Summary of the executive session on critical threats to the pharmacy supply chain and the effects on patient care

American Journal of Health-System Pharmacy

Volumn 70, Issue 19, 2013, Pages 1689-1698

  Abramowitz, Paul W ^a   Bass, Paula ^b   Chen, David ^a   DeChristoforo, Robert ^c   DeLuca, Ruth ^d   DePuy, Marjorie D ^e   Ducca, Anita T ^e   Firschein, Ben A ^f   Guenter, Peggi ^g   Hartmann, Ron ^h   Klein, Catherine N ^a   Knoer, Scott ⁱ   Lewin, John J ^j   Mirtallo, Jay M ^g   Pearlstein, Lisa ^k   Reilly, Cynthia ^a   Rosner, Jeffrey M ⁱ   Russell, Wayne L ^l   Scott, Bruce ^p   Schwartz, Lisa ^m   Schwartz, Rowena ⁿ   Van Hook, Matthew ^f   VanEeckhout, John ^o   Witmer, David R ^a   more..

^a AMERICAN SOCIETY OF HEALTH SYSTEM PHARMACISTS   (United States)

^b AMGEN INC   (United States)

^c NATIONAL INSTITUTES OF HEALTH   (United States)

^d Biotechnology Industry Organization   (United States)

^e Healthcare Distribution Management Association   (United States)

^f United States Pharmacopeial Convention   (United States)

^g American Society for Parenteral and Enteral Nutrition   (United States)

^h Methodist Medical Center   (United States)

ⁱ LERNER RESEARCH INSTITUTE   (United States)

^j DEPARTMENT OF PATHOLOGY   (United States)

^k American Society of Anesthesiologists   (United States)

^l Premier   (United States)

^m National Community Pharmacists Association   (United States)

ⁿ Hematology Oncology Pharmacy Association   (United States)

^o Children's Hospital Association   (United States)

^p Hematology/Oncology Pharmacy Association ^*

more..

Author keywords

[No Author keywords available]

Indexed keywords

GENERIC DRUG; PRESCRIPTION DRUG; DRUG;

CLINICAL DECISION MAKING; CONFERENCE PAPER; DRUG COST; DRUG INDUSTRY; DRUG LEGISLATION; DRUG MARKETING; DRUG PACKAGING; HEALTH CARE QUALITY; HEALTH CARE SYSTEM; HUMAN; MEDICATION THERAPY MANAGEMENT; PATIENT CARE; PATIENT SAFETY; PHARMACEUTICAL CARE; PHARMACY SUPPLY CHAIN; PRESCRIPTION; FRAUD; PHARMACY; PREVENTION AND CONTROL; RISK FACTOR; STANDARDS; SUPPLY AND DISTRIBUTION; TRENDS;

DRUG INDUSTRY; FRAUD; HUMANS; PATIENT CARE; PHARMACEUTICAL PREPARATIONS; PHARMACIES; RISK FACTORS;

EID: 84899781051     PISSN: 10792082     EISSN: 15352900     Source Type: Journal    
DOI: 10.2146/ajhp120771     Document Type: Conference Paper

References (41)

