Implementation of an opioid stewardship programme (OSP) at San Ignacio University Hospital
Pdf
European Statement
Patient Safety and Quality Assurance
Author(s)
Viviana Andrea Pinzon Garcia, Paula Camila Murcia Jaramillo, Reinaldo Grueso Angulo
Why was it done?
In 2018, concerned with the opioid crisis in USA, the pharmacy and therapeutic committee began to work on safer opioid use; an initial diagnosis showed an increase in the use of in hospital opioids and a lack of protocol for the disposal of the resultant remnants. Standard single-dose syringes (SSDS) were devised to avoid remnants, subsequently noticing that the strategies to be used should involve the whole medication order cycle (MOC). This gave rise to the OSP, which involves physician’s pain management and prescribing practices, pharmacy preparing and dispensing process, nurse’s custody, administration and disposing protocols.
What was done?
An Opioid Stewardship Programme (OSP) led by a multidisciplinary team: scientific direction, pharmacy and pain clinic, was implemented to ensure adequate and safe opioid prescription, dispensation, administration and disposing practices in San Ignacio University Hospital (HUSI), a tertiary level hospital in Bogota, Colombia.
How was it done?
Institutional pain practice guidelines were assessed, unifying the titration doses with SSDS and developing disposal protocols in which care staff is constantly being trained ever since. To trace the impact of the OSP, indicators for IV opioid consumption, SSDS prescription, naloxone use and guideline adherence were created.
Main obstacles on SSDS: <10% prescribing adherence, availability failures and dose expiration. In response, the whole ampoule prescription was narrowed to only pain specialists to face SSDS expiration costs and avoid shortage.
What has been achieved?
SSDS prescription proportion above 70% by July 2022, decreased milligram morphine equivalent (MME) consumption per hospital discharge (January 2019: 37, January 2020: 47, January 2021 (COVID 2nd surge): 39, January 2022: 25, July 2022 (COVID 3rd surge):16) and monthly costs decrease in 1997 USD, between 2019 and 2022.
An opioid shortage during the COVID surges, deepened in Colombia due to a hydromorphone recall, was avoided.
What next?
The OSP initiative could be replied in healthcare institutions considering our achievements. To keep working in a safer opioid MOC, our OSP has formulated new strategies with an active role of pharmacists, pain specialists and nurses oriented to: remnants disposal protocol, prescribing policies, medication error detection and healthcare staff and patient education.
Implementation of a multidisciplinary personalised medicine unit for pharmacogenetic testing
Pdf
European Statement
Clinical Pharmacy Services
Author(s)
Jorge Fernández-Fradejas, Matías Morín-Rodríguez, Eva Delgado-Silveira, Miguel Ángel Moreno-Pelayo, Ana María Álvarez-Díaz
Why was it done?
There is an increasing number of gene-drug interactions that have the potential to predict patient response. Although the study of some genetic variants can be a useful tool to achieve a safer and more effective pharmacotherapy, the integration of personalised medicine in clinical practice has been challenging over the years, mainly due to prescriber’s scepticism and lack of clinical guidelines and protocols.
What was done?
We have implemented a multidisciplinary Personalised Medicine Unit (PMU) at a third- level hospital to facilitate preemptive pharmacogenetic testing.
How was it done?
The PMU provides its service with the involvement of Pharmacy and Genetics Department according to the following workflow:
1. Physicians order the pharmacogenetic test in the first contact with a patient expected to be treated with a drug with an available pharmacogenetic test.
2. A peripheral blood sample is drawn for DNA extraction and analysed by the Genetics Department.
3. An integrated pharmacogenetics report is generated and uploaded to the patient’s electronic medical record. This report contains the molecular information and its interpretation (responsibility of Genetics Department) and the clinical pharmacotherapeutic recommendation according to the results obtained (responsibility of Pharmacy Department). Dose adjustment recommendations follow the Clinical Pharmacogenetics Implementation Consortium (CPIC) guidelines and Dutch Pharmacogenomics Working Group (DPWG) guidelines.
