[Mmcap_list] MMCAP News - February 2020

Wed Feb 19 13:06:59 PST 2020

FYI- News from MMCAP Infuse:

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>From the Managing Director

The new year has brought new challenges to our pharmacy and healthcare markets, and I would be remiss without mentioning two issues which we are monitoring closely. First, we remain committed to investigating and following developments in the pharmacy and healthcare products and services supply chain. As such, we are engaging in discussions and tracking efforts to develop avenues for Canadian importation of pharmaceuticals and will continue to do so in order to remain best able to serve our members. Additionally, we are continuing to monitor the Coronavirus outbreak and any potential impacts to our members.

Healthcare Products and Services

Coronavirus and Personal Protective Supplies
The Healthcare Products and Services teams is keeping a close eye on the Coronavirus situation and working with our vendors to make sure all Personal Protective Supplies are available. Members can expect shipment delays and shortages.

Vendors are reporting that the most requested item is the N95 mask, which is unavailable in the [From Page 2] short-term. Not only are there allocation issues, but most manufacturers are located overseas and are supplying their local customers before their U.S. customers. Distributors have said they supply existing customers first on an allocation basis until supplies run out. In this case, that has already happened. Vendors are making every effort to meet the demand, however, in the current supply situation, they likely will not be able to meet them.

A couple of MMCAP Infuse-contracted vendors have supplied information, and we expect others will follow suit. Follow this link <https://mms.mckesson.com/content/coronavirus-outbreak-update/> for the McKesson product formulary and to find out if they are on allocation.
We recommend members follow the link and sign into Supply Manager to order product. McKesson is working to maintain inventory levels but remain at the mercy of its suppliers. Members are encouraged to reach out to their local sales representative or customer service center with questions.

Henry Schein has provided the following update:

“Based on the recommendations provided by the World Health Organization and CDC, we have compiled a list of masks, face shields, gloves, isolation gowns, and other infection prevention products for Henry Schein Medical customers who would like to purchase appropriate PPE items for their practice.”

Use the links below for more information:

Henry Schein website<https://www.henryschein.com/us-en/Global.aspx>             Henry Schein Newsroom<http://investor.henryschein.com/newsandevents>

Medical Products Contract Extensions
The following Medical Products contracts have been extended:

•  McKesson, contract # MMS18000 has been extended until March 1, 2021. Amendment # 25 has been posted on the MMCAP Infuse website.

•  Concordance Healthcare Solutions, contract # MMS18008 has been extend April 9, 2021. Amendment # 12 has been posted on the MMCAP Infuse website.

        [Continued on Page 5]

Global Protection Corp. Amendment
Global Protection Corp. – contract # MMS18015 – has added new items to the contract. Amendment #8 has been posted to the MMCAP Infuse website, along with the updated price list.

Influenza Vaccine

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 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® 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.

Pharmaceutical Program

The current contract for pharmaceutical hazardous waste hauling with Clean Harbors (contract # MMS14036) will end on March 31, 2020. Members looking for a full-service waste hauling vendor will need to begin making alternative contract arrangements. MMCAP Infuse is currently in contract negotiations with one vendor that would be a complement to the new contracts but will not be a replacement for all of the services currently offered by Clean Harbors.
[From Page 5]Liletta WAC Update
Effective April 2, 2020, the Wholesale Acquisition Cost (WAC, sometimes used interchangeably with List Price) on Liletta NDC 00023-5858-01 will increase. Because this product’s pricing structure under contract #
MMS15013 is based on WAC, the MMCAP Infuse contract price on this product will increase by $23.98. This price increase is happening across the market. For more information on ordering, please see Amendment # 25 or reference the MMCAP Infuse Pharmacy Catalog.

Temporary Reduced Pricing Opportunities on Koate and Kedrab
Kedrion Biopharma is offering reduced pricing on certain lots of short-dated Koate Antihemophilic Factor:

Short-Dated KOĀTE Commencement Lot Numbers

Description

NDC #

Lot Number

Expiration Date

KOĀTE 1000 1060 IU Each

76125-0676-50

K5NCC00043

2/10/2020

KOĀTE 1070 IU Each

76125-0676-50

K5NCC00113

5/12/2020

KOĀTE 260 IU CTN

76125-0256-20

B2NAC00043

6/16/2020

KOĀTE 960 IU Each

76125-0676-50

K5NCC00133

6/22/2020

KOĀTE 1130 IU Each

76125-0676-50

K5NCC00153

6/30/2020

KOĀTE 570 IU CTN

76125-0668-30

B2NBC00103

7/21/2020

The magnitude of the price reduction depends on how much shelf life remains on the product at the time of purchase, with the product expiring soonest receiving the lowest price. Please see the comments in the “Item Description” column of the MMCAP Infuse Pharmacy Catalog for details. Product with expiration date equal to or greater than 12 months is not subject to these price reductions.

