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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.

 

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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
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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