NM Law Study Guide Flashcards
BOP Members consist of . . .
- 9 total members (appointed): 3 public, 5 NMPhA (1 from each district), 1 NMHSPA
- Must be pharmacist for 8 years (3 in NM)
- 5-year terms, July 1st annually, NTE 2 consecutive terms
BOP Meetings held . .
at least quarterly (once every 3 months), conducted by chairman of board (or vice-chairman or member of the board), held in office of the board unless waived by majority
Pharmacist Examinations
Examinations:
- Graduate from ACPE accredited college of pharmacy
- Pass NAPLEX & MPJE with score of at least 75
- Score transfer: per NABP
- If score transfer, can only take MPJE after passing NAPLEX and receiving score
- Not ACPE accredited college:
- Submit application, complete internship requirements, complete NABP FPGEE certification (foreign work experience may be accepted in place of internship)
Examination Repeats:
- Cannot take NAPLEX more than 5 time or MPJE more than 4 consecutive times without passing
- NAPLEX: wait 45 days to retake; MPJE: wait 30 days to retake
Pharmacist Reinstatement exams:
1. Inactive for >1 year - <6 years
2. Inactive for >6 years
Reinstatement exams:
Inactive for >1 year - <6 years:
- Submit renewal, pay past renewal + reinstatement fees, proof of CE for each inactive
renewal period, 60hr internship for each year of inactivity, complete MPJE
- Or complete 60hr internship for each year of inactivity, pass NAPLEX and MPJE
.
Inactive for >6 years: complete 60hr internship for each year of inactivity, pass NAPLEX and MPJE
Pharmacist Reciprocal Licensure:
- Applicant must be graduate from ACPE accredited college of pharmacy and complete required intern training OR worked 1 year as a pharmacist
- Less than 1 year as a pharmacist: complete internship (60 hr per each year inactive), pass NAPLEX or MPJE
Reinstatement of reciprocity license:
1. Inactive for >1 year - <6 years
2. Inactive for >6 years
Inactive for >1 year - <6 years:
- Submit renewal, pay past fees, proof of CE for each inactive renewal period, 60hr
internship for each year of inactivity, complete MPJE + submit current letter of good
standing from state of examination
- Or complete 60hr internship for each year of inactivity, pass NAPLEX and pass MPJE
.
Inactive for >6 years: complete 60hr internship for each year of inactivity, pass NAPLEX and MPJE
.
Jurisprudence Exam: must take within 1 year of application; same exam repeat requirements
Pharmacist Temporary license
- Evidence of current license by exam in another state: authorized to practice for 90 days with application + fee (must become licensed in 90 days)
- Unable to act as PIC, preceptor, or intern supervisor
- Cannot renew or extend beyond 90 days
Pharmacist Unprofessional Conduct Examples:
- Violation of any applicable acts (Pharmacy Act, CSA, Drug and Cosmetic Act), laws, and regulations as determined by the board
- Acquiring prescription stock from unlicensed sources
- Solicitation of business by providing prescribers with prescription blanks
- Failure to adequately train or supervise supportive personnel
- Dispensing a prescription to a patient without an established practitioner-patient relationship (exceptions: STI treatment of sexual partner, DoH provider under public health emergency, naloxone, immunization programs)
- Failure to perform prospective drug review
Pharmacist CE Requirements:
CE Requirements:
- 3.0 CEU (30 contact hours) every 2 years
- 1.0 CEU (10 contact hours) live (excluding law)
- 0.2 CEU (2 contact hours) in patient safety
- 0.2 CEU (2 contact hours) in safe and appropriate use of opioids
- 0.2 CEU (2 contact hours) in pharmacy law
Offered by NM BOP
0.1 CEU (1 hour) by attending one full day of a regularly scheduled NMBOP
meeting or serving on a board approved committee
0.2 CEU (2 hours) by successfully completing an open book test administered by
the board
0.2 CEU (2 hours) pharmacy law programs offered minimum every year in each of
the 5 pharmacy districts
.
