Fassett's MPJE Review Questions for Washington State

Define deliver/delivery

The actual, constructive or attempted transfer from one person to another of a drug or device, whether or not there is an agency relationship.

Define Dispense

The interpretation of a prescription or order for a drug, biological or device and, pursuant to that prescription or order, the proper selection, measuring, compounding, labeling or packaging necessary to prepare that prescription or order for delivery.

Define Distribute

The delivery of a drug or device other than by administering or dispensing.

Define Compounding

The act of combining two or more ingredients in the preparation of a prescription.

Define Labeling

The process of preparing or affixing a label to any drug, device or container. The label must include all information required by current federal and state law and pharmacy rules.

Define Administer

The direct application of a drug or device, whether by injection, inhalation, ingestion or any other means, to the body of a patient or research subject

How many members serve on the Board of Pharmacy?

15

How many are public members?

4

Complete the following table regarding prescriptive authority of those with various credentials.

Answer Key for the previous table

How long are prescriptions for legend drugs valid from the date issued?

1 year

Is there a maximum number of refills allowed for legend drugs? What is it?

11 refills (1 year of medication)

How long are prescriptions for each of the following valid: C-2s, C-3s, C-4s, C-5s?

6 months

Is there a maximum number of refills allowed for C-5s? What is it?

Five refills or six months total supply

Are the number of refills for C-3s and C-4s the same as federal or less?

Federal law places no restrictions on C-5s but WA does. Number of refills for C-3s and C-4s is the same in Washington as Federal; 5 refills, 6 month expiration

What must be on the label of an outpatient prescription?

Name and address of the pharmacy

Patient Name (if on the prescription)

Prescriber Name

Serial number (prescription number)

Directions for use

Date of filling

Name and strength of drug

Quantity

Expiration Date

RPh initials

Transfer Caution

Side effects statement (may be on other labeling)

Any cautionary statements on the prescription

Can the prescribed brand name be placed on the label when a generic is dispensed? If so, what wording is required?

Yes: "Generic for..."

How does a pharmacist determine whether a particular generic drug is suitable as a substitute for a brand name drug?

Orange/Purple book; Washington does not require utilization of a specific reference: it's up to the pharmacist's judgement.

Must generic savings be passed on to patients? If so, what proportion, and how determined?

Yes, Normal cash price of brand - (savings *0.6) = Max price; Savings = (Acq Cost brand - Acq cost generic)

How can a prescriber indicate that substitution is or is not permitted?

Sign on dispense as written line or write "DAW" on the face

Do patients have the option of demanding the brand name when substitution is permitted?

YES

How about patients whose prescriptions are paid for by public funds?

No

What are the temperature USP standards for controlled room temp, a "cool place", a "cold place"/refrigerator, and freezer?

Controlled room temp = 20° - 25° C

"Cool place" = 8° - 15° C

"Cold place"/refrigerated = 2° - 8° C

Freezer = ⁻25° - ⁻10° C

What documentation is required of the pharmacist when product interchange is performed?

To me, "product interchange" means brand/generic substitution; In WA, prescriptions blanks are required to be "two line" if the prescriber signs on the substitution permitted line, the pharmacist must use a generic and pass the savings on to the patient.

Under what conditions, if any, is therapeutic substitution allowed?

To me "therapeutic substitution" means therapeutic interchange e.g. changing losartan to valsartan. In WA, this may be executed by the pharmacist with prior authorization from the prescriber either per a formulary, protocol or on a per-prescription basis. Authorization may be verbal but must always be documented. Pharmacist substitution per a CDTA is not really "therapeutic interchange" so much as prescribing.

What minimum sets of references, products, or equipment are required in all community pharmacies?

Copy of WA pharmacy statutes and references necessary for the practice; all of which may be digital.

Do pharmacy hours have to be posted? Where?

Operating hours must be posted on/adjacent to the entrance of the pharmacy; if part of a larger establishment (i.e. grocery store) hours must be posted on/adjacent to the main entrance(s) and at the pharmacy.

Can the store be open but the pharmacy department closed? Under what requirements?

