Current and Emerging Board of Pharmacy Issues American Society for Automation in Pharmacy 2008 Annual Industry & Technology Issues Conference January 26, 2008 - PowerPoint PPT Presentation

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Current and Emerging Board of Pharmacy Issues American Society for Automation in Pharmacy 2008 Annual Industry & Technology Issues Conference January 26, 2008

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Title: Current and Emerging Board of Pharmacy Issues American Society for Automation in Pharmacy 2008 Annual Industry & Technology Issues Conference January 26, 2008


1
Current and Emerging Board of
Pharmacy IssuesAmerican Society for Automation
in Pharmacy2008 Annual Industry Technology
Issues ConferenceJanuary 26, 2008
  • Eleni Z. Anagnostiadis, RPh, Board Services
    Director
  • National Association of Boards of Pharmacy

2
NABP Who Are We?
  • The National Association of Boards of
    Pharmacy (NABP) is the international
    association for all jurisdictions that regulate
    pharmacy practice in the United States, District
    of Columbia, Guam, Puerto Rico, Virgin Islands,
    New Zealand, eight Canadian provinces, two
    Australian states, and South Africa.
  • Mission To assist the boards of pharmacy in
    protecting the public health.

3
Road Map
  • Scope of Drug Counterfeiting
  • Internet Pharmacy
  • Wholesale Drug Distributors
  • Durable Medical Equipment Accreditation
    Requirement
  • Medication Errors and Peer Review
  • Pseudoephedrine Regulation

4
The Scope of the Problem
  • Proliferation of Web sites offering Rx for
    lifestyle and popular drugs
  • Counterfeit Drugs in the US Drug
    Distribution System

5
What is a Counterfeit Drug?
  • US Food, Drug, and Cosmetic Act
  • A drug which, or the container or
    labeling of which, without authorization, bears
    the trademark, trade name, or other identifying
    markof a drug manufacturer, processoror
    distributor other than the personwho in fact
    manufactured, processedor distributed such drug
    and which thereby falsely purports or is
    represented to be the product of. such other
    drug manufacturer, processoror distributor.

6
Counterfeit Categories
  • Fake Packaging, Correct Quantity of Correct
    Ingredient (Clone)
  • Fake Packaging, Wrong Ingredient
  • Fake Packaging, No Active Ingredient
  • Fake Packaging, Incorrect Quantity of Correct
    Ingredient
  • Genuine Packaging, Wrong Ingredient
  • Genuine Packaging, No Ingredient
  • Genuine Packaging, Incorrect Quantity of Correct
    Ingredient

According to the World Health Organization
7
Prevalence of Drug Counterfeiting
  • According to the World Health Organization (WHO)
  • Industrialized Countries Around 1
  • Developing Countries Over 10

WHO Fact Sheet N275 Revised 14 November 2006
8
Prevalence of Drug Counterfeiting
  • Industrialized countries with effective
    regulatory systems (eg, USA, most of EU,
    Australia, Canada, Japan, New Zealand) less
    than 1
  • Many countries in Africa and parts of Asia and
    Latin America between 10 and 30
  • Many of the former Soviet republics above 20
  • Medicines purchased over the Internet from sites
    that conceal their physical address are
    counterfeit in over 50 of cases

WHO Fact Sheet N275 Revised 14 November 2006
9
A Growing Problem
  • Trade in counterfeits is extremely lucrative,
    thus making it more attractive to criminal
    networks. A report released by the Centre for
    Medicines in the Public Interest, in the United
    States, projects counterfeit drug sales to reach
    US 75 billion in 2010, a 92 increase from 2005.
  • WHO Counterfeit medicines, The Silent
    Epidemic Press
    release, February 2006

10
NABP Findings
  • Selling prescription meds
    without a valid prescription
  • Without any prescription
  • Online consult no physical exam
  • Online consult physical
    assessment by non-physician
  • Selling unapproved medications
  • Example unapproved generic versions
    of brand medications
  • Counterfeit medications

11
NABP Findings
  • Controlled Substances Isotretinoin Buys
  • December 2003 to January 2004
  • Purchased 8 drugs from 5 suspicious sites,
    including Xanax, codeine, Valium, injectable
    testosterone
  • Site shipped isotretinoin to US, despite contrary
    claim
  • All drugs labeled in foreign language
  • Limited USP testing some testosterone was
    subpotent

12
NABP Findings
  • Controlled Substances Isotretinoin Buys
  • Testosterone purchase
  • Thai manufacturer
  • Supplier based in Republic of Seychelles
  • Web site registered in Slovenia
  • Payment processed in Quebec Canada
  • Package arrived with Greek stamps

13
Internet Pharmacy
  • Canadas first confirmed death from counterfeit
    drugs purchased over the Internet (March 2007)
  • British Columbia Coroners report pills bought
    from a fake online pharmacy caused death of a
    Vancouver Island woman.
  • Drugs contaminated with extremely high quantities
    of metal.

