PharmLaw Missed Questions/ New info Flashcards
Q: What are the requirements for a pharmacist to obtain and maintain an active license?
A: A pharmacist must maintain competency through the development and maintenance of knowledge, skills, and aptitude, demonstrating this competence to the board. They must keep records of continuing education or professional development available for inspection. An active status license is issued upon proper application and payment of fees.
RX INFO NEEDED!!!! KNOW THIS
Definition of “Prescription”; Requirements for Controlled Substance Prescriptions
Definition of “Prescription”
- An order given individually for the person for whom it is prescribed
- Must include:
- Name and address of the prescriber
- Prescriber’s license classification
- Name and address of the patient
- Name and quantity of the drug prescribed
- Directions for use
- Date of issue
Requirements for Controlled Substance Prescriptions
- Must be:
- Dated and signed on the day issued
- Include the full name and address of the patient
- Specify the drug name
- Indicate the strength
- State the dosage form
- Provide the quantity prescribed
- Include directions for use
- Contain the name, address, and registration number of the practitioner
What are the conditions for a pharmacist to be issued an inactive status license and requirements to reactivate it?
A. A pharmacist not engaged or ceasing to be engaged in the practice of pharmacy for two or more years shall be issued an inactive status license upon proper application and payment of fees.
B. Pursuant to Section 61-11-13.B, an inactive status pharmacist applying for an active status license, who has not been actively engaged in pharmacy for two or more years, may be required to serve an internship training program and submit evidence of continuing education relating to the practice of pharmacy, as required by Section 61-11-6 and Section 61-11-13 and the board regulations.
Q: What are the responsibilities of pharmacists regarding opioid prescriptions and prescription monitoring programs (PMP)? …when to check PMP?
A: Pharmacists must obtain and review a PMP report when presented with an opioid prescription to identify risks of abuse, overdose, or diversion. They use professional judgment to decide if and when to review the report and must document their actions. After the initial report, pharmacists should determine how often to request further reports, with a minimum requirement of reviewing PMP reports at least once every three months during continuous opioid use for established patients, also documenting these reviews.
Prescriptions —what is correct
I. Telephoned into the pharmacy by a prescriber for a pharmacist to transcribe onto a hard-copy prescription are not required to be retained if stored electronically on a computer
II. Issued electronically and stored on a computer must be able to be printed out on demand
III. Issued electronically do not have to be reduced to hardcopy for record-keeping purposes
II. Issued electronically and stored on a computer must be able to be printed out on demand
III. Issued electronically do not have to be reduced to hardcopy for record-keeping purposes
Q: What are the requirements for maintaining permanent records of electronic prescriptions?
A: Electronic prescriptions do not need to be printed if the following conditions are met: (1) Information must be kept in its original format for 10 years. (2) Documentation of business associate agreements with vendors and intermediaries must be available to show the chain of trust for prescription access. (3) Reliable backup copies must be securely stored as approved by the board. (4) All prescription elements and record-keeping requirements, including identifying the dispensing pharmacist, must be fulfilled.
Q: What are the requirements for electronically archiving prescription records of scanned images of indirect written or faxed prescriptions?
A: Scanned images of prescriptions are allowed if: (1) They are retrievable and reproducible within 72 hours. (2) The identity of the approving pharmacist and the one destroying the original after three years is documented. (3) The electronic image accurately shows the original prescription. (4) The original paper must be kept for three years, and the electronic image for 10 years. (5) Prescriptions cannot be for controlled substances unless permitted by federal law. (6) Secure backup copies must be available. (7) All prescription elements and record-keeping requirements, including identifying the dispensing pharmacist, must be met. (8) Non-controlled paper prescriptions must be kept on-site for 120 days from dispensing; (9) controlled substance paper prescriptions must be kept for two years.
Q: What are the requirements for storing electronic records of prescriptions and patient prescription records offsite?
