Southeastern Pharmacy Officers Conference

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Southeastern Pharmacy Officers Conference

• Dale D. Masten
• August 2, 2008
• Director, State Government Affairs
• National Association of Chain Drug Stores

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What Am I Talking About?

• Pedigree, Track and Trace
• Health Information Technology and Privacy
• Federal Internet Legislative Activity

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Pedigree

• Food and Drug Administration Amendments Act of
  2007 added 21 USC 355e Pharmaceutical Security
  to the Food Drug and Cosmetic Act
• FDA to develop standards and identify and
  validate effective technologies for the purpose
  of securing drug supply chain against
  counterfeit, diverted, substandard, adulterated,
  misbranded or expired drugs.

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Federal Pedigree Requirement Where are we
now?

• 21 USC 355e
• Standards development - Secretary
• Consultation
• Federal and state agencies, manufacturers,
  distributors, pharmacies and other supply chain
  stakeholders
• Prioritize and develop standards
• Identification, validation, authentication, and
  tracking and tracing of prescription drugs
• Develop Standardized numerical identifier
• By March 2010
• Applied at point of manufacture and repackaging
  (linked to manufacturer identifier)
• At package or pallet level

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Federal Pedigree Requirement Where are we
now?

• 21 USC 355e
• Standards development continued
• Standards developed shall address promising
  technologies which may include
• RFID
• Nanotechnology
• Encryption technologies, and
• Other trace and trace or authentication
  technologies

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Federal Pedigree Requirement Where are we
now?

• FDA Standards development
• In March 2008 FDA issued requests for information
  from stakeholders on what standards are needed
  for
• Standardized numerical identifier
• Technologies for drug identification, validation,
  track and trace, authentication
• NACDS was just one group that submitted comments
• Waiting for FDA to provide further information

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HR 5839 (Reps Buyer and Matheson) Safeguarding
Americas Pharmaceuticals Act

• Introduced
• No action yet by Energy and Commerce Comm.
• Includes
• Allows FDA to destroy counterfeit drugs
• Interim Provisions
• Applicable before track and trace
• Manufacturer to provide packing list with
  information on drugs shipped
• Pedigrees (paper or electronic)
• Each person except mfg and wholesaler to provide
  pedigree ? 2 types of pedigrees
• Direct purchase pedigree (ADRs)
• Standard pedigree

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Federal HR 5839 (Reps Buyer and Matheson)

• Additional provisions
• Returns
• Must be shown on the pedigree
• Different categories of returns
• Saleable returns
• Mistakes in ordering/shipment
• Returned in 7 days with Certified Statement
• Other returns
• Drugs with Direct Purchase pedigree
• Returned with Certified Statement
• Non-saleable
• Returned without pedigree

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Federal HR 5839 (Reps Buyer and Matheson)

• TRACKING AND TRACING Requirements for
  prescription drugs
• Different requirement dates for high risk and
  generic drugs
• Complicated Timelines
• For when drugs must be tracked and traced i.e.
  not later than
• For when regulations must be issued

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Federal HR 5839 (Reps Buyer and Matheson)

• TIMING DEPENDS ON WHEN FDA announces STANDARDS
• POSSIBLE TIMELINE Scenario under the bill
• March 2009 FDA announces
• Standard identifier
• List of high risk drugs
• September 2010
• Manufacturers must apply std identifier to high
  risk drugs
• March 2012
• Manufacturers must apply std identifier to other
  drugs
• March 2012 to September 2012
• Track and trace starts for high risk drugs
• September 2012 to December 2012
• Track and trace starts for other drugs

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HR 5839 (Buyer and Matheson)

• Grants to independent pharmacies
• Not owned or operated by a publicly traded
  company
• Grant preference to independent pharmacies with
  annual gross revenues of 6,500,000 or less
• Purchase qualified identification and tracking
  technologies
• 1 matching for 3 federal funds
• Must report to Secretary within 1 year on impact
  of grant

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HR 5839 (Buyer and Matheson)

• Preemption of state laws for
• Pedigrees
• Manufacturer packing lists
• Unique standard identifiers
• Drug identification and tracking system

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HR 5839 (Buyer and Matheson)

• Other provisions
• Wholesale distributor licensure
• Increased requirements
• Bonds
• Mandatory background checks
• Fingerprinting
• Key personnel qualifications
• Mandatory physical inspections prior to licensure
• Injunctions, civil penalties
• States may bring civil enforcement proceedings
• Study on threats to domestic prescription drug
  supply chain

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Senate Approach

• In the Food Safety Bill there is a requirement
  that requires manufacturers to incorporate Track
  and Trace on raw products.

