A Comprehensive Guide to Dispensing Controlled Substances in Your Practice

Dispensing controlled substances in a medical practice is a critical and sensitive responsibility. As a physician, you must adhere to 21 U.S.C., Drug Enforcement Administration guidelines, Food and Drug Administration (FDA), and state laws.

When prescribing and dispensing controlled substances, you must also be mindful of safety and practical considerations. Controlled prescription drugs have come under increased public and governmental scrutiny in the wake of the opioid crisis due to their huge impact on public health.

Join us as we explore the nuances of dispensing controlled substances so you can ensure that each issuance is in line with ethical and legal guidelines.

Legal and Regulatory Landscape

When dispensing controlled substances, you must remain familiar with federal laws, especially 21 U.S.C., chapter 13, section 812. You’ll also need to know the key elements of the Controlled Substances Act (CSA). This piece of legislation outlines the process of scheduling controlled substances. All federally controlled substances are grouped into the following categories:

  • Schedule I
  • Schedule II
  • Schedule III
  • Schedule IV
  • Schedule V

Schedule I drugs have the highest propensity for abuse, whereas Schedule V drugs have a very low potential for abuse. Dispensing controlled substances that fall into the first few schedules in a healthcare setting requires the most diligence.

You’ll also need to adhere to physician dispensing laws. These include both state and federal mandates, which govern the issuance of controlled substance prescriptions. For instance, each state has different provisions regarding things like off-label medical use for oral prescriptions, partial filling, and whether you are permitted to use an electronic prescription or written prescription.

Your care facility must additionally follow all recordkeeping rules. Doing so helps to promote public health and safety.

Licensing and DEA Registration

Physician dispensing requires registration with the Drug Enforcement Administration. Specifically, each prescribing practitioner must obtain a DEA certificate to write prescriptions for controlled substances. Additionally, your state may require you to obtain a Controlled Dangerous Substances (CDS) certificate.

Neither of these is a one-off process. You’ll have to keep up with ongoing changes to these legal frameworks and periodically renew your registration. Failing to do so could open your practice up to significant civil and criminal repercussions, as dispensing controlled substances without proper licensure is a federal crime.

When in doubt, consult with a compliance professional or attorney who is well-versed in government regulations and your obligations under state and federal law. When it comes to dispensing controlled substances in your practice, you have a legal and ethical obligation to get it right the first time.

Prescription Protocols for Controlled Substances

Point-of-care medication dispensing of controlled substances involves specific, stringent protocols. DEA regulations dictate what information you must have to issue a prescription, how you must go about writing the prescription, and other details.

For instance, you must have the full name of the patient on the prescription. When issuing a written prescription, you have to use special paper that deters counterfeiting and forgery. When issuing electronic prescriptions, you have to use a system that is compliant with DEA regulations.

Prescription protocols also dictate what day supply you are allowed to issue. When issuing controlled substances to address chronic pain, most states allow you to issue a 30-day supply. Some exceptions permit you to issue up to a 90-day supply of a controlled substance, but these are rare.

In emergencies, such as in response to a severe injury, you can issue controlled substances like opioids (e.g., codeine) to address acute pain. Typically, you can prescribe up to a three-day supply in these scenarios, but there are exemption provisions that permit you to issue a seven-day supply.

Security and Storage Requirements

Security and storage of controlled substances are paramount in healthcare settings. You must implement stringent measures to prevent theft and burglary. Controlled substances must be stored in secured, locked areas with restricted access. Your office must also maintain an inventory log, conduct regular audits, and track substance movement.

As part of this process, you should implement protocols like dual verification for access and alarm systems to discourage tampering. Consider installing surveillance systems, too, so that you can quickly address any discrepancies and protect your practice from civil and criminal liability. Additionally, training staff on security protocols ensures that everyone is aware of the importance of safeguarding these substances.

With regulations continuously being reviewed and updated at the state and federal levels, diligence is key. Just because you are compliant today doesn’t mean that you will be tomorrow. Falling out of compliance can disrupt your practice, interfere with your patients’ ability to obtain the medications they need, and expose you to increased liability.

Record-Keeping and Reporting for Controlled Substances

Record-keeping for controlled substances is a rigorous — and required — aspect of dispensing within your medical practice. As a provider, you must meticulously document the dispensing of these drugs, including patient details, dosages, and dates. These records are vital for audits and regulatory compliance.

Additionally, you are obligated to report to state prescription drug monitoring programs (PDMPs) if your practice is located in a jurisdiction with such a program. PDMPs use electronic databases to track controlled substance prescriptions throughout the state and limit or prevent “doctor shopping.” The goal is to ensure that patients cannot get multiple overlapping controlled substance prescriptions from different physicians.

Patient Education and Informed Consent

Educating patients about controlled substances isn’t just the right thing to do; it’s also your legal obligation. You need to inform patients of the benefits and risks of a controlled substance, as well as proper usage and any potential side effects. The goal is to ensure that patients can make informed decisions about their journeys.

Obtaining informed written consent means that patients understand and agree to the treatment plan. It further serves to protect your office from liability. Should a patient deviate from your recommendations and inadvertently or intentionally cause harm to themselves, you can present the signed form as evidence that you provided the proper education.

Quality Control Measures

Quality control in dispensing controlled substances is critical for ensuring patient safety. Healthcare providers must adhere to strict standards in handling, preparing, and dispensing these medications. Measures include tracking expiration dates, verifying drug batches, and regularly inspecting storage conditions. You should also double-check prescriptions for accuracy and potential interactions.

Additionally, ensure you are working with distributors who are stringent regarding quality control. You want to safeguard your patients from the risks associated with lax quality standards, including adulteration and reduced efficacy. This rigorous approach ensures that the right medication reaches the right patient, thus maintaining the integrity of the treatment process.

Practical Implementation Challenges and Solutions

Dispensing controlled substances at your practice poses several challenges. Some issues you’ll encounter include:

  • Managing extensive documentation
  • Ensuring staff compliance with security protocols
  • Keeping up with changing regulations

Working with physician dispensing companies can help you overcome these hurdles, maintain compliance, and better serve your patients. The ideal physician dispensing partner for your practice is one with a strong functional knowledge of legal requirements and the technological tools to help you adhere to said regulations. With the right tech and the support of a knowledgeable partner, you’ll be able to provide safe, efficient dispensing services.

Emerging Trends and Future Considerations

The well-documented opioid crisis has led to public outcries for significant change. In response, state governments and the DEA are collaborating to enforce existing laws and enact new provisions meant to curb substance abuse and protect patients.

Moving forward, you will undoubtedly face tightening regulations. Therefore, you must have sound compliance policies and scalable technology in place to support your dispensing operations. Otherwise, you are at a heightened risk of compliance violations, regulatory penalties, and criminal liability.

These trends are fueling the widespread adoption of tracking and tracing technologies. Such tools allow you to digitally document every unit of controlled substances that flow into and out of your practice.

Stay Informed and Prioritize Compliance When Dispensing Controlled Substances

Do you want to learn more about how in-office dispensing works? Explore Proficient RX’s abundance of free resources, which help you adhere to applicable state laws, Board of Pharmacy provisions, and individual practitioner requirements.

As leaders in the dispensing industry, Proficient RX can also provide invaluable insights about DEA regulations, Department of Health and Human Services requirements, and Department of Justice best practices. Contact us to connect with a compliance expert and learn how we can support your in-office treatment programs.

Furthermore, prepackaged medicines and accompanying software are making great leaps to provide physicians and patients with the best quality service and product, backed by extreme safety practices.

The drugs you plan to dispense, especially if controlled substances, come with heavy restrictions.