rx requirements [type] // random Flashcards
Required Rx Fields (written)
Each pharmacy must document the following information:
● The name of the patient for whom or the owner of the animal and the species of the animal for which the drug is dispensed;
● The full name and, in the case of controlled substances, the address and the Drug Enforcement Administration registration number of the practitioner or other number as authorized;
● The name, strength, dosage forms of the substance, quantity prescribed and, if different from the quantity prescribed, the quantity dispensed;
● The directions for use, if given by the practitioner; and
● The date of filling, and the total number of refills authorized by the prescribing practitioner.
When a prescription is transmitted orally, both the receiving pharmacists’ name or initials and the name of the person transmitting must be noted on the prescription
The practitioner may specify that there may be no substitution for the specified brand name drug in a prescription
What can RPh Correct/Change/Add to Prescription (Legend/Controlled)?
Not specified –> Federal
What can non-RPh Pharmacy Staff Correct/Change/Add to a Prescription (Legend/Controlled)?
Not specified –> Federal
What Type of Substitutions Are Allowed? (Generic, Orange Book Equivalence, Therapeutic Substitution, Etc.)
Brand/Generic/Cost savings :
A pharmacist may substitute as follows(689.515):
● A drug product with the same generic name in the same strength, quantity, dose and dosage form as the prescribed drug which is, in the pharmacist’s professional opinion, therapeutically equivalent.
● When the prescriber is not reasonably available for consultation and the prescribed drug does not utilize a unique delivery system technology, an oral tablet, capsule or liquid form of the prescribed drug so long as the form dispensed or administered has the same strength, dose and dose schedule and is therapeutically equivalent to the drug prescribed.
● A practitioner may specify in writing, by a telephonic communication or by electronic transmission that there may be no substitution for the specified brand name drug in a prescription.
● A pharmacy shall post a sign in a location easily seen by patrons at the counter where prescriptions are dispensed or administered stating that, “This pharmacy may be able to substitute a less expensive drug which is therapeutically equivalent to the one prescribed by your doctor unless you do not approve.” The printing on the sign must be in block letters not less than one inch in height. If the pharmacist has reasonable cause to believe that the purchaser cannot read the sign or comprehend its content, the pharmacist shall endeavor to explain the meaning of the sign.
● A pharmacist may substitute a drug product under this section only when there will be a savings in or no increase in cost to the purchaser.
● If the practitioner prescribes a drug by its generic name, the pharmacist shall, consistent with reasonable professional judgment, dispense or administer the lowest retail cost, effective brand which is in stock.
● When a pharmacist dispenses a substituted drug as authorized, the pharmacist shall label the prescription container with the name of the dispensed drug. If the dispensed drug does not have a brand name, the pharmacist shall label the prescription container with the generic name of the drug dispensed along with the name of the drug manufacturer.
● A prescription dispensed by a pharmacist must bear upon the label the name of the medication in the container or shall be labeled as intended by the prescriber.
● The substitution of any drug by a pharmacist or the pharmacist’s employer pursuant to this section does not constitute the practice of medicine.
● A substitution of drugs made by a pharmacist or the pharmacist’s employer in accordance with this section and any rules that the State Board of Pharmacy may adopt thereunder does not constitute evidence of negligence if the substitution was made within reasonable and prudent practice of pharmacy or if the substituted drug was accepted in a generally recognized formulary or government list.
● Failure of a practitioner to specify that no substitution is authorized does not constitute evidence of negligence unless the practitioner knows that the health condition of the patient for whom the practitioner is prescribing
What Type of Substitutions Are Allowed? (Generic, Orange Book Equivalence, Therapeutic Substitution, Etc.) [Biosimilars]
A pharmacy or pharmacist filling a prescription or order for a biological product may not substitute a biosimilar product for the prescribed biological product unless:
● The biosimilar product has been determined by the United States Food and Drug Administration to be interchangeable with the prescribed biological product;
● The prescribing practitioner has not designated on the prescription that substitution is prohibited;
● The patient for whom the biological product is prescribed is informed of the substitution prior to dispensing the biosimilar product;
● The pharmacy or pharmacist provides written, electronic or telephonic notification of the substitution to the prescribing practitioner or the prescribing practitioner’s staff within three (3) business days of dispensing the biosimilar product; and
● The pharmacy or pharmacist retains a record of the substitution for a period of not less than three (3) years.
Special Restrictions on Refills?
