e-SupplyLink and The Pharma Compliance Group Form Strategic Partnership

 

e-SupplyLink brings supply chain technology for compliance to the Pharma Compliance Group experts to ensure the Drug Enforcement Administration’s regulations are being met.

 

TRAVERSE CITY, Mich., – Supply chain technology provider, e-SupplyLink announces strategic partnership with the Pharma Compliance Group to bring clients a holistic suspicious order monitoring solution.

e-SupplyLink developed SOMLink, a suspicious order monitoring software, in 2008 to combat the growing opioid abuse epidemic. We have helped several companies avoid fines from the DEA because of our rigorous 18 algorithms designed to catch and suspend orders of interest.

The Pharma Compliance Group is the leader in providing regulatory compliance services and investigations to the pharmaceutical industry. Their programs and services are done by former DEA agents, diversion investigators, and professional auditors. PCG assists clients in “traversing the regulatory requirements and in mitigating the associated risks” when operating in the field.

Maneuvering DEA regulations is no small feat and keeping track of order history manually can be extremely frustrating. The Drug Enforcement Administration requires pharmaceutical manufacturers and distributors know their customers to better understand order history. SOMLink by e-SupplyLink has a built-in repository, which automatically tracks customer’s orders and then compares incoming orders against them. In conjunction with PCG’s consulting services users will determine, address and prevent compliance concerns, and can continue to fulfill orders with the knowledge they’re operating safely.

Both companies work together to ensure clients’ success. e-SupplyLink works to understand supply chain needs, tailor our software and determine which of our 18 algorithms should be applied on SOMLink. The Pharma Compliance Group works to educate clients about DEA regulations. They provide several consulting opportunities to pharmaceutical manufacturers, distributors, pharmacies, and hospitals and physicians, including mock inspections, a complete internal review, and drug dispensing analysis to detect patterns or issues.

Partnering with the Pharma Compliance Group brings unparalleled services to clients in the regulatory pharmaceutical industry. When combined, these companies bring 46 years of experience to their clients in supply chain technology, and DEA requirements and practices. This partnership opportunity fills the gap for compliance and allows us to leverage the complimentary capabilities of both e-SupplyLink and the Pharma Compliance Group. This synergist approach provides great opportunities to tackle our clients’ challenges now and in the future.

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About e-SupplyLink

Founded in 1999, e-SupplyLink has been a leading provider of supply chain technology. We are devoted to providing premium solutions to monitor and track orders to reduce companies’ risk and eliminate human-error. Our software is always customized to meet our clients’ needs and easily integrates into existing third-party systems. Being in the supply chain industry for almost 20 years has put us at the front-line of technology’s exponential growth. We continually update our software to meet today’s demands helping shape supply chain management over the years. We’ve seen it all and will continue to evolve our software to meet market demands.

About The Pharma Compliance Group

The Pharma Compliance Group is made up of former DEA special agents, diversion investigators and private security experts providing specialized consultation, compliance, and field services to the pharmaceutical industry. Our team members have extensive experience conducting regulatory inspections, evaluations and investigations for DEA registered entities. Our staff is committed to providing the pharmaceutical industry with the expertise needed to maintain effective compliance with the Controlled Substances Act and the regulations contained in the Code of Federal Regulations.

Spooky Reality of Suspicious Order Monitoring

The Spooky Reality of Suspicious Order Monitoring

Have you ever taken the time to look at the reasons behind suspicious order monitoring? The concept of SOM was introduced by the Drug Enforcement Administration with regard to the opioid crisis spreading across the U.S.A. The DEA does not target users, but instead focuses on the supply: cartels and rogue individuals that divert products. Suspicious order monitoring is designed to help pharmaceutical manufacturers comply with these regulations to protect both their business and patients. Even with these protections in place though, opioids are still roaming across the states, forcing the DEA to open investigations on manufacturers.

Back in 2015, 200 Floridian primary care physicians admit to prescribing medications for unsuitable conditions and overlooked non-addictive prescriptions that have been shown to be more effective. Taking extreme measures to catch illegitimate suppliers and manufacturers, the DEA has found every region east of the Mississippi has drug dealers and users spanning across it. Many manufacturers have been fined, some upwards of $35 million for filling what are known to be orders of interest.

From the business world, not adhering to these regulations is seen as malpractice and result in large fines. But, looking on a broader level, these malpractices are impacting the everyday lives of Americans. Teenagers pack into vans, travel across state lines to access these pain management clinics in Florida; leaving with around 500 to 600 pills each. But this isn’t the only instance of “loosely regulated clinics” handing out prescriptions.  Seventeen thousand pills were sent via mail to a small town in West Virginia from a man in Hillsborough County, Florida. A major reason pill mills have proliferated Florida is because, unlike other states, there wasn’t a system for monitoring prescriptions. Law enforcement believed having a monitoring system would have prevented “doctor shopping” and the widespread of oxycodone.

How the Increase in DEA Presence Decreased Opioids

The DEA’s response to the opioid crisis was implementing strict regulations for pharmaceutical manufacturers with dire consequences if not followed. Their only goal is to protect the American public by preventing diversion of controlled substances. The “Know Your Customer” policy was created by the DEA for manufacturers to understand where their distributors take supplies. If manufacturers had known prescription drugs were headed to these pill mills in Florida, they could have stopped supplying them, avoided the outrageous fines and, ultimately, saved people from a lifetime of addiction.

Since the rise of the opioid epidemic, the DEA has been fighting tirelessly to end the diversion of opioids while ensuring they remain available to those with a genuine medical, scientific and industrial need. The administration’s increased ability to interfere with the diversion of controlled substances encourages vigilance from drug manufacturers, and opens the door for better communication between the DEA and individual states. In the past year alone, several significant settlements and court decisions have resulted from this new requirement.

Enhancing the role of the DEA boosts the protection they provide for the public. In order to get prescription drugs off the street, they needed the OK to step in and take action. Since then, the DEA was forced to shut down more than 250 “pill mills” in Florida,

Since implementing new regulations and compliance guidelines, the DEA has also launched a semi-annual event to collect unused and unwanted prescriptions. The main goal: to get these addictive drugs off the streets. The National Take Back Day occurs twice a year  and the DEA partners with almost 6,000 locations nationally to collect excess prescription drugs. The DEA hosted 15 Take Back Days since the fall of 2010, and collected and destroyed 4,982 tons of unused, unwanted and expired drugs. Drugs that could have easily been left in a medicine cabinet for a friend or family member to discover.

The Bottom Line:

The Drug Enforcement Administration is not out looking to fine businesses. They are fulfilling their mission focused on protecting the American public. These recent developments point to enhanced DEA expectations for compliance and escalated penalties for noncompliance throughout the prescription opioid distribution chain. The DEA is looking for consistency in reports, especially in those taking a “know-it-when-you-see-it approach” that is difficult to systematize. The lack of sufficient data and incomplete information from customers can make it difficult to decide whether or not to fill prescription orders.

Working with a trusted SOM developer takes the guess work out order fulfillment and can help align your business with the goals of the DEA; allowing for more trust as well from the administration. SOM is the safe step for the pharmaceutical industry. Defensive algorithms work around the clock checking orders so it doesn’t have to be a manual task. They are more reliable than humans and keep supply lines free of delays if an order is flagged as suspicious.

DEA regulations can be confusing to link together. Contact us today to see just how SOMLink ties your supply chain to the DEA.

Sources:
https://www.nij.gov/topics/drugs/markets/Pages/florida-legislation-helps-reduce-the-number-of-pill-mills.aspx
file:///C:/Users/ESL-Marketing/Documents/suspicious_order_monitoring-part1.pdf