drug-company-criminally-charged-opioid-epidemic

Major Drug Distribution Company Criminally Charged – What Does This Mean?

News broke late April about Rochester Drug Co-Operative, and its former chief executive and another top executive being criminally charged with conspiracy to violate narcotics laws, conspiracy to defraud the U.S., and willfully failing to file suspicious order reports. The major drug company criminally charged is being investigated further in New York.

What we know:

  • Both former executives face life in prison for failing to file suspicious order with the Drug Enforcement Administration.
  • This prosecution is the first of its kind – that is, “executives of a pharmaceutical distributor and the distributor itself have been charged with drug trafficking (and) trafficking the same drugs that are fueling the opioid epidemic.”*
  • Between 2012 and 2016 the drug company was accused of distributing tens of millions of doses of oxycodone, fentanyl and other opioids that their own compliance department flagged for the pharmacies having no legitimate need for them.
  • Prosecutors said what lead to this was practitioners working for the company acted outside of the scope of their medical practices, which they are now under investigation for.
  • The drug company purposely hid the red flags from the DEA to prevent pharmacy investigations and from potentially losing clients.
  • The company identified more than 8,000 potential orders of interest, either by size, frequency or pattern, however only one was reported.
  • During this 4-year period, RDC’s oxycodone sales grew from 4.7 million to 42.2 million, and fentanyl sales grew from 63,000 to 1.3 million.
  • Due to the growth, the former chief executive’s compensation rose to $1.5 million a year.
  • A spokesperson for RDC said the major downfall leading to these charges was not having adequate systems in place nor were their compliance team and practices rigorous enough to provide controls and oversight over the increased demand for narcotic drugs.

So now what?

Many times we see others thinking they’ll be the next drug company criminally charged because they don’t understand the regulations put in place by the DEA. And often, we see many smaller manufacturer, distributor and other pharmaceutical companies who don’t have the resources for a robust compliance team. So, what can keep companies on track is a robust software that monitors and tracks order data, and immediately reports anything marked suspicious. Not allowing any orders to slip by, or only having one person manage the system. If an order was flagged in an SOM software, it would have immediately been suspended from fulfillment and someone would have to go in, approve, adjust or completely reject the order, leaving an explanation as to why. They also would have been able to utilize previous order data from the permanent repository to gauge past, present and future orders to help make safe operating decisions.

Lately, so many investigations and compliance issues are due to human-error or lack of clear step-by-step protocols to follow when issues like this arise. This can be reduced when multiple users have access to the “order of interest” software workflow.

“Software that can help pharmaceutical companies identify, locate, suspend and investigate orders of interest in an easy-to-use environment is a key component to staying off of the DEA’s radar,” says e-SupplyLink CEO, Todd LaBonte. “DEA regulations can be an intimidating field to maneuver alone and, even more, a costly industry if operating without safety precautions.”

We have been helping companies operate safely within the scope of DEA regulations for more than 10 years. Our solution gives our clients the ability to select which administrators have access to the dashboard so profit doesn’t get ahead of ethics and safety. Having a robust software with customization capabilities would have protected this manufacturer. SOM software is all about supporting the compliance team or individual and giving them the control. We’ve worked with several users to understand their needs and worries, and apply order testing based on those discussions. We make order processing a team effort and ensure everyone using SOMLink is fully trained to maximize the investment. SOMLink has proven to be universally applicable, yet locally adaptable and continues to be a reliable source for identify orders of interest.

 

Keep reading: Pharmaceutical Ethics – Where Modern Day Practices Stand.

 

*Read the full NBC investigation article here.

April 29, 2019 Bussiness, News, SOMLink, TheLink No comments yet
hospitals changing practices

Hospitals Changing Practices To Curb Opioid Epidemic

We read an article from the American College of Physicians website talking about hospitals changing practices for their day-to-day routines. It was an interesting read for sure and we were left with a few thoughts we wanted to share.

 

The gist: Due to the ongoing opioid crisis and rise in the diversion of prescription narcotics, many hospitals are changing practices and protocols to reduce the amount of opioids they distribute to patients. A survey from Vizient in October 2018 shows the most common changes made are prescriber education, implementing new technologies to monitor prescribing and alternative therapies for acute pain management. Also, for any opioids that are prescribed, they are being cut significantly in length, hoping shorter timeframes for these prescriptions reduces the risk of them falling into the wrong hands.