4. Pharmacy Department follows up pharmacotherapeutic recommendation acceptance and clinical outcomes.
What has been achieved?
Since July 2021 we have implemented pharmacogenetic testing for seven drug-gene interactions:
July 2021. CYP2C9 – Siponimod.
November 2021. DPYD – Fluoropyrimidines (capecitabine, fluorouracil, tegafur).
April 2022. UGT1A1 – Irinotecan, liposomal pegylated irinotecan, sacituzumab govitecan.
Three hundred and seventy patients have benefited from pharmacogenetics testing. These tests have been requested by three different clinical departments and had a mean turnaround time of less than 10 days, preventing any potential treatment delays. An integrated Pharmacy-Genetics report with individualised pharmacotherapeutic recommendations was generated for every patient. These recommendations had an acceptance rate of 100%.
What next?
Since the creation of the PMU, we have been able to implement pharmacogenetic testing in clinical practice with a high level of acceptance. Our next challenges are introducing next- generation sequencing for the study of new gene-drug interactions in the unit portfolio and achieve a deeper integration of pharmacogenetic information in clinical decision support systems.
Determination of dihydropyrimidine dehydrogenase genotypes to guide physicians in the dosing of fluoropyrimidines
Pdf
European Statement
Clinical Pharmacy Services
Author(s)
Aina Oliver Noguera, Luis Pérez de Amezaga Tomáss, Margarita Nigorra Caro, Fernando Do Pazo Oubiña, Esther Falcó Ferrer, Teresa Fernández Rodriguez, Maria Fiorella Sarubbo, Antònia Obrador de Hevia, Montserrat Vilanova Boltó
Why was it done?
Treatment with fluoropyrimidine produces severe toxicity in about 30% of the patients. This toxicity has been related to a reduction in the activity of DPD, the rate-limiting enzyme for fluoropyrimidine catabolism. This is due to certain genetic variants of DPYD, the gene encoding DPD. For this reason, regulatory agencies such as the European Medicines Agency (EMA) recommend determining DPD deficiency in all patients who are candidates for treatment with fluoropyrimidines.
What was done?
Design of a protocol for the Implementation of dihydropyrimidine dehydrogenase (DPD) genotype tests in our hospital so that the results can be clinically interpreted by the pharmacists, and then used to guide physicians in the dosing of fluoropyrimidines (5-fluorouracil/capecitabine). The project was done with the collaboration of the Genetic and Genomic Laboratory (GGL) located in the reference hospital of our territory.
How was it done?
The elaboration of the protocol took place as follows, coordinated by the oncology pharmacist:
– Informatics. They created a formulary at the electronic prescription programme (HP-HCIS®) for the inclusion of the patients in the testing protocol.
– Oncologists and nursing service. They were trained in the implementation of this new determination, as well as in the procedure for obtaining and sending samples to the GGL.
– GGL. They conducted the DPYD genotype tests and report the results to the oncology pharmacist.
– Oncology pharmacist. They did the clinical interpretation of the result based on the following European Society for Medical Oncology (ESMO) recommendations for heterozygous DPYD variant allele carriers:
-DPYD*2A (rs3918290): dose reduction of 50%
-c.1679T>G (rs55886062): 50%
-c.2846A>T (rs67376798): 25%
-c.1236G>A/HapB3 (rs56038477): 25%
What has been achieved?
Since the implementation of the protocol, 73 determinations of DPYD polymorphisms have been performed (November 202 to August 2022). Three patients (4.1%) were found to be heterozygous DPYD gene variant carriers (two DPYD*2A and one c.2846A>T).
The average time for obtaining the results was 17.5 days. For this reason, in most cases the treatment was started before the result was obtained.
What next?
We are working on the implementation of a new fluorescence technique that will allow us to shorten the time of obtaining the genotype result.
Initiative to introduce database of compounded pharmacy preparations at the University Hospital Centre Zagreb
Pdf
European Statement
Production and Compounding
Author(s)
Mateja Ljubičić, Mirela Sadiković Tvorić, Mirela Ganza, Mirna Alebić
Why was it done?
