WV MPJE

Who comprises the WV BoP?

7 total members:

5 licensed pharmacist for at least 3 years

2 citizen members unrelated to pharmacy

Each member must be a resident of the state

Who chairs the WV BoP?

Members are appointed by the Governor with the advice and consent of the Senate.

How long do WV BoP members serve?

5 year term.

maximum of 2 consecutive terms.

Must wait at least 1 year after 2 consecutive terms to be appointed again.

How often does the WV BoP Convene?

At least 2 meetings a year.

Other meetings shall be held at the call of the chairperson or upon the written request of 3 members.

What is required for a new pharmacist license? (7)

(1) 18 years old

(2) accredited SoP graduate

(3) 1500 internship hours

(4) Pass exams approved by the board (NAPLEX & MPJE)

(5) Not be an alcohol or drug abuser, an applicant in an active recovery process may be consdiered.

(6) Certification of moral character

(7) Not been convicted in any jurisdiction of any other felony no sooner than 5 years after the date of conviction.

What is required for transfer/reciprocity of licensure? (5)

(1) Complete a preliminary application form from NABP

(2) Submit a certified copy of proof of experience

(3) Submit a head shot photograph within the previous 12 months

(4) complete a certified criminal records check

(5) Appear before the board

What does FPGEC certification mean?

Foreign Pharmacy Graduate Examination Committee certification. Required for licensure of foreign graduates.

What is the internship requirement for foreign graduates.

1500 hours of which 500 (1/3) may be earned in a foreign country.

What is the application fee for a pharmacist license?

$250

How many hours of CE are required for renewal?

30 hours every 2 years

Are there special CE requirements?

YES.

For general pharmacists:

Of the 30 hours, 6 must be LIVE and 3 must be a WV BOP approved drug diversion program unless a waiver is signed.

CE hours may be earned via volunteering at a charitable clinic:

PIC: 8 hours worked = 1 hour live CE

Staff Rph: 10 hours worked = 1 hour live CE

Immunizing pharmacists must have 2 hours of immunizations CE each licensing year

Consulting pharmacists must have 3 hours of consulting practice each licensing year

What is the minimum intern hours required for licensure in WV?

1500

What examinations are required for a new pharmacist license in WV?

NAPLEX & WV MPJE

What exams are required for license transfer/reciprocity?

WV MPJE

What exams are required for a WV licensure of a foreign graduate?

NAPLEX, WV MPJE, & FPGEC

What is the reinstatement process for a license that is expired 1 year or less?(3)

(1) complete reinstatement form

(2) Provide proof of any required CE

(3) Pay reinstatement fee of $250

What is the cost for (1) new licensure (2) reinstatement fee and (3) renewal fee?

(1) $250

(2) $250

(3) $100

What is the reinstatement process for a license that is is expired for more than 1 year?(3)

(1) complete reinstatement form

(2) Provide proof from national board of registration for MPJE

(3) Pay reinstatement fee of $250

How often must a WV pharmacist license be renewed?

Every 2 years (every other year)

How often must a pharmacist consultant renew and what is the fee?

annually with $20 fee

PIC requirements? (2)

(1) create/maintain 20 hour technician training program

(2) Must work at least 30 hours per week, working at least 3 days a week in that pharmacy.

...If the pharmacy is open less than 40 hours then the PIC must work the majority of the hours the pharmacy is open.

Who can apply for a pharmacy intern license? (4)

(1) currently enrolled in a pharmacy college

(2) graduate of an approved college of pharmacy

(3) qualified graduate who is awaiting examination

(4) individual participating in a residency or fellowship program

What documentation is required to obtain a pharmacy intern license? (2)

(1) 3X4 head and shoulder photo

(2) state & national electronic fingerprint based criminal history record check (identogo)

What is the application fee for a WV pharmacy intern license?

$10

How often must a pharmacy intern license be renewed and what is the fee?

renewed annually for a $5 fee

Who can apply to be a pharmacy technician? (2)

(1) high school graduate or GED certificate

(2) completed an approved pharmacy technician training program

What is the application fee for pharmacy technicians?

$25

What options exist for pharmacy technician training programs? (3)

(1) enrolled in competency-based pharmacy technician education and training program of a learning institution or training center as approved by legislative rule of the board.

