Article Text

Medication practice in hospitals: are nanosimilars evaluated and substituted correctly?
  1. Josefien Knoeff1,2,
  2. Beat Flühmann1,
  3. Stefan Mühlebach1,3
  1. 1Vifor Pharma Ltd., Glattbrugg, Switzerland
  2. 2Faculty of Sciences, Vrije Universiteit Amsterdam, Amsterdam, Noord-Holland, The Netherlands
  3. 3Department of Pharmaceutical Sciences, University of Basel, Basel, Switzerland
  1. Correspondence to Dr Beat Flühmann, Vifor Pharma Ltd, Flughofstrasse 61, Glattbrugg 8152, Switzerland; beat.fluehmann{at}viforpharma.com

Abstract

Introduction This study investigates the drug selection and dispensing behaviour of hospital pharmacists of intravenous iron products including iron sucrose and iron sucrose similar, with special emphasis on substitution and interchangeability in France and Spain. Iron–carbohydrate complex drugs represent different available intravenous iron drugs and are part of the non-biological complex drug (NBCD) class, an expanding drug class with up to 30 brands available in intravenous pharmacotherapy and over 50 in clinical development. Follow-on versions of iron sucrose have appeared in some markets such as France and Spain, which were authorised by the generic approval pathway. However, differences in clinical efficacy and safety of iron sucrose similars compared with the reference originator drug Venofer have been observed, putting a question mark on their equivalence as assessed for authorisation and consequently their substitutability and interchangeability.

Method 70 French and 70 Spanish hospital pharmacists were surveyed via an online questionnaire on their formulary selection and dispensing behaviour of intravenous iron medicines.

Results There is little awareness about the characteristics of this class of drugs and the reported differences in safety and efficacy between iron sucrose and iron sucrose similars. In approximately 85% of cases the intravenous iron is chosen according to the hospital formulary. In 30% (France) and 34% (Spain) of cases an iron sucrose similar was dispensed because the formulary requires dispensing an alternative lower cost drug when available. In 26% (France) and 52% (Spain) of cases the physician is not informed on such a medication change using a similar product.

Conclusions Evaluation of NBCD similars for substitution and interchange by hospital pharmacists is rarely based on scientific and clinical criteria but rather on cost aspects only, which does not ensure safe, efficacious and cost-effective use of such drugs.

  • non-biological complex drugs
  • drug interchange
  • intravenous iron

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

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