- If prescribe vaccines/contraception/naloxone/tobacco cessation: at least 2 hours in each area
- If outside NM: allowed if approved by ACPE
- Inactive status licensees: 1.5 CEU for each year the license was inactive + current CPE to reinstate license
- Audit: no less than 10% of registrants each year (inadequate: fine of $1000 + required to complete CPE)
Consultant Pharmacist
- General Responsibilities:
- Protocols
- Drug destruction
- Drug storage areas
- Review drug regimens
Consultant Pharmacist: Skilled Nursing Facilities (SNF) and Intermediate Care Facilities (ICF)
.
What are the requirements for customized patient medication packages in SNFs and ICFs?
A: Customized patient medication packages require the consent of the patient, caregiver, prescriber, or institution.
Consultant Pharmacist: Skilled Nursing Facilities (SNF) and Intermediate Care Facilities (ICF).
.
When can a pharmacist repackage patient medication packages?
A: A pharmacist may repackage a patient’s medication package if a drug is added or discontinued from the patient’s drug regimen. Removed drugs must be either destroyed or relabeled and returned to the patient. Drugs cannot be returned to pharmacy stock if they are part of a medication package containing more than one drug.
Consultant Pharmacist: Skilled Nursing Facilities (SNF) and Intermediate Care Facilities (ICF)
A: Customized patient medication packages require the consent of the patient, caregiver, prescriber, or institution.
Consultant Pharmacist: Skilled Nursing Facilities (SNF) and Intermediate Care Facilities (ICF).
.
Q: What are the guidelines for returning patient medication package drugs?
Non-Institutional: Drugs may not be returned to pharmacy stock.
Institutional: Storage and handling of the drugs must be assured. Specific guidelines include:
- Keep the drug in the patient medication package sealed and labeled until dispensed.
- The expiration date of the drug is adjusted to fifty percent of the remaining time.
- Schedule II drugs cannot be returned to inventory.
- Proper record-keeping is required for other scheduled drugs returned to inventory.
Consultant Pharmacist Clinic Reviews: Limited Drug Clinics A-E; what are they? the need for consultant pharmacist? how many sq ft needed?
Consultant Pharmacist: Custodial Care Facilities requirments
- Visit facility no less than once a quarter or more often
- Bulk containers of legend drugs not allowed unless 24/7 on-site nurse
- Allowable stock drugs: tuberculin testing solution, vaccines, naloxone
Impaired RPh …what does it means/ what needs to be done?
Impaired RPh: unable to safely and competently practice pharmacy due to drug abuse, mental illness, aging, or loss of motor skills
- report to BOP or impaired RPh program
Return and Relabeling Dispensed Drugs:
- Drug left premises: cannot be dispensed or reused again (except in a correctional facility; excluding controlled substances)
- The consultant pharmacist must maintain records at the facility for three years containing the following information if it is returned/ relabled:
- date of re-labeling
- name and ID of original patient and date discontinued
- name and ID of new patient
- name, strength and amount of the medication
- name of pharmacist re-labeling the medication
- label reused drug and maintain a dispensing log; expiration date for re-issued drugs = 50% of the time remaining from the date of repackaging until the expiration date
Responsibility of
- Pharmacist OR pharmacist intern:
- new verbal prescription orders and reduction to writing
- initial identification, evaluation and interpretation of the prescription order and any
necessary clinical clarification prior to dispensing - professional consultation with a patient or his agent regarding a prescription
- evaluation of available clinical data in patient medication record system
- patient counseling
- professional consultation with the prescriber, the prescriber’s agent, or any other health care professional or authorized agent regarding a patient and any medical information pertaining to the prescription
- drug regimen review
Responsibility of Pharmacists ONLY
Pharmacist only:
- final check on all aspects of the completed prescription
- evaluation of pharmaceuticals for formulary selection within the facility
- supervision of all supportive personnel activities
- ensure that supportive personnel have been properly trained
- any verbal communication with a patient or patient’s representative regarding a change in drug therapy or performing therapeutic interchanges (does not apply to substitution of generic equivalents)
- any other duty required of a pharmacist by any federal or state law.