1. Kirschenbaum BE. Specialty pharmacies and other restricted drug distribution systems: financial and safety considerations for patients and health-system pharmacists. Am J Health-Syst Pharm. 2009; 66(suppl 7):S13-20.
2. CuraScript Pharmacy. 2009 specialty drug trend report: a market and behavioral analysis. www.curascript.com/bin-webdocuments/09DrugTrend ReportCuraScript.pdf (accessed 2012 Aug 24).
3. Caselnova D 3rd, Donley K, Ehlers D et al. Report of the ASHP Task Force on Caring for Patients Served by Specialty Suppliers. Am J Health-Syst Pharm. 2010; 67:1650-8.
4. Joint Commission. National Patient Safety Goals effective January 1, 2012. Hospital accreditation program. www.jointcommission.org/assets/1/6/NPSG-Chapter-Jan2012-HAP.pdf (accessed 2012 Aug 21).
5. Berenson RA, Burton RA. Health policy brief: next steps for ACOs. http://healthaffairs.org/healthpolicybriefs/brief-pdfs/healthpolicybrief-61.pdf (accessed 2012 Aug 21).
6. Food and Drug Administration. Managing the risks from medical product use: creating a risk management framework: report to the FDA Commissioner from the Task Force on Risk Management. Executive summary. www.fda.gov/downloads/Safety/SafetyofSpecific Products/UCM180522.pdf (accessed 2012 Aug 21).
7. Woodcock J. Update from CDER. www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/UCM239634.pdf (accessed 2012 Aug 27).
8. Food and Drug Administration. Identification of drug and biological products deemed to have risk evaluation and mitigation strategies for purposes of the Food and Drug Administration Amendments Act of 2007. www.fda.gov/OHRMS/DOCKETS/98fr/E8-6201.pdf (accessed 2012 Aug 24).
9. Food and Drug Administration. Center for Drug Evaluation drug shortage workshop, September 26, 2011. www.fda.gov/downloads/Drugs/NewsEvents/UCM275801.pdf (accessed 2012 Aug 24).
10. Yankus W, Marks S, American Council on Science and Health. Counterfeit drugs: coming to a pharmacy near you with an update for 2009. www.acsh.org/docLib/20090202-counterfeitdrug09.pdf (accessed 2012 Aug 21).
11. Lubell J. Lawmakers hear evidence of gray market in shortage drugs. www.amaassn.org/amednews/2012/08/20/gvsa0820.htm (accessed 2012 Aug 21).
12. Lutter RW. Pharmaceutical supply chain security. Statement before the Subcommittee on Criminal Justice, Drug Policy, and Human Resources, House Committee on Oversight Government Reform. www.fda.gov/NewsEvents/Testimony/ucm111440.htm (accessed 2012 Aug 21).
13. Food and Drug Administration. Cargo thefts. www.fda.gov/ICECI/Criminal Investigations/ucm182888.htm (accessed 2012 Aug 24).
14. Traynor K. Drug industry, FDA try to stay ahead of cargo thieves. Am J Health-Syst Pharm. 2011; 68:1182,1192. News.
15. Counterfeit Drug Penalty Enhancement Act of 2012. www.govtrack.us/congress/bills/112/hr3668/2013Jul15 (accessed 2012 Aug 21).
16. Counterfeit Drug Penalty Enhancement Act of 2011. www.opencongress.org/bill/112-s1886/show (accessed 2012 Aug 21).
17. Safeguarding America's Pharmaceuticals Act of 2011. www.opencongress.org/bill/112-h3026/show (accessed 2012 Aug 21).
18. Food and Drug Administration. CPG Sec. 160.900 Prescription Drug Marketing Act - pedigree requirements under 21 CFR Part 203. www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm073857.htm (accessed 2012 Aug 21).
19. California Board of Pharmacy. California e-pedigree law. www.pharmacy.ca.gov/about/e-pedigree-laws.shtml (accessed 2012 Aug 21).
20. U.S. Pharmacopeia. Draft chapter <1083> good distribution practices - supply chain integrity. www.usp.org/sites/default/files/usp-pdf/EN/USPNF/revisions/c1083.pdf (accessed 2012 Aug 21).
21. Pharmaceutical Commerce. RxTEC: the new shape of track-and-trace systems? Newly announced Pharmaceutical Distribution Security Alliance is for product serialization, but against item-level tracking. www.pharmaceuticalcommerce.com/latest-news?articleid=26507&keyword=PDSA-RxTEC-serializationepedigree (accessed 2012 Aug 27).