(2) Working in a 500 hour pharmacy provided, on-the-job, competency-based education and training program approved by the board.

(3) Obtained a national certification as a pharmacy technician and have practiced in another jurisdiction for at least 1 year.

What requirements must a technician trainee fulfill? (4)

(1) Completed a 20-hour training program prior to performance of regular duties.

(2) complete background check

(3) the on-the-job, competency-based pharmacy technician training program shall consist of a minimum of 500 hours of employment within a 12-month period under the direct supervision of a pharmacist.

(4) 90 days from the date of graduation from a pharmacy technician program at a learning institution or training center, or the date of the certification of completion of the on the job training program by the PIC, to successfully pass the ExCPT or PTCE.

What exam(s) must a pharmacy technician pass to become certified.

ExCPT or PTCE

How often must a pharmacy technician renew their license and what is the fee?

every 2 years for a $20 fee

What stipulations are in place for a pharmacist to take a break? (5)

(1) indirect supervision of a registered pharmacy technician is permitted to allow a pharmacist to take 1 break of no more than 30 minutes during any contiguous 8 hour period.

(2) The pharmacist may leave the pharmacy but not the building.

(3) During the break, a technician may continue to prepare Rxs for the pharmacist to verify.

(4) A Rx may NOT be delivered until the pharmacist has verified the accuracy of the prescription, and counseling, if required has been provided to or refused.

(5) A pharmacy that permits indirect supervision of a pharmacy technician during a pharmacist break shall have either an IVR or voice mail system installed on the phone line.

Counseling area requirements?

The pharmacy shall have a separate area available for patient counseling which will ensure the privacy and confidentiality of the discussion, and which has adequate space to use any equipment, visual aids, and publications, if necessary to provide proper counseling.

Sanitary Regulations?

(1) The sink of the prescription area should be used for no other purpose than the cleaning of equipment and articles used for Rx preparation.

(2) Prescription counters shall remain clean and not used for any other purpose than compounding and dispensing.

What is the dress code for pharmacy employees?

(1) pharmacists and interns shall wear a clean white coat or jacket with a name tag identifying their first name and position.

(2) Technicians and trainees must wear a coat, jacket, or apron of a different color than white and a name tag.

Specifications on alarms? (3)

(1) A device for the detection of breaking and/or entering shall be installed in each prescription department. The device must be based on accepted burglar alarm industry standards.

(2) The device must be maintained in functioning order and have an auxiliary source of power.

(3) Deactivation of the alarm system must be restricted to the pharmacists working at the pharmacy, and the system shall be activated whenever a pharmacist is not on duty.

How should hard copies of prescriptions be sorted?

(1) Schedules I & II maintained in a separate prescription file.

(2) Schedules III, IV, & V shall be maintained either separately from all other records of the pharmacy or filed with either the C-I & C-II Rxs or non-controlled Rxs in a form that the information required is readily retrievable from ordinary business records.

What is considered "readily retrievable" for a filed CIII-V prescription hard copy?

If at the time they are initially filed the face of the Rx is stamped in red ink in the lower right corner with the letter "C" at least 1 inch high.

When may the requirement to mark the hard copy prescription with a red "C" be waived?

If the pharmacy employs an automated data processing (ADP) system or other electronic record keeping system for prescriptions.

How can controlled substances be stored?

(1) Schedule II, III, IV, & V shall be stored in a securely locked narcotic cabinet made of minimum 20 gauge metal OR

(2) Controlled substances may be dispersed throughout the stock of non-controlled substances in a manner to obstruct the theft or diversion of the controlled substance.

What is a unique option for storage of controlled substances in an institutional setting?

A secure automated distribution system, approved by the board, may contain controlled substances within an institutional setting in lieu of a narcotic cabinet.

How long does WV law require records of hard copy prescriptions be kept?

5 years

Where can records of hard copy Rxs be kept and for how long?

Hard copies must be maintained on-site for at least 1 year (12 months) from the last refill. After 1 year, records may be kept off-site, but must be produced within 72 hours upon request from proper authorities.

How long does a pharmacy have to produce a prescription record that is kept off-site?