1. Pharmacy must be separately secured from the rest of the store.

2. Equipment, records, devices, poisons etc. that are restricted to sale by a pharmacist must be kept in the pharmacy area.

3. If written prescriptions are to be accepted after pharmacy hours, a secure drop-box or mail slot is required.

4. Pharmacy must have a direct phone number

5. Oral prescriptions may be left on voicemail but it must announce pharmacy hours.

6. board requires 30-days notice before adopting differential hours.

Do pharmacist licenses have to be on display? The original or official copy? Is a photocopy ok? Can you obscure your address on the copy displayed to the public?

Yes. A printout of the active license from the DoH website may suffice. Home address may be obscured but any license restrictions may not be.

Are there any required notices that must be displayed to the public?

Generic interchange notice

Is a separate patient counseling area required?

Yes

Is OBRA counseling required for Medicaid only or all patients?

All patients

How must the offer to counsel be made?

The offer to counsel must come directly from the pharmacist to the patient or the patient's agent.

Does the offer to counsel need to be documented? Does the refusal of the offer need to be documented? How?

Documentation is not required, though it's not a bad idea.

Is counseling required on new prescriptions, refills, or both?

Both

Can printed materials satisfy the counseling requirement? Under what circumstances?

In the case of a prescription being delivered outside the confines of the pharmacy, printed materials as well as contact information for the pharmacist can suffice.

What about prescriptions that are delivered or mailed to the patient?

See previous question.

Are there any special requirements for mail order pharmacies?

In the case of a prescription being delivered outside the confines of the pharmacy, printed materials as well as contact information for the pharmacist can suffice.

Under what circumstances may a pharmacist fill prescriptions written in another state?

When the prescription is written by an authorized prescriber.

Is there any provision for dispensing an emergency refill supply of legend drugs when there are no refills left and the prescriber cannot be contacted? What is allowed/required?

72 hour supply and notification to the prescriber.

Are patient profiles required for all patients?

Yes

What information is required on the profile?

1. Patient name

2. Patient address/phone

3. Patient DOB

4. Drugs/devices used (including OTCs, herbals, prescriptions filled elsewhere etc)

5. Prescription information (drugs, strengths, forms, directions, Rx #s, quantities, refills, prescribers, Dispensing pharmacists, etc)

6. Allergies/chronic disease states

7. Authorization for non-CRC use

8. Pharmacist's comments

What use of the profile is required? Review prior to dispensing new Rx's? Review prior to refills?

Prospective DUR required before dispensing of any prescription (new or refill)

What is expected to be looked for during profile review?

1. DDIs

2. ADRs

3. Therapeutic duplication

4. Improper utilization

Can a patient refuse to give certain information for the profile? If so, must the refusal be documented, and how?

Yes. The pharmacist will not be held responsible for information withheld by the patient. Documentation of refusal is not required. For CSA drugs, the patient MUST provide an address.

What are the requirements for use of computers to process prescriptions?

Electronic patient record systems must maintain data integrity, confidentiality and availability (to those authorized).

What must be done if the computer system goes down?

Pharmacy must have an auxiliary record system for use (with provisions for prompt entry of info into the system, within 2 working days)

Is there any requirement for a daily printout of prescriptions that were entered into the computer? Who must sign the printout?

Pharmacists must sign a daily log sheet/book indicating the correctness of the computer records.

Can a pharmacist legally repackage another pharmacy's prescription? Under what circumstances?

No; unless the product has all of the required labeling (otherwise, misbranded)

Can legend drug prescriptions be FAXed? Under what circumstances and requirements?

Yes if faxed directly from the prescriber e.g. from the prescribers identifiable fax number.

Can legend drug prescriptions be transferred electronically (ie, by computer)? Under what circumstances and requirements?

Faxes yes.

Under what circumstances are FAXed CSA prescriptions allowed?

C-IIIs, C-IVs and C-Vs

Can refills of legend drugs be transferred from one pharmacy to another? Can they be transferred back?

Yes and yes

Can an intern transfer refills?

yes

Must information regarding the transfer of legend drugs be recorded on the hard copy of the original prescription, or can it merely be recorded in the computer?

For legend drugs the computer is enough.