14
DEA Operation Raw Deal
  • 11.4 million steroid dosage units seized as part
    of Operation Raw Deal September 27, 2007

15
State Board of Pharmacy Efforts
Recent Actions Against Internet Rx
  • Internet Pharmacy
  • Brick and mortar Rxs supplying Internet
    site(s)
  • Florida-based Internet Rx
  • CO pharmacy dispensed Tamiflu and tramadol
    based on online consultations
  • State Action Taken
  • NC Shut down several pharmacies dispensing drugs
    on behalf of pharmacy Web site
  • KY Seized 163 shipments of hydrocodone tabs
    from unlicensed online Rx
  • CO Pharmacy fined and licensure surrendered
    RPh manager disciplined

16
VIPPS Overview
  • Launched in 1999
  • Multi-group task force
    drafted standards
  • NOT industry regulated
    or maintained
  • Investigate and report rogue sites
  • Currently 15 VIPPS entities representing over
    12,000 pharmacies

17
Road Map
  • Scope of Drug Counterfeiting
  • Internet Pharmacy
  • Wholesale Drug Distributors
  • Durable Medical Equipment Accreditation
    Requirement
  • Medication Errors and Peer Review
  • Pseudoephedrine Regulation

18
FDAs Counterfeit Drug Task Force Interim Report,
October 2003
How are Counterfeit and Diverted Drugs Introduced
into Drug Distribution System?
Figure 1                                        
                                                  
                                                  
                                                  
                                                  
                                                  
                                                  
    
19
Regulators Greatest Challenges
  • Lack of jurisdiction
  • Little or no cooperation from some government
    officials
  • Difficulty identifying location/owner
  • Lack of resources
  • Funding
  • Staff
  • Consumer education

20
State Licensing of
Wholesale Distributors
  • State Boards of Pharmacy
  • Out-of-State Wholesale Distributors
  • NABP Model Rules for Licensure of Wholesale
    Distributors
  • PhRMA Pedigree Model
  • Stakeholder Meetings

21
2007 Wholesale Distributor Legislation State
Activity
  • Tracked 38 bills related to Wholesale Drug
    Distributors in 25 states
  • NABPs involvement at state level
  • Provides history and education to the boards
  • Reviews legislation/regulations
  • Testifies, upon board request

22
Wholesale Distributor Enacted Legislation
  • Nebraska
  • Nevada
  • New Jersey
  • New Mexico
  • North Dakota
  • Oklahoma
  • South Dakota
  • Texas
  • Vermont
  • Virginia
  • Wisconsin
  • Wyoming
  • Arizona
  • California
  • Colorado
  • Florida
  • Georgia
  • Idaho
  • Indiana
  • Illinois
  • Iowa
  • Kansas
  • Maryland
  • Mississippi

Denotes clean-up bills
Yellow text reflects 2007 activity
23
Wholesale Distributor Regulations
  • Arizona
  • Arkansas
  • Colorado
  • Delaware
  • Iowa
  • Missouri
  • Nebraska
  • New Mexico
  • Oregon
  • Nevada
  • Virginia
  • Wyoming

24
FDA Amendments Act of 2007
  • Authorizes HHS Secretary to develop standards and
    identify and validate effective technology to
    secure drug supply chain
  • Consult with manufacturers, distributors,
    pharmacies, other supply chain stakeholders

25
FDA Amendments Act of 2007
  • Requires HHS to establish a standardized
    numerical identifier to be applied at point of
    manufacturing (within 30 months)
  • Unclear if requirement for specific number
  • No explicit requirement to implement
    serialization
  • References promising technology but not
    prescriptive
  • RFID
  • Nanotechnology
  • Encryption Technology
  • Other technologies

26
NABPs Model RulesThree Tiers of Change
  • More stringent licensure requirements
  • Pedigrees and establishment of track and trace
    electronic pedigree system
  • Increased criminal penalties to dissuade
    criminals from counterfeiting drug

27
VAWD Overview
  • Accreditation of
    wholesale distributors
  • Launched in 2005
  • Multi-group task force
    drafted standards
  • NOT industry regulated or maintained
  • Currently 230 VAWD accredited wholesalers

