Federal Pharmacy Council regulates telepharmacy in Brazil

On July 20, 2022, the Federal Council of Pharmacy (CFF) published CFF Resolution No. 727/2022 to regulate telepharmacy in Brazil. The resolution was issued in line with new regulations from the Federal Councils of Medicine, Nursing, and Veterinary Medicine (CFM, Cofen and CFMV, respectively).

Telepharmacy regards the delivery of remote pharmaceutical care via real-time (synchronous) or asynchronous telecommunication services (ICT). It offers another way of promoting, protecting and monitoring patients’ health, assisting with recovery, preventing diseases and other health problems, as well as managing pharmacotherapy problems and incentivizing the rational use of medicines and other health-related technology. Telepharmacy is also now expressly permitted for health education and research programs.

Already in effect, the resolution’s main features are outlined below:

Forms of telepharmacy

According to CFF Resolution No. 727/2022, the following activities fall within the scope of remote pharmaceutical activities:

• Teleconsultation: remote pharmaceutical care provided in real-time via technology that allows pharmacists and patients (or their legal guardians or companions) to interact with each other. The patient (or their legal guardian) must consent to the teleconsultation, which the pharmacist is responsible for.

Pharmaceutical teleconsultation is mainly directed toward promoting and protecting patients’ health and assisting in health recovery, especially in regard to pharmacotherapeutic problems and the rational use of medicine. It is important to note that asynchronous interactions via text, audio, or video messages do not constitute teleconsultation. However, they can be used as complementary tools in the care process.

• Teleinterconsultation: remote interactions between pharmacists or interactions between pharmacists and other health professionals, regardless of whether the patient is present. Teleinterconsultation covers exchanges of information and opinions, evaluations of clinical cases, and decisions on the best course of action to optimize health results, prevent diseases and other clinical conditions, promoting the patient’s health.
• Telemonitoring/telesurveillance: remotely monitoring health or disease indicators in line with pharmacists’ recommendations, coordination, guidance and supervision. This involves clinical evaluations or acquisitions of images, signals and data from medical equipment and aggregate or implantable devices, including the collection, transmission, processing, and handling of clinical data when the patient is not physically present. Telemonitoring must only be conducted at the recommendation and justification of the responsible pharmacist, and the security and confidentiality of the information must be guaranteed at all stages.
• Teleconsulting: remote consultations between pharmacists and other professionals via telecommunications to issue technical and administrative opinions and healthcare recommendations. Teleconsulting does cover evaluations of specific clinical cases.

Requirements for telepharmacy services

CFF Resolution No. 727/2022 establishes the following requirements for companies that provide clinical or telepharmacy service platforms, telepharmacy software, or conduct services via telepharmacy:

• Foreign companies must have an official representative based in Brazil;
• Companies must register with Brazil’s Regional Council of Pharmacy (CRF) in the state where the company is headquartered and indicate a pharmacist to serve as a technical manager; and
• Meet the CFF’s registration criteria (which are still to be formally defined).

In addition, pharmaceutical professionals must inform the relevant branch of the CRF of the types of telepharmacy services they provide when applying for the Certificate of Regularity (CR) or the Certificate of Professional Activity for Pharmacists (AAPF).

Remote consultations must be recorded in the patient’s physical or digital medical records. They must also comply with representation, terminology and interoperability standards and the requirements of the Brazilian Public Key Infrastructure’s (ICP-Brazil) Security Assurance Level 2 (NGS2) or other legally accepted standards. Moreover, any records of appointments and digital documents the pharmacist issues must be signed using their digital certificate in the ICP-Brazil chain.

Importantly, pharmacists cannot assume remote technical responsibility for pharmacies, clinical laboratories, industries, establishments, public bodies, or sectors of any nature. This was also addressed in the Brazilian Senate via the Social Affairs Commission’s Amendments No. 2 and No. 3, which were then included in Bill No. 1,998/2020 to authorize telehealth practices in Brazil. In other words, procedures such as dispensing medications continue to require the physical presence of pharmaceutical professionals in the establishment.

Treatment of personal health data

The CFF’s new resolution is aligned with Brazil’s General Data Protection Law (LGPD), as it recognizes the sensitivity of personal health data. It also provides that actions conducted via technology must be recorded to ensure the information is traceable and can be processed and stored securely.

Finally, CFF Resolution No. 727/2022 establishes the responsibility of pharmacists and health establishments throughout Brazil concerning safeguarding records. If archiving services are outsourced, pharmacists must ensure personal data protection measures are addressed in the contract or terms of service.

For further information about digital health, please contact Mattos Filho’s Life Sciences & Healthcare practice area.