The EAHP Board, elected for three-year terms, oversees the association’s activities. Comprising directors responsible for core functions, it meets regularly to implement strategic goals. Supported by EAHP staff, the Board controls finances, coordinates congress organization, and ensures compliance with statutes and codes of conduct.
Assesing cold chain compliance for biotherapy drugs in a university hospital’s medical departments
European Statement
Patient Safety and Quality Assurance
Author(s)
AMINE BAYEN, OUMAIMA KHARKHACH, HICHAM EL HORR, LHOUSSAIN ZARAYBY, SANAE DERFOUFI
Why was it done?
It has been observed that within the gastroenterology, neurology, internal medicine, rheumatology, and dermatology departments, there exist inconsistencies and disparities. These include extended transportation times averaging 8 minutes, a lack of isothermal bags for transportation, and refrigerators not connected to the main hospital generator.
Strict adherence to storage guidelines is crucial, as any breach in the cold chain could compromise the drug’s therapeutic effectiveness, increase the risk of adverse effects, and lead to significant financial losses for healthcare institutions.
What was done?
Ensuring optimal storage and transportation conditions for biotherapy drugs in various medical departments within a university hospital by assessing and improving cold chain compliance.
How was it done?
Implemented corrective actions and recommendations have been primarily directed towards minimizing transportation duration and procuring thermal bags for all departments handling biotherapy products. These initiatives encompass enhancing staff awareness in the cold chain process through sensitization campaigns and regularly evaluating refrigerator temperatures. Moreover, a strategic plan is underway to establish their connectivity to the generator system in the near term.
What has been achieved?
A notable reduction in the transportation time of biotherapeutic drugs has been achieved, decreasing the average duration from 8 minutes to 6 minutes. Additionally, the widespread adoption of thermal bags across audited departments has substantially bolstered the stability of biotherapeutic drugs, mitigating temperature fluctuations and enhancing patient safety. Moreover, our efforts in sensitising medical and pharmaceutical staff within these departments have yielded a significant increase in awareness and adherence to stringent cold chain protocols.
What next?
The inconsistencies and disparities identified during the assessment of the biotherapy drug cold chain within our hospital suggest a potential lack of adherence to procedural standards. This situation poses a considerable risk to patient safety, warranting further investigation and action.
Our focus will extend beyond the cold chain assessment to evaluate other pharmaceutical procedures. Specifically, we will investigate the adherence to autoclave sterility cycles for medical devices and the robustness of the preparation process for oncology medicines.
DEVELOPMENT OF A PROTOCOL TO STANDARDISE CELL-BASED MEDICINAL PRODUCTS HANDLING IN AN ONCO-HAEMATOLOGY CLINICAL TRIALS UNIT
European Statement
Patient Safety and Quality Assurance
Author(s)
JOSE MANUEL DEL RIO GUTIERREZ, EUGENIA SERRAMONTMANY MORANTE, SARA GIMENEZ GINER, PILAR ROVIRA TORRES, PATRICIA GARCIA ORTEGA, CARLOTA VARON GALCERA, ISABEL CIDONCHA MUÑOZ, MARIA QUERALT GORGAS TORNER
Why was it done?
One of the most important challenges we currently face is the increase of clinical trials (CTs) including CBMPs. These drugs require special storage, preparation, delivery and administration; so developing standard operating procedures (SOPs) and ensuring proper coordination between all professionals involved, including pharmacists, is essential.
What was done?
Management of cell-based medicinal products (CBMPs) was protocolised in an onco-haematology clinical trials unit.
How was it done?
Pharmacists, doctors and nurses participate in a multidisciplinary team to standardise CBMPs handling. The following protocol was agreed:
1.The entire multidisciplinary team is notified when a CBMP prescription is planned to ensure proper coordination.
2.The CBMP is manufactured by the CT sponsor. Then, it is transferred to the blood bank for cryopreservation. CBMPs usually require a temperature between -80ºC and -200ºC and expire in some weeks.
3.Before CBMP administration, patients undergo lymphodepletion. The lymphodepletion regimen is performed according to the CT protocol or arranged between medical and pharmacy teams. Chemotherapy, serum therapy and antiemetic regimen are discussed and specified.
4.Once the treatment is prescribed, it is verified by a pharmacist who ensures its suitability.
5.On the infusion day, the blood bank delivers the CBMP. Then, a pharmacist checks if it arrives in proper condition and it is defrosted. The pharmacy department reconditions the CBMP in another infusion bag or syringe if required. This is the most critical point because CBMP expires after some minutes of defrosting, requiring extensive coordination.
6.CBMP is administered according to the CT protocol.
What has been achieved?
72 patients were recruited in 15 CT. 8 of them use as CBMP Chimeric Antigen Receptor T-Cells (CAR-T-CELLS), 4 Specific Peptide-Enhanced Affinity Receptor T-Cells (SPEAR-T-CELLS), 2 Tumour-Infiltrating Lymphocytes (TILs) and one cytokine-stimulated Natural-Killer-Cells (CS-NK-CELLS). Seven assays are intended for haematological neoplasms and eight for solid malignant neoplasms. One assay requires CBMP syringe reconditioning in the pharmacy department.
