va drug accountability conference national acquisition center steve thomas director, national...

VA Drug Accountability Conference

National Acquisition Center

Steve ThomasDirector, National Contract Service VA National Acquisition CenterP.O. Box 76, Bldg 37Hines, IL 60141(708) [email protected]

David CardenClinical PharmacistVA National Acquisition CenterP.O. Box 76, Bldg 37Hines, IL 60141(708) [email protected]

vaww1.va.gov/oamm/oa/nac/ncs/index.cfm

Presentation Outline

Steve ThomasNational Contract Service OrganizationDrug Purchasing Methods Used by VANational ContractsPharmaceutical Prime VendorPharmaceutical Repackaging Program

David CardenNotes from the NACVeterans Health Care Act of 1992

National Contract ServiceOrganization

Drug Purchasing Methods Used by VA

National ContractFederal Supply ScheduleBlanket Purchase AgreementIncentive AgreementOpen Market Purchase

Pharmaceutical National Contracts

Standardized productsLeveraged pricingEfficient deliverywww.fbo.govPoint of contact: Maria Ramirez

(708) 786-4985

Pharmaceutical National Contracts – Broad Objectives

Lower Cost with Same Outcomes

or, better still…Same Cost with Better Outcomes

or, best…Lower Cost with Better Outcomes

Pharmaceutical National Contracts -Clinically Driven Contracting

Individual Evaluation ToolsEfficacyOutcomesSafetyComplianceVA patient needsPharmacy factors

Clinical evaluation + Price = Best Value

Pharmaceutical National Contracts – Contracting Process

Step 1 – Pre-Procurement Request PBM works up clinical review, meeting

announcements, representative discussions with PBM

Step 2 – Procurement Request from PBM to NACStep 3 – FedBizOpps Notice Advertises Procurement for at least 15 daysStep 4 – Issue SolicitationStep 5 – Solicitation ClosesStep 6 – Award

Buy American ActFAR 25.1Restricts the purchase of supplies that are not

domestic end productsApplies to order values less than $194,000If domestic offer is not the low offer, apply:

An additional 6% to the low offeror’s price if the domestic offeror is a large business concern

An additional 12% to the low offeror’s price if the domestic offeror is a small business concern

Trade Agreements ActFAR 25.4Waives the Buy American Act and other

discriminatory provisions for eligible products from countries that have signed an international trade agreement with the United States, or that meet certain other criteria.

Offers of eligible products receive equal consideration with domestic offers.

Applies to order values over $194,000 (when not set-aside for small business)

Purchasing Open MarketIf item(s) are on contract, order from the contracted

source.If item(s) are not on contract, seek out the advice of

an acquisition professional. Why?If order value is $0 to $3,000:

Follow Micropurchase Procedures in FAR 13.202 Distribute orders equitably among qualified suppliers May be awarded without soliciting competitive quotations Use of purchase card is the preferred method Do not split orders to keep them under $3,000

Purchasing Open Market (continued)If order value is $3,001 to $25,000

Set-aside for small businessNon-manufacturer rule does not apply (FAR 19.502-

2(c)Buy American Act applies

If order value is $25,001 to $100,000Set-aside for small business with exception in FAR 19-

502-2Non-manufacturer rule does applyBuy American Act applies

Purchasing Open Market (continued)If order value is $100,001 to $194,000

Set-aside for small business if there is reasonable expectation that 2 or more small businesses will offer products of a small business concern.

Buy American Act appliesNOTE: For orders between $50,000 and $194,000, the

Israeli Trade Act Applies (FAR 25.406)If order value is over $194,000

Set-aside for small business if there is reasonable expectation that 2 or more small businesses will offer products of a small business concern.

