Committed to Safe Online Pharmacy NABP

Transcription

1 Committed to Safe Online Pharmacy

2 What Is.pharmacy? Pharmacy s new Internet namespace

3 What Is NABP? The National Association of Boards of Pharmacy ( ) is the impartial professional organization that supports its member boards of pharmacy in protecting the public health. Member boards include all 50 United States, the District of Columbia, Guam, Puerto Rico, the Virgin Islands, eight Canadian provinces, Australia, and New Zealand.

4 What Is.pharmacy? In 2012, NABP, with the support of a global coalition of stakeholders, applied to the Internet Corporation for Assigned Names and Numbers (ICANN) to own and operate a new generic Top-Level Domain (gtld).pharmacy. A gtld is the text to the right of the dot in a domain name. Words created from letters found in the Latin and Spanish alphabets can be used as.pharmacy domain names. Potential.pharmacy domain names include: Boots.pharmacy lamejorfarmacia.pharmacy Pfizer.pharmacy

5 What Is.pharmacy? Ultimate goal is for patients worldwide to: distinguish a.pharmacy website as legitimate; and know that the medications, information, and services they obtain from that site are authentic and safe.

6 Why.pharmacy? Addresses global concern about illegal online drug sellers distributing products that endanger patient health

7 Why.pharmacy? Supports regulatory efforts of individual countries, states, and territories

8 What are the Global Concerns? NABP research indicates that most websites selling medicine operate illegally and endanger patient health. NABP has reviewed nearly 11,0000 sites and has found over 10,300 (97%) to be in conflict with US federal and state pharmacy laws.

9 What are the Global Concerns? Multiple sites offer to sell foreign or non-food and Drug Administration (FDA)-approved drugs, many of which are thought to be counterfeit. Online sales of unregulated and counterfeit drugs are estimated at $75 billion per year. According to World Health Organization, in over 50% of cases, drugs purchased over the Internet from illegal sites that conceal their physical address have been found to be counterfeit.

10 Counterfeiting Cases The number of US FDA counterfeiting investigations has increased dramatically over the past several years. In 2000, the number of cases initiated was six, while in 2004, 58 cases were opened. In addition, the United Kingdom saw a 270% increase in counterfeiting incidents between 2004 and In June 2005, counterfeit Norvasc was found to have been dispensed from a pharmacy in Canada. Eleven deaths were investigated for a possible link to the counterfeit product.

11 Counterfeiting Cases Counterfeit Lipitor was found in the UK in 2005, resulting in a nationwide recall of 120,000 packages. An analysis revealed that 60% of the recalled product was counterfeit. In an earlier Lipitor counterfeiting incident, 18 million repackaged tablets, a mix of counterfeit tablets and authentic tablets intended for non- US markets, were recalled in the largest recall of a prescription medicine in the US.

12 More Counterfeiting Concerns In 2011, more than 50,000 packages shipped from rogue Internet drug sites were seized and found to contain more than 2.4 million illicit and counterfeit dosage units. FDA has found Counterfeit HIV/AIDS drugs that contained nonsterile tap water instead of an active ingredient, Fake schizophrenia medication containing aspirin, and Misbranded cough suppressant that caused the death of five consumers.

13 Additional Concerns Illegal sale of prescription drugs, including controlled substances, without a prescription One in six Americans has purchased medication via the Internet without a valid prescription.

14 Why Is This a Global Public Health Issue? Illegal prescription drug sales and counterfeit medicines threaten patient safety worldwide. Diseases needlessly left untreated Illness and death due to toxic substances Prescription drug abuse on the rise

15 Additional Concerns Pharmacy spam constituted 31% of all spam during 4Q11. Responsible for computer viruses and malware Ties to international organized crime

16 Earlier Initiatives by NABP Verified Internet Pharmacy Practice Sites (VIPPS ) program Includes policy and procedure evaluation, website review, license verification, and on-site visit Advantages Very thorough evaluation high confidence for consumers Disadvantages VIPPS seal has been hijacked and posted on rogue websites. Applicable only to pharmacy applicants Price may be out of reach for smaller practices. Process may be lengthy. US and Canadian applicants only

17 Earlier Initiatives by NABP NABP e-advertiser Approval CM Program Includes website review and license verification Advantages Shorter processing time and lower cost than VIPPS Applicable to pharmacies with a limited online presence and non-pharmacy applicants Disadvantages E-Advertiser seal may be hijacked US and Canadian applicants only

18 Goals of the.pharmacy gltd Program Restrict use of.pharmacy domain names to legitimate website operators that meet universal Internet pharmacy practice standards. Registrants must demonstrate adherence to all applicable laws where they are located and where their patients reside. Available to pharmaceutical manufacturers, pharmacy benefit management companies, schools and colleges of pharmacy, wholesale drug distributors, drug information sites, and more All current approved VIPPS and e-advertisers will be offered.pharmacy without having to undergo additional evaluation. Keep.pharmacy out of the hands of a third party that may allow illegal and/or counterfeit activity within the gtld

19 How Will.Pharmacy Attain These Goals? Evaluate domestic AND international applicants International partnerships worldwide to assist with screening and monitoring of all.pharmacy domain name registrants for adherence with standards Raise consumer awareness and build trust in the.pharmacy gtld

20 Screening and Monitoring of Applicants All applicants vetted prior to registration Evaluation for compliance with program standards and with regulatory standards in home jurisdiction and jurisdiction of patients Necessary jurisdictional pharmacy and practitioner licensure Only valid prescriptions filled Patient information protected Disciplinary history evaluated

21 Ongoing Compliance Monitoring Approved registrants of.pharmacy domain names will be monitored for continued compliance with standards. Domain names within.pharmacy will be subject to suspension or revocation upon the violation of the terms and conditions set forth in the registration agreements.

