17 May Patient information sheet and telemedicine
As the first auditor in Spain in private medical electronic private medical prescription, one of the doubts that my clients, generally IT development companies of this type of solutions, poses to me is how to properly prepare the information sheet for the patient, in order to obtain approval of the Collegiate Medical Organization regarding private electronic medical prescription solutions as published here and following RD1718 / 2010
Compulsory compliance with RD 1718/2010
The establishment of the SREP has its origin in compliance with article 14.4. RD 1718/2010 of December 17, on medical prescription and dispensing orders, that is why it is essential that the company that opts for this approval read and understand in depth, as well as enforce its electronic private prescription software with the requirements detailed here.
IMPORTANT NOTE: This report does not replace the content that the company that opts for approval must comply with, always following Royal Decree 1718/2010, of December 17, on medical prescription and dispensing orders: https://www.boe.es /buscar/act.php?id=BOE-A-2011-1013 and the documents published at https://www.cgcom.es/receta_medica_privada
Brief summary of the Patient Information Sheet.
Regardless of the mandatory compliance with the previous section, I will now highlight the characteristics that the patient information sheet, also called HIP, must have.
The HIP will collect the necessary treatment information to facilitate the proper use of prescribed medications or medical devices.
Requirement 1. Mandatory.
1. Of obligatory delivery to the same, in which the information of the necessary treatment will be collected to facilitate the adequate use of the prescribed medicines or health products.
Requirement 2. Patient data
1. The name, two surnames, and date of birth.
2. DNI or NIE number of the patient. In the event that the patient does not have such documentation, in the case of minors, the DNI or NIE of one of their parents or, where appropriate, the legal representative, and for foreign citizens, the passport number.
Requirement 3. Medication data
1. Name of the active ingredient / s.
2. Name of the medicine if it is a biological medicine or the prescribing health professional considers it necessary from a medical point of view, always in accordance with the provisions of Law 29/2006, of July 26, on guarantees and rational use of medicines and health products. In this case, the use of the trade name will be briefly justified in the recipe.
3. Dosage and pharmaceutical form and, where appropriate, the mention of the recipients: infants, children, adults.
4. Route or form of administration, if necessary.
5. Format: number of units per container or its content by weight or volume.
6. Number of containers or number of specific units of the medicine to be dispensed.
7. Dosage: number of administration units per dose, frequency of doses (per day, week, month) and total duration of treatment.
8. Optional data but other prescription software does include: Diagnosis, Patient Instructions, Pharmacist Instructions.
NOTE: The data referred to in sections 5. AND 6. They will only be required to be consigned in medical prescriptions issued on paper. In medical prescriptions issued in electronic support, they will only be completed by the prescriber when the electronic system does not generate them automatically.
Requirement 4. Prescriber data
1. The name and two last names.
2. Direct contact information (email and telephone or fax, these with the international prefix).
3. Professional address, including the population and the name of Spain. The reference to establishments, institutions or public bodies may only appear in their official medical prescriptions.
4. Professional qualification.
5. Registration number or, in the case of medical prescriptions from the National Health System, the identification code assigned by the competent Administrations and, where appropriate, the officially accredited specialty that they exercise. In the medical prescriptions of the Military Health Network of the Armed Forces, instead of the collegiate number, the number of the Military Identity Card of the doctor may be consigned. Likewise, it will be stated, where appropriate, the officially accredited specialty that he exercises.
6. The signature will be personally stamped once the mandatory consignment data and the prescription object of the recipe have been completed, in the case of paper. Electronic prescriptions will require an electronic signature, which must be produced in accordance with the criteria established by Law 11/2007, of June 22, on electronic access by citizens to public services.
Requirement 5. Other data
1. The prescription date (day, month, year): date of the day on which the prescription is filled. A clause will be included that informs the patient in the terms established in Organic Law 15/1999, of December 13, on the protection of personal data.
2. The information sheet for the patient will be differentiated from the prescription and may be separable from it, or constitute an independent form, where the prescriber will be able to list all the prescribed medicines and medical devices, providing the patient with information on the complete treatment and the diagnosis, if applicable, in the opinion of the prescriber.
3. All the data and instructions contained in the medical prescription must be clearly legible, without prejudice to their possible additional encoding with optical characters. The medical prescriptions will not present amendments or deletions in the mandatory consignment data, unless they have been saved by a new signature of the prescriber.
4. Approximate dimensions: DIN A-4 size.
5. “Prescription code”: Space reserved for the data assigned by the electronic system, with a unique and unrepeatable character, for the identification of the prescription of each medicine or medical device.
6. Datamatrix according to the WTO document – CGCOM.
7. Code of each recipe and in each recipe the prescription code.
8. Datamatrix and readable code.
9. PDF format, recommended with password (PIN) and signed by the doctor electronically.
Conclusion on electronic private medical prescription
Electronic private medical prescription is key to prescribing confidential, secure and integrates between private doctor and patient, from my point of view one of the pillars of telemedicine. Fortunately we have an approval that certifies that such software meets requirements that primarily protect the patient. Let’s demand this homologation in the computer solutions that we use in private clinics.
Luis Vilanova Blanco. Spain’s first auditor in electronic private medical prescription.
606954593
recetamedica@luisvilanova.es