Patient records: record and maintain at least the following information . . .
- Name
- Address
- Telephone number
- Date of birth (or age)
- Gender of the patient
- Medical history
- Allergies and drug reactions
- Comprehensive list of medications and devices
- Maintain for 3 years from date of last entry
Prospective drug review: prior to dispensing any prescription . . .what does it entails ?
- 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
Prescription monitoring program (PMP) report for opioid prescriptions:
- The following may indicate abuse:
Opioids from multiple prescribers
Opioid + BZD or carbisopodol
Opioids >12 weeks
>1 analgesic
>90 MME (Per CDC: use caution & carefully reassess individual benefits and
risks w/ ≥50 MME/day; avoid ≥90 MME/day or carefully justify)
Per CDC: recommend naloxone ≥50 MME/day
Overutilization
Early refills
Request to pay cash
Request specific opioid/brand
PMP Review Requirements
Review:
1-year report if any concern about prescription (abuse/misuse concerns,
unfamiliar prescriber/patient, long-acting opioid, opioid + BZD/carisoprodol)
Minimum once every three months during continuous use of opioids for
established patient
Exempt: LTCF or terminal illness
Counseling requirments/ counseling for mailed out medications? :
- New Rx: pharmacist or pharmacist intern offer to counsel
- Refill Rx: pharmacy technician offer counseling by the pharmacist or pharmacist intern
- In person or by telephone
- Not be required for hospital inpatients or institution where drugs administered
- Mailed Rx: written notice of available counseling
> 50% prescriptions by mail: minimum of 60 hours per week six days per week, counseling within 15 minutes - Post notice of available counseling at pharmacy
Pharmacist Clinicians:
- Certification:
- Proof of completion of 60 hour board approved physical assessment course, 150 hour/300 patient contact preceptorship supervised by physician or practitioner with prescriptive authority
- Patient encounters must be completed within 2 years of application
- Controlled substance registration required to prescribe schedule II-III drugs
Pharmacist Clinician Renewal CE requirments
Renewal:
- 2.0 CEU 20 contact hours of (10 hr live) CPE or continuing medical education (CME) approved by (ACPE) or AACME beyond required hours for pharmacists
- Controlled substance registration: minimum of 0.2 CEU (two contact hours) per renewal in responsible opioid prescribing practices
Pharmacist Clinician: Prescriptive Authority
- Register with NM medical board or osteopathic examiners
- Submit an application: supervising physicians’ name and current medical license, protocol of collaborative practice and other information requested by the board
- Protocol:
File with board and maintain at place of practice (approved by practitioner)
Practitioner and pharmacist clinician authorized to prescribe
Includes types of prescriptive authority: types of diseases, dangerous
drugs/categories, procedures
Review and revise: every two years if necessary - Prescribe controlled substances provided: NM CS Registration + DEA Registration, within guidelines/protocols
Prescription Monitoring Program: pharmacist clinician prescribing a controlled substance must
Register with board for PMP inquiry and reporting:
Review 1-year PMP report:
Prescribing > 4 days CII-IV
Gap in prescribing for 30 days
Once every 3 months for continuous use of opioid, BZD or carisoprodol
Once every 6 months for continuous use of CII-IV (non-opioid)
In opioid treatment program: initial enrollment and every 3 months
Except: nursing facility or hospice patient
INTERNSHIP TRAINING PROGRAM: Preceptor requirment, intern requirement?
Preceptor requirements:
- One year in practice of pharmacy, full-time, no violations of pharmacy laws or regulations
.