22 Support for.pharmacy Is Global Leaders Contributed $100,000 or more Pfizer, Inc Eli Lilly and Company Merck & Co, Inc Advocates Contributed $25,000 or more Gilead Sciences Janssen Therapeutics

23 Support for.pharmacy Is Global Endorsers Submitted a letter of support to ICANN or otherwise publicly expressed support Amgen, Inc, Alliance for Safe Online Pharmacies (ASOP), Boehringer Ingelheim, British Brands Group, Drugsdepot.com, DrugSource, Inc, EnforceTheAct.org, European Alliance for Access to Safe Medicines (EAASM), Indiana Board of Pharmacy, International Pharmaceutical Federation (FIP), Ipsen Pharma, LegitScript, National Association of Pharmacy Regulatory Authorities (NAPRA), North Dakota State Board of Pharmacy, Novo Nordisk, Inc, Rx Direct, Inc, Sanofi

24 Support for.pharmacy Is Global The Supporter Advisory Committee provides expertise and strategic input to the Executive Board for establishing core standards of operation that are universal to legitimate pharmacy practice and that will be required of all.pharmacy domain name registrants. The Supporter Advisory Committee includes: ASOP, California State Board of Pharmacy, Eli Lilly and Company, EAASM, FairWinds Partners, FIP, Indiana Board of Pharmacy, INTERPOL, LegitScript, Merck & Co, Inc, NAPRA, Neustar, North Dakota State Board of Pharmacy, Pfizer

25 .pharmacy Product Model Online and brick-and-mortar pharmacies will likely route the.pharmacy domain name to their current sites in the.com or.net TLD. Geographic names we hope to use geographic names to identify legitimate pharmacies operating legitimately in the geographic location. May be limited permission required from country authorities Germany.pharmacy, france.pharmacy, spain.pharmacy, us.pharmacy

26 Consumer Education Fundamental goal is to educate consumers to recognize.pharmacy as the valid designation for a legitimate pharmacy or pharmacy-related entity. Look to the right of the dot Increase awareness of rogue online drug sellers masquerading as pharmacies Dangers of counterfeit drugs and buying prescription drugs without a prescription As consumer recognition increases, more businesses will be willing to undertake the application process.

27 What Has Been Accomplished So Far? February 2013.Pharmacy gtld Advisory Committee convened May 2013.pharmacy application passed ICANN s initial evaluation July 2013.pharmacy gtld governance document finalized June 2014 contract with ICANN finalized Late 2014 anticipated launch

28 Recent Challenges Name collision issues will delay launch of some domain names. Name collision refers to the confusion that could occur when a new gtld string exactly matches an existing string used on an internal network. As new gtlds go live, they can potentially collide with existing names. Two-letter country codes cannot be used without permission of each country s ICANN Government Advisory Committee representative.

29 Recent Challenges Rogue drug sellers disguised as legitimate pharmacies have been vocal in their opposition to.pharmacy. Spreading misinformation and lies about the program and NABP Accusations of payoffs to NABP by pharmaceutical manufacturers PharmacyChecker Canadian International Pharmacy Association

30 Next Steps Develop international partnerships! Finalize and execute all necessary contracts Finalize domain registration polices and technical operations Launch consumer education campaign

31 Conclusion Success will not be measured by the number of domain names registered. Success will be measured by the level of recognition and trust placed in the.pharmacy domain.

32 VAWD Verified-Accredited Wholesale Distributors (VAWD ) VAWD was launched in 2005 and was developed due to concerns of counterfeit drugs affecting the US drug supply. FDA supported the development of the program. Wholesale distributors of prescription drugs and devices that are located in the US are eligible to apply for VAWD.

33 VAWD In 2013, NABP revised the VAWD criteria. Virtual manufacturers and virtual wholesale distributors could qualify for VAWD accreditation. Responsible distribution practices are mandated. Diverted drugs are prevented from entering into the supply chain.

34 VAWD Complex global supply chain for prescription drugs 80% of Active Ingredients (powder) for prescription drugs from overseas 40% of Finished Dosage Forms (capsules, tablets, liquids) from overseas Accreditation programs track drugs from start (manufacturer) to finish (patient or destruction of non-dispensed expired drugs).

35 VAWD Determine lawful sources to ensure drugs are safe and effective Examine security, storage, shipping of drugs Narrow temperature ranges for most drugs (68 o to 77 o F) Backup power for systems Shipping packaging maintains temperature

36 Monitor and Record Temperature

37 Backup Power for Security and AC Systems

38 Shipping

39 VAWD 21 states recognize VAWD in some manner. There are currently over 540 VAWD-accredited wholesalers.

40 Questions? Carmen A. Catizone Executive Director/Secretary National Association of Boards of Pharmacy 1600 Feehanville Drive Mount Prospect, IL