Research On Drug Safety – Partnership for Safe Medicines

Research On Drug Safety

Research Topic Areas and Articles
(A * indicates a PSM Board Member)

Consumer and Provider Education/Issues
Global Supply and Parallel Trade
Law Enforcement
Online Issues
Reporting and Data
Policy and Law
Technology and Detection

If you have an article from a peer-reviewed journal you'd like us to include, please use our contact form to let us know about it.

Consumer and Provider Education/Issues

Limbu, Lam B. and Bruce A. Huhmann, “Illicit Online Pharmacies: A Scoping Review” (June 27, 2023)

Jędrejko, Karol et al, “Unauthorized ingredients in ‘nootropic’ dietary supplements: A review of the history, pharmacology, prevalence, international regulations, and potential as doping agents” (June 27, 2023)

Binkowska-Bury, Monika, et al. “Counterfeit medicines in Poland: opinions of primary healthcare physicians, nurses and lay persons.” Journal Of Clinical Nursing 22, no. 3/4 (February 2013): 559-568. (August 6, 2014)

Nemlekar P, Shepherd M*, Lawson K, and Rush S. Web-Based Survey to Assess the Perceptions of Managed Care Organization Representatives on Use of Copay Subsidy Coupons for Prescription Drugs. J Manag Care Pharm. 2013;19(8):602-08. (October 19, 2013)

Shepherd M*. Examination of Why Some Community Pharmacists Do Not Provide 72-Hour Emergency Prescription Drugs to Medicaid Patients When Prior Authorization Is Not Available. J Manag Care Pharm. 2013;19(7):523-33. (September 19, 2013)

Chambliss W. G, Carroll W. A, Kennedy D, Shepherd M*, et al. Role of the Pharmacist in Preventing Distribution of Counterfeit Medications. In: J Am Pharm Assoc. 2012;52(2):195-199. (March 15, 2013)

Campbell N, Clark JP, Stecher VJ, Goldstein I. Internet-ordered viagra (sildenafil citrate) is rarely genuine. J Sex Med. 2012 Nov;9(11):2943-51. Epub 2012 Aug 27. (November 9, 2012)

Liang BA*, Mackey TK, Lovett KM. Suspect Online Sellers and Contraceptive Access. J.Contraception. 2012.04.011. (May 25, 2012)

Jackson G, Patel S, Khan S. Assessing the Problem of Counterfeit Medications in the United Kingdom. Int J Clin Pract. 2012 Mar;66(3):241-50. (March 1, 2012)

Liang BA.*, Mackey TK. Promoting online drug safety: Using Public–Private Partnerships to Deter Illicit Online Drug Sales. J Commer Biotechnol. (2011) 17, 266–271 (July 12, 2011)

Shcherbakova N, Shepherd M*, Lawson K, and Richards K. The role of authorized generics in the prescription drug marketplace. Journal of Generic Medicines. 2011; 8(1):28-40. (April 19, 2011)

Hosseini SA, Darbooy Sh, Tehrani Banihashemi SA, Naseri SM, Dinarvand R. Counterfeit medicines: report of a cross-sectional retrospective study in Iran. Public Health. 2011 Mar; 125(3):165-71. (March 1, 2011)

Liang B A*, Mackey T. Direct-to-Consumer Advertising With Interactive Internet Media. JAMA. 2011 2 23; 305 (8): 824-825. (February 23, 2011)

Law E, Youmans SL. Combating Counterfeit Medications: the California perspective. J. Pharm. Pract. 2011 Feb; 24(1):114-21 (February 1, 2011)

Ivanitskaya L, Brookins-Fisher J, O Boyle I, Vibbert D, Erofeev D, Fulton L. Dirt cheap and without prescription: how susceptible are young US consumers to purchasing drugs from rogue internet pharmacies? J Med Internet Res. 2010;12(2):e11. (December 1, 2010)

Traynor K. Counterfeit drugs pose growing health threat. Am J Health Syst Pharm. 2010;67(22):1896, 1898. (November 15, 2010)

Silva N. Tacking the Booming Trade in Counterfeit Drugs. Lancet. 2010;376(9754):1725-6 (November 10, 2010)

Orizio G, Rubinelli S, Schulz PJ, Domenighini S, Bressanelli M, Caimi L, Gelatti U. “Save 30% if you buy today”. Online pharmacies and the enhancement of peripheral thinking in consumers. Pharmacoepidemiol Drug Saf. 2010;19(9): 970-6. (September 10, 2010)

Burki T. The Real Cost of Counterfeit Medicines. Lancet Infect Dis. 2010;10(9):585-6. (September 1, 2010)

Gavaza P, Shepherd MD*, Shcherbakova N, Khoza S. The state of health economics and pharmacoeconomics research in Russia: a systematic review. Journal of Pharmaceutical Health Services Research. 2010 Sept; 1(3):113-21. (September 1, 2010)

Shepherd MD.* The effect of US pharmaceutical drug importation on the Canadian pharmaceutical supply. Can Pharm J. 2010 Sept/Oct; 143(5):226-33. (September 1, 2010)

Shepherd, MD*. Black medicine. AQ. 2010 Summer; 4(3):82-5. (July 29, 2010)

Sugita M, Miyakawa M. Economic analysis of use of counterfeit drugs: health impairment risk of counterfeit phosphodiesterase type 5 inhibitor taken as an example. Environ Health Prev Med. 2010 Jul; 15(4):244-51. (July 1, 2010)

Chaubey SK, Sangla KS, Suthaharan EN, Tan YM. Severe Hypoglycaemia Associated with Ingesting Counterfeit Medication. Med J Aust. 2010;192(12):716-7. (June 21, 2010)

World Health Organization. Growing Threat from Counterfeit Medicines. Bull World Health Organ. 2010;88(4):247-8. (April 1, 2010)

Ghodse H. Watching Internet Pharmacies. Br J Psychiatry. 2010;196:169-170. (March 10, 2010)

Jackson G, Arver S, Banks I, Stecher VJ. Counterfeit phosphodiesterase type 5 inhibitors pose significant safety risks. Int J Clin Pract. 2010;64(4):497-504. (January 18, 2010)