A: Offsite electronic records are permissible if: (1) They are readily retrievable. (2) All HIPAA and board of pharmacy patient privacy requirements are met. (3) Reliable backup copies are securely stored as approved by the board.
Q: What are the requirements for storing original paper prescription documents offsite after the minimum on-site storage period?
A: Original paper prescriptions can be stored offsite if: (1) The storage area is secure against unauthorized access. (2) It has appropriate fire suppression and climate control. (3) All HIPAA and board of pharmacy privacy requirements are met. (4) The pharmacist-in-charge maintains a system recording storage locations and an inventory of offsite documents. (5) Records must be producible within three business days upon request from the board or authorized law officers.
The following responsibilities require the use of professional judgment and therefore shall be performed only by a pharmacist or pharmacist intern:
(a) receipt of all new verbal prescription orders and reduction to writing;
(b) evaluation and interpretation of the prescription order and any necessary clinical clarification prior to dispensing;
(c) clinical consultation with a patient or his agent regarding a prescription or over-the-counter drug;
(d) evaluation of available clinical data in patient medication record system;
(e) oral communication with the patient or patient’s agent of information, as defined in the section under patient counseling, in order to improve therapy by ensuring proper use of drugs and devices;
(f) professional consultation with the prescriber, the prescriber’s agent, or any other health care professional or authorized agent regarding a patient and any medical information pertaining to the prescription.
ONLY A PHARMACIST SHALL PERFORM THE FOLLOWING DUTIES:
a) final check on all aspects of the completed prescription including sterile products and cytotoxic preparations, and assumption of the responsibility for the filled prescription, including, but not limited to, appropriateness of dose, accuracy of drug, strength, labeling, verification of ingredients and proper container;
(b) evaluation of pharmaceuticals for formulary selection within the facility;
(c) supervision of all pharmacy technicians and support personnel activities including preparations, mixing, assembling, packaging, labeling and storage of medication;
(d) ensure the pharmacy technicians and support personnel have been properly trained for the duties they may perform;
(e) any verbal communication with a patient or patient’s representative regarding a change in drug therapy or performing therapeutic interchanges (i.e. drugs with similar effects in specific therapeutic categories); this does not apply to substitution of generic equivalents;
(f) any other duty required of a pharmacist by any federal or state law.
D. PHARMACIST MANDATES
a. Pharmacists with prescriptive authority will document all prescription orders and with patient authorization, provide notice to the patient’s primary practitioner within ________________ of writing the prescription. Pharmacists that prescribe tobacco cessation drugs, naloxone, or tuberculin skin testing must inform the patient’s primary practitioner within how many days?
15 days
Q: What are the requirements for pharmacists regarding hormonal contraception drug therapy?
A: Pharmacists must exercise prescriptive authority for hormonal contraception drug therapy according to a board-approved written protocol. They must also maintain a current copy of this protocol.
Q: What are the education and training requirements for pharmacists prescribing hormonal contraception drug therapy?
A: Pharmacists must complete an ACPE-accredited training course in hormonal contraception, offered by the New Mexico Pharmacists Association or another approved body. Training includes: (a) mechanisms of action, contraindications, drug interactions, and monitoring; (b) current prescribing standards; (c) indications for use; (d) patient interviewing; (e) counseling on safety and efficacy; (f) evaluating drug interactions; (g) referral for follow-up care; (h) informed consent; and (i) management of adverse events. Additionally, pharmacists must complete a minimum of 0.2 CEU of live ACPE-approved continuing education related to hormonal contraception every two years.
Q: What are the guidelines regarding authorized drugs and record-keeping for pharmacists prescribing hormonal contraception?
A: (C) Prescriptive authority is limited to hormonal contraception drug therapy, excluding any devices for post-intercourse pregnancy prevention. Authority is restricted to drugs specified in the board-approved written protocol. (D) Pharmacists must generate a written or electronic prescription for any authorized dangerous drug. Informed consent must be documented according to the approved protocol, with records maintained in the pharmacy for at least three years.
