NMBOP: 16.19.06 PHARMACIES Flashcards

Question

NOTICE OF EMPLOYEE CHANGE: Proprietors of pharmacies must report on the annual application for renewal of pharmacy license the names and registry numbers of all registered pharmacist employees and registered interns and shall notify the secretary of the board of pharmacy within _________________, in writing, of any change in personnel.

Answer 1

**Answer:** The following must be displayed in full view of patrons: - Pharmacy license - Prohibition of the return of drugs sign - Current board of pharmacy inspection report - Current controlled substance registration - “Patient’s Bill of Rights” as approved by the board

Answer 2

**Answer:** All pharmacists must wear name tags that include their job title and the designation "R.Ph." while on duty.

Answer 3

**Answer:** Pharmacies permanently closing must: - Notify the public and the board of pharmacy at **least 30 days** prior to the final day of service. - 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. - Provide notice through one of the following methods: newspaper notice, radio broadcast, or other method approved by the executive director of the board.

Answer 4

**Answer:** Drugs, medicines, sickroom supplies, and items of personal hygiene cannot be accepted for return or exchange by any pharmacist or pharmacy once they have been taken from the premises where sold or distributed.

Answer 5

**Answer:** The record must include: - Patient name - Date filled - Prescription number - Drug name - Drug strength - Drug quantity **Additional Information:** The record must be retrievable within 72 hours.

Answer 6

**Answer:** Permission must be obtained in writing from the board, after inspection. All sales are subject to the laws of the state.

Answer 7

**Answer:** The pharmacy must submit a protocol or subsequent changes to the board or the board’s agent for approval. Once approved, the pharmacy is authorized to collect pharmaceuticals for destruction. The protocol must include: - **Secure Collection Unit:** A secure and enclosed collection unit that does not allow for unauthorized access. - **Dedicated Area Description:** A description of the dedicated area for the collection unit inside the pharmacy, within sight of authorized pharmacy staff. - **Direction of Collection:** Safe and secure disposition directions. - **Disposal Company Information:** Name of the contracted disposal company that is licensed for pharmaceutical destruction. - **Frequency of Collection:** Frequency of collection and destruction by the disposal company. - **Records of Collection:** Records of collection and destruction supplied by the disposal company.

Answer 8

**Answer:** - Dangerous drugs (prescription drugs) - Controlled substances if authorized under federal law or rule - Over-the-counter medications - Veterinary medications - Medicated ointments and lotions - Liquid medication in glass or leak-proof containers

Answer 9

**Answer:** - Needles - Thermometers - Bloody or infectious waste - Personal care products - Controlled substances (unless authorized by federal law) - Hydrogen peroxide - Empty containers - Business waste

Answer 10

**Answer:** Directions for take back for patients and a list of accepted and non-accepted products must be posted on the collection unit.

Answer 11

**Answer:** The pharmacy’s authority to collect and dispose of dispensed pharmaceuticals will be suspended. The pharmacy may petition the board for the removal of that suspension.

Answer 12

Answer: The owner must immediately file a signed statement with the board detailing the circumstances of the occurrence and provide evidence that local authorities were notified, if applicable.

Answer 13

Answer: The board may require an examination of any stock that may be adulterated, deteriorated, or of questionable quality. Merchandise deemed unfit for sale may be embargoed if the owner does not voluntarily consent to destruction. If drugs are embargoed, the owner must bear the expense of assay to prove purity, strength, and product quality.

Answer 14

**Answer:** The permit issued by the board must be immediately surrendered to the board office. All drug signs and symbols, either within or outside the premises, must be removed. All drugs, devices, and poisons must be removed or destroyed.

Answer 15

**Answer:** Any store or place of business with signs or words like "pharmacist," "pharmaceutical chemist," "druggist," "pharmacy," "drug store," "drugs," "drug sundries," "prescriptions," or similar terms must obtain a license from the board of pharmacy. If not licensed, the business must remove any such signs or words.

Answer 16

**Answer:** Yes, the board may grant a waiver upon petition. The petition must include: 1. Name of the party 2. Address of the business 3. Type of business 4. Reason for the waiver request 5. Supporting documents 6. Photographs of the business showing the use of the sign or words in question

Answer 17

**Answer:** Yes, pharmacists registered in New Mexico may advertise their professional services, but such advertisements must not solicit prescription drug sales unless done in conjunction with a licensed pharmacy.

Answer 18

**Answer:** An advertiser can use names like "pharmacy," "drug store," or similar terms only if: 1. The advertiser is or has a licensed pharmacy in New Mexico, or 2. The advertiser is or has a non-resident pharmacy licensed in New Mexico, or 3. The advertisement includes a clear statement such as "the advertiser is not a licensed pharmacy and does not fill prescriptions or practice pharmacy," and 4. The advertisement discloses the name of the licensed pharmacy where prescriptions are filled for New Mexico residents, and 5. Any confidential information is obtained by authorized persons.

