{"id":397,"date":"2012-03-01T00:00:54","date_gmt":"2012-03-01T07:00:54","guid":{"rendered":"http:\/\/rhochistj.org\/RCP_TEST\/?p=397"},"modified":"2014-02-04T21:55:43","modified_gmt":"2014-02-05T04:55:43","slug":"drug-shortage-update-fda-successfully-alleviates-chemotherapy-shortage","status":"publish","type":"post","link":"https:\/\/rhochistj.org\/RhoChiPost\/drug-shortage-update-fda-successfully-alleviates-chemotherapy-shortage\/","title":{"rendered":"Drug Shortage Update: FDA Successfully Alleviates Chemotherapy Shortage"},"content":{"rendered":"<p>By: Mahdieh Danesh Yazdi<\/p>\n<p>&#8211;<\/p>\n<p>As previously reported, there is currently great concern in the medical community because of the growing number of drug shortages.\u00a0 Many of these are drugs that are critical to patient care, such as chemotherapy agents and antibiotics.\u00a0 Last October, President Obama issued an executive order in an attempt to curb the ever-increasing number of drugs that are in dwindling supply.\u00a0 Part of the executive order addressed the FDA, which asked the agency to intervene (whenever possible) to avert a shortage.\u00a0 In compliance with the executive order, the FDA recently announced a successful attempt to stop the shortage of two major chemotherapy agents: methotrexate and doxorubicin.<\/p>\n<p>Methotrexate is an antimetabolite drug often used in the treatment of cancers and certain autoimmune disorders.\u00a0 It works by inhibiting purine synthesis by interfering in the folate pathway.\u00a0 Methotrexate can treat various cancers including but not limited to acute lymphocytic leukemia (ALL), breast cancer, head and neck cancer, psoriasis, and rheumatoid arthritis.\u00a0 Doxorubicin is an anthracycline antibiotic that works by intercalating the DNA and preventing replication.\u00a0 It can treat AIDS-related Kaposi sarcoma, multiple myeloma, leukemia, and Hodgkin\u2019s lymphoma.<\/p>\n<p>Both of these drugs are critical for cancer treatment, but have been in short supply for some time.\u00a0 For methotrexate, the shortage was due to the shutdown of one manufacturer (out of four that supply it) amid concerns over its manufacturing quality.\u00a0 To alleviate the shortage, the FDA came to an agreement with the other three manufacturers to increase their drug production.\u00a0 The FDA also approved APP Pharmaceuticals\u2019 application to produce a preservative-free version of the drug, which should be widely available by March.\u00a0 There are also reports of agreements with foreign manufacturers to compensate for the shortage of the drug.\u00a0 It was especially critical that the supply of methotrexate did not diminish further, as it is part of the treatment of choice for ALL (a leukemia commonly found in children).\u00a0 Not using it would compromise the care received by pediatric patients and jeopardize their chances of remission.<\/p>\n<p>On the other hand, doxorubicin has been in short supply for several years.\u00a0 The FDA is allowing the importation of another formulation of doxorubicin, LipoDox, produced by Sun Pharma Global FZE.\u00a0 The FDA is confident about the quality of the manufacturing firm; it oversees production of other drugs by the same company (Ault).<\/p>\n<p>With these steps, thousands of people who rely on methotrexate and\/or doxorubicin as their fundamental treatment may now receive them in a timely manner. \u00a0It is important to note that, despite these efforts, drug shortages continue to be a crippling problem within the medical world.\u00a0 To prevent future incidents and alleviate current shortages, it is imperative for us to address the problem at a fundamental level.