Q: What are the requirements for obtaining a remote tele-pharmacy license?
A: The license holder of the hub pharmacy must apply for a remote tele-pharmacy license, which is specifically for conducting remote tele-pharmacy operations. This license is issued to a remote tele-pharmacy connected to a hub pharmacy via an electronic link. The initial and renewal fees for this license are the same as those for retail pharmacies.
Q: What are the requirements for a remote tele-pharmacy operating under different ownership than its hub pharmacy?
A: A remote tele-pharmacy must have a written contractual agreement detailing the responsibilities of each pharmacy, which must be submitted with the initial licensure application. Any changes to this agreement require approval from the board’s executive director. The applicant must also provide evidence that the tele-pharmacy will enhance pharmacy services and access in the proposed location.
Q: What are the operational requirements for a remote tele-pharmacy connected to a hub pharmacy?
A: A remote tele-pharmacy must connect to a hub pharmacy via a HIPAA-compliant electronic link, operational during all hours of the tele-pharmacy. If the link fails, the tele-pharmacy must close unless a pharmacist is physically present. Specific requirements include:
(a) Video equipment must provide at least four simultaneous views of pharmacy operations.
(b) Video resolution must allow for identifying medication dosages and reading labels.
(c) Equipment must record and maintain at least 90 days of video surveillance.
(d) Access to the site is restricted to designated pharmacy technicians or present pharmacists.
(e) The tele-pharmacy may operate only when a technician is present and under indirect supervision from the hub pharmacist.
(f) The names of all certified pharmacy technicians at the remote site must be recorded with the board.
Additionally, the tele-pharmacy must use barcoding or similar technology to verify that the filled drug or device matches the prescription label.
Q: What is the prescriptive authority of dental hygienists
A: Dental hygienists may prescribe, administer, and dispense fluoride supplements, topically applied fluoride, and topically applied antimicrobials from a specified formulary. However, they are prohibited from prescribing, dispensing, or administering: (1) drugs whose primary effect is systemic; and (2) dangerous drugs or controlled substances.
Q: What are the personnel requirements for non-sterile compounding in a pharmacy?
A: The pharmacist-in-charge must ensure that all compounding personnel have the necessary education, training, and proficiency; obtain relevant continuing education; maintain equipment; provide a suitable compounding environment; follow quality control procedures; and have access to current reference sources. Pharmacists must inspect and approve all compounding materials, review records for accuracy, and maintain equipment cleanliness. Pharmacy technicians must also have the necessary education and training, obtain continuing education, and perform duties under a pharmacist’s direct supervision. All personnel must participate in ongoing training programs.
Frequency of training and assessment shall be conducted as required by USP 797 (USP General Chapters: 797 Pharmaceutical Compounding-Sterile Preparations) to assure continuing competency and include:
(1) initial training before compounding sterile preparations;
(2) annual refresher training and assessment in didactic topics;
(3) annual testing of glove fingertip and media fill for low and medium risk compounding;
(4) six-month testing of glove fingertip and media fill testing for high risk compounding.
The Pharmacy Act does not prohibit:
a pharmacist from exercising the pharmacist’s professional judgment in refilling a prescription for a prescription drug, unless prohibited by another state or federal law, without the authorization of the prescribing licensed practitioner, if:
The Pharmacy Act allows a pharmacist to refill a prescription without the prescribing practitioner’s authorization under specific conditions: (9) if failure to refill would interrupt treatment or cause patient suffering, the pharmacist cannot reach the practitioner after reasonable effort, the refill does not exceed a 72-hour supply, the patient is informed that the refill is unauthorized, and the practitioner is notified of the emergency refill as soon as possible. Additionally, (10) the Act permits possession, storage, distribution, and dispensing of opioid antagonists as outlined in Section 24-23-1 NMSA 1978. All prescriptions that require compounding must be done solely by a pharmacist if the necessary dosage forms or amounts are not available.
