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DETECTION OF PHARMACOKINETIC/PHARMACODYNAMIC DRUG INTERACTIONS OR PATHOPHYSIOLOGICAL CONTRAINDICATIONS WITH INJECTABLE CHEMOTHERAPIES: IMPLEMENTATION OF THE SOFTWARE PHARMACLASS® IN ONCOLOGY

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European Statement

Clinical Pharmacy Services

Author(s)

Pauline Barreau, Joséphine Courouble, Pierre Pilven, David Vandecapelle, Thibault Stala, Geoffrey Strobbe, Guillaume Marliot, Frédéric Feutry

Why was it done?

Two prescription assistance software are using in the hospital: DXCare®, for global drug management, and Chimio®, specific to the prescription and preparation of injectable chemotherapies. Clinical pharmacists (DXCare®) and pharmacists in charge of preparation (Chimio®) carry out the pharmaceutical analysis independently and they may not detect potential pharmacokinetics/pharmacodynamics drugs interactions or pathophysiological contraindications, slowing down the pharmaceutical analysis. Pharmaclass® can improve that by crossing all data flows between DXCare® and Chimio® and alerting the pharmacist. The objective were to select and code priority alerts and evaluate the detectability of drugs interactions and pathophysiological contraindications by the software Pharmaclass®.

What was done?

Pharmaclass® is a software based on rules created by the pharmacist, from pharmaceutical algorithms. This rules engine crosses in real time all data flows of several software and sends alerts that must be analyzed by a pharmacist. It was applied in oncology for injectable chemotherapies.

How was it done?

An interface was set up between DXCare®/Chimio® and Pharmaclass® to allow the creation of requests. An analysis of drug consumptions and drugs at risk of interactions helped to select seven molecules (Methotrexate, Bevacizumab, Fluorouracil, Ifosfamide, Irinotecan, Cisplatin, Pemetrexed). A study of the summaries of the product characteristics and the drug interaction thesaurus and a bibliography was conducted and the rules were coded. These were checked by creating test patients with false prescriptions.

What has been achieved?

Eleven rules were created and, after some tests and coding readjustments, all was detected. Nine rules are about drugs interactions: three contraindications (Methotrexate/Trimethoprim, Methotrexate/Acetylsalicylic acid, Bevacizumab/Naloxegol), three associations not recommended (Methotrexate/Amoxicillin, Methotrexate/Ciprofloxacin, Fluorouracil/Antivitamin K), one precaution of use (Ifosfamide/Aprepitant) and two other rules concern enzymatic induction and inhibition of the metabolism of Irinotecan. The last two rules link the glomerular filtration rate with Cisplatin and Pemetrexed.

What next?

Following these creations, Pharmaclass® has allowed to detect drug interactions and pathophysiological contraindications that were not previously detectable. Thereafter, objective will be to establish an organization for the management of alerts and evaluate the number and the relevance of these alerts. New rules will be created for all injectable chemotherapies used in the hospital. Other center of Unicancer will be able to use these rules.

COMPUTERIZED QUALITY CONTROL OF THE TABLET SPLITTING PROCESS

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European Statement

Production and Compounding

Author(s)

María Lourdes Recio Blázquez, Alberto Pérez Morales

Why was it done?

It was necessary to establish a quality control of this pharmaceutical process.

What was done?

A computer method of gravimetric quality control of the tablet splitting process was designed.

How was it done?

The procedure consists on a precision scale connected to a computer in which, according to the uniformity of mass assay of the European Pharmacopoeia, the weights of 20% of a batch of whole tablets destined to be split are automatically recorded in a spreadsheet, carrying out the following formulas:
=AVERAGE: provides the average weight of the sample of whole tablets.
=MAX and =MIN: selects respectively the largest and the smallest of the weights.
=STDEV: calculates the standard deviation of the sample weights.
With the average weight of the whole tablets, the theoretical weight of the half-tablets is calculated, establishing a maximum and a minimum admissible limit with the following formulas:
=AVERAGE(whole tablets)/2: determines the theoretical average weight of each half-tablet.
=AVERAGE(whole tablets)/2 ± 7.5%: establishes upper and lower gravimetric limits that cannot be exceeded by any half-tablet.
All the half-tablets need to be weighted, as the tablet-splitting process is carried out tablet-by-tablet and this modus operandi is not reproducible enough. In case of non-compliance with maximum and minimum weight criteria, the half-tablet must be discarded.
Conditional functions were established such that the spreadsheet itself reflects the half-tablet acceptance/rejection decision.
Basic technical computer skills, training in the technique of tablet splitting, appropriate clothing and environmental measures to avoid risks to the operator and the medications are required.

What has been achieved?

Since 2015, two different medicinal products were subjected to the tablet splitting technique. A total of 10,536 halves of suitable tablets were obtained, which permitted safe dosing at lower doses than commercialized, and also generated a financial asset of 101,724 Euros. 566 halves were discarded. The splitting efficiency was of 94.9%.

What next?

This quality control procedure is applicable to all divisible solid oral dosage forms. The standardization of the technique and the quality controls will allow to extend it to other medicinal products with dosing and economic purposes.

INTEGRATION OF THE PHARMACEUTICAL CARE RECORD INTO THE MULTIDISCIPLINARY ELECTRONIC OUTPATIENT RECORD

European Statement

Patient Safety and Quality Assurance

Why was it done?

So far, only pharmacists could access the pharmaceutical care record. The creation of the electronic medical record in the Health System has allowed patient data to be centralised and can be accessed easily and quickly. It is an opportunity to integrate our care service as pharmacists within the multidisciplinary care as well as to facilitate data consultation to other professionals that care for the same patient.

What was done?

Integrate the outpatient pharmaceutical care record to the electronic patient record via an application form included in the process of each pathology.

How was it done?

First question was where the application form should be included when the patient came in for a consultation. In order to unify all the actions relating to the process, it was decided to include the form in the main process instead of creating a specific process for the pharmacy department. For example, a form for an HIV patient should be included in his Infectious Disease Consult process.

Another issue was to define what items should be taken into account for the follow up.

Finally, the following items were included: reason for the visit, pathology, clinical data, outpatient treatment, regular treatment, drug-related problems, adverse drug allergies/past issues, adherence, checks to mark whether the patient has received the oral and written information, the leaflet from the host to the Outpatient Pharmacy Service and a free text to write down given recommendations.

What has been achieved?

Improvement of patient care, increased safety in the use of drugs and in the avoidance of medical errors has all been achieved, as well as the promotion of teamwork amongst professionals who attend to the patient. From the information technology perspective, data export can be provided for future researches.

What next?

All professionals should integrate their activities to take advantage of collaboration and increasing synergies.

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