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Implementation of a clinical pharmacokinetics unit in a third-level hospital

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European Statement

Clinical Pharmacy Services

Author(s)

María Calvo Arbeloa, Ana Isabel Idoate Grijalba, Mónica Uxue Beunza Sola, Daniel Fresán Restituto, Regina Juanbeltz Zurbano, Diana Tejada Marín , Andrea Rodriguez Esquiroz, Maite Sarobe Carricas

Why was it done?

Patients with special characteristics show a great variability in pharmacokinetic and pharmacodynamics (PK/PD) parameters, which may influence the efficacy and safety of antibiotic therapy.

What was done?

A Clinical Unit of Pharmacokinetics was implemented in the Service of Pharmacy (PS) for therapeutic drug monitoring (TDM) in patients.

How was it done?

1. Selection of drugs to be monitored: Antimicrobials (Vancomycin, amikacin, linezolid and voriconazole), Immunosuppressants (tacrolimus), Antineoplastics (methotrexate) and digoxin.
2. Installation of the Abbottbase Pharmacokinetic System (Pks®) software.
3. Creation in the Computerised Clinical History (CCH) a sheet for collecting anthropometric and pharmacological data and pharmacokinetic interpretation of the results obtained.
4. Creation in CCH of a consultation option for clinicians to request monitoring from the PS.
5. Formative session for clinicians and nurses.

What has been achieved?

To begin with the unit, we selected three drugs: vancomycin, amikacin and voriconazole. The hospital pharmacist or the clinician chose the susceptible patients.
Between December 2021 and September 2022, 171 determinations were made in 73 patients: 134 (78.36%) for vancomycin, 24 (14.06%) for amikacin and 13 (7.60%) for voriconazole. Forty-six (63.01%) patients were men and the mean age was 56.58 (17-97) years- old. Eighteen (24.66%) patients were obese. The mean creatinine level was 0.82 (0.4-2.69) mg/ml and glomerular filtration according to the Cockcroft and Gault formula was 81.16 (23.68-161.98) ml/min/m².
For vancomycin, 45 (88.24%) patients started the treatment with a standard dose of 1000 mg every 12 hours. In first determinations, 27 (52.94%) were under-therapeutic and 20 (42.55%) were overdosed. After modifying the dosage regimen, 35 (74.47%) were in range, 3 (6.38%) under-therapeutic and 13 (27.66%) supra-therapeutic.
In case of amikacin, 17 (85%) patients started with a standard dose (1000 mg every 24 hours) achieving target levels only in one case. All were under-therapeutic. After modifying the dosage regimen, we achieved the objective in all of them.
For voriconazole 3 patients were monitored. In 10 (43.5%) determinations, a change in dosage regimen was suggested due to subtherapeutic levels. All (100%) of the recommendations given by the PS were accepted.

What next?

The implementation of the unit in our hospital shows the usefulness and the need to extend pharmacokinetic monitoring to other medical services and drugs.

MEDICATION REGIMEN COMPLEXITY INDEX AMONG SOLID ORGAN TRANSPLANT PATIENTS

European Statement

Clinical Pharmacy Services

Author(s)

Andrea Costa-Navarro, Emilio Monte-Boquet, Mª Jesus Cuellar-Monreal, Ana Garcia-Robles, Eduardo Guerrero-Hurtado, Alejandra Ferrada-Gasco, Octavio Ballesta-Lopez, Andres Cruz-Sanchez, Jose Luis Poveda-Andres

Why was it done?

Complex medication regimens (MR) are associated with worse treatment adherence. The Medication Regimen Complexity Index (MRCI) is a validated tool used to quantify complexity of MR and it is the sum of the score in three sections: Dosage forms (A), dosing frequency (B) and additional directions (C).

What was done?

To assess the relative MR complexity among solid organ transplant patients (SOT; kidney, heart, lung and liver) in a tertiary hospital through the validated MRCI Spanish version.

How was it done?

