1 / 40

Current and Emerging Board of Pharmacy Issues American Society for Automation in Pharmacy 2008 Annu

NABP

cambree
Download Presentation

Current and Emerging Board of Pharmacy Issues American Society for Automation in Pharmacy 2008 Annu

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

    1. Current and Emerging Board of Pharmacy Issues American Society for Automation in Pharmacy 2008 Annual Industry & Technology Issues Conference January 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 mark…of a drug manufacturer, processor…or distributor other than the person…who in fact manufactured, processed…or distributed such drug and which thereby falsely purports or is represented to be the product of…. such other drug manufacturer, processor…or distributor.” The federal Food, Drug and Cosmetic Act contains an explicit and comprehensive definition of what a counterfeit drug is and the Model Rules have also adopted this definition as well. The federal Food, Drug and Cosmetic Act contains an explicit and comprehensive definition of what a counterfeit drug is and the Model Rules have also adopted this definition as well.

    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 WHO also has a classification system for counterfeit drugs I included this classification system primarily to keeps us mindful of how counterfeit drugs may present themselves; it keep us vigilant and cognizant of potential counterfeiting schemes.WHO also has a classification system for counterfeit drugs I included this classification system primarily to keeps us mindful of how counterfeit drugs may present themselves; it keep us vigilant and cognizant of potential counterfeiting schemes.

    7. Prevalence of Drug Counterfeiting According to the World Health Organization (WHO): ~ Industrialized Countries: Around 1% ~ Developing Countries: Over 10% Estimates The US based Centre for Medicines in the Public Interest predicts that counterfeit drug sales will reach US$ 75 billion globally in 2010, an increase of more than 90% from 2005. Although precise and detailed data on counterfeit medicines is difficult to obtain, estimates range from around 1% of sales in developed countries to over 10% in developing countries, depending on the geographical area. That range takes into consideration both regional disparities in the presence of counterfeits, and specific global market value shares. Apart from the huge differences between regions, variations can also be dramatic within countries, i.e. city versus rural areas, city versus city. Currently, the sources of information available include reports from non-governmental organizations, pharmaceutical companies, national drug regulatory and enforcement authorities, ad hoc studies conducted on specific geographical areas, and occasional surveys. Counterfeiting is greatest in those regions where the regulatory and legal oversight is weakest. Most industrialized countries with effective regulatory systems and market control (e.g. USA, most of EU, Australia, Canada, Japan, New Zealand) have a low proportion, i.e. less than 1% of market value Many countries in Africa and parts of Asia and Latin America have areas where more that 30% of the medicines on sale can be counterfeit, while other developing markets have less than 10%; overall, a reasonable range is between 10% and 30% Many of the former Soviet republics have a proportion of counterfeit medicines which is above 20% of market value — this falls into the developing country range Medicines purchased over the Internet from sites that conceal their physical address are counterfeit in over 50% of cases . Estimates The US based Centre for Medicines in the Public Interest predicts that counterfeit drug sales will reach US$ 75 billion globally in 2010, an increase of more than 90% from 2005. Although precise and detailed data on counterfeit medicines is difficult to obtain, estimates range from around 1% of sales in developed countries to over 10% in developing countries, depending on the geographical area. That range takes into consideration both regional disparities in the presence of counterfeits, and specific global market value shares. Apart from the huge differences between regions, variations can also be dramatic within countries, i.e. city versus rural areas, city versus city. Currently, the sources of information available include reports from non-governmental organizations, pharmaceutical companies, national drug regulatory and enforcement authorities, ad hoc studies conducted on specific geographical areas, and occasional surveys. Counterfeiting is greatest in those regions where the regulatory and legal oversight is weakest. Most industrialized countries with effective regulatory systems and market control (e.g. USA, most of EU, Australia, Canada, Japan, New Zealand) have a low proportion, i.e. less than 1% of market value Many countries in Africa and parts of Asia and Latin America have areas where more that 30% of the medicines on sale can be counterfeit, while other developing markets have less than 10%; overall, a reasonable range is between 10% and 30% Many of the former Soviet republics have a proportion of counterfeit medicines which is above 20% of market value — this falls into the developing country range Medicines purchased over the Internet from sites that conceal their physical address are counterfeit in over 50% of cases .

