Controlled Substance Compliance in Healthcare

Proper Controlled Substance Compliance is critical to avoiding regulatory penalties and maintaining patient safety. Our team provides guidance on prescribing practices, documentation, and inventory management to ensure full compliance with federal and state regulations. We help healthcare providers stay ahead of evolving laws while minimizing the risk of audits and enforcement actions.

The Safe Harbor Group approach to controlled substance compliance

Prescribing controlled substances is a key component of healthcare management for many types of healthcare providers, including family practice, pain management, and internal medicine. As these medications are prone to misuse and diversion, strict adherence to regulations for controlled substance prescribing is crucial.

The Pillars of Controlled Substance Compliance

To achieve controlled substance compliance, healthcare providers must focus on four key aspects:

Informed consent involves a transparent discussion between the healthcare provider and the patient regarding the prescribed medication’s potential risks, benefits, and responsibilities.
For controlled substances, the informed consent process should cover the following:

The purpose and expected benefits of the medication
Possible side effects and risks, including the potential for addiction
Safe use and storage guidelines, including proper disposal methods
The importance of not sharing medications with others
The provider’s monitoring plan, including regular follow-ups and periodic drug testing if necessary
Potential consequences for non-compliance or misuse

Providers should obtain written consent from patients, which should be kept in the patient’s medical record as documentation of this critical conversation.

Controlled Substance Training

Ongoing education and training are essential for healthcare providers to stay updated on the latest controlled substance regulations and best practices.

Training should cover the following topics:

Appropriate prescribing practices, including dosage selection and duration
Risk assessment and mitigation strategies
Identifying and managing patients with substance use disorders
Use of Prescription Drug Monitoring Programs (PDMPs)
Regulatory updates and changes to guidelines

By participating in regular training, providers can ensure they adhere to controlled substance compliance requirements and provide the best care for their patients.

DEA Controlled Substance Compliance

Healthcare providers must comply with DEA regulations when prescribing controlled substances. Key aspects of DEA compliance include:

Registering with the DEA and maintaining an active registration
Accurate record-keeping of controlled substance prescriptions, including patient information, drug type, quantity, and refills
Reporting any lost or stolen prescriptions to the DEA
Implementing security measures to prevent unauthorized access, theft, and diversion, such as securing prescription pads and maintaining a secure drug storage area
Complying with federal and state regulations for prescribing and dispensing controlled substances

Thorough Patient Evaluation and Documentation

Healthcare providers must carefully evaluate and document each patient’s medical history, current condition, and potential risk factors for substance misuse.

This process should include:

Reviewing the patient’s medical history and identifying any history of substance use disorders
Assessing the patient’s pain level, functional status, and quality of life
Checking the patient’s PDMP data to identify any patterns of misuse or doctor-shopping
Performing a physical examination and considering any additional diagnostic tests
Developing a comprehensive treatment plan that considers both pharmacological and non-pharmacological approaches

Regular follow-ups should be conducted to assess the effectiveness and safety of the medication, and any changes to the treatment plan should be documented in the patient’s record.

Partnering with Safe Harbor Group for Compliance Success

SHG provides comprehensive compliance solutions to help providers navigate the complex world of controlled substance compliance. A partnership with Safe Harbor Group provides access to the following:

Compliance Consultation:

Our team can assess current prescribing practices and develop a customized compliance plan to address any areas of concern.

Policy and Procedure Development:

We can assist in creating and implementing policies and procedures that meet controlled substance compliance requirements.

Controlled Substance Training:

We can deliver training programs to educate providers on the latest controlled substance regulations, best practices, and risk mitigation strategies.

Audit Support:

We can conduct periodic audits to ensure ongoing compliance with controlled substance regulations and identify areas for improvement.

Controlled substance compliance is vital to ensure patient safety and avoid legal consequences. Safe Harbor Group is a valuable partner for providers seeking expert guidance and support in navigating the complex world of controlled substance compliance.

Don’t leave controlled substance compliance to chance. Partner with SHG to develop a comprehensive compliance strategy that protects your patients and your practice. Contact us today to learn more about our services and get started on developing your controlled substance compliance plan.

OUR PROMISE TO OUR CLIENTS

Safe Harbor Group: A Nationally Trusted Healthcare Compliance Partner

With a national presence and two headquarters in Metro Detroit and Washington D.C., Safe Harbor Group is dedicated to serving healthcare organizations across the U.S. Our team of compliance experts is here to meet your unique needs, providing support wherever you’re located.