Transplant patients who collected medication in the Hospital Pharmacy between January and March 2021 were selected. A total amount of 40 patients (ten per transplant) were chosen randomly through Excel®, and a macro with a template of MCRI was created. The qualitative variables were age, sex and type of transplant; the quantitative ones were months from transplant, total amount of medications, sections A, B, C and total MRCI. All prescribed medications documented in medical records at the hospital ambulatory clinics and the electronic medication list were included. Patients were excluded if they were followed-up in other hospitals, were exitus or MR dosage or frequency was missed/unclear. Subgroup analyses was made to assess MRCI among type of transplants through ANOVA. All data analysis were made with SPSS® version 23, with a <0,05 significance level and a confidence interval of 95%.

What has been achieved?

Sample median age was 56,6±14,7 years (95%CI:51,9-61,3), a 40%(16/40) were women, median of time from trasplant was 92,7±69,9 months (95%CI:70,4-115,0) and number of medications 11,1±4,6 (95%CI:9,6-12,6). Subgroup median MCRI were 23,3±10,2 (kidney; [95%CI:16,0-30,5]), 46,2±12,8 (lung; [95%CI:37,1-55,3]), 28,5±11,1 (heart; [95%CI:20,6-36,4]) and 18,7±5,4 (liver; [95%CI:14,8-22,5]). Section B was the most contributor to MCRI (16,6±8,2 [95%CI:14,0-19,2]), followed by C (6,6±4,3 [95%CI:5,2-7,9]) and A (5,7±3,7 [95%CI:4,5-6,9]). Tukey test showed a statistically significant MCRI in lung transplant with p<0,001 when compared to kidney and liver transplants, and p=0,002 compared to heart transplant.

What next?

Medication regiment of our sample was more complex in lung patients than in any other SOT, therefore these patients could benefit more pharmaceutical interventions. Further studies with bigger samples are required to confirm differences among kidney, liver and heart transplants.

Formation and empowerment for pharmaceutical interview focused on opioids in acute non-cancerous pain

European Statement

Clinical Pharmacy Services

Author(s)

Esteban CHAUMET, Johanna RAYMOND, Eric BARAT, Catherine CHENAILLER, Rémi VARIN

Why was it done?

A clinical study, including a PI focused on the management of acute non-cancerous pain with opioids, was implemented in post-emergency units of our teaching hospital. Formation and empowerment procedures for PIs are little or not described in the literature. Given the multiplicity of actors, which could perform those PIs, it appeared necessary to standardize our practices and key messages delivered to the patient.

What was done?

Create an adapted formation allowing standardization of practices between various actors performing a pharmaceutical interview (PI) focused on the management of acute non-cancerous pain with opioids.

How was it done?

Creation of different tools : a resource pack with opioids literature to train learners; a theoretical and practical formation schedule and an empowerment procedure, supervised by a qualified tutor; an interview frame with topics to be addressed during the PI; two audio simulations of patient interviews; complex questions that the patient might ask during the PI.

What has been achieved?

The resource pack contains 11 documents that provide the learner with relevant concepts and the key messages to deliver to patients. The formation schedule consists of several stages. Firstly, theoretical formation : learning with the resource pack; written restitution of knowledge on the interview frame and identification of the points to be improved with the tutor; completion of the e-learning on performing a PI (currently being created by the French Society of Clinical Pharmacy); listening to the two audio simulations and oral restitution of information to the tutor; restitution by the learner, during a reversed class, of knowledge on opioids and key messages for the patient; answering complex questions. The practical formation consists of observing the tutor during a PI, then performing PIs with a qualified tutor.

What next?

The formation and empowerment will be implemented in November 2021. As part of a quality approach, learner’s satisfaction and general appreciation will be collected in order to optimise the formation. The creation of this procedure will guarantee a uniform, complete and modern formation based on a quality system thus minimising the biases induced by the multiplicity of actors performing the PIs. In the future, this formation schedule and empowerment could be adapted to other PI topics.

Dose a clinical pharmacy service in emergency department improve the safety of eldery patient ?

European Statement

Clinical Pharmacy Services

Author(s)

Ugo CARRERE, Charles-Henri BLANCHER, Julien ARCIZET, Serge BENETEAUD, Caroline ALLIX-BEGUEC, Benoit LE FRANC

Why was it done?

