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Pharmacy Law

Michael Unger・36 minutes read

Federal Pharmacy law focuses on patient safety, with limitations on pseudoephedrine sales set by the Combat Methamphetamine Epidemic Act of 2005. The DEA regulates controlled substances distribution, with specific requirements for DEA numbers and inventory checks every two years.

Insights

  • State law overrides federal pharmacy law in conflicts, impacting the implementation and enforcement of regulations at the local level, emphasizing the importance of understanding and adhering to specific state statutes in the pharmaceutical field.
  • The DEA plays a crucial role in controlling the distribution of controlled substances, striving to prevent misuse and diversion while ensuring legitimate medical needs are met, underscoring the agency's pivotal responsibility in maintaining the balance between access to medication and preventing substance abuse.

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Recent questions

  • What are the limitations on pseudoephedrine sales?

    Daily limit is 3.6 grams, monthly is 9 grams.

  • What is the purpose of NPI numbers?

    Issued to healthcare providers, organizations, and plans.

  • What is the significance of the Combat Methamphetamine Epidemic Act of 2005?

    Places limitations on pseudoephedrine sales.

  • What is the purpose of the Food, Drug, and Cosmetic Act of 1938?

    Requires medications to be safe and effective.

  • What is the role of the DEA in regulating controlled substances?

    Prevents diversion and misuse while ensuring supply.

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Summary

00:00

"Pharmacy Law: Patient Safety and Regulations"

  • Federal Pharmacy law is discussed with a focus on patient safety.
  • State law takes precedence over federal law in cases of conflict.
  • Daily and monthly limitations on pseudoephedrine sales are set at 3.6 grams per day and 9 grams per month.
  • Mail order pharmacies restrict Sudafed sales to 7.5 grams per month.
  • The Combat Methamphetamine Epidemic Act of 2005 places limitations on pseudoephedrine sales.
  • Sales of Sudafed must be logged for a minimum of two years.
  • NPI numbers are issued to healthcare providers, organizations, health plans, and clearinghouses.
  • The first group of numbers in an NDC identifies the manufacturer.
  • Form 222 is used for ordering, transferring, and returning C2 medications.
  • The Ryan Haight Act of 2008 reduces fraudulent distribution of controlled substances obtained online.
  • The Joint Commission accredits healthcare organizations.
  • Class 1 recalls are the most severe, with a high risk of serious adverse health consequences.
  • Providers can authorize up to five refills for C3 or C4 drugs.
  • Required information on a prescription for a controlled substance includes patient and prescriber details, drug information, and directions.
  • Legend drugs are prescription drugs requiring a prescription for purchase.
  • Schedule 1 drugs have the highest abuse potential with no accepted medical use.
  • The Food, Drug, and Cosmetic Act of 1938 required medications to be safe and effective.
  • Unfilled original epcs for controlled substances can be forwarded between DEA registered pharmacies.
  • Valid DEA numbers follow a specific format based on the provider's information.

15:30

"DEA and NPI Numbers in Healthcare"

  • To validate a DEA number, add the fourth and sixth numbers, multiply by two, then add the sums to get 44, with the last digit being 4, matching the seventh digit of the DEA number.
  • The second letter of a provider's DEA number is the first letter of their last name, aiding in identifying the prescriber on a Prescription Pad.
  • NPI numbers have a more complex algorithm compared to DEA numbers, with pharmacy software often validating license numbers.
  • The DEA requires controlled drug inventory checks every two years.
  • The Comprehensive Drug Abuse Prevention and Control Act of 1970 led to the establishment of the DEA in 1973 to regulate controlled substances distribution.
  • The DEA's role is to prevent diversion and misuse while ensuring a steady supply for legitimate medical needs.
  • DAW 0 on prescriptions indicates no product selection, allowing substitution, while DAW 9 is used for formulary preferences.
  • IRBs approve patient consent forms and safeguard drug research volunteer welfare.
  • ISMP focuses on error prevention strategies, sharing reports with the FDA and manufacturers to enhance patient safety.
  • The FDA's Pregnancy and Lactation Labeling Rule replaced the old pregnancy risk categories with detailed subsections for better decision-making.

31:38

Pharmacy Regulations and Medication Administration Essentials

  • Practitioners dispensing buprenorphine can initially treat 30 to 100 patients yearly, with an option to increase to 275 after a year.
  • The Support for Substance Use Disorder Prevention Act of 2018 broadened medication-assisted treatment programs to include more practitioners like MPS and PAs.
  • Drugs scheduled for substances include Lorazepam, Zolpidem, tramadol, Lamotil, and Vimpat.
  • Pharmacy technicians can process insurance claims, while other responsibilities belong to pharmacists or interns.
  • Error-prone abbreviations like Au, OD, HS, and QD can lead to confusion and errors in medication administration.
  • Look-alike sound-alike drugs are highlighted with tall man lettering to prevent confusion, like Prilosec (formerly Lossec) and Xanax (Triazolam).
  • The Orphan Drug Act of 1983 incentivizes pharmaceutical companies to develop drugs for rare diseases, offering tax benefits and patent protection.
  • Buprenorphine prescriptions for opioid use disorder require an X waiver, but recent legislation aims to eliminate this requirement to enhance treatment accessibility.
  • Schedule 2 substances like Lorazepam, Zolpidem, and tramadol have high misuse potential and are regulated by the FDA.
  • OTC drugs are overseen by the Center for Drug Evaluation and Research (CEDAR) and regulated by the Federal Trade Commission (FTC).
  • The Prescription Drug Monitoring Program (PDMP) tracks dispensed controlled substances to prevent abuse and misuse.
  • Facsimile prescriptions can serve as originals for schedule 2 substances in specific cases like compounding for direct administration or hospice care.
  • Schedule 2 substance prescriptions have no federal expiration date, but state laws may impose limits ranging from 30 days to one year.
  • Pharmacists must engage in DURs, counseling, and record-keeping for patients over 90, ensuring proper pharmaceutical care.
  • Emergency oral prescriptions for schedule 2 substances must be followed up with a written prescription within seven days, with recent extensions due to public health emergencies.
  • Partially filled schedule 2 prescriptions for terminally ill or LTCF patients are valid for up to 60 days, with strict record-keeping requirements.
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