NM MPJE TLDR Flashcards
THE BOARD OF PHARMACY
Who are the Board Members?
The board consists of nine members, each of whom shall be a US citizen and a resident of New Mexico.
- Six members shall be pharmacists, one from each of the five pharmacy districts and one at-large
- Three members of the public.
THE BOARD OF PHARMACY
Is the Board a Separate Entity or Under
Another Organization/Department?
Administratively attached to the regulation and licensing department
THE BOARD OF PHARMACY
Who Chairs the Board?
The board shall annually elect a chairman, vice chairman and secretary-treasurer from its membership
THE BOARD OF PHARMACY
How Are Board Members Selected?
Appointment/Election?
Appointed by the governor
THE BOARD OF PHARMACY
How Long do Board Members Serve?
5 years. A member may not serve more than two full terms.
THE BOARD OF PHARMACY
How Often Does the Board Convene?
The board shall meet at least once every three months
THE BOARD OF PHARMACY
Who Can Attend Meetings?
Open to the public
Licensure Requirements: Pharmacist
Who can apply? (NEW)
Must be at least 18 years old and not be addicted to the use of drugs or alcohol
Licensure Requirements: Pharmacist
Who can apply? (Transfer/Reciprocity)
Must be of good moral character
and not have been charged with,
convicted, fined or had license
suspended or revoked for violation
of pharmacy, liquor, narcotic or
drug laws
Licensure Requirements: Pharmacist
Who can apply? (Foreign Graduate)
Must be at least 18 years old and not be addicted to the use of drugs or alcohol.
Licensure Requirements: Pharmacist
Application fee?
$200
Licensure Requirements: Pharmacist
Number (#) of CE Hours of Renewal
- 30 hours every 2 years
- CPE approved in NM shall be limited to programs and activities offered by an ACPE approved provider, programs or courses approved by other state boards of pharmacy and pharmacy law programs offered by the NM board of pharmacy.
- Pharmacists granted NM initial licensure are exempt from CPE requirements.
- Inactive status licensees will be required to furnish CPE for the current licensing period, 15 hours for each year the licensee was inactive, only for the purpose of reinstating to active status
Licensure Requirements: Pharmacist
Special CE Requirements (e.g. live, compounding, preceptor,
HIV, MTM, vaccinations, opioid, medication safety)?
- 10 hours, excluding the law requirement, per renewal period shall be obtained through live programs
- 2 hours in the area of patient safety
- 2 hours in the area of pharmacy law offered by the NM board of pharmacy
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2 hours in the area of safe and appropriate use of opioids (16.19.4.10)
. - Any pharmacist exercising prescriptive authority for vaccines shall complete an additional 2 hours of live ACPE approved vaccine related CE every two years.
- Any pharmacist exercising prescriptive authority for emergency contraception drug therapy shall complete an additional 2 hours of ACPE approved EC drug therapy related CE every two years.
- Any pharmacist exercising prescriptive authority for tobacco cessation drug therapy shall complete an additional 2 hours of ACPE approved tobacco cessation drug therapy related CE every two years
- Any pharmacist exercising prescriptive authority for naloxone drug therapy shall complete an additional 2 hours of live ACPE approved naloxone drug therapy related CE every two years.
- Any pharmacist exercising prescriptive authority for hormonal contraception shall complete an additional 2 hours of live ACPE approved hormonal contraception related CE every two years.
Licensure Requirements: Pharmacist
Minimum Intern Hours? (NEW)
1,500 hours
Licensure Requirements: Pharmacist
Minimum Intern Hours? (Transfer/Reciprocity)
Must have completed required
intern training or have worked
one year as a licensed
pharmacist in the state in which
the applicant has licensure by
examination.
Licensure Requirements: Pharmacist
Minimum Intern Hours? (Foreign Graduate)
1,500 hours
(Note: Applicants with work
experience as a pharmacist in
another country may petition the
board to accept the work
experience in lieu of internship
requirements.)
Licensure Requirements: Pharmacist
Degree/Education Required?
-New
-Transfer/Reciprocity
-Foreign Graduate
- New: Must be a graduate from a college of pharmacy accredited by ACPE.
- Transfer/Reciprocity: Must be a graduate of an approved
college of pharmacy. - Foreign Grad: Must have completed the FPGEE certification program.
Licensure Requirements: Pharmacist
Examinations Required?
