Physician dispensing in Pennsylvania is the process of prescribing and distributing medications directly to patients in your healthcare practice. While offering dispensed drugs at your practice offers improved convenience and access for patients, it’s important to familiarize yourself with Pennsylvania physician dispensing regulations so that you can ensure safety and compliance.

With that in mind, this blog explores the rules and regulations governing the administration of drugs in the Commonwealth of Pennsylvania.

Introduction to Physician Dispensing in Pennsylvania

In-office dispensing is the process of prescribing and dispensing or administering medications directly in your practice. This approach has become increasingly popular in recent years as it allows providers to maintain direct oversight of drug dispensing. As a result, they consider a patient’s medical record and care history when prescribing medications. Moreover, it allows providers to capture more revenue through insurance reimbursements.

Overview of Pennsylvania Physician Dispensing Laws

Physician dispensing in Pennsylvania is regulated at both the state and federal levels. The state governs in-office dispensing through the Pennsylvania Code, as well as via the Board of Pharmacy. The Drug Enforcement Administration (DEA) also regulates some aspects of physician dispensing, particularly activities that involve the prescription and distribution of controlled substances (e.g., Schedule II, Schedule III).

The following takes a closer look at the state regulations you’ll need to adhere to when creating an in-office dispensing program.

State Regulation for Physician Dispensing

When engaging in Pennsylvania physician dispensing, you must adhere to both state and federal regulations. The Pennsylvania Code governing dispensing at healthcare facilities is 18.158. According to this law, a supervising physician or a designated healthcare provider, such as a physician assistant, may prescribe, dispense, or administer therapeutic devices or drugs.

However, physician assistants and supervising physicians are prohibited from dispensing or prescribing a Schedule I controlled substance. This is stipulated in both federal law and subsection 4 of the Pennsylvania Controlled Substances, Drug, Device, and Cosmetic Act.

Physician assistants are also limited in their ability to prescribe a Schedule II controlled substance (e.g., oxycodone or other opioids). While the issuance of these substances is permitted, the PA may only provide a 72-hour dose. If the supervising physician approves long-term care, the PA may prescribe a 30-day supply for ongoing therapy.

Additionally, physicians and their designees can only prescribe drugs to individuals under their care. When engaging in physician dispensing in Pennsylvania, it’s vital that you adhere to stringent recordkeeping requirements and carefully document all refills to demonstrate that you are complying with these restrictions.

Role of the Pennsylvania State Board of Pharmacy

The Pennsylvania State Board of Pharmacy regulates all entities that dispense medications directly to consumers. Before you participate in dispensing activities, you’ll need to apply for the proper licensure with the state board and pay the registration fee.

Additionally, the state board requires medical physicians, PAs, surgeons, and licensed nurse-midwife applicants to complete opioid education in order to prescribe and dispense opioid-based medications. This requirement helps promote the safe prescription and use of the drug while also aiming to reduce instances of abuse or overuse.

Key Considerations and Requirements

After you’ve familiarized yourself with the state regulatory landscape, you’ll need to address the following additional considerations.

Prescription Labeling and Patient Counseling

The Food and Drug Administration (FDA) has created stringent labeling and record-keeping requirements for prescription drugs. These regulations are meant to promote real-time traceability and improved patient safety. The state of Pennsylvania has its own labeling requirements, which closely align with those mandated at the federal level. At a minimum, the prescription drugs you issue must include:

  • Name of the drug
  • Name of the manufacturer
  • Dosage amount
  • Number of doses
  • Manufacturer’s control number
  • Expiration date
  • Name of the patient
  • Issuing physician

For simplicity’s sake, many providers invest in dispensing machinery and pre-packaged medications. This approach saves time and promotes accuracy during dispensing. For instance, if you prescribe a patient a 30-day supply of medication, your staff can dispense a pre-packaged bottle or blister pack with the specified number of doses.

Controlled Substances and DEA Compliance

According to federal law, physicians must obtain a DEA number before dispensing controlled substances. To get a DEA number, simply fill out an application with the Drug Enforcement Administration and pay the registration fee. Once approved, you’ll receive a number and be eligible to dispense controlled substances.

