Tackling the challenges of nanomedicines: are we ready?

Abstract

Disclaimer In an effort to expedite the publication of articles related to the COVID-19 pandemic, AJHP is posting these manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time. Purpose This review provides an overview of the proceedings of the symposium “Tackling the Challenges of Nanomedicines: Are We ready?” organized by the International Pharmaceutical Federation (FIP) Hospital Pharmacy Section and Non-Biological Complex Drugs (NBCDs) Working Group at the 2019 FIP World Congress of Pharmacy and Pharmaceutical Sciences. Debate centered on reasons underlying the current complex regulatory landscape for nanomedicines and their follow-on products (referred to as nanosimilars) and the pivotal role of hospital pharmacists in selecting, handling, and guiding usage of nanomedicines and nanosimilars. Summary The evaluation and use of nanomedicines are recognized among scientific, pharmaceutical, and regulatory bodies as complex. Interchangeability and substitutability of nanomedicines and nanosimilars are confounded by a lack of pharmaceutical and pharmacological equivalence, reflecting the inherent complex nature of these drug products and manufacturing processes. Consequences include implications for clinical safety and efficacy and, ultimately, comparability. Local regulatory approvals of some nanomedicines have occurred, but there is no standard to ensure streamlined evaluation and use of consistent measures of therapeutic equivalence of reference products and their nanosimilars. Hospital pharmacists are expected to be experts in the selection, handling, and substitution of nanomedicines and familiarize themselves with the limitations of current methods of assessing pharmaceutical and clinical equivalence of nanosimilars in order to ensure informed formulary decision-making and eventual patient benefit. Conclusion Supportive guidance for pharmacists focusing on the substitutability and/or interchangeability of nanomedicines and their nanosimilars is needed. Current FIP guidance for pharmacists on therapeutic interchange and substitution should be extended to include nanomedicines and nanosimilars.

How Do Hospital Pharmacists Approach Substitution of Nanomedicines? Insights from a Qualitative Pilot Study and a Quantitative Market Research Analysis in Five European Countries

“…Establishing an appropriate regulatory framework for nanomedicines and their follow-ons and improving the consistency of prescribing practices in Europe would help to harmonize the practical use of these complex products and ensure their safety and efficacy for the patient [ 10 , 15 , 25 ]. Currently, national authorities, clinicians and pharmacists are required to translate the decision of regulators to determine prescribing practices, leading to inconsistent practices between countries, as shown in the current study.…”

“…Additionally, hospital pharmacist scientific societies should issue clear statements regarding the interchangeability and substitution of nanomedicines and “nanosimilars”. For example, current guidance for pharmacists on the substitution of biologics and biosimilars [ 36 ] could be extended to include the selection and substitution of nanomedicines and “nanosimilars” [ 25 ].…”

“…In daily clinical practice, hospital pharmacists have a central role in making substitution decisions [ 25 ]. Substitution of follow-on medicinal products approved via the generic pathway is usually straightforward, since with some exceptions, therapeutic equivalence can be assumed, and so national bodies have established clear rules on substitution and interchangeability.…”

Need for Expansion of Pharmacy Education Globally for the Growing Field of Nanomedicine

“…Pharmacists also need to be aware of new scientific discoveries that affect the regulatory evaluation of nanomedicines in the drug development pipeline [1,27]. Pharmacists are the primary members of interdisciplinary teams with adequate training in pharmaceutical science, pharmacokinetics, and regulatory science to synthesize data on known research gaps and new discoveries and then apply these concepts to clinical therapeutic decision making, formulary management, and research investigations [28].…”

Practical Guidance for Diagnosing and Treating Iron Deficiency in Patients with Heart Failure: Why, Who and How?

“…Ferric carboxymaltose (FCM), a precision-engineered nanomedicine with a characteristic clinical profile [ 54 ], is the most extensively studied IV iron in randomised controlled clinical trials of patients with CHF [ 15 , 16 , 17 , 18 ]. Therefore, the majority of the evidence-base for IV iron in HF applies to IV FCM and, as such, FCM is the only iron formulation specifically recommended for the treatment of iron deficiency in the 2021 ESC HF guidelines [ 3 ].…”