California E-Pedigree Update
Virginia Herold
Executive Officer
California State Board of Pharmacy
www.pharmacy.ca.gov
[email protected]
10/18/2013
October
18, 2013
1
Statutory Mandate
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Protection of the public shall be the highest
priority for the California State Board of
Pharmacy in exercising its licensing,
regulatory, and disciplinary functions.
Whenever the protection of the public is
inconsistent with other interests sought to be
promoted, the protection of the public shall
be paramount.
CA Business and Professions Code 4001.1
2
Pedigree Definition
• “Pedigree” means a record, in electronic form,
containing information regarding each
transaction resulting in a change of ownership
of a given dangerous drug, from sale by a
manufacturer, through acquisition(s) and
sale(s) by one or more wholesalers,
manufacturers, or pharmacies, until final sale
to a pharmacy or other person furnishing,
administering or dispensing the dangerous
drug.
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Interoperable electronic system
defined
• Electronic track and trace system
for prescription drugs
• Uses unique identification number
• Established at point of manufacture
• Contained within standardized nonproprietary data format and architecture
• Uniformly used by manufacturers, wholesalers
and pharmacies
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California’s Requirements
the law is really simple
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• Unit Level Serialization
• Certification of Sales and Purchases
• Tracking of product information including lot
level and expiration date
• All owners must append
• Nonproprietary and Interoperable
• Sanctions to cite and fine $5,000 per
transaction for violations
5
Quick History Review
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• 2004 First E-pedigree requirements
established in CA starting 2007.
• 2006 E-pedigree law amended pushing back
dates to 2009, and 2011 if supply chain
documents need for a bit more time
• 2008 E-pedigree law amended pushing back
implementation on a staggered basis to:
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California Law Today
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• January 1, 2015: 50 percent of a
manufacturers products sold in CA must be
serialized
• January 1, 2016: remaining 50 percent must
be serialized
• July 1, 2016: repackagers and wholesalers
must be compliant
• July 1, 2017: distribution centers and
pharmacies need to be compliant
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How “Bad” is it today
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• Problem is: we do not know what
we do not know
We know only what we discover
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Pharmaceutical Supply Chain
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Wholesaler
Manufacturer
Pharmacy
Wholesale Broker Z: Unlicensed California Wholesaler
Arranges Sales & Purchases Through the Following
WHOLESALER
Nevada
CA Licensee
WHOLESALER
Puerto Rico
Not CA licensee
WHOLESALER
New York
Not CA licensee
WHOLESALER
Ohio
CA Licensee
WHOLESALER
Oregon
Not CA licensee
WHOLESALER
New York
Not CA licensee
WHOLESALER
Kentucky
CA Licensee
WHOLESALER
Mexico
Not CA licensee
WHOLESALER
New Jersey
Not CA licensee
WHOLESALER
Oregon
Not CA licensee
WHOLESALER
Louisiana
Not CA licensee
WHOLESALER
Ohio
Not CA licensee
WHOLESALER
Texas
Not CA licensee
WHOLESALER
2 Individuals
Location unknown
Employer unknown
WHOLESALER
Minnesota
Not CA licensee
Pedigree is created by Pharmacy Located in California
Same address as another Pharmacy
Address on ALL pedigrees show purchase by Pharmacy
located in California – licensed as a pharmacy, not as a wholesaler.
PHARMACY
California
CA Licensee
WHOLESALER
California
CA Licensee
WHOLESALER
California
CA Licensee
WHOLESALER
California
CA Licensee
Brokers sales to
pharmacies.
PHARMACY
California
CA Licensee
Pharmacy
California
CA Licensee
Wholesaler
Puerto Rico
Not CA licensee
PHARMACY
California
CA Licensee
PHARMACY
California
CA Licensee
Wholesaler
PHARMACY
New Jersey
California
Not CA licensee CA Licensee
PHARMACY
California
CA Licensee
Wholesaler
Connecticut
Not CA licensee
PHARMACY
California
CA Licensee
Wholesaler
Arizona
CA Licensee
PHARMACY
California
CA Licensee
Wholesaler
California
Not CA licensee
California
Not CA licensee
PHARMACY
California
CA Licensee
PHARMACY
California
CA Licensee
PHARMACY
Hawaii
CA Licensee
Wholesaler
Wholesaler
Pharmacy
Pharmacy
California
Georgia
New Jersey
California
Not CA licensee Not CA licensee Not CA licensee CA Licensee
PHARMACY
California
CA Licensee
Pharmacy
California
CA Licensee
WHOLESALER
Puerto Rico
Not CA licensee
Puerto Rico
Not CA licensee
Recalls
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Ever increasing number: Yesterday, the board
received notice of five recalls by the
manufacturer at the pharmacy or patient
level.
