TrackTrace Rx

Month: May 2018

Integrity Issues In the Drug Supply Chain

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The Drug Supply Chain Security Act (DSCSA) was created to address integrity issues within the drug supply chain. What exactly are the issues the DSCSA was created to tackle? Most of the issues the DSCSA seeks to solve involve preventing the distribution of unsafe or ineffective drugs within US borders. Many drugs within the country are counterfeit, tainted, or otherwise unsafe which can greatly harm the health of people who use them.

Fighting Drug Counterfeiting

Getting anywhere close to an exact number regarding the amount of counterfeit drugs in the US is difficult, precisely because counterfeit drugs aren’t labeled and tracked like legitimate drugs are. Yet the World Health Organization estimates that approximately 1% of all drugs in developed countries could be counterfeit, with this percentage being much higher in other countries.

Known examples of drugs that have suffered from counterfeiting in the US include Lipitor (a medication to lower cholesterol), Procrit (stimulates the growth of red blood cells) and Alli (an over-the-counter drug used for weight-loss). These counterfeit drugs often contain the wrong ingredients for treating a condition or inactive ingredients, and as such counterfeit drugs can cause a variety of unexpected and dangerous side effects or be utterly ineffective in their treatment of a condition.

The production and distribution of counterfeit, tainted, or low-quality drugs can even harm people who haven’t taken the drug. Low-quality drugs – drugs that do not contain enough active ingredient to be effective – can end up contributing to the development of drug-resistant diseases and the outbreak of diseases in a population. If a drug contains an insufficient dose of an ingredient to kill off all of the bacteria, the remaining bacteria can become resistant to it. In addition, if a drug fails to kill off the bacteria in one host, that host can propagate it to other people.

Combating counterfeit or tainted drugs is difficult because not only must the FDA account for drugs produced within the country, but many drugs and medical devices are manufactured outside of the country as well. These drugs and medical devices are imported into the country, but many of the imported drugs are unapproved.

The importation of drugs also allows criminals a chance to steal drug cargo and resell them on a black market, where the distribution of the drugs is not monitored for safety. Drug heists aren’t extremely common, but when drugs do get stolen millions of dollars worth of drugs can quickly disappear. Cargo thefts that occur in the pharmaceutical industry cost around 4 million dollars per theft on average.

The Supply Chain Security Toolkit

One of the ways the FDA is dealing with drugs coming from other countries is by creating a “Supply Chain Security Toolkit”. This toolkit is supposed to be useable by drug supply chain authorities in other countries, including countries that are part of the Asia-Pacific Economic Cooperation (APEC) group, as well as non-APEC countries, academics, and non-governmental organizations (NGO)s.

The toolkit provides comprehensive information relating to every aspect of the drug supply chain and advises people on things like counterfeit detection technology, track and trace procedures, and internet sales tracking.  The toolkit covers things like the raw materials used in manufacturing to the information provided to patients about best use practices. It is hoped that regulators and stakeholders alike will implement its tools and advice to adopt better safety practices and standards, with the ultimate goal of reducing counterfeit or substandard drugs and protecting consumers.

Regarding the drug supply chain in the US, the DSCSA was created to help protect the integrity of the drug supply chain as a whole. It has provisions in it that mandate the creation of a system for tracking drugs through the entire supply chain, from manufacturers to distributors, repackagers and dispensers.

The Role of the DSCSA

The hope is that through the creation of a system that labels and tracks all drugs within a system, verifying the authenticity and safety of a drug will be much easier and quicker. One of the ways that the DSCSA is seeking to ensure a drug can be traced through the supply chain is with product identifiers, a unique label that has information relevant to that batch of drugs on the packaging or case. The identifiers will enable people to look up the specific case of drugs in a database and see their entire history, from manufacturer down the entire drug supply chain.

Not all medical substances must fall under the purview of the DSCSA. Some exemptions from the DSCSA include blood for transfusion, radioactive biological products, medical gases, and products for sterilizing water. Compounds like these are often more difficult to counterfeit and they are not considered DSCSA products, so trading partners dealing only with these substances do not have to abide by DSCSA regulations.

FDA Education Initiatives

In addition to the creation of the DSCSA, the FDA has launched multiple initiatives to help combat substandard or counterfeit drugs and protect consumers. The FDA has a campaign referred to as BeSafeRx, which is intended to alert the public about the dangers associated with purchasing medication through uncontrolled online pharmacies. The FDA tells consumers not to buy drugs from these sites.

The FDA also has a program called Know Your Source. While BeSafeRx is an educational program for the general public, the Know Your Source program is designed to target healthcare professionals. The program aims to educate healthcare professionals about potential sources and warning signs of unsafe drugs so they can avoid passing them on to their patients. Finally, the FDA sends out letters to health care providers, with the goal of advising them that they might have unintentionally purchased drugs from dangerous and unregulated sources.

There are many integrity issues with the drug supply chain that pose substantial risks to the health of society. This makes the DSCSA necessary to protecting the health of patients and consumers across the United States.

