Globalization of the Illicit Online Drug Supply Chain: Potential Risks to Patients and Pets

Transcription

1 Timothy K. Mackey, MAS 31 st Annual Meeting Society of Veterinary Hospital Pharmacists May 2012 Globalization of the Illicit Online Drug Supply Chain: Potential Risks to Patients and Pets

2 Pre Test Question #1: What is the global estimated prevalence of counterfeit medicines? A. Less than 1% B. Around 10% A. Around 32% B. None of the above

3 Pre Test Question #1: What is IMPACT? A. A specialized division/department within the WHO permanently committed to combating counterfeits B. An initiative by the U.S. government to combat counterfeit medicines based on intellectual property violations C. A WHO initiated coordination body bringing together various public and private stakeholders D. A collection of law enforcement agencies that coordinate legal and enforcement action against counterfeits

4 Pre Test Question #1: What risk factors are associated with online purchasing of drugs (human)? A. A website that purports to be foreign-based B. A website that sells to consumers using an online consultation/questionnaire C. A website that purports to be USA-based but does not have VIPPS accreditation D. (a) and (b) above E. All of the above

5 Pre Test Question #1: What prescription pet medications are considered high-risk by the US FDA? A. Advantage, Frontline, Topspot and other pet pesticide products B. Heartgard Plus, Interceptor and other heartworm preventives C. Nonsterodial anti-inflammatory drugs (NSAIDs) D. (b) and (c) above E. All of the above

6 Pre Test Question #1: What does the acronym A.W.A.R.E. stand for? A: W: A: R: E:

7 Global Counterfeits In Search of Better Global Health Governance Current Challenges Global distribution of counterfeit medicines in both resource-poor and developed country settings Argument over terminology of counterfeits based on IPR and public health considerations Lack of coordinated surveillance/data (e.g. total global prevalence % unknown) Exacerbated by frenetic pace of globalization and technology advance (Internet/Online Pharmacies)

8 Scope of Problem: Counterfeit Medicines Resource-poor settings Global Counterfeit Incidents Manufacturing/Sourcing: Interpol seizures of 20 million pills in China and Southwest Asia, 34 million in Europe, and millions of dollars worth in Egypt Essential Medicines: Resource poor settings lack strong regulatory systems and low SES populations may turn to counterfeits due to lack of access. This can lead to anti-microbial resistance. Surveys show that estimated 30% of drugs sold in Kenya are counterfeit Estimated 38-53% of vital antimalarial drugs in Southeast Asia are counterfeit Counterfeits implicated in approx. 700,000 deaths for Malaria and TB Detected in a number of resource poor countries

9 Scope of Problem: Counterfeit Medicines Resource-poor settings Resource-poor characteristics Sold in small local drugstores where owners/pharmacists may lack knowledge/ability to detect counterfeits Populations of low SES may purchase counterfeits due to lack of access and price considerations Deceptive packaging/markings may be added to counterfeits to make them look more legitimate Corruption, weak border control, and high profits fuel this illicit trade in developing countries Fake artesunate pills in Cambodia detected with a variety of drugs and chemicals Source: Smithsonian Magazine

10 Scope of Problem: Online Dangers Growing Use of the Internet Growing Use of the Internet 2 billion people currently access internet today Approximately 51% of U.S. users access internet for health information Online searches for health information may lead to risky online drug purchases Online pharmaceutical sales estimated at $11 billion Drug Safety: Sell tainted, unapproved, fake, misbranded, or poor quality drugs to unsuspecting users (counterfeit) Patient Safety: Online sales advertised do not require a prescription, marketing of drugs may be misleading, establishments are unregulated Security Issues: Online pharmacies are connected with financial fraud and funding of other criminal activities

11 Scope of Problem: Online Dangers Drug Safety Global Scope and Reach Everyone and Anything: Online drugs available for anything and accessible to anyone. Dangerous: High prevalence of counterfeit medicines sourced from various countries using questionable manufacturing practices Counterfeit Drugs almost impossible to differentiate: Packaging and labeling of drugs very authentic though drugs may be dangerous