72 hours.

A sign with a minimum of 4 inch letters stating: "Pharmacy Closed. No Pharmacist On Duty."

In the absence of a pharmacist, a sign with what must be displayed?

"West Virginia law requires pharmacists to substitute a less expensive generic-named therapeutically equivalent drug for a brand name drug, if available, unless you or your physician direct otherwise."

Lettering on sign must be at least 1&1/2 inches in height with appropriate margins & spacing.

What sign is required in all WV pharmacies?

(1) Sanitary method of measuring & dispensing 5 - 250 mL of liquids

(2) Mortars & pestles, spatulas, ointment pads, counting trays, balance & weights, and any other equipment or supplies necessary.

(3) Proper equipment & facilities to prepare sterile products & meet requirements of good compounding practice.

(4) Adequate facilities for the proper storage of pharmaceuticals; appropriate temperatures, dry, well-lighted, well-ventilated, and maintained in a clean and orderly condition.

(5) Facilities for the safe storage of controlled substances if the dispersion method is not used.

(6) Acceptable system of keeping records of prescriptions dispensed as required by the Uniform Controlled Substance Act and any rules and regulations pertaining to the act.

(7) A system of keeping patient profiles as required by Title 15, Series 4.

(8) Current pharmacy law book and book of rules and regulations published by the Board, a readily retrievable electronic copy may suffice.

What are some of the equipment requirements for a pharmacy? (8)

Must be for immediate security or surveillance purposes as long as the reason for entry, the name of the person entering, and the time and date of entry are documented & immediately available to the Board.

What is required for the pharmacy permit holder to enter the pharmacy without a pharmacist present?

(1) Drugs are properly labeled

(2) On prepackaged drugs are available, in amounts sufficient for immediate therapeutic requirements.

(3) Whenever access to the cabinet occurs, written practitioner's orders and proof-of-use are provided.

(4) All drugs in the cabinet are inventoried no less than once per week.

(5) Complete audit of all activity concerning the cabinet is conducted no less than once per month.

(6) Written policies & procedures are established to implement the patient care provisions of this subdivision.

During times that an institutional pharmacy may be unattended by a pharmacist, arrangements shall be made in advance by the PIC for provision of drugs to the medical staff. These arrangements shall ensure: (6)

Whenever a drug is not available from floor supplies or night cabinets, and the drug is required to immediately treat a life-threatening situation of a patient.

Under what circumstances may a supervisory nurse access an institutional pharmacy?

The PIC shall, in conjunction with the appropriate committee of the institution, designate 1 supervisory nurse in any given 8 hour shift responsible for obtaining drug from the pharmacy during an emergency situation.

How is a supervisory nurse selected?

(1) Patient's name

(2) Location within the institution

(3) Name, Strength, & Quantity of the drug

(4) Date and time

(5) Nurse's signature

The form shall be left with the container from which the drug was removed and the supervisory nurse shall contact the pharmacist "on call."

Removal of any drug from the pharmacy by an authorized nurse shall be recorded on a suitable form showing: (5)

(1) The mail-order pharmacy or non-resident pharmacy shall maintain a permit, registration, or license as required by the state where located and in WV.

(2) The PIC or at least 1 designated pharmacist of the out-of-state mail order pharmacy or non-resident pharmacy shall be licensed to practice in WV & act as the PIC of the registration.

(3) Any other pharmacist providing pharmacist care from the out-of-state mail order pharmacy or non-resident pharmacy shall be licensed int he state where the pharmacy is located.

Requirements for mail-order pharmacy? (3)

$150

What are the fees for a pharmacy license?

Registration is issued on the joint application of the owner and the PIC, on the sworn statement that it will be conducted in accordance with the provisions of the federal and state laws, rules, and regulations.

What does the application to register a pharmacy include?

Renewal every 2 years.

$150 renewal fee.

Renewal takes place on July 1st of each year.

How often must a pharmacy license be renewed and what is the fee. When does renewal take place each year?

90-days

How long is a pending license good for when a change of ownership application is submitted?

The applicant may apply to the Board for additional time, otherwise the pending number will become null and void.

What happens if all requirements are not met by the end of the 90-day pending license for change of ownership?

