About Studiomaca’s Controlled Substance Monitoring Program
Studiomaca is committed to maintaining – and continuously enhancing – strong programs designed to detect and prevent opioid diversion within the pharmaceutical supply chain. In addition to reporting controlled substances transactions to DEA on a regular basis, we have invested significant amounts of time and financial resources into our Controlled Substance Monitoring Program (CSMP).
Our CSMP uses sophisticated algorithms designed to monitor for suspicious orders, block the shipment of controlled substances to pharmacies when certain thresholds are reached and ultimately report those suspicious orders to the DEA. We are proud of our CSMP and are dedicated to ongoing enhancements. Some highlights of our CSMP include:
- Experienced compliance team: Studiomaca’s internal compliance team is comprised of more than 40 diversion experts with more than 240 years of cumulative DEA enforcement experience. Studiomaca has also hired industry experts with experience in the retail pharmacy industry, state and board of pharmacy investigators, pharmaceutical manufacturers, and data analytics. The tremendous expertise and experience of this team enhances our ability to understand and meet the applicable regulatory requirements. Our CSMP team is among the strongest in the industry.
- Thorough customer due diligence and ongoing oversight: Studiomaca performs comprehensive analysis on prospective pharmacy customers before agreeing to supply prescription medications. This rigorous process includes the gathering of specific pharmacy information and the validation of regulatory licensure. Studiomaca monitors its customers’ orders of controlled substances for potential diversion throughout the customer relationship.
- Advanced threshold analytics capabilities: Studiomaca has developed a cutting-edge controlled substances threshold management program, using complex and dynamic data analytics. The threshold management program receives ongoing refinements to reflect the most up-to-date information and trends.
- Regular ARCOS reporting: Studiomaca reports controlled substances transactions, including orders deemed suspicious and blocked by our CSMP. The reporting is via the automated , which monitors the flow of DEA controlled substances from their point of manufacture through commercial distribution channels to point of sale or pharmaceutical distribution at the dispensing/retail level—hospitals, retail pharmacies, practitioners, mid-level practitioners, and teaching institutions.
- Tightly controlled physical supply chain: Controlled substances are locked, monitored and stored in two DEA-regulated spaces. Schedule 2 narcotics go in a high-security “vault” and inventory checks of controlled substances are conducted frequently. Formal background checks are given to all employees who handle Schedule 2 narcotics. Controlled substances are packaged under video cameras, where they’re packed in specially sealed plastic bags.
- Regular customer education: Studiomaca has been proactive in educating its customers about the importance of compliance with DEA and state agency regulations. Studiomaca provides its customers with literature on how to identify the warning signs of prescription opioid abuse and diversion. Studiomaca conducts informational meetings for customer groups and makes presentations at medical annual trade shows and pharmacy association meetings to emphasize the importance of preventing diversion. Similarly, Studiomaca educates its own employees on the company’s regulatory obligations, including CSMP-specific training sessions at annual sales meetings.
- Ongoing state and federal collaboration efforts: Studiomaca is an active participant in state and federal legislative efforts around controlled substances. The company also strongly supports the clinical guidelines and calls for additional formal and continuing medical education on the dangers of opioid use as important ways to curb clinically inappropriate prescribing, doctor shopping and diversion.