Answer 19

**Answer:** "Labeling" or "to label" means the act of affixing, applying, or attaching written, printed, or graphic matter on or in the immediate container of any human use drug, repackaged or dispensed on a practitioner's order. This function is restricted to registered pharmacists and registered pharmacist interns as required by the Pharmacy Act, Section 61-11-21 NMSA 1978, except as specified in board Regulation Article 15.

Answer 20

**Answer:** Under the Drug and Cosmetic Act, "label" or "labeling" refers to the manufacturer or repackager's label required on the commercial container when the substance is offered for sale or distributed by the manufacturer or repackager.

Answer 21

**Answer:** Both pharmacists and drug manufacturers are responsible for packaging drug products according to the monographs for drug products recognized in the official compendium. After August 27, 1978, drug products must provide information for the pharmacist to maintain the identity, strength, quality, and purity of the product. Standards for proper dispensing containers, effective April 1, 1977, apply to both manufacturers' containers and pharmacists' dispensing containers. Manufacturers of non-compendia drug products must use terminology from an official compendium to describe suitable containers, including standards for tightness of seal, light resistance, moisture permeability, and special instructions like "keep in a cold place" or "avoid exposure to excessive heat."

Answer 22

**Answer:** The label must identify the contents by generic or trade name. For compounded prescriptions containing more than three drugs or trade name products, the label may state "Compound" at the pharmacist's or prescribing physician's discretion. The label must also include the expiration date, per USP/NF guidelines, and the quantity dispensed, as required by the Drug and Cosmetic Act, Subsection B of Section 26-1-16 NMSA 1978, unless the prescribing practitioner specifically requests that such information be omitted from the label.

Answer 23

**Answer:** Before changing its location or physical dimensions, a licensed pharmacy must submit a new application to the board detailing the changes. After approval, the pharmacy must request an inspection from the chief inspector. There is no charge for the new application, but the inspection will incur the same fee as for a new pharmacy inspection.

Answer 24

A. The sale of the pharmacy to another individual or individuals by the present owner. B. The addition or deletion of one or more partners in a partnership. C. The death of a singular or sole owner. D. The change of ownership of thirty percent or more of the voting stock of a corporation since the issuance of the license or last renewal application. A new license application will be required to be filed in each of the above circumstances. As stated in the Pharmacy Act, Subsection I of Section 61-11-14 NMSA 1978, licenses are not transferable, and shall expire on December 31 of each year unless renewed.

Answer 25

**Answer:** An advertisement must not stimulate demand or promote the overuse or abuse of dangerous drugs, as this can negatively impact public health. Advertisers must provide truthful information to avoid misleading consumers. They should avoid sales "gimmicks" and misleading terms like "cheapest" or "lowest" that falsely suggest bargains.

Answer 26

**Answer:** Comparisons should not be made or implied between the price of an article and another reference price unless the reference price is explicitly identified and substantiated. Comparative pricing should clearly differentiate current prices from reference prices and not use vague terms like "same forty percent" unless supported by evidence. . . . When comparing drug prices in ads, you need to clearly show the price you’re comparing to and prove it’s accurate. You shouldn’t use vague phrases like "forty percent cheaper" without solid evidence. Make sure it’s obvious which price is current and which one you’re comparing it to.

Answer 27

**Answer:** Advertisements offering lowered prices due to unusual circumstances (like clearance) must accurately reflect the lower prices and the true circumstances. The terms of the sale, quantities available, and the period during which the prices are valid must be clearly disclosed.

Answer 28

**Answer:** Advertised prices for different articles should only be compared if the price for each article is explicitly identified and substantiated. The comparability must be based on established standards of identity or performance, or the advertiser must prove that the articles are substantially identical, or the articles must be specifically identified.

Answer 29

**Answer:** Advertisements must include: 1. The proprietary or trade name of the drug. 2. The established name of the drug. 3. The established name and quantity of each active ingredient, unless the drug has more than three active ingredients (except for specific combinations). 4. The name of the manufacturer, packager, or distributor. 5. The dosage form. 6. The price for a specific quantity of the drug, including all charges. 7. Included services like professional fees, patient records, delivery, charge privileges, pharmaceutical counseling, emergency service, tax/insurance info, and service hours.

Answer 30

**Answer:** Advertising is prohibited for: 1. Prescription drugs or OTC drugs that are controlled substances under the New Mexico Controlled Substances Act, except for price disclosure. 2. Prescription drugs requiring a box warning statement by the FDA due to significant risks of fatalities or serious damage. 3. Drugs evaluated as "possibly effective" by the drug efficacy study group, with no higher efficacy claims

Answer 31

**Answer:** Computers used for storing prescription information must be maintained in compliance with the Pharmacy Act, the Drug, Device, and Cosmetic Act, the Controlled Substance Act, and board regulations. Prescriptions written or telephoned to a pharmacist must be retained as permanent records in hardcopy.

