NM MPJE TLDR Flashcards

Question

# Licensure Requirements: Pharmacy Intern Who Can Apply? (New)

Answer 1

Must be at least 18 years old and have satisfactorily completed not less than 30 semester hours in a college of pharmacy curriculum accredited by the ACPE and meet other requirements established by regulations of the board.

Answer 2

Graduates from non-ACPE accredited colleges of pharmacy may apply for a pharmacist intern license upon successful completion of FPGEC certification.

Answer 3

1500 hours. Maximum of 48 hours per week.

Answer 4

Yes. Each preceptor must be certified as a preceptor by the board or be an approved preceptor for intern training in another state, have been actively engaged in the practice of pharmacy for one year, and be engaged in full-time practice of pharmacy.

Answer 5

The intern registration must be renewed annually on or before the last day of September. The intern shall submit, annually, at the time of registration renewal, all completed required forms for the prior year or period of computed time.

Answer 6

Application and required registration fee shall be submitted to the board prior to performing any technician duties. Two types of technicians are licensed in NM - non-certified and certified.

Answer 7

Must be at least eighteen years of age and not addicted to drugs or alcohol. A non-certified technician applicant must submit a completed application, fees, and a technician training record signed by a Technician Training Sponsor. A certified technician applicant must submit a completed application, fees, and a copy of current certification from PTCB or ExCPT.

Answer 8

**No requirement for general renewal** Two hours are required if technician is certified and completes training and education to administer vaccines

Answer 9

2 hours Vaccine-related if trained to administer.

Answer 10

Non-certified technicians are required to obtain board approved certification within one year of registration with the board as a technician. Certified pharmacy technicians must maintain current national certification.

Answer 11

Non-certified pharmacy technician registrations expire exactly one year from the date of issue and cannot be renewed unless the technician is certified. Registration for certified pharmacy technicians will expire biennially on the last day of their birth month and must be renewed prior to expiration. Registration renewal applications must include documentation of current national certification.

Answer 12

Every licensed pharmacy will be under continued daily supervision of a registered pharmacist who shall have direct control of the pharmaceutical affairs of the pharmacy. The restricted pharmacy area shall be locked in the absence of a pharmacist on the premises.

Answer 13

The restricted area to be occupied by the prescription department shall be an undivided area of not less than **240 square feet**. No space in this area shall provide for an office, auxiliary store room or public restroom.

Answer 14

The prescription compounding counter must provide a minimum of **16 square feet** of unobstructed compounding and dispensing space for one pharmacist and a minimum of **24 square feet for two or more pharmacists when on duty concurrently**. The counter shall be of adequate height of at least **36 inches**, if necessary, 5% or at least one workstation will comply with the American with Disabilities Act. The restricted floor area shall be unobstructed for a minimum width of **30 inches** from the compounding center.

Answer 15

Each pharmacy shall provide facilities whereby a pharmacist may professionally counsel a patient or a patients' agent and protect the right to privacy and confidentiality.

Answer 16

The pharmacy restricted area shall be separated from the merchandising area by a barrier of sufficient height and depth to render the dangerous drugs within the pharmacy inaccessible to the reach of any unauthorized person. All windows, doors, and gates to the restricted area shall be equipped with secure locks. . The restricted area of a retail pharmacy established in conjunction with any other business other than a retail drug store, shall be separated from the merchandising area of the other business by a permanent barrier or partition from floor to roof with entry doors that may be securely locked when a pharmacist is not on duty.

Answer 17

All facilities used for off-site drug storage (drug warehouses) shall be equipped with an alarm system to detect entry after hours.

Answer 18

- **Schedule II Prescriptions**: Must be filed separately. - **Schedules III, IV, V Prescriptions**: Can be filed separately or with other records if marked with a red "C" (at least 1 inch high) in the lower right corner, making them readily retrievable. They can be filed with Schedule II prescriptions or among non-controlled drug prescriptions. - **Storage**: All controlled substances (Schedules II-V) must be stored in locked cabinets or dispersed among non-controlled substances to prevent theft or diversion.

Answer 19

All facilities used for drug warehouses shall be secure from unauthorized entry.

Answer 20

● records are readily retrievable; ● all HIPAA and board of pharmacy patient privacy requirements are met; ● reliable backup copies of the information are available and stored in a secure manner as approved by the board.

Answer 21

Original paper prescription documents may be stored offsite after the minimum period of storage on the licensed premises has been reached, provided that the following requirements are met: . ● the storage area is maintained so that records are secure and prevented from unauthorized access; ● the storage area is maintained with appropriate fire suppression safeguards and climate control capabilities; ● all HIPAA and board of pharmacy patient privacy requirements are met; ● the PIC maintains a record-keeping system that records storage location(s) and documents an inventory of original paper prescription documents that are maintained offsite; ● original paper prescription records must be able to be produced within three business days upon the request of the board or an authorized officer of the law.

Answer 22

In every pharmacy there shall be prominently posted in a place conspicuous to and readable by prescription drug consumers a notice concerning available counseling.

Answer 23

Pharmacies permanently closing shall notify the public and the board of pharmacy of the closure at **least 30 days** prior to the final day of service. The notice shall include the last date of service and the name, address, and phone number of the location where patient records will be transferred and /or stored.

Answer 24

**Q:** What are the requirements for displaying licenses and important documents in a pharmacy? **A:** 1. **Display Requirements**: - **Licenses**: Both personal and business licenses must be conspicuously displayed in the pharmacy. - **Documents to Display**: - Pharmacy license - Prohibition of drug returns sign - Current Board of Pharmacy inspection report - Current controlled substance registration - Patient’s Bill of Rights (as approved by the board) 2. **Pharmacy Closure**: - Surrender the permit to the board. - Remove all drug signs and symbols. - Remove or destroy all drugs, devices, and poisons. 3. **Personnel Identification**: - All staff in restricted areas must wear an ID badge with their name and job title.

Answer 25

A PIC must notify the board immediately upon his knowledge that his service as PIC has been or will be terminated. Upon termination of the PIC each pharmacy owner shall immediately designate a successor PIC and **immediately notify** the state board of pharmacy of such designation.

Answer 26

Any registrant or licensee shall report in writing any change of address or employment to the board **within 10 days**. . A preceptor must notify the board of any change of address or employment in writing, **within 10 days**. Change of employment shall serve to suspend certification as preceptor in the former place of employment where the individual was training an intern.

Answer 27

The pharmacy shall have a Class A prescription balance, or analytical balance and weights when necessary.

Answer 28

- Facilities: Must have a sink with hot and cold water and a refrigerator maintaining proper temperature. - Equipment: Necessary for safe storage, compounding, packaging, labeling, dispensing, and preparation of drugs and parenteral products. - References: Must have an updated reference source and the most recent New Mexico pharmacy laws and regulations (electronic or paper).

Answer 29

- Design and Control: Must meet USP/NF <797> standards. - Monitoring: Must be tested and certified with documentation retained for 3 years. - Space: At least 100 square feet dedicated to CSP preparation. - Environment: Clean, well-lit (80-150 foot candles), and minimize particle-generating activities.

Answer 30

- Current References: USP/NF or USP on Compounding, New Mexico pharmacy laws, rules, and regulations. - Specialty References: Stability and incompatibility, sterilization and preservation, pediatric dosing, and drug monograph references, as appropriate.

Answer 31

- Accuracy Verification: Verify accuracy at least every 30 days per manufacturer's specs. - Monitoring: Operator must observe the device during mixing every 30 days. - Data Entry: Verify data entry by a pharmacist or have accurate final documentation for verification. - End Product: Accuracy of the final product must be verified according to written policies and procedures.

Answer 32

A managing pharmacy may use an automated drug distribution system to supply medications for patients of a healthcare facility. The automated drug distribution system may be located in a healthcare facility that is not at the same location as the managing pharmacy. When the automated drug distribution system is used to deliver routine doses of controlled substances, the managing pharmacy must submit and maintain a separate registration with the drug enforcement administration. At least 60 days prior to the initial use of an automated drug distribution system, the PIC of the managing pharmacy must provide the board with written notification of: ● the physical address at which the system will be located; ● the health facility’s board of pharmacy registration type and number; ● the managing pharmacy’s registration number, address, and PIC; ● written policies and procedures that govern the operation of the system; and ● the managing pharmacy PIC must notify the board within 10 days whenever an automated drug distribution system is taken permanently out of service. . A pharmacist shall perform prospective drug use review and approve each medication order prior to administration of a drug except an override medication. A pharmacist shall perform retrospective drug use review for an override medication. The managing pharmacy PIC shall maintain, for at least three years, records related to the automated medication system in a readily retrievable manner including the managing pharmacy’s distribution records for all dangerous drugs, including controlled substances, transferred to each automated medication system and perpetual inventories of controlled substances contained within each automated medication system.

Answer 33

The hospital pharmacy shall be enclosed and locked if a pharmacist is not present in the facility. A pharmacist shall be "on call" during all absences from the facility. Only one registered or certified pharmacy technician may be present in the pharmacy when the pharmacist is not in the facility, only to perform clerical tasks. A written log shall be maintained of technician activities while alone in the pharmacy. The hospital administrator or designee may possess a key to the pharmacy for emergency access, if allowed by the PIC.

Answer 34

Floor stock drugs, including those issued from automated medication management systems, shall be limited to drugs for emergency use and routinely used items as listed in the pharmacy policy and procedure manual and approved by the pharmacy and therapeutics committee. Floor stock drugs shall be supplied in individual doses unless the bulk container cannot be individualized. . All medications, with the exception of those for emergency use, shall be issued for inpatient use pursuant to the review of the physician's order or direct copy thereof, prior to dispensing. If the pharmacy is closed when the order is written, the pharmacist shall review the order within 24 hours.

Answer 35

● Only one designated nurse per shift may remove drugs from the pharmacy. The quantity of drugs shall notexceed the quantity needed to last until the pharmacist is in the facility, ● A record shall be made at the time of withdrawal by the authorized person removing the drugs. The original or copy of the medication order may substitute for such record. ● The nurse withdrawing the drug shall place upon the record of withdrawal an example of the medication removed. ● An electronic record of the withdrawal is required when the nurse is withdrawing more than a 72 hour supply. ● The pharmacist shall verify the withdrawal after a reasonable interval, but in no event may such interval exceed 72 hours from time of withdrawal. ● A drug regimen review, pursuant to a new medication order, will be conducted by a pharmacist either on- site or by electronic transmission within 24 hours of the new order.

