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.
Integration of clinical trials management into a safe and fully-automated onco-haematology workflow
Pdf
European Statement
Production and Compounding
Author(s)
FRANCESCA VAGNONI, ANDREA MARINOZZI, SABRINA GUGLIELMI, CHIARA CAPONE, FRANCESCA MURA, ADRIANA POMPILIO, SIMONE LEONI
Why was it done?
The management of CT requires thorough documentary evidence and well-organized reporting system in compliance with the Good Clinical Practice. Since 2009, the entire onco-haematology workflow is fully-controlled by information technology devices and robotic systems to prevent medication errors and guarantee data integrity. The implementation of APOTECAtrial was aimed to extend the same level of control to CTs.
What was done?
In 2018, a clinical trial (CT) managing system (APOTECAtrial) was integrated into the existing fully-automated workflow of the chemotherapy production unit. APOTECAtrial was developed to enable real-time visualization of CT-related data and trace the processing of investigational (IMP) and non-investigational (NIMP) medical products, such as delivery, assignment, preparation, return, and disposal.
How was it done?
A team of hospital pharmacists, physicians, clinical data managers, and IT specialists analysed the CT workflow and defined the system specifications. Data related to IMP/NIMPs (both for parenteral and oral administration), patients enrolled, and investigator/sponsor affiliations were entered into APOTECAtrial and sorted by CT. The onco-haematology unit’s electronic prescribing system was bidirectionally interfaced with APOTECAtrial. Aseptic preparation of patient-specific injectable therapies was implemented in the supporting device for manual preparation that checks dosage accuracy and identity by photographic and barcode recognition.
What has been achieved?
Since 2018, the overall number of CTs managed was 95. In total, 81 IMPs/NIMPs and 135 patients were entered into the system, while 2740 injectable therapies were prepared, 690 oral medications and 60 pre-filled syringes delivered. The following major objectives were achieved: automated inventory accounting and stock management, reduced manual time-consuming activities (i.e. documentation, transcription), standardized reports in digital not-editable format, and full traceability. In addition, audit trail tool tracks all user edits and changes performed at any stages of the CT management by electronically recording user’s name, date, and time. APOTECAtrial was evaluated by clinical research associates (CRA), clinical research organizations (CRO) and CT sponsors and approved for use in the daily clinical practice.
What next?
The project represents a good example of multidisciplinary collaboration focused on improving the quality of the processes in healthcare settings. The implementation of information technology and automation ensures improved data integrity, safety, and working efficiency, which are key determinants for managing CTs in hospital pharmacies.
HOSPITAL PHARMACY CONTRIBUTION TO CLINICAL TRIALS: TYPIFICATION OF MEDICATION INCIDENTS AND PHARMACEUTICAL INTERVENTIONS IN A CLINICAL TRIAL UNIT
Pdf
European Statement
Patient Safety and Quality Assurance
Author(s)
Paula Arrabal-Durán, Carmen Herrero-Domínguez-Berrueta, María Norberta Sánchez-Fresneda, Ana Mur-Mur, Ana Herranz-Alonso, María Sanjurjo-Sáez
Why was it done?
MI and PI are normally recorded in Hospital Pharmacy Services as a method for evaluating safety. Nevertheless, classical methods for reporting MI do not allow for a correct classification in the field of clinical trials. The reason is their more complex processes involving drugs compared to the processes in daily clinical practice. If there are no specific categories, the information obtained by recording usually gets lost and could not reflect exactly what occurred. In September 2016, a clinical tool to notify MI and PI was implemented in the Pharmacy Service, with the aim of unifying their classification criteria and gathering complete information for analysis and further implementation of improvement measures.
What was done?
A database to notify medication incidents (MI) and pharmaceutical interventions (PI) in the Clinical Trials Unit was developed in the Pharmacy Service of a tertiary hospital.
How was it done?
All the processes involving drugs in clinical trials were evaluated by a Failure Mode and Effects Analysis (FMEA). For each process, the possible incidents and their resulting effects on the patient were recorded. After that, a database was designed in Microsoft® Access with defined lists of choices to allow pharmacists notify both MI and PI that occur in the Clinical Trials Unit.
What has been achieved?
A database with the following information has been implemented:
a) Identification of the MI:
1. Date of the MI.
2. Number of patient.
3. Clinical Trial protocol.
4. Investigational product.
b) Process in which the MI took place (16 options).
c) Process in which the MI was detected (16 options).
d) Process that caused the MI (24 options).
e) Person who detected the MI (9 options).
f) Did any PI take place? (Yes/No).
g) PI performed (12 options).
h) Did the MI reach the patient? (Yes/No).
i) MI that reached the patient (21 options).
j) Patient outcome (8 options).
k) Effect in the clinical trial (4 options).
What next?
The implemented notification system will be further expanded and adapted over time.
Future aim is to analyse MI for establishing improvement measures and checking their results.