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Health Information Technology (HIT)/Privacy

• H.R. 6357 the Protecting Records, Optimizing
  Treatment, and Easing Communication through
  Healthcare Technology Act of 2008 or the
  PRO(TECH)T Act of 2008.
• Sponsored by Chairman Dingell (D-MI) and
  Representative Joe Barton (R-TX).
• Has Bi-partisan support.
• Passage is a priority of sponsors.

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Health Information Technology (HIT)/Privacy

• Weighed down with onerous privacy provisions.
• Substituted and passed by voice vote in House
  Energy and Commerce Committee.
• Some concerns addressed, agreement to address
  others prior to full passage.

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Health Information Technology (HIT)/Privacy Contd

• Changes made in Committee
• Clarifies that consent may be a one-time
  aggregated consent, revocation of consent can
  only be for data collected prospectively (not
  retrospectively), and that providers can maintain
  a patients information in an electronic medical
  record (whether or not the provider receives
  consent).
• Requires the Secretary of HHS to promulgate
  regulations implementing the consent provisions
  in a manner that protects health information and
  is deemed reasonable and workable, including
  providing the Secretary with the authority to
  exempt certain healthcare operations from the
  consent requirement.

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Health Information Technology (HIT)/Privacy Contd

• Provides a safe harbor by which an individual
  would not need to be notified if the breached
  information was encrypted and clarifies that good
  faith disclosures of health information will not
  constitute a breach.
• Allows for industry-developed technology
  standards to determine what information is
  unsecured personal health information and require
  the Secretary of HHS to develop and disseminate
  model, informed consent through notice and
  comment, respectively.

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Health Information Technology (HIT)/Privacy Contd

• Changes the accounting for disclosures for
  treatment, payment, and healthcare operations so
  that it goes into effect either when an entity
  acquires or upgrades its electronic medical
  record or six months after a technical standard
  is adopted by the Secretary of HHS (whichever is
  sooner). In addition, the amount of time a
  provider must retain the information was reduced
  from six years to three years.

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Health Information Technology (HIT)/Privacy Contd

• Concerns to be addressed prior to passage
• Sponsored by Representative Rogers (R-MI)
• Change the bill requirement of accounting for
  disclosures so pharmacies would have to account
  only for disclosures made for the purpose of
  healthcare operations.
• change the bill requirement for obtaining patient
  consent by stating that the regulations to
  implement the consent requirement must ensure
  that such requirement does not impede access to
  healthcare or reduce healthcare quality or
  safety.

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Federal Internet Legislative Activity

• Senate passed S. 980, Feinstein
• Referred to House, introduced their version, H.
  6353
• Provisions
• Restrictions on dispensing controlled substances
  over the Internet
• Requires valid prescription
• Legitimate medical purpose
• At least 1 in-person medical evaluation

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Federal Internet Legislative Activity

• Requires online pharmacies to meet additional
  requirements
• Supplemental DEA registration as online pharmacy
• Website disclosure of pharmacy information name,
  address, telephone numbers, name, license and
  professional degree of PIC for each pharmacy,
  list of states where pharmacy is licensed to
  dispense controlled substances, certification
  that the pharmacy has required supplemental DEA
  registration to dispense controlled substances
  over the Internet, and name and other information
  on any practitioner who has a contractual
  relationship to provide medical evaluations or
  issues prescriptions for controlled substances

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Federal Internet Legislative Activity

• Reporting to the DEA - in an aggregate total
  quantity - the amount of each controlled
  substance dispensed
• Statement on website of compliance with the law
• Specific Statement as required in the law that
  the online pharmacy will only dispense a
  controlled substance pursuant to a valid
  prescription

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Federal Internet Legislative Activity

• Increases criminal penalties
• List of offenses involving unlawful dispensing of
  controlled substances by means of the Internet
• Rule of construction nothing in the law to be
  construed to authorize, limit, or prohibit
  electronic prescriptions for controlled
  substances

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Federal Internet Legislative Activity

• Exempts certain entities from being online
  pharmacies
• DEA registered pharmacies that by means of the
  Internet refill controlled substances
  prescriptions or obtain new Rx for patient with
  existing CS Rx
• Manufacturers, distributors, hospitals operated
  by US, Indian tribal health care facilities, mere
  advertisements on the Internet that do no attempt
  to facilitate transaction with a controlled
  substance
• Non-US Internet sites that do not facilitate
  dispensing controlled substances by the Internet
  to persons in the US

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THANK YOUQUESTIONS ??