 

Our five key takeaways/thoughts:

  1. We think these steps, while not ideal, are a logical step for ending the diversion of illegal narcotics. Too many times opioids fall into the hands of pill mills and other black markets to continue allowing “free-range” prescribing.
  2. Our big question is how will limiting prescriptions be enforced among doctors? As far as DEA regulatory statutes, there is nothing in there about doctors and their involvement with opioids, and there are multiple sides to this making it difficult to monitor doctors. How can this be generalized across the board? Hospitalists have many different specialties, and the number of prescriptions a cancer specialist writes will be vastly different from a hospitalists who specializes in family practice.
  3. We don’t think taking these narcotics off the line is a reasonable solution. They were created out of need and people rely on them in order to be a functioning member of society. We don’t want doctors and hospitalists to think they need to stop prescribing opioids all together. It’s their job to help their patients, and it’s our jobs to provide tools to make that happen. So when it comes to employing technology to monitor prescriptions, it does all the tracking and allows medical professionals to focus on caring for patients.
  4. Alternative therapies for pain management can be beneficial, however most patients don’t explore those avenues due to insurance. Alternatives can include physical therapy, yoga, or acupuncture, but aren’t covered under a basic healthcare plan, leading to opioids being the “affordable” option. This is an insurance issue, and until it gets resolved and adapted, the number of opioid prescriptions won’t be decreasing any time soon.
  5. And Finally, technology can be the difference for getting off the DEA’s radar. When you implement a software solution that tracks orders, compares them to a historical archive, approves or denies them and then fulfills them, you are demonstrating due diligence for scouting out potential orders of interest.

 

Do you agree with our thoughts? Let us know in the comments below.

March 21, 2019 Bussiness, News, SOMLink, TheLink No comments yet
pharma-compliance-group-partnership

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.

###

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.

January 14, 2019 SOMLink, TheLink No comments yet
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
October 29, 2018 SOMLink, TheLink No comments yet
dea-regulations-folder-jpg

Pharmaceutical Ethics – Where Modern Day Practices Stand

Lately, when looking at pharmaceutical ethics, many organizations focus on quantity and not quality of orders. Attempting to fill as many as possible in the spirit of competition; which leads to companies mismanaging orders and wrong orders being filled. An article in the latest Pharmaceutical Technology magazine provoked the question: Whose responsibility is it to regulate the quality and legitimacy of drug orders?

This question has 15 different responses: is it the DEA, pharmaceutical manufacturing manager, supply chain laborers, or the end customer? The unknown is troubling to the pharmaceutical industry. There is no role of agreement when it comes to regualtions. So, how will the DEA’s code of federal regulations be followed by drug manufacturers? When companies encounter an issue with an order, they mainly work to solve the individual citation, but fail to look at the what’s potentially causing it. Allowing the chance for it to happen again. The most effective solution for quality assurance and compliance strategies begins with robust internal procedures. And that could be as simple as dedicating part of the manufacturing and distributing process to monitoring activity of their customers.

“People complain that quality costs money, but if they really want to see how expensive things can be, they should try a consent decree.” – Chris Moreton, FinnBrit Consulting

The Problem:

With the opioid epidemic growing exponentially, the DEA instituted a federal regulation that all manufacturers and distributors must check their client has the agency’s authorization to possess controlled substances. This mandate opens a need for supply chain monitoring personnel, as a result, requires minor adjustments throughout supply chain procedures. Processes and procedures are not carved into stone, and need to be continually adapted to industrial needs and requirements. A combination of strong personnel training, keeping tools and equipment updated, having a strong quality unit, and developing a quality company culture at all levels allow for a smooth adoption of change. Similarly, there should be on-the-job training and oversight on a continual basis to reduce companies’ risk.

Consequently, one of the biggest difficulties in maintaining good manufacturing practices is complacency. “Once a process or procedure is established and functional, there does not seem to be the impetus to update and revise it,” says Susan Schniepp, executive vice president of Post-Approval Pharmaceuticals. General practices that have been in place at a company for a good length of time are hard to revise. One option companies use to update their GMPs is establishing a policy that ties failure to follow procedures with an internal audit and detect improper performance. A better option to explore is upgrading company tools and equipment, especially computer-driven programs, to monitor manufacturing practices. New technologies and new product types may necessitate an update to procedures.