(1:4 ratio) In any pharmacy setting there is a max of 4 pharmacy technicians and/or pharmacy technician trainees per on on-duty pharmacist.

What is the maximum RPh to Tech/trainee ratio?

(> 15 Rxs/hour) Any pharmacy dispensing more than 15 prescriptions per hour on average during a day shall have a registered pharmacy technician assisting the pharmacist.

What is the prescription volume threshold to require a pharmacy technician?

No pharmacist may work more than 12 hours within a 24 hours period without at least 8 hours off duty in that 24 hours.

What is the working hour limit for pharmacists?

In a case of emergency when a pharmacist calls off work, the pharmacist on duty may work more than 12 hours in order to keep the pharmacy open. The pharmacists would have to document and date the amount of time worked beyond the 12 hours limit along with the reason for extended hours of work and make it available to the board.

Under what circumstances may a pharmacist work greater than 12 hours in a 24 hour period?

Sterile Compounding Permit

What documentation is required for a pharmacy compounding or mixing prescription orders for sterile solutions suspensions to be administered parenterally, enterally, by irrigation, or ophthalmic drops.

(1) Expiration date

(2) Date of preparation

(3) the drug's control #

What additional labeling is required for compounded products?

anyone who is engaged in manufacturing, preparing, propagating, compounding, processing, packaging, repacking, or labeling of a prescription drug.

What is the law definition for a manufacturer?

(1) $500 manufacturer permit fee

(2) Authorization to operate as a manufacturer with the FDA

(3) Satisfactory inspection by the FDA within the previous 5-year period OR pay an additional $400 fee for inspection by the board.

What is required to obtain a Manufacturer permit? (3)

Yes. EXCEPT for schedule II medications.

Can an employee or agent of the individual practitioner communicate a prescription to a pharmacist?

Written for a legitimate medical purpose and in the usual care of the prescribers usual professional practice.

What 2 factors are important when determining if a prescription is legally valid?

No. The prescriber must provide appropriate documentation through the use of an invoice or other federally required forms.

Can a prescriber write a prescription to obtain drugs for office use?

(1) full name and address of the patient

(2) the name, address, and registration # of the practitioner

What information is required on a controlled substance prescription?

add or change the patient's address after verification.

What changes can a pharmacist make to a prescription for a controlled substance without consulting the prescriber?

Add or change the dosage form, drug strength, drug quantity, directions for use, or issue date.

What changes can a pharmacist make to a prescription for a controlled substance ONLY AFTER consulting the prescriber?

The patient's name, the drug prescribed (except for generic substitution), or the prescriber's signature.

What changes is a pharmacist NEVER authorized to make to a prescription for a controlled substance?

No. Controlled substances must be written on a separate blank. A controlled substance cannot be on the same blank as another controlled or non-controlled substance.

Can a controlled substance be written on the same prescription as another drug?

90 days

How long is a Schedule II prescription valid for from the date it was issued?

Pursuant to a paper prescription manually signed bu the prescriber or by electronic prescribing. A schedule II prescription can be faxed to a pharmacy BUT the original paper prescription must be presented before the prescription can be dispensed.

How must a schedule II prescription be received?

Within 15 days (new)

Within 7 days (old)

How long does a prescriber have to deliver a valid paper or electronic prescription to the pharmacy after an Authorization for Emergency Dispensing has occurred?

NO. However, a prescriber may issue multiple prescriptions authorizing the patient to received a total of up to a 90-day supply. Each prescription must indicate the earliest date in which that prescription may be dispensed.

Are refills permitted for Schedule II prescriptions?

72 hours. If it is not filled within 72 hours, the patient will need a new prescription.

When a C-II medication is partial filled, how long does the pharmacy have to fill the remaining quantity?

6 months.

How long is a prescription for a Schedule III or IV valid for?

No more than 3 days prior to the date the prior dispensing would be exhausted.

How early can a controlled substance legally be filled?

YES.

The total quantity dispensed in all partial fills cannot exceed the total quantity supplied and no dispensing can occur after 6 months of the date it was written.

If partial filling permitted for Schedule III, IV, and V drugs?

DEA Form 106

What form must be filed in the event of any controlled substances being lost or stolen?