Answer 32

**Answer:** A pharmacy must produce a printout within 72 hours on demand, including: 1. Original prescription number. 2. Practitioner’s name. 3. Patient's full name and address. 4. Date of issuance and date filled. 5. Name, strength, dosage form, and quantity of the drug. 6. Total number of refills authorized. 7. Quantity dispensed if different from prescribed. 8. For controlled substances: practitioner’s name, address, DEA number, and drug schedule. 9. Identification of the dispensing pharmacist.

Answer 33

**Answer:** Electronic prescription records must be maintained in the original format for 10 years. Documentation of business associate agreements, reliable backup copies, and fulfillment of all prescription and record-keeping requirements, including identifying the dispensing pharmacist, are required.

Answer 34

**Answer:** Scanned images must be: 1. Readily retrievable and reproducible within 72 hours. 2. Clearly document the approving pharmacist and the pharmacist responsible for destroying the original document after three years. 3. Show an exact and legible image of the original prescription. 4. Maintain the original paper document for three years and the electronic image for 10 years. 5. Not be for controlled substances unless permitted by federal law. 6. Include reliable backup copies stored securely. 7. Maintain original paper documents for 120 days for non-controlled substances and two years for controlled substances on the licensed premises.

Answer 35

**Answer:** Offsite storage of electronic records must ensure: 1. Records are readily retrievable. 2. Compliance with Health Insurance Portability and Accountability Act (HIPAA) and board privacy requirements. 3. Reliable backup copies are securely stored as approved by the board.

Answer 36

**Answer:** Offsite storage must: 1. Secure records from unauthorized access. 2. Maintain appropriate fire suppression and climate control. 3. Comply with HIPAA and board privacy requirements. 4. Include a record-keeping system that documents storage locations and inventory. 5. Ensure records can be produced within three business days upon request by the board or authorized law officers.

Answer 37

**Answer:** A valid prescription is an order for a dangerous drug given individually for the person prescribed, either directly from the practitioner to the pharmacist or indirectly via a written order signed by the practitioner. Signing includes handwritten, stamped, or electronic signatures. Each prescription record must include the prescriber’s name and address, patient’s name and address, drug name and strength, quantity prescribed, directions for use, date of issue, and preferably the diagnosis or indication.

Answer 38

**Answer:** Yes, a prescription may be prepared by a secretary or agent under the practitioner’s supervision, and may be communicated to the pharmacist by an employee or agent of the registered practitioner. The prescribing practitioner is responsible if the prescription does not conform to legal and regulatory requirements.

Answer 39

**Answer:** Prescription information received from a patient, other than a signed written prescription from a practitioner, has no legal status as a valid prescription. The pharmacist must contact the prescribing physician for a new prescription.

Answer 40

**Answer:** 1. The original prescription must be marked in the pharmacy’s computer system or on the hard copy if no computer is used. 2. The prescription must indicate it has been transferred and include the original pharmacy location and file number. 3. The prescription must show the date of original filling and the number of valid refills remaining. 4. Unfilled non-controlled substance prescriptions transferred are subject to the same record-keeping as filled prescriptions. 5. Controlled substance prescriptions cannot be transferred electronically except as permitted by federal law. 6. A pharmacy cannot refuse to transfer original prescription information and must do so in a timely manner.

Answer 41

**Answer:** 1. The pharmacist must verify the accuracy and authenticity of the faxed prescription. 2. The fax prescription must be printed and stored as per state and federal law and board rules. 3. The fax must include the pharmacy’s name and fax number, prescriber’s phone number, time and date of transmission, and any required information. 4. In institutional practice, the fax machine operator must be identified in the facility policy. 5. The fax machine must be in a restricted area for patient confidentiality. 6. Electronically generated prescriptions can be transmitted via telephone lines or through “contracted” network vendors to a pharmacy’s fax machine. 7. Electronically generated prescriptions from a practitioner’s office computer or “point of care vendor” must include required details. 8. Non-compliant vendors are considered invalid sources. 9. The pharmacist must exercise professional judgment regarding the accuracy and authenticity of faxed prescriptions.

Answer 42

**Answer:** 1. The receiving device must be located within the pharmacy with access limited to authorized personnel. 2. The electronic prescription must include all required information and the prescriber’s electronic signature or secure validation. 3. The electronic prescription can serve as the hard copy record if it can be stored in its original format and is readily retrievable. 4. The transmission must maintain patient confidentiality with no unauthorized access or alteration, except for format modifications. 5. Prescriptions must be sent to the pharmacy of the patient’s choice. 6. Non-compliant vendors are invalid sources. 7. Pharmacists must exercise professional judgment regarding electronically transmitted prescriptions from approved vendors.