Answer 36

No nonresident pharmacy shall ship, mail or deliver prescription drugs to a patient in this state unless licensed by the board. In addition, no nonresident pharmacy shall ship, mail or deliver controlled substances to a patient in this state unless registered by the drug enforcement administration and the board for controlled substances. Any person that mails prescription drugs to NM patients from more than one nonresident pharmacy shall obtain a separate NM nonresident pharmacy license for each pharmacy. . Each nonresident pharmacy must provide a toll-free telephone service to facilitate communication between patients in NM and a pharmacist at the nonresident pharmacy who has access to the patient's records. The pharmacy shall provide the toll-free telephone service during its regular hours of operation, but not less than six days a week and for a minimum of 40 hours a week. The toll-free telephone number shall be disclosed on a label affixed to each container of drugs dispensed to patients in this state

Answer 37

$300 (in-state pharmacy) biennially. The license expires December 31 of every other year.

Answer 38

● the name under which the business is to be operated; ● the address of each location to be licensed and the address of the principal office of the business; ● in the case of a retail pharmacy, the name and address of the owner, partner or officer or director of a corporate owner; ● the type of business to be conducted at each location; ● a rough drawing of the floor plan of each location to be licensed; ● the proposed days and hours of operation of the business; and ● other information the board may require, including a criminal background check and financial history.

Answer 39

**Q:** What are the requirements for a nonresident pharmacy applying for licensure or renewal in New Mexico? **A:** - **Application Information**: - Address of the principal office. - Names and titles of all principal corporate officers and pharmacists dispensing to NM patients. - Report changes in office location, corporate officers, or PIC within 10 days. - **Documentation**: - Proof of valid pharmacy license in the resident state. - Most recent inspection report by the resident state’s regulatory agency. - If shipping compounded sterile preparations (CSPs), submit the most recent CSP inspection report showing compliance with USP/NF General Chapters below 1000, or current good manufacturing practices if acting as an outsourcing facility. - Policy and procedure manual. - Proof of toll-free telephone service for NM patients. - Name and address of a resident in New Mexico for service of process. - **Controlled Substances**: Submit a separate application if shipping, mailing, or delivering controlled substances to NM patients.

Answer 40

The pharmacy license shall terminate upon sale or transfer of ownership. A transfer of ownership occurs upon the sale of the pharmacy to another individual or individuals by the present owner, the addition or deletion of one or more partners in a partnership, the death of a singular or sole owner, ot the change of ownership of 30% or more of the voting stock of a corporation since the issuance of the license or last renewal application. . Upon termination of the PIC each pharmacy owner shall immediately designate a successor PIC and immediately notify the state board of pharmacy of such designation. The owner shall request the license application form to be completed by the successor PIC and filed with the board within 10 days.

Answer 41

A new license application will be required to be filed in each of the above circumstances.

Answer 42

After preliminary approval of the application, the applicant shall submit a request for inspection and the inspection fee, where applicable, in advance of fourteen days of the requested date for inspection.

Answer 43

The permissible ratio of pharmacy technicians to pharmacists on duty is to be determined by the pharmacist in charge. The board reserves the right to impose a ratio of pharmacy technicians to pharmacists if circumstances so dictate. . Vaccine-related ratio: Supervision: A qualified pharmacist may not supervise more than two pharmacy technicians administering vaccines in a pharmacy setting. A pharmacist whose duties are dedicated to vaccination (e.g. vaccination clinic) may not supervise more than six qualified pharmacy technicians administering vaccines at one time.

Answer 44

Yes, for an out-of-state sterile compounding pharmacy or for an outsourcing facility.

Answer 45

Non-sterile drug products may be compounded in licensed pharmacies as a result of a practitioner’s prescription order based on the practitioner-patient-pharmacist relationship in the course of professional practice. Preparing limited quantities of prescription drug orders in anticipation based upon a history of receiving valid prescriptions issued within an established practitioner-patient-pharmacist relationship in the course of professional practice is acceptable.

Answer 46

● name and strength of the compounded medication or list of the active ingredient and strengths; ● facility’s lot number; ● beyond-use date; and ● quantity or amount in the container.

Answer 47

● for non-aqueous formulations - the BUD is not later than the time remaining until the earliest expiration date of any API or six months, whichever is earlier; ● for water-containing oral formulations - the BUD is not later than 14 days when stored at controlled cold temperatures; ● for water-containing topical/dermal and mucosal liquid and semisolid formulations - the BUD is not later than 30 days. . Beyond-use date limits may be exceeded when supported by valid scientific stability information for the specific compounded preparation; the BUD shall not be later than the expiration date on the container of any component.

Answer 48

Primary engineering controls used to provide an aseptic environment shall be tested in the course of normal operation by an independent qualified contractor and certified as meeting the requirements presented in USP/NF <797> at least every six months and when relocated. Certification records will be maintained for three years. . All personnel involved in non-sterile compounding shall be trained and must participate in continuing relevant training programs. Pharmacy technicians shall complete 100 hours of documented experiential training in compounded sterile preparations prior to compounding sterile preparations. . Other training is in the next slide :)

Answer 49

● initial training before compounding sterile preparations; ● annual refresher training and assessment in didactic topics; ● annual testing of glove fingertip and media fill for low and medium risk compounding; ● six-month testing of glove fingertip and media fill testing for high risk compounding.

Answer 50

In addition to the labeling requirements of the pharmacy’s specific license classification, the label dispensed or distributed pursuant to a prescription or medication drug order shall contain the following: ● the generic name(s) or the designated name and the strength of the compounded preparation; ● the quantity dispensed; ● the date on which the product was compounded; ● a lot or batch number; and ● the beyond-use date after which the preparation should not be used. . Unless otherwise indicated or appropriate, compounded preparations are to be prepared to ensure that each preparation shall contain not less than 90.0 percent and not more than 110.0 percent of the theoretically calculated and labeled quantity of active ingredient per unit volume and not less than 90.0 percent and not more than 110.0 percent of the theoretically calculated weight or volume per unit of the preparation.

Answer 51

● such dispensing is made by a pharmacist or registered pharmacist intern; ● not more than eight ounces of any controlled substance containing opium, nor more than 48-dosage units is dispensed at retail to the same person in any given 48-hour period; ● not more than four ounces of any other controlled substance or more than 24-dosage units may be dispensed at retail to the same person in any given 48-hour period; ● the purchaser is at least 18 years of age; ● the pharmacist requires every purchaser of such substance, not known to him to furnish suitable identification; ● a bound record book for dispensing such substances is maintained requiring the signature and address of the purchaser, the name and quantity of the controlled substance purchased, the date of each purchase and the name or initials of the pharmacist who dispensed the substance; the book shall contain a statement on each page where purchaser is required to sign, stating no purpose of such substance has been made within the given 48- hour period at another pharmacy and the purchaser shall be made aware of such statement before signing the record.

Answer 52

The CMEA created a new category of products called “scheduled listed chemical products” (**SLCPs**). It includes any product that may be marketed or distributed lawfully in the US as a non- prescription drug, and that contains **ephedrine, pseudoephedrine, or phenylpropanolamine**. SLCPs must be stored behind the counter or in locked cabinets.

Answer 53

Any pseudoephedrine containing product listed as a schedule V controlled substance shall be dispensed, sold or distributed only by a licensed pharmacist, pharmacist intern, or a registered pharmacy technician. Unless pursuant to a valid prescription, a person purchasing, receiving or otherwise acquiring the compound, mixture or preparation shall: ● produce a driver’s license or other government-issued photo ID showing the date of birth of the persons; ● sign a log after reading the purchaser statement for pseudoephedrine receipt or other program or mechanism indicating the date and time of the transaction, name of the person, address, driver’s license number or government issued identification number, name of the pharmacist, pharmacist intern or pharmacy technician conducting the transaction, the product sold and the total quantity, in grams or milligrams, of pseudoephedrine purchased; this log will be only for exempt pseudoephedrine products and shall be kept separate from all other records; the log is to be produced in a way that a customer’s personal information is not available to other purchasers. . **The following substances are excluded from schedule V controlled substances: pseudoephedrine products in liquid form including liquid filled gel caps and pseudoephedrine products already classified as dangerous drugs.**

Answer 54

A person shall be limited to purchasing or acquiring no more than **3.6 grams per day** or more than a total of **9 grams** of a product, mixture or preparation containing pseudoephedrine within a **30-day period**.

Answer 55

Prescriptive authority for vaccines shall be exercised solely in accordance with the written protocol for vaccine prescriptive authority approved by the board. Any pharmacist exercising prescriptive authority for vaccines shall have current live BLS/CPR certification and must have completed an approved training course. Prescriptive authority shall be limited to those drugs and vaccines delineated in the written protocol for vaccine prescriptive authority approved by the board, and other vaccines as determined by the CDC, ACIP, or New Mexico department of health that may be required to protect the public health and safety.

Answer 56

Prescriptive authority for emergency contraception, tobacco cessation, and hormonal contraception drug therapies and for TB testing shall be exercised solely in accordance with the written protocols approved by the board.

Answer 57

The prescribing pharmacist must generate a written or electronic prescription for any dangerous drug authorized. Informed consent must be documented and a record of such consent maintained in the pharmacy for a period of at least three years. Upon signed consent of the patient or guardian the pharmacist shall notify the patient’s designated physician or primary care provider and update the New Mexico DOH immunization program’s electronic database (NMSIIS) of any vaccine administered.

Answer 58

B. PURPOSE To assist Pharmacists in providing safe and effective tuberculin testing in New Mexico. C. GUIDELINES All pharmacists participating in prescriptive authority for tuberculin testing will follow the US Center for Disease Control Clinical Practice Guideline.

Answer 59

a. Pharmacists with prescriptive authority will document all prescription orders and with patient authorization, provide notice to the patient's primary practitioner within 15 days of writing the prescription. b. Pharmacists with prescriptive authority will take patient histories and consult with patients’ medical providers as appropriate. c. Pharmacists with prescriptive authority will follow patients according to recommended guidelines.

Answer 60

a. Pharmacists will follow the US Center for Disease Control (CDC) recommendations for skin testing. b. Pharmacists will include an education component including both face to face and telephonic/electronic interventions to patients.

Answer 61

a. patient history. b. family history. c. current living environment. d. concurrent illness. e. allergies and hypersensitivities. f. medication history.

