Pharmaceutical care has changed significantly in recent years thanks to advances in technology. This has seen a shift from traditional, in-person ways of dispensing medications, to an online model, known as telepharmacy, where pharmacists and patients interact remotely. As a result, patients in rural and underserved areas, or those with mobility issues can still receive the pharmaceutical care they need without the challenges of traveling to a physical pharmacy. 

 

This was particularly beneficial a few years ago when the  COVID-19 pandemic severely limited access to pharmacies due to lockdowns. During this time, patients had to find alternative ways to access their medications and the impact of the pandemic has been a significant reason behind the growth of telepharmacy, which is forecast to grow at an annual CAGR of 20.42% between 2024 and 2029.

 

However, as telepharmacy continues to grow and become an essential part of healthcare, it is also increasingly important to maintain regulatory compliance to ensure the highest standards of patient care are being delivered. This article will look at the regulatory framework surrounding telepharmacy and outline strategies for maintaining compliance.

 

Federal Regulation

The main regulatory bodies that oversee telepharmacy at a federal level are:

• HIPAA: The Health Insurance Portability and Accountability Act (HIPAA) sets out federal standards to safeguard patients’ medical records and other sensitive patient information through the Privacy Rule which applies to both face-to-face and remote healthcare services. The HIPAA Security Rule protects electronic communications between healthcare providers and patients and requires safeguards such as encryption to be placed on electronic personal health information, protecting from unauthorized access.

• • Ryan Haight Act: This 2008 Act prohibits the delivery, distribution, or dispensing of a controlled substance that is a prescription drug over the internet without a valid prescription. Since telepharmacy relies on the internet for dispensing controlled medications, healthcare providers must first carry out an in-person medical evaluation of the patient before prescribing medications to them online.

• DEA:  The Drug Enforcement Administration (DEA) regulates the manufacturing, distribution, and dispensing of controlled substances. Anyone involved in these activities must therefore register with the DEA. For telepharmacies, this means adhering to DEA guidelines on things like patient confidentiality and record-keeping when prescribing and dispensing medications online.

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State Regulation

Many states authorize the practice of telepharmacy under their general legislative authority and various state regulatory bodies, including:

• State boards: State boards require telepharmacies to be licensed and set practice standards that are focused on their needs. They may also introduce policies on issues like the use of technology, record-keeping, and patient interactions to ensure telepharmacies are meeting state and federal laws.

• The Model Act: The Model Pharmacy Act (Model Act), developed by the National Association of Boards of Pharmacy provides the framework for pharmacy services and sets out best practices for providing safe and effective telepharmacy services.

 

At the moment, telepharmacy is permitted in 28 states and regulation between states varies depending on the needs and healthcare goals of each state.

 

Maintaining Regulatory Compliance

Telepharmacy providers have to  adhere to state and federal regulations and non-compliance can result in fines, license revocation, and legal action. The following steps should taken to  minimize the risk of a regulatory violation:

• Use secure communication channels: Keep all personal health information on patients secure and confidential. This includes using end-to-end encryption on communication channels and authentication can enhance security and reduce the risk of data breaches.

• Sign business associate agreements (BAAs): Telepharmacies must also maintain patient confidentiality when dealing with third parties who handle sensitive patient information, such as IT vendors or billing companies. This can be achieved by outlining their responsibilities in a BAA and requiring third parties to agree to their terms by signing.

• Obtain informed consent: Patients need to be made aware of the limitations and risks involved with remote healthcare services. This requires telepharmacies to receive informed consent from each patient, ensuring they understand matters such as the potential risks of online consultations, and that they agree to an in-person telehealth visit.

• Be aware of prescribing laws: Telepharmacies must remain up-to-date on the laws regarding the prescribing of controlled substances online. At present, the rules allowing more flexible telemedicine practices will end on December 31, 2024, unless the DEA extends them. To maintain compliance, telepharmacies must stay updated and make any adjustments to their practices.

• Conduct risk assessments: Telepharmacies should conduct regular risk assessments to spot any vulnerabilities in their systems and practices. This should cover areas such as IT security, data protection and record-keeping to ensure patient information stays secure and regulatory compliance is met.

 

As telepharmacy continues to grow, the regulatory landscape surrounding these services will evolve, requiring healthcare providers to stay informed and compliant to uphold patient safety and security while maintaining the highest standards of healthcare.