Answer 43

**Answer:** Confidential information, including prescription contents, therapeutic effects, or any medical information, may be released: 1. Pursuant to written consent or court order. 2. To the patient or their authorized representative. 3. To the prescriber or licensed practitioner for the patient. 4. To another licensed pharmacist if in the patient's best interest. 5. To authorized governmental agencies or the board as permitted by law. 6. In compliance with HIPAA regulations. **Exceptions:** 1. Transferring a prescription to another pharmacy for patient counseling. 2. Providing a copy of a non-refillable prescription marked “for information purposes only.” 3. Providing drug therapy information to authorized prescribers. 4. As required by patient counseling regulations.

Answer 44

**Answer:** Yes, prescription information retrieved from answering machines or voice recording devices from an authorized practitioner or approved agent is considered a direct transmission of a prescription order.

Answer 45

**Answer:** A pharmacist may: 1. Change the quantity, dosage, dosage form, or directions for use if it meets the prescriber’s intent. 2. Complete missing information if there is sufficient evidence to support the change. 3. Document the adaptation as part of the original prescription record. 4. Notify the prescriber within 24 hours and maintain documentation of the notification. 5. Provide patient counseling, including information pertinent to the adaptation.

Answer 46

means any pharmacy located outside New Mexico that ships, mails or delivers in any manner prescription drugs to New Mexico patients or consumers. For purposes of this definition only, “delivers” includes the provision of dispensing process pharmacy services such as prescription entry, prospective drug review, or prescription verification.

Answer 47

means any drug required by federal or New Mexico law or regulation to be dispensed only by a prescription and includes "dangerous drugs" and "controlled substances" as defined by federal and New Mexico law.

Answer 48

means the state in which the nonresident pharmacy is a resident

Answer 49

Answer: No nonresident pharmacy may ship, mail, or deliver prescription drugs to a patient in New Mexico unless it is licensed by the board. Additionally, no nonresident pharmacy may ship, mail, or deliver controlled substances to a patient in New Mexico unless it is registered with both the Drug Enforcement Administration (DEA) and the board for controlled substances.

Answer 50

Answer: A person who ships, mails, or delivers prescription drugs to New Mexico patients from more than one nonresident pharmacy must obtain a separate New Mexico nonresident pharmacy license for each pharmacy.

Answer 51

**Answer:** Each nonresident pharmacy applying for licensure must submit: - The address of the principal office, names, and titles of all principal corporate officers and dispensing pharmacists, with annual updates and within 30 days of any changes. - Proof of a valid license, permit, or registration to operate in the resident state. - A copy of the most recent inspection report from the resident state's regulatory or licensing agency. - If compounding sterile preparations (CSP), a copy of the most recent CSP operations inspection report showing conformance with applicable USP/NF General Chapters, conducted within the last 12 months. - The policy and procedure manual required by the board. - Proof of a toll-free telephone service available to New Mexico patients. - The name and address of a resident in New Mexico for service of process. - An application for controlled substances if applicable. - All fees required by the board. - A completed application within 12 months of receipt by the board, or it will be considered withdrawn, requiring a new application and fee for consideration.

Answer 52

**Answer:** Each nonresident pharmacy must designate a resident agent in New Mexico for service of process. If no agent is designated, the secretary of state will be deemed the true and lawful attorney for serving legal process in any action arising from such delivery.

Answer 53

**Answer:** A nonresident pharmacy may apply for license renewal by submitting a renewal application on a form provided by the board.

Answer 54

**Answer:** The policy and procedure manual must set forth: - Normal delivery protocols and times. - The procedure if the patient's medication is unavailable or if delivery is delayed beyond the normal time. - The procedure for handling prescriptions for acute illness, including timely delivery or alternative solutions. - The procedure if medication is not received within the normal delivery time and interim dosage is needed. - The procedure for ensuring proper medication storage conditions until delivery.

Answer 55

**Answer:** Each nonresident pharmacy must: - Comply with New Mexico’s statutory and regulatory requirements regarding controlled substances, drug product selection, labeling, advertising, and dispensing of prescription drugs, including differences from federal law, unless it conflicts with resident state laws. - Maintain a valid license, permit, or registration to operate in compliance with the laws of the resident state. - Maintain a federal registration for controlled substances if applicable. - Supply all information requested by the board or the regulatory authority of the resident state for board responsibilities under state and federal law. - Provide a toll-free telephone service for communication between New Mexico patients and a pharmacist at the nonresident pharmacy, available during regular hours (not less than six days a week and 40 hours a week), with the toll-free number disclosed on drug containers.

Answer 56

**Answer:** The board may: - Withhold, suspend, or revoke any nonresident pharmacy license for failure to comply with conditions specified by law or regulations. - Suspend or revoke a license if the license, permit, or registration to operate in the resident state has been suspended or revoked, with a certified copy of the resident state’s record serving as conclusive evidence. - File a complaint with the resident state’s regulatory or licensing authority if there is information indicating a violation of resident state laws or regulations.