Answer 62

1. The Mantoux tuberculin skin test (TST) is the standard method of determining whether a person is infected with Mycobacterium tuberculosis. 2. Other FDA approved products for tuberculin skin testing

Answer 63

A. handouts can include the following: 1. skin test reaction drug information 2. others as appropriate 3. lifestyle modifications

Answer 64

a. The Mantoux tuberculin skin test (TST) is the standard method of determining whether a person is infected with Mycobacterium tuberculosis. Reliable administration and reading of the TST requires standardization of procedures, training, supervision, and practice. b. The TST is performed by injecting 0.1 ml of tuberculin purified protein derivative (PPD) into the inner surface of the forearm. The injection should be made with a tuberculin syringe, with the needle bevel facing upward. The TST is an intradermal injection. When placed correctly, the injection should produce a pale elevation of the skin (a wheal) 6 to 10 mm in diameter. c. The skin test reaction should be read between 48 and 72 hours after administration. A patient who does not return within 72 hours will need to be rescheduled for another skin test. The reaction should be measured in millimeters of the induration (palpable, raised, hardened area or swelling). The reader should not measure erythema (redness). The diameter of the indurated area should be measured across the forearm (perpendicular to the long axis).

Answer 65

a. Documentation of test and result must be maintained by the pharmacist and provided to the patient for the test results. b. All positive reports must be sent to the Department of Health and to the patients primary care practitioner for follow up. c. Patient test results, either positive or negative, may be provided to others upon patient request. This can include employers when testing is provided as a requirement for employment.

Answer 66

a. consent form. b. records of notification c. billing. d. prescription order

Answer 67

B. PURPOSE To assist Pharmacists in providing safe and effective tobacco cessation drug therapy Mexico. C. GUIDELINES All pharmacists participating in prescriptive authority for tobacco cessation drug therapy will follow the US Department of Health and Human Services, Public Health Services, Clinical Practice Guideline.

Answer 68

a. Pharmacists with prescriptive authority will document all prescription orders and with patient authorization, provide notice to the patient's primary practitioner within 15 days of writing the prescription. b. Pharmacists with prescriptive authority will take patient histories and consult with patients’ medical providers as appropriate. c. Pharmacists with prescriptive authority will follow patients according to recommended guidelines.

Answer 69

a. Pharmacists will follow the US Department of Health and Human Services, Public Health Services, Clinical Practice Guideline – Treating Tobacco Use and Dependence. b. Pharmacists will implement the Five A’s (ask, advise, assess, assist, arrange) to help patients quit using all forms of tobacco. c. Pharmacists will include an education component including both face to face and telephonic/electronic interventions to patients of 90 minutes.

Answer 70

a. patient history. b. family history. c. current living environment. d. concurrent illness. e. allergies and hypersensitivities. f. medication history.

Answer 71

1.Nicotine replacement therapies 2. patch 3. gum 4. inhaler 5. lozenge 6. nasal spray 7. Bupropion 8. Other FDA approved products for tobacco cessation.

Answer 72

withdrawal symptoms side affects drug information others as appropriate lifestyle modifications motivation

Answer 73

Pregnancy. Current seizure disorder for bupropion therapy. Current eating disorder for bupropion therapy.

Answer 74

PROTOCOL FOR PHARMACIST PRESCRIPTION OF HORMONAL CONTRACEPTION - https://www.rld.nm.gov/uploads/files/OCProtocolApproved(1).pdf . Emergency Contraceptive Pills (ECPs) Protocol for NM Pharmacist - https://www.rld.nm.gov/uploads/FileLinks/e3740e56e0fe428e991dca5bd25a7519/protocolofpharmacistprescribingofEC.pdf . PROTOCOL FOR PHARMACIST PRESCRIBING OF VACCINES - https://www.rld.nm.gov/uploads/FileLinks/e3740e56e0fe428e991dca5bd25a7519/IZprot2015___June_BOP_Aug_MB_Aug_BONApproved.pdf

Answer 75

Summary of Conscience Protections in Health Care Conscience protections are established for health care providers, patients, and other participants in federal programs who refuse, on religious or moral grounds, to partake in specific health care services. Federal statutes ensure these rights by prohibiting recipients of federal funds from mandating that individual providers participate in actions that conflict with their religious or moral beliefs The statutes particularly protect providers who object to providing or referring for abortions or assisted suicide and safeguard against discrimination based on these beliefs. Additionally, these protections extend to federally funded health care entities, allowing them to refrain from participating in actions they find objectionable. Regarding patients, provisions clarify that certain programs, such as mental health treatment and compulsory health care services, shall not compel them to receive services they oppose for religious or moral reasons.

Answer 76

You may file a complaint with OCR if you believe you have been discriminated against in violation of the Federal Health Care Conscience Protection Statutes. You can file a complaint online or via mail, fax, or e-mail. Learn more about how to file a complaint with OCR.

Answer 77

The Final Rule clarifies existing authorities and processes for handling complaints related to federal health care conscience protection statutes. OCR receives complaints under the federal conscience statutes, and a short summary of those statutes is below.

Answer 78

The conscience provisions in 42 U.S.C. 300a-7, collectively known as the Church Amendments, were established in the 1970s to safeguard the rights of individuals and entities to refuse participation in certain medical procedures based on their religious or moral beliefs. Key provisions include: Prohibition on Requirements: Public officials cannot mandate recipients of federal financial assistance to facilitate abortion or sterilization if they object on moral or religious grounds. Protection Against Discrimination: Entities receiving such assistance cannot discriminate against healthcare personnel for either performing or refusing to perform lawful services like sterilization or abortion, based on their beliefs. Rights of Objectors: Individuals opposed to certain federally funded health services or research activities due to their beliefs are protected from being compelled to assist in these services. Non-Discrimination in Training: Applicants for medical training cannot be discriminated against based on their willingness or unwillingness to participate in abortions or sterilizations due to their beliefs.

Answer 79

Refuses to undergo training in the performance of abortions; Refuses to require or provide abortion training; Refuses to perform abortions, or to provide referrals for abortion training or for abortions; Refuses to make arrangements for any of the above activities related to abortion; or Attends (or attended) a post-graduate physician training program, or any other program of training in the health professions, that does not (or did not) perform induced abortions or require, provide, or refer for training in the performance of induced abortions, or make arrangements for the provision of such training.

Answer 80

The Weldon Amendment - PDF was originally passed as part of the HHS appropriations act for 2005, and has been readopted (or incorporated by reference) in each subsequent HHS appropriations act since then. It provides that none of the funds made available in those HHS appropriations acts may be made available to a Federal agency or program, or to a state or local government, if the agency, program, or government discriminates against any institutional or individual health care entity on the basis that the health care entity does not provide, pay for, provide coverage of, or refer for abortions. It defines “health care entity” to include “an individual physician or other health care professional, a hospital, a provider-sponsored organization, a health maintenance organization, a health insurance plan, or any other kind of health care facility, organization, or plan.”

Answer 81

Section 1553 (42 U.S.C. 18113) prohibits discrimination by the federal government, state and local governments, and healthcare providers receiving federal assistance against individuals or entities that choose not to provide services related to assisted suicide, euthanasia, or mercy killing. Section 1303 includes several sub-sections: 1303(b)(1)(A) permits qualified health plans to choose whether to cover abortion services. 1303(b)(4) prohibits discrimination against healthcare providers or facilities in exchanges based on their refusal to provide, pay for, or refer for abortions. 1303(c)(2)(A) clarifies that the ACA does not alter existing federal laws pertaining to conscience protections regarding abortion-related services. Finally, Section 1411(b)(5)(A) addresses exemptions from the ACA's individual responsibility requirement, allowing for exemptions based on hardship, including inability to obtain affordable coverage that excludes abortion services, or religious affiliations.

Answer 82

No medications, including OTC medications, PRN medications, or treatment shall be started, changed or discontinued by the facility without an order from the physician, physician assistant or nurse practitioner and with entry into the resident's record. State board of nursing licensed or certified health care professionals are responsible for the administration of medications.

Answer 83

All medications, including non-prescription drugs, shall be stored in a locked compartment or in a locked room, as approved by the board of pharmacy and the key shall be in the care of the administrator or designee.

Answer 84

All drugs shall be stored in locked cabinets, locked drug rooms, or state of the art locked medication carts. Medication requiring refrigeration shall be kept in a secure locked area of the refrigerator or in the locked drug room.

Answer 85

The patient specific label of a CSP shall contain: ● patient name; ● solution, ingredient names, amounts; ● beyond use date, and time when applicable; ● route of administration; ● directions for use, including infusion rates, specific times scheduled, when appropriate and applicable; ● identifier of person preparing the product and, if prepared by supportive personnel, the identifier of the pharmacist that completed the final check; ● when appropriate, ancillary instructions such as storage instructions or cautionary systems, including hazardous material warning labels and containment bags; and ● device instructions when needed; ● if dispensed for other than inpatient use, the label shall include all other required information.

Answer 86

All units of repackaged medication must be labeled with the following information: ● name, address, and telephone number of repackaging pharmacy, unless the repackaged drug is used in an automated drug distribution system; ● name, strength, and quantity of the drug; ● lot number or control number; ● name of manufacturer; ● beyond use date; ● date drug was repackaged; ● name or initials of repackager; and ● federal caution label, if applicable.

Answer 87

In lieu of dispensing one, two, or more prescribed drug products in separate containers or standard vial containers, a pharmacist may, with the consent of the patient, the patient's care-giver, the prescriber, or the institution caring for the patient, provide a customized patient medication package. The pharmacist preparing a patient medication package must abide by the guidelines as set forth in the current edition of the USP for labeling, packaging and record keeping. . In the event a drug is added to or discontinued from a patient's drug regimen, when a container within the patient medication package has more than one drug within it, the pharmacist may repackage the patient's patient medication package and either add to or remove from the patient medication packaged as ordered by the physician. The same drugs returned by the patient for repackaging must be reused by the pharmacist in the design of the new patient medication package for the new regimen, and any drug removed must either be destroyed, returned to the DEA or returned to the patient properly labeled. Under no circumstances may a drug within a container of a patient medication package which contains more than one drug be returned to the pharmacy stock.

Answer 88

The consultant pharmacist is responsible for setting the policy and procedures in the facility as related to all facets of drug handling and distribution; these policies and procedures to be reviewed and updated on an annual basis.

Answer 89

The consultant pharmacist shall provide or make arrangements for provision of pharmacy services to the facility on a 24-hour, seven days a week basis, including stat orders. The consultant pharmacist shall furnish and replenish emergency drug supply in acceptable containers and maintain a log of use and replacement of drugs in the emergency tray. . In licensed nursing homes an emergency drug supply shall be maintained, contents and quantity to be determined by a physician, nursing director and the pharmacist of each institution. In licensed custodial care facilities without a 24-hour/365 day per year on-site nurse, the emergency drug tray shall not contain any controlled substances. A list of the contents of the emergency drug supply shall be attached to the outside of the tray.