EDs are the main entry point for hospitalizations. Medication errors are a major threat to patients safety. They are exacerbated by the high flow of patient admitted, the increase in polypharmacy in eldery patients, lack of knowledge of medication and time constraints.

What was done?

We have implemented proactive medication reconciliations (MR) for eldery patients in our emergency department (ED). Retroactive MR was performed in downstream departments (DD) for similar patients. Goals were to save physicians’ and nurses’ times, to improve patient safety.

How was it done?

A pharmacist provided MR in the ED unit three half-days per week. In agreement with the emergency physicians, we targeted patients aged 75 years and over and/or 65 years and over with multiple medications remained hospitalized. Pharmacists collected patients’ medication history and shared the information to ED prescribers. The drug assessment was recorded in a prescription support software. Prescribers, in the DD, could use it to prescribed without transcription and save time.
Our study was based on the comparison of the two groups : the proactive MR group in the ED and the control group with retroactive MR in downstream departements. Discrepancies were recorded and rated as intentional and unintentional in the two groups.

What has been achieved?

Between February and April 2021, 139 medication reconciliations were performed (proactive group n=61 ; retroactive group n=78). The age (about 83 years) and mean number of drugs per patient (about seven) of the two groups were not statistiquely different. We observed a statistically significant reduction in the number of unintentional discrepancies with proactive reconciliation in the ED (7% in the proactive group versus 20% in the retroactive group, p-value = 0.0034). Drugs for the nervous system and the cardiovascular system were the most affected by discrepancies. These discrepancies were mainly detected in prescriptions for patients taken care in the orthopedic surgery, the hepato-gastrology and the polyvalent medicine departments.

What next?

Clinical, economic and organizational scoring of unintentional discrepancies will be performed by a physician-pharmacist pair (CLEO scale of the French Society of Clinical Pharmacy)
Downstream departments with the most UD will be encouraged to use medication reconciliation.
A satisfaction survey will be conducted among the teams.

Implementation of a telepharmacy service in outpatient’s pharmaceutical consultation

European Statement

Clinical Pharmacy Services

Author(s)

QUERALT LOPEZ NOGUERA, ÀNGELA CASTELLÓ NÒRIA, CRISTINA DIEZ VALLEJO, LAURA VIÑAS SAGUÉ, MARTA COMA PUNSET, SILVIA CABARROCAS DURAN, MIREIA VILA CURRIUS, ANNA DORDÀ BENITO, EDUARDO TEJEDOR TEJADA, CRISTINA TORO BLANCH, ROSA NURIA ALEIXANDRE CERAROLS, ROSA SACREST GÜELL

Why was it done?

The declaration of the state of emergency by SARS-CoV-2 pandemic on March of 2020 had an impact on hospital PC.
During that period, it was advised by Healthcare Authorisations to minimize the risk of infection or spread of SARS-CoV-2 in order to protect vulnerable groups. For that reason, it was not recommended to assist in the hospital if it was not necessary. This fact caused some organizational changes in OPC to adapt to the current situation.

What was done?

Our hospital Pharmacy Department created a telepharmacy service in outpatient’s pharmaceutical consultation (OPC) after state of emergency declaration by SARS-CoV-2. We created a standard operating procedure working together with communitarian pharmacists and the Region Pharmacist’s College. The main aim was to ensure pharmaceutical care (PC) quality in vulnerable patients and the correct medication distribution and conservation. Pharmaceutical care was developed by telephone call and medication was send to communitarian pharmacy.
A comprehensive analysis was made to concern the impact on drugs delivery selecting certified distribution company which ensured drug traceability, custody and conservation.

How was it done?

In 2020, approximately 60 patients per day used to attend in OPC. According to the large number of patients, we defined which patients could take advantage of this programme. The selection criteria were adherent patients with pulmonary pathologies (cystic fibrosis, asthma, bronchiectasis, etc.), multiple sclerosis, amyotrophic lateral sclerosis, reduced mobility or patients over 65 years old who lived in more than 30km closed to the hospital or without any family member that could come.
In order to ensure the process traceability, an informatics tool has been created by Region Pharmacist’s College. Pharmacy Department, community pharmacy and the distribution company assumed all expenses.

What has been achieved?

