Podcast
Questions and Answers
What does USP 795 primarily govern?
What does USP 795 primarily govern?
Which of the following is NOT a requirement of USP 797?
Which of the following is NOT a requirement of USP 797?
What distinguishes 503b compounding from 503a compounding?
What distinguishes 503b compounding from 503a compounding?
What is the main purpose of the Drug Quality and Security Act?
What is the main purpose of the Drug Quality and Security Act?
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Which of the following best describes the purpose of USP 800 standards?
Which of the following best describes the purpose of USP 800 standards?
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What type of information is considered Protected Health Information (PHI) under HIPAA?
What type of information is considered Protected Health Information (PHI) under HIPAA?
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Which ISO standard must be maintained in the compounding area according to USP 797?
Which ISO standard must be maintained in the compounding area according to USP 797?
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What role does NIOSH play in relation to USP 800?
What role does NIOSH play in relation to USP 800?
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What must be included in a controlled substance prescription?
What must be included in a controlled substance prescription?
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Which schedule of drugs has the highest abuse potential?
Which schedule of drugs has the highest abuse potential?
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What does the 5% Rule require of pharmacies?
What does the 5% Rule require of pharmacies?
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What is required for documenting the destruction of controlled substances?
What is required for documenting the destruction of controlled substances?
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Which of the following statements regarding patient education on medication is true?
Which of the following statements regarding patient education on medication is true?
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When must the Notice of Privacy Practices be provided to patients?
When must the Notice of Privacy Practices be provided to patients?
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What is the primary focus of OBRA 90?
What is the primary focus of OBRA 90?
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What is the purpose of de-identification of PHI?
What is the purpose of de-identification of PHI?
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What is required for a valid prescription of a Schedule II drug?
What is required for a valid prescription of a Schedule II drug?
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How long must detailed inventory records for controlled substances be maintained on-site?
How long must detailed inventory records for controlled substances be maintained on-site?
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What does the DEA Form 106 report?
What does the DEA Form 106 report?
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Which of the following is NOT a requirement for online pharmacies?
Which of the following is NOT a requirement for online pharmacies?
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Which drug schedule includes medications like alprazolam and diazepam?
Which drug schedule includes medications like alprazolam and diazepam?
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What method is not allowed for the prescriptions of controlled substances?
What method is not allowed for the prescriptions of controlled substances?
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What is the requirement for conducting a retrospective Drug Utilization Review (DUR)?
What is the requirement for conducting a retrospective Drug Utilization Review (DUR)?
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Which of the following schedules includes drugs with moderate abuse potential and accepted medical uses?
Which of the following schedules includes drugs with moderate abuse potential and accepted medical uses?
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How often must a pharmacy conduct an inventory of controlled substances?
How often must a pharmacy conduct an inventory of controlled substances?
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What is a requirement for a Schedule II prescription regarding partial fills?
What is a requirement for a Schedule II prescription regarding partial fills?
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What documentation must pharmacies maintain for distributing controlled substances?
What documentation must pharmacies maintain for distributing controlled substances?
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Which of the following elements is NOT required on a controlled substance prescription?
Which of the following elements is NOT required on a controlled substance prescription?
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What must be reported using DEA Form 106?
What must be reported using DEA Form 106?
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Which aspect does the 5% Rule pertain to in pharmacies?
Which aspect does the 5% Rule pertain to in pharmacies?
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What must pharmacies do if they distribute more than 5% of their controlled substance inventory?
What must pharmacies do if they distribute more than 5% of their controlled substance inventory?
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Which of the following describes a key component of a Notice of Privacy Practices?
Which of the following describes a key component of a Notice of Privacy Practices?
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Which of the following are necessary for compliance with USP 800 standards?
Which of the following are necessary for compliance with USP 800 standards?
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What is a primary difference between the 503a and 503b compounding categories?
What is a primary difference between the 503a and 503b compounding categories?
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Which of the following concerns is addressed by Title II of the Drug Quality and Security Act?
Which of the following concerns is addressed by Title II of the Drug Quality and Security Act?
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Which statement is true regarding USP 797 standards?
Which statement is true regarding USP 797 standards?
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What is one of the requirements for personnel under USP 795 regulations?
What is one of the requirements for personnel under USP 795 regulations?
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Which of the following is part of the documentation required under USP 795?
Which of the following is part of the documentation required under USP 795?
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What type of information falls under Protected Health Information (PHI) according to HIPAA?
What type of information falls under Protected Health Information (PHI) according to HIPAA?
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Which of the following protocols is essential for maintaining efficacy in compounding sterile medications?
Which of the following protocols is essential for maintaining efficacy in compounding sterile medications?