What information must be recorded by the transferring pharmacy?

1. Record that the prescription has been transferred

2. the name and address of the pharmacy to which it was transferred

3. The name of the receiving pharmacist/intern

What information must be placed on the original copy of the transferred prescription by the receiving pharmacy?

1. the word "transfer"

2. Date of transfer

3. original written date

4. Date of last refill (Rx) and all previous fills (CSAs)

5. Refills remaining

6. Name/address/RX # of transferring pharmacy

7. Name of transferring pharmacist

Is it possible for pharmacies under a common ownership to share a single patient/prescription database? If so, what are the rules for prescription transfers?

Yes, if common database/software is used that can track fill/refill info, it doesn't count as a transfer.

How long must the pharmacy maintain the following records: original prescriptions

2 years (6 for Medicaid)

How long must the pharmacy maintain the following records: refill records

2 years (6 for Medicaid)

How long must the pharmacy maintain the following records: drug purchase records

2 years (6 for Medicaid)

How long must the pharmacy maintain the following records: patient profiles

2 years (6 for Medicaid)

Are any of the record maintenance requirements different for CSAs?

2 years (6 for Medicaid)

Must every pharmacy have a pharmacist-in-charge?

RPM; "Every portion of the establishment coming under the jurisdiction of the pharmacy laws shall be under the full and complete control [of the RPM]." (WAC 246-869-070)

Are there any special requirements to be pharmacist-in-charge?

Pharmacist licensure and notification to the commission

May a person be pharmacist-in-charge for more than one pharmacy?

Yes

When must the Board of Pharmacy be notified of a change of pharmacist-in-charge?

Immediately

When must the Board of Pharmacy be notified of a change of pharmacy address?

The pharmacy must re-apply for licensure; application must be thirty days prior to the next commission meeting.

When must the Board of Pharmacy be notified of the closing or sale of a pharmacy?

15 Days prior

When must the Board of Pharmacy be notified of a change of pharmacy telephone number?

Unknown, I'd go with promptly.

When must the Board of Pharmacy be notified of a change of an individual pharmacist's address, change of an intern's address, change of a technician's address, change of a person's name?

Promptly

What must be on the label of a unit-dose or singledose package of a legend drug dispensed for a patient in a hospital or nursing home?

on cassette (pt name, location), drug name, strength/conc, dosage, lot no., CSA schedule

What must be on the label of a multiple-dose container dispensed for a patient in a hospital? In a nursing home?

hospital: drug name, conc., exp. date, storage, auxiliary labels

LTC: pharmacy name/address, Rx#, prescriber, pt name, drug name, conc., CSA schedule, quantity, date prepared/disp., exp date, RPh initials

What is required on the label of a parenteral solution dispensed for a patient in a hospital?

hospital: pt name, location, drug name, conc., exp. date, exp. time, RPh initials, preparer initials

What is required on the label of a parenteral solution dispensed to a patient for home infusion therapy?

pharmacy name/address/phone#, Rx#, 24-hr phone, pt name, prescriber, drug name, conc., directions, infusion rate, date prepared/disp., exp. date, exp. time, storage, RPh initials, auxiliary labels, transfer caution label

What is required on the label of a radiopharmaceutical agent?

Immediate outer container:

1. Standard radiation symbol

2. "Caution-Radioactive material"

3. Name of the radiopharmaceutical

4. Amount of radioactive material in millicuries or microcuries

5. if liquid, volume in mL

6. requested calibration time

7. Expiration

8. Specific concentrationof radioactivity

Immediate container:

1. Standard radiation symbol

2. "Caution-Radioactive material"

3. Name of the radiopharmaceutical

4. Amount of radioactive material in millicuries or microcuries

5. Name of the nuclear pharmacy

6. Prescription number

7. Date

What are special requirements, if any, to be a nuclear pharmacist?

certification of ≥ 6 months on-the-job training, completed nuclear pharmacy training program in an accredited COP

Can transfers of refill information be faxed between pharmacies?

Yes

How rapidly must a pharmacy respond to a patient's request to amend the information in his or her medication record?

