Non-biological Complex Drugs (NBCDs): Complex Pharmaceuticals in Need of Individual Robust Clinical Assessment Before Any Therapeutic Equivalence Decision.

Non-Biological Complex Drugs (NBCDs) are complex non-biological drugs comprised of large high molecular weight molecules and, often, nanoparticular structures (including liposomes and block-copolymer micelles). In the case of NBCDs, the entire complex is the active pharmaceutical ingredient and its properties cannot be fully characterized by physicochemical analysis. Moreover, the manufacturing process is fundamental in creating the correct originator product. The same is true for generic versions of the product. A recent appraisal of approval procedures for NBCDs "follow-on products" approved in Europe shows a diversity of regulatory pathways. In fact, three different abridged application procedures, under European legislation, were used: the generic application procedure of Article 10(1), the hybrid application procedure of Article 10(3), and the biosimilar application procedure of Article 10(4). Three informed consent applications via Article 10(c) from innovator companies of glatiramer acetate and sevelamer carbonate were submitted shortly after the approval of the first follow-on products. Furthermore, a number of "well-established use" applications [via Article 10(a)] were approved for iron sucrose and iron dextran complexes. In order to protect patients from the increased risks of NBCD products and NBCD follow-on products, two complementary approaches should be considered: (i) improving the regulatory procedures and their guidance documents within the pre-registration phase, and (ii) not considering interchangeability whenever clinical data is not available. With regards to the latter, the need for adequate safety and efficacy data might also include risk management programmes within post-approval pharmacovigilance actions. This, however, would depend on a risk appraisal that must be considered for individual medicinal products, based on the nature of the submitted relevant set of safety/efficacy data.

Optimising patient safety using pharmaceutical intervention in domiciliary hospitalization.

Introduction The domiciliary hospitalization unit (DHU) is an innovative model of care provision, where hospital care is transferred to the patients' home. However, this shift adds a care transition layer to the process, which may increase the probability of medication errors to occur. Method A pharmacist has been integrated into the DHU team to improve medication use. We developed an observational study documenting his intervention for 6 months. Information about the patient's drug therapy before admission, during hospitalization and after hospital discharge were gathered, enabling comparison of possible discrepancies that may happen during care transitions. The pharmacist evaluated the appropriateness, necessity, effectiveness, and safety of medication and intervened when deemed appropriate. Conclusions Data suggests that a pharmacist involved in the DHU may have a positive impact on medication use. Medication review and reconciliation are examples of pharmaceutical interventions that may lead to increased effectiveness and patient safety.