12 Scope of Problem: Online Dangers Individual Patient Safety Consumer Driven/Demand Patient Deaths Around the World: Marcia Bergeron died of metal toxicity caused by counterfeit drugs she bought online Canada 2006 Laura Clearwater USA, CA 2009 Ryan Haight (17 years old) died from mixing drugs purchased online - San Diego Canada: Drug Toxicity/Counterfeit -New Zealand: Poisoning/Overdose -USA: Drug mixing -USA: Accidental overdose -USA: Prescription Drug Addiction Dangerous Behavior: Patients may illegally import unapproved drugs, may self-prescribe, may lead to drug abuse/dependency, may mix drugs or use with counter indications, may fail to receive effective treatment, may suffer adverse event, etc.

13 Scope of Problem: Online Dangers Individual Patient Safety Targets all members of society At risk health consumers are at significant risk and include: The website caption is How Online Pharmacies Make Life Easy with a link to generic medicine in online pharmacies targeted for seniors -Seniors -Adolescents -Uninsured and Underinsured -Those with limited access (handicapped, etc.) -Consumers who are extremely price sensitive/low socio economic Targeted Marketing: Ads promise low-cost, convenient, high quality and generic medicines to those who may lack health literacy

14 Scope of Problem: Online Dangers Misleading Marketing and Promotion Varying Illicit and Legal Private Actors and Platforms No Prescription : Advertise that no prescription is necessary or that patients can buy via online script Misleading: Promote use of personal import and may use fraudulent forms of certifications, promote generic drugs and Canadian pharmacies Social Media: Utilize social media marketing to promote their services/products

15 Scope of Problem: Online Dangers Security and Other Issues Shared Public and Private Sector Threats Financial Security: Financial/credit card information may be fraudulently used by criminals Bioterrorism: Tainted online drugs or drug supply chain can be used by bioterrorists Cyber Criminals: Online drug sales linked to terrorists, illicit drug dealers, the mafia ( Canadian Pharmacy, ) and other organized crime

16 Anatomy of an Online Pharmacy Variety of drugs including lifestyle, essential, pain relief, weight loss, pet meds, etc. Extremely low pricing compared to legal sources and various sales specials FAQ does not require Rx for dispensing, medical questionnaire is taken at point-of-sale Multiple languages, worldwide coverage

17 Technology the Solution? Emerging Tools and Limitations Counterfeit Technology Detection Devices: Detection kits are still in development and often require cooperation and drug assays from industry but show promise (mass spectrometry, chromatography, mini labs, etc.) mpedigree: Authenticating drug supply through mobile phones and codes on packaging. Mobile phone coverage increasing but requires IT infrastructure. RFID and Track & Trace: Authentication technology through radiofrequencies affixed to packaging. Promising but interoperability, cost and logistical challenges abound.

18 Utilizing Existing Systems Leveraging tools and systems currently existing in combating illicit online pharmacies Prevalence of Online Vaccines NABP VIPPS: NABP s Verified Internet Pharmacy Practice Sites accreditation program serves as an important tool to identify legitimate online pharmacies Legitscript: Allows for safe searching and verification of online pharmacies and also provides reporting mechanism to shut down illicit pharmacies FDA: Has reporting system including toll-free number and online reporting

19 Veterinary Medicines Emerging Drug Class On the Rise Robust Pet Spending. Survey by APPA estimates 62% of households own a pet ($72.9 million homes) $50 billion spend on U.S. Pet Industry Expenditures in 2011 Veterinarian care estimated at some $13.59 billion in 2012 Increasing sale of pet medications by large retailers (Kroger, Target, etc.) Largely recession-resistant industry with rising revenues from increasingly complex health interventions

