Good Intention, Uncertain Outcome… ISMP's Take on Physician Dispensing in Offices and Clinics

ISMP Medication Safety Alert 

In This Article

Abstract and Introduction

Introduction

Spurred by current legislative action in Utah that would allow oncologists to dispense oral chemotherapy from the office or outpatient clinic setting, the topic of physician dispensing has again surfaced with polarizing views from both sides. Proponents of physician dispensing cite improved patient access to medications, patient convenience, greater use of lower-cost generic medications and therapeutic substitutions due to the physician's enhanced awareness of medication costs, and improved patient adherence with medication regimens. Opponents of physician dispensing cite serious medication safety concerns, particularly the loss of a crucial second check by a pharmacist and use of software to detect prescribing errors, and lack of regulatory oversight, which may lead to lax procedures for medication labeling, record-keeping, storage, and supervision of the dispenser. There's also a sense of unease regarding a potential conflict of interest when the physician prescribing the medication is also the person dispensing the medication and, perhaps, making a profit from the sale.

Utah Senate Bill 161 (SB161) (http://le.utah.gov/~2012/bills/sbillint/sb0161s06.pdf), sponsored by Sen. Curt Bramble, R-Provo, exempts oncologists and medical personnel acting under their direction from the Utah Pharmacy Practice Act for the next 3 years, and allows them to dispense drugs used to support cancer treatment (not Schedule I, II, or III drugs), bypassing the usual pharmacy safety checks. Currently, oncologists in Utah and elsewhere can administer intravenous (IV) chemotherapy in the office or clinic—a practice ISMP endorses only if a pharmacist is directly involved in the preparation and admixture process and a second trained professional conducts an independent check before administration. The bill would allow oncologists to also dispense oral chemotherapy and other medications associated with the patient's chemotherapy regimen. With the recent influx of new targeted oral chemotherapy medications, the bill was introduced as a way to ensure that cancer patients have better access to these newer drugs. Despite opposition from numerous professional organizations, the bill passed the Utah Senate and underwent six revisions while in the House Health and Human Services Committee before approval. The latest revision calls for a subcommittee with key stakeholders to address any concerns with physician prescribing and requires dispensing physicians to notify the Board of Pharmacy. The full House approved the bill earlier this year, and word is, the governor is expected to sign it.

ISMP fully supports the removal of any barriers to patients' access to medications, cost containment that can be achieved by use of lower-cost but effective medications, and steps that improve patient adherence to prescribed medication therapy. However, we cannot support unbridled physician dispensing due to the increased risk of medication errors, particularly with high-alert medications such as chemotherapy. While physician dispensing is permitted in most states, it is often carefully regulated and restricted to samples or conditions of immediate need. Some states require dispensing physicians to be licensed by or registered with the Board of Pharmacy, or they must obtain a special permit. The American Medical Association Code of Ethics notes that "Physicians may dispense drugs within their office practices provided such dispensing primarily benefits the patients." However, we worry about the unintended consequences of physician dispensing, as described in more detail below.

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