Liang BA.* Supporting Pharmaceutical Diversion and Counterfeiting Prosecutions: A Role for Medical Professionals. J Biolaw Bus. 2010;13(1&2): 55-57. (January 1, 2010)

Cheng MM. Is the drugstore safe? Counterfeit diabetes products on the shelves. J Diabetes Sci Technol. 2009;3(6):1 516-20. (November 10, 2009)

Winegar A, Shepherd MD*, Lawson KA, Richards K. Comparison of claim percent gross margin earned by Texas community independent pharmacies for dual-eligible beneficiaries claims before and after Medicare Part D. J Am Pharm Assoc. 2009 Sept/Oct; 49(5):617-2 (September 1, 2009)

Seiter A. Health and economic consequences of counterfeit drugs. Clin Pharmacol Ther. 2009;85(6):576-8. (June 10, 2009)

Gautam CS, Utreja A, Singal GL. Spurious and counterfeit drugs: a growing industry in the developing world. Postgrad Med J. 2009;85(1003):251-6. (May 10, 2009)

Graham MR, Ryan P, Baker JS, Davies B, Thomas NE, Cooper SM, Evans P, Easmon S, Walker CJ, Cowan D, Kicman AT. Counterfeiting in performance- and image-enhancing drugs. Drug Test Anal. 2009;1(3):135-42 (March 11, 2009)

Panjabi SS, Panjabi RS, Shepherd MD*, Lawson KA, Johnsrud M, Barner J. Extended-release, once-daily morphine (Avinza) for the treatment of chronic nonmalignant pain: effect on pain, depressive symptoms, and cognition. Pain Medicine. 2008 Aug; 9(8):985-93. (August 7, 2008)

Swaminath G. Faking it – I The Menace of Counterfeit Drugs. Indian J Psychiatry. 2008;50(4):238-40. (January 10, 2008)

Class JN.* Behind the Curve: A Critique of NGO Activity with regards to the Safety Concerns of Biologics. J Biolaw Bus. 2007;10(4):33-36. (December 7, 2007)

Roberts R. Counterfeit Biologics: A Personal Narrative. J Biolaw Bus. 2007;10(4):37-39. (December 7, 2007)

Shepherd, M.* Impact of drug importation on community pharmacy and patient care. J Am Pharm Assn. 2007; 47(3):319-327 (May 27, 2007)

Liang BA.* Structurally Sophisticated or Lamentably Limited? Mechanisms to Ensure Safety of the Medicine Supply. Albany Law J Sci Technol. 2006;16(3):483-524 (June 1, 2006)

Cates A. Medication, ID Theft, and Health Care: A Haven for the Criminal Element. J Biolaw Bus. 2006;9(4):61-64. (February 7, 2006)

Liang BA.* Fade to Black: Importation and Counterfeit Drugs. Am J Law Med. 2006 Feb 1;32(2-3):279-323 (February 1, 2006)

Rodriguez RF. Drug Importation and the Hispanic Physician. California Western Intl Law J. 2005;36:117-124. (December 7, 2005)

Bro WP. Importation of Prescription Drugs and Risks to Patient Safety. California Western Intl Law J. 2005;36:105-116. (December 7, 2005)

Langston EL. The Quality Quandary. California Western Intl Law J. 2005;36:19-32. (December 7, 2005)

Global Supply and Parallel Trade

Acri K (2020) State Pharmaceutical Importation Programmes: an Analysis of the Cost‐Effectiveness (May 4, 2020)

Shepherd M (2019) New pathways for U.S. importation threaten Canadian prescription drug supply. Canadian Health Policy Journal, (September 23, 2019)

Nayyar GM., Breman JG, Et Al. Falsified and Substandard Drugs: Stopping the Pandemic AJTMhH 2019 Mar; 18-0981. (March 11, 2019)

Bastiaan J Venhuis, Angela E Oostlander, Domenico Di Giorgio, Ruth Mosimann, Ines du Plessis. Oncology Drugs In The Crosshairs Of Pharmaceutical Crime. The Lancet. 2013;19:e209-15. (April 17, 2018)

Shepherd M (2018) U.S. Drug Importation: Impact on Canada’s Prescription Drug Supply. Health Econ Outcome Res Open Access 4: 146. (August 9, 2017)

Nayyar, Gaurvika M. L. et al., “The Global Pandemic of Falsified Medicines: Laboratory and Field Innovations and Policy Perspectives,” The American Journal of Tropical Medicine and Hygiene, Volume 92, Issue 6_Suppl, Jun 2015, p. 2 – 7 (May 12, 2017)

Mackey, Tim K.*, and Bryan A. Liang*. “Pharmaceutical digital marketing and governance: illicit actors and challenges to global patient safety and public health.” Globalization & Health 9, no. 1 (November 2013): 1-21. (August 6, 2014)

Glass, Beverley D. “Counterfeit drugs and medical devices in developing countries.” Research & Reports In Tropical Medicine 5, (March 2014): 11-22. (August 6, 2014)

Hottinger M, Liang BA*. Deficiencies of the FDA in Evaluating Generic Formulations: Addressing Narrow Therapeutic Index Drugs. Am J Law Med. 2012. Forthcoming. Available at SSRN: http://ssrn.com/abstract=2121528. (December 13, 2012)

Campbell N, Clark JP, Stecher VJ, Goldstein I. Internet-ordered viagra (sildenafil citrate) is rarely genuine. J Sex Med. 2012 Nov;9(11):2943-51. Epub 2012 Aug 27. (November 9, 2012)

McCoy D, Pitsillidis A, Jordan G, et al. PharmaLeaks: understanding the business of online pharmaceutical affiliate programs. In: Security’12 Proceedings of the 21st USENIX conference on Security symposium. Pages 1-1; USENIX Assn Berkeley, CA 2012. (August 8, 2012)

Nayyar GM., Breman JG, et al. Poor-quality antimalarial drugs in southeast Asia and sub-Saharan Africa. Lancet Infect Dis. 2012 Jun; 12:6: 488-496. (June 1, 2012)