20 Veterinary Medicines Emerging Drug Class On the Rise Rise of Online Pet Pharmacies Rapid proliferation of questionable online sources of pet medications Similar risks to online pharmacies of lack of regulation, misleading marketing, and difficulty in distinguishing legitimate and illegal online pharmacies Pet Risks: Failure to adequately instruct on administration, risk of drug interactions, risk of counterfeit or substandard drugs from gray market that may poison pets

21 Pet Med Counterfeits Rise of Counterfeit Veterinary Medications Online Not just pharmaceuticals anymore FDA warning against Internet sites selling pet medications discount pet drugs-no prescription required Sites selling unapproved, counterfeit, expired pet meds, and making fraudulent claims Use of online veterinarian questionnaire to evaluate pet and release product Specific concerns by FDA for risks associated with NSAIDS and heartworm preventives given need for vet exam and possible side effects

22 Pet Med Counterfeits Rise of Counterfeit Veterinary Medications Online Counterfeit Pesticide Products U.S. EPA concerned about counterfeit pesticide products for dogs and cats (largely non-prescription) Man sentenced for 2 years in federal prison for illegal online sale of Frontline and Frontline Plus including 3,500 sales through ebay Materials sourced from various parts of the world including U.S., Canada, Australia, and China

23 FDA A.W.A.R.E. Be Online Pet Pharmacy AWARE:

24 VIPPS for Veterinarians Vet-VIPPS Accreditation Overview Submit an application, required documentation, and specified fees to NABP NABP reviews policies and procedures to ensure adherence to Vet-VIPPS criteria NABP verifies the pharmacy s license status NABP performs an on-site survey Alternatively consumers should order from an outsourced Rx management service that the Vet uses

25 The above Vet-VIPPS online pharmacies made up only 3 out of 9 (1/3 rd ) of providers listed in the first page of search results when searching for pet medications on Google search engine 25 April 2012

26 FDA Public Service Announcement

27 Globalization of Crime via Online Pharmacies Globalization and its Discontents No borders: The virtual marketplace is borderless and allows distribution of counterfeit drugs to patients globally Lack of Global Framework: Global markets are hard to regulate resulting in a patchwork of ineffective state based regulation which does not address the multitude of actors Open Markets: Global supply chains allows for export and import of drugs which are not approved or properly inspected for quality (i.e. Free Trade Zones )

28 Global Counterfeits Fragmented Global Health Governance Challenges and Regional Progress Ryan Haight Act: U.S. legislation against online pharmacies but only for controlled substances and limited to U.S. Kenya: Kenya Anti-Counterfeit Act criticized as protected IPRs and precluding access to medicines ACTA: Currently in discussion but may emerge as a plurilateral instrument for IPR enforcement of counterfeits MEDICRIME: A dozen countries signed on to Council of Europe s MEDICRIME convention that seeks to criminalize trade in counterfeit medicines.

29 Plethora of Actors The Need to Engage Multiple Actors/Stakeholders Multifaceted problem involving both public and private sectors. Need for coordination and cooperation from multiple stakeholders Global drug trade implicates many different countries and impacts global patient populations Private sector role key in surveillance and identification of illicit drugs/online pharmacies Global enforcement efforts against online pharmacies have only been successful through multi-sector efforts

30 Shadow Online Drug Supply Chain Illegal Manufacturer Internet Pharmacies do not act alone but in concert with illicit and legitimate private sector actors Online Drug Seller Illegal Manufacturers: Vary to a high degree in quality and scale and distribute counterfeits into global drug supply chain (illicit) Facilitators: Individuals or organizations who act as middle men in counterfeit supply chain (illicit) Facilitators Service Providers Service Providers: Companies which enable illegal commerce [i.e. hosting, e- commerce, payment processors, logistic providers] (often legal providers)

31 Network of Private Sector Actors Role of Service Providers Illegal Manufacturers Often overseas in countries such as 1 India, China, Pakistan. Require local enforcement efforts Search Engines: Index online pharmacies through paid and non-paid systems. Receive ad fees. Facilitators 2 Source counterfeit or diverted products for online drug sellers Logistic Providers: Freight carriers/forwarders involved in shipment and detection of illicit online drug sales Service Providers 3 Mostly legal providers which enable e-commerce of online drug sales and secure financial benefit Payment Processor: Allow for payment and financing of illicit online pharmacies. Also benefit from service fees.

