Saturday, September 20, 2014
Inquirer Daily News

When doctors - not pharmacists - dispense meds

More and more doctors are dispensing medications directly to patients, rather than send people to their pharmacist with prescriptions in hand. And that raises safety issues on several fronts.

When doctors - not pharmacists - dispense meds

A pharmacist in Centre Hill, Pa., advising a customer. The role of dispensing medications has increasingly been played by physicians.  (AP Photo / Pat Little)
A pharmacist in Centre Hill, Pa., advising a customer. The role of dispensing medications has increasingly been played by physicians. (AP Photo / Pat Little)

There’s a bit of a trend in the last few years for more and more doctors to dispense medications directly to patients rather than send them to their pharmacist with prescriptions in hand. A number of companies sell turnkey setups that resemble a mini-pharmacy, with prepackaged medications, office storage facilities and tracking software. Doctors see dispensing as a way to offset declining reimbursements by creating an ancillary revenue source. Last week, the Utah legislature even passed a bill that would allow cancer doctors to dispense cancer medications from their offices.

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 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.

For many doctors and pharmacists, though, there’s 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.

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 doctors to have a special permit or license, as they do in New Jersey, or they need to be registered with their state’s Board of Pharmacy. In Pennsylvania, there are no requirements for a permit or a license for doctors to dispense, although there are regulations that set some requirements. The American Medical Association Code of Ethics notes that “Physicians may dispense drugs within their office practices provided such dispensing primarily benefits the patients.”

It’s the medication safety issue that worries me. A 2007 Institute of Medicine report showed that medication errors originate most often during the medication prescribing process. At least half of these prescribing errors are detected and corrected when pharmacists review the safety and appropriateness of the medication. But having the same physician prescribe and dispense eliminates that safety net before the error reaches the patient. In reality, it may not even be the doctor who does the dispensing. It could be ancillary office personnel, instead, and dispensed medications may not be given a final check.

A pharmacist’s review of prescribed medications is especially important with cancer drugs – oral as well as injectable, given the difficulty in achieving an adequate therapeutic effect without causing undue toxicity. The safety concerns with oral chemotherapy have been magnified as the use of oral chemotherapy has increased. Physicians may not have access to special software that pharmacists have to screen prescribed drug therapy for overdoses, sub-therapeutic doses, and drug-drug interactions among all the medications their patient takes, including those prescribed by various specialists. There also needs to be screening to protect against drug allergies or drugs that shouldn’t be given in certain disease states, as well as duplicate therapy.

Physician dispensing also 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 patient’s name, medication name, strength, dose that should be taken, route of administration, frequency of taking the medication, reason for taking the medication, special precautions (e.g., may cause drowsiness; take with food or, as with a number of oral targeted therapies, after fasting for a specified period of time), an expiration date (if not on the package), the prescribing physician’s name, and a telephone number in case the patient has questions.

Patient counseling, including review of any serious side effects, is also a necessity, particularly given that insufficient knowledge about health and medication therapy is a key contributor to patients’ non-adherence to their prescribed drug therapy. Much of the patients’ education (as well as dispensing tasks) may be delegated to office or clinic staff that may not have sufficient knowledge of the drug. As with sample medications, drug storage conditions, checking for expired drugs, safe handling of toxic medications like chemotherapy, and the security of drug storage may also be compromised more easily in a physician’s office or clinic than in a pharmacy.

What about conflict of interest? It’s hard to overlook that a physician could profit from medications he or she prescribes. An oft-repeated concern is that the more they prescribe the more they profit, which could put someone at added risk. However, despite this risk, I believe the vast majority of physicians put the health and safety of their patients well above profit margins. So I’m not too concerned in this regard.

In the end, physician dispensing without regulatory oversight that upholds the same standards required of dispensing pharmacists could be quite costly to patients in terms of their health and safety. Both the U.S. Office of the Inspector General of the Department of Health and Human Services and the National Association of Boards of Pharmacy emphasize the necessity of regulatory oversight and accountability in the drug distribution and dispensing process in order to protect patient safety. Borrowing from the Joint Commission’s stance, physician dispensing and pharmacy dispensing should be held to equivalent standards of care. Don’t let advocates for doctor dispensing fool you. The potential safety issues with physician dispensing cannot be easily dismissed.


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About this blog
Michael R. Cohen, R.Ph. President, Institute for Safe Medication Practices
Daniel R. Hoffman, Ph.D. President, Pharmaceutical Business Research Associates
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