369 of 2.346 patients were included in our telepharmacy service during the state of emergency. There was high level of acceptance by all patients. Only low-risk patients or patients who had an on-site doctor visit were attends in OPC. Nowadays, 196 patients still benefit from the initiative.

What next?

Telepharmacy program avoids patient’s displacements that are particularly susceptible to COVID-19 negatives effects. Moreover, it guarantees PC quality, patient’s adherence, process traceability and correct medication conservation from hospital to patient’s home.

Pharmaceutical Consultation in Primary Care Multidisciplinar Team

European Statement

Clinical Pharmacy Services

Author(s)

Claudia Elias, Nadine Ribeiro, Anacleto Mariana, Amaral Daniel, Cimadeira Fátima, Abreu Ana Paula, Vaz Filomena, Martinho Helena , Bernardo Mónica , Mateus Rita , Martins Sandra

Why was it done?

The care of elderly patients with multi-morbidities is a great challenge faced by the our National HealthCare System, due to the complexity of the most vulnerable in society. When the medication risks begin to outweigh benefits, polypharmacy may become inappropriate. Management of polypharmacy is an essential element of patient safety and adherence, preventing medicines harm and infectivity. In the primary care setting there was no integrated multidisciplinary pharmacotherapy management service.

What was done?

Clinical Pharmacist was included in multidisciplinary team in Primary Care for Pharmaceutical Consultation implementation.

How was it done?

The Pharmacy Department and of the Regional Team, supported by the Board of Directors, joined efforts for the implementation of a Program for the Management of Polymedication in Complex and Chronic Fragile. It implies patients with medication problems referral by physicians to the pharmacist. Pharmacist schedules a face-to-face, or telephone, interview, inviting them to bring all drug packages. During consultation, patient’s health literacy, therapeutic adherence and drug management skills are assessed. Doubts are clarified and information on drugs best use and non-pharmacological measures benefits are provided. The pharmacist then makes the pharmacotherapeutic review looking up for any unaddressed medication related problem. In conjunction with the attending physician, they agree in the best pharmacotherapeutic plan for the patient.

What has been achieved?

The project started 2.5 years ago, being implemented in four primary care units. We had 124 patient referrals and made 171 consultations. Before Covid pandemic, all the contacts were face-to-face now 60% are teleconsultation. The median age is 76 years, 59% female with an average of 11 comorbidities and 11 medicines prescribed/patient, being cardiovascular and endocrine pathologies the most commons. Only 33% of patients took medicines has prescribed and of them, only 61% could identify their indication. The most prevalent drug problems were safety (42%) and need (25%). Off the 539 interventions, 48% addressed desprescription, drug substitution and dose adjustment by physicians; 14,3% aimed drug education use by patients or caregivers; 88% of the suggested interventions were accepted.

What next?

We expect to expand the project to other health care units briefly.
Even though the inclusion of a clinical pharmacist in primary care units is currently centered in the management of polypharmacy, it may encourage involvement in other activities that enhance the pharmacist role in the primary care units.

Development of a clinical pharmacy program for very frail elderly hospitalized patients

European Statement

Clinical Pharmacy Services

Author(s)

Baptiste Fulbert, Florian Poncelet, Marilyne Legrand, Céline Mongaret, Dominique Hettler

Why was it done?

Very frail elderly patients are a particularly high-risk population due to their frequent multi-medication and the risk of associated adverse effects.
Clinical hospital pharmacists play an increasingly important role in patient care.

What was done?

We developed a program comprising several clinical pharmacy services for very frail elderly hospitalization.

How was it done?

We conducted a 3 month prospective study in short and middle geriatric stay included patients admitted in emergency department aged at least 75 with a Short Emergency Geriatric Assessment (SEGA) frailty score above 11. We performed, as clinical pharmacy services, best possible medication history (BPMH) in the emergency department and medication reconciliation at admission (MRA) in hospital ward and medication review during hospitalization. Medication reconciliation at discharge (MRD) was carried out on a geriatric medicine unit over 2 months. All activities were performed by pharmacy students, two residents and a pharmacist.

What has been achieved?

