Fred M. Eckel, RPh, MS, Pharmacy Times Editor-in-Chief
Efforts are under way in some states to restrict the pharmacist's ability to select generics.
When I started pharmacy practice, pharmacists could not dispense a generic drug when a brand name drug was prescribed by the physician. This probably seems unbelievable to many of you because this type of substitution has been commonplace for all of your practice life. In fact, most of you are comfortable making therapeutic substitutions. The changes in the laws governing pharmacy practice were a hard-fought victory. Hospital pharmacists helped start this effort as they gained the opportunity to do generic substitution with the approval of the pharmacy and therapeutics committee.
When the medical staff realized that this practice was safe, they also authorized the pharmacists to make therapeutic substitutions. As these practices became widespread in hospitals, there was a desire to accomplish it in the community setting as well. This effort initially was promoted by pharmacists as a means to both expand their role and save their patients money.
Pharmaceutical companies and the medical profession initially opposed this expanded role for pharmacists, but pharmacy prevailed and eventually all state pharmacy practice acts allowed this practice. Payers supported it because it saved money, especially when therapeutic substitution allowed a generic drug to be used instead of a brand name drug. Although some tried to make the case that generic drugs were not of the same quality as their brand name equivalents, this message did not win the day because the savings were so significant.
Is this practice once again under scrutiny from legislatures? Could these accepted pharmacist roles be limited again, at least in specific situations? Patients have complained that a specific generic drug does not work as well as the brand name. An article in Fortune
(January 14, 2013) says this issue is giving momentum to “a movement that has been quietly building among many doctors and medical societies that are increasingly willing to ask a question that borders on heresy: Are generics really identical to the branded products they are meant to replicate? To a surprising degree, they say, the answer is no.”
The FDA is now aware of this issue and will be reevaluating bioequivalence standards. As price becomes a driving force in drug purchasing, manufacturers may try to cut corners and pharmacy purchasers may do likewise, so until the FDA cleans up the situation pharmacists must act. The passage of the Generic Drug User Fee Amendments of 2012 should eventually help give generic drugs greater legitimacy. Until then, pay attention to patients who may complain about a generic drug not working, especially for narrow therapeutic index drugs or extended release dosage forms. Put extra vigilance into your generic drug purchases. Price may be important, but may not be the only thing to consider. Things such as FDA plant inspections may be equally important.
If pharmacists work with the patient and prescriber to address any problems, we should be able to maintain our professional prerogative to make drug product selections on behalf of the patient. If we don’t exercise professional judgment we may lose our privilege. In some states, legislation is appearing that will limit the pharmacist’s ability to work with patients in selecting certain generic drugs.
There is another effort in some states to restrict the pharmacist’s professional judgment in the area of biosimilars. As patents expire on many biological products, generic products will appear. Although patient safety is offered as the reason to restrict pharmacists from substituting these products, some suggest that money may be the overriding reason. The FDA must approve a biosimilar before it is put on the market and been approving these products for more than 30 years, so it has experience in determining whether a product is interchangeable with the reference product.
Current state drug substitution laws primarily cover small molecule generics because biosimilars weren’t considered when those laws were passed. Therefore state laws may need to be amended to cover biosimilars and interchangeable biosimilars. If the pharmacy profession isn’t alert to this issue, an amendment or new laws may be offered that could restrict the pharmacist’s prerogative to dispense an interchangeable biosimilar when a brand name drug is ordered. It also means that pharmacists must learn about biosimilars so that they can use judgment when they make purchasing or dispensing decisions.
Our profession has made giant advances in the pharmacist’s professional prerogative during my career. Let’s make sure we continue to use professional judgment so that we continue to advance and not regress.
*As presented in Pharmacy Times
, May 2013
Mr. Eckel is a professor emeritus at the Eshelman School of Pharmacy, University of North Carolina at Chapel Hill. He is interim executive director of the North Carolina Association of Pharmacists.