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Drug Supply Chain Security

Drug Supply Chain Security Act

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All Trxade Suppliers Are Pedigree Compliant

(AKA Track & Trace)

Drug Supply Chain Security Act (DSCSA), July 1st 2015

What You Need To Know About Trxade’s Pedigree Compliance

Quick Version:
Have peace of mind that Trxade suppliers are 100% DSCSA compliant, and as always, we have you and your best interests covered!

Be Informed:

With the new Drug Supply Chain Security Act (DSCSA) requirements and processes pharmacies must follow, Trxade makes this transition even easier. Trxade has reached out to each Supplier and confirmed each Supplier’s Pedigree process to ensure compliance. We are compliant, our suppliers are compliant, shop away with confidence!

Pharmacy: DSCSA July 1st, 2015 Checklist

Through Trxade, you have direct access to Transaction Pedigree information via Electronic Web Portal, Invoice/Pedigree Request Combo at Point of Sale, or Directly Requesting Transaction History up to six years from point of sale from each Supplier.

Supplier: DSCSA July 1st, 2015 Checklist

Each supplier will maintain point of sale transaction information, supply chain history, and transaction statements on behalf of Purchaser and provide access to documentation for up to six years after point of sale.

ADDITIONAL INFORMATION

Drug Safety Via Track-and-Trace, You Are A Key Component
Title II of the Drug Supply Chain Security Act (DSCSA) of 2013 created a safeguard for patients to ensure they receive uncompromised medications. This system makes drug distribution affordable, clear, efficient, and transparent. The DSCSA has created a 10-year plan that includes an interoperable system to protect patients through national serialization and traceability of pharmaceutical drugs. There is a series of steps to be taken to reach complete electronic traceability and serialization by 2023. It will require product identification, product tracing, product verification, detection and response to any suspect drugs, notification of suspect drugs to the FDA, wholesaler and third party licensing reports.

Pharmacies: Steps Now (Steps 1 & 2)

The first step of this system was rolled in January 2015

  • Pharmacies can verify that they are receiving legitimate medications through authorized suppliers via a document that they will receive containing a transaction history of drug shipments every company that has owned the drug.

The second step of this system is going live on July 1, 2015

  • Pharmacies will be required to quarantine and investigate any suspicious drugs they have that may appear to be tampered with or are missing important information, such as the NDC code.
  • Create standard operating procedures for unpacking drugs.
  • The records of their investigation must be retained by the pharmacy for 6 years and any medication that is deemed tampered with, counterfeit etc., must be reported to the FDA.

Planning Ahead: 2017-2023 (Steps 3 – 5)

The third step is set to roll out in 2017

  • Drug packages will have a two-dimensional (2D) bar code with a distinct serial number on it.
  • It is recommended that the pharmacy check the authenticity of these serial numbers, but it is not required.

The fourth step is planned for 2020

  • Pharmacies can only purchase drugs with these serial numbered, 2D bar codes
  • A percentage of these serial numbers must be verified when conducting investigations into drugs that may appear unsafe, counterfeit, compromised etc.

The last and fifth step of this safety system is forecasted for 2023

  • All pharmaceutical companies and pharmacies must be a part of the fully electronic traceability system that uses unique serial numbers to eradicate illegitimate drugs.

Diane Darvey, the Director of Federal and State Public Policy for the National Association of Chain Drug Stores, states explains how this new process includes the entire supply chain, “It’s a shared responsibility and team effort. Pharmacists play an important role in that.”

TRAINING: For those seeking “FDA” training, the FDA has posted a 22 minute recorded webinar: “DSCSA Updates and Readiness Check: Requirements for Dispensers and other Trading Partners Webinar“.

References:

Drug Shortages On The Rise

Drug Shortages On The Rise

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Drug Shortages On The Rise

Global shortages of drugs are causing unnecessary surgeries, relapses of cancer, and even fatalities in the U.S. This is an ever-increasing problem that could affect you, your business, and your loved ones. In just five years, the shortage of drugs in the U.S. has risen to an amazingly high, 74%. The shortage has a broad coverage of drugs, from saline and anti-inflammatories to cancer treatments and anesthesia (Loftus, 2015). Even treatments as simple as a Vitamin A injection and pain medication can be hard to come by (Eban, 2014).