-New
-Transfer/Reciprocity
-Foreign Graduate
- New: NAPLEX and NM MPJE
- Transfer/Reciprocity: NM MPJE
- Foreign Graduate: NAPLEX and NM MPJE
Licensure Requirements: Pharmacist
Documents (Transcript/Drug Test/Background Check)?
-New
-Transfer/Reciprocity
-Foreign Graduate
- NEW: Affidavit covering College of Pharmacy attendance and graduation 2 photographs
- Transfer/Reciprocity: Complete NABP Preliminary Application for License Transfer 2 photographs
- Foreign graduate: Copy of FPGEC Certification 2 photographs
Licensure Requirements: Pharmacist
Reinstatement Process?
.
If a pharmacist has not been active in the area of pharmacy practice for greater than one year but less than six years, the pharmacist candidate shall complete the following:
If a pharmacist has not been active in the area of pharmacy practice for greater than one year but less than six years, the pharmacist candidate shall complete the following:
● submit renewal form and pay past renewal fees and reinstatement fees;
● submit proof of CE for each inactive renewal period;
● submit proof of completed internship of minimum of 60 hours for each year of inactivity;
● sucessfully complete the MPJE; or
● In lieu of past renewal fees, reinstatement fees and proof of continuing education an inactive pharmacist may successfully complete the internship minimum of 60 hours for each year of inactivity, and successfully pass the NAPLEX and the MPJE.
Licensure Requirements: Pharmacist
Reinstatement Process?
.
If a pharmacist has not been active in the area of pharmacy practice for six years or more, the pharmacist candidate shall:
If a pharmacist has not been active in the area of pharmacy practice for six years or more, the pharmacist candidate shall:
● complete the internship minimum of 60 hours for each year of inactivity; and
● successfully pass the NAPLEX and the MPJE.
Licensure Requirements: Pharmacist
Probation Reasons/Process?
The board of pharmacy may deny, withhold, suspend or revoke any registration or license held or applied for under the Pharmacy Act upon grounds that the licensee or applicant is guilty of gross immorality or dishonorable or unprofessional conduct or has violated any rule or regulation adopted by the board pursuant to the Pharmacy Act.
Licensure Requirements: Pharmacist
Renewal Period?
The renewal date shall be the last day of the licensee’s birth month, every other year.
Licensure Requirements: Pharmacy Intern
License/Registration Required?
Application shall be made to the board on the required application form provided by the board prior to the beginning of internship.
Licensure Requirements: Pharmacy Intern
Who Can Apply? (New)
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.
Licensure Requirements: Pharmacy Intern
Who Can Apply (Foreign Graduate)
Graduates from non-ACPE accredited colleges of pharmacy may apply for a pharmacist intern license upon successful completion of FPGEC certification.
Licensure Requirements: Pharmacy Intern
Application Fee?
$25
Licensure Requirements: Pharmacy Intern
Application Fee?
$25
Licensure Requirements: Pharmacy Intern
Hours Required?
1500 hours. Maximum of 48 hours per week.
Licensure Requirements: Pharmacy Intern
Preceptor Required?
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.
Licensure Requirements: Pharmacy Intern
Renewal Period?
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.
Licensure Requirements: Pharmacy Technician
Licensure Requirements: Pharmacy Technician
License/Registration Required?
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.
Licensure Requirements: Pharmacy Technician
Who Can Apply?
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.
Licensure Requirements: Pharmacy Technician
Number # of CE Hours for Renewal?
No requirement for general renewal
Two hours are required if technician is certified and completes training and education to administer vaccines
Licensure Requirements: Pharmacy Technician
Special CE Requirements (e.g. compounding,
live, HIV, opioid, medication safety)?
2 hours Vaccine-related if trained to administer.
Licensure Requirements: Pharmacy Technician
Requirements? Examination, PTCB, Education?
Drug Test? Background Check?
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.
Licensure Requirements: Pharmacy Technician
Renewal Period?
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.
Licensure Requirements: Pharmacy Technician
Application Fee?
$25
The Pharmacy: The Physical Space
Specific Requirements on Who Can Access the Pharmacy?
Without Pharmacist? BOP? Police?
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.
The Pharmacy: The Physical Space
Minimum Square Footage?
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.
The Pharmacy: The Physical Space
Minimum Counter Space?
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.
The Pharmacy: The Physical Space
Counseling Area
Requirements?
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.
The Pharmacy: The Physical Space
Security System Requirements
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.
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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.
The Pharmacy: The Physical Space
Specifications on Alarms?
