In our ongoing exploration of the Controlled Substances Monitoring Program (CSMP), this blog dives into the intricate world of Red flags. Red flags are the signals to CSMP personnel that a potential diversion risk exists in a pharmacy. These red flags have the potential to evolve and change over time as the CSMP personnel learn more about what signals are actually leading to the discovery of diversion.
It is important for pharmacists and pharmacy owners to understand how their behaviors can grab the unwanted attention of CSMP personnel. With this understanding pharmacy owners can implement changes within their pharmacy to mitigate both the risk of an audit and the risk of diversion. Let’s unravel the mysteries of these red flags.
Nine CSMP Red Flags Used to Evaluate Your Pharmacy
1. Ordering Ratio of Highly Diverted Controlled Substances to Non-Controlled Substances
CSMP personnel scrutinize the ratio of Highly Diverted Controlled Substances to non-Controlled Substances. Highly Diverted Controlled Substances includes: oxycodone; hydrocodone; hydromorphone; tramadol; oxymorphone; morphine; methadone; carisoprodol; alprazolam; and fentanyl.
An unusually high ratio could signal pharmacies with significant rates of ordering these substances, prompting a closer look at their distribution practices. Having a holistic view of your inventory at all times should help maintain a healthy stock without setting off any alarms.
2. Ordering Ratio of Specific Controlled Substance Base Codes or Drug Families
A more detailed examination involves analyzing the ratio of each Highly Diverted Controlled Substance base code or drug family to the total order volume of non-Controlled Substances. This meticulous evaluation helps identify pharmacies with notably higher rates of ordering specific substances, adding an extra layer of scrutiny.
3. Excessive Ordering Growth of Controlled Substances
Rapid growth in the ordering volume of Controlled Substances raises eyebrows. CSMP personnel use specific criteria to identify pharmacies exhibiting substantial percentage growth in Controlled Substances compared to non-Controlled Substances, ensuring a proactive stance against potential issues.
4. Unusual Formulation Ordering
An analysis of ordering patterns extends to identifying pharmacies with significant orders of high-risk formulations. They include, but are not limited to drugs containing 10mg hydrocodone, 8mg hydromorphone, 2mg alprazolam, single-ingredient buprenorphine (i.e., buprenorphine without naloxone), and highly-abused formulations of oxycodone. These formulations are subject to periodic review and annual adjustments (or as otherwise necessary). CSMP remains vigilant, adapting to emerging trends and regulatory guidance.
5. Out-of-Area Patients
CSMP personnel can examine data from pharmacy customers or dispensing activities to evaluate the prescription volume of Highly Diverted Controlled Substances among patients residing outside the pharmacy’s area. This assessment is based on the distance traveled between a patient’s zip code and the pharmacy’s location, with adjustments made according to the geographic region under scrutiny. Additionally, the analysis takes into account the proportion of out-of-area patients for non-Controlled Substances.
6. Cash-Paid Prescriptions
Examining payment methods from customer data or dispensing data, CSMP personnel assess the percentage of cash payments for Controlled Substances against non-Controlled Substances. This scrutiny aims to detect any irregularities in purchase patterns.
7. Prescriber Activity of Pharmacies
The CSMP dives deep into prescriber activity, using pharmacy customer data or dispensing data to identify pharmacies engaging in activity related to dispensing Highly Diverted Controlled Substance prescriptions from Top Prescribers by:
- Identifying Top Prescribers whose practice locations are more than 50 miles from the pharmacy (“out-of-area”), relative to the percentage of out-of-area prescriptions for non-Controlled Substances.
- Detecting Top Prescribers issuing prescriptions for the same Highly Diverted Controlled Substances in consistent quantities and dosage forms, indicating pattern prescribing. For instance, prescribing many patients with identical high-dose, high-quantity supplies of 30mg oxycodone without adjusting for varying medical needs.
- Identifying Top Prescribers where the top five (5) or fewer prescribers account for over fifty percent (50%) of total prescriptions for Highly Diverted Controlled Substances during a specified period.
8. Public Regulatory Actions Against Pharmacies
CSMP personnel can examine data obtained from companies offering licensing and disciplinary history records, such as LexisNexis, and other publicly available sources, including governmental entities. This review aims to determine whether the pharmacy, pharmacists employed by the pharmacy, or the pharmacy’s Top Prescribers have faced professional disciplinary measures within the last five (5) years concerning the dispensing or management of Controlled Substances. Additionally, it aims to determine whether they have been involved in law enforcement actions related to the diversion of Controlled Substances.
While the ongoing licensing by a relevant state agency may be taken into account, it should not solely determine the resolution of the Red Flag. In the case of chain pharmacy locations, confirmation from each chain pharmacy that it conducts annual reviews of its pharmacists’ licensing statuses and addresses regulatory actions by either implementing appropriate employment measures, or disclosing the regulatory action to the Distributor, may also be considered when resolving the Red Flag.
9. Pharmacy Termination Data
CSMP personnel analyze termination data from due diligence files, shedding light on pharmacies terminated by other distributors due to concerns regarding Controlled Substances. This critical information contributes to a well-rounded evaluation. It could also have an impact on a pharmacies ability to onboard with a new distributor in the future, which we will cover at another time.
Conclusion: Understanding the Nine CSMP Red Flags and What to Expect
The heightened scrutiny of pharmacy activities around controlled substances underscores the evolving landscape of drug distribution following the opioid crisis. The nine red flags the CSMP focuses on can serve as guideposts pharmacy stakeholders may use to ensure the controlled substances they dispense don’t end up with individuals in the community that do not need them. This will not only deter drug diversion but it can also prevent another opioid crisis.
On the other hand, doing this work adds more responsibilities to the already heavily-burdened pharmacy staff, being asked to act as ‘gatekeepers’ of controlled substances with risks of losing their abilities to purchase the same drugs. Pharmacies will do well to adopt technology that streamlines this work and keeps them from the potential of being fined.
Given the complexities that come with providing patient care and the diversity in community pharmacy settings, staying vigilant on how the Red Flags are enforced by the wholesalers is important to Pharmacies the desire to stay compliant and continue serving their communities.
Forward-thinking pharmacies navigate operational complexities while promoting accountability and integrity. It’s imperative that pharmacy owners and pharmacists remain vigilant in upholding responsible prescription filling practices to safeguard the well-being of their patients and their communities.