Answer 90

The consultant pharmacist shall make routine inspections of drug storage areas, patient health records, and review drug regimen of each patient at least once a month and report irregularities, contraindication, drug interactions, etc., to the medical staff.

Answer 91

● Must be currently certified as a Nuclear Pharmacist by the Board of Pharmaceutical Specialties; or ● Must have attained a minimum of **500 contact hours** of experiential training in nuclear pharmacy under the **supervision of a qualified nuclear pharmacist and 200 contact hours of didactic instruction** in nuclear pharmacy and the safe handling and use of radioactive materials, from a nationally-accredited college of pharmacy or other training program sponsored by an ACPE-accredited provider of CPE.

Answer 92

Any pharmacy that will provide radiopharmaceutical services must obtain a nuclear pharmacy license from the Board. A nuclear pharmacy shall operate in conformance with USP Chapter <825> and all other applicable chapters numbered 1000 or less. A radiopharmaceutical shall be dispensed only to a licensed practitioner authorized by the Nuclear Regulatory Commission or an equivalent agreement state agency to possess, use and administer such drug.

Answer 93

Both the hub pharmacy and remote tele-pharmacy must be located within and licensed by the NM board of pharmacy. The remote tele-pharmacy must be greater than 20 miles from an existing retail pharmacy.

Answer 94

A remote tele-pharmacy shall be connected to a hub pharmacy via HIPAA-compliant electronic link. All links must be fully operational during all hours of operation of the remote tele-pharmacy. All controlled substances kept in inventory by the remote tele-pharmacy shall be listed on a perpetual inventory log, which shall be updated upon the dispensing of each controlled substance prescription or other disposition. A remote tele-pharmacy is limited to filling no more than 200 prescriptions per day.

Answer 95

A NM licensed pharmacy may employ one or more pharmacists for the purpose of conducting drug utilization reviews in remote practice sites provided that all security requirements are met. All pharmacists employed to work at a remote DUR practice site must be NM licensed pharmacists. All remote pharmacist DUR sites will operate under a NM licensed pharmacy and under the authority of its PIC. No drug inventory shall be kept at any remote pharmacist DUR site and no dispensing shall take place from a remote DUR site. If the remote DUR site is located within a home there must be a designated area in which all of the pharmacist’s work will be performed. All remote DUR sites are subject to unannounced inspection by representatives of the New Mexico board of pharmacy during established hours of operation.

Answer 96

A NM licensed pharmacy located within the state may employ one or more certified pharmacy technicians for the purpose of data input in remote practice sites. No drug inventory shall be kept at any remote pharmacy technician data entry site and no dispensing shall take place from a remote pharmacy technician data entry site. Each data entry pharmacy technician shall ● be a certified pharmacy technician registered with the board and reside in New Mexico; ● have a minimum of one year experience performing data entry functions as a certified pharmacy technician; and ● be trained in the use of all equipment necessary for secure operation of the remote site.

Answer 97

The practice of telepharmacy within and across state lines is permitted in NM.

Answer 98

- **Outsourcing Prescription Dispensing**: A retail pharmacy may outsource the dispensing of prescription drug orders to another retail or nonresident pharmacy if they share the same owner or have a written contract detailing services, responsibilities, and compliance with federal and state laws. They must also have a common electronic file or appropriate technology for accessing necessary information. - **Patient Notification**: Pharmacies that outsource dispensing must inform patients that their prescriptions may be sent to another pharmacy and provide the name of that pharmacy. This notification can be given via a one-time written notice or a sign in the pharmacy. If the prescription is delivered directly, the dispensing pharmacist must ensure the patient receives written notice about available counseling. - **Prescription Labeling**: The dispensing pharmacy must include on the prescription label the name, address, or pharmacy license number of the dispensing pharmacy and the pharmacy that received the prescription. It should clearly indicate which pharmacy filled the prescription (e.g., "filled by ABC Pharmacy for XYZ Pharmacy") while adhering to all prescription labeling requirements. - **Policies and Record Keeping**: Both pharmacies must maintain a centralized dispensing policy and procedure manual, which must be approved by the board and available for inspection. Each pharmacy is required to comply with all record maintenance laws and must produce an audit trail showing all prescriptions dispensed and the involvement of each pharmacist or technician.

Answer 99

Licensed practitioners in NM may supply to their patients any drug if the licensed practitioner is practicing within their profession and does not keep a pharmacy.

Answer 100

No person regulated by the board including a person acting as principal or agent for a manufacturer, wholesaler, or distributor shall buy, sell, trade, barter or exchange pharmaceutical product samples.

Answer 101

Practitioners licensed in this state may prescribe, provide samples of and dispense any dangerous drug to a patient where there is a valid practitioner-patient relationship.

Answer 102

A record of all dispensing shall be kept showing the date the drug was dispensed and bearing the name and address of the patient to whom dispensed. It is the duty of every licensed physician, dentist, veterinarian, pharmacist or person holding a limited license, when dispensing any dangerous drug, to mark on the dispensing container the name of the patient, the date dispensed, the name and address of the person dispensing the drug, the name and strength of the drug, expiration date where applicable, adequate directions for use and the prescription number when applicable.

Answer 103

A pharmacy may distribute a quantity of controlled substances to a registered practitioner for general dispensing to his patients if the total number of dosage units of all controlled substances distributed by the pharmacy by this method during the 12 month period in which the practitioner is registered to dispense does not exceed 5% of the total number of dosage units of all controlled substances distributed and dispensed by, the pharmacy during the 12 month period. A prescription may not be issued in order for a practitioner to obtain controlled substances for supplying the practitioner for the purpose of general dispensing.

Answer 104

● the patients must reside in the same facility; ● the reused medication must have been discontinued from the original patient’s drug regimen; ● the drug was never out of the possession of the licensee - “keep on person” pharmaceuticals may never be reused; ● the drugs were originally dispensed in packaging that is unopened, single-dose or tamper-evident containers; ● the patient receiving the re-labeled medication must have a valid prescription/order for the medication that is to be reused; ● repackaging and relabeling may only be completed on site by the consultant pharmacist designated for that facility.

Answer 105

The consultant pharmacist must maintain records at the facility for **three years** containing the following information: ● date when the re-labeling occurred; ● the name and ID of the patient for whom the medication was originally intended for and the date in which it was discontinued from his or her drug regimen; ● the name and ID of the patient who will receive the reused medication; ● the name, strength and amount of the medication being reused; ● the name of pharmacist re-labeling the medication; ● the pharmacist must label the reused pharmaceutical and maintain a dispensing log for all such reissued pharmaceuticals and the expiration date for such re-issued drugs shall be no greater than fifty percent of the time remaining from the date of repackaging until the expiration date indicated on the original dispensing label or container.

Answer 106

A licensed pharmacy may compound veterinary non-controlled substance drug preparations in reasonable quantities to be used by veterinarians in their office for administration to patients (“office use preparations”). Compounded office use preparations may be dispensed by a veterinarian to clients if the patient has an emergency condition that the compounded drug is necessary to treat, the dispensed amount is for use in a single course of treatment (not to exceed a 120-hour supply), and the medication is not a controlled substance.

Answer 107

Medications dispensed in the emergency room must be dispensed only by a licensed pharmacist, a licensed pharmacist intern or a licensed practitioner.

Answer 108

● **Class A clinics** shall have the on-site services of a consultant pharmacist for the dispensing or distribution of dangerous drugs. ● **Class B clinics** shall have the services of a consultant pharmacist as listed: Category 1 clinics shall be visited by the consultant pharmacist at least bi-monthly, Category 2 clinics shall be visited by the consultant pharmacist at least monthly, and Category 3 clinics shall be visited by the consultant pharmacist at least bi-weekly. ● **Class C clinics** shall be visited by the consultant pharmacist at least every three months. ● **Class D clinics** shall be reviewed at least once yearly during school session.

Answer 109

● review records at least annually; this review shall include a review of the self-assessment form, receipt and disposition records, and storage records; ● oversee the removal of expired or unwanted dangerous drugs; ● review dangerous drug administration records within 72 hours of administration; this review shall be documented and available for inspection at the licensed location for three years; review shall include verification of compliance with procedures and protocols, including administration by properly trained personnel. ● ensure required records are available for inspection at the licensed location for three years, including a log of comments and activities of consultant pharmacist; ● verify a current list of trained staff, in accordance with New Mexico department of health requirements, is maintained at the licensed location and available for inspection; ● approve a policy and procedures manual outlining procedures for the receipt, storage, record keeping, administration and accountability of all dangerous drugs; this includes policies and procedures for the removal and destruction of unwanted, unused, outdated or recalled dangerous drugs; must verify compliance with all training and protocols required by the NM department of health.

Answer 110

● The administrator or a designated employee of the facility will sign a receipt for prescription drugs upon delivery. ● All prescription drugs will be stored in a locked cabinet or room and the key will be assigned to a designated employee or the administrator as indicated in the procedures manual. ● The consultant pharmacist shall be responsible for the following records: incoming medications - including refills; record of administration; waste or loss. This accountability record shall be maintained on a patient log, on forms provided to the consultant pharmacist by the board of pharmacy. ● No bulk containers of legend drugs will be kept on the premises, except in a facility with a 24-hour per day and 365 day per year on-site licensed nurse. Only the following stock dangerous drugs may be kept: tuberculin testing solution; and vaccines. ● The consultant pharmacist shall be required to maintain a patient profile on each individual, if applicable to the facility and individual. ● The consultant pharmacist shall visit the facility no less than once a quarter.

Answer 111

● proof of completion of 60 hour board approved physical assessment course, followed by a 150 hour, 300 patient contact preceptorship supervised by a physician or other practitioner with prescriptive authority, with hours counted only during direct patient interactions; ● the applicant will submit a log of patient encounters as part of the application; ● patient encounters must be initiated and completed within two years of the application; ● a pharmacist clinician requesting a controlled substance registration to prescribe controlled substance in schedule II or schedule III shall be trained in responsible opioid prescribing practices. ● The board shall register each pharmacist certified as a pharmacist clinician. ● Upon certification and registration by the board, the name and address of the pharmacist clinician, (name of the supervising physician if applicable), and other pertinent information shall be enrolled by the board on a roster of pharmacist clinicians.

