[Mmcap_list] MMCAP News March 2020

Wed Mar 18 12:39:50 PDT 2020

Hello,

I wanted to let you know that  MMCAP, our Representative, Kim Hankins, and suppliers are working hard to provide updates about products that are in short supply that are needed by all states and information on the supply chain for Medical and Pharmaceutical Products as they receive the information.

     Updates will be provided as we received them.

Below is information received from the MMCAP Newsletter March 2020:

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As MMCAP Infuse members across the country become increasingly impacted by the COVID-19 virus, we want to assure you that our state and agency leaders continue to monitor the situation. We have plans in place that prioritize the safety of our team members and partners as well as the continuation of MMCAP Infuse services. Our teams remain in constant communication with our contracted vendors who are monitoring the availability of needed supplies. (You can find our vendors' contracts and product offerings on our
legacy website<http://www.mmd.admin.state.mn.us/MMCAP/Account/Login.aspx>. Please note you must be logged in to access this information.)

MMCAP Infuse is also working with leaders at state and national organizations such as HSCA and NASPO to gain a broader understanding of the situation and to help inform any business decisions moving forward.
For the most accurate and up-to-date information and guidance related to the COVID-19 virus, please visit the Center for Disease Control (CDC) or the World Health Organization (WHO):

Center for Disease Control (CDC)<http://www.cdc.gov/coronavirus> World Health Organization (WHO)<https://www.who.int/emergencies/diseases/novel-coronavirus-2019/advice-for-public>
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Generally, for those entities who have order history that there are Allocations in place and folks may not receive their whole order. Contact Jim for more information concerning COVID 19 test kits, he has two company's providing tests, one is a Blood test and the other is non FDA approved, both would need additional verification, but these test kits are available.  If you haven't been ordering products that are on short supply,  masks, hand sanitizers, etc., you won't be able to get these products.
If you have questions please call Jim @ 651 201.2440

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Influenza Vaccine Direct from Manufacturers

Contact the vendors directly to place your pre-book orders.

To view the products and pricing, log in to the MMCAP Infuse legacy website and click on Programs. Under "What's inside" click on MMCAP Influenza Vaccine Products and Pricing information. The completed agreements are posted on the MMCAP Infuse legacy website log in and click on the Contracts tab.

Reminder: Be sure to communicate to the vendors when placing your orders that you are an[Continued on Page 6] MMCAP Infuse member and want to be attached to MMCAP Infuse contract pricing.

Influenza vaccine pre-book reminder postcards have been sent to all MMCAP Infuse member facilities.

Of note for the 2020-21 season:

*    Sanofi Pasteur will no longer offer the 0.25-mL single-dose pre-filled syringe presentation of Fluzone(r) Quadrivalent influenza vaccine for the 2020-2021 influenza season.

*    GSK will no longer offer multidose vials for the 2020-2021 season. Only single dose syringe presentations of influenza vaccine will be offered for the 2020-2021 influenza season.
*    Quadrivalent High Dose FLUZONE is a 0.7ml dose for the 20-21 season.

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Shortages : There are alternatives please ask the question.

Cardinal orders have skyrocketed. Picking times have gone to 8+ hours. Cardinal is on a fair share allocation system and information can be obtained at the website. There is a process in place for new members, sign-ups, etc.

Sunovion Product Distribution
Sunovion has recently notified MMCAP Infuse that its licensing agreement with Novartis for Arcapta(r) Neohaler(r), Utibron(r) Neohaler(r) and Seebri(r) Neohaler(r) will end March 31, 2020, and these products will no longer be available in the U.S. Products are expected to be depleted quickly. Sunovion will continue to honor contract pricing until June 30, 2020, or until supply is depleted. Novartis does not have plans to license the products through any other vendors in the U.S.
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Link to FDA's DSCSA web page<https://www.fda.gov/drugs/drug-supply-chain-integrity/drug-supply-chain-security-act-dscsa>

DSCSA Q&A
What does DSCSA stand for?
DSCSA stands for the Drug Supply Chain Security Act, which is Title II of the Drug Quality and Security Act (DQSA)

What is the purpose of the DSCSA?
The purpose of DSCSA is to create an electronic system to track and trace certain prescription drugs in the United States.

What is DSCSA Compliance?
DSCSA outlines critical steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the U.S. In this outline there are requirements laid out for Authorized Trading Partners. MMCAP Infuse members who either serve as a point of pharmaceutical distribution (i.e., DOCs may have a central supply, and may bring in pharmaceuticals to a central location and distribute them among the prisons in their system), or as a pharmacy, dispensing medications are required to be compliant with the DSCSA

Does DSCSA apply to OTC drugs or are OTCs exempt?
DSCSA applies to prescription drugs in finished dosage form for human use.

What is product tracing?
Product tracing is the ability to trace potentially contaminated product, the consumption of which may cause an adverse health impact, through the supply chain. Product tracing is found not only with drugs but can be used in food safety as well.

What is serialization in pharmaceuticals?
Serializing product, the assigning of unique, traceable numbers to individual saleable units, is the cornerstone of all the regulations. Serialization is a complex process that will have a ripple effect throughout operations at both pharmaceutical companies and their contract manufacturing and packaging partners.

As an MMCAP Infuse member, what do I need to do to be compliant with the DSCSA?
Under DSCSA, most MMCAP Infuse members must already comply with the following:

*   Confirm the entities you do business with are licensed or registered, also known as Authorized
Trading Partners
o  Check the registration of manufacturers and repackagers

o  Check the licensing of wholesalers/distributors and third-party logistics providers

*   Receive, store, and provide product tracing documentation
o  Only accept prescription drugs that are accompanied by three pieces of product tracing documentation - 3T Data: transaction information, transaction history, and transaction statement. If the trading partner you purchased the drugs from does not provide all this documentation, work with them to promptly get it, and quarantine the drugs until the documentation is received.

o               Store the product tracing documentation you receive in paper or electronic format for six years.

o  Generate and provide all product tracing documentation with the transaction if you sell a prescription drug to a trading partner. You do not need to provide this information when you dispense a prescription drug to a patient or if you sell to a pharmacy for dispensing to a specific patient.

*   Investigate and properly handle suspect and illegitimate drugs
o  Pharmacies must have a process to investigate and handle suspect and illegitimate prescription drugs, which includes drugs that may be or have evidence that it is counterfeit, diverted, stolen, intentionally adulterated, or unfit for distribution, including steps to:

*                Quarantine and investigate suspect prescription drugs to determine if they are illegitimate; and

*  If they are illegitimate, pharmacies should work with the manufacturer and take specific steps to ensure patients do not receive the illegitimate drugs. Pharmacies must also notify FDA and the trading partners they bought the drug from and sold the drug to.

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Want to receive MMCAP Infuse information, industry news and updates via your social networks? MMCAP Infuse is active on Facebook, Twitter, Instagram and LinkedIn.

                  Also, if you have further questions, please contact Kim Hankins Oregon's MMCAP Representative kim.hankins at state.mn.us<mailto:kim.hankins at state.mn.us>, or at 503 999-5013.

          Be safe, take care..

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Lori Doke<mailto:lori.doke at oregon.gov>, CPPB, OPBC, CTAC
State Procurement Analyst
(C) - (971) 719-1627
Department of Administrative Services
EGS-Procurement Services
1225 Ferry St. SE U140
Salem, OR 97301
http://procurement.oregon.gov<http://procurement.oregon.gov/>
Data Classification Level 2 - Limited
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