32 Network of Private Sector Actors Role of Service Providers Part 2 Internet Service Providers and Domain Registrars: Enable both hosting, indexing, collection of data, and operation of illicit online pharmacies and spam. Have techical information necessary for enforcement. Other Data Aggregators: Affiliate/mirror sites, forums and membership sites enable illicit online pharmacy sales but are not actively involved in sale of product

33 Example: Typical Path of Confiscated Online Drug Purchase Online Drug seller makes drug available (private-illicit and legitimate) Illicit drug is sent back to shipper/seller Consumer purchases drug online (patient) FDA required to inform customer and request info (public sector) Drug shipment inspected by CBP (less than 1%) (public sector) FDA required to inspect package (public sector)

34 Challenges of Online Regulation Virtual Criminals in a Virtual Marketplace Private Sector Enabled Public Enforcement Challenges No Partnership 1 Websites are easily 2 Regional law opened and closed with enforcement not many affiliate sites sufficient in bringing making it difficult to down online pharmacy pinpoint source networks 3 Fragmented local laws and regulations addressing counterfeits that serve only as a patchwork Forms of online and emarketing can impact thousands of consumers instantly driving demand Anonymity of the web allows criminals to endanger patient safety without getting caught and leads to lack of transparency Impossibility in screening and confiscating millions of illegal imports Difficult to attribute patient death or injury to online drug consumption or purchase Territorial/jurisdictional challenges No global regulatory regime to surveil and engage public and private sectors leading to fragmented regulation Failure of state-based law makers to specifically address challenges of online pharmacies

35 Additional Research High prevalence of FDA Shortage Drugs Available from Online Pharmacies Prevalence of Shortage Drugs Of 72 shortage drugs, 68 (94%) were available online Majority (68%) of online drug sellers identified were on NABP Not Recommended Sites list Of shortage drugs with online seller 91% had at least one site not recommended and 36% only had sites nr Online Availability and Safety of Drugs in Shortage: A descriptive study of internet vendor characteristics. Liang BA, Mackey TK. J Med Internet Res Feb 9;14(1):e27 PMID:

36 Additional Research High prevalence of FDA Shortage and WHO Essential Medicines List Vaccines available from online pharmacies Prevalence of Online Vaccines All FDA Biologic Drugs Shortage list vaccines were available online None of the identified FDA shortage vaccine sellers were VIPPS accredited, 75% were international and 10/12 were not recommended Wide range of WHO EML vaccines available online Vaccine shortages and suspect online pharmacy sellers. Liang BA, Mackey TK. Vaccine Jan 5;30(2): Epub 2011 Nov 15. PMID:

37 Online Vaccines Over-the-counter

38 Additional Research High prevalence of online pharmacy advertising via high traffic social media Top 20 DTCA spend drugs with illicit online pharmacy edtca link 90% of Top 10 DTCA spend drugs have illicit social media links 60% and 50% prevalence on Facebook among top 10 and top 20 DTCA advertised drugs respectfully High prevalence of use of social media by illicit online pharmacies Direct-to-Consumer Advertising With Interactive Internet Media: Global Regulation and Public Health Issues. Liang BA, Mackey TK. JAMA Feb 23;305(8): Prevalence and Global Health implications of social media in direct-to-consumer drug advertising. Liang BA, Mackey TK. J Med Internet Res Aug 31;13(3):e64. PMID: Free PMC Article

39 Online Pharmacy edtca Examples

40 Case Study Operation Pangea III: Global Cooperation Operation Pangea III Global Response: Participation of more than 40 countries in int l week of action against online sale of counterfeit drugs Multi-sector: Involved law enforcement, customs, national drug regulators, ISPs, and payment providers and delivery services Results: Shut down 290 websites, 1 million counterfeit pills confiscated, 76 individuals under investigation. Seized illicit drugs valued at $2.6 mil Criticized: IMPACT has been criticized by member states and its future is no longer viable