Liang BA*, Mackey TK, Lovett KM. Suspect Online Sellers and Contraceptive Access. J.Contraception. 2012.04.011. (May 25, 2012)

Ambroise-Thomas P. The Tragedy Caused by Fake Antimalarial Drugs. Mediterr J Hematol Infect Dis. 2012; 4(1): e2012027. (May 1, 2012)

Pillai DR., Lau R, Khairnar K, et al. Artemether resistance in vitro is linked to mutations in PfATP6 that also interact with mutations in PfMDR1 in travellers returning with Plasmodium falciparum infections. Malar J. 2012, 11:131. (April 27, 2012)

Jackson G, Patel S, Khan S. Assessing the Problem of Counterfeit Medications in the United Kingdom. Int J Clin Pract. 2012 Mar;66(3):241-50. (March 1, 2012)

Liang BA*, & Mackey TK, Online Availability and Safety of Drugs in Shortage: A Descriptive Study of Internet Vendor Characteristics. J Med Internet Res. 2012 Feb 9;14(1):e27. (February 9, 2012)

Jena AB, Goldman DP, Foster SE, Califano JA. Prescription Medication Abuse and Illegitimate Internet-based Pharmacies. Ann Intern Med. 2011 Dec 20;155(12):848-50. (December 20, 2011)

Mackey TK, Liang BA*. The Global Counterfeit Drug Trade: Patient Safety and Public Health Risks. J Pharm Sci. 2011 Nov;100(11):4571-9. (November 30, 2011)

Liang BA*, Mackey TK. Vaccine shortages and suspect online pharmacy sellers. Vaccine (2011), doi:10.1016/j.vaccine.2011.11.016 (November 15, 2011)

Leontiadis N, Moore T, Christin N. Measuring and Analyzing Search-Redirection Attacks in the Illicit Online Prescription Drug Trade. Proceedings of the USENIX Security Symposium; 2011: San Francisco, California: USENIX Security Symposium; 2011 p. 1-17. (September 14, 2011)

Golocorbin Kon S, Mikov M. [Counterfeit Drugs as a Global Threat to Health]. [Article in Serbian]. Med Pregl. 2011 May-Jun;64(5-6):285-90. (June 1, 2011)

Levchenko K, Pitsillidis A, Enright B, et al. Click Trajectories: End-to-End Analysis of the Spam Value Chain. Proceedings of the IEEE Symposium and Security and Privacy, Oakland, CA, May 2011. (May 14, 2011)

Danzon P, Johnson SJ, Long G, Furukawa MF. Commercial Importation of Prescription Drugs in the United States: Short-Run Implications. Journal of Health Politics, Policy and Law 2011 36(2):295-316. (May 1, 2011)

Liang B A*, Mackey T. Direct-to-Consumer Advertising With Interactive Internet Media. JAMA. 2011 2 23; 305 (8): 824-825. (February 23, 2011)

Veronin M. Packaging and Labeling of Pharmaceutical Products Obtained from the Internet. J Med Internet Res. 2011 Feb 15;13(1):e22. (February 15, 2011)

Watson R. European Union prepares to tackle counterfeit drugs. BMJ. 2010;340:c2425. (January 25, 2011)

Bhan A. Health ministry institutes reward scheme for whistle-blowers reporting spurious drugs. Natl Med J India. 2010;23(1):56 (December 7, 2010)

Alkahtani S, Sammons H, Choonara I, Epidemics of Acute Renal Failure in Children (diethylene glycol toxicity). Arch Dis Child. 2010 Dec;95(12):1062-4. (December 1, 2010)

Ivanitskaya L, Brookins-Fisher J, O Boyle I, Vibbert D, Erofeev D, Fulton L. Dirt cheap and without prescription: how susceptible are young US consumers to purchasing drugs from rogue internet pharmacies? J Med Internet Res. 2010;12(2):e11. (December 1, 2010)

Silva N. Tacking the Booming Trade in Counterfeit Drugs. Lancet. 2010;376(9754):1725-6 (November 10, 2010)

Shepherd MD.* The effect of US pharmaceutical drug importation on the Canadian pharmaceutical supply. Can Pharm J. 2010 Sept/Oct; 143(5):226-33. (September 1, 2010)

Shepherd MD*, The effect of US pharmaceutical importation on the Canadian drug supply. CPJ. 2010 Sept/Oct; 143(5):226-33. (September 1, 2010)

Shepherd, MD*. Black medicine. AQ. 2010 Summer; 4(3):82-5. (July 29, 2010)

Sugita M, Miyakawa M. Economic analysis of use of counterfeit drugs: health impairment risk of counterfeit phosphodiesterase type 5 inhibitor taken as an example. Environ Health Prev Med. 2010 Jul; 15(4):244-51. (July 1, 2010)

Shepherd M.* Beef up international cooperation on counterfeits. Nat Med. 2010;16(4):366. (April 16, 2010)

Liang BA.* International Drug Production and Supply: Challenges for Biopreparedness. J Biolaw Bus. 2010;12(3): 31- 34. (January 1, 2010)

Lewis K. China’s counterfeit medicine trade booming. CMAJ. 2009;181(10):E237-8. (November 16, 2009)

Liang BA.* Pigs, Drugs, and Terrorists. Patient Safe Qual Healthcare. 2008 Nov 1:10-12 (November 1, 2008)

Trefi S, Routaboul C, Hamieh S, Gilard V, Malet-Martino M, Martino R. Analysis of illegally manufactured formulations of tadalafil (Cialis®) by 1H NMR, 2D DOSY 1H NMR and Raman spectroscopy. J Pharm Biomed Anal. 2008 May 12;47(1):103-113 (May 1, 2008)

Amon JJ. Dangerous medicines: unproven AIDS cures and counterfeit antiretroviral drugs. Global Health. 2008;4:5. (February 10, 2008)

Lammons KD. The October 2005 Fake Flu Vaccine Incident. J Biolaw Bus. 2007;10(4):40-43. (December 7, 2007)

Liang BA.* A Dose of Reality: Promoting Access to Pharmaceuticals. Wake Forest Intell Prop LJ. 2007 Dec 1;8:301-386 (December 1, 2007)