Answer 57

**Answer:** - Nonresident pharmacies are not authorized to dispense contact lenses. - The regulation does not replace or modify any other legal or regulatory requirements applicable to nonresident businesses.

Answer 58

means the dispensing or refilling of a prescription drug order by a retail or nonresident pharmacy

Answer 59

**Answer:** A retail pharmacy may outsource prescription drug order dispensing if: - The pharmacies have the same owner, or - They have a written contract or agreement outlining services, responsibilities, and compliance with federal and state laws and regulations, and - They share a common electronic file or have technology allowing access to sufficient information needed to dispense or process a prescription drug order.

Answer 60

**Answer:** The pharmacist-in-charge must ensure: - The pharmacy uses adequate storage or shipment containers and processes to maintain drug stability and potency, including appropriate packaging to maintain the drug's temperature and integrity during delivery. - The dispensed prescriptions are shipped in containers sealed to show evidence of opening or tampering.

Answer 61

**Answer:** The pharmacy must: - Notify patients that their prescription may be outsourced and provide the name of the pharmacy or network of pharmacies. - Notify the patient through a one-time written notice or a sign in the pharmacy.

Answer 62

**Answer:** The pharmacist must: - Ensure the patient receives written notice of available counseling, including days and hours of availability, and the right to request counseling. - Provide a toll-free number for obtaining oral counseling from a pharmacist with access to the patient’s record. - For pharmacies delivering more than 50% of prescriptions by mail, counseling must be available for at least 60 hours per week, six days per week, with sufficient toll-free lines and personnel for counseling within 15 minutes.

Answer 63

**Answer:** The prescription label must include: - The name and address or name and pharmacy license number of the pharmacy dispensing the prescription. - The name and address of the pharmacy that receives the dispensed prescription. - Indication of which pharmacy dispensed the prescription (e.g., "filled by ABC pharmacy for XYZ pharmacy") and compliance with all other prescription labeling requirements.

Answer 64

**Answer:** The manual must: - Outline responsibilities of each pharmacy involved. - Include names, addresses, telephone numbers, and license/registration numbers of the pharmacies. - Include policies and procedures for: - Notifying patients about outsourcing and providing the name of the pharmacy. - Protecting patient information confidentiality and integrity. - Dispensing orders when the filled order is not received or if the patient needs interim medication. - Compliance with federal and state laws. - Operating a continuous quality improvement program. - Identifying the pharmacist responsible for each aspect of prescription preparation. - Identifying the pharmacist responsible for patient counseling. - Annually reviewing and documenting the policy and procedure manual. **Note:** An application not completed within 12 months of initial receipt by the board is considered withdrawn, requiring a new application and fee for license issuance.

Answer 65

**Answer:** Records may be maintained in an alternative data retention system if: - They contain all required information and - The system can produce a hard copy of the record upon request by the board, its representative, or authorized law enforcement or regulatory agencies within 48 hours. Pharmacies must: - Comply with all laws and rules related to record maintenance and produce an audit trail of all prescriptions dispensed and each pharmacist’s or technician’s involvement. - Maintain records indicating: - The date the request for dispensing was transmitted to the dispensing pharmacy. - The date and method of delivery of the dispensed prescription to the requesting pharmacy, including the name of the person accepting delivery. The dispensing pharmacy must maintain records indicating: - The date the prescription was shipped. - The name and address where the prescription was shipped. - The method of delivery (e.g., private, common, or contract carrier).

Answer 66

**Answer:** 1. A New Mexico licensed pharmacy may employ one or more pharmacists for conducting drug utilization reviews at remote practice sites provided all security requirements are met. 2. All pharmacists working at a remote DUR site must be New Mexico licensed pharmacists. 3. Remote pharmacist DUR sites will operate under the authority of a New Mexico licensed pharmacy and its pharmacist-in-charge. 4. No drug inventory shall be kept at any remote pharmacist DUR site, and no dispensing shall take place from a remote DUR site. 5. Remote pharmacists will not be considered in the computation of the technician to pharmacist ratio. 6. There must be a procedure identifying the pharmacist responsible for each aspect of prescription preparation.

Answer 67

**Answer:** 1. The pharmacist-in-charge must provide a written policy and procedure document outlining the operation and security of each remote pharmacist DUR location, which must be available at each practice site. 2. They must keep a continuously updated list of all remote DUR sites, including addresses, phone numbers, and hours of operation, retained as part of the records of the licensed pharmacy. 3. They are responsible for ensuring that the New Mexico licensed pharmacy and each remote pharmacist have entered into a written agreement outlining all conditions and policies governing the operation of the remote site. 4. They must ensure that all computer equipment used at the remote site is in good working order and complies with all security requirements.

