Handle With Care: Dispensing Controlled Substances in the Pharmacy

When a patient presents a prescription for a controlled substance to their pharmacist, what happens next is a complex coordination of care and oversight. Each prescription for a controlled substance requires manual documentation from pharmacists, including the quantity dispensed, the date of distribution, and the pharmacist’s signature. For refills, the pharmacist will retrieve the prescription and sign and date below the initial fill, which is a process that can take anywhere from 3 to 15 minutes.

There are technology solutions that can help with this documentation and can give a pharmacist peace of mind. For example, by using electronic data management and log modification from software, no time is wasted and audit hiccups from lost prescriptions or forgetting to sign are eliminated. Still, filling prescriptions for controlled substances is vastly different than filling standard prescriptions, as medications such as opioids and stimulants come with stricter rules and must comply with both federal and state laws and regulations.

Controlled substances have the highest potential for misuse and abuse and therefore have the strictest regulations and prescription requirements on both a federal and state level. To fill these prescriptions in the first place, a pharmacist must have a controlled substance license.

Zsuzsanna Biran, RPh, owner of West Marin Pharmacy in Port Reyes Station, California, explained that there are certain protocols pharmacists must adhere to in order to ensure they are dispensing controlled substances in the right amounts to the right patients. “It’s a lot stricter than a regular prescription that has a diagnostic code,” she said. “We have to really do [our] due diligence and act responsibly. [We must] follow guidelines, stick to protocols, and never waver.”

As with all medications, a valid prescription is required before a pharmacist can dispense a controlled substance. Prescriptions for controlled substances must include specific information according to guidance from the National Institutes of Health, including the date of issue; the patient’s name and address; the patient’s date of birth; the prescriber’s name, address, and valid Drug Enforcement Administration (DEA) number; and the drug name, strength, dosage form, and quantity prescribed.

Biran has had patients come into the pharmacy with a broken leg or another injury, and although though they have a valid prescription and identification, she cannot take any shortcuts, and the patient must wait for however long the process takes. Other times, the information on their prescription is incomplete and, as much as she wants to help, she is unable to.

“Sometimes you have to say no, and there’s nothing you can do if they don’t have everything they need,” Biran said. “That can be a really hard thing to do. Sometimes you’re between a rock and a hard place, and your best judgment tells you not to fulfill the prescription because you’ll do more harm than good. And it’s never worth losing your license for.”

Zeeshan Afzal, MD, works for online pharmacy Welzo and has extensive experience dealing with issues around controlled substance prescriptions.
“Some challenges [pharmacists] may face include identifying fraudulent prescriptions, detecting potential abuse or diversion of controlled substances, and ensuring proper recordkeeping and reporting,” Afzal said. “To ensure compliance, pharmacists should stay up-to-date with the latest regulations, implement appropriate policies and procedures, train staff on best practices, and maintain accurate records.”

Staying Out of Trouble

If there is any confusion or questions that arise regarding a particular prescription, pharmacists should always contact the provider directly. Pharmacists can play a crucial role in helping to limit any fraud that may occur, from someone stealing a clinician’s prescription pad to an individual calling in a medication while pretending to be a clinician or altering a preexisting prescription, which are all fraudulent activities that most pharmacists have faced at one time or another.

Larry P. Cote, founding partner at Cote Law PLLC in Washington, DC, and a DEA compliance attorney, noted that pharmacists must be able to identify red flags as they arise and properly document the resolution of any red flags that do pop up. “Failure to document resolution of red flags is a common factual basis for DEA enforcement actions,” Cote said. “Independent pharmacies also need to periodically review their own pharmacy dispensing data to identify red flags or potentially problematic dispensing [or] prescribing trends.” Compliance requirements and diversion trends continuously evolve, so pharmacists must be proactive and stay abreast of identifying and resolving any issues. The rules from 10 or 20 years ago are not the same as those in today’s world.

Thankfully, there is an abundance of publicly available information to support pharmacists with complying with state and federal controlled substance laws. For instance, Cote noted that individual state boards of pharmacy, as well as the DEA, have significant resources posted online. “Moreover, many enforcement actions are publicized by the DEA,” he said. “It is important to review those actions to understand the DEA’s enforcement priorities and the factual basis for those actions.”

Addressing Audits

Pharmacists are required to submit reports regarding controlled substance prescriptions on a regular basis. As long as there are no discrepancies, they should not be facing an audit. However, if they are identified for an audit, phar-macists must have a plan in place.

If audited by the DEA, Afzal explained that pharmacists should be prepared to cooperate fully with the investigation and to provide documentation of their compliance efforts, Afzal explained. This includes being prepared to answer commonly asked questions about prescribers, patients, and the pharmacy’s policies and procedures. This is another reason why keeping perfect records is a must and should be on the top of any pharmacist’s to-do list.

“Pharmacists should also be aware of the limits of DEA’s authority when conducting an audit, including the types of records the DEA is allowed to inspect, copy, or both,” Cote said. “It is important that pharmacists understand that there is no such thing as a ‘routine’ DEA audit. The DEA usually has a reason to conduct an audit or inspection. [Although] it is important to cooperate with the DEA, that does not mean that you cannot have an attorney present while the audit is being conducted.”