WASHINGTON MPJE UPDATED COMPREHENSIVE
EXAM QUESTIONS AND ANSWERS SURE A+
✔✔Applying to establish a new pharmacy is made to whom? What forms are used and
what items must be sent? - ✔✔Pharmacy Commission
One application form for all pharmacies
Differential hours - supplemental application
Ancillary personnel - supplemental application
Must be submitted 30 days prior to a Commission meeting
DEA - use form 224, online application process
✔✔What are Pharmacy owner responsibilities for a new pharmacy? - ✔✔Place a
pharmacist in charge
Pay an annual license fee
File a statement of ownership and location
If these people change needs to be an adendum or submit a new statement
Maintain records of prescriptions and dispensing for a minimum of 2 years (business
requirement for maintaining, pharmacist responsibility of accuracy)
Maintain CSA records for a minimum of 2 years
Ensuring the quality of drug products (safe and pure products, that it is in working order,
security, hot and cold running water, etc)
,✔✔When do you need a Responsible Pharmacist Manager? Who do you notify when
you assign one? - ✔✔Unlawful to operate a pharmacy without placing a pharmacist in
charge (RCW 18.64.020)
Each non-licensed proprietor must appoint a responsible pharmacist manager (RPM)
Must notify Commission when appointed
Must notify Commission when appointment is terminated
Each RPM must notify Commission when appointed or appointment terminated
"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)
Example: Commission held an RPM responsible for inappropriate labeling on OTCs in
the front section of a larger pharmacy
RPM retains responsibility for ancillary personnel.
Policies and procedures in place
✔✔What are some Things Pharmacies cannot do - ✔✔Destroying a lawful unfilled
prescription
Both person destroying and business
Refusing to return lawful unfilled prescriptions
Violations of the patient's privacy
Ex. Computer system breach
Discrimination against patients or agents in a manner prohibited by law
Intimidating or harassing a patient or patient's agent
✔✔Do pharmacies need Physical standards: adequate stock - ✔✔Must have
appropriate supplies to meet needs of patients
No outdated drugs in stock
Free from adulteration, contamination, or deterioration
Properly labeled
Stored in accordance with USP standards
✔✔What are some Adequate equipment items that a pharmacy needs - ✔✔Washington
is less prescriptive than most states
Must have equipment needed for the types of prescriptions filled
Must have other references needed for pharmacists to furnish information to patients
and practitioners concerning drugs
Must have access to current copy of Washington laws and regulations relating to
pharmacy; electronic version is permitted and on-line access satisfies this requirement
✔✔What are the Inspection & Grades of a pharmacy? - ✔✔Class A: 90-100
Conditional: 80-89
60 days to improve to Class A
Unsatisfactory: <80
14 days to improve to Class A
5 pts + taken off for violation of ancillary personnel rules automatic Unsatisfactory grade
Self-inspection procedures
,✔✔What are considered Non-Resident Pharmacies (Pharmacies not located in
Washington State)? What are their requirements? - ✔✔Sell or ship drugs to patients in
WA
Must register with WA Pharmacy Commission
Registered & regulated by home state
Must put 800-number on label for patients to receive consultation
Must maintain patient profiles
Must provide patient information
May be disciplined or fined by WA if home state doesn't investigate a complaint within
45 days.
✔✔What are Hospital Pharmacy Requirements - ✔✔040 - Must have director of
pharmacy
Appropriately qualified by education, training, and experience
Each decentralized unit of a hospital pharmacy must have a pharmacist supervisor
050 - Must have 24 hour pharmacy services
Policy for after-hours nurse access
060 - Plan for emergency outpatient meds
080 - Distribution of drugs
090 - Administration of drugs
100 - Investigational drugs
110 - Additional responsibilities
Authenticated - authorized in writing in the record by means of signature containing at
least first initial, last name, and title
Drug administration - an act in which a single dose is given to a patient
-Removing dose from previously dispensed container
-Reviewing the order
-Properly recording time and dose given
Protocol - written set of guidelines
-Workflow that you will follow
-HOWEVER A CDTA: authorizes the pharmacist to change therapy, whereas the
protocol just explains the process.
