Opioid Use, Unspecified — Effect of Opioid Shortage on Drug Selection
Citation(s)
1 Durkin, M. (n.d.). IV drug shortages present challenges, opportunities. Retrieved March 6, 2019, from https://acphospitalist.org/archives/2018/09/iv-drug-shortages-present-challenges-opportunities.htm 2. Press Announcements > Statement from Douglas Throckmorton, M.D., deputy center director for regulatory programs in FDA's Center for Drug Evaluation and Research, on the agency's response to ongoing drug shortages for critical products. (n.d.). Retrieved March 6, 2019, from https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm611215.htm 3. Klaus DA, de Bettignies AM, Seemann R, Krenn CG, Roth GA. Impact of a remifentanil supply shortage on mechanical ventilation in a tertiary care hospital: a retrospective comparison. Crit Care. 2018 Oct 26;22(1):267. doi: 10.1186/s13054-018-2198-3. PubMed PMID: 30367645; PubMed Central PMCID: PMC6204001.
The Effects of the Opioid Drug Shortages on Selection of Nonopioid Analgesics During Laparoscopic Cholecystectomy
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