Trade Agreements Act applies

Pharmaceutical National Contracts – ProductsPharmaceuticalsMedical gasesDietary supplementsIV solutionsInfluenza vaccine

Prime VendorWide variety of product coverageOne stop shoppingFlexible delivery to multiple sitesElectronic ordering and price look-upInventory and space reductionFill rates greater than 97%

Pharmaceutical Prime Vendor ProgramAwarded to McKesson Corporation on December

31, 2003Potential 8 Year Contract (2 year contract with three,

2 year options)Negative distribution feesPoint of contact: German Arcibal

(708) 786-7663

Pharmaceutical Repackaging Initiative

NAC coordinates bulk order shipments to PrePak

PrePak repackages product in government labeled bottles

Facilities order from PrePak7 Drugs Currently Covered by the Program –

Alprazolam, Furosemide, Ibuprofen, Isosorbide Dinitrate, Omeprazole, Spironolactone & Temazepam

Point of Contact: Fran DeRosa (708) 786-5921

Notes from the NACNotes From The NAC March 26, 2010

Attached are this week's Top 10+ Report, an Open Market Report, a Prepak Fax in order form, a Wyeth Product Status Report a Merck Vaccine Status Report and a copy of the FDA Unapproved Drug Initiative Link I forgot last week. FSS QUESTIONS…The Federal Supply Schedule management now has a “Help Desk” for any questions you may have about products that may have dropped off contract or need to be on contract. [email protected] or 708-786-7737. Please copy me on e-mails so I can follow up and maybe suggest alternatives and let other centers with the same problem know. Many Big Shortages Continue…Since the end of last year there has continued to be ongoing shortages of many drug products. Ciprofloxin regular release tablets is one drug that is experiencing shortages due to the Apotex and Ranbaxy problems with the FDA; the other generics and the brand have been either unavailable or on very low allocation. Only in the past few weeks have products from Teva,Watson and a few smaller companies been available open market along with the contract brand but all of these are still subject to allocation. Doxazosin and Prazosin generics are still not available in most cases and the brands are allocated. The newer problem is Flunisolide Nasal where the brand was discontinued and the generic used most by the VA had raw material shortages. The other generic has not been able to keep up and conversion of patients to Fluticasone has created a shortage and allocation of that product. This little review does not even cover half the drugs that have been in short supply. The only good news is that where many of the products since January have had no expected return date, many are now listed as “April”. Some say “early April” and some say “late April” but we now have some hope. Let’s just hope that in April the expected return date does not change to June or July, that would make a painful summer.

Notes from the NACThe Attachments

Top 10+ ReportOpen Market ReportPrepak Fax in Order FormWyeth Product Status ReportMerck Vaccine Status ReportOthers as needed

Notes from the NAC

Econo # Description Generic Name NDC Vendor Name Comments

1381342 FLUNISOL N/SOL 0.025% APX25ML@

FLUNISOLIDE 60505082400

APOTEX CORPORATION @

This company is reporting production delays with NO return date. There is a shortage of raw material. The brand to this product has been discontinued so little is available as an alternative.

2736726 FLUNISOL N/SPR 0.025% B&L25ML@

FLUNISOLIDE 24208034425

BAUSCH & LOMB PHARM @

Due to the shortage of the product above the demand for this product has it in production delays with allocation. B&L is ramping up to produce more but it is not available yet.

2794386 IPRATRO INH SOL .02% NEPH 30

IPRATROPIUM BROMIDE 00487980130

NEPHRON PHARMACEUTICALS

This is listed with production delays with return in Mid March. The 25s are available in most areas. There are also some other FSS products, check McKesson Connect.

3231610 SIMVASTAT TAB 80MG BLU 45

SIMVASTATIN 24658021445

BLU PHARMACEUTICALS LLC

These are samples of some out products others may be allocated.




BLU cannot keep up with the current demand so some sizes have




been on and off. A number of sizes shipped the middle of last week.




They have told McKesson they will continue to be on and off and have not given a back to normal date.