120 patients were included. 96 BPMHs were performed : 62 in emergency department and 34 in hospital ward.
MRA was performed for 81 patients (68%), identifying 774 discrepancies of which 19 (3%) were unintentional discrepancies (UD), 6 (32%) involving Digestive Tract and Metabolism drugs. 9 (47%) of these UDs concerned omissions.
During the 163 medication reviews, pharmacist performed 98 pharmaceutical interventions (PIs) for 53 patients, with an acceptance rate of 56%. Most of drugs involved with the acceptance rate was Nervous System drugs (20;36%) and Digestive Tract and Metabolism drugs (16;29%). Among the accepted PIs, 22 (40%) relate to dosage adjustment.
Finally, MRD was performed for 25 (21%) of patients identifying 256 discrepancies, 8 of which (3%) were UDs, mainly involving Digestive Tract and Metabolism drugs (5;63%). 5 (63%) of these UDs concern omissions.

What next?

The high number and nature of the discrepancies support the idea that this population is a relevant target for a clinical pharmacy program.
This program could be applied in other hospitals with the hospital pharmacists and provide a better care for these patients.
The development of MRD in geriatric wards and collaboration between hospital pharmacists and primary care professionnals, by a discharge summary to handover the changes between the entry and the exit prescription can complete this study.

ORAL IVERMECTIN EFFECTIVENESS IN THE TREATMENT OF PERMETRIN-RESISTANT SCABIOSIS: A DESCRIPTIVE, RETROSPECTIVE AND OBSERVATIONAL STUDY

European Statement

Clinical Pharmacy Services

Author(s)

Emilio Monte-Boquet, Mª Jesus Cuellar-Monreal, Mª Vicenta Tarazona-Casany, Ana Alejandra Garcia-Robles, Eduardo Guerrero-Hurtado, Inmaculada Beltran-Garcia, Patricia Polo-Montanero, Antonio Solana-Altabella, Jose Luis Poveda-Andres

Why was it done?

Ivermectin is used as a therapeutic alternative for permethrin-resistant scabies. The recommended treatment consists of administering two single doses (SD) separated by 7-14 days. An increased incidence and resistance to permethrin was observed in late 2020 possibly influenced by SARS-CoV-2 pandemic.

What was done?

To assess the effectiveness of oral ivermectin as a treatment for topical 5% permethrin-resistant scabies in patients from a tertiary hospital and to analyze the characteristics of the sample and the treatment.

How was it done?

An observational, retrospective and descriptive study was done including patients who collected Ivermectin 3mg tablets in the Outpatient Pharmaceutical Care Unit of the hospital between April 2020 and April 2021. All patients were previously treated with 5% permethrin and had failed. Treatment with ivermectin was considered effective in patients who were discharged from Dermatology Clinics or did not consult for itching or other symptoms 4 weeks after the last dose. Other variables were: number of doses received, age, sex and antecedents within family nucleus or cohabiting cases were also collected.

What has been achieved?

A total of 37 patients were included and 39 applications were made. There were 16 applications from April 2020 to December 2020 (mean of 1.78±1.79 applications/month [95%CI:0,41-3,05), and 23 from January to April 2021 (mean of 4,6±2.6 applications/month [95%CI:1,37-7,83]). Ivermectin was effective in 87,2%(34/39) patients and in the remaining 12,8%(5/39) therapeutic failure happened, so they required treatment for a second time. A patient was excluded because it was unclear if treatment had been ineffective or reinfestation happend. The 56,4%(22/39) of patients received two SD separated for 7–14 days. The 58,5%(24/39) of patients were women and the mean age of the sample was 31,1±19,3 years old (95%CI:26,8-37,4). The 54,0%(21/39) of the patients had between 11-30 years old, and the 74,4%(29/39) had a history or cohabitants within their family nucleus.

What next?

In our study sample, effectiveness of Ivermectin was greater than 90% in scabies resistant to topical 5% permethrin and seems independent of the number of doses received. Results suggest that scabies mainly affects women and Young people. Infections in cohabitants seem to have an increased frequence and may had been influenced by confinament and delays of treatments during SARS-CoV-2 pandemic.