DEA Form 222

What form must be filed for any transfer of a Schedule II controlled substance to another registrant without a prescription?

(1) ephedrine

(2) pseudoephedrine

(3) phenylpropanolamine

(4) Iodine Solution > 2%

What drugs are required to be behind the counter? (4)

(1) Prescription issued by a veterinarian or WV licensed physician

(2) Must have specified # of refills

(3) May be sold to an individual actively engaged in the legal practice of animal husbandry of livestock.

(4) must keep records of sales

(5) If the person is unknown to the seller, then valid ID is needed

What are the dispensing requirements surrounding Iodine solution?

No more than 240 cc of any substance containing opium

No more than 120 cc of other controlled substances

No more than 48 dosage units of any substance containing opium

No more than 24 dosage units of other controlled substances

What quantities may a pharmacists dispense of a controlled substance listed in Schedules II, III, IV, or V which is not a prescription drug as determined by the Federal Food, Drug, and Cosmetic Act?

3.6 grams per day

7.2 grams in a 30-day period

48 grams annually

What are the maximum quantities of ephedrine, pseudoephedrine, and phenylpropanolamine that may be dispensed without a prescription?

(1) Must be kept behind the counter

(2) >/=18 years with valid government-issued photo ID with DOB

(3) The pharmacist MUST offer counseling

(4) Must electronically submit the information to the Multi-State Real-Time Tracking System (MSRTTS)

What are the rules surrounding pseudoephedrine sales?

Expires Jun 30th biennially (every 2 years)

Registration fee = $10

In order to be an immunizing pharmacist, you must be registered with the WV BOP. When does a registration expire and how much is the registration fee?

(1) Those 18 years and older

(2) Those 11-17 years of age WITH written informed parental consent, a prescription from a physician, and no contraindications.

What age groups can pharmacists vaccinate?

(1) Influenzae

(2) Pneumococcal

(3) Hepatitis A

(4) Hepatitis B

(5) Herpes Zoster

(6) Tetanus

(7) Meningococcal

(8) HPV

What vaccinations can be administered to those 18 years and older? (8)

(1) Influenzae

(2) HPV

What vaccinations can be administered to those 11-17 years of age WITH written informed parental consent, a prescription from a physician, and no contraindications? (2)

(1) An unrestricted pharmacist license

(2) Insurance coverage

(3) PLUS ONE OF THE FOLLOWING

(a) Certification from Board of Pharmaceutical Specialties or completed an ASHP residency program.

(b) PharmD + 3 years of clinical experience + completion of ACPE certificate program

(c) BSPharm + 5 years of clinical experience + completion of 2 ACPE approved certificate programs

What must any pharmacist wanting to enter into a collaborative practice agreement have? (3)

Within 30 days the pharmacist shall report the immunization to the WV Statewide Immunization Information (WVSII) database AND to the patient's primary care provider.

Who must the pharmacist report the administration of the patient to and how many days do they have?

The immunization questionnaire, the consent form, and the record of the immunization administration must be kept for at least 5 years.

Upon administration of an immunization, what documentation must be filed and for how long?

An individual employed y an authorized entity who administers or provides an epinephrine auto-injector to a person is immune from liability for any civil action arising out of the act or omission resulting from the administration of the epinephrine auto-injection unless the act or omission was the result of the individual's gross negligence or willful misconduct.

Are there laws/protections for emergencies when giving immunizations?

(1) Name of solution, lot number, & volume of the solution

(2) The patient's name

(3) Infusion rate

(4) Bottle sequence number or other system control number

(5) Name and quantity of each additive

(6) Date of the preparation

(7) The beyond-use-date & time of parental admicture

(8) Ancillary precaution labels

What are the requirements for IV labeling for a dispensing unit? (8)

(1) Name & strength of the drug

(2) name of the manufacturer or the packager

(3) lot number

(4) expiration date

What must each individual unit-dose container be labeled with? (4)

(1) Name & strength of each drug contained in the unit of use packet

(2) Name of the manufacturer or the packager of each drug

(3) Lot number of each drug int he unit use packet

(4) expiration date of each drug in the unit of use packet.

What must each unit of use packet be labeled with? (4)