A recent editorial in The Wall Street Journal raised safety concerns when the authors suggested that “instead of forcing patients to stand in line at a drugstore to fill their prescriptions, it would be easier and cheaper if these patients could get their meds directly from the doctors prescribing them.”1

The editorial provided commentary about a lawsuit by 3 doctors in Montana who are seeking the freedom to dispense “noncontrolled medications directly to their patients at cost,” which is banned in the state.The ban was less about protecting patients and more about protecting a middleman from competition, according to the editorial.

Proponents of physician dispensing often cite improved patient access, adherence, and convenience. Opponents cite serious medication safety concerns, particularly the loss of a crucial second check by a pharmacist and lack of regulatory oversight, which may lead to lax procedures for medication labeling, record keeping, storage, and supervision of the dispenser. There is also unease regarding a potential conflict of interest when the physician prescribing the medication is also dispensing the medication and, perhaps, making a profit from the sale, which appears to not be the case in the Montana lawsuit. Two of these areas of concern are described in more detail below.

Education and labeling. Physician dispensing raises concerns regarding proper labeling of dispensed products using the same standards that pharmacies must follow. Regardless of where the prescription medication is dispensed, each product should include a label with the dose frequency, expiration date if not on the package, frequency, medication name, patient’s name, prescriber’s name, reason for taking the medication, route of administration, strength, special precautions (eg, may cause drowsiness, take after fasting for a specified period of time, or take with food), strength, and a telephone number in case the patient has questions. Patient counseling, including review of any serious adverse effects, is also a must, particularly given that insufficient knowledge about health and medication therapy is a key contributor to patients’ nonadherence to their prescribed drug therapies. Much of the patients’ education, as well as dispensing tasks, may be delegated to clinic or office staff members who may not have sufficient knowledge about the drug. With sample medications, checking for expired drugs, drug storage conditions, safe handling of hazardous medications, and the security of drug storage may be more easily compromised in a physician’s clinic or office than in a pharmacy.

Pharmacy checks and balances. Errors that occur in the prescribing phase of the medication use process are typically less likely to reach the patient and cause harm because of the opportunity to intercept the error in the phases of dispensing and administering. However, physician dispensing bypasses these opportunities, particularly the crucial second check of the prescribed drug therapy by a pharmacist. When prescribing errors reach the patient, they can cause significant harm. A pharmacist’s review of prescribed medications is especially important with high-alert and narrow therapeutic medications, given the potential for harm when these drugs are used in error. Do not overlook the poten-tial safety issue with physician prescribing, such as bypassing clinical decision–support alerts issued during order entry. Having the same physician prescribe and dispense a medication introduces a potential single pathway failure, meaning there is no safety net to catch the error before it reaches the patient. Single pathway failures suggest low reliability when it comes to safety.

CONCLUSION
Physician dispensing introduces potential safety issues that cannot be overlooked. The proper regulatory oversight of this practice needs to be well funded and thought out if physician dispensing trends continue. Any legal action or state legislation that grants dispensing privileges to physicians should make sure that the requirements mimic existing language in the state’s Pharmacy Practice Act. Otherwise, the potential harm from physician dispensing is too great, and the medication dispensing process should continue to be managed by a licensed pharmacist and state regulatory agencies that aggressively enforce standards of care in dispensing pharmacies. ®
 
Michael J. Gaunt, PharmD, is a medication safety analyst and the editor of ISMP Medication Safety Alert! Community/Ambulatory Care newsletter at the Institute for Safe Medication Practices in Horsham, Pennsylvania.


REFERENCES
  1. The editorial board. Letting the docs dispense: should patients have to make a trip to the drugstore to fill a prescription? The Wall Street Journal. June 11, 2020. Accessed August 5, 2020. http://www.wsj.com/articles/letting-the-docs-dispense-11591918907
  2. Montana doctor dispensing: Montana bans doctors from offering medications to their patients just to protect pharmacies from competition. Institute for Justice. Accessed August 5, 2020. https://ij.org/case/montana-doctor-dispensing/