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What role does NIOSH play in relation to hazardous drug handling guidelines?
What role does NIOSH play in relation to hazardous drug handling guidelines?
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Which requirement is outlined in 503b compounding regulations concerning drug labeling?
Which requirement is outlined in 503b compounding regulations concerning drug labeling?
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Study Notes
USP Standards
- USP 795 governs non-sterile compounding for preparations like creams, ointments, tablets, and capsules.
- USP 797 establishes standards for sterile products like injectables and ophthalmic solutions.
- USP 800 addresses safe handling of hazardous drugs to protect healthcare workers and patients.
503a & 503b Compounding
- 503a compounding is patient-specific, prescribed by a doctor and regulated by state pharmacy boards.
- 503b compounding is large-scale compounding without patient-specific prescriptions. It is registered with the FDA.
Drug Quality and Security Act (DQSA) 2013
- Title I reinforces standards for 503a and 503b compounding facilities.
- Title II establishes a tracking system for drugs to prevent counterfeits in the supply chain.
HIPAA (Health Insurance Portability and Accountability Act)
- PHI includes medical records, insurance, and payment data. It can be disclosed without authorization for Treatment, Payment, and Operations (TPO).
- Notice of Privacy Practices must be given to patients at their first visit with a signed acknowledgement.
- De-identification of PHI removes identifying data to ensure privacy in research and statistical analyses.
OBRA 90 (Omnibus Budget Reconciliation Act of 1990)
- The Act promotes safe and effective medication use.
- Prospective DUR includes reviewing prescriptions for potential problems, providing patient education about medication use, and documenting patient history.
- Retrospective DUR analyzes prescription data over time to identify patterns needing improvement.
Drug Schedules I-V
- Schedule I drugs have a high abuse potential with no accepted medical use like heroin, LSD, and MDMA
- Schedule II drugs have a high abuse potential but accepted medical uses like morphine, oxycodone, and methamphetamine.
- Schedule III drugs have moderate abuse potential with accepted medical uses like anabolic steroids and codeine.
- Schedule IV drugs have a lower abuse potential than Schedule III drugs like alprazolam (Xanax) and diazepam (Valium).
- Schedule V drugs have the lowest abuse potential among controlled substances like over-the-counter cough syrups containing codeine and pregabalin.
Storage and Handling of Controlled Substances
- Schedules I and II drugs require secure storage in locked cabinets or safes.
- Schedules III-V drugs require secure storage, but less strict than Schedules I-II drugs
- 5% Rule requires pharmacies distributing more than 5% of their annual controlled substance inventory to other facilities to register as a distributor with the DEA.
Distribution, Dispensing, and Manufacturing
- Dispensing includes providing medication based on a prescription with DEA registration and record-keeping.
- Distributing involves transferring controlled substances between registrants without a prescription.
- Manufacturing includes producing, preparing, or packaging controlled substances for sale and requires DEA registration and CGMP compliance.
Prescribing Authority and DEA Number Requirements
- DEA numbers are 2-letter identifiers for each prescriber. The first letter indicates prescriber type and the second letter matches the last name.
- Schedule II drugs require written or electronic prescriptions.
- Schedule III-V drugs can be refilled up to 5 times within 6 months.
- Partial fills for Schedule II drugs are allowed if the pharmacy is out of stock, and the refills must be completed within 30 days.
Records and DEA Forms
- Inventory of controlled substances must be conducted every 2 years and must be tracked and recorded.
- DEA Form 222 is used to order Schedule I and II drugs and requires a Power of Attorney (POA) if not the registrant.
- DEA Form 106 is used to report theft or loss of controlled substances to the DEA within 1 business day of discovery.
- DEA Form 41 documents the destruction of controlled substances and requires details on the method of destruction and witnesses.
DEA Form 222:
- Copy 1 is retained by the supplier
- Copy 2 is sent to the DEA by the supplier
- Copy 3 is retained by the purchaser
Loss Reporting
- Any significant theft or loss of controlled substances must be reported to the DEA within 1 business day using DEA Form 106.
Additional Notes on Controlled Substance Handling
- Distribution to Practitioners: Requires documenting sales with invoices for Schedules III-V drugs and DEA Form 222 for Schedules I-II drugs.
- Online Pharmacies: Must be DEA registered and issue prescriptions only for legitimate medical needs.
USP Standards
- USP 795 (Non-Sterile Compounding): Focuses on preparations like creams, ointments, tablets, and capsules. Enforces clean environments, standardized equipment, and personnel training in hygiene and quality control.
- USP 797 (Sterile Compounding): Addresses sterile products like injectables and ophthalmic solutions. Requires ISO 5 air quality in compounding areas, rigorous aseptic techniques, and staff competency tests.