Pharmacogenetic variation and the importance for medication treatment in patients at a Geriatric Psychiatry Unit

European Statement

Patient Safety and Quality Assurance

Author(s)

Margareth Kristiansen, Viola Melvik, Jahn Olav Svartsund, Randi Trondsen, Lise Nystad

Why was it done?

Patients admitted to the unit often have long-term illnesses, extensive medication histories and lengthy medication lists at admission. Psychopharmaceuticals are largely metabolized by enzymes that have polymorphism. We wanted to investigate the degree of pharmacogenetic variation in our patients and if genetic testing would have an impact on medication treatment.

What was done?

We have investigated the degree of genetic variation in our patients and to what extent the genetic profile impacted the choice of medication treatment.

How was it done?

We started out educating the staff at the ward. In 2018, 37 of a total 40 admitted patients were genetically tested at admission. The implication of the test result was discussed during the morning rounds for each patient ensuring implementation.
Results from each genetic test were continuously entered into a database including age, gender and medications at admission and discharge. Change of medication due to the genetic test result was recorded.
26 (70%) of patients had a genetic profile that could impact the choice of medication treatment. As a result, half of the patients had changes made to their medications. A total of 27 changes were made in these patients.

What has been achieved?

We have established that patients at the geriatric psychiatry unit in Nordland Hospital Trust have a pharmacogenetic profile that affects medication treatment options. Testing has an impact on the choice of pharmacotherapy to such an extent that all patients are now genetically tested at admission.

What next?

Pharmacogenetic testing has proven easy to implement and at the same time of substantial benefit for many patients. We also use our experiences to educate and inspire health care professionals in the community setting including GP’s so they can understand, reuse the test results and identify when a pharmacogenetic test would be a useful tool to determine the most adequate choice of pharmacotherapy.

EXPANDING OPPORTUNITIES FOR PHARMACISTS IN ONCO-HEMATOLOGIC CLINICAL TRIALS: DESIGN AND IMPLEMENTATION OF THE OUTPATIENT SERVICE MODEL

European Statement

Clinical Pharmacy Services

Author(s)

Eugenia Serramontmany Morante, Patricia Garcia Ortega, Lorena Garcia Basas, Pablo Latorre Garcia, Pilar Rovira Torres, Laura Maños Pujol, Isabel Cidoncha Muñoz, M. Queralt Gorgas Torner

Why was it done?

The provision of outpatient oncology services by pharmacists is still limited, but it is an emerging role. It can add value while increasing the quality of patient care required, maximizing the likelihood of achieving positive outcomes and thus improving the patient’s quality of life. It is important to incorporate clinical pharmacists into outpatient clinics to ensure the safe use of investigational drugs and guarantee the best treatment for the patient.

What was done?

The oncology clinical trials pharmacy team initiated an outpatient clinic at a tertiary hospital. This enabled review of patients’ medications, monitoring of interactions, appropriate oral chemotherapy counseling, design of medication diaries and instructions, discussion of side effects, as well as other dietary and daily living recommendations.

How was it done?

A multidisciplinary team was formed: pharmacy, medical, nursing, ancillary and administrative staff, to discuss circuits and strategies to address outpatient pharmacy clinic.
The pharmaceutical care program was implemented gradually during 6 months, first in phase I, then phases II and III clinical trials.
Factors including appointment scheduling, patient prioritization, clinic room availability as well as detailed definition of pharmaceutical activity were discussed, in order to have a standard procedure for all patients included in a clinical trial.
The group continued to meet weekly to further discuss the progress of the pharmaceutical care program and any obstacles and unforeseen events.

What has been achieved?

Medication has been dispensed to 8447 patients in the outpatient pharmacy, of which 1172 patients have been attended by the clinical pharmacist during the first 8 months (January-August 2021) of the programme’s implementation.
Pharmaceutical care at the first day of treatment has been provided to 275 patients to explain how to take the treatment and resolve doubts. The concomitant medication of 312 patients has been reviewed for the screening and 425 telephone queries about concomitant medication have been resolved.

What next?

The evolutionary change in cancer care along with the increase in the number of clinical trials and its complexity will emphasize the need to include the oncology pharmacist in the cancer care team. The role of a clinical pharmacist is vital to ensure the safety and controlled use of the drug, ensuring the best possible outcomes.

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