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FH Before Advanced Treatments? Technically and economically possible; legally and operationally necessary

FH Before Advanced Treatments?  Technically and economically possible;  legally and operationally necessary

CARLOS ARGANDA | 27.11.2022 – 20:07

The advent of Advanced Therapies meant a paradigm shift in clinical and healthcare, and it can and should mean something else in hospital pharmacy. The logistics, quality, production and monitoring requirements, and the challenges associated with each of these requirements, require the hospital pharmacy to take another step and be involved in a few years. go from being occasional in terms of volume to something generalized in our country’s hospitals.

Therefore, director of the Clinical Medicine Field at Hospital la Fe and head of the Hospital Pharmacy Service. Valencia, Jose Luis Povedaencouraged all hospital pharmacists to take this train, which “starts now and still has no speed”. Call of Poveda, 67. Spanish Hospital Pharmacy Association (SEFH).

The discussion was moderated by the head of the Central Hospital Pharmacy Service. Asturias (HUCA), Ana Lozano and Poveda, as well as Javier Gordillo, joined the Cell Therapies medical business in Kite Spain.

The colloquium, as introduced by Lozano, focused on logistics management processes, pharmacists’ responsibility, certification steps and the importance of having drugs in the pharmacy service.

Poveda explained that the adaptation Pharmacy services need to do to start the process of delivering CAR-T treatments is like “flying a plane while it’s being built,” as procedures and protocols are developed on the fly, just like Design and Design. installation of necessary equipment.

For Poveda, the role of pharmacists in the management of CART medications is important for several reasons. In the first place, it will be the pharmacist’s responsibility to “ensure that it is kept with guarantees”, as it is “a drug as specified by the regulatory authorities”, that is, “unless the legislation changes”. Another compelling reason given by this pharmacist is that in the not-too-distant future, there will be quite a few clinical services beyond that. hematologyThose with CART drugs, so it doesn’t seem logical that their management is decentralized.

professional implications

Poveda also discussed the situation in terms of the professional implications working with advanced treatments could have for pharmacists. First of all, the pharmacist needs to “regain his role as a manufacturer” because more and more progress will be made towards producing drugs, so that near the point of administration the pharmacist will become the “other” professional if the pharmacist does not do so.

Regarding logistics, he realized that CART administration required new procedures, as they were living cells in cryopreservation environments but drugs with different properties. However, for Poveda, this is “not a barrier, but different properties compared to other drugs,” specifically for achieving temperature control. Continuing with this logistics issue, the person in charge of Farmacia de La Fe pointed out that, as it makes sense, investment in infrastructure, both in terms of space and equipment and training, should be made, but the amount, especially the amount. can be assumed and reused, compared to the costs of the treatments to which they are referred. Therefore, for Poveda, the decision to invest in infrastructure is “professional, not economic.”

To try to persuade pharmacists who want to begin their adventure in advanced treatments, Poveda offered help from his service to relay his experience. Not only that, but also explaining that the first thing he did was to deliver a flash drive with standard operating procedures (SOP) prepared in La Fe, the President said, “It’s about acting together and moving forward.”

As currently every therapy requires accreditation and the corresponding annual re-accreditation, most critical was the need to establish a pattern with each company in terms of accreditation; Given the predicted arrival of these treatments in the future, their management may be unapproachable.

Qualification processes

Gordillo explained that his company has treated more than 11,000 people to date. patients They stated that they are working to speed up production times, which are currently 18-19 days, which is a key factor for the success of the treatment.

The person in charge of Kite explained that since it is a process that starts and ends in the hospital, the qualification processes required to guarantee both apheresis and the correct traceability and correct logistics and management of medicines are a request from regulatory agencies. need to reinforce security Patient and product quality.

From overseeing hospitals’ quality procedures and updating SOPs to align with those of the company, training in apheresis management in shipment and receipt of medication, as well as a specific risk management plan, Gordillo said.

Regarding future challenges, this expert noted the need to consolidate the use of these drugs, as only two out of ten patients who could benefit have finally received the drug. In addition, manufacturing processes must be accelerated, and from a research perspective, changes are being made to the vector as well as allogeneic CARTs that will allow pharmacies to have CART libraries.

Gordillo also agreed with Poveda that a solution to the accreditation problem must be found when there is more than one drug that requires them.

During the discussion, both experts explored the advantages of the pharmacy centralizing the logistics of advanced treatments. In this context, Gordillo explained that although there are currently different management models in Spain (blood bank, hematology, central and hospital pharmacy), the latter will facilitate management when the use of CART and other advanced therapies reaches other areas. saw this as a “very clear opportunity” for departments to deliver the service.

Regarding cryopreservation tanks and other equipment, Poveda stated that all hospital supplies are “hospital-owned” and not the property of this or that service. He acknowledged that the infrastructure has been adapted in some places, as CARTs derive from the world of transplants, but the point, he says, is that “the structure cannot mark where the drug is unless the law changes” “because the pharmacy is the guarantee of the quality of all drugs,” he pointed out.


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#Advanced #Treatments #Technically #economically #legally #operationally

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