    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 Estimates The US based Centre for Medicines in the Public Interest predicts that counterfeit drug sales will reach US$ 75 billion globally in 2010, an increase of more than 90% from 2005. Although precise and detailed data on counterfeit medicines is difficult to obtain, estimates range from around 1% of sales in developed countries to over 10% in developing countries, depending on the geographical area. That range takes into consideration both regional disparities in the presence of counterfeits, and specific global market value shares. Apart from the huge differences between regions, variations can also be dramatic within countries, i.e. city versus rural areas, city versus city. Currently, the sources of information available include reports from non-governmental organizations, pharmaceutical companies, national drug regulatory and enforcement authorities, ad hoc studies conducted on specific geographical areas, and occasional surveys. Counterfeiting is greatest in those regions where the regulatory and legal oversight is weakest. Most industrialized countries with effective regulatory systems and market control (e.g. USA, most of EU, Australia, Canada, Japan, New Zealand) have a low proportion, i.e. less than 1% of market value Many countries in Africa and parts of Asia and Latin America have areas where more that 30% of the medicines on sale can be counterfeit, while other developing markets have less than 10%; overall, a reasonable range is between 10% and 30% Many of the former Soviet republics have a proportion of counterfeit medicines which is above 20% of market value — this falls into the developing country range Medicines purchased over the Internet from sites that conceal their physical address are counterfeit in over 50% of cases . Estimates The US based Centre for Medicines in the Public Interest predicts that counterfeit drug sales will reach US$ 75 billion globally in 2010, an increase of more than 90% from 2005. Although precise and detailed data on counterfeit medicines is difficult to obtain, estimates range from around 1% of sales in developed countries to over 10% in developing countries, depending on the geographical area. That range takes into consideration both regional disparities in the presence of counterfeits, and specific global market value shares. Apart from the huge differences between regions, variations can also be dramatic within countries, i.e. city versus rural areas, city versus city. Currently, the sources of information available include reports from non-governmental organizations, pharmaceutical companies, national drug regulatory and enforcement authorities, ad hoc studies conducted on specific geographical areas, and occasional surveys. Counterfeiting is greatest in those regions where the regulatory and legal oversight is weakest. Most industrialized countries with effective regulatory systems and market control (e.g. USA, most of EU, Australia, Canada, Japan, New Zealand) have a low proportion, i.e. less than 1% of market value Many countries in Africa and parts of Asia and Latin America have areas where more that 30% of the medicines on sale can be counterfeit, while other developing markets have less than 10%; overall, a reasonable range is between 10% and 30% Many of the former Soviet republics have a proportion of counterfeit medicines which is above 20% of market value — this falls into the developing country range Medicines purchased over the Internet from sites that conceal their physical address are counterfeit in over 50% of cases .

    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 Seychelles (pronounced / ["say shells"] in English according to wikipedia Seychelles (pronounced / ["say shells"] in English according to wikipedia

    13. Internet Pharmacy Canada’s first confirmed death from counterfeit drugs purchased over the Internet (March 2007) British Columbia Coroner’s report – pills bought from a fake online pharmacy caused death of a Vancouver Island woman. Drugs contaminated with extremely high quantities of metal. Canada's first confirmed death from counterfeit drugs purchased over the Internet reinforces long-stated concerns of the Canadian Pharmacists Association (CPhA), the association states in a July 6, 2007 press release. A British Columbia Coroner's report concludes that pills bought from a fake online pharmacy are to blame for the March death of a Vancouver Island woman. Drugs were later determined to be contaminated with extremely high quantities of metal. Canada's first confirmed death from counterfeit drugs purchased over the Internet reinforces long-stated concerns of the Canadian Pharmacists Association (CPhA), the association states in a July 6, 2007 press release. A British Columbia Coroner's report concludes that pills bought from a fake online pharmacy are to blame for the March death of a Vancouver Island woman. Drugs were later determined to be 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 DEA – Operation Raw Deal Largest steroid enforcement action in US history Seized 11.4 million steroid dosage units, 242 kg raw steroid powder from China Anabolic steroids, human growth hormone Illegal internet operations DEA – Operation Raw Deal Largest steroid enforcement action in US history Seized 11.4 million steroid dosage units, 242 kg raw steroid powder from China Anabolic steroids, human growth hormone Illegal internet operations

    15. State Board of Pharmacy Efforts 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 Rx Depot – federal judge granted FDA request to close Rx Depot Nov 2003 In addition, many states have passed legislation or regulations to clearly define a “Dr.-Patient Relationship” and to impose limitations of what can occur with our a face-to-face Dr. visit. Rx Depot – federal judge granted FDA request to close Rx Depot Nov 2003 In addition, many states have passed legislation or regulations to clearly define a “Dr.-Patient Relationship” and to impose limitations of what can occur with our a face-to-face Dr. visit.

    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. FDA’s Counterfeit Drug Task Force Interim Report, October 2003

    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 As you know, the average board has between 5 and 6 inspectors for potentially hundreds of wholesale distributors; and that would be fine if they only inspected wholesalers; they also inspect pharmacies, device distributors, medial oxygen distributors, etc. As a result, wholesale distributors may not be routinely inspected. Also the lack in relative uniformity of state regulations has resulted in some unscrupulous entities seeking licensure in states with less stringent licensure requirements. As a result, NABP, under the direction of the boards, has taken great strides to address these regulatory challenges. Some solutions being: A. the Model Rules aimed at achieving uniformity in regulation and B. the VAWD Program and Clearinghouse to provide states with resources and a mechanism for convenient information sharing. As you know, the average board has between 5 and 6 inspectors for potentially hundreds of wholesale distributors; and that would be fine if they only inspected wholesalers; they also inspect pharmacies, device distributors, medial oxygen distributors, etc. As a result, wholesale distributors may not be routinely inspected. Also the lack in relative uniformity of state regulations has resulted in some unscrupulous entities seeking licensure in states with less stringent licensure requirements. As a result, NABP, under the direction of the boards, has taken great strides to address these regulatory challenges. Some solutions being:A. the Model Rules aimed at achieving uniformity in regulation andB. the VAWD Program and Clearinghouse to provide states with resources and a mechanism for convenient information sharing.

