Pharmacists Not Required to Substitute Generics for Brand-Name Drugs in Most US States

By Lisa Rapaport

September 01, 2020

(Reuters Health) - Only 19 U.S. states mandate that pharmacists fill prescriptions for brand-name small molecule drugs with generics when available, with the 31 remaining states allowing but not requiring these substitutions, a new study finds.

Researchers examined laws on the books as of September 2019 pertaining to generic substitution of small molecule drugs as well as so-called biosimilars or interchangeable biologics, in all 50 states and Washington, D.C.

Seven states and Washington, D.C., required that patients provide consent for generic substitutions of small molecule drugs, the study found. In addition, 32 states and Washington, D.C., required patients to be notified of substitutions even if this was clearly stated on the drug packaging.

"Prior analyses have found that variation in state drug product selection laws can impact generic drug use and prescription drug spending," said senior study author Ameet Sarpatwari, assistant director of the Program On Regulation, Therapeutics, And Law (PORTAL) at Brigham and Women's Hospital and Harvard Medical School in Boston.

"The current study findings document the extent of this variation and reveal greater barriers for interchangeable biosimilar substitution in most states," Sarpatwari said by email. "These results are important because they reveal that there is considerable scope for states to optimize their laws to achieve greater reductions in spending and improvements in medication adherence from generic drugs and future interchangeable biosimilars."

Researchers scored the regulatory systems on the books in each state on a scale from 0 to 4, with lower scores indicating a more permissive environment for substituting brand-name medicines with generics.

A total of 13 states had scores of 0 to 1, indicating favorable conditions for dispensing small molecule generics: Arizona, Illinois, Kentucky, Massachusetts, New Jersey, New York, North Carolina, Oklahoma, Rhode Island, Tennessee, Washington, Wisconsin, and Wyoming.

At the same time, Washington, D.C. and a total of 9 states had scores of 3 or higher, indicating more barriers to generic substitution for small molecule drugs: Alaska, Arkansas, Connecticut, Iowa, Louisiana, Ohio, South Carolina, Utah, and Virginia.

For large molecule drugs, state regulations tended to be more restrictive than for small molecule medicines, the study team reports in JAMA Internal Medicine. Overall, 45 states had more stringent requirements for substitutions of biologics than for small molecule drugs.

Forty states required that physicians be notified of any large molecule substitution, the study found.

Seven states required patient notification for substitution of brand-name biologics with interchangeable biologics not for small molecule substitutions.

"States may be more restrictive regarding automatic substitution of biologic drugs owing to their greater structural complexity than small-molecule drugs, and thus to concerns over the 'sameness' of biosimilars to biologics," Sarpatwari said.

If the biosimilar can be shown to be completely clinically identical to the original biologic drug, the U.S. Food and Drug Administration can classify it as "interchangeable," as opposed to similar to the brand-name product, noted Dr. Francis Crosson, a senior instructor at the Kaiser Permanente Bernard J. Tyson School of Medicine in Pasadena, California, who wrote a commentary accompanying the study.

However, the FDA has not yet classified any generic biologics as interchangeable, Dr. Crosson said by email.

"So, in many states, regulators can't really maintain that biosimilars are exactly the same as the original biologic, like they can with generics," Dr. Crosson said. "So, they have been more conservative in their approach. If and when interchangeable biosimilars are classified as such by the FDA, some states may see the situation differently."

SOURCE: and JAMA Internal Medicine, online August 31, 2020.