Home / Biosimilars / Research / Study reveals wide variation in US state drug product substitution laws

Study reveals wide variation in US state drug product substitution laws Posted 04/12/2020

A new study, published in JAMA Internal Medicine [1], has revealed substantial variation in the drug product substitution rules for pharmacists across states in the US. 

In the US, increased prescription drug spending is mainly due to the high price of brand-name drugs [2]. Each US state has specific drug product selection laws that regulate whether and how pharmacists can substitute prescriptions for brand-name drugs with more affordable equivalents. These are relevant to both small-molecule generic drugs or interchangeable biologicals. In each state, the details of these laws can vary [3]. As such, the team of researchers based in Boston, US explored the variation in state drug product selection laws and the factors that affect which version of a drug is dispensed.

The team carried out cross-sectional analysis using a legal database to obtain information on state laws of all 50 US states plus Washington, DC. They determined information related to whether substitution was mandatory or permissive, patient consent was needed prior to substitution, patient notification of substitution was required independent of the drug’s packaging, and/or pharmacists were protected from special risk of liability for substitution. All data were for the laws in existence on 1 September 2019.

Summary of results:

  • 19 states required pharmacists to perform generics substitution
  • 7 states (and Washington, DC) required patient consent for substitution
  • 32 states (and Washington, DC) mandated patient notification independent of the drug’s packaging
  • 24 states did not explicitly protect pharmacists from greater liability
  • 9 states (and Washington, DC) had a generics substitution score for small-molecule drugs of three or higher
  • 45 states had more stringent requirements for interchangeable biological substitution (commonly mandatory physician notification)

The researchers concluded that there is substantial variation in substitution rules when it comes to small-molecule drugs. However, there are heightened requirements for interchangeable biological substitution in almost all states. In light of this, their findings suggest that state drug product selection laws need to be optimized to promote generics and interchangeable biologicals substitution. With this, there may be improved medication adherence and reduced drug spending.

Related articles
Evaluating reasons for US low generics substitution rates

Tackling the challenge of safe automatic substitution of biologicals

We are pleased to announce, that starting January 2021, the launch of a new section on GaBI Online, the ‘Latin American Forum’ (in Spanish) featuring the latest news and updates on research and developments in generic and biosimilar medicines in Latin America.
Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative.

1. Chana AS, Van de Wiele VL, Fulchino LA, et al. Assessment of variation in state regulation of generic drug and interchangeable biologic substitutions. JAMA Intern. Med. 2020;e203588.
2. GaBI Online - Generics and Biosimilars Initiative. US policy to combat high-priced generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Dec 4]. Available from: www.gabionline.net/Generics/Research/US-policy-to-combat-high-priced-generics 
3. GaBI Online - Generics and Biosimilars Initiative. 45 US states have passed biosimilar substitution laws [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Dec 4]. Available from: www.gabionline.net/Policies-Legislation/45-US-states-have-passed-biosimilar-substitution-laws 

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2020 Pro Pharma Communications International. All Rights Reserved.

Comments (0)

Generics News Research General


Biosimilars News Research General