P.R. Laws tit. 20, § 410a

2019-02-20 00:00:00+00
§ 410a. Dispensation of prescription medications

(a) All prescription medications shall only be dispensed by a pharmacist in a registered pharmacy authorized by the Secretary to operate as such and pursuant to the provisions of § 407(i) of this title. The pharmacist shall exercise his/her professional judgment as to the accuracy, validity and authenticity of the prescription he/she receives in a manner consistent with the applicable laws and regulations. The pharmacist technician, pharmacist intern or pharmacist technician intern may intervene in the dispensation of drugs under the direct supervision of the pharmacist as provided by this chapter. In the case of prescription medications to be used in animals, these may also be dispensed pursuant to that which is established in §§ 2951—2969 of this title.

(b) Patients shall have the right to freely and voluntarily select the pharmacy by which each prescription is to be dispensed on a case by case basis. Provided, That no physician, medical group, dentist, odontologist, or podiatrist may sell or participate in any profitable business transaction when providing medication samples to any patient.

(c) The original prescription shall be the written order issued and signed by hand or electronically generated and transmitted by the prescribing professional and shall include the following information, in addition to any other information required under other provisions of this chapter and other applicable laws and regulations:

(1) Date of [issuance].

(2) Full name and address of the patient.

(3) Patient’s age.

(4) Full name, address, telephone number, license number, and signature of the prescribing professional; Provided, That the electronic signature of the prescribing professional shall be deemed to be authenticated when the prescription is electronically generated and transmitted, as provided in this chapter.

(5) Name of the medication prescribed with its form, dosage, potency, and amount.

(6) Use indications for the patient.

The pharmacist may complete any information not appearing on the prescription by recording the same on the back of the prescription, in the case of an order signed by hand, or recording the same in the device that receives and stores electronically transmitted prescriptions when the prescription has been electronically generated and transmitted, after having verified the same with the prescribing professional or the patient, as the case may be. The electronic device that receives and stores prescriptions shall have capacity to keep, print, and, upon request, provide any information as provided in this chapter.

(d) The labeling of all medications dispensed by prescription shall contain, among other things, the following data: name of the pharmacy with its address and phone number; serial number assigned to the prescription; date of dispensation; name, potency, and indications for use of the medication; name and surname of the patient and the prescribing professional; and expiration date and lot number of the medication. In the event that the pharmacist interchanges the prescribed medication, pursuant to § 410b of this title, the labeling of the dispensed product shall include the names of both medications together with the phrase “bioequivalent to” or a similar language indicating that the prescribed medication was interchanged, except when the prescribing professional indicates otherwise in writing.

(e) To expedite the prescription dispersing process, the contents thereof may be transmitted verbally, or by fax, electronic image or e-mail, by the patient him/herself or his/her representative or by the prescribing professional to the pharmacy freely selected by the patient or his/her representative, thus guaranteeing the patient’s right to freely select his/her pharmaceutical services provider. The pharmacist shall transcribe the prescription transmitted orally upon receipt. Both the prescription transmitted verbally and the prescription transmitted by fax, electronic image or e-mail, shall include all the data required under subsection (c) of this section, and a record of the date and time such transmission was made. In these cases, the patient or his/her representative shall hand over the original prescription to the pharmacist when receiving the prescribed medication. This shall not apply when the prescription has been electronically generated and transmitted pursuant to this chapter.

(f) The pharmacist may refill a prescription upon previous authorization of the prescribing professional, recorded in the original or subsequently received prescription, whether verbally or by fax, electronic image or e-mail, if the same is accessible in its original form, whether issued and signed by hand or electronically generated and transmitted or in the patient’s pharmacy record. The pharmacist shall record the refill on the back of the original prescription or in the patient’s pharmacy record.

(g) When handling emergency cases, to be defined as provided by the Secretary by regulation, the contents of a prescription may be transmitted verbally or by fax, electronic image or e-mail directly by the prescribing professional to the pharmacy selected by the patient. The pharmacist shall transcribe the prescription transmitted verbally upon receipt. Both the prescription transmitted orally and the prescription transmitted by fax, electronic image or e-mail shall include the data required under subsection (c) of this section. The pharmacist shall record the date and time the transmission was made and shall dispense a limited amount of the medication which shall not exceed the amount needed for a period of one hundred twenty (120) hours. The prescribing professional who transmitted the contents of the prescription verbally or by fax, electronic image or e-mail shall deliver the prescription to the pharmacy that filled the prescription not later than one hundred twenty (120) hours from the time the same was issued, except when the prescription has been electronically generated and transmitted pursuant to this chapter. Provided, That in the case of prescriptions for controlled substances, the term provided for such cases under §§ 2101 et seq. of Title 24, shall apply.

(h) Any electronic equipment used to receive prescriptions or prescription refill orders as allowed under subsections (e), (f), and (g) of this section shall be kept in a suitable location inside the pharmacy counter in order to prevent the same from being accessed by unauthorized persons and to guarantee the right to privacy of patients.

(i) No prescription shall be filled after six (6) months have elapsed from its date of issue. This shall likewise apply to prescription refills, with the exception of those prescriptions issued by physicians authorize[d] to practice in any state of the United States of America which may be refilled only in Puerto Rico within the term of three (3) months, counting from the date the prescription was originally filled. This shall not be applicable to the dispensing of prescription oxygen for ambulatory use which may be dispensed within a term of one (1) year as of the issue of the prescription.

(j) When filling a prescription or verifying the filling of a prescription when a pharmacy technician, a pharmacist intern or a pharmacy technician intern has intervened in the prescription process filling, the pharmacist must sign the prescription on the front at the bottom right. Provided, That in cases where the prescription has been electronically generated and transmitted, the device that receives and processes the same shall authenticate the identity of the pharmacist assuming responsibility for such dispensation.

(k) Pharmacists may interchange a prescribed drug by a bioequivalent medication following the criteria and procedures established in this chapter and the regulations adopted thereunder.

(l) The filling of a prescription shall include the delivering and the person-to-person confidential orientation by the pharmacist to the patient or his/her authorized representative.

(m) The prescription shall be filed in a secure place at the pharmacy counter for a minimum term of two (2) years from the dispensation date. The prescription and any notes made thereon as required by this chapter or other applicable laws, as well as the patient’s pharmacy record, may be kept on electronic files. In the case of controlled substance prescriptions, the provisions of §§ 2101 et seq. of Title 24, known as the “Puerto Rico Controlled Substances Act”, shall apply.

(n) All prescriptions, as well as patient pharmacy records and the information contained in any of these, shall be considered to be confidential information. This information is privileged and may only be disclosed, regardless if in writing or kept by electronic means: (1) to the patient or another person authorized by the latter; (2) to other health care providers of the patient, when according to the professional judgment of the pharmacist, the disclosure of such information is necessary to protect the health and welfare of the patient; and (3) when so required by government agencies or officials authorized by law to receive such confidential information in the exercise of their investigative, adjudicative or overseeing powers or by court order. In order to guarantee the patient’s right to the privacy of his/her protected health information, the pharmacy shall comply with all applicable provisions of the Health Insurance Portability and Accountability Act of 1996, better known as HIPAA.

(o) The Secretary shall provide by regulation the norms, requirements, and procedures necessary to implement the provisions of this section.

History —Sept. 3, 2004, No. 247, § 5.02; Feb. 26, 2008, No. 20, § 2; Apr. 29, 2008, No. 50, § 3; Oct. 28, 2008, No. 286, § 1; Nov. 16, 2009, No. 138, § 2; June 5, 2011, No. 85, § 1.