Dispensing CS (slides 1-20) - NOV3

Overview of the Lecture

  • The lecture covers a review of federal law, in conjunction with Massachusetts law (Mass law).

  • The agenda includes discussion of Chapter 5, followed by details on controlled substances and counseling.

  • The instructor has jury duty next week but will manage to record the lecture if unable to attend.

  • There are only four weeks left in the semester, indicating urgency in the material coverage.

Chapter 5 Objectives

  • Discuss the dispensing of controlled substances.

  • Explore the prescription requirements for controlled substances in outpatient settings.

  • Understand the rules surrounding prescriptions in hospital settings.

  • Emphasize the importance of drafting prescriptions and recognizing common mistakes.

Controlled Substance Prescriptions

Definitions and Distinctions

  • Outpatient Prescriptions: Issued for external patients, have specific rules that differ from inpatient settings.

  • Inpatient Medication Orders: Used in hospital settings, generally limited to specific protocols for drug administration.

Prescription Requirements in Massachusetts

  • Allowed Items: In Massachusetts, only one prescription per blank is allowed, whereas other states might permit multiple prescriptions.

  • Required Information on Prescriptions:

    • Patient's Name

    • Patient's Address

    • Date of Birth (not required in Mass)

    • Prescriber's Name

    • Drug Name

    • Quantity of the drug

    • Directions for use

    • Number of refills

    • No substitution language indicating brand medication preference.

    • Partial fill language for Schedule II drugs if applicable.

Prohibition Against Office Use Prescriptions

  • Doctors cannot write prescriptions for their office use; all medications must be tied to specific patients.

  • If a doctor requires controlled substances such as cocaine for office use, they must submit a form (e.g., Form 222 for Schedule I and II drugs).

Prescriber Authority and Requirements

  • Only individual practitioners can prescribe, and they must possess a DEA registration.

  • In Massachusetts, practitioners additionally require a Mass-controlled substance registration.

  • Agents or employees of doctors are not required to be registered unless they have prescriptive authority.

Communication of Prescriptions

  • Agents of doctors may relay prescriptions to pharmacies but cannot authorize refills unless they have prescriptive authority.

  • Prescriptions can be prepared by agents except for the doctor’s signature.

Verification of Prescriptions

DEA Registration

  • Prescribers must be registered under the Drug Enforcement Administration (DEA) to prescribe controlled substances.

  • Key components of a DEA number:

    • Nine digits, with two letters followed by seven numbers.

    • The second letter typically corresponds with the first letter of the prescriber's last name.

Examples and Validation of DEA Numbers

  • Given a DEA number example, methods to verify it using specific calculations:

    • Add the 1st, 3rd, and 5th digits and sum.

    • Add the 2nd, 4th, and 6th digits, multiply by 2, then combine this with the previous sum.

    • Validate if the last digit of the DEA number corresponds with the check digit.

Responsibilities of Pharmacists

Corresponding Responsibility

  • Pharmacists share liability to ensure controlled substances are prescribed for legitimate medical purposes.

  • Examples of illegitimate prescriptions include those for narcotics without valid medical reasons, or prescriptions written without proper evaluations.

Legal and Ethical Implications

  • Pharmacists must exercise professional judgment when there is uncertainty about a prescription's legitimacy.

  • The opioid epidemic has heightened scrutiny regarding the dispensing of controlled substances.

  • Knowledge of the usual course of professional practice is crucial; for example, a pediatrician writing prescriptions for an adult is outside the norm.

  • Essential to recognize potentially red flags, such as repetitive filling of certain prescriptions.

Emergency Situations and Exceptions

Emergency Protocols

  • In an emergency, a doctor may call in a CII prescription without a written order under specific conditions:

    1. Immediate patient administration is necessary.

    2. No alternative treatment is available.

    3. It's not feasible to provide a written prescription.

  • A follow-up written prescription must be provided within a certain timeframe based on Massachusetts law.

Partial Fills of CII Drugs

  • Under federal law, partial fills are allowed upon request from the prescriber or patient.

  • The remaining amount does not need to be filled within 72 hours but can be between remaining up to 30 days.

  • Long-term care facilities have specific provisions for dispensing such substances.

Conclusion

  • Topics to continue in next class will include further discussion on controlled substances and subsequent dispensing protocols. Attention given to insurance implications will also be considered.