An American College of Cardiology Foundation (ACCF) and American Heart Association (AHA) health policy statement outlines how drug alternatives should be dispensed and administered. The report, which refers to either generic drugs or drugs that are similar after therapeutic interchange, was developed after the proper technique to handle these specific interchanges gained recent attention.
“One of the most common reasons [for this increasing attention] is the development of multiple drugs in a similar class, for example, angiotensin-converting enzyme (ACE) inhibitors, beta-blockers, diuretics, statins or calcium channel blockers,” the authors wrote in the Aug. 15 issue of the Journal of the American College of Cardiology. However, how these drugs drive economic issues is also critical.
“As healthcare costs rise inexorably and the limits of patent protections are either exceeded, circumvented, or ignored worldwide, generic drugs and devices are often developed and marketed under the understanding that they provide the same benefit and safety but with greatly reduced costs,” the report stated.
FDA does not regulate generic substitution, therapeutic interchange or therapeutic substitution, nor does it have the authority to limit prescribing, the statement noted. Generic substitution laws are state specific and in most states, pharmacists are not allowed to substitute nontherapeutic equivalent products. However, some states allow substitution as long as state-specific criteria are met, such as having the same active ingredient, dosage form, dose and route of administration.
“One of the most persuasive arguments for generic substitution is cost containment, a critical component of healthcare,” the authors noted.
Another issue is the legal and regulatory factors surrounding drug availability, for example, how some devices or drugs can be purchased outside the U.S. but are not yet approved in the U.S. for use. Additionally, some drugs still on patent in the U.S. can be manufactured as generics and purchased in other countries.
ACCF and AHA recommend the following:
- Therapeutic substitution should not be accepted. When considering therapeutic interchange, third-party payors must take into account multiple factors when approving the interchange such as level and strength of evidence for medication and a patient’s condition;
- Each healthcare facility should have a formally chartered interdisciplinary pharmacy and therapeutics committee charged with ensuring medication safety and developing an evidence-based formulary;
- All formulary decisions should be made based on the recommendations of the healthcare team after considering the scientific evidence in the specific patient or patient groups to be treated and the ratio of risk/balance in that setting;
- After initiating a therapeutic interchange policy, healthcare systems are responsible for implementing processes for informing individual patients of the change in medications prescribed;
- Applicable state, federal and international policies concerning metrics of equivalence, manufacturing, packaging and purity need to be monitored annually, at minimum; and
- Pharmacists must understand the rationale for the use of the Orange Book. Contemporary pharmacy practice requires confirmation that a substituted generic drug is bioequivalent to the prescribed product.
“Pharmacogenomics may have a substantial impact on the field in the future. As scientific data and evidence continue to emerge and technologies improve, policies should be adapted as needed. This may enhance the ability to personalize medical care for the individual patient,” the authors concluded.