Manufacturers recall by lot number, but
pharmacies and wholesalers currently don’t
often track it.
Other Needs/Uses for EPedigree:
Because life depends on us™
• Significant recent thefts of drugs, $75 M, $37
M, $8 M – drugs may re-enter supply
• Recalls, returns, drug take-backs will be
greatly facilitated by electronic track and
trace, will help end fraud
Problems Uncovered in CA
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• Canadian drugs being dispensed in US by
pharmacies no NDC, just DIN
• Overly complex drug distribution makes
investigation involving diversion and counterfeiting
difficult
The Never Event
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Counterfeit drug identified
• Chain store pharmacy
• Came from one of the where drug was
purchased from one of the Big 3
• Low cost, brand name
• Mfg did not make it.
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Regulations will be Needed
for:
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• Grandfathering
• Identification of how a manufacturer will
establish the 50 percent
• Serialized numeric identifier
• Inference
• Certification
• Drop shipments
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The Regulation Process
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Intended to encourage public input:
1. Identification of problem, develop solutions,
alternative language
2. Formal rulemaking process
3. Review by outside administrative agencies
The process takes about one year
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Currently
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• Board has drafted regulations needed to
implement e-pedigree requirements
-- Serialized unique identifier
-- How mfg. are to report the 50 percent of
compliant product on January 1, 2015
-- “Grandfathering”
Copies are available from
http://www.pharmacy.ca.gov click under laws
and regulations, then pending regulations
Final action expected by October 25, 2013
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Serialized Numeric Identifier
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• Regulation adopted as section 1747
• Shall conform to the FDA’s SNI guidelines
• NDC plus 20 digit alpha numeric number
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Identification of 50 percent
Serialized Product
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• Section 1747.1
• Requires a list to be submitted to the board by
December 31, 2014
• A Statement by someone authorized to bind
the company
• A list of what products have been serialized,
and how the 50 percent was calculated (SKU,
unit volume, drug product family)
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50 Percent
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• A statement providing the calculations to
reach the 50 percent
• A list and quantity of remaining drugs that are
not yet serialized
• A statement describing what technology was
used including platform, vendor, hardware,
software and communications technology
employed
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Remaining 50 Percent
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• And due December 31, 2015, the same
information for the remaining 50 percent.
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No Lists Submitted?
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• Failure to provide the lists as specified by
December 31, 2014 and December 31, 2015
are specifically defined as violations of
pharmacy law.
• In addition to sanctions available to the board,
products cannot be sold in CA
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“Grandfathering”
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• Any manufacturer, wholesaler or repackager
seeking to identify drugs it possesses as not
serialized must submit to the board by July 31,
2016, a signed statement by someone
authorized to bind the company:
1. a list of drugs by name, SKU and NDC that it
possessed BEFORE July 1, 2016
2. a statement of how acquired
3. a statement discussing how the drugs will be
handled
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Grandfathering Part 2
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• For pharmacies and pharmacy warehouses, by
July 31, 2017, a list by someone authorized to
bind the company according to the same
criteria as for wholesalers and manufacturers
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The Board May . .
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• The board may declare submissions as
noncompliant, and can reject and require
resubmissions until determined to be
compliant for all declarations specified in this
regulation section
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Where is the text of this
regulation?
