Generic drug substitution laws vary greatly across US
State laws regarding generic drug and interchangeable biologic substitutions vary widely in the United States, researchers reported.
Generic drugs saved the U.S. health care system $1.7 trillion between 2007 and 2016, and biologics currently account for 2% of dispensed medications and almost 40% of spending, according to researchers.
Past research has linked generic drugs with improved medication adherence and health outcomes, Chana A. Sacks, MD, member of a regulation, therapeutics and law program in the department of medicine at Brigham and Women’s Hospital, and colleagues wrote. They added that more consistency in substitution laws across states could “reduce health system spending [and] improve population health.”
Sacks and colleagues examined state laws regarding generic drug substitution in all 50 states and the District of Columbia as of Sept. 1, 2019. Findings showed that:
- 7 states and the district needed patient consent before switching to a generic.
- 19 states required pharmacists to perform generic substitution for small-molecule drugs.
- 24 states did not specifically protect pharmacists from greater liability when substituting the generic.
- 32 states and the district required patient notification regardless of the drug’s packaging.
“Our findings highlight considerable room for optimizing state drug product selection laws to promote generic and interchangeable biologic substitution,” Sacks and colleagues wrote.
The findings should be alarming to the medical community, added Ameet Sarpatwari, PhD, JD, member of a regulation, therapeutics and law program in the department of medicine at Brigham and Women’s Hospital.
“Physicians should be concerned over this variation because it reveals that policies are lacking to ensure optimal use of generic drugs, the use of which has been associated with improved medication adherence and health outcomes,” he told Healio Primary Care.
In an invited commentary, Francis J. Crosson, MD, senior lecturer of health systems science at Kaiser Permanente Bernard J. Tyson School of Medicine in Pasadena, California, encouraged the removal of "poorly designed state regulations that inhibit the use of generic drugs, while at the same time ensuring that treating physicians are aware of what formulations their patients are actually receiving.”
Crosson, also a member of JAMA Internal Medicine's editorial board, added that the rising costs of many prescription drugs are contributing to increasing Medicare Part B and D expenditures. However, after the COVID-19 pandemic subsides, those programs will be expected to cut costs. Therefore, “efforts to ensure that unnecessary expenditures for drugs are mitigated must continue unabated,” he wrote.