There are numerous cases of injury resulting from various improperly compounded medications.11 An outbreak of meningitis in 2012 caused by a contaminated steroid injection intended for epidural injection made in a compounding pharmacy23 affected 753 patients in 20 states with 64 deaths.24 Subsequently, the United States Congress passed the Drug Quality and Security Act in November, 2013.25 Among other requirements, the Act stipulates that pharmaceutical compounders are not allowed to essentially copy products that are already FDA-approved and commercially available, unless there is a manufacturing product shortage.25 Serious patient illness and death associated with poor quality compounded drugs continue to occur.26 This is also made clear under Section 503A of the Federal Food, Drug, and Cosmetic Act:27
- National Heart Lung and Blood Institute; National Institute of Health. Varicose Veins. Available: https://www.nhlbi.nih.gov/health-topics/varicoseveins. Accessed: July 2019.
- Attaran RR, Ochoa Chaar CI. Compression therapy for venous disease. Phlebology. 2017;32:81-88.
- Woźniak W, Kielar M, Mlosek RK, Ciostek P. Comparative analysis of fiveyear outcomes of lower extremity varicose vein therapy using monopolar and segmental radiofrequency ablation. Int Angiol. 2018;37:457-464.
- Wallace T, El-Sheikha J, Nandhra S, et al. Long-term outcomes of endovenous laser ablation and conventional surgery for great saphenous varicose veins. Br J Surg. 2018 105:1759-1767.
- Kemp N. A synopsis of current international guidelines and new modalities for the treatment of varicose veins. Aust Fam Physician. 2017;46:229-233.
- Duffy DM. Sclerosants: a comparative review. Dermatol Surg. 2010;36:1010- 1025.
- Zimmet SE. Sclerotherapy treatment of telangiectasias and varicose veins. Tech Vasc Interv Radiol. 2003;6:116-120.
- Bush R, Bush P. Evaluation of sodium tetradecyl sulfate and polidocanol as sclerosants for leg telangiectasia based on histological evaluation with clinical correlation. Phlebology. 2017;32:496-500.
- Asclera®(polidocanol) Injection [package insert]. Raleigh, NC: Merz North America, Inc: 2010.
- United States Food and Drug Administration. Center for Drug Evaluation and Research, 2018. Guidance for Industry. Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act.
- Gudeman J, Jozwiakowski M, Chollet J, Randell M. Potential risks of pharmacy compounding. Drugs R D. 2013;13:1-8.
- Goldman MP. Sodium tetradecyl sulfate for sclerotherapy treatment of veins: is compounding pharmacy solution safe? Dermatol Surg. 2004;30:1454- 1456.
- Weiss RA, Voigts R, Howell DJ. Absence of concentration congruity in six compounded polidocanol samples obtained for leg sclerotherapy. Dermatol Surg. 2011;37:812-815.
- Almeida JI, Raines JK. FDA-approved sodium tetradecyl sulfate (STS) versus compounded STS for venous sclerotherapy. Dermatol Surg. 2007;33:1037- 1044.
- Rabe E, Pannier F. Sclerotherapy of varicose veins with polidocanol based on the guidelines of the German Society of Phlebology. Dermatol Surg. 2010;36:968-975.
- Weiss MA, Hsu JT, Neuhaus I, Sadick NS, Duffy DM. Consensus for sclerotherapy. Dermatol Surg. 2014;40:1309-1318.
- Rabe E, Schliephake D, Otto J, Breu FX, Pannier F. Sclerotherapy of telangiectases and reticular veins: a double-blind, randomized, comparative clinical trial of polidocanol, sodium tetradecyl sulphate and isotonic saline (EASI study). Phlebology. 2010;25:124-131.
- Weiss RA, Weiss MA, Goldman MP. Physicians' negative perception of sclerotherapy for venous disorders: review of a 7-year experience with modern sclerotherapy. South Med J. 1992;85:1101-1106.
- Mann MW. Sclerotherapy: it is back and better. Clin Plast Surg. 2011;38:475- 487.
- United States Food and Drug Administration. Asclera (polidocanol) 0.5% and 1% Injection Approval Letter (NDA 021201) March 30, 2010. Available: http:// www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021201s000ltr. pdf. Accessed: May 2019.
- Eckmann DM. Polidocanol for endovenous microfoam sclerosant therapy. Expert Opin Investig Drugs. 2009;18:1919-1927.
- United States Food and Drug Administration. Code of Federal Regulations Title 21: Part 211 Current Good Manufacturing Practice for Finished Pharmaceuticals. 2012. Available: http://www.accessdata.fda.gov/scripts/ cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=211 Accessed May 2019. 2
- Cabaleiro J. New England Compounding Center indictment. Int J Pharm Compd. 2015;19:94-102.
- Centers for Disease Control and Prevention. Multistate Outbreak of Fungal Meningitis and Other Infections – Case Count. October 29, 2015. Available: https://www.cdc.gov/hai/outbreaks/meningitis-map-large.html#casecount_ table. Accessed: 17 May 2019.
- Gabay M. The drug quality and security act. Hosp Pharm. 2014;49:615-676.
- United States Food and Drug Administration. Compounding Risk Alerts. 2018. Available: https://www.fda.gov/drugs/human-drug-compounding/ compounding-risk-alerts. Accessed: May, 2019.
- United States Food and Drug Administration. Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act. Guidance for Industry 2018. Available: https://www.fda.gov/media/98973/download Accessed: May 2019.
- McKenna KJ. Compounding sclerosing agents. Risks and consequences. Vein Magazine. 2008;March 31.
- McKenna KJ. Compounded sclerosing agents: risks and consequences. Vein Magazine. 2015;April 1.