- USP 800 (Handling Hazardous Drugs): Focuses on protecting healthcare workers and patients from hazardous drugs. Requires engineering controls like negative-pressure rooms and PPE, and includes protocols for labeling, storage, and disposal.
503a vs. 503b Compounding
- 503a Compounding (Traditional Pharmacy Compounding): Patient-specific compounding regulated by state pharmacy boards, exempt from certain FDA regulations if adhering to USP standards and preparing small quantities.
- 503b Compounding (Outsourcing Facilities): Large-scale compounding without patient-specific prescriptions, registered with the FDA and subject to CGMP standards.
Drug Quality and Security Act (DQSA 2013)
- Title I: Compounding Quality Act: Reinforces standards for 503a and 503b facilities to prevent contamination and compounding errors.
- Title II: Drug Supply Chain Security Act (DSCSA): Establishes a tracking and tracing system to prevent counterfeit drugs. Requires serialization and verification of drug sources.
HIPAA (Health Insurance Portability and Accountability Act)
- Protected Health Information (PHI): Identifiable information like names, medical records, and payment data, can be disclosed without authorization for Treatment, Payment, and Operations (TPO).
- Notice of Privacy Practices: Patients receive a notice at their first visit, outlining how their PHI will be used and disclosed.
- De-identification of PHI: Removal of identifying data for privacy purposes, often used in research.
OBRA 90 (Omnibus Budget Reconciliation Act of 1990)
- Objective: Promotes safe and effective medication use, improving health outcomes and reducing healthcare costs.
- Prospective Drug Utilization Review (DUR): Conducted before dispensing to identify potential issues, such as drug interactions or allergies.
- Retrospective DUR: Analyzes prescription data over time to identify patterns needing improvement.
Drug Schedules I-V
- Schedule I: High abuse potential, no accepted medical use. Examples: Heroin, LSD, MDMA.
- Schedule II: High abuse potential with accepted medical uses. Examples: Morphine, oxycodone, methamphetamine.
- Schedule III: Moderate abuse potential, accepted medical uses. Examples: Anabolic steroids, codeine (less than 90 mg per dosage unit).
- Schedule IV: Lower abuse potential than Schedule III. Examples: Alprazolam, diazepam.
- Schedule V: Lowest abuse potential among controlled substances. Examples: Cough preparations with codeine, pregabalin.
Storage and Handling of Controlled Substances
- Storage: Schedule I and II require secure storage in locked cabinets or safes, less strict standards for Schedule III-V.
- 5% Rule: Pharmacies distributing more than 5% of their annual controlled substance inventory to other facilities must register as a distributor with the DEA.
Definitions: Distributing, Dispensing, and Manufacturing
- Dispensing: Providing medication to a patient based on a prescription, requires DEA registration and strict record-keeping.
- Distributing: Transferring controlled substances between registrants without a prescription.
- Manufacturing: Producing, preparing, or packaging controlled substances, requires adherence to CGMP and DEA regulations.
Prescribing Authority and DEA Number Requirements
- DEA Number Structure: Unique identifier for each prescriber, indicating the prescriber type and matching the last name.
- Controlled Substance Prescription Requirements: C2 prescriptions must be written or e-prescribed, except in emergencies. C3-C5 can have refills within 6 months. Partial fills for C2 are allowed if the pharmacy is out of stock, and refills must be completed within 30 days.
- Prescription Elements: Prescriber's name, address, DEA number, patient's name, address, and date of issuance.
Records and DEA Forms
- Recordkeeping: Controlled substances require detailed inventory records, receipts, and dispensation records for at least 2 years.
- Inventory: Conducted every 2 years, exact counts are required for Schedule I and II, estimates for Schedule III-V unless containers hold more than 1,000 units.
DEA Forms
- DEA Form 222: Used for ordering Schedule I and II drugs, requiring three copies.
- DEA Form 106: Used to report theft or significant loss of controlled substances to the DEA.
- DEA Form 41: Used to document the destruction of controlled substances.
Loss Reporting
- Significant theft or loss of controlled substances must be reported to the DEA within 1 business day using DEA Form 106.
Additional Notes on Controlled Substance Handling
- Distribution to Practitioners: Schedule III-V documentation through invoices, Schedule I-II requires DEA Form 222.
- Internet Pharmacy Regulations: Online pharmacies must register with the DEA and can only issue prescriptions based on legitimate medical needs verified through in-person evaluations.
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Description
Test your knowledge on USP standards, compounding regulations, and the Drug Quality and Security Act. This quiz covers essential guidelines for pharmacists concerning non-sterile and sterile compounding, along with HIPAA regulations on patient information protection.
