to expand our services to other medical departments within our hospital.

A QUALITY IMPROVEMENT PROJECT ON HEPARIN INFUSION SAFETY IN AN ACUTE TEACHING HOSPITAL (submitted in 2019)

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European Statement

Patient Safety and Quality Assurance

Author(s)

Anthony Hackett, Alice Oborne, Emma Ritchie, Caroline Broadbent, Rebecca Chanda, Karen Breen

Why was it done?

Anticoagulants such as UFH are recognised as high risk drugs. UFH requires frequent monitoring of the activated partial thromboplastic time ratio (APTTr), ensuring therapeutic anticoagulation and minimising adverse effects. UFH infusions and the APTTr were recorded using a paper based system. Incident reporting identified by the paper system resulted in inappropriate monitoring and management of UFH infusions, and dose omissions which could have resulted in harm.

What was done?

A Trust-wide electronic prescribing and medicines administration (EPMA) system was implemented in 2015. Complex infusions, e.g. unfractionated heparin (UFH) infusions, remained on paper due to EPMA functionality limitations. The complex infusion function was added into later EPMA upgrades. A multidisciplinary team (MDT) involving nursing, medical and pharmacy staff working within anticoagulation, EPMA and medication safety sought to design UFH infusions in EPMA.

How was it done?

Baseline audit (Paper-March 2016): Patients prescribed UFH infusions (n=14) were identified using SharePoint (e-reporting) by searching for the UFH infusion placeholder. Performance was measured against eight audit standards.
Re-audit (EPMA-March 2019): Patients prescribed UFH infusions (n=26) were identified using SharePoint by searching for those prescribed a UFH infusion on EPMA. Performance was measured against the same eight audit standards.
Chi square applied to results to test for statistical significance.
Incident rate per prescription: The Datix system was searched to identify heparin incidents reported during the data collection periods.

What has been achieved?

Audit standard 2016 audit v 2019 audit
1-Baseline APTTr checked before starting infusion 93% v 100%, p=0.1
2-Received correct loading dose of heparin based on APTTr 79% v 96%, p=0.07
3-APTTr checked 6 hours after infusion started 72% v 100%, p<0.05
4-APTTr checked 6 hours after infusion titrations 86% v 96%, p=0.2
5-APTTr in target range within 24 hours 50% v 70%, p=0.2
6-APTTr checked 24 hourly after 2 consecutive APTTr’s in range 100% v 100%=no change
7-Patient receives a medical review 24 hrly 65% v 100%, p<0.05
8-Heparin syringe and giving set changed 24 hrly 65% v 100%, p<0.05

UFH related incidents reduced from one incident per 1.6 infusions, to one incident per 6.5 infusions following the implementation of an EPMA system.
UFH incidents as a proportion of all anticoagulant incidents reduced from 43% (March-2016) to 20% (March-2019).

What next?

Electronic solution’s for high-risk, complex infusions such as heparin prescribing and monitoring improved care, quality and safety. Further high-risk infusions such as insulin are being developed

THE IMPACT OF AN ELECTRONIC ALERT IN PREVENTING DUPLICATE ANTICOAGULANT PRESCRIBING (submitted in 2019)

European Statement

Patient Safety and Quality Assurance

Author(s)

Alison Brown, Gillian Cavell, Nikita Dogra, Cate Whittlesea

Why was it done?

Anticoagulants are high-risk drugs. An NHS England Patient Safety Alert was published in 2015 highlighting harm from inappropriate co-prescription of anticoagulants1.

What was done?

A ‘duplicate anticoagulant alert’ (Anticoagulant MLM) was implemented within our electronic prescribing system (EPMA) to alert prescribers if co-prescription of two or more anticoagulants was attempted, with the intention of preventing the completion of a potentially harmful prescription. We conducted a retrospective review of the impact of the Anticoagulant MLM on preventing co-prescription of low-molecular weight heparin (LMWH) and direct oral anticoagulants (DOACS)

How was it done?

The study took place in a 950 bed UK acute teaching hospital. A report of all Anticoagulant MLM alerts generated for adult inpatients between 26th June 2017 and 8th October 2018 was extracted from EPMA. Data on drugs prescribed, alert acceptance or override and duplicate anticoagulant administration were collected. Where alerts were overridden, appropriateness of the override was assessed by an anticoagulation specialist pharmacist. Ethics approval was not needed.

What has been achieved?

The Anticoagulant MLM triggered on 894 occasions; 113 in response to attempted prescription of a LMWH for a patient already prescribed a DOAC. 65 of 113 alerts were overridden (duplicate prescription completed). 48 alerts were accepted (duplicate prescription avoided). Of the 65 overridden alerts, consecutive doses of both anticoagulants were scheduled appropriately. No duplicate doses were administered in 44 cases (44/65, 67.7%). 15 duplicate prescriptions were either cancelled before administration or not administered concurrently (15/65, 23.1%). Duplicate doses were administered against 6 prescriptions (6/65, 9.2%), on 3 occasions. No patient harm was identified. The alert prevented inappropriate co-prescription of anticoagulants to 48 patients. Overrides were justified in 44 cases. Anticoagulants were correctly prescribed for 92/113 (81.4%) patients. It was outside the scope of this project to investigate why alerts were overridden. ‘Alert fatigue’2 and alert frequency3 are recognised factors limiting the effectiveness of electronic alerts in changing a planned course of action.

What next?

The alert remains in place as a barrier to error. Further work is needed to identify reasons for anticoagulant alert overrides.

HOSPITAL PHARMACY UNIFIES ELECTRONIC STANDARD PRESCRIPTION THROUGHOUT THE REGION

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European Statement

Patient Safety and Quality Assurance

Author(s)

Linda Jeffery

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.

THE EFFECT OF A PRESCRIBER TRAINING INTERVENTION ON THE PREVALENCE OF PRESCRIBING ERRORS FOUND IN A ELECTRONIC PRESCRIBING SYSTEM

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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.

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