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• www.pharmacy.ca.gov
• Click under “laws and regulations”
• Click under pending regulations
CURRENT STATUS:
work and hearings completed by board,
undergoing review by administrative agencies
necessary to implement a regulation, final
action due October 25, 2013
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Currently Under Development –
More Regulations
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• Drop shipments to e-pedigree
Status: Currently undergoing 45 days of public
comment. Written comments to be submitted
to board by October 28, 2013
Oral testimony before board on October 29,
2013
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Drop Shipments
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For the purposes of Business and
Professions Code section 4163.1, when a
manufacturer utilizes the “drop shipment”
method of sale as defined by that section,
the data elements pertaining to transfers
of ownership to and from the wholesaler
distributor, including any certifications for
receipt and delivery thereby, may be
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More text of drop shipment
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omitted from the pedigree, in which case the
manufacturer shall convey the pedigree directly
to the pharmacy or other person authorized by
law to dispense or administer the dangerous
drug prior to or contemporaneous with delivery
of the corresponding dangerous drug.
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Still Under Development by the
Board
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• Inference
• Certification
• Inspection
_________________
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New Regulations Under
Development
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• September 26, 2013
Proposed draft regulation text for inference and
certification refined.
• See the text at www.pharmacy.ca.gov
Click under “about the board”
Enforcement Committee meetings, then
September 26, 2013, then
meeting materials
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What Type of Inference is
Proposed?
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• Homogeneous sealed case from manufacturer
• Advance receipt of pedigree record establishing
eaches to case,
• Digital signature by responsible party
• The case remains unopened by wholesaler, and
package shows no signs of tampering
• When case is opened, all its contents are
immediately scanned
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Regulations in the Future
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• Closure of Pedigree at end of life of product
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Get Involved!
•
•
•
•
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Meetings are public
We are webcasting most meetings
Join the subscriber alert
Web section to be devoted to all things
pedigree. Will include Qs and As
34
Next E-Pedigree Meetings
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December 10 – San Francisco
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Preemption?
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• Currently pending in federal Congress is a bill
that could preempt California’s e-pedigree
requirements.
36
Preemption
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Preemption of CA law, if:
• Federal legislation or federal regulations are enacted addressing pedigree
or serialization measures for dangerous drugs
– Within 90 days board must publish notice of inoperation of pedigree
requirements
– Within 90 days board must adopt emergency regs stating inoperation of
requirements
• If FDA enacts any rules or takes action inconsistent with any provision of
CA law, that CA provision is inoperative
– Within 90 days board must publish notice of inoperation
– Within 90 days board must adopt emergency regs stating inoperation of
specific requirements
If there is no preemption
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• Will California push back the implementation
dates if manufacturers, wholesalers and
pharmacies are not ready?
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Senator Ridley-Thomas’ Letter
to the Senate Journal (8/25/08)
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• Commemorating agreements that the amendments incorporated in SB
1307 by all involved parties to operate in good faith to implement the
requirements as soon as possible and by the dates established in the
bill. Writing in support are:
• Abbott Laboratories Biocom
• Amgen
CA Healthcare Institute
• Arena Pharmaceuticals
CA Pharmacists Association
• Barr Pharmaceuticals CA Retailers Association
• Baxter Healthcare
CA Society of Health-System
• Bayer Healthcare
Pharmacists
Entities in Support (cont)
•
•
•
•
CA State Association of Counties
Cardinal Health
Compressed Gas Association
Council on Radionuclides and
Radiopharmaceuticals
• Daiichi-Sankyo
• Genentech
• Generic Pharmaceutical
Association
• Gray Panthers
• Healthcare Distribution
Management Association
• Hospira
• Johnson and Johnson
• McKesson Corporation
• Merck, Inc.
• Mylan, Inc.
• National Association of Chain
Drug Stores
Entities in Support (cont)
•
•
•
•
CA State Association of Counties
Cardinal Health
Compressed Gas Association
Council on Radionuclides and
Radiopharmaceuticals
• Daiichi-Sankyo
• Genentech
• Generic Pharmaceutical
Association
• Gray Panthers
• Healthcare Distribution
Management Association
• Hospira
• Johnson and Johnson
• McKesson Corporation
• Merck, Inc.
• Mylan, Inc.
• National Association of Chain
Drug Stores
Entities in Support (cont)
• National Coalition of
Pharmaceutical Distributors
• Novartis Pharmaceuticals
• Pfizer
• Pharmaceutical Research
and Manufacturers of
America
• Rite Aid
•
•
•
•
Sandoz, Inc.
Teva Pharmaceuticals, USA
Walgreens
Wyeth
Because life depends on us™
Thank You.
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