Minimising quality and safety differences between commercially available medicines and compounded pharmacy preparations depends on the pharmacists’ professional education and skills. The purpose of this initiative is to specify the most common pharmacists’ adjustments of the commercially available medicines and to determine the level of quality assurance and safety measures which should be applied to the hospital pharmacy throughout planning the procurement of installations and equipment.
What was done?
Our existing computer system does not have the ability to provide information on the compounded pharmacy preparations made in the hospital pharmacy from raw material or commercially available medicines. We have introduced a database for keeping up-to-date records of pharmacy preparations compounded by pharmacists for special needs of paediatric population in the University Hospital Centre Zagreb in a period of 6 months.
How was it done?
The following information on pharmacy preparations were added to the new database: dosage form, dosage strength, shelf life and serial number of the commercial drug or raw material that was used; patient data: name and hospital department unit; and identification of the pharmacist. Data was structured as presented in Table 1. and Table 2.
Pharmacists’ adjustments Total Number
dosage strength Oral divided powders (DPs) 628
dosage form Extemporaneous oral liquids 473
In total 1101
Preparations with HD Aseptic processing Containment Complexity of process
0.05% Cyclosporine eye drops + + 2
1% 5-FU eye drops + + 2
1% Voriconazole ear drops – + 1
Vemurafenib DPs – + 1
Imatinib DPs – + 1
Capecitabine DPs – + 1
Hydroxycarbamide oral suspension – + 1
Tretinoin oral solution – + 1
What has been achieved?
Keeping up-to-date records improved the traceability inpatient care and reduced the incidence of adverse events. Specific requirements for procurement of equipment for aseptic processing and containment of Hazardous Drug (HD) were successfully recognised.
What next?
Harmonisation of standards of pharmacy preparations throughout the country could be enabled by creating a national portfolio of preparations from all hospital pharmacies. This initiative of creating an overview of the pharmacy preparation practice should be considered in other hospitals to guide the pharmacy departments in the developing quality assurance programme.
6 months after the implementation of a Good Practice Form (GPF): the example of Versatis
Pdf
European Statement
Selection, Procurement and Distribution
Author(s)
Laetitia ALRIC, Isabelle PLOCCO-DESMONTS, Anne-Laure DUBOIS, Sophie TOUQUET-ARNAUD, Kim NGUYEN, Blandine ARMAND, Isabelle HERMELIN, Audrey LEFRANCOIS
Why was it done?
Versatis is a lidocaine patch used in case of post-zona neuralgia. In June 2021, after a note of concern raised by the OMEDIT (Observatoires du MEdicament, des Dispositifs médicaux et de l’Innovation Thérapeutique) regarding its overuse by staff members of the CHRO (Centre Hospitalier Régional d’Orléans).
What was done?
We analysed the change in prescriptions and consumption since the implementation of a Good Practice Form (GPF) in September 2021, concerning Versatis created in collaboration with the CLUD (Comité de LUtte contre la Douleur).
How was it done?
Analysis of nominative dispensations between 09/21 and 02/22.
Consultation of shared electronic patient records.
Medical evaluation of prescriptions by rheumatology and pain-management physicians.
Methodological strategy validated by the physician in charge of professional practices evaluation.
What has been achieved?
Before the implementation, 3839 patches would have been consumed over a 6-month period versus 1541 after, marking a 59.9% decrease.
The population under scrutiny was made up of 106 patients (male-to-female ratio = 1,3; average age = 64 years). The average number of patches delivered per patients was of 15 (min=5; max=160), with 1,1 patches per localisation, for an average length of treatment of 14,4 days. 97 GPF were archived, representing 91,5% of use.
In-label prescriptions (post zona neuralgia with localised allodynia) concerned 14 (13,2%) patients.
Regarding pertinent off-label prescriptions (neuropathic pain with localised allodynia, with a maximum of 1 patch/zone/day): 36% of patients exhibited neuropathic pain, including 9% with allodynia, with 4% 1 patch/zone/day. 9,4% benefited from rheumatological or pain management consultations.