According to the Infectious Diseases Society of America, it is highly probable that in the near future, the U.S. will suffer from a drug shortage of five important injectables to prevent infection, which can have a significant negative impact on the care of our patients and the healthcare system as a whole. The FDA currently has 64 drugs on its Shortage list. To view a current list of drug shortages visit https://rx.trxade.com/drug-shortages/.

The FDA focuses on shortages of medically necessary products since these shortages have the greatest impact on public health. The FDA lists shortages primarily of medically necessary products. Shortages that are expected to be resolved quickly or which involve only a particular strength or package size, are not usually listed on FDA’s Drug Shortage list.

Trxade Helps Acquire Drugs in Short Supply

Ketorolac Tromethamine is an example of an important anti-inflammatory medication that is in short supply. Trxade currently has 6 suppliers representing 3 different manufacturers of Ketorolac Tromethamine on its online comparison shopping platform. Trxade is a great resource to search multiple suppliers, price compare, and acquire drugs in short supply and high demand.

Causes of U.S. Drug Shortages

There are multiple factors that contribute to drug shortages, both due to a lower supply and a higher therapeutic demand. Some of the specific factors are quality requirements, internal or external price referencing, manufacturing process requirements, and even noncompliance (Weerdt, Simoens, Hombrockx, Casteels, & Huys, 2015). Knowing the exact cause of a shortage in drug supply can be difficult to determine “because manufacturers have no legal obligation to transparency” (Valquette & Laupland, 2015).

The FDA states the top reported reason a drug shortage occurs is due to quality/manufacturing issues. On their website they explain “However there have been other reasons such as production delays at the manufacturer and delays companies have experienced receiving raw materials and components from suppliers. Discontinuations are another factor contributing to shortages. FDA can’t require a firm to keep making a drug it wants to discontinue. Sometimes these older drugs are discontinued by companies in favor of newer, more profitable drugs.

With fewer firms making older sterile injectable drugs, there are a limited number of production lines that can make these drugs. The raw material suppliers the firms use are also limited in the amount they can make due to capacity issues at their facilities. This small number of manufacturers and limited production capacity for older sterile injectables, combined with the long lead times and complexity of the manufacturing process for injectable drugs, results in these drugs being vulnerable to shortage. When one company has a problem or discontinues, it is difficult for the remaining firms to increase production quickly and a shortage occurs.”

References:

Eban, K. (2014, June).  Drug shortages: the scary reality of a world without meds. Reader’s Digest.

Loftus, P. (2015, May). U.S. drug shortages frustrate doctors, patients. The Wall Street Journal.

Valquette, L., & Laupland, K. (2015). Antimicrobial shortages: another hurdle for clinicians. The Canadian Journal of Infectious Diseases & Medical Microbiology, 26 (2), 67-68. Retrieved from: search.proquest.com

Weerdt, E., Simoens, S., Hombroeckx, L. Casteels, M., & Huys, I. (2015, March). Causes of drug shortages in the legal pharmaceutical framework. Science Direct-Regulatory Toxicology and Pharmacology, 71 (2), 251-258. doi:10.1016/j.yrtph.2015.01.005.

Is Increased Government Regulation the Answer for High Drug Cost?

Is Increased Government Regulation the Answer for High Drug Cost?

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Is Increased Government Regulation the Answer for High Drug Cost?

The Pharmaceutical industry is a highly regulated submarket in terms of what drugs get approved for national, safe, and legal consumption, however, drug pricing still remains mostly a free market. There have been some proposals to drug cost regulation, such as Clinton’s 1993, Health Security Act. Its purpose was keep pharmaceutical price increases below or steady at the average consumer price inflation. This resulted in pharmaceutical companies pledging to do so. The House Bills 2951 and 3486, discussed in an earlier post are two other proposals that focus on lowering drug prices through capitation and cost transparency. Some even propose we adopt the highly stringent regulations of the European Union (E.U.) that has increased control over drug prices since the 1980’s.

Would E.U. Price Regulations Work In The U.S.?

A 19-year sample period study was done that compared the pharmaceutical drug price regulations of the E.U. and the U.S. It’s easy to see why price control would benefit the patient in the short term, due to them saving money and being able to afford their medications. What about the long term benefits? Are there any potential risks to patients in the long term? Something to consider regarding drug price regulation is, “price constraints affect the profitability, stock returns, and R&D [research and development] of E.U. and U.S. firms. Had the U.S. used controls similar to those used in the E.U., a study estimates it would have led to 117 fewer new medicines and 4,368 fewer research jobs in the U.S.” (Golec & Vernon, 2010) during the 19 year study.