Intern requirements:
- Completion of first semester courses in ACPE college of pharmacy
- Wear standard identification tag
- Computed time: max of 48 hr/week
- Internship requirement: 1500 hours
- Change of address, employment or preceptor: notify board in writing within 10 days
- Display intern certificate in training area where intern is employed
- Preceptor supervises repacking, labeling and dispensing
- Renewal: due annually last day of September
Pharmacies: New Licensure Requirment
- Required application and fee
- Preliminary approval of application à applicant submits “request for inspection” at least fourteen days before requested date for inspection
- Reviews license application and the inspection report at next board meeting
- License terminates with sale or transfer of ownership
Pharmacies: PIC Responsibilities
- Policies and procedures review annually
- Supervision
- Storage of drugs
- Notify of technician employment/termination within 10 days
- Immediately notify board for change of PIC, file new PIC application within 10 days,
controlled substance inventory within 72 hours - Self-assessment inspection form completed with pharmacy renewal application (expire annually Dec 31st)
Pharmacy Minimum Standards: Areas/ Sq ft
- 240 square feet
- Floor area extends the full length of the prescription compounding counter
- Private counseling space
- 1 RPh: 16 sq-ft prescription compounding counter
- 2 or more RPh: 24 sq-ft prescription compounding counter
- Counter height: at least 36 inches
- 5% or at least one work-station will comply with the American with Disabilities Act (note: applies with 15 or more employees)
- Minimum width of 30 inches from the prescription compounding center
Pharmacy Conspicuous Display Requirements:
- License
- Prohibition of drug return sign
- Current BOP inspection
- Current CS registration
- Patients Bill of Rights (approved by BOP)
Pharmacy closure requirments
Send written notice to DEA at least 14 days prior to closure (return DEA registration + unused 222); notify the PUBLIC and BOARD at least 30 days prior to the final day of service + include notice in newspaper, radio or other method
.
Provide name/address/phone number for records (purchase records = 3 years, prescriptions = 10 years)
Return to stock labeling requirments
Return stock:
- Patient name
- Date filled
- Rx number
- Drug name/strength/quantity
- **Maintain record, retrievable within 72 hours
Drug take back - what is accepted/ not accepted for take back
Robbery, Burglary, Fire, Flood Report…what must be done in this situation?
Robbery, Burglary, Fire, Flood Report: Owner immediately files with the board a signed statement of the circumstances of such occurrence and evidence that local authorities were notified
Labeling of Human Use Drugs: define it, who can do it?, and label for compounded drugs?
- Definition: Labeling involves affixing or applying written, printed, or graphic matter on or in the immediate container of any human use drug, whether repackaged or dispensed on a practitioner’s order.
- Authorized Personnel: Only a Registered Pharmacist (RPh) or an intern under their supervision can label the immediate container of a drug.
- Compounding Labeling: A dispensing container for a compound with more than three drugs must be labeled as “compound.”
Transfer of Ownership:
- Transfer =
Transfer =
- Sale
- Addition/deletion of partners
- Death of owner
- Change in 30% of stock
- **New license required
- Expiration: Dec 31st annually
What are the retention requirements for prescription information?
What are the requirements for a valid prescription?
Prescriptions:
- Faxed, Electronic, Verbal (via practitioner or agent), Written
- Physician signature can be hand-written, stamped/printed, electronic
- Must contain name and address of prescriber, name and address of patient, name and strength of drug, quantity, directions for use, date of issue, and preferably the diagnosis or indication
Emergency refills requirement
Emergency refills:
- Pharmacist can refill script (INCLUDING CS) without prescriber authorization if:
- Failure to refill will result in interruption of therapeutic regimen (essential for chronic therapy or serious health consequences) or create patient suffering
- Unable to contact prescriber with reasonable effort
- Cannot provide > 72hrs supply
- Notify prescriber at earliest reasonable time
Q: What are the requirements for 3rd party payer audits?
A:
- The payer must provide 2 weeks’ notice for an on-site audit.
- Audits cannot cover a time period greater than 2 years.
- Audits may not be conducted during the first 5 days of the month.
Q: What are the requirements and procedures for inspections by regulatory agencies?
FDA:
- Requires credentials and a notice of inspection (no warrant or explanation needed). They fill out a form without needing to go to a judge.
