NABP®

Committed to Safe Online Pharmacy

NABP®

What Is .pharmacy?

• Pharmacy’s

new Internet

namespace

NABP®

What Is NABP?

• The National Association of Boards of

Pharmacy® (NABP®) 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.

NABP®

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

NABP®

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.

NABP®

Why .pharmacy?

• Addresses global concern

about illegal online drug

sellers distributing products

that endanger patient health

NABP®

Why .pharmacy?

• Supports regulatory efforts of

individual countries, states,

and territories

NABP®

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.

NABP®

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.

NABP®

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 2005.

• 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.

NABP®

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.

NABP®

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.

NABP®

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.

NABP®

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

NABP®

Additional Concerns

• Pharmacy spam constituted 31% of all spam

during 4Q11.

– Responsible for computer viruses and malware

– Ties to international organized crime

NABP®

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

NABP®

Earlier Initiatives by NABP

• NABP e-Advertiser ApprovalCM 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

NABP®

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

NABP®

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

NABP®

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

NABP®

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.

NABP®

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

NABP®

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

NABP®

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

NABP®

.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

NABP®

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.

NABP®

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

NABP®

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.

NABP®

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

NABP®

Next Steps

• Develop international partnerships!

• Finalize and execute all necessary contracts

• Finalize domain registration polices and

technical operations

• Launch consumer education campaign

NABP®

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.

NABP®

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.

NABP®

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.

NABP®

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).

NABP®

VAWD

• Determine lawful sources to ensure drugs are

safe and effective

• Examine security, storage, shipping of drugs

– Narrow temperature ranges for most drugs (68o to 77o

F)

– Backup power for systems

– Shipping packaging maintains temperature

Monitor and Record Temperature

Backup Power for

Security and AC Systems

Shipping

NABP®

VAWD

• 21 states recognize VAWD in some manner.

• There are currently over 540 VAWD-accredited

wholesalers.

NABP®

Questions?

Carmen A. Catizone

Executive Director/Secretary

National Association of Boards of Pharmacy

1600 Feehanville Drive

Mount Prospect, IL 60056

exec-office@nabp.net