22. GS1. GS1 standards document. Business process and systems requirements for full chain traceability. GS1 global traceability standard. Issue 1.1.0. www.gs1.org/docs/gsmp/traceability/GS1-Global-Trace ability-Standard-i1.pdf (accessed 2012 Aug 22).
23. Fox ER, Birt A, James KB et al. ASHP guidelines on managing drug product shortages in hospitals and health systems. Am J Health-Syst Pharm. 2009; 66:1399-406.
24. U.S. Government Accountability Office. FDA has conducted more foreign inspections and begun to improve its information on foreign establishments, but more progress is needed. www.gao.gov/new.items/d10961.pdf (accessed 2012 Aug 24).
25. Food and Drug Administration. Fact sheet: drug products in shortage in the United States. www.fda.gov/Regulatory Information/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FDASIA/ucm313121.htm (accessed 2012 Aug 21).
26. American Society of Anesthesiologists, American Society of Clinical Oncology, American Society of Health-System Pharmacists et al. Drug shortages summit summary report. www.ashp.org/drug shortages/summitreport (accessed 2012 Aug 22).
27. Jensen V, Rappaport BA. The reality of drug shortages - the case of the injectable agent propofol. N Engl J Med. 2010; 363:806-7.
28. Provisional observations on drug product shortages: effects, causes, and potential solutions. Am J Health-Syst Pharm. 2002; 59:2173-82.
29. Kavilanz P. Johnson & Johnson's drug problem: drug recalls surge. http://money.cnn.com/2010/08/16/news/companies/drug-recall-surge/index.htm (accessed 2012 Aug 24).
30. Fox E, Tyler LS. Recent trends in drug shortages: an update from the 2003 report. Am J Health-Syst Pharm. 2009; 66: 798-800.
31. Institute for Safe Medication Practices. Drug shortages: national survey reveals high level of frustration, low level of safety. www.ismp.org/Newsletters/acutecare/articles/20100923.asp (accessed 2012 Aug 24).
32. Generic Pharmaceutical Association. GPhA reveals the Accelerated Recovery Initiative: an unprecedented multi-stakeholder proposal to address drug shortages. www.gphaonline.org/media/press-releases/2011/gpha-reveals-accelerated-recovery-initiative-unprecedented-multi-stakehold (accessed 2012 Aug 22).
33. Policy and Medicine. FTC approves Accelerated Recovery Initiative to reduce drug shortages. www.policymed.com/2012/09/ftc-approves-accelerated-recovery-initiative-to-reduce-drugshortages.html (accessed 2012 Dec 17).
34. Food and Drug Administration Safety and Innovation Act, Pub. L. No. 112-144. www.gpo.gov/fdsys/pkg/PLAW-112 publ144/pdf/PLAW-112publ144.pdf (accessed 2013 Jun 24).
35. Pedersen CA, Schneider PJ, Scheckelhoff DJ. ASHP national survey of pharmacy practice in hospital settings: dispensing and administration - 2008. Am J Health-Syst Pharm. 2009; 66:926-46.
36. Pedersen CA, Schneider PJ, Scheckelhoff DJ. ASHP national survey of pharmacy practice in hospital settings: dispensing and administration - 2011. Am J Health-Syst Pharm. 2012; 69:768-85.
37. Rinehart JR, Chan D, Cunningham M et al. ASHP guidelines on outsourcing sterile compounding services. Am J Health-Syst Pharm. 2010; 67:757-65.
38. Centers for Disease Control and Prevention. Frequently asked questions for clinicians: multistate outbreak of fungal meningitis and other infections. www.cdc.gov/hai/outbreaks/clinicians/faq-meningitis-outbreak.html (accessed 2012 Dec 17).
39. Pedersen CA, Schneider PJ, Scheckelhoff DJ. ASHP national survey of pharmacy practice in hospital settings: prescribing and transcribing - 2010. Am J Health-Syst Pharm. 2011; 68:669-88.
40. Henry J. Kaiser Family Foundation. Follow the pill: understanding the U.S. commercial pharmaceutical supply chain. www.kff.org/rxdrugs/upload/Follow-The-Pill-Understanding-the-US-Commercial-Pharmaceutical-Supply-Chain-Report.pdf (accessed 2012 Aug 24).
41. American Society for Parenteral and Enteral Nutrition. A.S.P.E.N. response to patient deaths in Alabama from contaminated parenteral nutrition - iv nutrition. www.nutritioncare.org/News/Industry-and-Product-News/A-S-P-E-N-Response-to-Parenteral-Nutrition- Contamination-Deaths/ (accessed 2012 Aug 23).