IMPLEMENTATION OF A MULTIDISCIPLINARY PHARMACOKINETIC-PHARMACOGENETIC UNIT
European Statement
Clinical Pharmacy Services
Author(s)
Jose Luis Sánchez Serrano, Ana Valladolid Walsh, Andrea Drodz Vergara, Carolina Andrés Fernández, Laura Navarro Casado
Why was it done?
Due to a reorganization of health professionals in our hospital, we identified an opportunity to include in our clinical services the preparation of pharmacokinetic reports for all drugs for which blood levels were carried out both at the hospital and external laboratories.
What was done?
We have implemented a multidisciplinary pharmacokinetic-pharmacogenetic unit with the Laboratory Department in our hospital. Until the end of 2023 we participated in the preparation of pharmacokinetic reports for a limited number of drugs in inpatients, basically in haematological and critical patientes. After this, we have included this clinical service for all drugs for which levels were carried out at the hospitalization and outpatient level.
How was it done?
The first step was to present a joint project to the hospital management to reorganize this activity and meet with medical departments to identify their needs and areas of improvement.
At the same time we acquired and implemented a specific software to assist us with the elaboration of recommendations.
We included training sessions in pharmacokinetics for pharmacists in the Pharmacy Department´s annual training program, in addition to offering an external course on Pharmacogenetics Course for staff pharmacists.
As to the clinical services offered, the project has gone through two stages:
• First stage (1 month duration): We reviewed all requests for drug levels obtained both from hospital and primary care level.
• Second stage (10 months duration): The pharmacist monitors all drug serum levels of narrow therapeutic margin and monoclonal antibodies both at the hospitalization and outpatient level. We have updated the available catalogue of drug serum concentrations tests in our center including Voriconazole, Linezolid, Ustekinumab, Adalimumab and Infliximab.
What has been achieved?
We have improved the whole process from ordering tests to sample extraction, serum level determination, and making recommendations in both inpatients and outpatients.
An average of about 160 pharmaceutical interventions per month are done with a 95% acceptability.
What next?
Our future objectives include updating the available pharmacogenetic testing in this unit in order to include recommendations based on test results.
Meropenem treatment optimisation in patients using PK/PD criteria
Pdf
European Statement
Clinical Pharmacy Services
Author(s)
Marina Rodríguez-Marín, Paula Novo-González
Why was it done?
To optimize and improve patient treatment as well as reduce the risk of multiresistance in the case of broad-spectrum antibiotics.
What was done?
Using Monte Carlo simulation to calculate the probability of treatment success (pTA) in patients receiving meropenem, defined as the percentage of time the drug level is above the minimum inhibitory concentration (MIC). The cumulative fraction of response of the antibiotic meropenem was also measured.
How was it done?
At a hospital in the Community of Madrid, the TDMx pharmacokinetics program was employed by inputting clinical and pharmacokinetic data of patients who had received meropenem between September 15th and October 15th, 2022. The data were extracted from the SELENE electronic medical records system, and both probabilistic dosing and Bayesian dosing were performed using these data. The following information was entered: age, weight, height, antibiotic dose, dosing interval, creatinine level, MIC, and meropenem PK/PD parameter (% of time above MIC).
What has been achieved?
Twenty patients were recruited: 10 women and 10 men, with a median age of 84 years [Q1: 77, Q3: 89] years.
With a dose of 1000 mg every 4 hours, all patients, assuming a PTA of either 50% or 90%, achieved the desired probability of success.
When the PTA was set at 50%, all patients could benefit from the Monte Carlo simulation within the studied intervals. However, when the PTA was set at 90%, a dose of 2000 mg every 1 hour was required in an infusion time interval.
The majority of patients (17 out of 20) were prescribed a dose of 1000 mg every 8 hours.
Except for two patients, most of the MICs were unknown. Since this parameter influences the probability of success, the results obtained are theoretical.
What next?
1- Obtain the minimum inhibitory concentrations (MICs) for all patients using this antibiotic, with the aim of planning the program and providing recommendations.