Shepherd, M.* Drug Importation and Safety of Drugs Obtained from Canada. Ann Pharmacother. 2007;41:1288-1291. (June 19, 2007)

Shepherd, M.* Impact of drug importation on community pharmacy and patient care. J Am Pharm Assn. 2007; 47(3):319-327 (May 27, 2007)

Shepherd MD.* Impact of Drug Importation on Community Pharmacy and Patient Care. J Am Pharm Assoc. 2007 May-Jun ;47:319-20, 323-4, 327 (May 1, 2007)

Eban K. Dangerous Doses. J Biolaw Bus. 2006;9(4):57-60. (December 7, 2006)

Schulte G. An Overview of Pharmaceutical Smuggling Cases in San Diego: It Goes Better When Agencies Work Together. J Biolaw Bus. 2006;9(4):41-45. (December 7, 2006)

Thomson J. The European Pharmaceutical Supply Chain: Implications for the USA. J Biolaw Bus. 2006;9(4):65-68. (December 7, 2006)

Liang BA.* Crime, Terrorism, and Counterfeit Drugs: Addressing the International Regime. J Biolaw Bus. 2006;9(4): 36-40. (December 7, 2006)

Liang BA.* Parallel Trade in Pharmaceuticals: Injecting the Counterfeit Element into the Public Health. NC J Int Law Com Reg. 2006;31(4):847-900 (June 1, 2006)

Liang BA.* Fade to Black: Importation and Counterfeit Drugs. Am J Law Med. 2006 Feb 1;32(2-3):279-323 (February 1, 2006)

Gilbert T, Halwani S. Confusion and Contradiction: Untangling Drug Importation and Counterfeit Drugs. California Western Intl Law J. 2005;36:41-54. (January 7, 2006)

Liang BA.* Over The Virtual and Geographic Borders: Understanding Importation and Counterfeit Drugs. Cal W Int Law J. 2005 Jun 3;36(1):7-18 (June 3, 2005)

Liang BA.* International Drug Importation: Issues in Public Policy, Patient Safety, and the Public Health. Cal W Int Law J. 2005 Jun 3;36(1):1-6 (June 3, 2005)

Law Enforcement

Former FBI Director Louis Freeh Updates His 2017 Report on the Threat of Congressional Drug Importation Proposals (February 4, 2019)

Former FBI Director Discusses the Dangers of Allowing Drug Importation in Radio Interview (July 17, 2017)

“Operation Pangea VI: combating sale of unapproved medicines.” WHO Drug Information 27, no. 3 (September 2013): 227. (August 6, 2014)

Ganor, Boaz, and Miri Halperin Wernli. “The Infiltration of Terrorist Organizations Into the Pharmaceutical Industry: Hezbollah as a Case Study.” Studies In Conflict & Terrorism 36, no. 9 (September 2013): 699-712. (August 6, 2014)

Mackey TK, Liang BA*. The Global Counterfeit Drug Trade: Patient Safety and Public Health Risks. J Pharm Sci. 2011 Nov;100(11):4571-9. (November 30, 2011)

Liang B A*, Mackey T. Direct-to-Consumer Advertising With Interactive Internet Media. JAMA. 2011 2 23; 305 (8): 824-825. (February 23, 2011)

Kubic TT.* Law Enforcement and Industry: Key Partners for Safe Medicines. J Biolaw Bus. 2010;13(1&2):38-41. (January 1, 2010)

Giacolone RP. Drug Wholesaling and Importation: Challenges and Opportunities. California Western Intl Law J. 2005;36:65-76. (January 7, 2006)

Liang BA.* Over The Virtual and Geographic Borders: Understanding Importation and Counterfeit Drugs. Cal W Int Law J. 2005 Jun 3;36(1):7-18 (June 3, 2005)

Reporting and Data

O’Donnell J, Tanz LJ, Gladden RM, Davis NL, Bitting J. Trends in and Characteristics of Drug Overdose Deaths Involving Illicitly Manufactured Fentanyls — United States, 2019–2020. MMWR Morb Mortal Wkly Rep. ePub: 14 December 2021. (December 14, 2021)

Nayyar GM., Breman JG, Et Al. Falsified and Substandard Drugs: Stopping the Pandemic AJTMhH 2019 Mar; 18-0981. (March 11, 2019)

Bastiaan J Venhuis, Angela E Oostlander, Domenico Di Giorgio, Ruth Mosimann, Ines du Plessis. Oncology Drugs In The Crosshairs Of Pharmaceutical Crime. The Lancet. 2013;19:e209-15. (April 17, 2018)

CDC Paints a Grim Picture of the U.S. Fentanyl Crisis in Ohio (September 14, 2017)

da Justa Neves, Diana Brito, Ravane Gracy Ament Marcheti, and Eloisa Dutra Caldas. “Incidence of anabolic steroid counterfeiting in Brazil.” Forensic Science International 228, no. 1-3 (May 10, 2013): e81-e83. (August 6, 2014)

Nemlekar P, Shepherd M*, Lawson K, and Rush S. Web-Based Survey to Assess the Perceptions of Managed Care Organization Representatives on Use of Copay Subsidy Coupons for Prescription Drugs. J Manag Care Pharm. 2013;19(8):602-08. (October 19, 2013)

Shepherd M*. Examination of Why Some Community Pharmacists Do Not Provide 72-Hour Emergency Prescription Drugs to Medicaid Patients When Prior Authorization Is Not Available. J Manag Care Pharm. 2013;19(7):523-33. (September 19, 2013)

Liang BA*, Mackey TK, Lovett KM. Illegal “No Prescription” Internet Access to Narrow Therapeutic Index Drugs. Clin Ther. 2013 Apr 15; S0149-2918(13)00167-7. (April 15, 2013)

Chambliss W. G, Carroll W. A, Kennedy D, Shepherd M*, et al. Role of the Pharmacist in Preventing Distribution of Counterfeit Medications. In: J Am Pharm Assoc. 2012;52(2):195-199. (March 15, 2013)

Csupor D, Boros K, Dankó B, Veres K, Szendrei K, Hohmann J. Rapid identification of sibutramine in dietary supplements using a stepwise approach. Pharmazie. 2013 Jan;68(1):15-8. (December 31, 2012)