48% of prescriptions respected the 12/24h rest-time, and 79% the limit of 1 patch/zone/day off-label.
After medical expertise, 3 prescriptions were found to be unjustified – 2 due to lack of information and 1 concerning post-gout crisis pain.
What next?
Despite the patch’s small price, the implementation was of significant impact over the hospital’s consumption (and by extension, over the hospital prescribing dispensed in the community), due to its adoption by over 90% of medical prescribers. This, despite a majority of off-label prescriptions, which were rated as pertinent over 90% of the time. The GPF will have been optimised since this evaluation took place, notably with a more precise definition of allodynia.
Improving people living with HIV therapies compliance: a practical tool customised for patients and designed by hospital pharmacists
Pdf
European Statement
Patient Safety and Quality Assurance
Author(s)
Sabrina Trivellato, Daniele Mengato, Maria Mazzitelli, Anna Maria Cattelan, Francesca Venturini
Why was it done?
An optimal compliance is an essential requirement for people living with HIV (PLWHA) to grant drugs effectiveness and safety. Given the complexity of the therapeutic regimen, and the multiple changes to it due to the clinical status, compliance to therapy may be suboptimal. Patients who are not well educated on how to follow their therapy are more keen on quitting the treatment or facing virological failure. According to previous analysis, we reported that 120 patients out of more than 1500 managed by our centre experienced suboptimal adherence to therapy.
What was done?
We created a user-friendly tool to educate HIV-patients on their drugs’ adherence in our University Hospital.
How was it done?
We studied every drug prescribed in our centre and we analysed it from the patient’s point of view. The question we aimed to answer was: “If I were a PLWHA, what would help me assuming the correct drug, at the proper time, avoiding misunderstandings?”. We analysed the shape, colour and dimensions of both the package and the pills/capsules. We focused on the most appropriate way to take every drug and we investigated possible interactions with OTC drugs or dietary supplements.
What has been achieved?
A poster reporting all the drugs available in our formulary was developed: 34 medicines were described in alphabetical order, specifying for each one the image of the package, the usual dosage, the picture of the pill/capsule compared to the dimension of current coins and special warnings about possible drug-drug interactions. We also adopted practical symbols to indicate whether to assume the drug with or without food. The poster became available starting from April 2022 and during the following 5 months a cohort of 960 patients could rely on it.
What next?
In order to help our patients taking their therapies, we expect to get a digital form of this poster to make it available on the phone scanning a QR code. Alongside, we aim to enlarge and improve this digital version by adding a final section with an interactive survey to closely monitor the compliance of the patients and help them to improve it. Through this project we could also obtain an active pharmacovigilance setting.
Pharmacist prescriber embedded within medical team improves patient care by timely and accurate discharge medication prescribing
Pdf
European Statement
Clinical Pharmacy Services
Author(s)
Fiona Watson, Amanda Plummer, Aqleema Akhter
Why was it done?
For discharge medication to be dispensed a medicines list plus discharge letter, often referred to as a To-Take-Out (TTO) is required. The letter section communicates information for safe patient transfer and provides context for the pharmacist clinical verification. With increasing demands on junior doctors, the production of TTOs is often delayed until after all urgent clinical duties are completed, so dispensing commences late in the working day. in addition, junior doctors’ prescribing errors cause delay while queries are resolved. The late completion of TTOs slows patient flow across the whole system. It was accepted that a different strategy, using a PP to prioritise prescribing, needed exploration.
What was done?
A prescribing pharmacist (PP) was embedded within a specialist medical team, to perform prescribing activities in a timely manner, with a focus on discharge prescriptions. The PP was additional to the standard ward pharmacy establishment, allowing prescribing to be the focus of the role.
How was it done?
A PP was embedded within the Respiratory team and another within Gastroenterology with the primary aim of producing TTOs as early as possible. There was a requirement for the PP to learn how to write the discharge letter, via training with junior doctors. The PP prioritised any prescribing to facilitate discharge, but also attended the consultant ward round undertaking medicines optimisation for each patient. Rather than the junior doctor returning later to prescribe, the PP made any necessary medication changes during the ward round, facilitating the timely receipt of appropriate therapy.
