Advancing Online Drug Safety: FDA Perspective

Transcription

1 Advancing Online Drug Safety: FDA Perspective Leigh Verbois, PhD Acting Deputy Director Division of Supply Chain Security Office of Drug Security, Integrity, and Recalls Office of Compliance Center for Drug Evaluation and Research U.S. Food and Drug Administration NABP 108 th Annual Meeting May 21, 2012

2 Overview Buying Online- Rogue Internet Pharmacies Public Health Concerns Supply Chain Threats Compromised Integrity FDA s New Office of Drug Security, Integrity & Recalls FDA Supply Chain Security Initiatives 2

3 Are there Perceived Benefits of Buying Drugs Online? Fast Easy- Shopping from home Price comparisons Privacy 3

4 What s the Buzz on Online Pharmacy Issues? Buzz Analysis and Wordle done by Nielsen Company for FDA. Sample of 3,853 consumer messages about buying online prescription drugs July 2010-July

5 FDA s Concerns with Websites that Health Concerns: Sell Medicine Some websites aren t U.S. state-licensed pharmacies or aren t pharmacies at all May give a diagnosis that is not correct and sell medicine that is not right for you Websites are deliberately misleading Other Concerns: Won t protect personal information (health/financial) 5

6 FDA Warns of FDA impersonators- Jan 2011 Criminals call victims which ordered drugs over the internet and identify themselves as FDA special agents or other law enforcement personnel Inform the victims that purchasing drugs over the Internet or the telephone is illegal Inform victim that law enforcement action will be pursued unless a fine or fee ranging from $100 to $250,000 is paid. Victims often also have fraudulent transactions placed against their credit cards. Similar warning in

7 FDA s Concerns about the Product Sold Online Public health risk created by: Introduction of stolen product into the legitimate supply chain Resurfacing of product many months or years after the theft Improper Storage Expired Products Dilution and adulteration Counterfeiting Importation 7

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9 Products that are offered for sale online with claims to diagnose, prevent, mitigate, treat or cure the 2009 H1N1 influenza virus must be carefully evaluated. Medicines purchased from Web sites operating outside the law put consumers at increased risk due to a higher potential that the products will be counterfeit, impure, contaminated, or have too little or too much of the active ingredient. ~Margaret A. Hamburg, M.D Commissioner, U.S Food and Drug Administration (October 15, 2009) 9

10 Fraudulent Tamiflu 2009 H1N1 (Swine) influenza public health emergency, shortage of Tamiflu Oral Suspension October 2009 FDA Warns of Unapproved and Illegal H1N1 Drug Products Purchased Over the Internet Containing Talc and Acetaminophen, sometimes oseltamvir June 2010 FDA Warns about Fraudulent Tamiflu Dangerous to patients allergic to penicillin, contained cloxacillin Did not contain Tamiflu s active ingredient, oseltamvir Represented as Generic Tamiflu 10

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13 Compromised Integrity: Recent Supply Chain Threats not Related to purchasing on the Internet Counterfeit Avastin Counterfeit Altuzan Counterfeit Counterfeit 13

14 Letters from FDA Sent to 19 medical practices in the U.S. Warned against the use of counterfeit Avastin Risks of purchasing from foreign sources Quality Specialty Products (QSP) Volunteer Distribution Report adverse events to MedWatch 14

15 What can patients do? Learn how to buy online safely Buying medicine over the Internet Know where the drugs are coming from buy only from U.S. licensed pharmacies Inspect product and packaging (does it look different from before? any cracked tablets? seals intact?) Be aware of the risks Watch out for SPAM offering Consider possible counterfeits and talk to your Pharmacist about: New/unusual side effects Lack of therapeutic effect Products tastes/smells abnormal Report any adverse event from suspect products or product quality issues of suspect product to 15

16 What can healthcare providers do? Know where the drugs are coming from/who you are doing business with Safeguard your products Inspect product and packaging (any cracked tablets? seals intact?) Destroy empty packaging/containers Be aware of the risks Educate and counsel patients Encourage patients to shop only at US licensed pharmacies RPh s should tell patients when you dispense a drug that may look different from their previously dispensed drug If cost is an issue, counsel on assistance programs and generics, rather than buying cheaper drugs online Listen to Patient Complaints - consider possible counterfeits and report if warranted. Report any suspect products to 16

17 Heightened Vigilance and Awareness MedWatch should be used to report suspect counterfeit or other substandard drugs to FDA Health professionals MedWatch Consumers contact pharmacist Suspected criminal activity can be reported to FDA Office of Criminal Investigations (OCI) Counterfeit Alert Network Partnerships with health professional and consumer groups Disseminate Alerts 17

18 Office of Drug Security, Integrity, and Recalls (ODSIR) Enhanced and targeted resources Address increasing supply chain threats Intentional adulteration, cargo theft, counterfeiting, diversion, other Focus on life-cycle of the product from drug components through to the finished dosage from delivered to the patient New and coordinated approaches, policies and enforcement strategies Recalls Drug Shortages Imports Exports Drug Supply Chain Integrity 18

19 Threats Throughout the Drug Supply Chain Globalization Counterfeit Terrorism Diversion Counterfeit Cargo theft Intentional Adulteration Unknown threats Manufacturer Importer Wholesaler Finished dosage form or API Unknown threats Manufacturer Wholesaler Pharmacy Terrorism API and Inactive Ingredients Patient 19

20 Difficult for Customs (CBP) and FDA to effectively screen all packages VOLUME: 5 million packages from Canada (based on 2003 IMS data) + FDA estimate of 5 million from the world = 10 million packages 20

21 Collaborations to Address SC Threats White House Activities (IPEC) - To combat counterfeiting in all commodities Other Federal Agencies - FBI (Federal Bureau of Investigations) - ICE (Immigration and Customs Enforcement) - CBP (Customs Border Protection) - DEA (Drug Enforcement Agency) - DoS (Department of State) - DoC (Department of Commerce) - FTC (Federal Trade Commission) 21

22 Collaborations to Address SC Threats - Rx Council on Foreign Relations - USP - WHO - NABP - Interpol - IOM - Center for Safe Internet Pharmacies 22

23 Global Collaborations Operation Pangea IV - INTERPOL led global operation targeting internet websites supplying illegal and dangerous drugs; - 81 countries participated - 13,500 websites shutdown - Approximately 8,000 packages seized million illicit counterfeit pills were confiscated 23

24 Roadmap for Global Medical Product Quality and Supply Chain Integrity Goal: develop and implement strategies Effort to coordinate globally Recognition of the challenges and the need for collaboration Requires better understanding life cycle of product FDA proposed a path forward toward practices necessary to ensure the integrity of marketed medical products 24

25 Roadmap for Global Medical Product Quality and Supply Chain Integrity Proposed Gap Assessment Key Elements - State of applicable cgmp - Good Distribution Practices - Good Importer Practices - Product Identification, Authentication and Traceability - Detection Technologies - Internet Sales - Single Point of Contact - (Any Other Agreed Upon Issue) 25

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27 Pending Legislation in Congress May further strengthen FDA s ability to secure the drug supply chain 27

28 Resources Buying Medicines Online ODSIR Drug Integrity and Supply Chain Security lychainsecurity/default.htm Counterfeit Medicine 28

29 ank you Thank You! Leigh Verbois, PhD Acting Deputy Director Division of Drug Security and Integrity Office of Drug Security, Integrity & Recalls Center for Drug Evaluation and Research U.S. Food and Drug Administration 29