Answer 68

**Answer:** 1. Remote pharmacists must be New Mexico licensed pharmacists. 2. They must be trained in the use of all equipment necessary for the secure operation of the remote site.

Answer 69

**Answer:** 1. If the remote DUR site is located within a home, there must be a designated area where all of the pharmacist’s work will be performed. 2. All computer equipment used at remote DUR sites must establish a secure connection while operating. Equipment must be configured so that patient information is not stored at the remote site electronically or in printed form. 3. Computer equipment may only be used for remote DUR; no other use of equipment is allowed. 4. Computer equipment must be locked or shut down whenever the pharmacist is absent. 5. All remote DUR sites are subject to unannounced inspections by representatives of the New Mexico board of pharmacy during established hours of operation.

Answer 70

**Answer:** 1. Remote pharmacist DUR sites must have adequate security to maintain patient confidentiality. 2. They must utilize equipment that prevents unauthorized storage or transfer of patient information. 3. If the remote site is in a home, the equipment must be located in a designated area where patient information cannot be viewed by anyone other than the remote pharmacist.

Answer 71

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.

Answer 72

means an in-state retail pharmacy licensed by the board, pursuant to 16.19.6 NMAC that controls and is responsible for the operation of an automated drug distribution system.

Answer 73

means the pharmacist-in-charge, or the consultant pharmacist, and one or more representatives of the health care facility.

Answer 74

(a) A drug that may be removed from an automated medication system prior to pharmacist review because the multi-disciplinary committee has determined that the clinical status of the patient would be compromised by delay; (b) a drug determined by the multi-disciplinary committee to have a low risk of drug allergy, drug interaction, dosing error, or adverse patient outcome, which may be removed from an automated medication system independent of a pharmacist's review of the medication order or clinical status of the patient.

Answer 75

**Answer:** 1. A managing pharmacy may use an automated drug distribution system to supply medications for patients of a health care facility. 2. The automated drug distribution system may be located in a health care facility that is not at the same location as the managing pharmacy. 3. When located within a health care facility, the system is considered an extension of the managing pharmacy. 4. If used to deliver routine doses of controlled substances, the managing pharmacy must submit and maintain a separate registration with the Drug Enforcement Administration (DEA).

Answer 76

**Answer:** 1. The physical address where the automated drug distribution system will be located. 2. The health facility’s board of pharmacy registration type and number. 3. The managing pharmacy’s registration number, address, and pharmacist-in-charge. 4. Written policies and procedures governing the operation of the system, addressing requirements of Subsection F and board rules. 5. Notification to the board within 10 days if an automated drug distribution system is permanently taken out of service.

Answer 77

**Answer:** 1. Maintain a record of each transaction or operation. 2. Control access to the automated medication system. 3. Maintain policies and procedures for: - Operating the automated medication system. - Training personnel who use the system. - Maintaining patient services when the system is not operating. - Defining procedures for granting or denying access to drugs. - Maintaining security of the system. - Assuring appropriate pharmaceutical care. - Maintaining the integrity of system information and protecting patient confidentiality. - Stocking or restocking the system. - Compliance with packaging, storing, and labeling requirements. 4. Perform prospective drug use review and approve each medication order before drug administration except for override medications. 5. Perform retrospective drug use review for override medications. 6. Convene or identify a multi-disciplinary committee to advise on the operations of the automated medication system.

Answer 78

**Answer:** 1. Responsibility for accurate stocking and restocking lies with the pharmacist-in-charge and any supervising pharmacist. 2. If performed by someone other than a pharmacist: - A pharmacist must conduct and document a daily audit of drugs placed into the system, including random sampling. - Barcode verification, electronic verification, or similar processes must be used, requiring initial quality assurance validation and quarterly reviews by a pharmacist. - Stocking and restocking may be performed by a pharmacy technician or a registered nurse trained and authorized by the pharmacist-in-charge. 3. The pharmacist performing the quality assurance review must maintain a record of the process and approval. 4. Drugs removed from the system must not be replaced unless their purity, packaging, and labeling have been examined according to established policies and procedures.

Answer 79

**Answer:** 1. Establish criteria and processes for determining which drugs qualify as override medications. 2. Develop policies and procedures for the operation of the automated drug distribution system. 3. Conduct an annual review of override medications.

Answer 80

**Answer:** 1. Records must be maintained for at least three years and include: - Distribution records for dangerous drugs, including controlled substances, transferred to each automated medication system. - Perpetual inventories of controlled substances within each system. - Records showing date and time of transactions, type of transaction, nature of emergency, medication details, patient details, person making the transaction, prescribing practitioner, pharmacist conducting the review, and device identity. - Delivery records including date of receipt, drug details, dosage form, strength, quantity, device identity, and person accepting delivery. - Reports or analyses generated as part of the quality assurance program.