McCoy D, Pitsillidis A, Jordan G, et al. PharmaLeaks: understanding the business of online pharmaceutical affiliate programs. In: Security’12 Proceedings of the 21st USENIX conference on Security symposium. Pages 1-1; USENIX Assn Berkeley, CA 2012. (August 8, 2012)

Nayyar GM., Breman JG, et al. Poor-quality antimalarial drugs in southeast Asia and sub-Saharan Africa. Lancet Infect Dis. 2012 Jun; 12:6: 488-496. (June 1, 2012)

Pillai DR., Lau R, Khairnar K, et al. Artemether resistance in vitro is linked to mutations in PfATP6 that also interact with mutations in PfMDR1 in travellers returning with Plasmodium falciparum infections. Malar J. 2012, 11:131. (April 27, 2012)

Orizio G, Merla A, Schulz PJ, Gelatti U. Quality of Online Pharmacies and Websites Selling Prescription Drugs: a Systematic Review. J Med Internet Res. 2011 Sep 30;13(3):e74. (September 30, 2011)

Hosseini SA, Darbooy Sh, Tehrani Banihashemi SA, Naseri SM, Dinarvand R. Counterfeit medicines: report of a cross-sectional retrospective study in Iran. Public Health. 2011 Mar; 125(3):165-71. (March 1, 2011)

Veronin M. Packaging and Labeling of Pharmaceutical Products Obtained from the Internet. J Med Internet Res. 2011 Feb 15;13(1):e22. (February 15, 2011)

Law E, Youmans SL. Combating Counterfeit Medications: the California perspective. J. Pharm. Pract. 2011 Feb; 24(1):114-21 (February 1, 2011)

Kuzma J. Web Vulnerability Study of Online Pharmacy Sites. Inform Health Soc Care. 2011 Jan;36(1):20-34. (January 30, 2011)

Gavaza P, Shepherd MD*, Shcherbakova N, Khoza S. The state of health economics and pharmacoeconomics research in Russia: a systematic review. Journal of Pharmaceutical Health Services Research. 2010 Sept; 1(3):113-21. (September 1, 2010)

Kubic TT.* Beer Cooler Biologics! J Biolaw Bus. 2007;10(4):28-32. (December 7, 2007)

Shepherd MD*, Richards KM, Winegar AL. Prescription drug payment times by Medicare Part D plans: results of a national study. J Am Pharm Assoc. 2007 Nov/Dec; 47(6):695-701. (November 1, 2007)

Kubic TT,* Mollo SJ. Pharmaceutical Counterfeiting Trends: Understanding The Extent of Criminal Activity. J Biolaw Bus. 2006;9(4):51-56. (December 7, 2006)

Liang BA.* Measuring the Impact of Counterfeit Drugs: Applying the Patient Safety Reporting System Approach. Proceedings of the OECD/WIPO meeting on measurement of counterfeiting and piracy, 17-18 October 2005. (October 17, 2005)

Online Issues

Former FBI Director Louis Freeh Updates His 2017 Report on the Threat of Congressional Drug Importation Proposals (February 4, 2019)

Guerra C, Mackey TK. “USA criminal and civil prosecutions associated with illicit online pharmacies: legal analysis and global implications.” Med Access @ Point Care 2017; 1(1): e104-e118. (December 14, 2017)

Mackey TK, Liang BA*. Global Reach of Direct-to-Consumer Advertising Using Social Media for Illicit Online Drug Sales. J.Med Internet Res. 2013 Sept 12; 15(5):e105. (May 1, 2013)

Liang BA*, Mackey TK, Lovett KM. Illegal “No Prescription” Internet Access to Narrow Therapeutic Index Drugs. Clin Ther. 2013 Apr 15; S0149-2918(13)00167-7. (April 15, 2013)

Campbell N, Clark JP, Stecher VJ, Goldstein I. Internet-ordered viagra (sildenafil citrate) is rarely genuine. J Sex Med. 2012 Nov;9(11):2943-51. Epub 2012 Aug 27. (November 9, 2012)

Liang BA,* Mackey TK. Stem Cells, Dot-Com. Sci Transl Med. 2012 Sept 12; 4;151:151-9. (September 12, 2012)

McCoy D, Pitsillidis A, Jordan G, et al. PharmaLeaks: understanding the business of online pharmaceutical affiliate programs. In: Security’12 Proceedings of the 21st USENIX conference on Security symposium. Pages 1-1; USENIX Assn Berkeley, CA 2012. (August 8, 2012)

Liang BA*, Mackey TK, Lovett KM. Suspect Online Sellers and Contraceptive Access. J.Contraception. 2012.04.011. (May 25, 2012)

Jackson G, Patel S, Khan S. Assessing the Problem of Counterfeit Medications in the United Kingdom. Int J Clin Pract. 2012 Mar;66(3):241-50. (March 1, 2012)

Liang BA*, & Mackey TK, Online Availability and Safety of Drugs in Shortage: A Descriptive Study of Internet Vendor Characteristics. J Med Internet Res. 2012 Feb 9;14(1):e27. (February 9, 2012)

Jena AB, Goldman DP, Foster SE, Califano JA. Prescription Medication Abuse and Illegitimate Internet-based Pharmacies. Ann Intern Med. 2011 Dec 20;155(12):848-50. (December 20, 2011)

Mackey TK, Liang BA*. The Global Counterfeit Drug Trade: Patient Safety and Public Health Risks. J Pharm Sci. 2011 Nov;100(11):4571-9. (November 30, 2011)

Liang BA*, Mackey TK. Vaccine shortages and suspect online pharmacy sellers. Vaccine (2011), doi:10.1016/j.vaccine.2011.11.016 (November 15, 2011)

Orizio G, Merla A, Schulz PJ, Gelatti U. Quality of Online Pharmacies and Websites Selling Prescription Drugs: a Systematic Review. J Med Internet Res. 2011 Sep 30;13(3):e74. (September 30, 2011)

