Linked to EAHP Statements:
Section 6: Education and Research
Section 3: Production and compounding

ACPE UAN: 0475-0000-16-019-L04-P. A knowledge based activity.

Abstract

Advanced-therapy medicinal products (ATMPs) are medicines for human use that are based on gene therapy, somatic-cell therapy or tissue engineering. They offer groundbreaking new opportunities for the treatment of disease and injury.

With the introduction of EU Regulation 1394/2007 in December 2008, all cell products that are substantially manipulated prior to clinical application have to be regarded as medicines, meaning that hospital pharmacies in Europe are responsible for these products and have to oversee all aspects of their use in the hospital. Furthermore, gene therapy medicinal products are commonly already considered as drugs. A first gene therapy drug is already marketed in Europe. However, the amount of cellular and gene therapy-related research and development continues to grow rapidly, arising to introduce them by far in the current pharmacotherapy during the following years.

Advanced therapies introduce enhanced roles for pharmacists in health-system decisions concerning clinical trials, selection, use, and management in hospitals. These goals are reached using the same principles as those of the medication formulary system in which decisions are based on clinical, ethical, legal, social, quality-of-life, safety and pharmacoeconomic factors that result in optimal patient care and include the active and direct involvement of physicians and other healthcare practitioners. However, hospital pharmacist’s training in these new technologies requires a stepwise process to be familiar with highly complex technical and scientific concepts that provide a complete new knowledge paradigm for most pharmacists.