Answer 81

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

Answer 82

means an electronic verification, bar code verification, weight verification, radio frequency identification (RFID), or similar electronic process or system that accurately verifies medication has been properly dispensed and labeled by, or loaded into, an automated filling system.

Answer 83

means a drug dispensed in the manufacturer’s original and sealed packaging, or in the original and sealed packaging of a repackager, without additional manipulation or preparation by the pharmacy, except for application of the pharmacy label.

Answer 84

means any drug that has been removed from the original packaging of the manufacturer or an FDA repackager and is placed in a properly labeled dispensing container by a pharmacy for use in an automated filling system for the purpose of dispensing to the ultimate user from the establishment in which the prepacking occurred.

Answer 85

means a repackager registered with the United States food and drug administration (FDA)

Answer 86

**Answer:** Automated filling systems (hereinafter “system”) may be stocked or loaded by: 1. A pharmacist. 2. An intern pharmacist or pharmacy technician under the direct supervision of a pharmacist.

Answer 87

**Answer:** Except as otherwise provided, a licensed pharmacist shall: 1. Inspect and verify the accuracy of the final contents of any dispensing container filled or packaged by a system. 2. Verify any label affixed to the dispensing container prior to dispensing, pursuant to Paragraph (1) of Subsection B of 16.19.4.16 NMAC.

Answer 88

**Answer:** The verification criteria are met if: 1. Pharmacy personnel establish and follow a policy and procedure manual complying with Subsection E of 16.19.6.28 NMAC. 2. The filling process is fully automated from initiation until a completed, labeled, and sealed prescription is produced; no manual intervention with the medication occurs after loading into the system (manual intervention does not include preparing the prescription for mailing, delivery, or storage). 3. A pharmacist performs a prospective DUR and verifies the accuracy of prescription information prior to initiating the automated fill process; the verifying pharmacist’s identity is recorded in the pharmacy’s records. 4. A pharmacist verifies the correct medication and strength, prepacked container, or manufacturer unit of use package was properly stocked, filled, and loaded in the system prior to initiating the fill process; alternatively, an electronic verification system may be used for verification. 5. The medication to be dispensed is selected, filled, labeled, and sealed by the system or dispensed in a manufacturer’s unit of use package or a prepacked container. 6. An electronic verification system verifies the proper prescription label affixed to the correct medication and strength for the correct patient. 7. Daily random quality testing is conducted by a pharmacist on at least two percent of the prescriptions filled by the system on the date tested or the last day of system operation; proof of compliance and testing results are documented. 8. The product dispensed is a solid oral dosage form. 9. The product dispensed is not a controlled substance listed in DEA or Schedule II of 16.19.20 NMAC.

Answer 89

**Answer:** Policies and procedures must ensure: 1. The system and electronic verification system are maintained in good working order. 2. Accurate filling, loading, and stocking of the system. 3. Sanitary operations and prevention of cross-contamination. 4. Reporting, investigating, and addressing filling errors and system malfunctions. 5. Testing the accuracy of the system and verification system before first use or after modifications. 6. Training for individuals authorized to access, stock, or load the system. 7. Tracking and documenting prescription errors not corrected before dispensing. 8. Conducting routine and preventive maintenance and calibration. 9. Removing expired, adulterated, misbranded, or recalled drugs. 10. Preventing unauthorized access to the system, including security access management. 11. Identifying and recording persons responsible for stocking, loading, and filling the system. 12. Ensuring compliance with state and federal laws, including labeling, storage, and security requirements. 13. Proper drug storage within the system as per manufacturer’s specifications and USP requirements. 14. Maintaining an ongoing quality assurance program to monitor system performance.

Answer 90

**Answer:** Records and documentation must be: 1. Maintained electronically or in writing for at least three years. 2. Available for inspection and produced to the board or the board’s agent upon request

Answer 91

**Answer:** Prepacking conditions include: 1. Prepacking occurs at the licensed pharmacy utilizing the system. 2. Only products that will be dispensed directly to the patient may be prepacked. 3. Containers must meet USP standards, including using light-resistant containers if necessary. 4. Each prepacked drug must have a label with the name, strength, quantity, manufacturer or distributor, expiration date, date prepacked, and identity of the prepacker. 5. A record of drugs prepacked must be kept, including drug details, lot number, manufacturer, expiration date, date of prepacking, quantity, and initials of the prepacker and pharmacist performing the final check. 6. Drugs prepacked by an intern or technician must undergo a final check by a pharmacist.