Answer 112

● documentation of CE hours, including proof of completion of 20 hours of live CPE or CME approved by ACPE or AACME, beyond the required CE hours for a pharmacist; and ● a pharmacist clinician with a controlled substance registration to prescribe controlled substances listed in schedule II or schedule III shall complete a minimum of 2 hours per renewal period in the subject area of responsible opioid prescribing practices, and ● a current protocol of collaborative practice signed by the supervising physician (if prescriptive authority is sought); and ● a copy of the pharmacist clinicians registration with the supervising physicians board (if prescriptive authority is sought); and ● other additional information as requested by the board.

Answer 113

● name of the physician(s) authorized to prescribe dangerous drugs and name of the pharmacist clinician; ● statement of the types of prescriptive authority decisions the pharmacist clinician is authorized to make, including, but not limited to: (i) types of diseases, dangerous drugs or dangerous drug categories involved and the type of prescriptive authority authorized in each case; (ii) ordering lab tests and other tests appropriate for monitoring of drug therapy; (iii) procedures, decision criteria or plan the pharmacist clinician is to follow when exercising prescriptive authority; ● activities to be followed by the pharmacist clinician while exercising prescriptive authority, including documentation of feedback to the authorizing physician concerning specific decisions made; documentation may be made on the prescriptive record, patient profile, patient medical chart or in a separate log book; ● description of appropriate mechanisms for consulting with the supervising physician, including a quality assurance program for review of medical services provided by the pharmacist clinician, (this quality assurance program will be available for board review); and ● description of the scope of practice of the pharmacist clinician.

Answer 114

**“Automated filling system”** means an automated system used by a pharmacy in the state of New Mexico to assist in filling a prescription drug order by selecting, labeling, filling, or sealing medication for dispensing. An “automated filling system” shall not include automated devices used solely to count medication that is then subject to final product check by a pharmacist prior to dispensing, vacuum tube drug delivery systems, or automated dispensing and storage systems used to dispense medication directly to a patient or to an authorized health care practitioner for immediate distribution or administration to the patient. A managing pharmacy may use an automated drug distribution system to supply medications for patients of a health care facility. The automated drug distribution system may be located in a healthcare facility that is not at the same location as the managing pharmacy. When located within a healthcare facility, the system is considered to be an extension of the managing pharmacy. When the automated drug distribution system is used to deliver routine doses of controlled substances, the managing pharmacy submit and maintain a separate registration with the drug enforcement administration.

Answer 115

“Automated drug distribution system”, or “automated medication system” or, “system” means a mechanical system that performs operations or activities, other than compounding or administration, related to the storage, packaging, or dispensing of drugs, and collects, controls, and maintains transaction information and records. 16.19.6.27

Answer 116

No, computers for the storage and retrieval of prescription information do not replace the requirement to retain hard copies of prescriptions written by a practitioner or telephoned to the pharmacist. Hard copies must be maintained as a permanent record.

Answer 117

The computer system must be capable of producing a printout of prescription information on demand within a 72-hour period. This printout must include a certification by the practitioner stating it is a true and accurate record. Printouts can be patient specific, practitioner specific, drug specific, or date specific.

Answer 118

No, permanent records of electronic prescriptions that are transmitted directly over approved secure electronic prescribing networks or through other board-approved transmission standards do not need to be reduced to hardcopy.

Answer 119

Electronic prescription information or data must be maintained in the original format for 10 years.

Answer 120

Yes, electronically archived prescription records of scanned images of indirect written or faxed prescriptions are permitted if the following requirements are met: - Images are readily retrievable and can be reproduced within a 72-hour period in compliance with state and federal laws. - The identity of the pharmacist approving the scanned image and the pharmacist responsible for destroying the original document after three years is clearly documented.

Answer 121

- The original paper prescription document must be maintained for a minimum of 3 years. - The original paper prescription for a non-controlled substance must be maintained on the licensed premises for 120 days from the initial date of dispensing. - The original paper prescription for a controlled substance must be maintained on the licensed premises for 2 years from the initial date of dispensing.

Answer 122

Confidential information in the patient record may be released only as follows: ● pursuant to the express written consent or release of the patient or the order of direction of a court; ● to the patient or the patient’s authorized representative; ● to the prescriber or other licensed practitioner then for the patient; ● to another licensed pharmacist where the best interest of the patient require such release; ● to the board or its representative or to such other person or governmental agencies duly authorized by the law to receive such information; ● in compliance with HIPAA regulations regarding protected health information. A pharmacist may provide a copy of a non-refillable prescription to the person. for whom the prescription was issued which is marked “for information purposes only.”

Answer 123

● a licensed hospital pharmacy that distributes such substances for the purpose of inpatient hospital care; ● a practitioner, or other authorized person who administers such a substance; ● a practitioner who dispenses to the patient no more than 12 dosage units or 72 hours’ worth (whichever is less) of such a substance; ● clinics, urgent care or emergency departments dispensing to the patient no more than 12 dosage units or 72 hours’ worth (whichever is less) of such a substance; ● veterinarians or veterinary clinics dispensing to non-human patients.

Answer 124

Occurrences of significant adverse drug events shall be reported in writing to the board **within fifteen days of discovery**. In long-term and custodial care facilities, medication errors and drug reactions should be documented and a method of reporting shall be addressed in the pharmacy procedure manual.

Answer 125

If any person knows or suspects that a licensee is impaired, that person shall report any relevant information either to the **impaired pharmacist program** or to the **board of pharmacy**. . A significant loss or theft of a controlled substance shall be reported in writing to the board of pharmacy and **DEA on form 106 as required by federal regulations**. “Significant loss” includes suspected diversions, in-transit losses or any other unexplained loss and must be reported to the board of pharmacy within five days of becoming aware of that loss. . When a pharmacy is involved in a robbery, burglary, fire, flood or any unusual event in which dangerous drugs might be missing or damaged, the **owner shall immediately file with the board** a signed statement of the circumstances of such occurrence and evidence that local authorities were notified, if applicable.

Answer 126

Dissemination of confidential information or personally identifiable information to a person other than a person authorized by the provisions of the Pharmacy Act or regulations adopted pursuant to that act to receive such information must be reported to the board, in writing, within fifteen days of discovery.

Answer 127

A reasonable effort must be made to obtain, record and maintain at least the following information: ● name, address, telephone number, date of birth (or age) and gender of the patient; ● individual medical history, if significant, including disease state or states, known allergies and drug reactions and a comprehensive list of medications and relevant devices; and ● pharmacists comments relevant to the individual's drug therapy. . Such information contained in the patient record should be considered by the pharmacist or pharmacist intern in the exercise of their professional judgment concerning both the offer to counsel and the content of counseling. . A patient record shall be maintained for a period of not less than three years from the date of the last entry in the profile record.

Answer 128

● clinical abuse/misuse; ● therapeutic duplication; ● drug-disease contraindications; ● drug-drug interactions; ● incorrect drug dosage; ● incorrect duration of drug treatment; ● drug-allergy interactions; ● appropriate medication indication. . Upon recognizing any of the above, a pharmacist, using professional judgment, shall take appropriate steps to avoid or resolve the potential problem. These steps may include requesting and reviewing a controlled substance prescription monitoring report or another states’ reports if applicable and available, and consulting with the prescriber and counseling the patient. The pharmacist shall document steps taken to resolve the potential problem.

Answer 129

● a pharmacist becomes aware of a person currently exhibiting potential abuse or misuse of opioids; ● a pharmacist receives an opioid prescription issued by a prescriber with whom the pharmacist is unfamiliar (i.e. prescriber is located out-of-state or prescriber is outside the usual pharmacy geographic prescriber care area); ● a pharmacist receives an opioid prescription for an unfamiliar patient who resides outside the usual pharmacy geographic patient population area; ● a pharmacist receives an initial prescription for any long-acting opioid formulations, including oral and transdermal dosage forms (e.g fentanyl or methadone); ● a pharmacist becomes aware of a patient receiving an opioid concurrently with a benzodiazepine or carisoprodol. . The pharmacist shall document the review of these PMP reports. PMP reports shall be reviewed a minimum of once every three months during the continuous use of opioids for each established patient. A prescription for an opioid written for a patient in a long term care facility (LTCF) or for a patient with a medical diagnosis documenting a terminal illness is exempt from PMP checking requirements.

Answer 130

Established FDA

Answer 131

OTC vs. Rx

Answer 132

Thalidomide

Answer 133

Child-resistant packaging requirement

Answer 134

Privacy of identifiable health information and security of electronic PHI

Answer 135

Electronic health record implementation

Answer 136

Drug Pricing

Answer 137

Therapeutic Equivalance

Answer 138

International Travel Vaccines

Answer 139

Animal Drug Products

Answer 140

Vaccine-preventable diseases

Answer 141

Biological products

Answer 142

USP 795 Nonsterile Compounding USP 797 Sterile Compounding USP 800 Hazardous Drug Handling

Answer 143

"Prescription" means an order given individually for the person for whom prescribed, and bearing the name and address of the prescriber, the prescriber's license classification, the name and address of the patient, the name and quantity of the drug prescribed, directions for use and the date of issue. All prescriptions for controlled substances shall be dated as of, and signed on, the day when issued and shall bear the full name and address of the patient, the drug name, strength, dosage form, quantity prescribed, directions for use, and the name, address and registration number of the practitioner.

Answer 144

● change the quantity, dosage, dosage form, or directions for use of the medication dispensed if it meets the intent of the prescriber, or ● complete missing information on a prescription if there is sufficient evidence to support the change. ● The pharmacist will document the prescription adaptation as part of the original prescription record. ● The pharmacist will notify the prescriber of the prescription adaptation within 24 hours; and will maintain documentation of notification. ● The pharmacist will provide patient counseling, to include information pertinent to the prescription adaptation. . Information on a controlled substance prescription may be added or clarified by the pharmacist after consultation with the practitioner.

Answer 145

Name of the patient Name of the drug Name of the prescribing physician

Answer 146

Yes, the New Mexico Board of Pharmacy allows pharmacists to add or change information on a Schedule II prescription, following specific guidelines.

Answer 147

The pharmacist should refer to instructions available on the DEA website regarding what changes may be made to a prescription written for a controlled substance in Schedule III-V.

Answer 148

- Add or change the patient’s address upon verification. - Add or change the dosage form, drug strength, drug quantity, directions for use, or issue date only after consulting and obtaining agreement from the prescribing practitioner. These consultations and changes should be noted by the pharmacist on the prescription.

Answer 149

Yes, a pharmacist may add the prescriber’s DEA number and/or address only after consulting and obtaining agreement from the prescribing practitioner. This can be written directly on the prescription or added via a label.