About TrackTraceRx Suite

Other solutions on the market today are totally fragmented by only providing one piece of the puzzle. Pharmaceutical companies today are stuck subscribing to multiple services, accessing different companies for support and paying thousands of dollars to integrate different systems. The TrackTraceRx Suite is a game changer by combining the TrackTraceRx Traceability Solution, a ERP, and a Commerce Platform completely integrated out of the box. This eliminates having to deal with multiple support, feature services and integration costs.

Please watch our video at http://www.tracktracesuite.com

About the Author

Chris Souza is the Co-Founder of TrackTraceRx. He loves all things traceability in order to keep products safe! Follow him on Twitter

Chris Souza

What Will Happen In The Next Phase Of The DSCSA?

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This year will see the end of the Drug Supply Chain Security Act (DSCSA)’s midterm goals. The DSCSA will hit its second milestone and proceed into the third phase of the Act. What does the transition into the third phase of the DSCSA mean for trading partners involved in the drug supply chain?

The Different Phases Of The DSCSA

Seeing how the third phase of the DSCSA will impact trading partners requires laying the groundwork for the DSCSA. The DSCSA was created to give the FDA more ability to regulate drugs involved in the drug supply chain. Many drugs that move through the drug supply chain are illegitimate or dangerous. They can be counterfeit, contaminated, stolen, or otherwise hazardous. To combat these hazardous drugs, the DSCSA’s goal is to allow the tracking of specific drugs from the manufacturer all the way down to the consumer. The fact that every time the drug changes hands it is logged means that it is much easier for regulatory bodies to find out where a problem occurred if something goes wrong.

The transition from the current system of tracking drugs to the advanced traceability system of the DSCSA couldn’t happen overnight. Members of the drug supply chain had to have time to transition to the new requirements. Because of this fact, the DSCSA was broken up into different phases with different milestones.

The phases of the DSCSA are as follows:

  1. Lot-level Management
  2. Item Serialization
  3. Serialized Traceability

The Previous Phases Of The DSCSA:

Lot-Level Management

The DSCSA’s first phase dealt with lot-level management. It started on January 1st, 2015 and applied to manufacturers, repackagers, and wholesalers. It started applying to pharmacies on July 1st of that year. The lot-level management system was intended to kick off the transition between monitoring lots and batches of drugs to the monitoring of individual items. Lots and batches refer to specific groups of prescription drugs manufactured or packaged at a specific location. The way these batches and lots were tracked involved the compilation of three different datasets.

Transaction Information, Transaction History, and Transaction Statements all had to be included along with a transaction. Transaction information contained things like the number of containers, the lot number of the product, the strength and dosage of the product, and the transaction date. The history of the transaction was a statement that contained all previous transaction information going back to the manufacturer. The transaction statement is a statement acknowledging that the product has changed hands to another trading partner.

Item Serialization

We are currently in the middle of the midterm portion of the DSCSA. This period runs until November of 2019 and it mandates that re-packagers and manufacturers of drugs must serialize the individual packages with a unique product identifier.

The product identifier that the DSCSA requires is a combination of several different systems previously used to track drugs. These include systems like the national drug code established by the FDA, barcodes which are part of the GS1 Global Trade Item Number system, individual serial numbers, lot numbers, and expiration dates. These various forms of information are to be combined into a single label that can be applied to an individual drug package. This product information is put into a 2-D DataMatrix that enables the product to be (with some effort) tracked back through the system by a human or computer. Product packages cannot change hands in between trading partners without the included product identifier.

Tracing Products At The Item Level

By November 2023 the FDA expects that all trading partners involved in the drug supply chain will be utilizing product identifiers and have a system capable of tracking these product identifiers all the way through the chain. Whereas previous levels of the DSCSA mandated that packages of drugs must be trackable, by this point individual items must be traceable as well.

The product identifier information must be entered into some kind of system that allows an individual item to be traced in between trading partners. Currently, members of the drug supply chain are experimenting with possible solutions to the drug tracing problem. Various pilot programs are being tested out by different companies, and solutions like blockchain and other communal databases are being explored. December of last year saw the FDA released statements regarding their standards for data exchange, data architecture, and data aggregation. These standards must be taken into account by companies and pilot programs moving forward.

So to recap, what exactly will happen in the next phase of the DSCSA? As the next milestone for the DSCSA comes ever closer, the companies involved in the drug supply chain will not only need to implement serialization at the item level of the supply chain, they will also need to create a method of storing serialization information and allowing the FDA or other authorities to trace products all across the supply chain. The task may be daunting, but the benefits for consumer health and safety will be worth it.

About TrackTraceRx Suite

Other solutions on the market today are totally fragmented by only providing one piece of the puzzle. Pharmaceutical companies today are stuck subscribing to multiple services, accessing different companies for support and paying thousands of dollars to integrate different systems. The TrackTraceRx Suite is a game changer by combining the TrackTraceRx Traceability Solution, a ERP, and a Commerce Platform completely integrated out of the box. This eliminates having to deal with multiple support, feature services and integration costs.

Please watch our video at http://www.tracktracesuite.com

About the Author

Chris Souza is the Co-Founder of TrackTraceRx. He loves all things traceability in order to keep products safe! Follow him on Twitter

Chris Souza