Limits on Prescription Drug Dispensation and Sales

Description

Limits on prescription drug dispensation and sales were suggested by the federal Controlled Substances Act (CSA), which outlines specific guidelines. However, some states (and health insurance companies) have further regulations regarding the dispensation of controlled substances.

Objective(s)

To limit access to controlled substances that have the potential for misuse and abuse

Typical Elements

  • Sub-federal restrictions on prescription drug dispensation and sales fall into several broad categories:
    • The time after a prescription is issued during which a pharmacist can fill a prescription
    • The quantity of a drug that may be prescribed and/or dispensed
    • The ability to prescribe refills and/or the quantity of those refills
    • Prescriptions issued orally (“called in”)
    • The quantity of a drug that may be prescribed by health practitioners other than doctors (physician assistants, nurse practitioners, etc.)
    • The identification required to collect a prescription
  • Health insurers (including Medicaid) can impose limitations on the time between prescriptions based on the days’ supply (for example, Medicaid will not pay for a new prescription until 85% of the days’ supply has elapsed; Centers for Disease Control and Prevention [CDC], 2015).
  • While federal law does not set a time limit within which controlled substance prescriptions must be filled after being signed by the practitioner, some states and insurance companies have instituted such limits (Rannazzisi & Caverly, 2006; CDC, 2015). 
  • There are no specific federal limits on the quantity of drugs dispensed via a prescription, but states and some insurance carriers have created specific quantity limitations based on a host of factors, including drug schedule, drug type, and patient diagnosis (Rannazzisi & Caverly, 2006). These laws limit the drug by days’ supply, by dosage units, or both. Five states have set limits for all prescription drugs or all controlled drugs, while 23 states and the District of Columbia have restrictions for specific schedules of drugs (CDC, 2015). For example (CDC, 2015):
    • Missouri limits Schedule II prescriptions to a 30-day supply, while limiting Schedules III, IV, and V prescriptions to a 90-day supply
    • South Carolina limits Schedules III-V to a 30-day supply
    • Seven states and the District place special restrictions on oral prescriptions
  • Under federal law, prescriptions for Schedule II substances cannot be refilled. Prescriptions for Schedule III and IV controlled substances can be refilled up to five times in six months, and prescriptions for Schedule V controlled substances can be refilled as authorized by the practitioner. However, a practitioner can issue multiple prescriptions for a Schedule II drug, allowing a patient up to a 90-day supply, if the following conditions are met (Leonhart, Rannazzisi, & Caverly, 2010):
    • Each separate prescription is issued for a legitimate medical purpose by a practitioner acting in the “usual course of professional practice” (Leonhart, Rannazzisi, & Caverly, 2010, p. 3)
    • The practitioner provides written instructions on each prescription indicating the earliest date that a pharmacy can fill it
    • The practitioner concludes that there is not excessive risk of diversion or abuse
    • Multiple prescriptions are allowable under applicable state laws
    • The practitioner complies fully with all other applicable requirements under the CSA and Code of Federal Regulations, as well as any additional state laws
  • Additional regulations regarding prescription refills can be based on a variety of factors, for example (FSMB, n.d.):
    • In Oklahoma, a new prescription for a specific controlled substance voids any existing refills or other prescriptions for the same drug, and refills cannot be granted at the same time as the initial filling of the prescription for Schedule III or IV controlled substances
    • In South Carolina, no prescription can be refilled sooner than 48 hours prior to the time that the prescription should be consumed, if the prescribed daily dosage is divided into the total prescribed amount
    • In Utah, the dispensing date of a second or third prescription can be no less than 30 days from the dispensing date of the previous prescription (though some exceptions apply)
  • Under federal law, oral (“call in”) prescriptions for Schedule II controlled substances are allowable only in emergency situations, and significant restrictions apply to faxed prescriptions. However, oral prescriptions are allowed for Schedule III and IV controlled substances (Rannazzisi & Caverly, 2006).  
  • Limitations can be imposed on prescribers who are not doctors. While prescriptions for controlled substances can be issued by a Drug Enforcement Administration-registered practitioner (including physicians, dentists, and mid-level practitioners) under specific conditions, some states limit the prescribing abilities of non-doctors. Kentucky, North Carolina, and Pennsylvania, for example, limit the prescription of controlled substances by nurse practitioners (CDC, 2012).
  • Health plans (both private and public) can impose quantity or days’ supply limitations and refill limitations on their enrollees. For example, Arizona, Delaware, and New Jersey’s Medicaid programs impose limitations on prescription quantity and days’ supply and refills, which apply to all prescription medications, including controlled substances (Arizona Health Care Cost Containment System Administration, 2014; General Assembly of the State of Delaware, 2006; New Jersey Division of Medical Assistance and Health Services, 2004).

Populations

Pharmacists, prescribers, patients

Outcomes

No outcome data have been found regarding limits on prescription drug dispensation and sales in preventing the nonmedical use of prescription drugs and/or its consequences.

Guidelines

Pharmacist’s Manual: An Informational Outline of the Controlled Substances Act. 

Acknowledged by

Centers for Disease Control and Prevention. State Laws on Prescription Drug Misuse and Abuse. 

References

Arizona Health Care Cost Containment System Administration. (2014). Arizona Administrative Code § R9-22-209. Retrieved from http://apps.azsos.gov/public_services/Title_09/9-22.pdf

Centers for Disease Control and Prevention. (2012, August 27–28). Patient review and restriction programs: Lessons learned from state Medicaid programs. CDC Expert Panel Meeting Report, Atlanta, GA. Retrieved from http://www.cdc.gov/drugoverdose/pdf/pdo_patient_review_meeting-a.pdf

Centers for Disease Control and Prevention. (2015). Prescription Drug Time and Dosage Limit Laws. Retrieved from http://www.cdc.gov/phlp/docs/menu_prescriptionlimits.pdf

Federation of State Medical Boards. (n.d.). Pain management policies: Board-by-board overview. Retrieved from  http://www.fsmb.org/siteassets/advocacy/key-issues/pain-management-by-state.pdf

General Assembly of the State of Delaware. (2006). 16 Delaware Code § 3005B. Retrieved from http://delcode.delaware.gov/sessionlaws/ga143/chp017.shtml

Leonhart, M. M., Rannazzisi, J. T., & Caverly, M. W. (2010). Pharmacist’s manual: An informational outline of the Controlled Substances Act. Springfield, VA: Drug Enforcement Administration. Retrieved from www.deadiversion.usdoj.gov/pubs/manuals/pharm2/pharm_manual.pdf

New Jersey Division of Medical Assistance and Health Services. (2004). New Jersey Administrative Code § 10:51-1.15. Retrieved from https://www.state.nj.us/humanservices/providers/rulefees/regs/NJAC%2010_51%20Pharmaceutical%20Servies%20Manual.pdf

Rannazzisi, J. T., & Caverly, M. W. (2006). Practitioners manual: An informational outline of the Controlled Substances Act. Springfield, VA: Drug Enforcement Administration. Retrieved from http://www.deadiversion.usdoj.gov/pubs/manuals/pract/pract_manual012508.pdf