Leontiadis N, Moore T, Christin N. Measuring and Analyzing Search-Redirection Attacks in the Illicit Online Prescription Drug Trade. Proceedings of the USENIX Security Symposium; 2011: San Francisco, California: USENIX Security Symposium; 2011 p. 1-17. (September 14, 2011)

Liang BA.*, Mackey TK. Prevalence and Global Health Implications of Social Media in Direct-to-Consumer Drug Advertising. J Med Internet Res 2011;13(3):e64 (August 31, 2011)

Liang BA.*, Mackey TK. Promoting online drug safety: Using Public–Private Partnerships to Deter Illicit Online Drug Sales. J Commer Biotechnol. (2011) 17, 266–271 (July 12, 2011)

Golocorbin Kon S, Mikov M. [Counterfeit Drugs as a Global Threat to Health]. [Article in Serbian]. Med Pregl. 2011 May-Jun;64(5-6):285-90. (June 1, 2011)

Levchenko K, Pitsillidis A, Enright B, et al. Click Trajectories: End-to-End Analysis of the Spam Value Chain. Proceedings of the IEEE Symposium and Security and Privacy, Oakland, CA, May 2011. (May 14, 2011)

Liang B A*, Mackey T. Direct-to-Consumer Advertising With Interactive Internet Media. JAMA. 2011 2 23; 305 (8): 824-825. (February 23, 2011)

Veronin M. Packaging and Labeling of Pharmaceutical Products Obtained from the Internet. J Med Internet Res. 2011 Feb 15;13(1):e22. (February 15, 2011)

Law E, Youmans SL. Combating Counterfeit Medications: the California perspective. J. Pharm. Pract. 2011 Feb; 24(1):114-21 (February 1, 2011)

Kuzma J. Web Vulnerability Study of Online Pharmacy Sites. Inform Health Soc Care. 2011 Jan;36(1):20-34. (January 30, 2011)

Liang BA.*, Mackey T. Searching for Safety: Addressing Search Engine, Website, and Provider Accountability for Illicit Online Drug Sales. Am J Law Med. 2009;35:125-184. (December 10, 2010)

Ivanitskaya L, Brookins-Fisher J, O Boyle I, Vibbert D, Erofeev D, Fulton L. Dirt cheap and without prescription: how susceptible are young US consumers to purchasing drugs from rogue internet pharmacies? J Med Internet Res. 2010;12(2):e11. (December 1, 2010)

Orizio G, Rubinelli S, Schulz PJ, Domenighini S, Bressanelli M, Caimi L, Gelatti U. “Save 30% if you buy today”. Online pharmacies and the enhancement of peripheral thinking in consumers. Pharmacoepidemiol Drug Saf. 2010;19(9): 970-6. (September 10, 2010)

Shepherd, MD*. Black medicine. AQ. 2010 Summer; 4(3):82-5. (July 29, 2010)

Ghodse H. Watching Internet Pharmacies. Br J Psychiatry. 2010;196:169-170. (March 10, 2010)

Jackson G. Faking It: The Dangers of Counterfeit Medicines on the Internet.Int J Clin Pract.2009;63(2):181. (February 27, 2009)

Trefi S, Routaboul C, Hamieh S, Gilard V, Malet-Martino M, Martino R. Analysis of illegally manufactured formulations of tadalafil (Cialis®) by 1H NMR, 2D DOSY 1H NMR and Raman spectroscopy. J Pharm Biomed Anal. 2008 May 12;47(1):103-113 (May 1, 2008)

Shepherd, M.* Drug Importation and Safety of Drugs Obtained from Canada. Ann Pharmacother. 2007;41:1288-1291. (June 19, 2007)

Montoya ID, Jano E. Online Pharmacies: Safety and Regulatory Considerations. Int J Health Serv. 2007;37(2):279-89. (April 11, 2007)

Policy and Law

COVID’s Impact On The Flow Of Counterfeits (May 6, 2022)

Conti R, Dusetzina S. B. , and Sachs R. “How The ACA Reframed The Prescription Drug Market And Set The Stage For Current Reform Efforts.” Health Affairs. VOL. 39, NO. 3 (March 2020) (May 4, 2021)

Pitts, Peter J. “The Spreading Cancer of Counterfeit Drugs, Pharmaceutical Fakery Metastasizes from Lifestyle to Lifesaving Medicines,” Journal of Commercial Biotechnology (2020) 25(3), 20–14. doi: 10.5912/jcb940 (October 19, 2020)

Acri née Lybecker, Kristina M.L., State Pharmaceutical Importation Programs: An Analysis of the Cost Effectiveness (June 12, 2019). Colorado College Working Paper 2019-02 June 2019. (August 1, 2019)

Former FBI Director Louis Freeh Updates His 2017 Report on the Threat of Congressional Drug Importation Proposals (February 4, 2019)

Guerra C, Mackey TK. “USA criminal and civil prosecutions associated with illicit online pharmacies: legal analysis and global implications.” Med Access @ Point Care 2017; 1(1): e104-e118. (December 14, 2017)

Making Canada America’s Medicine Cabinet Is Not The Solution To High Drug Prices (September 6, 2017)

Traynor, Kate. “California pharmacy board takes next steps toward electronic pedigree.” American Journal Of Health-System Pharmacy 70, no. 4 (February 15, 2013): 303-304. (August 27, 2014)

Dégardin, Klara, Yves Roggo, and Pierre Margot. “Understanding and fighting the medicine counterfeit market.” Journal Of Pharmaceutical & Biomedical Analysis 87, (January 18, 2014): 167-175. (August 6, 2014)

Hottinger M, Liang BA*. Deficiencies of the FDA in Evaluating Generic Formulations: Addressing Narrow Therapeutic Index Drugs. Am J Law Med. 2012. Forthcoming. Available at SSRN: http://ssrn.com/abstract=2121528. (December 13, 2012)

Liang BA,* Mackey TK. Stem Cells, Dot-Com. Sci Transl Med. 2012 Sept 12; 4;151:151-9. (September 12, 2012)

Mackey TK, Liang BA*. The Global Counterfeit Drug Trade: Patient Safety and Public Health Risks. J Pharm Sci. 2011 Nov;100(11):4571-9. (November 30, 2011)