    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 Due to the PDMA….majority of regulatory responsibility falls to the State BOPs One of the primary issues and reasons that counterfeiters are able to introduce counterfeit product into the legitimate distributions system is because of the inconsistent and sometimes frighteningly inadequate laws from state. A wholesaler may be licensed in another state and want to do business in your state, but regulatory entity in your state has no real way of knowing or evaluating their state of domicile’s requirements….some wholesalers have NEVER been inspected. At the request of the FDA and in response to the needs of our Member Boards, NABP has revised our Model Rules for licensure of wholesale distributors and developed an accreditation program and a clearinghouse for wholesalers to promote uniformity and standardization across the country. 3 Tiers of change…. Two phase pedigree system, the first phase of which provides a concept called the normal distribution channel. This is a system by which pedigrees are not required for wholesale distributions, as long as the product moves along a particular path while it is on its way to the patient. Meaning that the product would move from a Manufacturer ? Wholesaler ? Pharmacy ? Patient. A pedigree would not be required in this instance. However, if a product moved laterally to other wholesalers, a pedigree would be required. Think of it in terms of the product moving on a vertical plane….what this prevents is those lateral transactions that make the system susceptible to counterfeiting. This is the concept that has been widely endorsed and adopted across the country. Due to the PDMA….majority of regulatory responsibility falls to the State BOPs One of the primary issues and reasons that counterfeiters are able to introduce counterfeit product into the legitimate distributions system is because of the inconsistent and sometimes frighteningly inadequate laws from state. A wholesaler may be licensed in another state and want to do business in your state, but regulatory entity in your state has no real way of knowing or evaluating their state of domicile’s requirements….some wholesalers have NEVER been inspected. At the request of the FDA and in response to the needs of our Member Boards, NABP has revised our Model Rules for licensure of wholesale distributors and developed an accreditation program and a clearinghouse for wholesalers to promote uniformity and standardization across the country. 3 Tiers of change…. Two phase pedigree system, the first phase of which provides a concept called the normal distribution channel. This is a system by which pedigrees are not required for wholesale distributions, as long as the product moves along a particular path while it is on its way to the patient. Meaning that the product would move from a Manufacturer ? Wholesaler ? Pharmacy ? Patient. A pedigree would not be required in this instance. However, if a product moved laterally to other wholesalers, a pedigree would be required. Think of it in terms of the product moving on a vertical plane….what this prevents is those lateral transactions that make the system susceptible to counterfeiting. This is the concept that has been widely endorsed and adopted across the country.

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

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

    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 Bottom line: Language in PDUFA legislation that authorizes the FDA to establish standards for track and trace technology, but does not require that it be implemented in the supply chain. · Language MAY set the stage for industry to take implement voluntarily. Enacted a few weeks ago Bottom line: Language in PDUFA legislation that authorizes the FDA to establish standards for track and trace technology, but does not require that it be implemented in the supply chain. · Language MAY set the stage for industry to take implement voluntarily. Enacted a few weeks ago

    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 Bottom line: Language in PDUFA legislation that authorizes the FDA to establish standards for track and trace technology, but does not require that it be implemented in the supply chain. · Language MAY set the stage for industry to take implement voluntarily. Enacted a few weeks ago Bottom line: Language in PDUFA legislation that authorizes the FDA to establish standards for track and trace technology, but does not require that it be implemented in the supply chain. · Language MAY set the stage for industry to take implement voluntarily. Enacted a few weeks ago

    26. NABP’s Model Rules: Three 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 Licensing Requirements Designated Representative Surety Bond Requirements Criminal and Financial Background Checks Ownership Key Personnel Designated Representatives Pedigree Requirement Phase 1: Pedigrees required for products that leave the “normal distribution channel” Serves as a “stop-gap” measure Phase 2: Pedigrees required from the point of manufacture, until final sale to the pharmacy Standardized and large-scale implementation No impact on safety or efficacy of product. Criminal Penalties/Prohibited Acts Establishes 14 different violations and corresponding Criminal Penalties Establishes 18 Prohibited Acts Licensing Requirements Designated Representative Surety Bond Requirements Criminal and Financial Background Checks Ownership Key Personnel Designated Representatives Pedigree Requirement Phase 1: Pedigrees required for products that leave the “normal distribution channel” Serves as a “stop-gap” measure Phase 2: Pedigrees required from the point of manufacture, until final sale to the pharmacy Standardized and large-scale implementation No impact on safety or efficacy of product. Criminal Penalties/Prohibited Acts Establishes 14 different violations and corresponding Criminal Penalties Establishes 18 Prohibited Acts

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

    33. NABP’s 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. Retail Provisions became effective on September 30, 2006. Other states have passed regulations, further implementing suspicious purchase reporting requirements. Retail Provisions became effective on September 30, 2006. Other states have passed regulations, further implementing suspicious purchase reporting requirements.

    41. Eleni Z. Anagnostiadis, RPh Board Services Director eanagnostiadis@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

More Related