28
Adoption of VAWD / AccreditationConcept since
2005
29
Road Map
  • Scope of Drug Counterfeiting
  • Internet Pharmacy
  • Wholesale Drug Distributors
  • Durable Medical Equipment Accreditation
    Requirement
  • Medication Errors and Peer Review
  • Pseudoephedrine Regulation

30
History
  • Medicare Modernization Act 2003
  • Secretary of Health and Human Services
  • Quality standards for DMEPOS suppliers
  • Independent accreditation organizations (AO)
  • Compliance with standards accreditation
  • Accreditation Medicare Part B reimbursement for
    DMEPOS items

31
Impact on Pharmacy
  • DMEPOS Suppliers must be Accredited to
    competitively bid for and provide DMEPOS,
    Diabetes and Part B supplies and services for
    beneficiaries.
  • Suppliers from 10 Metropolitan Statistical Areas
    (MSAs) were required to obtain Accreditation by
    October 31, 2007.
  • Suppliers in 70 other MSAs will be required to
    obtain Accreditation in 2009 for second round of
    competitive bidding.

32
Impact on Pharmacy
  • ALL Medicare Part B Suppliers must be accredited
    by a CMS-approved Accreditation body by
    September 30, 2009.

33
NABPs DMEPOS Accreditation Program
  • NABP deemed an Accreditation Organization by CMS
    in November 2006
  • Launched in January 2007
  • DMEPOS Suppliers that possess a valid pharmacy
    permit
  • Accredited entities representing over 12,000
    licensed pharmacies

34
Road Map
  • Scope of Drug Counterfeiting
  • Internet Pharmacy
  • Wholesale Drug Distributors
  • Durable Medical Equipment Accreditation
    Requirement
  • Medication Errors and Peer Review
  • Pseudoephedrine Regulation

35
Medication Errors / Peer Review
  • Regulatory bodies have few options for addressing
    medication errors
  • Most state laws require discipline but do not
    offer alternatives, such as peer review
  • 14 state boards require continuous quality
    improvement (CQI) programs to monitor
    quality-related events
  • Peer Review
  • Evaluate errors to identify weaknesses in systems
  • Modify practices to prevent similar errors
  • Non-punitive

36
NABP Resolution 103-5-07 Medication Error
Reporting
  • Passed during 103rd Annual Meeting, May 2007
  • Whereas
  • Institute of Medicine (IOM) report recommends
    boards of pharmacy implement quality improvement
    initiatives related to community pharmacy
    practice
  • IOM report suggests that medication error
    reporting be promoted more aggressively
  • NABP and boards of pharmacy have endorsed
    reporting medication errors
  • Preventing Medication Errors Quality Chasm
    Series, 2006

37
NABP Resolution 103-5-07 Medication Error
Reporting
  • Therefore be it resolved
  • NABP support the boards by encouraging and
    promoting the reporting of medication errors
    occurring in all pharmacy practice settings to
    reporting programs
  • NABP review and revise, if necessary, the Model
    Act regarding implementation of CQI and peer
    review programs and best practice
    recommendations, in accordance with non-discovery
    provisions
  • NABP request that ISMP or other groups study the
    creation of a standardized approach to conduct
    root cause or causative factor analysis for
    medication errors ...

38
Task Force on CQI, Peer Review, Inspecting for
Patient Safety
  • NABP convened a Task Force in December 2007
  • Review Language in Model Act
  • Develop an implementation plan and educational
    program to assist states
  • Assess the need for a tool for the boards to
    evaluate pharmacies in the area of patient
    safety.
  • Task Force Results
  • February 2008

39
Road Map
  • Scope of Drug Counterfeiting
  • Internet Pharmacy
  • Wholesale Drug Distributors
  • Durable Medical Equipment Accreditation
    Requirement
  • Medication Errors and Peer Review
  • Pseudoephedrine Regulation

40
Combat Methamphetamine Epidemic Act of 2005
Impact on Pharmacy
  • Prior to selling PSE, retailers must check
    consumers ID and must keep a log book of all PSE
    transactions.
  • Retailers must store PSE behind the counter or in
    a locked cabinet.
  • Daily sales limit of 3.6 grams per purchaser,
    regardless of number of transactions.
  • All non-liquid forms of PSE must be packaged in
    blister packs, no more than 2 to a package.
    Products may also be packaged in unit-dose
    packets or pouches.
  • Persons distributing PSE must confirm identity of
    recipient before shipping through mail.

41
  • Eleni Z. Anagnostiadis, RPh
  • Board Services Director
  • eanagnostiadis_at_nabp.net




  • Visit the NABP Web site at www.nabp.net
  • VIPPS Accreditation Program and Criteria
  • VAWD Accreditation Program and Criteria
  • DMEPOS Accreditation Program and Criteria
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