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Module 2
Section 6 Public safety and reporting errors
| Question | Answer |
|---|---|
| System for voluntarily reporting side effects and medication errors with pharmaceutical products | MedWatch |
| Public safety information about medications distributed to the medical community and public by the FDA | Safety alerts, Recalls, Withdrawals, and Important labeling changes |
| Three courses of action the FDA can take if it determines a medication presents a risk of illness, injury, or consumer deception | Seize the medication, Issue a recall, and Seek an injunction to prevent the manufacturer from distributing the medication. |
| Description of an FDA Class I medication recall | A dangerous or defective product that could cause serious health problems or death |
| Description of an FDA Class II medication recall | A product that might cause a temporary health problem or pose a slight threat of a serious nature. |
| Description of an FDA Class III medication recall | A product that is unlikely to cause any adverse health reaction but that violates FDA labeling or manufacturing law |
| An educating body for health care professionals ad consumers regarding medication safety and error prevention | Institute for Safe Medication Practices (ISMP) |
| Three commonly used Institute for Safe Medication Practices (ISMP) references | List of Error-Prone Abbreviations Look-Alike Drug Names with Recommended Tall Man Letters List of Oral Dosage Forms That Should Not Be Crushed |
| Components of the pharmacy workplace regulated by the Occupational Safety and Health Administration (OSHA) | Medication storage Workplace ergonomics Disposal of hazardous medications |
| What are distributed to the medical community and general public via the FDA Enforcement REport? | Safety allers, Recalls, Withdrawals, and Important labeling changes |
Created by:
PRO Teacher
Lane.Wendy
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