I. RATIONALE
Last 17 March 2020, the Food and Drug Administration issued FDA Circular No. 2020-007 entitled “Guidelines on the Implementation of the Use of Electronic Means of Prescription for Drugs for the Benefit of Individuals Vulnerable to COVID-19.”
Said Guidelines were issued to allow dispensation of drugs to Senior Citizens, Persons with Disability (PWD), and patients with chronic illness or those with immuno-compromised conditions who need to take prescription medicines and maintenance drugs with based in an electronic prescription issued by a licensed physician.
Through amendments, the effectivity of said Circular was extended until 31 December 2020 regardless of the level of the imposed quarantine restrictions due to COVID-19.
Considering that the COVID-19 Pandemic continues to threaten the health and safety of vulnerable individuals, it is imperative that the Guidelines implementing the use of electronic prescriptions be maintained to ensure continuous access of said individuals to prescription medicines and maintenance drugs.
Hence, the Guidelines on the Implementation of the Use of Electronic Means of Prescription for Drugs for the Benefit of Individuals Vulnerable to COVID-19 is hereby reissued.
II. OBJECTIVES
This Circular aims to achieve the following:
- Ensure access to prescription medicines and maintenance drugs for all individuals vulnerable to COVID-19 through the use of electronic means or electronic prescription;
- Ensure efficient and effective process for electronic prescription of drugs; and
- Provide guidelines on how to dispense prescription drugs based on the electronic prescription issued by licensed physician.
III. SCOPE AND COVERAGE
This Circular shall apply to all individuals vulnerable to COVID-19 as defined under this Circular and to all licensed physicians authorized to prescribe drugs to the aforementioned individuals. The same Circular shall cover all Drugstore/Pharmacy/Botica and similar outlets, but shall not include prescription that requires PDEA S-2 license.
IV. DEFINITION OF TERMS AND ACRONYMS
- Dispensingrefers to the sum of processes performed by a pharmacist from reading, validating, and interpreting prescriptions; preparing; packaging; labeling; record keeping; dose calculations; and counseling or giving information, in relation to the sale or transfer of pharmaceutical products, with or without a prescription or medication order;
- Drugsis defined as:
a. articles recognized in official pharmacopeias and formularies, including official homeopathic pharmacopeias, or any documentary supplement to any of them, which are recognized and adopted by the FDA
b. articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals
c. articles (other than food) intended to affect the structure of any function of the body of humans or animals
d. articles intended for use as a component of any articles specified in clauses (1), (2), or (3) but do not include devices or their components, parts or accessories.
- Individuals Vulnerable to Covid-19 refers to all individuals, regardless of age and nationality, who are either Senior Citizens, Persons with Disability (PWD), with chronic illness or those with immuno-compromised conditions who need to take prescription medicines and maintenance drugs;
- Licensed Physician refers to all individuals licensed or authorized to practice medicine as defined by Republic Act No. 2382 or the Medical Act of 1959, as amended;
- Electronic Prescription refers to the optical electronic data (captured image in pdf, jpeg or other photo file format) issued by or made by a licensed physician which is generated, sent, received or stored through email and messaging applications (i.e. WhatsApp, Viber, Line, and Messenger among others). The said electronic document shall contain the medical prescription needed by the individuals vulnerable to COVID-19 and the electronic signature of the licensed physician;
- Pharmacistrefers to a health professional who has been registered and issued a valid Certificate of Registration (COR) and Professional Identification Card (PIC) by the PRC and the Professional Regulatory Board of Pharmacy;
- Drugstore/Pharmacy/Botica and similar outlets including hospital pharmacy and institutional pharmacy shall refer to drug establishment were registered drug, chemical products, dental, medicinal and household remedies are dispensed directly to the general public on a retail basis.
V. GUIDELINES
A. Issuance of Electronic Prescription by Licensed Physician
- All licensed physicians shall be authorized to issue electronic prescriptions pursuant to this Order by issuing it via email or any other alternative modes considered electronic document acceptable under the Electronic Commerce Act of 2000.
- The electronic prescription shall be deemed equivalent to a written prescription required under FDA Circular No. 2014-025.
- All licensed physician shall issue a separate electronic prescription for all Anti-biotic, Anti-infectives, and or Anti-viral preparations.
- All electronic prescriptions shall contain the name of the individual to whom the medicines or drugs are prescribed, the name of the medicines and/or drugs prescribed, the dosage and all other pertinent matters similarly contained in a written prescription.
- All electronic prescriptions shall contain a digital signature, name, license number, Professional Tax Receipt (PTR) [if applicable] of the licensed physician.
- All licensed physicians who made us of the electronic prescription shall keep records of all electronic prescriptions he/she issued pursuant to this Order.
B. Dispense of Medicines pursuant to an Electronic Prescription
- All Drugstore/Pharmacy/Botica and similar outlets shall recognize the validity and effectivity of the electronic prescription issued by the licensed physician. Prescription containing Anti-biotic, Anti-infectives, and or Anti-viral preparations shall only be valid for one (1) week after its issuance.
- All Drugstore/Pharmacy/Botica and similar outlets shall strictly dispense drugs as prescribed by the electronic prescription and the latter shall be deemed equivalent to a written prescription for all intents and purposes.
- All Drugstore/Pharmacy/Botica and similar outlets shall not require the actual presence of the individual vulnerable to COVID-19 before dispensing the needed drugs. A duly authorized representative may purchase the said drugs on behalf of the latter.
In the event that the patient is a Senior Citizen (SC) and/or Persons with Disability (PWD), the following should be presented together with the electronic prescription prior to the dispensing of the needed drugs:
- A letter of authorization duly signed by the concerned individual; and
- Identification card of the SC and/or PWD
VI. REPEALING CLAUSE
In the event that any provision or part of this Circular is declared unauthorized or rendered invalid by any court of law, those provisions not affected by such declaration shall remain valid and effective.
VII. EFFECTIVITY
This Circular shall take effect immediately and shall be valid until 12 September 2021, regardless of the level of the imposed quarantine restrictions due to COVID-19.
Attachment:-> FDA Circular No.2020-037