Liang BA.*, Mackey TK. Promoting online drug safety: Using Public–Private Partnerships to Deter Illicit Online Drug Sales. J Commer Biotechnol. (2011) 17, 266–271 (July 12, 2011)

Danzon P, Johnson SJ, Long G, Furukawa MF. Commercial Importation of Prescription Drugs in the United States: Short-Run Implications. Journal of Health Politics, Policy and Law 2011 36(2):295-316. (May 1, 2011)

Liang B A*, Mackey T. Direct-to-Consumer Advertising With Interactive Internet Media. JAMA. 2011 2 23; 305 (8): 824-825. (February 23, 2011)

Watson R. European Union prepares to tackle counterfeit drugs. BMJ. 2010;340:c2425. (January 25, 2011)

Liang BA.*, Mackey T. Searching for Safety: Addressing Search Engine, Website, and Provider Accountability for Illicit Online Drug Sales. Am J Law Med. 2009;35:125-184. (December 10, 2010)

Bhan A. Health ministry institutes reward scheme for whistle-blowers reporting spurious drugs. Natl Med J India. 2010;23(1):56 (December 7, 2010)

Alkahtani S, Sammons H, Choonara I, Epidemics of Acute Renal Failure in Children (diethylene glycol toxicity). Arch Dis Child. 2010 Dec;95(12):1062-4. (December 1, 2010)

Shepherd MD.* The effect of US pharmaceutical drug importation on the Canadian pharmaceutical supply. Can Pharm J. 2010 Sept/Oct; 143(5):226-33. (September 1, 2010)

Feldschreiber P. Public Health Issues with Counterfeit Medicines. Clin. Med. 2009;9(1):63-4. (February 7, 2009)

Nsimba SE. Problems Associated with Substandard and Counterfeit Drugs in Developing Countries: A Review Article on Global Implications of Counterfeit Drugs in the Era of Antiretroviral (ARVs) Drugs in a Free Market Economy. East Afr J Public Health. 2008; (December 13, 2008)

Liang BA.* Pigs, Drugs, and Terrorists. Patient Safe Qual Healthcare. 2008 Nov 1:10-12 (November 1, 2008)

Liang BA.* Safety Issues in Regulating Follow-On Biologic Drugs. J BIolaw Bus. 2007;10(4):44-49. (December 7, 2007)

Shepherd MD.* Impact of Drug Importation on Community Pharmacy and Patient Care. J Am Pharm Assoc. 2007 May-Jun ;47:319-20, 323-4, 327 (May 1, 2007)

Theriault J. Counterfeit Pharmaceuticals: Understanding the Threat. J Biolaw Bus. 2006;9(4): 46-50. (December 7, 2006)

Liang BA.* Structurally Sophisticated or Lamentably Limited? Mechanisms to Ensure Safety of the Medicine Supply. Albany Law J Sci Technol. 2006;16(3):483-524 (June 1, 2006)

Liang BA.* Parallel Trade in Pharmaceuticals: Injecting the Counterfeit Element into the Public Health. NC J Int Law Com Reg. 2006;31(4):847-900 (June 1, 2006)

Liang BA.* The Scourge of Counterfeit Drugs: No Easy Answers. J Biolaw Bus. 2006;9(2):3-7. (April 7, 2006)

Liang BA.* Fade to Black: Importation and Counterfeit Drugs. Am J Law Med. 2006 Feb 1;32(2-3):279-323 (February 1, 2006)

Giacolone RP. Drug Wholesaling and Importation: Challenges and Opportunities. California Western Intl Law J. 2005;36:65-76. (January 7, 2006)

Liang BA.* Over The Virtual and Geographic Borders: Understanding Importation and Counterfeit Drugs. Cal W Int Law J. 2005 Jun 3;36(1):7-18 (June 3, 2005)

Liang BA.* International Drug Importation: Issues in Public Policy, Patient Safety, and the Public Health. Cal W Int Law J. 2005 Jun 3;36(1):1-6 (June 3, 2005)

Technology and Detection

Weaver, Abigail A., et al. “Paper Analytical Devices for Fast Field Screening of Beta Lactam Antibiotics and Antituberculosis Pharmaceuticals.” Analytical Chemistry 85, no. 13 (September 3, 2014)

Ortiz, R, de Cássia Mariotti, K, Fank, B, Limberger, R, Anzanello, M, & Mayorga, P 2013, ‘Counterfeit Cialis and Viagra fingerprinting by ATR-FTIR spectroscopy with chemometry: Can the same pharmaceutical powder mixture be used to falsify two medicines?’ (August 27, 2014)

Lu, Feng, et al. “A novel identification system for counterfeit drugs based on portable Raman spectroscopy.” Chemometrics & Intelligent Laboratory Systems 127, (August 15, 2013): 63-69. (August 27, 2014)

Lebel, Philippe, et al. “A rapid, quantitative liquid chromatography-mass spectrometry screening method for 71 active and 11 natural erectile dysfunction ingredients present in potentially adulterated or counterfeit products.” Journal Of Chromatography A (August 27, 2014)

Custers, D., et al. “Headspace–gas chromatographic fingerprints to discriminate and classify counterfeit medicines.” Talanta 123, (June 2014): 78-88. (August 27, 2014)

Bunaciu, Andrei A., Şerban Fleschin, and Hassan Y. Aboul-Enein. “Spectroscopic Analytical Methods for Detection of Counterfeit Pharmaceutical Preparations — A Mini-Review.” Gazi University Journal Of Science 26, no. 3 (July 2013): 407-417 (August 27, 2014)

Broad, N. W., C. Dentinger, and J. Pasmore. “Advantages of 1064-nm Portable Raman for Counterfeit Pharmaceuticals Authentication.” Spectroscopy (June 2, 2013): 22-31 (August 27, 2014)

Anzanello, Michel J., et al. “A framework for selecting analytical techniques in profiling authentic and counterfeit Viagra and Cialis.” Forensic Science International 235, (February 2014): 1-7. (August 27, 2014)

