I recently had the opportunity to join a panel discussion with Rita Jew from the Institute for Safe Medication Practices (ISMP) and moderator Brian Serumaga from the United States Pharmacopeia (USP) to discuss emerging patient safety and quality landscape. This panel session occurred during a USP event for their Healthcare Quality and Safety Collaborative Group.

My portion of the conversation focused on how pharmacy practice is, at times, evolving faster than regulations can adapt, particularly in areas like electronic prescribing, compounding technology, artificial intelligence, supply chain oversight, and the rapid expansion of wellness clinics and med spas. In this blog post, I will cover some of the major discussion themes and key takeaways from the session.

Technology Is Advancing Faster Than Regulation

E-Prescribing

Electronic prescribing, or “e-prescribing,” is a perfect example of how regulators over the years have adapted to rapidly changing health care technology.

In the early days of e-prescribing, significant transmission and formatting issues created patient safety concerns. Examples included:

  • Shortened drug descriptions.
  • Truncated fields that led to incomplete prescription directions.
  • Missing provider identifiers and licensure numbers.
  • Formatting inconsistencies between systems.

One example shared during the discussion involved an e-prescription where “500 mg” was interpreted as “5 mg” because the zeros were wrongfully interpreted by the closed system transfer as blank digits. While a pharmacist might immediately question an amoxicillin 5 mg prescription, similar errors involving medications like warfarin (Coumadin) could present far greater risk if a 10 mg dose became 1 mg.

The pharmacy industry has made substantial progress through collaboration among regulators, technology providers, and health care stakeholders. Drug Enforcement Administration’s (DEA) interim final rule on e-prescribing controlled substances in 2010 was a landmark federal rule that set the stage for state regulators on requirements for safe and secure transmission of controlled substances. Even as recently as 2023, DEA published a final rule on the transferring of controlled substance prescriptions between pharmacies for initial filling. Regulators and legislators have responded to the need for enhanced patient safety. In one example, in New York, regulation was passed in 2016 to require all prescriptions to be electronically prescribed.

Compounding Technology

Regulators are also rushing to keep up with advancements in pharmacy compounding.

20 years ago, systems like Intellifill represented early automation advances. Today, state boards are seeing technologies and processes that historically existed only in pharmaceutical manufacturing environments, including:

These technologies create both opportunities and challenges for the pharmacy industry and regulation. One concern we discussed was the growing number of compounding facilities assembling vials outside of a primary engineering control (PEC), which may constitute insanitary conditions under current standards.

As these technologies become more prevalent, pharmacies will need clearer standards and practical educational resources from regulators.

Artificial Intelligence (AI)

AI is another major area where technology is evolving faster than regulatory oversight. 2 main concerns with AI in pharmacy are data security and the reliability of AI outputs.

All health care organizations using AI tools must ensure patient information remains protected and that any AI systems operate behind secure firewalls. Preserving patient confidentiality is a must for all health care entities. Along with security, AI outputs are only as reliable as the quality of the input data and prompts behind them. This idea has been referred to as the “garbage in, garbage out” concept.

One example we discussed involved AI-generated patient counseling for metformin that incorrectly warned patients about hypoglycemia risk. While some diabetes medications can cause hypoglycemia, metformin alone generally does not.

AI can sound authoritative while still providing inaccurate information. Reviewing and validating AI-generated content is a major area of concern. Read more about AI in Pharmacy in our blog.

Jurisdictional Challenges Continue to Grow

State boards increasingly face complex jurisdictional challenges during investigations and complaint reviews.

When complaints involve licensed health care professionals or licensed facilities, boards generally have clear authority to investigate and act. However, more difficult questions arise when patient harm involves entities operating outside traditional health care structures. These questions often are: Does the jurisdiction follow the drug, the practitioner, or both? What happens when none clearly apply?

These challenges become especially significant in areas involving compounded preparations, online distribution, and wellness businesses operating outside traditional medical oversight structures.

Large-Scale Compounding

An emerging challenge seen today involves pharmacies producing extremely large batches of compounded preparations, particularly nonsterile compounds, that are distributed across many states. These situations can blur the line between traditional patient-specific compounding and manufacturing.

State regulators continue navigating how existing laws and standards apply in these scenarios, particularly when operations begin resembling outsourcing or manufacturing models without falling under traditional FDA oversight under cGMPs.

Supply Chain Risks and Bad Actors

One of the most concerning discussion areas involved illegal or unregulated drug supply chains. The rise in demand for GLP-1 medications has created opportunities for bad actors to engage in compounding and distribution activities.

In some of these situations, the individuals involved are not licensed health care professionals, and state pharmacy boards may lack jurisdiction, unless a licensed entity is involved. Because of this, cases involving patient harm may ultimately become matters for law enforcement rather than professional licensing boards.

The Rise of Med Spas and Wellness Clinics

One of the most rapidly evolving regulatory areas for prescription drugs involves medical spas and wellness clinics, especially due to the popularity of GLP-1s.

In these cases, the concern is not with legitimate medical practices where licensed physicians or nurse practitioners evaluate patients, establish medical necessity, and prescribe treatments within accepted standards of care. Rather, challenges arise in settings where there is little or no supervision by licensed prescribers, medication selection follows generalized protocols instead of individualized patient evaluation, and staff may lack appropriate training or licensure.

Examples of med spa state investigations have involved:

  • Poor environmental controls
  • Unlicensed activity
  • Questionable ingredient sourcing
  • Inadequate oversight
  • Increased patient safety risks

Read more about med spa safety and oversight in our blog and Innovations.

Labeling Errors Create Risks

Even sophisticated facilities and advanced technologies cannot compensate for unclear, inconsistent, or inaccurate labeling practices. As standards evolve, labeling requirements must continue emphasizing clarity, consistency, and conflict-free information presentation.

Regulators should continue to review labeling requirements and standards to make sure confusing labeling doesn’t put patients at risk.

Why Clear Minimum Standards Matter

Minimum standards must be fully described and clearly written to protect patients. When writing minimum regulatory standards, they should be: 

  • Objective rather than subjective
  • Clearly defined
  • Supported with examples

Standards should not assume certain practices are “obvious.” If an expectation matters for patient safety, it should be written clearly within the standard itself. Including examples and practical scenarios can also help ensure greater regulatory consistency across jurisdictions. Providing additional education to licensees may help address emerging practice trends.

As health care technology, compounding practices, and treatment models continue evolving, regulators and standards-setting organizations can provide clear guidance and ongoing education for both practitioners and stakeholders. By addressing new challenges, regulators can help the industry adopt new innovations while keeping patients safe.