This proposes an interesting viewpoint for patients, U.S. economy, and the U.S. being a leader in R&D. Should the Government increase their regulation over the Pharma industry? A study published this week by PublicAgendaArchives.org shows that over 50% of Americans say there’s not enough government regulation when it comes to prescription drugs, 39% about right, 8% say too much, and 3% had no opinion. USNews.com also reported this week “so far in the U.S., we have not been willing to run the risk of government regulation of drug pricing, just because there are so many conflicting interests and no bright line to lead government officials to choose a better price.”

Office of Pharmacy Affairs’ 340B Drug Pricing Program:

Programs like the Office of Pharmacy Affairs’ 340B Drug Pricing Program where drug manufacturers are required to provide outpatient drugs to eligible non-profit entities at significantly reduced prices to stretch scarce Federal resources as far as possible could be implemented at many levels of the Pharma supply chain, including specific programs focused solely on independent pharmacies. This allows them to reach more eligible patients and provide more comprehensive services.

The Federal government is not the only one trying to balance a checkbook and make the best of each dollar spent, if they can create programs for themselves, they can do the same for us! They have the power to create change. Will they take action? Who will lead the way? We are waiting! Stay tuned! The next few years with price transparency and big data being on the forefront change is inevitable.

References:

Golec, J., & Vernon, J. (2010). Financial effects of pharmaceutical price regulation on R&D spending by EU versus U.S. firms. PharmacoEconomics, 28 (8). 615-628.

Is the Concept of Biosimilars Feasible

Is the Concept of Biosimilars Feasible?

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Is the Concept of Biosimilars Feasible?

With the introduction of the Biologics Price Competition and Innovation Act that was included in the Patient Protection and Affordable Care Act, drug prices have been changing. This legislation allows companies to produce medications that are similar to brand drugs and use these medications interchangeably. There must be clinical evidence that the biosimilar product produces the same medical result as the brand medication.

In March of 2015, Zarxio, a biosimilar for Neupogen, was the first biosimilar medication approved by the FDA. These medications are granulocyte colony stimulating factors (G-CSF) that treat Neutropenia. A PBM estimates that the introduction of this biosimilar could reduce US Drug costs by $5-7 billion over the next ten years. The release of Zarxio has now been put on hold due to the U.S. Court of Appeals approving an injunction to block the launch of this medication due to a possible patent infringement.

In the short-term drug prices may go down, but as seen with the wave of generics, this could result in drug prices spiking in the long term. The price of biosimilars could increase as the generic drug prices have increased. Is this really an effective way to control drug costs? Short term it is a great solution! It makes sense… Immediate gain for all! Long term, the old saying “learn from your mistakes” (aka generic pricing all over the place) comes to mind. Will this just be another round of smoke and mirrors of steps taken to help lower drug costs?

Will Manufacturers play the same games to control the cost of biosimilars as they have with generics? Only time will tell although combined with new proposed legislations and a big push for industry transparency, we are hopeful that these positive changes will take place!

References:
Burki, T., (2015). First biosimilar drug approved in the USA. Lancet Oncology, 16 (4), 161. Retrieved from: http://proquest.com
Maas, A. (2015). Biosimilars update: appeal date is set; FDA finalizes guidance. Speciality Pharmacy News, 12 (5). Retrieved from: http://aishealth.com | http://www.dpc.senate.gov/healthreformbill/healthbill70.pdf

You Have a Friend in Trxade

Did you know that Trxade is a pharmacist-led team of business and technology professionals working together to help independent pharmacies save money and improve cash flow by taking back control of their profit margins? We understand first-hand the issues independent pharmacies experience and work together with our members and industry partners to do our part to ensure independent pharmacies thrive by saving thousands at no cost.

If there is anything that we can do to help, as a member of the Trxade family we will do our part to go above and beyond to help. Just let us know how we can help. We care about your pains, and most importantly we genuinely care about your success. That is what motivates us! Share with us what Trxade has done for your Pharmacy. We love to make a difference and hear success stories.