Testing, screening and treatment of health conditions.
A. Pursuant to a board-approved protocol approved by the New Mexico medical board, a pharmacist may order, test, screen, treat and provide preventative services for health conditions or situations that include:
(1) influenza;
(2) group A streptococcus pharyngitis;
(3) SARS-COV-2;
(4) uncomplicated urinary tract infection;
(5) human immunodeficiency virus, limited to the provision of pre-exposure prophylaxis and post-exposure prophylaxis; and
(6) other emerging and existing public health threats identified by the board or department of health during civil or public health emergencies.
PROTOCOL FOR PHARMACIST PRESCRIBING OF DANGEROUS DRUGS IN
CONJUNCTION WITH POINT-OF-CARE TESTING (POCT)
.
. PURPOSE: To assist pharmacists in providing safe and effective prescribing of dangerous drugs in conjunction with CLIA-Waived point-of-care testing (POCT) in New Mexico. Additionally, to set criteria for properly trained and certified pharmacists to prescribe in a safe manner for all eligible and appropriately screened patients in New Mexico who would benefit from testing and therapy
a. HIV Post-Exposure Prophylaxis (PEP) therapy for patients who have potentially been
exposed to HIV within the past 72 hours, in a manner that puts them at risk for HIV
infection;
b. Statin therapy;
c. SARS-CoV-2 (“COVID-19”)
d. Group A Beta-Hemolytic Streptococcus (GAS) Pharyngitis antimicrobial therapy;
e. Influenza antiviral therapy, and influenza antiviral prophylaxis therapy.
When compounding immediate-use CSPs, may more than three individual containers of a sterile products be used?
Immediate-use CSPs must not involve more than three different sterile products. Multiple vials of the same component (e.g., two vials of the same drug) can be used, provided the total does not exceed three different sterile components. For example, combining two vials of a drug and two vials of Sterile Water for Injection in a single intravenous diluent bag counts as two different sterile components. All preparations must meet the criteria for immediate-use CSPs.
Can a single-dose container be used to prepare doses for more than one patient when compounding an immediate-use CSP?
No. One of the conditions of the immediate-use CSP provision specifies that any unused starting components from a single- dose container must be discarded after preparation for the individual patient is complete. Single-dose containers must not be used for more than 1 patient when used for preparing immediate-use CSPs.
Q: What are the guidelines for using single-dose and multiple-dose containers for sterile products?
A: Opened or needle-punctured single-dose containers must be used within 1 hour if opened in air worse than ISO Class 5, with any remaining contents discarded. Single-dose vials exposed to ISO Class 5 air may be used for up to 6 hours after puncture. Opened single-dose ampuls must not be stored. Multiple-dose containers, designed for multiple uses due to antimicrobial preservatives, have a beyond-use date (BUD) of 28 days after opening, unless the manufacturer specifies otherwise.
Is a conventionally manufactured single-dose container required to be stored in an ISO Class 5 PEC in order for it to be allowed to be used for up to 12 hours?
No, opened or punctured conventionally manufactured single-dose containers may be stored outside of an ISO Class 5 PEC. However, the chapter does require that the conventionally manufactured single-dose container be entered or punctured inside of an ISO Class 5 PEC. These containers may be used up to 12 hours after initial entry or puncture provided that the storage requirements (e.g., controlled room temperature, cold temperature) are maintained. Opened single-dose ampules must not be stored for any period of time.
Q: How long can a single-dose vial be stored after puncture if the package insert states “use immediately”?
A: If a single-dose vial is punctured and the package insert states “use immediately,” it typically should not be stored. However, if compounded in an ISO Class 5 or cleaner air, it may be used up to 12 hours after initial puncture, provided labeled storage requirements are maintained. If the insert lacks sterility data and emphasizes immediate use, the 4-hour immediate-use time may apply instead. It’s advisable to contact the manufacturer for specific stability information.