Where refill authority is given other than by the original prescription, documentation that such refill authorization was given, the date of authorization, and name of the authorizing prescriber or the prescriber’s agent must be recorded.
Refills may be combined into single filling if the prescription is not a controlled substance or psychotherapeutic drug, where the prescriber is notified of the change.
Special Restrictions on Emergency Refills?
A pharmacist may dispense a 72-hour supply of the drug in emergency situations, provided it is not a controlled substance. The practitioner should be promptly notified. [check accuracy]
Special Restrictions on Auto-refill program?
A mail order or retail pharmacy, excluding cycle-fill for long term care, may use a program that automatically refills non-controlled prescription medications, that have existing refills available and are consistent with the patient’s current medication therapy only when the following conditions are met:
● A patient or patient’s agent must enroll each prescription medication in an auto-refill program before a pharmacy can include the prescription medication as part of the auto-refill program; and
● The prescription is not a controlled substance; and
● The pharmacy must discontinue auto-refill program enrollment when requested by the patient or patient’s agent; and
● Pick-up notification to a patient or patient’s agent may be generated upon completion of a prescription refill; and
● When an auto-refill prescription is returned to stock or when delivery is refused, that prescription medication is removed from the auto-refill program for that patient.
Special Requirements for Prescription Pads?
[Tamper-resistant Prescription]
● Where used in this chapter, Tamper-resistant Prescription means a form for the purpose of issuing a handwritten or typed prescription, intended to be manually delivered to a pharmacy, which has been developed, produced and formatted to ensure security, integrity and authenticity using currently accepted technologies.
● Formatted features may include but are not limited to characteristics such as:
o The word “void” appears when photocopies are attempted;
o Background ink which reveals attempted alterations;
o Heat sensitive ink that changes colors;
o Penetrating ink to prevent chemical alterations;
o A watermark which cannot be photocopied;
o Coin reactive ink that reveals word when rubbed with a coin;
o Sequential numbering Fax Prescriptions
Requirements for Type of Fax Machine?
Not specified
Can Patients Fax Their Prescription? Prescribers from Outside Their Practice?
No, patients may not fax their prescription. Upon receipt of a facsimile prescription, the pharmacist must be confident that the prescription was sent by an authorized practitioner or practitioner’s agent
What Controlled Schedules are Allowed?
[FAXED RXs]
CIII-V (475.185)
If the facsimile prescription is for a controlled substance, the prescription contains an original, manually-signed signature of the prescriber. In this rule, manually-signed specifically excludes a signature stamp or any form of digital signature unless permitted under federal regulations.
Requirements for Electronic Prescribing? Requirements for Certification/Technology?
Electronically Transmitted Prescription:
Where used in this chapter, Electronically Transmitted Prescription (ETP) means a prescription for a drug or medical device issued by a practitioner, who is licensed and authorized to prescribe pursuant to the laws of this state and is acting within the scope of his or her practice, which has been transmitted by an electronic means that may include but is not limited to:
● Transmission by facsimile or hand held digital electronic device to a computer or facsimile;
● Transmission from a computer to another computer;
● Transmission by facsimile to computer; or
● Transmission from a computer to facsimile.
ETP does not include an oral prescription that has been reduced to writing by a pharmacist pursuant to OAR 855-041-0085 and does not include prescriptions, or drug or device orders written for inpatient use in a hospital.
*For an ETP to be valid, it must contain the name and immediate contact information of the prescriber, and be electronically encrypted or in some manner protected by up-to-date technology from unauthorized access, alteration or use
Required Fields on Electronic Prescriptions?
Each pharmacy must document the following information:
● The name of the patient for whom or the owner of the animal and the species of the animal for which the drug is dispensed
● Full name, address, and DEA # of the practitioner (address and DEA # required if controlled substance)
● Name, strength, dosage forms of substance, quantity prescribed, and if different from the quantity prescribed, the quantity dispensed
● Directions for use, if given by the practitioner
● Date of filling
● Total number of refills authorized by prescribing practitioner
● A practitioner may specify that there may be no substitution for the specified brand name drug in a prescription by way of text saying “brand medically necessary” or words with similar meaning.
What Control Schedules Are Allowed? [Electronic]
CII-V (475.185)
Key points: CII
(1)
(a) Except when dispensed directly by a practitioner to an ultimate user, a controlled substance in Schedule II may not be dispensed without a written or electronically transmitted prescription of a practitioner.
