The Drug Enforcement Administration (DEA) has raised hackles up and down the pharmacy distribution chain with its proposal to allow electronic prescribing of controlled substances. Computer-generated prescriptions from physicians to pharmacies for drugs such as oxycodone (OxyContin, Purdue), methylphenidate (Ritalin, Novartis), diazepam (Valium, Roche), and hydrocodone bitartrate/acetaminophen (e.g., Abbott’s Vicodin or Forest’s Lorcet and Lortab), are illegal—until the DEA finalizes this rule. Even though the DEA believes that e-prescribing of those and other Schedule II–V controlled substances will help combat diversion of sedatives and pain medications, the security measures that the agency wants physicians and pharmacies to adopt have those groups up in arms.
John A. Gans, PharmD, Executive Vice President and Chief Executive Officer of the American Pharmacists Association, says:
“We are concerned with several provisions in the proposed rule that would create undue burdens on prescribers and pharmacists that, if left unaddressed, may have the unintended consequence of limiting prescriber and pharmacist uptake of e-prescribing of controlled substances.”
Paradoxically, pharmacies and pharmacists have been waiting for the “green light” from the DEA, viewing it as a kind of catalyst for physicians to move much more aggressively to electronic prescribing, which is seen as saving time and money for pharmacies. In the current environment, physicians have been hesitant to fully embrace e- prescribing because they would need a second, paper system for Schedule II–V controlled substances, which constitute about 10% of all prescriptions. That two-tiered system was viewed as a pain, even though many physicians have e-prescribing capabilities through the electronic health record (EHR) systems. They simply have not been using that e-prescribing capability.
The DEA, of course, is concerned about the diversion of Schedule II–V controlled substances such as OxyContin and those mentioned previously, to name a few. Diversion of those drugs, whether through theft at pharmacies, alteration of legitimately written prescriptions, or the actions of rogue Internet pharmacies has become more of a problem over the past decade, leading to what the DEA calls an “alarming” increase in substance abuse. Recently, Cardinal Health agreed to pay $34,000,000 in civil penalties for the diversion of millions of dosage units of hydrocodone from its 27 DEA-registered distribution facilities to pharmacies that filled illegitimate prescriptions originating from illegal Internet pharmacy Web sites.
The DEA believes that a secure electronic system for prescribing Schedule II–V controlled substances would actually reduce diversion. But that’s where the rub is: ensuring a pharmacy system is secure. Almost all pharmacies have computerized prescription records, which are integrated into overall pharmacy management systems that process insurance claims and billings. Many pharmacies have the ability to accept electronic prescriptions, but few orders of this type are currently sent. Many of the “electronic prescriptions” generated are actually transmitted to the pharmacy as faxes, or they are simply printed out and given to the patient. Renewals, rather than original prescriptions, are more likely to be handled electronically. Nonetheless, the capability to accept electronic prescriptions is widespread in the pharmacy sector.
Having said that, though, many problems exist with the current system, not only at the pharmacy levels. The service providers to whom the electronic prescription system is outsourced do not know whether a physician signing up to transmit electronic prescriptions is legally permitted to do so. Some services, which enroll practices over the Internet, don’t ask for the presumed physician’s DEA registration and state license.
But the DEA has proposed a number of security measures that haven’t gone over well with anyone. C. Edwin Webb, Director of Government and Professional Affairs for the American College of Clinical Pharmacy (ACCP), says the proposal does not fully recognize the authority of pharmacists to practice drug therapy management under collaborative practice agreements with physicians in 45 of the 50 states. Pharmacists in those states are legally allowed to prescribe drugs, but they might not be able to do so under the DEA proposal.
Pharmacy groups are also worried about an additional workload. For example, to help get around a physician’s DEA registration, a pharmacist would have to check the DEA database before giving a customer a controlled substance to make sure that the prescribing physician is in the database. Mark Merritt, president of the Pharmaceutical Care Management Association, says that would be costly and ineffective. Moreover, the DEA database is updated not in real time but on a weekly basis. The lack of real-time information may result in the rejection of scripts from prescribers who have not yet been integrated into the database.
Maybe a bigger problem for pharmacy benefit managers and formularies is that the DEA doesn’t want to allow the pharmacist to switch an electronic prescription for a brand-name drug to a generic agent; it wants the DEA to clarify that pharmacists are allowed to change prescriptions according to state law and should not be considered to be “altering the prescription during transmission.”
Given the necessity of pushing e-prescribing into higher gear, the DEA is likely to accommodate pharmacy groups to some extent when it publishes the final rule on controlled substances.