Top 10 + Report

Notes from the NAC

8144 8148 8149 8165

CMOP HINES CHARLESTONMURFREESBOR

O DALLAS

Econo Sell DescriptionOn

HandOn

OrderOn

HandOn

OrderOn

HandOn

OrderOn

HandOn

Order

1238690 ACCU-CHEK COMF CV GLU T/STR 50 19663 0 289 0 10559 1152 1604 0

1695477 ACETAM TAB 325MG MARL 100 3502 12912 277 4128 27 0 0 4080

1696129 ACETAM TAB 500MG MARL 100 1208 11267 0 7400 142 0 0 6000

1953181 ALBUTEROL INH 0.083% UDNEPH 25 7588 5016 1448 0 478 360 717 360

2434801 ALBUTEROL INH SGL 0.083%NEPH30 1076 972 2237 0 787 720 791 360

1417542 ALENDRONAT TAB 70MG UU COB 4@ 164 0 1274 0 448 0 941 0

1271386 AMLODIPINE TAB 10MG COB 90@ 87 0 8032 0 568 0 2103 0

1271220 AMLODIPINE TB 5MG COB 90 N/C N/C 547 0 0 0

Top 10+ Report Stock Status

Notes from the NAC

Econo NDC Num Vendor Name Sell DescriptionOpen

Market $ Notes3251048 93067005 TEVA

PHARMACEUTICALS GEMFIBR TAB 600MG TEV 500@ $83,530.62 There continues to be a shortage of the

1421338 31722022505 CAMBER PHARMACEUTICALS I@

GEMFIBR TAB 600MG CAMB 500@

$48,438.85 contract Gemfibrizol and these two items are all that is available. Major just added it to FSS 4/1/2010 so ask McKesson to stock the Major items on contract.

1749852 143120110 WEST WARD PHARMACEUTICALS

COLCHICIN TAB 0.6MG WEST 1000

$40,326.34 This is one of those generics that is being reviewed by the FDA. There is a brand available that is FDA approved and on FSS.

1254846 781105310 SANDOZ @ BUPROPIO TAB 75MG SAN 1000@ $29,576.16 I am not sure why anybody bought this. There seems to be plenty of the National Contract item available everywhere I look. Please do not reorder…ask McKesson to stock the Golden State contract item.

2716033 407222317 GE HEALTHCARE VISIPAQUE 320MG POLYB 100ML 10

$28,133.00 GE Healthcare products that are not on FSS

1227107 407222323 GE HEALTHCARE VISIPAQUE 320MG POLYB 500ML 10

$17,584.64 are made in China. McKesson should have a corresponding product available on FSS. If they do not stock it ask them to.

Open Market Report

Notes from the NAC

Other AttachmentsPrepak Fax in Order FormWyeth Product Status ReportMerck Vaccine Status ReportOthers… Notices from companies, Holiday hours for

ordering and pages that may help clarify one of the “Notes”.

Veterans Health Care Act of 1992 Public Law 102-585 Section 603

• Only covers brand name (NDA) prescription products and biological products.

• For these “covered” drugs, companies must follow the rules under the Public Law and their product is given a Federal Ceiling Price (FCP).

• Generic products (ANDA), OTC (non-prescription) and certain brands that were grandfathered out of the law in 1992 are not subject to the law.

Veterans Health Care Act of 1992 Public Law 102-585 Section 603• Companies are required to submit their NFAMP

(Non Federal Average Manufacturer’s Price) for each new drug (NDC).

• The companies are given temporary FCPs during the first 90 days of sales but basically once the NFAMP is determined they have a permanent FCP.

FCP = 76% of the NFAMP

(The VA gets about a 24% discount)

Veterans Health Care Act of 1992 Public Law 102-585 Section 603• “Covered” drugs must be on FSS.• The Big4 price must be equal to or lower than the

FCP.• Some companies have “dual” pricing. That means

their product has a Big 4 FCP price but can have a FSS negotiated price for all “OGAs” other government agencies.

• Companies can have National Contracts, BPAs (Blanket Purchase Agreements) or TPRs (Temporary Price reductions) but the price must be lower than the FCP for Big 4 customers.

Veterans Health Care Act of 1992 Public Law 102-585 Section 603• Each year in November companies must supply their

current NFAMP.• The previous calculation is done and compared to

the current FSS price plus the increase in the CPI-U as of October.

• The lower of the two is the new FCP.• Every 5th year, the FCP goes back to the original

calculation, not lower of the two. (2009)• In some cases, where a company raises prices too

fast, they can cause an additional discount which causes a negative FCP. The company then gets a penny price for a year.

THANK YOU

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