Where The Responsibility Lies:

The DEA planted regulations on all prescription drug manufacturers and distributors. It doesn’t verify incoming orders, rather the agency investigates orders that come across as suspicious. It has tasked the manufacturers and distributors with complying with the regulations, or face several large fines for supplying illegitimate customers. Repeat mistakes, often caused by tunnel vision, stem from a lack of monitoring orders and from “know your customer” protocols. Today, a pharmaceutical supply chain has to be in constant communication with every department. Applying vertical and horizontal communication principles passes information from the DEA, to company administrators, on down through the company. Through fostering communication between employees on several levels helps ensure the supply chain is a smooth operation.

Developing and Maintaining New Procedures:

Change is inevitable, especially when the industry is facing unheard of fines on the horizon of an epidemic. One way to incorporate new policies and procedures is to involve all parties in the process of developing them. What new protocols need followed when fulfilling orders? One way to combat an overwhelming change is to seek the help of professionals because the concept of suspicious order monitoring is new for companies and the fine print in the regulations can be intimidating. The first step is having a solid understanding of where your current order-manufacturing process is at. Having the knowledge of your employees’ abilities is crucial before incorporating new software because it informs management of the best way to introduce and train staff on suspicious order monitoring software.

At e-SupplyLink, we are those professionals your company requires. We work with DEA agents to ensure our suspicious order monitoring software complies with the federal regulations for controlled substances. Which means less work for your company. SOMLink has been on the market for eight years and continues to be a leader in suspicious order monitoring. To keep procedural alterations to a minimum, we integrate our software into existing EDI translators and ERP management systems.

 

August 14, 2018 SOMLink, TheLink No comments yet
supply-chain-digitization-jpg

5 Ways Digitization Transformed the Supply Chain

Digitization has proved to benefit the efficiency and productivity of the supply chain. The point of digitizing is to revamp supply chain management and to streamline repetitive tasks. A 2017 study from McKinsey found the average supply chain has a digitization level of 43 percent and only 2 percent of executives said that the supply chain is the focus of their digital strategies. Seizing an opportunity to digitize the supply chain has surprisingly been a challenge for a lot of companies. Embracing new technology also means revamping operational practices – which could even mean building a whole new management strategy.

The best way to digitize is to integrate advanced, leading-technology and revamp operations. Management usually understands the measures to the transformation approach – establishing a vision for the future supply chain, assessing the current state and envisioning the future path to take.

We’ve analyzed five different ways that digitization influenced the innovation of the supply chain.

  1. Supporting major operations like warehouse management.

    It was clear there was a need for innovating warehouse management. Tasks were becoming too tedious and were at risk for being mismanaged. Digital technology provides tansformative capabilities for inventory management. Linking cross-functional data like inventory, shipments, and schedules from internal and external sources, forecasting demand and performance. This is a way for planning to become more precise, and problems can be anticipated and prevented. A supply chain digital-transformation, then, is about establishing how applications can improve cost, agility and inventory levels to drive operational excellence. Our ComplyLink software is an automated database that tracks and traces every order that comes through an order management system – helping to manage inventory levels. Scanning routines like scan/pack, scan/print and scan/verify with ComplyLink automatically updates the database with shipping data. As a result, it eliminates the need for manual entry of order data making warehouse management more efficient and accurate.

  2. Digital transformation employs analytics, artificial intelligence, and other advanced technology to collect and process information automatically.

    Before digital technology, orders were processed by hand; getting passed along, person to person. Each time facing error-prone updates causing incorrect or delayed orders. Files were easily lost and entering data was a painstaking task. Our suspicious order monitoring software, SOMLink, is designed with a repository to store critical information pertaining to each customer. Each time an order is processed we compare it to past orders in regards to frequency, size and pattern. This allows companies to quickly identify and be alerted about orders of interest. Instead of delegating a single person to manually keep track of records for orders of interest and report then to the DEA, we created a solution to automatically process and store that information. SOMLink automatically captures orders of interest before they are fully processed and directly reports them to the Drug Enforcement Administration. Significantly reducing the risk for businesses.

  3. New technology can integrate better methods for collaboration.

    The key to supply chain success isn’t just a matter of buying and installing software. It’s about utilizing this software to reach the highest level of collaboration because it allows for an end-to-end perspective and update of the supply chain. This supports the overall mission of changing the ways employees and teams share/gather information. It also seeks out problems and opportunities for improvement, reaches decisions and carries out actions. The newest digital technologies can move a company forward with better methods of collaboration and prevent them from returning to their old ones. For that reason, both of our solutions have a multi-user interface feature that encourages collaboration among team members. It’s a key value for us to ensure our solutions make businesses more efficient and operations a lot smoother.