2- Additionally, gradually implement this approach in other medications
Implementation of a clinical pharmaceutical service for ostomates
Pdf
European Statement
Clinical Pharmacy Services
Author(s)
Iris Summer, Marina Zakhari-Betros, Alice Poier, Christine Fegerl-Stadlober
Why was it done?
There had been reports from healthcare professionals of the presence of undigested tablets in ostomy pouches and reasonable doubts of adequate drug absorption. In addition, there were recurring inquiries from clinicians about drug related problems in ostomy-patients.
What was done?
Implementation of a clinical pharmaceutical service for patients with an intestinal ostomy following their stoma-surgery. In this service, oral drug therapy of patients with either ileostomy or colostomy was assessed to determine whether possible impairment of drug liberation or absorption could lead to malabsorption of drug therapy.
How was it done?
A project was conducted, where 30 ileostomy and colostomy patients were observed. Simultaneously, a literature review concerning all orally administered drugs of this patient collective was done. During the project time, two interviews were done with the patients. The first one was lead during hospitalisation whereas the second one was conducted within 4 weeks after hospital discharge. To standardise the interviews, two different questionnaires were developed. Medical status of the patient as well as pharmacokinetic properties of the drugs administered orally were thus assessed. It was evaluated whether there are any drugs which may feature any impaired drug liberation or absorption. In case of anomalies presented, such as undigested tablets found in the pouch, a plasma level measurement of the drug was done, if reasonable. In addition, the subjective perception of the patients was also taken into account, to measure whether malabsorption of drugs is recognised or not and if patients are aware of possible impairment of absorption.
What has been achieved?
A strategy was established to help healthcare professionals assess oral drug therapy in ostomates. In addition, awareness in healthcare professionals as well as patients was raised, concerning possible impaired drug liberation because of the use of inappropriate dosage drug form. Moreover, prevention of prospective drug related complications was also achieved.
What next?
1. Modification of our electronic medical record concerning automated pharmaceutical counselling.
2. Integration of a clinical pharmaceutical service within the ostomy care service of our hospital to provide better therapeutic outcome, especially when ostomy-related problems are presented.
3. Providing patient information leaflets to improve health literacy and patient satisfaction.
Implementation of a clinical pharmacokinetics unit in a third-level hospital
Pdf
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.
SIMULATION CURVES MAY HELP TO ASSESS ANTIBIOTICS ORALISATION PROCEDURES (submitted in 2019)
European Statement
Clinical Pharmacy Services
Author(s)
Andreas von Ameln-Mayerhofer, Martin Breuling, Ina Geist
Why was it done?
In the context of antibiotic stewardship, rapid oralisation of a parenteral antibiotic is recommended in many antibiotic stewardship guidelines. Such a sequence therapy is easy to implement if both application pathways lead to comparable efficacy levels at the site of infection. However, this does not apply to all anti-infectives, in particular some beta-lactam antibiotics represent a challenge in therapy. Additionally, the information about this topic is very sparse in the literature.
What was done?
In order to achieve an improvement in antimicrobial prescriptions, we have addressed possible problems regarding oralisation of antibiotics. For this purpose, we graphically compared the simulated efficacy levels of parenteral and oral forms of beta-lactams.
How was it done?
We programmed a computer based procedure that allows a simulation of plasma levels of antibiotics upon intravenous versus oral administration. Based on the obtained data and EUCAST-based MIC-distributions for a set of bacteria, we assessed the respective putative clinical actions.
What has been achieved?
Our simulations show that some oral beta-lactams do not reach the PK/PD condition of a sufficient therapy (fT>MHK) in the approved dosage. The simulations have been used for education seminars with physicians and partly led to an improvement in oralisation procedures. Additionally, an oralisation standard has been established.
What next?
Our next step is to develop a special prescription form for oral antibiotics which will enable us to control prescription behaviour even more effectively. We plan to monitor the prescription habits for anti-infectives more closely before and after establishing the prescription form.