We've been focusing a lot lately on medication compliance concerning patients. Blogs have discussed topics such as medication compliance tips for improving patient safety and how medication compliance affects outcomes.
But medication compliance can refer to something other than patients complying with their medication regimen. It can also concern the rules practitioners who prescribe medications, their organizations, and pharmacies must follow to comply with medication-related laws and guidelines. In this blog, we share five medication compliance tips to help you adhere to regulations.
1. Don't deviate from prescription requirements.
An easy way to run afoul of the law is to fail to follow the requirements for completing a controlled substance prescription. As the Drug Enforcement Administration (DEA) notes, all prescriptions for controlled substances must be dated as of and signed on the day when issued and must include the following information:
- patient's full name and full address;
- practitioner's full name, address, and DEA registration number
- drug name;
- drug strength;
- dosage form;
- quantity prescribed;
- directions for use, and
- number of refills (if any) authorized.
Furthermore, the prescription must be written in ink or indelible pencil or typewritten. It must also be manually signed by the practitioner on the date when issued.
Omitting any of these details can lead to significant penalties, as Kaiser Foundation Health System learned when it paid $850,000 to settle allegations that a Kaiser Permanente pharmacy improperly filed defective prescriptions as well as failed to maintain accurate records (more on this later).
2. Take controlled substance security seriously.
Theft and misuse of controlled substances are significant issues that can have serious ramifications for an organization. For example, in mid-June 2019, the U.S. Attorney's Office of the District of Minnesota ordered a pharmacy to pay nearly a quarter of a million dollars for its failure to comply with some requirements of the Controlled Substances Act, which enabled a pharmacy employee to engage in a years-long pattern of diverting opioids for personal use.
DEA rules cover a number of security issues. Those with access to controlled substances should regularly review these rules and ensure they and their department is following them without deviation. Rules cover matters including effective controls and procedures to guard against theft and diversion of controlled substances, which also speaks to storage requirements and hiring practices.
3. Act fast when theft or loss occurs.
The federal government requires essentially immediate action when a practitioner or organization becomes aware of the theft or loss of controlled substances. As DEA notes, "Federal regulations require that registrants notify the Field Division Office of the Administration in [their] area, in writing, of the theft or significant loss of any controlled substance, disposal receptacles, or listed chemicals within one business day of discovery of such loss or theft."
It is vital a process in place to complete this requirement so you can meet the short turnaround time. Consider that in 2017, the Safeway grocery chain paid a $3 million fine to resolve allegations that the chain failed to timely report missing controlled substances. U.S. Attorney Annette Hayes stated, "As our community struggles with an epidemic of opioid abuse, we call on all participants in drug distribution to carefully monitor their practices to stem the flow of narcotics to those who should not have them. Pharmacies have a key role to play in making sure only those with legitimate prescriptions receive these powerful and potentially addictive drugs, including by timely reporting losses of those drugs."
4. Maintain spotless records.
This is an issue referenced earlier when discussing the Kaiser Foundation settlement. Proper recordkeeping is essential to medication rule compliance. As a Modern Healthcare article summarizes, pharmacies "… must maintain complete, accurate, up-to-date records for every controlled substance purchased, received, stored, distributed, dispensed, disposed of, or otherwise [passed] through…" Practitioners have their own set of recordkeeping requirements that cover matters including inventory, controlled substances dispensed to patients, and length of time records must be maintained. DEA notes that there are some records practitioners are not required to keep, including controlled substances prescribed and administered in the lawful course of professional practice, with some caveats.
As CVS and Walgreens found out, poor recordkeeping can come with a price — potentially a high one. In April 2013, CVS agreed to pay $11 million to settle recordkeeping violations. Only a few months later, Walgreens agreed to pay $80 million to settle its recordkeeping and dispensing violations.
Concerning the Walgreens settlement, U.S. Attorney Wifredo Ferrer said, "Every day, individuals die from prescription drug overdoses. The recordkeeping requirements of the Controlled Substances Act and DEA regulations are designed to prevent prescription pain killers, like oxycodone, from ending up on our streets. For this reason, we cannot allow pharmacies to circumvent their regulatory recordkeeping and dispensing obligations."
5. Know e-prescribing rules.
Finally, electronic prescribing, or e-prescribing, has its own set of regulations, some of which overlap with written prescribing, some of which are unique to the digital method. Since e-prescribing is still relatively new, state and federal rules have been undergoing some changes in recent years to better ensure safety and security.
One of the most significant medication compliance developments concerns e-prescribing of controlled substances, specifically opioids. As a July 2019 Health Data Management article notes, "More than half of all states in the nation now require electronic prescribing of opioids, other controlled substances or all prescriptions." This threshold was crossed when the governors of Texas, Florida, and Delaware signed legislation in June 2018. A federal law requiring e-prescribing for all controlled substances under Medicare Part D — the SUPPORT for Patients and Communities Act — is scheduled to go into effect in 2021.
What's also important to know is that states with e-prescribing laws often have exceptions to the laws. Take New York, for example. While practitioners in the state are mandated to electronically prescribe controlled and non-controlled substances (as of March 2016), there are many circumstances in which a practitioner may issue an official New York State prescription form, fax of this official form, or oral prescription. These exceptions include complicated or long (more than 140 characters) directions, temporary technical/electronic failure, and select compounded prescriptions.