DEA:
- Requires credentials, a notice of inspection, and an administrative inspection warrant (does not require probable cause but explains the purpose of the inspection and must go before a judge).
Inspection Scope:
- Inspectors can look at all types of records (inventory, order forms, prescriptions, etc.) but cannot take them without a warrant or subpoena.
- Cannot look at financial data, sales data, or pricing data.
- Can take a physical inventory.
NMBOP (New Mexico Board of Pharmacy):
- Requires credentials (administrative warrant can be requested).
- Can inspect inventory and copy records.
- Can take samples but must pay for them.
Non-Resident Pharmacies: pharmacy outside of NM that dispenses drugs to patients in NM
- Licensure Application includes:
censure Application:
- Address of the nonresident pharmacy and pharmacists
Report annually and within 10 days after any change of office location or pharmacist in charge
- Valid state license
- Recent inspection report
- CSP: recent CSP operations inspection report within the past 12 months
- Policy and procedure manual
- Proof that the nonresident pharmacy has a toll-free telephone service available to New Mexico patients (six days a week and for a minimum of 40 hours a week);
- The name and address of a resident (agent of record) in New Mexico for service of process;
- If the nonresident pharmacy wants to ship, mail or deliver controlled substances to New Mexico patients, then the pharmacy must submit an application for controlled substances
Centralized Prescription Dispensing Requirements
Q: What are the ownership and contract requirements for centralized prescription dispensing?
A: Pharmacies must have the same owner or a written contract and must share files/sufficient information.
Centralized Prescription Dispensing Requirements
Q: What is required regarding patient notification in centralized prescription dispensing?
A: Patients must be notified when outsourcing occurs.
Centralized Prescription Dispensing Requirements
Q: What are the phone counseling requirements if more than 50% of prescriptions are mailed?
A: There must be a minimum of 60 hours of phone counseling per week, available six days per week, within 15 minutes.
Centralized Prescription Dispensing Requirements
Q: What records must the requesting pharmacy maintain in centralized prescription dispensing?
A: The requesting pharmacy must maintain records of the request for dispensing, the dispensed prescription, the method of delivery, and the name of the person accepting delivery.
Centralized Prescription Dispensing Requirements
Q: What records must the dispensing pharmacy maintain?
A: The dispensing pharmacy must maintain records of the date the prescription was shipped, the name/address where it was shipped, and the method of delivery. Hard copies of records must be maintained within 48 hours.
Centralized Prescription Dispensing Requirements
Q: What are the phone counseling requirements if more than 50% of prescriptions are mailed?
A: There must be a minimum of 60 hours of phone counseling per week, available six days per week, within 15 minutes.
Centralized Prescription Dispensing Requirements
Q: What is required regarding policies and procedures for centralized prescription dispensing?
A: Policies and procedures must be reviewed annually.
Automated Drug Distribution:
- Notification: physical address of ADS, health facility registration type/number, managing pharmacy/PIC, policies + procedures
- Written notification by PIC at least 60 days prior to the initial use of ADS
- PIC notifies BOP within 10 days of taking permanently out of service
- Stocking or restocking of an automated medication system: PIC/pharmacist responsible
- Records: maintain for at least three years
- Perpetual inventories of controlled substances
Automated Filling Systems: what is it?
- Select/fill/label medication for dispensing
- Does not include: counting devices, vacuum delivery device
- Medication stocking: pharmacist/intern/supervised technician
- Pharmacist verification: Daily random quality testing is conducted by a pharmacist on at least two percent of the prescriptions filled by the automated system, results documented and maintained in the pharmacy’s records
- Recordkeeping: maintained for a minimum of three years
Repackaging and Distribution by a Pharmacy:
- Label:
- name, address, and telephone number of repackaging pharmacy
- 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
- federal caution label, if applicable
Board Reports:
1. Confidential info or personally identified info disseminated
2. Employee conviction for violating federal or state law
3. Change of location
- Confidential info or personally identified info disseminated – report within 15 days
- Employee conviction for violating federal or state law – report within 15 days
- Change of location – report within 15 days???? (10 days)
Q: What are the dispensing regulations for a pharmacy registered as a hospital pharmacy?