  4. Digitization can provide better end-to-end customer engagement.

    When supply chains utilize digital technology it allows the process to be undeniably transparent. The technology gives mangers more control with the orders and having a system that automates everything provides customers with detailed updates about their shipments. These updates include routing information, quantity of contents, and the date they’ll be shipped and delivered, also known as an advanced shipping notice. ComplyLink has a transportation management feature where suppliers and their customers can electronically exchange information from purchase orders to shipment authorizations. We make it easy to keep your customer “in the loop” so communication is not lost, and shipments are expected. The TMS feature also sends detailed advanced shipping notices to customers allowing them to prepare ahead of time for orders.

  5. Digital technologies provide deeper, more insightful assessments on supply chain performance.

    Integrating supply chain processes with ERP systems sets up data streams from sources within its organization. Incoming data is fed into the same processing engine where it can be connected to show how activities and decisions in one area of the supply chain affect other operations.  Linking related data sets can uncover systemic issues including: mismatched lead times and past-due purchased orders that hinder future key performance indicators of future demand for extended suppliers.  The consequences of not linking related data sets leads to customer order delays. This ties closely with that end-to-end perspective necessary for supply chain success.  Supply chains quickly have a domino effect if technology is not employed. One area of the supply chain isn’t fully up to speed and another area is waiting on them, it prevents high levels of work getting done. This feature ensures efficiency and create high-end productivity among the team.

 

 

Source: https://www.mckinsey.com/business-functions/operations/our-insights/digital-transformation-raising-supply-chain-performance-to-new-levels
July 17, 2018 ComplyLink, SOMLink, TheLink No comments yet
national-take-back-day-jpg

National Take Back Day 2018

The next National Take Back Day is Oct. 27, 2018!

June is National Safety Month, but we’re not talking big machinery safety. We’re talking about the safety of our health. Twice a year the Drug Enforcement Administration sponsors National Take Back Day. They partner with law enforcement and various pharmacies within communities to provide ways for patients to dispose of unused, unwanted and expired prescriptions. The purpose behind this day is to provide a safe, convenient and responsible way to dispose of drugs, opposed to tossing them in the trash. The day also serves as a way of educating the public about the potential for drug abuse. Your medicine may be helpful for you, but remember it’s most likely harmful to someone else.

What if I can’t make it to a registerd facility to dispose my prescriptions?

While it is preferred prescriptions be taken back to registered officials, there are ways to dispose of them at the house. Most prescriptions come with specific directions on how to get rid of them when they are no longer needed. Be sure to always check the patient information booklet attached to your prescriptions packaging. Some medicines can be especially harmful to others, in which case they have instructions to immediately flush them down a sink or toilet. This fully eliminates the potential risk of someone reaching into the garbage and taking them.

Another common household way to dispose of your prescriptions is by throwing them in the trash. Now it’s not as simple as it

seems. There’s definitely extra steps involved to ensure the safety of everyone in the house. If you opt to throw medicine away, follow these steps provided by the FDA:

  1. Remove the drugs from their original container and mix them with something that is unappealing such as coffee grounds, cat litter, or dirt. This makes the medicine undesirable to children and pets, and unrecognizable to someone who may go through the trash.

    Photo courtesy of the FDA; www.fda.gov

  2. Put the mixture in a seal-able container to prevent the drug from leaking or spilling out.
  3. Throw the container in the garbage.
  4. Take the original prescription bottle and with a permanent marker scratch out all personal information. Doing so protects your identity and privacy. You may also peel the label off and shred it.

Should you have any questions about your medicine always contact your health provider or pharmacist.

Environmental Concerns Addressed

 

Keeping these drugs out of our water supply is crucial as well for preventing drug addictions. That is why it is important only drugs with instructions to be flushed or poured down the drain. Other prescriptions and over-the-counter drugs should be taken to take-back-programs or mixed with other trash in a seal-able container. While we’re trying to keep medicine out of the wrong hands, we also need to strive to keep it out of our water supply.

As we continue to combat the opioid epidemic, helpful tips like these, or even days dedicated to collecting loose and unwanted drugs benefit everybody.

Any further questions, or for more background information and regulations visit the DEA’s website here.

 

Sources:
https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm101653.htm#steps
June 17, 2018 SOMLink, TheLink No comments yet
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