By means of Decree 98/2023, the President regulated Law No. 27,553, which purpose is to rule the prescription and dispensing of medicines, especially of electronic and digital prescriptions, as well as the use of tele-healthcare platforms.
To this end, both prescriptions were defined as follows:
1. Digital prescription: Es el documento digital de carácter sanitario, confeccionado y firmado por un profesional de la salud, mediante firma digital y sello de competencia digital conforme la normativa que los regula, mediante el que se prescribe a un paciente, medicamentos o se indica cualquier otra prescripción, a través de una plataforma digital que permita dicha prescripción.
2. Electronic Prescription: is the digital document of a sanitary nature, prepared and signed by a healthcare professional, by means of electronic signature, through which medicines or any other prescription is prescribed to a patient, through an allowed platform.
These type of prescriptions will be valid, as long as they adopt and comply with the following requirements:
1. Identification: Each prescription, digital or electronic, must include a unique and unrepeatable identifier, which must include the patient’s information, the healthcare professional’s signature, and its authorship, as well as the medicine or prescription itself.
The prescriptions are just for a single dispense or use, in accordance with the Law No. 25,649 provisions on “Promotion of the use of medicines by their generic name“, and other applicable regulations.
2. Contents: The prescription’s content, whether electronic or digital, shall be included in the section intended for such purpose, to promote the accessibility, equity and quality of healthcare and in accordance with the structure determined by the Enforcement Authority (i.e., the National Ministry of Health).
3. Validity: The effective date shall be included, which may be the same or subsequent to the date the prescription was issued.
When medicines are prescribed, the prescription shall be valid just for thirty (30) days, whereas, when other types of prescriptions are made, the term shall extend to sixty (60) days, unless otherwise provided by law.
4. Integrity and Inalterability: Whatever the support of the prescription is, it shall be integral and unalterable. Controlled modifications, linked to the processes necessary for the annotations and/or headings of patients or of the intervening health team, dispensing and/or consumption, may be incorporated.
5. Security and confidentiality: The electronic or digital document must comply with the security, availability, inviolability and protection of personal data standards.
6. Interoperability: is the ability of systems to exchange, use, and apply information. To this end, the digital or electronic prescription will use syntactic and semantic standards that allow the exchange and use of information for health, statistical, control and epidemiological purposes, in accordance with the requirements established by the Enforcement Authority, according to the in-force regulations.
It also incorporates other institutes, such as “Teleassistance“, which is understood as the distance health services provision, through the use of information and communication technologies, in a synchronous or asynchronous manner, by health teams within the national territory, for promotion, prevention, diagnosis, treatment and rehabilitation.
On the other hand, it establishes that the platforms through which electronic or digital prescriptions are prescribed, validated and/or dispensed, or manage telecare, should:
1. Be responsible for data processing, which must be handled with confidentiality and security in accordance with the regulations.
2. Provide mechanisms to safeguard the credentials and accesses of the actors involved, to guarantee the security, privacy, purpose, opportunity, veracity and inviolability of the data.
3. To host the platform servers in a safe place.
4. Comply with the provisions of Law No. 25,326 on Personal Data Protection.
Additionally, those who own these platforms shall be subject to the limitations and/or prohibitions set forth in the rules of medicine and pharmaceutical practices, as well as to the requirements in force regarding the advertising of stored health data services.
In the case of the use of artificial intelligence, the restrictions and limitations imposed on them must be observed, i.e., it can only be used to provide support to professional decision-making, always requiring the supervision of health professionals or medical collaborators.
The Decree also created the “Federal Health License”, which will include all health professionals’ licenses registered in the Health Professionals’ Federal Network of Registries. This license will determine a Unique Health Professional Identification Key, which will allow health professionals to be univocally identified, as well as to access interoperable systems for the implementation of Information and Communication Technologies (TIC for Spanish Acronym) in the Argentine Health System.
To this end, it designated the National Ministry of Health as the enforcement authority, which will have the obligation to promote the use of these types of prescriptions to strengthen the healthcare’s access, equity and quality, always viewing and protecting the security, privacy and inviolability of data.
On the other hand, the Decree introduces four types of products. The first one, the “Legally restricted products”, which involves those containing narcotic or psychotropic substances that must be prescribed, either in handwritten, electronic, or digital form, in officialized forms and according to the model approved by the Ministry of Health, through the ANMAT.
The second, the “Prescription products on file”, being those that the Ministry of Health through the ANMAT, considers that they should be dispensed to the public with such requirements.
Handwritten prescriptions shall be transcribed in the prescription book, numbered, sealed and signed by the Technical Director of the pharmacy and filed in an orderly manner; and, electronic or digital prescriptions shall be recorded in the digital register or file enabled for such purpose, once they have been dispensed and signed electronically or digitally by the pharmacist who dispensed them, according to the form and procedure established by the Ministry of Health.
The same procedure shall be followed by the Technical Director and/or auxiliary pharmacist with the master formulas dispensed, provided that their composition is integrated by the substances established under the condition of sale and, shall add to the container -as provided by the Ministry of Health for products manufactured in industrial pharmaceutical establishments- the legend “This medicine must be used exclusively under medical prescription and supervision and cannot be repeated without a new prescription“. Those that do not comply with this requirement will be confiscated and those responsible for their manufacture will be liable to the penalties established by law.
As for the third one, the “prescription-only” products, are those that the Ministry of Health, through ANMAT, considers that they should be dispensed to the public with such requirements.
The Technical Directors and/or auxiliary pharmacists are obliged to sign, seal and number the prescriptions, or in the case of electronic or digital prescriptions sign them electronically or digitally, when they contain magistral and official formulas, being responsible for their correct preparation.
The specialties authorized by the Health Ministry as “prescription-only”, in the case of handwritten prescriptions, may be dispensed repeatedly with the same prescription, the number of times the physician has indicated, and the pharmacist must stamp, number and sign it each time.
Finally, with respect to the fourth product, the “free sale” or over the counter products, these are those that the Ministry of Health, through ANMAT, has authorized with such characteristics. When the size or content of the container is omitted in the prescription, the pharmacist must dispense the one with the smallest content.
In the event that a medicinal specialty is circulating in various doses, and this is not indicated in the prescription, the pharmacist is obliged to dispense the lowest dose, unless, after personal consultation with the prescribing physician, he/she indicates different doses. In this case, the pharmacist shall proceed before dispensing it, to leave, with his or her signature, the appropriate record in the prescription”.
On the other hand, it provides that the current implementations of electronic and digital prescriptions will continue to be in force as long as they comply with the requirements presented by the new regulations. This regulation does not alter the validity of prescriptions with handwritten signature. It also stipulates that, in the course of the implementation, and until the new technologies are operating, all applicable legal requirements will remain in force, maintaining the current modality of accessibility for patients to prescriptions and dispensing.