Answer 92

**Answer:** 1. A New Mexico licensed pharmacy located in New Mexico may employ certified pharmacy technicians for data input at remote practice sites if all security requirements are met. 2. Pharmacy technicians at remote data entry sites must be registered as certified pharmacy technicians with the board and have at least one year of experience in data entry functions. 3. Remote pharmacy technician data entry sites operate under a New Mexico licensed pharmacy located in New Mexico under the authority of its pharmacist-in-charge. 4. No drug inventory shall be kept at any remote pharmacy technician data entry site, and no dispensing shall occur from these sites. 5. Each remote pharmacy technician data entry site must have a procedure to identify the pharmacy technician and pharmacist responsible for each aspect of prescription preparations. 6. Quality monitoring and improvement programs must be in place at all remote pharmacy technician data entry sites.

Answer 93

**Answer:** 1. Provide a written policy and procedure document outlining the operation and security of each remote pharmacy technician data entry site; the document must be available at each site. 2. Keep a continuously updated list of all remote pharmacy technician data entry sites, including address, phone number, and hours of operation; this record must be retained as part of the pharmacy’s records. 3. Ensure that the New Mexico licensed pharmacy and each remote data entry pharmacy technician have entered into a written agreement outlining all conditions and policies governing the remote site operation. 4. Ensure that all computer equipment at the remote site is in good working order, provides data protection, and complies with all security and HIPAA requirements.

Answer 94

Answer: Must be a certified pharmacy technician registered with the board and reside in New Mexico. Must have at least one year of experience performing data entry functions as a certified pharmacy technician. Must be trained in the use of all equipment necessary for the secure operation of the remote site.

Answer 95

**Answer:** 1. If located within a home, there must be a designated area where all pharmacy technicians’ work is performed. 2. Computer equipment used must establish a secure connection and must be configured so that patient information is not stored electronically or in printed form at the remote site. 3. Computer equipment may only be used for remote pharmacy technician data entry; no other use is allowed. 4. Computer equipment must be locked or shut down whenever the pharmacy technician is absent. 5. Remote pharmacy technician data entry sites are subject to unannounced inspections by representatives of the New Mexico Board of Pharmacy during established hours of operation.

Answer 96

**Answer:** 1. Remote pharmacy technician data entry sites must have adequate security to maintain patient confidentiality. 2. Must use equipment that prevents unauthorized storage or transfer of patient information. 3. If the remote site is in a home, the equipment must be in a designated area where patient information cannot be viewed by anyone other than the remote pharmacy technician.

Answer 97

**Answer:** 1. The pharmacy must qualify for an exemption from registration and listing requirements under Section 510 of the FD&C Act. Specifically, pharmacies that: - Maintain establishments in conformance with applicable local laws regulating the practice of pharmacy and medicine. - Are regularly engaged in dispensing prescription drugs or devices upon prescriptions of practitioners. - Do not manufacture, prepare, propagate, compound, or process drugs or devices for sale outside their regular dispensing or selling activities. 2. The drug product is not sold or transferred by an entity other than the entity that repackaged it. Note that administration of a repackaged drug product in a healthcare setting is not considered a sale or transfer.

Answer 98

**Answer:** 1. The drug must be a finished prescription drug that is: - A non-sterile solid or liquid oral dosage form. - Approved under Section 505 of the FD&C Act. - Repackaged by or under the direct supervision of a pharmacist and undergoes a final check by a pharmacist. - Handled and repackaged in accordance with all applicable USP chapters numbered less than <1000>. - Assigned a beyond-use date in accordance with USP standards. - Repackaged, stored, and shipped in a way that does not conflict with approved drug product labeling. - Not adulterated by insanitary conditions. - Repackaged into a sealed unit-dose container, unless distributed in an appropriately labeled and packaged form to a contracted correctional facility for distribution to an inmate upon release. 2. The repackaged drug product must be distributed under the following conditions: - By a managing pharmacy for use in an automated drug distribution system or emergency kit. - To a correctional facility for administration to an inmate or for distribution of a properly labeled take-home supply upon release. - To a clinic under the same ownership as the repackaging pharmacy for administration to a patient of the clinic.

Answer 99

**Answer:** 1. All units of repackaged medication must be labeled with: - Name, address, and telephone number of the repackaging pharmacy, unless used in an automated drug distribution system. - Name, strength, and quantity of the drug. - Lot number or control number. - Name of the manufacturer. - Beyond use date. - Date the drug was repackaged. - Name or initials of the repackager. - Federal caution label, if applicable.

Answer 100

**Answer:** 1. A record of drugs repackaged must include: - Date of repackaging. - Name and strength of the drug. - Manufacturer-assigned drug lot number and expiration date. - Name of the drug manufacturer. - Assigned beyond-use date and lot number or control number. - Total number of dosage units repackaged. - Quantity per each repackaged unit container. - Number of dosage units wasted. - Initials of the repackager and the pharmacist performing the final check. 2. Records required by the Pharmacy Act, Drug, Device, and Cosmetic Act, Controlled Substance Act, and board regulations must be maintained.

NMBOP: 16.19.06 PHARMACIES Flashcards

(127 cards)