(b) In emergency situations, as defined by rule of the State Board of Pharmacy, Schedule II drugs may be dispensed with an oral prescription of a practitioner, reduced promptly to writing and filed by the pharmacy. Such prescriptions shall be retained in conformity with the requirements of ORS 475.165.
(c) A prescription for a Schedule II substance may not be refilled.
Key points: CIII-CIV
(2) Except when dispensed directly by a practitioner to an ultimate user, a controlled substance included in Schedule III or IV may not be dispensed without a written, oral or electronically transmitted prescription of a practitioner. The prescription may not be filled or refilled more than six months after the date on which it was issued and a prescription authorized to be refilled may not be refilled more than five times. Additional quantities of the controlled substances listed in Schedule III or IV may be authorized by a practitioner only through issuance of a new prescription.
Key points: CV
Except when dispensed directly by a practitioner to an ultimate user, a controlled substance included in Schedule V that is a prescription drug may not be dispensed without a written, oral or electronically transmitted prescription of a practitioner. The prescription may not be filled or refilled more than six months after the date on which it was issued and a prescription authorized to be refilled may not be refilled more than five times. Additional quantities of the controlled substances listed in Schedule V may be authorized by a practitioner only through issuance of a new prescription.
Can RPh Make Changes to Electronic Prescriptions?
Yes; Notes of clarifications of and changes to the prescription are directly associated with the electronic form of the prescriptions
Can Electronic Prescriptions Be Transmitted Across State Lines?
A prescription written by a practitioner licensed in a state or territory of the United States, other than Oregon, may be filled only if the pharmacist called upon to fill such prescription determines, in the exercise of professional judgment:
● That it was issued pursuant to a valid patient-practitioner relationship; and
● That it is authentic.
However, if the practitioner writing the prescription is not known to the pharmacist, the pharmacist shall obtain proof to a reasonable certainty of the validity of the prescription.
The provisions authorizing generic substitution shall not apply to prescriptions described in this section unless authorized on the prescription.
What Information Must Be Provided? [Phone Rx]
Upon receipt of an oral prescription, the Pharmacist must promptly reduce the oral prescription to writing or create a permanent electronic record by recording:
● The date when the oral prescription was received;
● The name of the patient for whom, or the owner of the animal for which, the drug is to be dispensed;
● The full name and, in the case of controlled substances, the address and the DEA registration number, of the practitioner, or other number as authorized under rules adopted by reference under Division 80 of this chapter of rules;
● If the oral prescription is for an animal, the species of the animal for which the drug is prescribed;
● The name, strength, dosage form of the substance, quantity prescribed;
● The direction for use;
● The total number of refills authorized by the prescribing practitioner;
● The written signature or initials or electronic identifier of the receiving pharmacist or intern and the identity of the person transmitting the prescription
Who Can Phone in Prescriptions (Prescriber, Staff, Receptionist)?
A practitioner or someone designated by the practitioner, which includes a clinical associate of the practitioner or any other practitioner acting in the practitioner’s absence
Can Interns Receive New Prescriptions Via Phone/Voicemail? Refills?
Yes, interns can receive new prescriptions and refills orally and reduce them to writing or on the electronic system.
Can Technicians Receive New Prescriptions Via Phone/Voicemail? Refills?
A technician may not communicate or accept by oral communication a new or transferred prescription of any nature
A technician may initiate or accept oral and electronic refill authorization from a practitioner or practitioner’s agent, provided that nothing about the prescription is changed
Can Clerks/Cashiers/Others Receive New Prescriptions Via Phone/Voicemail? Refills?
No; Non-licensed pharmacy personnel may enter non-prescription information into a computer record system and may perform clerical duties such as filing prescriptions, delivery, housekeeping, and general record keeping, but the responsibility for the accuracy of the non-licensed pharmacy personnel’s work lies with the Pharmacist.
What Information Must Be Provided?
[Transfer Rx]
Prescriptions may be transferred between pharmacies for the purpose of refill dispensing provided that:
● The prescription is invalidated at the sending pharmacy; and
● The receiving pharmacy obtains all the information constituting the prescription and its relevant refill history in a manner that ensures accuracy and accountability.
Prescriptions for controlled substances can only be transferred one time.
Pharmacies using the same electronic prescription database are not required to transfer prescriptions for dispensing purposes.
An Oregon registered pharmacy must transfer a prescription:
● To a pharmacy requesting a transfer on behalf of the patient or patient’s agent unless the transfer would compromise patient safety or violate state or federal laws or rules; and
● By the end of the next business day of the request.