A: A hospital pharmacy can fill discharge prescriptions and scripts for employee benefits only. If the pharmacy dispenses to the general public, it must register as a retail pharmacy.
HOSPITAL PHARMACIES: Q: What are the requirements for a Pharmacist-in-Charge (PIC) in a pharmacy?
A:
- The PIC can be part-time or full-time.
- If part-time, the PIC must visit the facility at least every 72 hours.
- The PIC is responsible for reviewing policies and procedures annually.
Q: What are the regulations for hospitals without a pharmacy regarding medication storage and distribution?
A: In hospitals without a pharmacy, prelabeled and prepackaged medications can be stored and distributed from a drug storage area or an automated medication management system under the supervision of a Registered Pharmacist (RPh).
Q: What are the regulations for drug withdrawal and pharmacy operations in facilities?
- Drug Withdrawal: If the pharmacy is closed or drugs are not available, one designated licensed nurse per shift may remove drugs from the pharmacy.
-
Record Keeping: If withdrawing more than a 72-hour supply, an electronic record is required, including:
- Name of the patient
- Name of the drug, strength, dose, and dosage form
- Quantity taken
- Time and date of withdrawal, along with the nurse’s signature
- Pharmacist Verification: The pharmacist must verify the withdrawal within 72 hours, which may be done electronically.
- Drug Regimen Review: The pharmacist must review the drug regimen within 24 hours of a new medication order.
- Inpatient Medication Dispensing: All medications for inpatients must be dispensed following a review of a physician’s order prior to dispensing.
- Pharmacy Technician Regulations: Only one registered or certified pharmacy technician may be present when the pharmacist is not in the facility, performing only clerical tasks. A written log of activities must be maintained.
Hospital Pharmacies: Space Requirements, Equipment, references
Q: What are the requirements for a Pharmacy Service Unit?
- Separation: The Pharmacy Service Unit must be separate from the central hospital pharmacy.
- Inpatient Services: It provides limited and/or specialized inpatient pharmacy services.
- Space Requirements: A minimum of 100 square feet is necessary, including space for references and equipment to perform the pharmacy service.
- Controlled Substances: Controlled substances must be stored in a locked area.
Drug Distribution and Control: Patient medication profile
- patient name and room number
- name/strength/quantity and dosage form
- tech filling order + RPh verifying
- date filled
- date and amount of unwanted/ unused drug returned to the pharmacy stock
Drug Distribution and Control: Records
- Records for schedule II controlled substances must be kept separate
- Schedule III-V must be kept separate or if stored with non-controlled records, readily retrievable
- Distribution, stock and med profiles can be stored electronically (readily retrievable within 72 hours)
Automated Pharmacy Systems:
- Review of user access at least quarterly
- Downtime log (hould include what info):
date
patient
drug/dose/quantity
nurse signature
beginning count & ending count; wasted amount
witness signature, if needed
prescriber (for controlled substances only)
In-House Clinics: licensing req?
clinic may operate under the license of the hospital pharmacy and is not required to obtain a separate license or permit from the Board
Q: What information is required for ER dispensing when a physician prescribes and dispenses medication?
A: The following information is necessary for ER dispensing:
- Patient Name
- Hospital
- Drug Name, Strength, Quantity
- SIG (Directions for Use)
- Expiration Date
- Name of Physician
- Date Dispensed
(Note: Either a physician, pharmacist, or intern can dispense the medication.)
Q: What are the key requirements for limited dispensing by an inpatient hospital pharmacy?
A: Inpatient hospital pharmacies not licensed as retail pharmacies must adhere to the following:
- Labeling Requirements: Medications must be labeled with the patient’s name, drug name, strength, quantity, and directions for use.
- Counseling Requirements: Patients must receive appropriate counseling regarding their medications.
- Record Retention: Records of dispensing must be retained for 3 years.
- Electronic Records: Electronic records must be retrievable within 72 hours.