WA - 15 days (+ possible 6 day extension)

HIPAA - 30 days (+ possible 60 day extension)

May a pharmacy transmit a patient's prescription claim information electronically to a third party payor without the patient having provided written consent to the payor or the pharmacy?

Yes as long as it's in due course of healthcare operations

When must a pharmacy provide a copy of its Notice of Privacy Practices to a patient or other person requesting one?

At first point of contact or when requested by anyone

How can changes in the NOPP be communicated to patients?

changes posted within the pharmacy

Can a non-custodial parent act on behalf of a minor to authorize disclosure of information in the patient medication record?

"relatives" (incl. grandparents, aunts/uncles, siblings): may require a signed authorization from the child's parent, or declaration that the caregiver is responsible for the child

What is the maximum amount of pseudoephedrine that can be sold OTC to an individual in a given day?

No more than 3.6 grams per day

May pharmacists administer drugs? By which route(s)?

Yes, by any route

What are the requirements for immunizations administered by pharmacists?

Vaccines may be administered by pharmacists by virtue of their license.

To what extent are collaborative practice agreements allowed?

Submit to PQAC for records; PQAC just wants to know that you have a CDTA, they don't approve/deny them.

What is the status of carisoprodol? Tramadol?

C- IV

Under what circumstances may a pharmacist refuse to fill a lawful prescription?

Conscientious Objection

What is the maximum ratio of technicians to pharmacists? Of interns to pharmacists?

1:3 when an approved ancillary personnel utilization plan is on file with PQAC; no limit on interns, but only one intern per preceptor may count hours.

"5 Musts" of hospital pharmacy

Under the direction of the Director of Pharmacy, the hospital pharmacy must:

1. Control all drugs throughout the hospital

2. Conduct monthly inspections of all areas where drugs are stored or used.

3. Monitor drug therapy

4. Provide drug information to patients, physicians and others

5. Monitor for and report adverse drug reactions and drug defects.

"5 Shoulds" of hospital pharmacy

Under the direction of the Director of Pharmacy, the hospital pharmacy should:

1. Obtain and record drug use histories and participate in discharge planning

2. Prepare all sterile products except in emergencies

3. Distribute and control all radiopharmaceuticals

4. Be involved in the administration of drugs

5. Be involved in prescribing

What are the requirements for storage and accountability for controlled substances in a hospital?

1. Perpetual inventory of C-IIs

2. Pharmacy must maintain records of drugs distributed to other units.

3. Units must document drug administration.

4. Wastage/Destruction of C-IIs must be witnessed (2 signatures)

5. Hospital must have policies in place for the destruction of all CSAs (DEA form 41)

6. Periodic chart monitoring by RN or PharmD to ensure accuracy of chart records.

7. Physical count of all C-IIs and C-IIIs at each shift change.

8. CSA records maintained for 2 years.

What are the requirements for storage and accountability for controlled substances in a longterm care facility?

1. CSA schedule must be printed on the label

2. C-II must be stored separately under lock and key.

3. C-IIIs must be stored separately under lock and key (may be stored with C-IIs)

4. A bound log book must be maintained for C-IIs and C-IIIs

5. Physical count of all C-IIs at least daily

6. Physical count of all C-IIIs at least weekly

7. D/C'd or remainder C-IIs must be destroyed within 30 days; C-IIIs, C-IVs and C-Vs must be destroyed within 90 days.

Are tech-check-tech programs allowed? Under what circumstances?

Yes, Tech-check-tech of unit dose drugs is allowed when the checking tech has completed additional training and testing with 99% accuracy or better.

Can techs fill IVs?

Yes, additional training must include proficiency testing with 100% accuracy. A PHARMACIST must check all IV admixtures; no interns.

Can techs fill or check drug dispensing machines?

Yes with additional training

What are the requirements for remote processing of prescriptions?

1. Commission approval required.

2. All pharmacists must be trained on the policies and procedures of both pharmacies.

3. Pharmacies must share common electronic files or have secure access to each others.

4. All pharmacies involved must be licensed in Washington or licensed as NRPs.

5. Must have policies/procedures in place for QA, data integrity/security, responsibilities of each pharmacy involved.