Answer 150

Missing or incorrect information can be written directly on the prescription or added by affixing a label containing the required information to the face or reverse side of the prescription.

Answer 151

Any necessary clinical clarification of a prescription order prior to dispensing may only be performed by a pharmacist or pharmacist intern.

Answer 152

A pharmacist may dispense any of the listed therapeutically equivalent drugs or interchangeable biological products that is lower in cost than the prescribed drug or biological product. A licensed practitioner shall prohibit drug or biological product selection by making an entry that is electronically accessible that includes the words "no substitution" or the diminution "no sub" on a prescription. If drug or biological product selection occurs, the pharmacist shall indicate on the label of the dispensed container the brand of drug or the specific biological product prescribed and the name of the drug or interchangeable biological product dispensed. Within five business days following the dispensing of a biological product, the dispensing pharmacist shall make an entry of the specific product provided to the patient. The communication shall be conveyed by making an entry that is electronically accessible to the prescriber.

Answer 153

A pharmacist may dispense a quantity up to a ninety-day supply of a dangerous drug by combining valid fills when an indication on the prescription or label does not specifically prohibit a combined fill and the dangerous drug to be filled is not a controlled substance. When the practitioner indicates on the original prescription calling for noncontrolled drugs that it may be filled "prn", the pharmacist may fill it within the limits of the dosage directions for a period of twelve months.

Answer 154

The receiving fax machine must be physically located in a restricted area to protect patient confidentiality. The fax prescription shall include name and fax number of the pharmacy, the prescriber’s phone number, for verbal confirmation, time and date of transmission, as well as any other information required by federal and state statute or regulation.

Answer 155

Prescription information received from a patient, other than a signed written prescription from a practitioner, has no legal status as a valid prescription. Electronically generated prescriptions faxed from a practitioner’s office computer shall include the prescriber’s name, phone and fax number, time and date of transmission as well as any other information required by federal and state statutes or regulation.

Answer 156

Answer: Schedule II (with restrictions), Schedules III-V . Explaination: A pharmacist may dispense directly a controlled substance listed in schedule III, IV, or V which is a prescription drug as determined under the New Mexico Drug Device and Cosmetic Act, only pursuant to either a written prescription signed by a practitioner or a facsimile of a written, signed prescription transmitted by the practitioner or the practitioner’s agent to the pharmacy or pursuant to an oral prescription made by an individual practitioner and promptly reduced to written form by the pharmacist containing all information required for a prescription except the signature of the practitioner. A telephone order for a new therapy for an opiate listed in schedule III, IV, or V shall not exceed a 10 day supply, based on the directions for use, unless a written prescription is on file at this pharmacy from any practitioner for the same opiate within the past six months. A telephone order for this new opiate therapy may not be refilled.

Answer 157

Electronically transmitted prescriptions or drug orders shall be sent only to the pharmacy of the patient’s choice.

Answer 158

The receiving computer or other similar electronic device used to view the prescription shall be located within the pharmacy or pharmacy department with only authorized personnel having access.

Answer 159

The electronically transmitted prescription or drug order shall contain all information required by state and federal law including the prescriber’s name, address and phone number, time and date of transmission. The prescribing practitioner’s electronic signature, or other secure method of validation shall be provided with the electronically transmitted prescription or drug order.

Answer 160

Schedules II-V

Answer 161

What Information Must Be Provided? Same as for a written prescription. . Who Can Phone in Prescriptions (Prescriber, Staff, Receptionist)? A prescription may be communicated to the pharmacist by an employee or agent of the registered practitioner. Prescription information retrieved by a pharmacist from an answering machine or voice recording device from an authorized practitioner or approved agent is considered to be a direct transmission of a prescription order.

Answer 162

● The original prescription entry shall be marked in the pharmacy computer system. ● The prescription shall indicate that it has been transferred and pharmacy location and file number of the original prescription. ● In addition to all information required to appear on a prescription, the prescription shall show the date of original fillings as well as the number of valid refills remaining. ● An original unfilled non-controlled substance prescription that is transferred shall be subject to the same record keeping requirements as filled prescriptions. ● Transfer or forwarding of controlled substance prescriptions shall not be allowed electronically except as permitted by federal law. Any transfer of controlled substances listed in Schedules III, IV, and V must be within any rule adopted by the federal DEA under Title 21 CFR 1306.25, for refill purposes. . A pharmacy may not refuse to transfer original prescription information to another pharmacy who is acting on behalf of a patient and who is making a request for this information as specified in this subsection. The transfer of original prescription information must be done in a timely manner.

Answer 163

Intern: YES Techs: NO

Answer 164

The transfer of original prescription information for a controlled substance listed in Schedule III, IV, or V for the purpose of refill dispensing is permissible between pharmacies on a one-time basis only. However, pharmacies electronically sharing a real-time, online database may transfer up to the maximum refills permitted by law and the prescriber's authorization.

Answer 165

The label on the dispensing container must include: ● the name of the patient, ● the date dispensed, ● the name and address of the pharmacy, ● the name and strength of the drug, ● expiration date where applicable, ● adequate directions for use and ● the prescription number. The label affixed to the dispensing container of a drug listed in Schedule II, III or IV, when dispensed to or for a patient, shall contain a clear concise warning that it is a crime to transfer the drug to any person other than the patient.

Answer 166

Compounds - The label attached to the dispensing container shall identify the contents by generic or trade name, or a compounded prescription containing more than three drugs or trade name products, may be labeled "Compound" at the discretion of the pharmacist or prescribing physician, and shall contain the expiration date, per USP/NF's guidelines, as well as the quantity dispensed.

Answer 167

The principal display panel of an over-the-counter packaged drug or device shall bear as one of its principal features a statement of the identity of the commodity. The statement shall include the established name of the drug or the common name of the device and an accurate statement of the general pharmacological category of the drug or the principal intended action of the drug or device in terms meaningful to the layman.

Answer 168

The label for a compounded product dispensed to a patient must include the beyond-use date after which the preparation should not be used.

Answer 169

Upon receipt of a new prescription drug order and following a review of the patient's record, a pharmacist or pharmacist intern shall personally offer to counsel on matters which will enhance or optimize drug therapy with each patient or the patient's agent. Upon receipt of a refill prescription drug order a pharmacy technician may query the patient or patient's agent regarding counseling by the pharmacist or pharmacist intern concerning drug therapy. Patient counseling shall not be required for in-patients of a hospital or institution where other licensed health care professionals are authorized to administer the drug(s). A pharmacist shall not be required to counsel a patient or patient's agent when the patient or patient's agent refuses such consultation. When the patient or agent is not present when the prescription is dispensed including a prescription that was shipped by the mail, the pharmacist shall ensure that the patient receives written notice of available counseling. Such notice shall include days and hours of availability, and of his or her right to request counseling; and a toll-free telephone number in which the patient or patient's agent may obtain oral counseling from a pharmacist who has ready access to the patient's record. For pharmacies delivering more than fifty percent of their prescriptions by mail or other common carrier, the hours of availability shall be a minimum of 60 hours per week and not less than six days per week. The facility must have sufficient toll-free phone lines and personnel to provide counseling within 15 minutes.

Answer 170

● the name and description of the drug; ● the dosage form, dosage, route of administration, and duration of drug therapy; ● intended use of the drug and expected action; ● special directions and precautions for preparation, administration and use by the patient; ● common severe side or adverse effects or interactions and therapeutic contraindications that may be encountered, including their avoidance and the action required if they occur; ● techniques for self-monitoring drug therapy; ● proper storage; ● prescriptions refill information; ● action to be taken in the event of a missed dose; ● the need to check with the pharmacist or practitioner before taking other medication; and ● pharmacist comments relevant to the individual's drug therapy, including any other information peculiar to the specific patient or drug.

Answer 171

Permission must be obtained in writing from the board before any inventory of dangerous drugs or controlled substances can be sold, transferred, disposed of, or otherwise removed from the current premises.

Answer 172

A registrant who wishes to dispose of controlled substances should: 1. Contact the Special Agent in Charge of the DEA in their area by submitting a DEA form 41, which lists the substances to be disposed of, to obtain authority and instructions for disposal. 2. Keep a written memorandum report and use DEA form 41 to record the destruction.

Answer 173

The registrant can: 1. Promptly deliver the controlled substance to a reverse distributor's registered location via common or contract carrier pick-up or by reverse distributor pick-up at the registrant's location. 2. For return or recall, deliver the controlled substance by common or contract carrier pick-up or pick-up by other registrants to: * The registered person from whom it was obtained * The registered manufacturer of the substance * Another registrant authorized by the manufacturer to accept returns or recalls on the manufacturer's behalf.

Answer 174

Records of disposition must be maintained in proper form and available for inspection for at least three years.

Answer 175

Patient dispensed legend and OTC medications that are unwanted or expired may be returned to an authorized pharmacy for destruction. The pharmacy must submit a protocol or subsequent changes to the board or the board’s agent, for approval. Directions for take back for patients and list of accepted and non-accepted products must be posted on the collection unit. Collected medications are not for re-dispensing.

Answer 176

● register with the New Mexico board of pharmacy as a practitioner who will facilitate prescription drug donation; ● provide donor with appropriate form for documentation and verification upon acceptance of an eligible donated drug; and ● identify drug as eligible or ineligible prior to accepting the donated drug.

Answer 177

An "eligible drug" is an unused prescription drug stored in a tamper-evident container or using a tamper-evident process, with an expiration date of six months or greater listed on the packaging. It can only be re-dispensed once.

Answer 178

An "ineligible drug" includes any controlled substances or prescription drugs with REMS requirements (excluding MedGuides, patient package inserts, or communication plans) unless approved by the board.

Answer 179

A: Clinics and participating practitioners must provide separate records or forms documenting the receipt and redistribution of all unused prescription drugs and maintain these records for three years.

Answer 180

Drugs shall not be accepted for return or exchange of any pharmacy after such articles have been taken from the premises where sold or distributed. The pharmacy shall maintain a record of prescriptions which are returned to stock. The record shall include patient name, date filled, prescription number, drug name, drug strength, and drug quantity. The record shall be retrievable within 72 hours.