41 Solutions: Need for Public-Private Partnerships Multiple Actors, Multiple Problems, Need for Public-Private Cooperation PPPs are a required solution in a new GHG framework Private Sector (surveillance, prevention, education and reporting) Public Sector (Law making, research, education enforcement) Public-Private Partnerships (comprehensive) Private Sector: Role of surveillance and reporting of illegal activity. Adherence to laws and regulations. Public Sector: Role of education, enforcement and prevention through law enforcement and legislation/regulation PPPs: Comprehensive solution involving cooperation and sharing of information to engage in active surveillance, enforcement, and prevention.

42 PPPs Combating Online Pharmacies Active Coordination and Cooperation Surveillance: >Active and real-time surveillance by ISPs, search engines, domain registrars, etc. to central database >Development of web tools including algorithms, search bots/crawlers, online screening Enforcement: >Sharing of information from service providers and public to manufacturers, regulators, and law enforcement for verification >Collaborative evaluation of information and takedown of technical infrastructure Prevention: >Utilize centralized database for communicating information to stakeholders for proactive prevention >Partnership in providing education to patients about purchasing online Public Private Partnership Models The global counterfeit drug trade: patient safety and public health risks. Mackey TK, Liang BA. J Pharm Sci Nov;100(11): doi: /jps Epub 2011 Jun 22.PMID:

43 Counterfeit Drugs Integration, governance and multidisciplinary efforts Discussion Public Health and HCPs Patient Safety Public Health: Risk to vulnerable patients and animals needs to be addressed through prevention, health education and promotion and better surveillance and research Legal & Policy: Global actors need to come together and agree to appropriately regulate online pharmacies and coordinate enforcement efforts Private-sector and IT industry Policy-makers and law enforcement Private & Technology Sector: Actors that enable illegal online pharmacy transactions must be held accountable and part of the solution. Pharma needs to improve access to medicines

44 Final Summary Action is needed to protect the global public/animals Internet Pharmacies Present Global Health Risks 1 Unregulated internet pharmacies sell counterfeit drug products and represent a significant threat to global public health with potential tragic consequences for consumers and pets Current Enforcement is Inadequate 2 Current enforcement is inadequate. Search now and you will still be able to find illicit drugs online. PPPs are necessary to combat this global problem. Progressive Reform is Necessary 3 Additional research is necessary on the scope of this problem. Dynamic and active surveillance, enforcement and prevention through PPPs is necessary.

45 Post Test Question #1: What is the global estimated prevalence of counterfeit medicines? A. Less than 1% B. Around 10% A. Around 32% B. None of the above

46 Post Test Question #1: What is IMPACT? A. A specialized division/department within the WHO permanently committed to combating counterfeits B. An initiative by the U.S. government to combat counterfeit medicines based on intellectual property violations C. A WHO initiated coordination body bringing together various public and private stakeholders D. A collection of law enforcement agencies that coordinate legal and enforcement action against counterfeits

47 Post Test Question #1: What risk factors are associated with online purchasing of drugs (human)? A. A website that purports to be foreign-based B. A website that sells to consumers using an online consultation/questionnaire C. A website that purports to be USA-based but does not have VIPPS accreditation D. (a) and (b) above E. All of the above

48 Post Test Question #1: What prescription pet medications are considered high-risk by the US FDA? A. Advantage, Frontline, Topspot and other pet pesticide products B. Heartgard Plus, Interceptor and other heartworm preventives C. Nonsterodial anti-inflammatory drugs (NSAIDs) D. (b) and (c) above E. All of the above

49 Post Test Question #1: What does the acronym A.W.A.R.E. stand for? A sk your veterinarian W atch for red flags A lways check for site accreditation "R eport problems and suspicious online pet pharmacies E ducate yourself about online pet pharmacies

50 THANK YOU! Questions?