What has been achieved?
Both pilots reduced the time from medically fit for discharge to the TTO written by approximately 3 hours. There was a reduction in prescribing error rate of 37% to 1% in Respiratory and 9.5% to 0.7% in the Gastroenterology project.
What next?
The “Embedded Prescribing Pharmacist” role is now permanent within the two pilot specialities, with plans for further extension under consideration. The role demonstrates the “Right first time” concept and a modernised model of hospital pharmacist practice.
Prescription review of digoxin-treated inpatients: Pharmacist involvement in its pharmacokinetic monitoring and dosage adjustment
Pdf
European Statement
Clinical Pharmacy Services
Author(s)
DEL RIO GUTIERREZ JOSE MANUEL, MARTA MIARONS FONT, SONIA GARCIA GARCIA, TONI SORIANO COLOMÉ, ALBA PAU PARRA, ARIADNA GRACIA MOYA, NIEVES HERRANZ MUÑOZ, BRUNO MONTORO RONSANO, PAU RELLO SABATE, GERARD ORISTRELL SANTAMARIA, MARIA QUERALT GORGAS TORNER
Why was it done?
Digoxin is a drug frequently implicated in medication errors due to its difficult clinical management. It has also been observed that digoxin pharmacokinetics could change in acute medical conditions, compromising its effectiveness and safety. As hospital pharmacists, we have the opportunity to review which dose is the most appropriate for every patient.
What was done?
Twice-weekly active and extensive pharmaceutical review of digoxin-treated inpatients was established to identify whether the prescription was adequate and to adjust dosage according to plasma concentrations (PCs) and clinical situation.
How was it done?
1. A multidisciplinary team comprising pharmacists and cardiologists was created to identify possible solutions to improve digoxin prescribing.
2. It was agreed that a twice-weekly extensive review of digoxin-treated inpatients would be conducted by a pharmacist. Candidates for digoxin monitoring were:
a. Patients on chronic digoxin therapy and with at least one of the following risk factors: presence of renal failure (RF), recent surgery, elderly patients (≥65 years), critically ill patients, or patients with suspected toxicity.
3. Once the patients were identified by the pharmacist, they would be discussed with the cardiology team.
4. Digoxin prescriber would be contacted to recommend performing a determination of digoxin PC. PC reference range was set at 0.8–1.2 µg/L for atrial fibrillation (AF) and 0.5–0.8 µg/L for heart failure (HF).
5. PCs would be interpreted using a pharmacokinetic monitoring software (PKS Abbot).
6. Monitoring results and recommended dosage adjustments would be communicated.
What has been achieved?
From August 2021 to May 2022, 190 patients were identified. Sixty-five (33.7%) were considered for monitoring, of whom 21 (32.3%) were women. The average age was 77.9 (SD 11.7). Sixty-five (100%) with AF and 8 (12.3%) also with HF. The most prevalent risk factors warranting monitoring were patients aged 65 years or older (N=57, 61.9%) and RF (N=31, 33.7%). Thirty-three (51%) of monitored patients required a dosage adjustment, of whom 23 (69.8%) required a dose decrease, 5 (15.1%) an increase and 5 (15.1%) to stop the treatment. Median digoxin concentrations were 1.23 µg/L (interquartile range: 0.75-2.03).
What next?
The process described applies to any centre able to monitor digoxin CPs both in inpatient and outpatient settings.
Sustainability initiative: dose banding of paclitaxel to minimise drug waste
Pdf
European Statement
Production and Compounding
Author(s)
Peder Nygard, Helle-Brit Fiebrich-Westra, Elise Smolders
Why was it done?
The aim of this project was to reduce paclitaxel waste caused by cancellation of administrations. Standardised dose bands make interchangeability of already reconstituted paclitaxel bags easier, as more patients use the same dose. This could potentially save drug- and material waste and costs even as manpower.
What was done?
Paclitaxel fixed dose bands were created for patients treated with a weekly dose of 80 mg/m2.