All facilities used for off-site drug storage (drug warehouses) shall be equipped with an alarm system to detect entry after hours.
The Pharmacy: The Physical Space
Separate Storage for Prescription Hard Copies by Control? Drugs by Control?
- 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.
The Pharmacy: The Physical Space
Must Storage Area Be Locked
for Hard Copies? Drugs?
All facilities used for drug warehouses shall be secure from unauthorized entry.
The Pharmacy: The Physical Space
Must Storage Area Be On Site for Hard Copies? Drugs?
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Every clinic, hospital or pharmacy requiring off-site storage of drugs shall license with the board by application.
Electronic records of prescriptions and patient prescription records may be stored offsite on secure electronic
servers provided the following requirements are met:
● 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.
The Pharmacy: The Physical Space
Must Storage Area Be On Site for Hard Copies? Drugs?
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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:
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.
Signage
Sign Requirement for
Counseling?
In every pharmacy there shall be prominently posted in a place conspicuous to and readable by prescription
drug consumers a notice concerning available counseling.
Signage
Sign Requirement for Closures?
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.
Signage
What are the requirements for displaying licenses and important documents in a pharmacy?
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)
-
Pharmacy Closure:
- Surrender the permit to the board.
- Remove all drug signs and symbols.
- Remove or destroy all drugs, devices, and poisons.
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Personnel Identification:
- All staff in restricted areas must wear an ID badge with their name and job title.
Board Notification
Time to Notify Board of
Changes to PIC?
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.
Board Notification
Time to Notify Board of
Changes to Address?
Any registrant or licensee shall report in writing any change of address or employment to the board within 10 days.
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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.
Equipment
Type of Prescription Balance
Required?
The pharmacy shall have a Class A prescription balance, or analytical balance and weights when necessary.
Equipment
What are the requirements for a pharmacy’s restricted area?
- 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).
Equipment
What are the requirements for a room where compounded sterile preparations (CSPs) are made?
- 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.
Equipment
What references must be available in the pharmacy?
- 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.
Equipment
What are the requirements for automated compounding devices?
- 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.
Equipment
Special Rules on Automated
Dispensing Cabinets?
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.
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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.
Access (Hospital)
Must RPh Be On-Site for
Access to Pharmacy?
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.
Access (Hospital)
After Hours Dispensing
Allowed? Requirements (i.e.
Dispensing Cabinet?
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.
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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.
Access (Hospital)
Access (Hospital)
Emergency Access to
Pharmacy Procedures?
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For the purposes of withdrawing limited doses of a drug for administration in emergencies when the pharmacy
is closed, if the drugs are not available in floor or emergency drug supplies, the following is applicable:
● 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.
Mail-Order
Mail Allowed? (In-State to Out,
Out-of-State to In)
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.
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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
Ownership Requirements
What Are the Fees for A
Pharmacy License?
$300 (in-state pharmacy) biennially. The license expires December 31 of every other year.
Ownership Requirements
Ownership Requirements
Who Can Apply? (owning a pharmacy)
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Any person making application to the board for a license to operate a pharmacy in this state shall submit to the
board an application for licensure indicating:
● 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.
Ownership Requirements
Must be RPh to Own
Pharmacy?
NOPE :)
Ownership Requirements
Additional Requirements for Ownership?
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What are the requirements for a nonresident pharmacy applying for licensure or renewal in New Mexico?
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.
Ownership Requirements
Rules on Sales/Transfers of Ownership
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.
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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.
Ownership Requirements
Application/Fees Required?
A new license application will be required to be filed in each of the above circumstances.
Ownership Requirements
How Long for Notification
Period?
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.
Staffing Requirements
RPh-Tech Ratio? Different by
Setting?
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.
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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.
Compounding
Is Facility Licensure Required for General Compounding? Sterile
Compounding?
Yes, for an out-of-state sterile compounding pharmacy or for an outsourcing facility.
Compounding
Restrictions on Compounding
Without Prescription?
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.
Compounding
Any product compounded in anticipation of future prescription drug or medication orders shall be labeled. Each label shall contain:
● 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.
Compounding
Stability of Compounded Product?
In the absence of stability information applicable for a specific drug or preparation in the USP/NF the preparation shall adhere to the following maximum BUD guidelines:
● 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.
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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.
Compounding
Certifications/Licensure Required?
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.
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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.
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Other training is in the next slide :)
Compounding
For sterile compounding, frequency of training and assessment for personnel shall include:
● 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.
