Controversies in Drug Substitution

Seema Z. Kazmi, PharmD

Disclosures

November 07, 2007

In This Article

Introduction

Skyrocketing healthcare costs have become a national issue, and drug expenditures account for 11% of those costs in the United States.[1] Generic drugs have been identified as a cost-effective alternative to more expensive branded medications. In fact, according to some estimates, $8.8 billion could be saved each year in the United States alone if generic medications were prescribed and used in an optimal manner.[2]

However, some physicians continue to prescribe branded medications when generics are available, believing that the branded formulations are superior. In addition, some patients are uncomfortable with the idea of taking a "substitute" for a medication that their doctor prescribed.

Recent news reports have stirred up the matter further. An independent laboratory released test findings earlier this month that raised questions about a particular generic formulation of bupropion hydrochloride extended-release tablets (Wellbutrin XL).[3] The laboratory said that Budeprion XL (made by Teva Pharmaceutical Industries) did not perform the same as Wellbutrin XL, releasing the active ingredient more quickly and thus potentially being less effective. Although the report raised concerns for some drug safety advocates, others noted that even if it was correct, it involved only a tiny segment of the generic drug market.

A separate issue is the increasing number of drug therapies that are biologic in nature, or protein-based, making them more costly to manufacture and thus even more expensive for patients. In light of growing concerns over the high price of such therapies, "biosimilars" or "follow-on biologics" are being studied as less expensive alternatives. However, questions have been raised over whether one biologic agent can be a true substitute for another. In fact, Congress is currently wrestling with that issue and may provide new guidance within the coming months.

Meanwhile, the pharmacist must discern whether any drug substitution is really appropriate for a given patient. In most states, pharmacists can dispense generic substitutes for brand-name drugs unless the prescriber specifies otherwise. Pharmacists can be a vital resource for prescribers, providing current information about the effectiveness of appropriate substitutes. Pharmacists and prescribers can work together to educate patients about the equivalence of generic medications that may cost them significantly less.

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