The described process optimises CBMPs handling, avoids delays in administration and reduces the risk of misuse.
What next?
CBMPs represent a novel therapy, and pharmacists have an essential role in developing new procedures to incorporate them into clinical practice. This protocol may be helpful for other centres to implement guidelines to work with CBMPs.
Elaboration of a Good Practice Guide for the administration of parenteral antibiotics at children’s hospital
European Statement
Patient Safety and Quality Assurance
Author(s)
MOHAMMED ADNANE EL WARTITI, WAFAA ENNEFFAH, BOUCHRA MEDDAH, MUSTAPHA BOUATIA
Why was it done?
The GPG was developed in a concern of practices standardization to guarantee the safety and efficacy of parenteral antibiotics, especially those stored in vials which reuse in possible only if conditions of administration and stability are respected.
What was done?
We developed a Good Practice Guide (GPG) for the usage of major available parenteral antibiotics.
How was it done?
After we listed all parenteral antibiotics available at the hospital pharmacy, we selected the most used ones and we synthesized all manufacturers’ data to establish a GPG for their administration. We also used literature data to complete missing information in “Summaries of Product Characteristics” related to pediatric use of these drugs. Finally we determined the most antibiotics consuming units according to their defined daily doses, where GPG recommendations will be implemented, before their extension to all other units.
What has been achieved?
The GPG concerned the most used antibiotics, which mainly belong to the following classes: Beta-lactam, Glycopeptide and Imidazole antibiotics, Aminoglycosides and Quinolones. It specifies the galenical presentation, used solvents, volume and duration of administration, stability after reconstitution as well as incompatibilities and special measures relating to the use of these drugs. The most antibiotics consuming units are pediatric intensive care units, “IIB” pediatric unit and pediatric surgical emergency department.
What next?
The approach used in this work can be adopted in other similar structures in order to establish GPGs within the framework of a quality control policy aiming to raise the standard of care.
IMPLEMENTATION OF A SAFETY AND HEALTH PROGRAMME FOR THE MANAGEMENT OF PATIENTS WITH HEPATITIS C RECEIVING TREATMENT WITH DIRECT ACTING ANTIVIRAL AGENTS
European Statement
Clinical Pharmacy Services
Author(s)
S. IBAÑEZ GARCIA, C.G. RODRIGUEZ-GONZALEZ, A. GIMENEZ-MANZORRO, E. CHAMORRO DE VEGA, R. COLLADO-BORELL, E. LOBATO-MATILLA, A. DE LORENZO-PINTO, M. TOVAR-POZO, A. HERRANZ-ALONSO, M. SANJURJO-SAEZ
Why was it done?
CHC affects approximately 3% of the world’s population. The development of well tolerated and effective AADs has changed the therapeutic landscape. These therapies have a high efficacy with a good safety profile. Numerous challenges in terms of patient education, monitoring, medication errors, drug interactions and adherence exist. Our National Health System launched a strategy plan for proper CHC management in April 2015, establishing, among other things, measures to optimise AAD use.
What was done?
We have developed a pharmaceutical care programme.
I. The following protocols were defined:
– A case selection and treatment guideline, following the recommendations from health authorities.
– A protocol for the management of drug interactions.
– A protocol with recommended dosages and administration techniques.
– A protocol with potential adverse drug events and recommendations about how to prevent and manage them.
– A protocol about clinical interview to ensure patient literacy and co-responsability.
– Patients information leaflets.
II. The pharmacy department was provided with:
– 3 full time pharmacists.
– 2 patient information offices.
– a queue management system.
III. Appointment scheduling:
Pharmacy visits were scheduled after the hepatologist/infectious disease specialist appointments every 28 days.
IV. The clinical interviews were documented in the electronic health record.
How was it done?
A multidisciplinary team was formed with two hepatologists, one infectious disease specialist, three clinical pharmacists and one nurse to:
– Address the key points associated with the safe and efficient use of AADs.
– Create a useful clinical guideline.
– Identify staffing and logistics needs.
What has been achieved?
No of patients included in the programme: 674
No of initial visits: 674
No of follow-up visits: 1750
No of patients attended/day: 19.9
No (%) adherent patients at the end of treatment: 412/412 (100%)
No of pharmacist interventions: 195
No (%) pharmacist interventions accepted: 194 (99%)
Average waiting time to be attended by the pharmacist: 15 min
No of queries made to the hospital pharmacist: 84
No of adverse drug events reported to the pharmacovigilance centre: 31
Cost savings (€): 121 194
What next?
This initiative provides a set of recommendations regarding CHC management and a support guide to standardise and guarantee high quality pharmaceutical care.
The next step is to develop pharmaceutical care programmes for the management of other pathologies following the same methodology that we have used for this initiative.