Define
Wholesale Distributor:
a person or entity who facilitates distribution of a prescription drug to a person other
than a consumer or patient
Define
Third-Party Logistics Provider:
an entity that provides or coordinates warehousing, or other logistics services
of a product in interstate commerce on behalf of a manufacturer, wholesale distributor, or dispenser of a product, but does not take ownership of the product, nor have responsibility to direct the sale or disposition of the product
Repackager:
a person who owns or operates a facility that repackages and re-labels a product or package for further sale or distribution without a further transaction
Manufacturer:
a person or entity who engages in the production, preparation, propagation, conversion or processing of a drug or device, either directly or indirectly, by extraction from substances of natural origin or independently by means of chemical or biological synthesis; and includes packaging or repackaging, labeling or relabeling and the promotion and marketing of such drugs or devices
Radioactive pharmaceutical preparation:
- Minimum equipment:
- Glassware:
- Supplies:
- References:
- Space:
Radioactive pharmaceutical preparation:
- Minimum equipment: fume hood (> 30 inches), laminar flow hood, dose calibrator, lead-lined refrigerator, Mettler balance, spectrophotometer, drawing station
- Glassware: 3 50 mL beakers, 3 150 mL beakers, 1 500 mL beaker, 2 50 mL volumetric flasks, 6 100 mL volumetric flasks, 2 10 mL graduated cylinders, 2 100 mL graduated cylinders
- Radiochromatographic strip scanner and/or well counter
- Supplies: 1, 3, and 5 mL disposable syringes; 10, 20, and 30 mL multidose vials; alcohol swabs, disposable gloves
- References: AHFS, National Formulary, USP
- Space: minimum of 240 sq ft; sink with hot and cold water
limited drug clinic
Medical Stations and First Aid Stations:
- Minimum variety/quantity of medications to meet needs of station
- Physician in charge of station orders drugs; controlled substances require separate controlled substance registration
- Drugs kept locked unless nurse or physician present
- Maintain record book for receipt and administration of drugs
limited drug clinic
Animal Control Clinics:
- Veterinarian in charge of clinic specifies drugs to be used; controlled substances require separate controlled substance registration
- Drugs kept locked unless veterinarian or designee present
- Maintain record book for receipt and administration of drugs; schedule II must be separate
- Any clinic licensed by the Board of Pharmacy is required to have a consultant pharmacist
—- Controlled substances: pharmacist visits at least quarterly
—- No controlled substances: pharmacist visits annually
limited drug clinic
Public Health Clinics:
- Formulary:
- Developed by the pharmacy and therapeutics committee or pharmacist and medical
director of the clinic - Drug procurement and storage is limited to the drugs listed in the administration formulary for on-site administration
limited drug clinic
Q: What are the requirements for maintaining clinic drug stock in a pharmacy?
A: The requirements for clinic drug stock maintained by a pharmacy include:
- Dispensing via Valid Rx: Medications must be dispensed only with a valid prescription.
- Separation of Drugs: Clinic drugs must be kept separate from other drugs in the pharmacy.
- Labeling: Each medication must be labeled “Dispensed for clinic by pharmacy.”
- Patient Records: Patient records related to clinic drug dispensing must be maintained separately.
Nuclear Pharmacy
Requirements for Provision of Radiopharmaceuticals:
- Verbal Rx:
- Name of institution
- Date
- Radiopharmaceutical + dose
- Name of procedure
- Date/time calibration (administration)
- Name or pt (for blood components or therapeutic use)
- Specific instructions
CS
Q: What are the requirements for DEA registration and renewal?
A: To register with the DEA:
- Use DEA Form 224 (or Form 224a for renewal).
- Registration must be renewed every 3 years.
- Renewal should occur within 60 days of expiration. If renewal forms are not received within 45 days of expiration, contact the DEA in writing.
Refills rules for CII-CV? general? for in person vs mailed?
PHARMACIST
PRESCRIPTIVE
AUTHORITY - training/ req
