Which of the following Is a Legal Method for Obtaining Prescription Medicines
The FDCA defines two main classes of drugs: over-the-counter drugs and prescription drugs. Prescription drugs are drugs that require a prescription and specific labeling and instructions to be considered safe. These drugs are limited to prescription only because they are considered addictive, toxic, have the potential to harm, or are restricted by the FDA [21 U.S.C.§ 321]. The three legal categories are explained here, with examples of drugs in each of the categories. We also explain how the categories relate to the term over-the-counter (OTC) drugs. No newly initiated and abused prescription painkillers less than 52 days in the past year. Frequent users are defined as those who have not been new initiates and who have abused prescription painkillers for 52 days or more in the past year. A rectangular box with the letters POM appears on prescription drug packaging. This flowchart and timeline (PDF, 65.5KB, 6 pages) describes the process for simple and larger reclassifications. All applications that do not relate to an analogue product must be submitted as voluminous, and will be downgraded to the standard if necessary during the assessment process.
Background: Misuse of prescription drugs is a public health issue. It may be helpful to understand the sources of prescription drugs that are being abused and whether these sources differ depending on the type of user abusing the substance. Methods: This report uses combined 2013 and 2014 data from the National Survey on Drug Use and Health to estimate the non-medical use of prescription painkillers and the source of the most recent pain reliever abused by perpetrators in the past year. Results are reported by three mutually exclusive groups: (1) recently initiated initiators, (2) recently initiated frequent users, and (3) uninitiated occasional users. Recent insiders are defined as those who initiated prescription painkiller abuse in the past year. Occasional users are defined as those who have not been initiated recently and who have abused prescription painkillers for less than 52 days in the past year. Frequent users are defined as those who have not been new initiates and who have abused prescription painkillers for 52 days or more in the past year. Results: An annual average of 10.7 million people aged 12 and older abused prescription painkillers last year. About half of those who abused prescription painkillers in the past year reported receiving the free prescription painkillers they abused from a friend or relative. For all three types of users, the two most cited sources for getting the prescription painkillers were getting the drug from a friend or relative for free, and getting the drug from a doctor. Frequent users were more likely than recent insiders and occasional users to obtain their recently abused painkillers by buying them from a friend or relative, buying them from a drug dealer or other stranger, or receiving them from more than one doctor.
Bottom Line: The findings of this report suggest that Americans may be able to play a direct role in influencing access to these prescription painkillers by not sharing their prescription medications and eliminating unused painkillers once the need for medication is over. Regardless of age, gender, or type of user, most people who abuse prescription painkillers have received the medication from a friend or relative. However, the second most common source came from a doctor. Therefore, in order to reduce the availability of painkillers for non-medical purposes, physicians may not only need to continue to exercise due diligence in prescribing and monitoring their patients for signs of abuse, but also consider counseling their patients on disposing of remaining dosage units. A 2017 study found a significant reduction in prescribing errors for patients discharged from emergency rooms when medications were prescribed electronically rather than by hand. Specific results were that e-prescribing showed a decrease in the incidence of missed doses, inaccurate frequency of medications, inaccurate dose, and general ability to read the document (e.g., clinician`s handwriting was illegible).  In addition, the Durham-Humphrey amendment established guidelines for all pharmacists dispensing prescription drugs.