<\/p>\n<p>For a list of all current drug shortages, please visit:<\/p>\n<p><a href=\"http:\/\/www.fda.gov\/Drugs\/DrugSafety\/DrugShortages\/ucm050792.htm\" class=\"external external_icon\">http:\/\/www.fda.gov\/Drugs\/DrugSafety\/DrugShortages\/ucm050792.htm<\/a><\/p>\n<p>&#8211; OR &#8211;<\/p>\n<p><a href=\"http:\/\/www.ashp.org\/DrugShortages\/Current\/\" class=\"external external_icon\">http:\/\/www.ashp.org\/DrugShortages\/Current\/<\/a><\/p>\n<p><b><span style=\"text-decoration: underline;\">SOURCES:<\/span><\/b><\/p>\n<ol>\n<li>Ault, Alicia. &#8220;FDA Acts to Curb Doxorubicin, Methotrexate Shortages.&#8221; 21 February 2012. Internal Medicine News. 25 February 2012 &lt;<a href=\"http:\/\/www.internalmedicinenews.com\/views\/observation-unit\/blog\/fda-acts-to-curb-doxorubicin-methotrexate-shortages\/766f825674.html&gt;\" target=\"new\" class=\"external external_icon\">http:\/\/www.internalmedicinenews.com\/views\/observation-unit\/blog\/fda-acts-to-curb-doxorubicin-methotrexate-shortages\/766f825674.html&gt;.<\/a><\/li>\n<li>Lexi-Comp OnlineTM ,\u00a0 Lexi-Drugs OnlineTM , Hudson, Ohio: Lexi-Comp, Inc.; February 25, 2012.<\/li>\n<li>Nelson, Roxanne. &#8220;Stopgaps Avert Methotrexate and Doxil Shortages&#8211;For Now.&#8221; 21 February 2012. Medscape. 25 February 2012 &lt;<a href=\"http:\/\/www.medscape.com\/viewarticle\/758954&gt;\" target=\"new\" class=\"external external_icon\">http:\/\/www.medscape.com\/viewarticle\/758954&gt;.<\/a><\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"<p>By: Mahdieh Danesh Yazdi &#8211; As previously reported, there is currently great concern in the medical community because of the growing number of drug shortages.\u00a0 Many of these are drugs that are critical to patient care, such as chemotherapy agents and antibiotics.\u00a0 Last October, President Obama issued an executive order in an attempt to curb&hellip;<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[5],"tags":[1825,2237,343,54,2231,1144,40,702,830,831,13,2250,2229,2227,2232,94,2268,314,1647,210,211,100,363,968,1625,19,704,999,184,1679,24,2228,16,1061],"class_list":["post-397","post","type-post","status-publish","format-standard","hentry","category-news-politics","tag-agents","tag-aids","tag-and","tag-antibiotic","tag-ashp","tag-breast","tag-cancer","tag-children","tag-doxil","tag-doxorubicin","tag-drug","tag-drug-shortage","tag-drugs","tag-ebola-virus-disease","tag-fda","tag-february","tag-folate","tag-for","tag-formulation","tag-note","tag-observation","tag-october","tag-of","tag-one","tag-or","tag-patient","tag-pediatric","tag-preservative-free","tag-problem","tag-short","tag-shortage","tag-shortages","tag-treatment","tag-with"],"views":656,"_links":{"self":[{"href":"https:\/\/rhochistj.org\/RhoChiPost\/wp-json\/wp\/v2\/posts\/397","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/rhochistj.org\/RhoChiPost\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/rhochistj.org\/RhoChiPost\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/rhochistj.org\/RhoChiPost\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/rhochistj.org\/RhoChiPost\/wp-json\/wp\/v2\/comments?post=397"}],"version-history":[{"count":0,"href":"https:\/\/rhochistj.org\/RhoChiPost\/wp-json\/wp\/v2\/posts\/397\/revisions"}],"wp:attachment":[{"href":"https:\/\/rhochistj.org\/RhoChiPost\/wp-json\/wp\/v2\/media?parent=397"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/rhochistj.org\/RhoChiPost\/wp-json\/wp\/v2\/categories?post=397"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/rhochistj.org\/RhoChiPost\/wp-json\/wp\/v2\/tags?post=397"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}