The company also announced an extension on the reduced pricing of Kedrab Rabies Immune Globulin 150 unit/ml (2ml and 10 ml vials - NDC 76125-0150-02 and NDC 76125-0150-10, respectively). Those price reductions are in effect until March 31, 2020. The items will revert to regular contract pricing on April 1, 2020.

Kedrion Biopharma products are available through Cardinal SPD, Morris & Dickson, FFF Enterprises, and
directly from the manufacturer – KedrionCS at icsconnect.com <mailto:KedrionCS at icsconnect.com> or 855.353.7466.

Mead Johnson Nutritional Products Changes
A few Mead Johnson nutritional products – contract # MMS15140 – have new item numbers:

Enfamil NeuroPro Infant products

•  Item # 163203 changed to item # 897204 (NDC 00087-5121-07)

•  Item # 163205 changed to item # 897205 (NDC 00087-5121-11)

•  Item # 169301 changed to item # 897901 (NDC 00087-5115-62)

Enfamil NeuroPro Gentlease Infant RTU

•  Item # 172202 changed to item # 897405 (NDC 00087-5121-41)

Find all Mead Johnson products and pricing under contract, in the MMCAP Infuse Pharmacy Catalog.

Pharmacy Distribution Services

Holiday Notification
Please be mindful of “non-standard” holidays Presidents’ Day in February. The wholesalers observe six national holidays (New Year’s Day, Memorial Day, Independence Day, Labor Day, Thanksgiving, Christmas Day). These days are clearly defined as days that deliveries from wholesalers are not expected to occur. However, if there are holidays or planned facility closings, in which staff will not be available to accept a delivery, you may need to provide notification to your respective wholesaler.

If you are placing an order in the days before a holiday closure (either full- or partial-day), please use the available tools (wholesaler ordering systems, customer service call centers) to advise your wholesaler that staff will not be available to receive orders. There are many expenses associated with a failed delivery: labor to pick the order, loading it onto the delivery truck, transportation to the facility, transportation to return with the
undelivered order, restocking, etc. These costs are borne by the entire distribution system, so the entire system benefits when these expenses can be averted. Also, Cardinal Health has a $60 delivery fee imposed when a facility fails to inform the Cardinal distribution center of a “planned” closure. A planned closure includes state/ city/county holidays for which Cardinal is still in operation. This fee will not be assessed if the delivery attempt failure is due to an unexpected facility closure, like unsafe winter weather conditions.

Questions:

         Kim Hankins
503.399.7006
Kim.Hankins at state.mn.us<mailto:Kim.Hankins at state.mn.us>

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[cid:image040.png at 01D5E725.7696FAF0]DSCSA Information Corner

[From Page 9]FDA’s DSCSA web page<https://www.fda.gov/drugs/drug-supply-chain-integrity/drug-supply-chain-security-act-dscsa>

The 2013 Drug Supply Chain Security Act
(DSCSA) is a 10-year plan to an interoperable, electronic system to identify and trace
pharmaceutical products throughout their distribution in the United States to be completed by November 2023.

The DSCSA states, all dispensers, which includes 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.

[From Page 10]In addition to requirements under the DSCSA already subject to FDA audits, pharmaceutical products must be marked with a 2-D barcode that includes the four essential data points required by the DSCSA: Global Trade Item Number (GTIN) which embeds the NDC, serial number, lot number, and expiration date. There must also be a human readable NDC and linear barcode on the product. On homogeneous cases there must be a 2-D barcode or linear barcode. This requirement was to go into effect as of November 27, 2017, however, pharmaceutical manufacturing was not ready, so the FDA allowed products that were placed into commerce before November 27, 2018, to be “grandfathered,” exempting from serialization enforcement under the DSCSA.

The next requirement date on the DSCSA timeline of November 27, 2020, is a focus on dispensers. As of November 27, 2020, dispensers can only purchase product that is serialized, unless it is the product has grand- fathered status. The only way to distinguish grandfathered product is to review the 3T Data which will identify when the product went into commerce. If the 3T Data shows the product was placed into inventory before November 27, 2018, then the product is acceptable without a 2-D barcode. Facilities will need to update their Standard Operating Procedures (SOPs) to reflect the process to be used to validate grandfathered status of a product received after November 27, 2020, if the product does not have a 2-D barcode. This will be auditable by the FDA through your facilities’ invoices, so it is recommended that changes to your SOPs be made as to ensure this does not become an audit finding.

For questions and inquires please go to: http://www.mmd.admin.state.mn.us/MMCAP/background/Default.aspx

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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

*****CONFIDENTIALITY NOTICE*****

This e-mail may contain information that is privileged, confidential, or otherwise exempt from disclosure under applicable law. If you are not the addressee or it appears from the context or otherwise that you have received this e-mail in error, please advise me immediately by reply e-mail, keep the contents confidential, and immediately delete the message and any attachments from your system.

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