Answer 181

Patient medication packages with more than one drug within a container may not under any circumstances be returned to a pharmacy stock. A patient medication package stored in a non- institutional setting where there is no assurance of storage standards may not be returned to pharmacy stock. A patient medication package stored in an institutional setting where the storage and handling of the drugs are assured and are consistent with the compendia standards may be returned to the pharmacy stock provided the following guidelines are followed: ● the drug is to be kept within the patient medication package and it is to remain sealed and labeled until dispensed; ● the expiration date of drug shall become fifty percent of the time left of the expiration for the drug; ● no schedule II drugs may be returned to inventory; and ● proper record keeping for the addition of other scheduled drugs into inventory must be done.

Answer 182

E-prescribing for Schedules II-V is now mandatory in most cases.

Answer 183

A pharmacy employee shall verify the identity of the patient or the patient’s representative who is receiving any prescription for a controlled substance listed in schedule II, III, IV, or V before it is released. The ID type, number, name imprinted on that identification, and state must be recorded. Exceptions are: a new controlled substance prescription filled for a patient known to the pharmacist or pharmacist intern, whose identification has already been documented in a manner determined by a written policy developed by the PIC; a controlled substance prescription filled for home delivery; or a controlled substance prescription filled for and delivered to a licensed facility.

Answer 184

Practitioners licensed or certified to prescribe and administer drugs that are subject to the Controlled Substances Act, manufacturers, distributors, and dispensers (among others) are required to register with the Board of Pharmacy. Separate registration is required for each principal place of business or professional practice with the address indicated on the application if drugs are dispensed or distributed from the different locations.

Answer 185

Practitioners, excluding veterinarians, must register with the New Mexico prescription monitoring program in conjunction with their controlled substance registration.

Answer 186

● for patients residing in an intermediate care, skilled nursing or correctional facility; ● for patients enrolled in hospice; ● for an animal by a licensed veterinarian; ● a prescription dispensed by a federal facility not subject to state regulation (e.g. department of veteran affairs, indian health services, military bases); ● a prescription requiring information that makes electronic transmission impractical; ● for compounded prescriptions; ● for prescriptions issued during a temporary technical or electronic failure or in an emergency. . Unless otherwise specified, a pharmacist who receives a written, oral, or facsimile prescription shall not be required to verify that the prescription is subject to an exemption.

Answer 187

● A prescription for a schedule II may be transmitted by the practitioner or agent to a pharmacy via fax, provided the original written, signed prescription is presented to the pharmacist for review prior to the actual dispensing of the controlled substance. ● A prescription written for a schedule II narcotic to be compounded for the direct administration to a patient by parenteral, intravenous, intramuscular, or subcutaneous infusion may be transmitted by the practitioner or agent to the parenteral products pharmacy by fax. The fax serves as the original written prescription. ● A prescription written for a schedule II for a resident of a long term care facility may be transmitted by the practitioner or agent to the dispensing pharmacy by fax. The fax serves as the original written prescription. ● A prescription written for a schedule II narcotic for a patient enrolled in a hospice program certified by Medicare under title XVIII or licensed by the state may be transmitted by the practitioner or agent to the dispensing pharmacy by fax. The practitioner or agent will note on the prescription that the patient is a hospice patient. The fax serves as the original written prescription. ● A pharmacist may dispense directly a controlled substance listed in schedule III, IV, or V which is a prescription drug, only pursuant to either a written prescription signed by a practitioner or a fax of a written, signed prescription transmitted by the practitioner or agent to the pharmacy or pursuant to an oral prescription made by an individual practitioner and promptly reduced to written form by the pharmacist containing all information required for a prescription except the signature of the practitioner.

Answer 188

**Q: What are the classifications of pseudoephedrine, butalbital, and nalbuphine in New Mexico?** **A:** In New Mexico: - **Pseudoephedrine** is classified as a Schedule V drug, with exceptions for pseudoephedrine products in liquid form (including liquid-filled gel caps) and those products already classified as dangerous drugs. - **Butalbital** (Fioricet) is classified as a Schedule III drug. - **Nalbuphine** is classified as a Schedule IV drug.

Answer 189

**A:** Prescriptions for any controlled substance cannot be filled more than six months after the date of issue.

Answer 190

A: A telephone order for a new therapy involving opiates listed in Schedule III, IV, or V shall not exceed a 10-day supply based on the directions for use, unless a written prescription for the same opiate from any practitioner is on file at the pharmacy from the past six months. Additionally, a telephone order for this new opiate therapy may not be refilled.

Answer 191

- **Schedule II drugs**: Prescriptions may not be refilled. - **Schedule III, IV, or V controlled substances**: Prescriptions may be refilled up to five times. For controlled substances: - **Directly dispensed to a patient**: Refills cannot occur before 75% of the prescribed days' supply has passed, unless authorized by the practitioner and documented by the pharmacist. - **Delivered indirectly (e.g., mail order)**: Refills cannot occur before 66% of a 90-day supply or 50% of a 30-day supply has passed, unless authorized by the practitioner and documented by the pharmacist.

Answer 192

● the total quantity dispensed in all partial fillings does not exceed the total quantity prescribed; ● the partial fill amount is recorded on the written prescription or in the electronic prescription record; and ● the remaining portions shall be filled not later than 30 days after the date on which the prescription is issued.

Answer 193

● the pharmacist is unable to dispense the total quantity prescribed; ● the partial fill amount is recorded on the written prescription or in the electronic prescription record; ● the remaining portion is filled within 72 hours of the partial filling; and ● the pharmacist notifies the prescribing physician if the remaining portion cannot be filled within the 72 hour period. No further quantity may be supplied beyond 72 hours without a new prescription.

Answer 194

- Partial Filling: Schedule II prescriptions may be filled in partial quantities, including individual dosage units. - Recording Requirements: The prescription must note if the patient is “terminally ill” or an “LTCF patient.” Each partial fill must be recorded with the date, quantity dispensed, remaining quantity authorized, and the pharmacist's identification on the back of the prescription or on a uniformly maintained and retrievable record. - Quantity Limit: The total quantity dispensed through partial fillings cannot exceed the total quantity prescribed. - Prescription Validity: Schedule II prescriptions are valid for up to 60 days from the issue date, unless discontinued earlier.

Answer 195

- Recording Requirements: Partial fillings must be recorded in the same manner as refills. - Quantity and Time Limit: The total quantity dispensed through partial fillings cannot exceed the total quantity prescribed, and no dispensing can occur after six months from the date of the prescription.

Answer 196

● the quantity prescribed is **limited to the amount needed to treat the patient during the emergency period**; ● the pharmacist shall reduce the prescription to a written form and it contains all information required of a schedule II prescription except the signature of the prescribing practitioner; ● the prescribing physician, **within seven days** after authorization of the emergency dispensing, shall furnish a written, signed prescription to the pharmacist. The signed prescription shall have written on the face “AUTHORIZATION FOR EMERGENCY DISPENSING” and the date of the oral order or facsimile order; ● the signed prescription shall be attached to the oral emergency prescription order or the fax emergency prescription order and be filed as other schedule II prescriptions. In the event the prescribing physician fails to deliver a signed written prescription to the pharmacist, **within the seven days period, the pharmacist shall notify the nearest DEA office, and the board of pharmacy.**

Answer 197

A: All registrants must conduct an initial inventory of all controlled substances on hand on the date they first engage in controlled substances activity. If no controlled substances are on hand, this fact must be recorded on the initial inventory.

Answer 198

A: Registrants must conduct an annual inventory on May 1 or on their regular physical inventory date. If an alternate annual inventory date is used, the board of pharmacy must be notified.

Answer 199

A: When a substance is added to any schedule and was not previously listed, every registrant who possesses that substance must take an inventory of all stock of the substance and file this record with the other inventory records.

Answer 200

A: Upon a change of PIC, an inventory of all controlled substances must be taken within 72 hours by the new PIC.

Answer 201

A: Upon the transfer of ownership of a pharmacy, an inventory of all controlled substances must be taken by the PIC.

Answer 202

A: The inventory must include: The date and time taken (e.g., opening or close of business). Drug name, strength, and form (e.g., tablet, capsule). Number of units or volume and the total quantity. Documentation of expired or unusable controlled substances. The name, address, and DEA registration number of the registrant. The signature of the person or persons responsible for taking the inventory.

Answer 203

Every pharmacy that dispenses a controlled substance must be registered with the DEA. A state license must be obtained. Federal agencies are exempt from the state license requirement.

Answer 204

The requirement of registration is waived for any official of the U.S. Army, Navy, Marine Corps, Air Force, Coast Guard, Public Health Service, or Bureau of Prisons who is authorized to prescribe, dispense, or administer, but not to procure or purchase, controlled substances in the course of his/her official duties.

Answer 205

DEA Form 224 – Retail Pharmacy, Hospital/Clinic, Practitioner, Teaching Institution, or Mid-Level Practitioner

Answer 206

DEA Form 225 – Manufacturer, Distributor, Researcher, Canine Handler, Analytical Laboratory, Importer, Exporter

Answer 207

DEA Form 363 – Narcotic Treatment Programs

Answer 208

DEA Form 510 – Domestic Chemical

Answer 209

The Unique Identification Number (UIN) or “X” number authorizes a DEA registered, Qualified Practitioner (e.g., a physician) under the Drug Addiction Treatment Act of 2000 or Qualifying Other Practitioner (i.e., nurse practitioner, physician’s assistant, clinical nurse specialists, certified registered nurse anesthetists, or certified nurse midwives) under the Comprehensive Addiction and Recovery Act of 2016 and the SUPPORT for Patients and Communities Act of 2018, to prescribe schedule III-V narcotic controlled substances approved by the Food and Drug Administration specifically for maintenance and detoxification treatment.

Answer 210

Two letters followed by seven numbers. ● First letter: o A, B, F is a full practitioner. X is a full practitioner with buprenorphine privileges. o M is a mid-level practitioner ● Second letter: First letter of prescriber’s last name ● Math o Step one: 1st, 3rd, and 5th number are added together. o Step two: 2nd, 4th, and 6th number are added together and multiplied by two. o Step three: Add the products from step one and two together o The 7th number of the DEA number should be equal to the last digit of the number in step three

Answer 211

$888, must be renewed every 3 years.

Answer 212

Complete DEA Form 224a online

Answer 213

DEA policy allows the reinstatement of an expired registration for one calendar month after the expiration date. If the registration is not renewed within that calendar month, an application for a new DEA registration is required.