Compounding
Special Requirements for Patent
Drugs? Controlled Drugs? OTC?
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.
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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.
Behind the Counter
Can Legend Drugs (e.g. Codeine, Opium Tinctures) Be Dispensed Without Prescription? Which Ones? Logging Requirements?
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A controlled substance listed in schedule V and a substance listed in schedules II, III, or IV which is not a prescription drug, may be dispensed by a pharmacist without a prescription provided:
● 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.
Behind the Counter
Which Drugs Are Required to Be
Behind the Counter?
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.
Behind the Counter
Dispensing Requirements for pseudoephedrine products
(Maximum Allowed/Logging)?
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.
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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.
Behind The Counter
What are the Rules Around
Pseudoephedrine? Limits?
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.
Drug Administration
Can Pharmacists Administer
Immunizations? Which Ones Can
They Administer?
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.
Drug Administration
Can Pharmacists Administer
Medications? Which Ones Can
They Administer?
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.
Drug Administration
What are some other requirments for pharamcist drug admin process? Other Requirements? Patient
Age Limit?
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.
PROTOCOL FOR PHARMACIST PRESCRIBING FOR TB SKIN TESTING
Purpose and Guidelines
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.
PROTOCOL FOR PHARMACIST PRESCRIBING FOR TB SKIN TESTING
Pharmacist Mandates
a. Pharmacists with prescriptive authority will document all prescription orders and with patient
authorization, provide notice to the patient’s primary practitioner within 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.
PROTOCOL FOR PHARMACIST PRESCRIBING FOR TB SKIN TESTING
General recommendation
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.
PROTOCOL FOR PHARMACIST PRESCRIBING FOR TB SKIN TESTING
Health Screening
a. patient history.
b. family history.
c. current living environment.
d. concurrent illness.
e. allergies and hypersensitivities.
f. medication history.
PROTOCOL FOR PHARMACIST PRESCRIBING FOR TB SKIN TESTING
Prescribing - Medications which may be prescribed
- The Mantoux tuberculin skin test (TST) is the standard method of determining whether a person
is infected with Mycobacterium tuberculosis. - Other FDA approved products for tuberculin skin testing
PROTOCOL FOR PHARMACIST PRESCRIBING FOR TB SKIN TESTING
Patient education / handout can include the following
A. handouts can include the following:
1. skin test reaction drug information
2. others as appropriate
3. lifestyle modifications
PROTOCOL FOR PHARMACIST PRESCRIBING FOR TB SKIN TESTING
Pharmacist Procedures - Steps in TST
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).
PROTOCOL FOR PHARMACIST PRESCRIBING FOR TB SKIN TESTING
Referral
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.
PROTOCOL FOR PHARMACIST PRESCRIBING FOR TB SKIN TESTING
Records
a. consent form.
b. records of notification
c. billing.
d. prescription order
PROTOCOL FOR PHARMACIST PRESCRIBING FOR TOBACCO CESSATION
Purpose and Guidelines
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.
PROTOCOL FOR PHARMACIST PRESCRIBING FOR TOBACCO CESSATION
PHARMACIST MANDATES
a. Pharmacists with prescriptive authority will document all prescription orders and with patient
authorization, provide notice to the patient’s primary practitioner within 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.
PROTOCOL FOR PHARMACIST PRESCRIBING FOR TOBACCO CESSATION
General Recommendations
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.
PROTOCOL FOR PHARMACIST PRESCRIBING FOR TOBACCO CESSATION
Health Screening
a. patient history.
b. family history.
c. current living environment.
d. concurrent illness.
e. allergies and hypersensitivities.
f. medication history.
PROTOCOL FOR PHARMACIST PRESCRIBING FOR TOBACCO CESSATION
G. PRESCRIBING
a. Medications which may be prescribed:
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.
PROTOCOL FOR PHARMACIST PRESCRIBING FOR TOBACCO CESSATION
H. PATIENT EDUCATION
handouts can include the following:
withdrawal symptoms
side affects
drug information
others as appropriate
lifestyle modifications
motivation
PROTOCOL FOR PHARMACIST PRESCRIBING FOR TOBACCO CESSATION
Referral
Pregnancy.
Current seizure disorder for bupropion therapy.
Current eating disorder for bupropion therapy.
Other protocols to read:
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
Your Conscience Rights
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.
How to File a Conscience Complaint
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.
Federal Health Care Conscience Protection Statutes
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.
Laws & Requirements
Recalls (Class I - III + other stuff)