How was it done?
In consultation with prescribers the dose bands for paclitaxel where created (see table). These dosages were implemented as a dose-rounding rules in the drug preparation software (Hix 6.2, ChipSoft BV). The maximum deviation for dose-rounding rules for paclitaxel in our hospital is 10% of the prescribed dose. Dosage ≤72mg or >200mg were rounded as normal.
Prescribed dose (mg) Dose-band (mg) m2 (dose 80 mg/m2
>72 ≤88 78 1.0
>88 ≤102 96 1.2
>102 ≤116 114 1.4
>116 ≤136 126 1.6
>136 ≤152 144 1.8
>152 ≤168 162 2.0
>168 ≤184 174 2.2
>184 ≤200 192 2.4
What has been achieved?
These rules were implemented in April 2022. Data from 1 May 2022 to 31 August 2022 is compared with the same time period in 2021. In 2022, a total of 729 infusions where prepared compared with 872 infusions in 2021.
In this 4 month time period in 2022 a total of 14 different dosages were prescribed, compared with 24 in the same time period in 2021. Additionally, interchangeability was improved as the top 3 dosages prepared by the pharmacy were: 144 mg (36%), 162 mg (22%), and 126 mg (19%) compared with 144 mg (17%), 138 mg (14%), and 126 mg (10%) in 2021.
Furthermore, in 2021 we discarded 33 prepared dosages of paclitaxel of which three infusions could be reused. Compared to 13 discarded dosages in 2022 of which eight were reused giving a reduction of 25 infusions less waste (83% reduction, savings ~2500 euros).
What next?
Pharmacists need to be instructed to adapt these rounding rules, which must decrease the variation in dosages and thus waste. Secondly, this project will be monitored the upcoming year and evaluated together with prescribers. The aim is to implement dose bands for paclitaxel dosages 175 mg/m2 and other chemotherapeutic drugs (eg, oxaliplatin, docetaxel, cyclophosphamide).
Pharmacist-led antimicrobial stewardship in the management of COVID-19 patients
Pdf
European Statement
Clinical Pharmacy Services
Author(s)
Nóra Gyimesi, Andrea Bor, Eszter Erika Nagy, András Süle
Why was it done?
Evidence suggests that the rate of bacterial co-infection among COVID-19-infected patients is low. However, routine use of antibiotics was common in the early stages of the treatment.
What was done?
Clinical pharmacist participated in the therapeutic decision making of COVID-19 patients treated in our institution in order to ensure the optimal choice of medicines with special regard to the use of antibiotics.
How was it done?
A daily therapeutic discussion was started in the quarantine department from 2021, with the participation of clinical pharmacists, during which all therapy initiation were consulted. The pharmacist was involved in the walk-arounds and reviewed the medication therapies of each patient daily. The clinical pharmacist advised on the starting, or, if it was considered unnecessary, the stopping of the antibiotic therapies, as well as the monitoring required. The choice and dosage of antibiotics were also consulted.
What has been achieved?
Of the 314 patients treated in the Quarantine Department of our institution between September 2020 and May 2021 104 (33%) received antibiotic therapy during treatment, with 73% of cases initiated within 72 hours of admission. In 68 cases, bacterial superinfection was the indication for antibiotic therapy, of which only 9 cases had radiologist-confirmed bacterial co-infection. The rate of antibiotic usage has decreased after the intervention was started. During the second wave of the coronavirus epidemic (until February 2021), 41% of patients received antibiotics, while during the third wave (from March 2021), 28% of patients.
What next?
The pharmacist involvment, along with increasing experience and evidence for the clinical management of COVID-19, have moderated antibiotic use, however antibiotic overuse is still significant. Our Department of Pharmacy developed a local COVID-19 treatment guideline with emphasis on antibiotic use requirements. The education and promotion of this guideline will be undertaken by clinical pharmacists. Multidisciplinary therapeutic decision-making and strengthening of antibiotic stewardship programs are necessary for proper antibiotic use practices in the treatment of coronavirus patients.