Drugs

Safe Use Initiative - Completed Projects

Colchicine

Impact of the unapproved drug initiative on colchicine use

FDA put its Unapproved Drug Initiative in place to guarantee marketed drugs are safe and effective. The unapproved formulations of colchicine were phased out of the market as a result of the approval of Colcrys in 2009. Stanford University conducted a project that uses data retrieved from the Stanford Translational Research Integrated Database Environment (STRIDE) to compare the utilization pattern of colchicine, its dosing and the associated adverse outcomes before and after the approval of Colcrys. To get an idea of the lag between the approval of Colcrys and a change in the clinical practice, the project prospectively determined the prevalence and risk factors of the inappropriate use of the unapproved colchicine formulations using the Stanford University Rheumatic Disease Registry and the Stanford Gout Database. The project was completed in September 2014.

For more information on the FDA Unapproved Drug Initiative, please see FDA’s page, Unapproved Prescription Drugs: Drugs Marketed in the United States That Do Not Have Required FDA Approval.

Compounded oral liquid medications

Statewide pediatric safety collaboration to standardize compounded oral liquids

The University of Michigan and the Michigan Pharmacists Association joined in a collaboration to improve the safety of compounded oral liquid medications prepared for pediatric patients in Michigan. The collaborators gathered information on the current practices regarding the preparation of oral liquid medications in pharmacies across the state of Michigan, and then developed a set of voluntary standard concentrations prescribers and pharmacists can use in compounding these medications to reduce the potential risk of errors when patients change pharmacies or at transitions of care. Standardization can lower the risk of delivering the wrong dose due to confusion between concentrations of oral liquid medication.

This initiative’s several phases involved surveying pharmacists across Michigan to gain a better understanding of compounding practices for oral liquids, collaborating with healthcare providers to determine standard concentrations and creating a Web site to disseminate information on those concentrations. In August 2014, University of Michigan published an abstract and article, “Variability in Compounding of Oral Liquids for Pediatric Patients: A Patient Safety Concern,” in the Journal of the American Pharmacists Association. In December 2014, the Institute for Safe Medication Practices (ISMP) presented this project with its 2014 "Cheers Award" for helping to address crucial safety concerns and educate practitioners and health consumers. For more information, please see the project’s page, State-Wide Initiative to Standardize the Compounding of Oral Liquids in Pediatricsdisclaimer icon.

Epidural steroid injections

Experts in the practice of epidural steroid injections (ESIs) approached FDA for assistance in addressing the issue of rare, serious neurologic events observed in association with ESIs. As a result, the Safe Use Initiative facilitated the organization of an expert working group made up of physicians external to the FDA who have published scientific studies or scholarly works on the topic of ESIs. The Safe Use staff facilitated the meetings but did not participate in the deliberations or the decision-making process.

The working group drafted a set of clinical considerations intended to minimize the risks associated with ESIs. The clinical considerations were initially voted upon by representatives of several national organizations, and later discussed, revised, and voted upon by representatives and Boards of Directors of an expanded list of national organizations. The organizations included national societies of anesthesiologists, pain medicine physicians, physical medicine and rehabilitation specialists, neurosurgeons, orthopedic surgeons, and radiologists. The final clinical considerations were published online on February 9, 2015 in Anesthesiology: Safeguards to Prevent Neurologic Complications after Epidural Steroid Injections: Consensus Opinions from a Multidisciplinary Working Group and National Organizations (citation: February 2015 doi:10.1097/ALN.0000000000000614). The clinical considerations are intended for the medical community. They are not recommendations for the FDA and, as such, are neither binding on FDA nor endorsed by the FDA.

As part of FDA’s ongoing effort to investigate concerns over the safety of ESIs, the agency convened a two-day advisory committee meeting of external experts on November 24-25, 2014. The Anesthetic and Analgesic Drug Products Advisory Committee Meeting discussed the risk of serious neurologic adverse reactions associated with ESIs administered to reduce inflammation for pain management. These considerations assist the Agency in its discussions of possible regulatory options, including but not limited to changes to product labeling. A “Viewpoint” article on this effort also published on March 30, 2015, in the Journal of the American Medical Association (JAMA): Improving the Safety of Epidural Steroid Injectionsdisclaimer icon.

For information on FDA’s April 2014 drug safety communication on ESIs, please see FDA’s page: FDA requires label changes to warn of rare but serious neurologic problems after epidural corticosteroid injections for pain.

Isotretinoin

Improving the safe use of isotretinoin

Isotretinoin is used to treat severe skin disease, such as acne, which has not responded to other treatments.

Because isotretinoin can cause serious side effects, including fetal injury and severe birth defects if a woman becomes pregnant during treatment, FDA approved isotretinoin for marketing under a special, restricted distribution program (called a Risk Evaluation and Mitigation Strategy, or REMS). The REMS requires women of childbearing potential use effective contraception.  This project developed and evaluated a contraceptive informational sheet for women who are considering using isotretinoin.  The sheet provides clear recommendations about the most effective contraceptive methods available to avoid pregnancy before during and after drug therapy.  In April 2014, University of Pittsburgh published an abstract and articledisclaimer icon, “Women’s Experiences with Isotretinoin Risk Reduction Counseling,” in the Journal of the American Medical Association Dermatology (JAMA Derm). In February 2015, another abstract and articledisclaimer icon, "Promoting Safe Use of Isotretinoin by Increasing Contraceptive Knowledge," published in JAMA Derm, following the September 2014 completion of the project. 

Preventing surgical fires

An estimated 550 to 650 fires occur per year in inpatient and outpatient surgical settings.1 This number is small compared to the number of surgical procedures performed every year in the United States, but a surgical fire can have serious consequences to patients. Surgical fires are preventable medical errors, but despite the fact that the root causes are well understood, surgical fires still happen. Many healthcare organizations develop tools, implement strategies, and conduct education and outreach efforts to reduce the risk of fires. To supplement FDA's regulatory and non-regulatory efforts and highlight the efforts of FDA’s partners, in October 2011 the Safe Use Initiative, CDER, and CDRH launched an initiative and several Web pages. For more information on preventing surgical fires, please see FDA’s page, Preventing Surgical Fires webpage.

 

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Page Last Updated: 08/11/2015
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