Anzanello, Michel J., et al. “A multivariate-based wavenumber selection method for classifying medicines into authentic or counterfeit classes.” Journal Of Pharmaceutical & Biomedical Analysis 83, (September 2013): 209-214. (August 27, 2014)

Dégardin, Klara, Yves Roggo, and Pierre Margot. “Understanding and fighting the medicine counterfeit market.” Journal Of Pharmaceutical & Biomedical Analysis 87, (January 18, 2014): 167-175. (August 6, 2014)

Csupor D, Boros K, Dankó B, Veres K, Szendrei K, Hohmann J. Rapid identification of sibutramine in dietary supplements using a stepwise approach. Pharmazie. 2013 Jan;68(1):15-8. (December 31, 2012)

Leontiadis N, Moore T, Christin N. Measuring and Analyzing Search-Redirection Attacks in the Illicit Online Prescription Drug Trade. Proceedings of the USENIX Security Symposium; 2011: San Francisco, California: USENIX Security Symposium; 2011 p. 1-17. (September 14, 2011)

Liang BA.*, Mackey TK. Prevalence and Global Health Implications of Social Media in Direct-to-Consumer Drug Advertising. J Med Internet Res 2011;13(3):e64 (August 31, 2011)

Levchenko K, Pitsillidis A, Enright B, et al. Click Trajectories: End-to-End Analysis of the Spam Value Chain. Proceedings of the IEEE Symposium and Security and Privacy, Oakland, CA, May 2011. (May 14, 2011)

Liang B A*, Mackey T. Direct-to-Consumer Advertising With Interactive Internet Media. JAMA. 2011 2 23; 305 (8): 824-825. (February 23, 2011)

Alkahtani S, Sammons H, Choonara I, Epidemics of Acute Renal Failure in Children (diethylene glycol toxicity). Arch Dis Child. 2010 Dec;95(12):1062-4. (December 1, 2010)

Coustasse A, Arvidson C, Rutsohn P. Pharmaceutical counterfeiting and the RFID technology intervention. J Hosp Mark Public Relations. 2010 Jul;20(2):100-15 (July 20, 2010)

Gaudiano MC, Di Maggio A, Antoniella E, Valvo L, Bertocchi P, Manna L, Bartolomei M, Alimonti S, Rodomonte AL. An LC method for the simultaneous screening of some common counterfeit and sub-standard antibiotics Validation and uncertainty estimation. J Pha (May 6, 2010)

Martino R, Malet-Martino M, Gilard V, Balayssac S. Counterfeit drugs: analytical techniques for their identification. Anal Bioanal Chem. 2010;398(1):77-92. (May 1, 2010)

Rodomonte AL, Gaudiano MC, Antoniella E, Lucente D, Crusco V, Bartolomei M, Bertocchi P, Manna L, Valvo L, Alhaique F, Muleri N. Counterfeit drugs detection by measurement of tablets and secondary packaging colour. J Pharm Biomed Anal. 2010;53(2):215-20. (April 29, 2010)

Tomić S, Milcić N, Sokolić M, Martinac AI. Identification of counterfeit medicines for erectile dysfunction from an illegal supply chain. Arh Hig Rada Toksikol. 2010;61(1):69-75. (March 6, 2010)

Dai XM, An N Wu JM, Li HY, Zhang QM. Development and Validation of HPLC-UV-MS method for the control of four anti-diabetic drugs in suspected counterfeit products. Yao Xue Xue Bao. 2010 Mar; 45(3):347-52. (March 1, 2010)

Twohig M, Skilton SJ, Fujimoto G, Ellor N, Plumb RS. Rapid detection and identification of counterfeit of adulterated products of synthetic phosphodiesterase type-5 inhibitors with an atmospheric solids analysis probe. Drug Test Anal. 2010;2(2):45-50. (February 2, 2010)

Erdem E, Zeng H, Zhou J, Shi J, Wells DL. Investigation of RFID tag readability for pharmaceutical products at item level. Drug Dev Ind Pharm. 2009;35(11):1312-24. (November 25, 2009)

Hargreaves MD, Macleod NA, Smith MR, Andrews D, Hammond SV, Matousek P. Characterisation of transmission Raman spectroscopy for rapid quantitative analysis of intact multi -component pharmceuticals capsules. J Pharm Biomed Anal. 2011;54(3):463-8. (September 19, 2009)

Puchert T, Lochmann D, Menezes JC, Reich G. Near-infrared chemical imaging (NIR-CI) for counterfeit drug identification–a four-stage concept with a novel approach of data processing (Linear Image Signature). J Pharm Biomed Anal. 2010;51(1):138-45. (August 26, 2009)

Nyadong L, Harris GA, Balayssac S, Galhena AS, Malet-Martino M, Martino R, Parry RM, Wang MD, Fernández FM, Gilard V. Combining two-dimensional diffusion-ordered nuclear magnetic resonance spectroscopy, imaging desorption electrospray ionization mass spe (June 18, 2009)

Trefi S, Routaboul C, Hamieh S, Gilard V, Malet-Martino M, Martino R. Analysis of illegally manufactured formulations of tadalafil (Cialis®) by 1H NMR, 2D DOSY 1H NMR and Raman spectroscopy. J Pharm Biomed Anal. 2008 May 12;47(1):103-113 (May 1, 2008)

Thevis M, Schrader Y, Thomas A, Sigmund G, Geyer H, Schanzer W. Analysis of confiscated black market drugs using chromatographic and mass spectrometric approaches. J Anal Toxicol. 2008;32(3):232-240. (April 25, 2008)

Shi YQ, Yao J, Liu F, Hu CQ, Yuan J, Zhang QM, Jin SH. Establishment of an HPLC identification system for detection of counterfeit steroidal drugs. J Pharm Biomed Anal. 2008;46(4):663-9. (November 27, 2007)

Liang BA.* Structurally Sophisticated or Lamentably Limited? Mechanisms to Ensure Safety of the Medicine Supply. Albany Law J Sci Technol. 2006;16(3):483-524 (June 1, 2006)

Giacolone RP. Drug Wholesaling and Importation: Challenges and Opportunities. California Western Intl Law J. 2005;36:65-76. (January 7, 2006)

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