After you begin dispensing, make sure to follow all state and federal recordkeeping requirements. You’ll also have to renew your registration with the DEA periodically.

Benefits and Challenges of Physician Dispensing in Pennsylvania

Integrating an in-office dispensing program into your workflows can provide a wealth of benefits for your patients and the practice, as well as a few specific challenges. In particular, you’ll see an effect on patient care and access and regulatory compliance and practice efficiency.

Impact on Patient Care and Access

Under the traditional pharmacy model, patients may encounter a wide range of barriers that can negatively impact medication adherence. One of the major hurdles involves errors or miscommunications between the pharmacy and your office.

Even seemingly small mistakes can lead to prescription disbursement delays and frustrated patients. Those with transportation or mobility limitations may struggle to return to the pharmacy at a later date.

By handling everything in-house, you eliminate the risk of errors and delays. Your office will no longer have to engage in multiple communications with the pharmacy. If there is a concern about a prescription or dosage, you can easily address the problem and get the patient the correct medication.

By improving accessibility, you can also increase adherence and enhance patient outcomes. Patients will be able to start critical medications, such as antibiotics, sooner in the care journey and mitigate their exposure to adverse conditions caused by their disease.

Regulatory Compliance and Practice Efficiency

From an organizational perspective, physician dispensing in Pennsylvania paves the way for much greater operational efficiency. Think of the countless hours you and your team waste communicating with third-party pharmacies and addressing prescription errors. You can eliminate all these challenges by offering in-office dispensing.

Additionally, dispensing drugs internally can create supplemental revenue streams for your practice. You have the ability to generate income via insurance reimbursements and patient cash pay options. This revenue can be used to support investments in better equipment, staff training, and expansion efforts.

To realize these benefits, though, you’ll need to navigate an incredibly complex regulatory framework. Physician dispensing in Pennsylvania is regulated by multiple entities, including the FDA, DEA, and state Board of Pharmacy.

Fortunately, many of these regulations are complementary and overlapping. Still, it’s important to stay up-to-date on the latest provisions, as the world of in-office dispensing is rapidly evolving.

Best Practices for Pennsylvania Physicians

Successfully integrating an in-office dispensing program into your practice requires a multifaceted approach that focuses on the following areas:

Training and Continuing Education

The state of Pennsylvania requires dispensing physicians to successfully complete an opioid educational program prior to dispensing controlled substances at their practices. In addition to this training, you should invest in other upskilling resources for you and your team. After all, offering medications in your office shifts a great deal of liability to you and your staff.

Don’t stop with basic compliance training, either. Explore opportunities to teach your team dispensing best practices and provide education on using new inventorying software. With the right focus on training and education, you can give your team members the confidence they need to thrive.

More importantly, well-trained staff will support objectives like optimizing practice efficiency and ensuring patient safety. They will be your most valuable tool for ensuring compliance, safety, and positive care outcomes.

Integration of Technology and Automation

Training your team is only part of the equation. You also need to invest in technology to streamline your dispensing programs. Specifically, you’ll require an inventorying solution with automation capabilities, which helps to keep your team accountable and ensures transparency.

Physician dispensing companies can provide you with guidance, resources, and the underlying technology necessary to automate critical inventorying processes. Partners such as Proficient Rx deliver bespoke software, which we designed specifically for in-office dispensing. The platform can also be tailored to your state’s unique requirements to ensure compliance and efficiency.

If you aren’t doing so already, consider adopting an electronic health records system. By integrating that system with your dispensing platform, you can maintain a holistic view of the patient care journey and inform your decision-making processes. The end result is an expedited delivery of care and a more frictionless journey for those you treat.

Connect With Proficient Rx

Pennsylvania physician dispensing laws provide a clear framework for creating a safe, impactful, and compliant program within your practice. However, it’s vital to equip your team with the confidence, skills, and tools necessary to bring your vision of in-office dispensing to fruition.

Moreover, ensure that they understand the importance of compliance by taking advantage of resources and technologies, such as those offered by Proficient Rx. Do you want to learn more about how physician dispensing works? If so, contact Proficient Rx today to speak to one of our experts.