Answer 214

222 form-ordering controlled substances

Answer 215

106 form- theft or loss of controlled substances

Answer 216

41 form- expiration of controlled substances

Answer 217

Receipts for Schedule III-V controlled substances must include the following information: 1. **Substance Name:** The name of the substance. 2. **Finished Form Details:** Each finished form and the number of units or volume of finished form in each commercial container. 3. **Acquisitions from Other Persons:** - Number of units of finished forms and/or commercial containers acquired. - Date of acquisition. - Number of units and/or commercial containers in each acquisition. - Name, address, and registration number of the person from whom the units were acquired. 4. **Distributions to Other Persons:** - Number of commercial containers distributed. - Date of distribution. - Number of containers in each reduction from inventory. - Name, address, and registration number of the person to whom the containers were distributed. 5. **Other Distributions or Disposals:** - Number of units of finished forms and/or commercial containers distributed or disposed of. - Date and manner of distribution or disposal. - Name, address, and registration number of the person to whom distributed. - Quantity in finished form distributed or disposed. Receipts must be maintained either separately from all other records or in a manner that makes the required information readily retrievable from the registrant’s ordinary business records.

Answer 218

**For Pharmacists:** 1. **Prescriptive Authority:** - Pharmacist prescriptive authority for naloxone must follow a written protocol approved by the board. 2. **Prescription Requirement:** - A written or electronic prescription must be generated for any naloxone dispensed. 3. **Informed Consent:** - Document and maintain informed consent in the pharmacy for at least three years. 4. **Notification:** - Notify the patient's designated physician or primary care provider within 15 days of naloxone dispensing, provided the patient has signed consent. **For Healthcare Providers:** 1. **Initial Opioid Prescription:** - Advise the patient on the risks of overdose. - Inform the patient of the availability of an opioid antagonist. 2. **Opioid Analgesic Prescription (Five-Day Supply or More):** - Co-prescribe an opioid antagonist if the opioid analgesic prescription is for at least a five-day supply.

Answer 219

1. Participating Pharmacists will successfully complete a certification prescriptive authority training approved by the Board and maintain this certification with the Board by completing 2 hours of live continuing education in this area every two years. 2. A primary option of an NRK may include the following contents (the pharmacist will be responsible for the assembly of the NRKs): i. Naloxone 2mg/2ml syringes ii. Intranasal trumpet device iii. Educational handout(s) 3. Other secondary options of naloxone for rescue use as approved by the FDA may be used.

Answer 220

1. Patient is screened and evaluated by the Pharmacist for the risk of overdose. Potential opioid overdose witnesses do not need to be screened, although the Pharmacist should discuss the person the potential witness believes to be at risk of overdose. 2. Consent form must be completed and signed before the prescribing and dispensing of NRK to the individual at Risk of Experiencing, or Witnessing an Opioid-Related Overdose. 3. Notify the patient’s primary care provider with the consent of the patient (if available) **within 15 days** of the original prescription.

Answer 221

1. An individual who there is reason to believe is experiencing or at risk of experiencing an opioid-related overdose; or 2. A family member, friend, or other person in a position to assist an individual who there is reason to believe is at risk of experiencing an opioid-related overdose.

Answer 222

1. Prescribed long-acting opioid (oxycodone ER, oxymorphone ER, morphine ER, transdermal fentanyl, methadone or buprenorphine). 2. A high daily dose of opioid prescribed. 3. Prescribed opiates or opioid use greater than 30 days. 4. History of or current polyopioid use. 5. Opioid use with certain concurrent diseases such as: renal dysfunction, liver disease, respiratory infection, sleep apnea, COPD, emphysema or other respiratory/airway disease that can lead to potential airway obstruction. 6. Concurrent prescription or OTC medication that could potentiate the CNS and respiratory depressant properties of opioid medications, such as benzodiazepines, antipsychotics, carisoprodol, and/or antihistamine use. 7. Known or suspected substance use, such as alcohol and/or marijuana. 8. Elderly patients (> 65) receiving an opioid prescription. 9. Teens receiving an opioid prescription. 10. Households with people at risk of overdose, such as children and/or someone with a substance abuse disorder. 11. Patients who may have difficulty accessing emergency medical services (distance, remoteness, lack of transportation, homelessness, and/or without phone services). 12. Patients as determined by the Pharmacist using their professional judgment.

Answer 223

**G. Mechanism of Action** Naloxone is an opioid antagonist with greatest affinity for the mu receptor. It acts by competing for the mu, kappa, and sigma opioid receptor sites in the CNS. **H. Indication** Naloxone is indicated for known or suspected overdose of an opioid and for the reversal of opioid activity, respiratory depression, with therapeutic opioid use. **I. Contraindications** Hypersensitivity to naloxone.

Answer 224

1. Abrupt reversal of opioid depression may result in nausea, vomiting, sweating, tachycardia, increased blood pressure, tremulousness, seizures, ventricular tachycardia and fibrillation, pulmonary edema, and cardiac arrest which may result in death. 2. Abrupt reversal of opioid effects in persons who are physically dependent on opioids may precipitate an acute withdrawal syndrome which may include, but not limited to the following signs and symptoms: body aches, fever, sweating, runny nose, sneezing, piloerection, yawning, weakness, shivering or trembling, nervousness, restlessness or irritability, diarrhea, nausea or vomiting, abdominal cramps, increased blood pressure, and tachycardia. 3. Known or suspected physical dependence on opioids; naloxone will precipitate withdrawal symptoms within minutes after administration and will subside in about 2 hours; observe patients for recurrence of respiratory depression and other narcotic effects for at least 2 hours after the last dose of naloxone and until there is no reasonable risk of recurrent respiratory depression. 4. Acute toxicity caused by levopropoxyphene; naloxone is not effective. 5. Agitation; excessive doses of naloxone may result in significant reversal of analgesia. 6. Liver disease; naloxone is primarily metabolized in the liver; use with caution. 7. Newborns of mothers suspected of long-term opioid use; do not administer naloxone due to risk of seizures and/or acute withdrawal. 8. Partial opioid agonist and mixed opioid agonist/antagonist overdose: Reversal of partial opioid agonists or mixed opioid agonist/antagonists (e.g., buprenorphine, pentazocine) may be incomplete and large doses of naloxone may be required.

Answer 225

1. Cardiac Disorders: pulmonary edema, cardiac arrest or failure, tachycardia, ventricular fibrillation, and ventricular tachycardia. Death, coma, and encephalopathy have been reported as sequelae of these events. 2. Gastrointestinal Disorders: vomiting, nausea. 3. Nervous System Disorders: convulsions, paresthesia, grand mal convulsion. 4. Psychiatric Disorders: agitation, hallucination, tremulousness. 5. Respiratory, Thoracic, and Mediastinal Disorders: dyspnea, respiratory depression, hypoxia, pulmonary edema. 6. Skin and Subcutaneous Tissue Disorders: nonspecific injection site reactions, sweating. 7. Vascular Disorders: hypertension, hypotension, hot flashes, or flushing.

Answer 226

1. Once the patient is identified to be at high risk, the Pharmacist will provide overdose prevention education and training, which includes proper administration of nasal naloxone and the required immediate medical follow-up after proper use of NRK. Potential overdose witnesses should receive the same education and training. 2. Face-to-face education is required on the proper use of the NRK, including a plan for overdose prevention and adverse effects. A designated rescue person or persons must be identified by the patient. 3. The individual at Risk of Experiencing or Witnessing an Opioid-Related Overdose will be provided with educational materials and a handout describing caregiver medication administration. 4. Family members and/or caregivers are encouraged to attend the appointment to also receive training at the time the patient receives the NRK. 5. Follow-up training and reinforcement is encouraged, the pharmacist will provide their contact information for any questions or concerns. 6. In the event the NRK is used or expired, the patient or potential overdose witness will return to the Pharmacist to request a new prescription; a thorough evaluation will be completed by the Pharmacist regarding the events leading to NRK use and to determine whether appropriate medical follow-up was completed, as required.

Answer 227

A prescription may not be issued for the dispensing of narcotic drugs listed in any schedule to a narcotic dependent person for the sole purpose of continuing his dependence upon such drugs, unless the narcotic controlled drug is in Schedule III, IV, or V and is approved by the FDA specifically for use in maintenance or detoxification treatment; and the prescribing practitioner meets all state and federal requirements to prescribe the narcotic for maintenance or detoxification treatment (e.g. DATA waived practitioner.)

Answer 228

Number of Refills Allowed: 0 How long is RX valid for?: 6 months

Answer 229

Number of Refills Allowed: 5 How long is RX valid for?: 6 months

Answer 230

Number of Refills Allowed: 5 How long is RX valid for?: 6 months

Answer 231

Number of Refills Allowed: 5 How long is RX valid for?: 6 months

Answer 232

* The purpose of the Act is to allow the beneficial use of medical cannabis in a regulated system for alleviating symptoms caused by debilitating medical conditions and their medical treatments. * The Department’s objective is to provide patients with safe access to safe medicine.

Answer 233

**Patient can apply by completing an application. Application requirements include:** * Patient information and signature. * Signature from a provider with prescribing authority certifying the applicant has been diagnosed with one of the qualifying conditions to become a patient in the program. * A valid New Mexico ID. * A patient can designate a primary caregiver to purchase, possess, store and help with dosing of medicine. The Department issues identification cards to approved primary caregivers.

Answer 234

* Each application is reviewed medically and administratively to ensure all requirements are met. * Beginning June 14, 2019 patient cards will be issued for three years. * Cards approved prior to 06-14-19, will keep the current expiration date and patients will need to reapply thirty (30) days prior to the expiration date.

Answer 235

* Patients or primary caregivers are allowed to possess no more than 230 units (approximately eight ounces of flower or buds). * The right to purchase from a Licensed Non-Profit Producer. * The right to possess any paraphernalia in connection with their use of medical cannabis. * If the patient is not in possession of their card, they shall be given time to produce the card before arrest or criminal charges (Lynn and Erin Compassionate Use Act). * The right to apply for a personal production license (PPL), to allow enrollee to grow for personal use. If approved, the patient or primary caregiver can have up to sixteen plants, with no more than four flowering plants. No more than two PPLs are allowed per location (address). * Patients or primary caregivers with a Personal Production License can keep their harvest. * Patients or primary caregivers may transfer (not sell) up to two ounces of cannabis to other patients or primary caregivers. * Primary caregivers may care for up to four patients. * A primary caregiver may hold a PPL to grow plants for a patient.

Answer 236

(1) criminal prosecution or civil penalties for activities not authorized in the Lynn and Erin Compassionate Use Act; (2) liability for damages or criminal prosecution arising out of the operation of a vehicle while under the influence of cannabis; or (3) criminal prosecution or civil penalty for possession or use of cannabis: (a) in the workplace of the qualified patient's or primary caregiver's employment; (b) at a public park, recreation center, youth center or other public place.