Self-administration of drugs" - patient administers his or her own meds from properly
labeled containers (not same as PCA)
-Patient's responsibility to take, however institution must document if they were taken or
not... this is done through a policy
✔✔What are Hospital: Drug distribution and control - ✔✔MUSTS
Control of all drugs throughout hospital
-Ultimately the responsibility of director of pharmacy
Monthly inspections of all areas where drugs are stored or used
Monitoring of drug therapy
Provision of drug information
-Patients (counseling)
-Monthly inservices
, -Providers calling pharmacy
SHOULDS
Obtaining and recording drug use histories (med rec upon admit)
Preparation of all sterile products
Distribution and control of all radiopharmaceuticals
Administration of drugs
Prescribing
Director maintains policies, with annual updates
-i.e. receiving inventory, inspections, nurse access to pharmacy while closed
Labeling (see textbook) (4.1 and 4.2 page 123)
Pharmacist must see copy of order before drugs dispensed, except according to
policies developed to handle emergencies
Controlled substance accountability
-Policies in place for inventory and control
Handling of recalls, ADRs, and error reporting
✔✔What are Hospital: Verbal Orders - ✔✔Commission Rule: Verbal orders shall be
issued in emergency or unusual circumstances, and countersigned within 48 hours.
"Interpretive Guideline:"
Allows for "passive authorization" of certain verbal orders. These order can be
authenticated by review and monitoring undertaken by other health professionals, such
as nurses or pharmacists.
Orders not subject to the passive authorization policy must be countersigned by the
prescriber. Exclusion from the policy must be spelled out in the policy (e.g.,
chemotherapy)
A quality assurance program must be in place to monitor and improve the passive
authorization program.
✔✔What are policies for Drugs brought into hospital by patients/familes - ✔✔Written
policy must be in place.
Such drugs may be administered only if properly ordered.
Prior to use a pharmacist must examine them and assure they meet quality standards
If not use, remain sealed and are returned to patient or family.
By policy, hospital may choose to not return certain drugs if it would be dangerous to
the patient
Non returned drugs must be destroyed.
✔✔Are patients allowed to perform Self-administration of Medicines (SAM) - ✔✔May be
done under a policy and approved protocols in a program of self-care or rehabilitation.
Policy must be developed by Director of Pharmacy, and be approved by the
administration, and medical and nursing staffs
✔✔What are Assisted Living Services: Med-packs - ✔✔Bingo cards and dosage
cassettes, prepared under immediate supervision of a pharmacist
Original bulk Rx container stays in pharmacy
EXAM QUESTIONS AND ANSWERS SURE A+
✔✔Applying to establish a new pharmacy is made to whom? What forms are used and
what items must be sent? - ✔✔Pharmacy Commission
One application form for all pharmacies
Differential hours - supplemental application
Ancillary personnel - supplemental application
Must be submitted 30 days prior to a Commission meeting
DEA - use form 224, online application process
✔✔What are Pharmacy owner responsibilities for a new pharmacy? - ✔✔Place a
pharmacist in charge
Pay an annual license fee
File a statement of ownership and location
If these people change needs to be an adendum or submit a new statement
Maintain records of prescriptions and dispensing for a minimum of 2 years (business
requirement for maintaining, pharmacist responsibility of accuracy)
Maintain CSA records for a minimum of 2 years
Ensuring the quality of drug products (safe and pure products, that it is in working order,
security, hot and cold running water, etc)
,✔✔When do you need a Responsible Pharmacist Manager? Who do you notify when
you assign one? - ✔✔Unlawful to operate a pharmacy without placing a pharmacist in
charge (RCW 18.64.020)
Each non-licensed proprietor must appoint a responsible pharmacist manager (RPM)
Must notify Commission when appointed
Must notify Commission when appointment is terminated
Each RPM must notify Commission when appointed or appointment terminated
"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)
Example: Commission held an RPM responsible for inappropriate labeling on OTCs in
the front section of a larger pharmacy
RPM retains responsibility for ancillary personnel.
Policies and procedures in place
✔✔What are some Things Pharmacies cannot do - ✔✔Destroying a lawful unfilled
prescription
Both person destroying and business
Refusing to return lawful unfilled prescriptions
Violations of the patient's privacy
Ex. Computer system breach
Discrimination against patients or agents in a manner prohibited by law
Intimidating or harassing a patient or patient's agent
✔✔Do pharmacies need Physical standards: adequate stock - ✔✔Must have
appropriate supplies to meet needs of patients
No outdated drugs in stock
Free from adulteration, contamination, or deterioration
Properly labeled
Stored in accordance with USP standards
✔✔What are some Adequate equipment items that a pharmacy needs - ✔✔Washington
is less prescriptive than most states
Must have equipment needed for the types of prescriptions filled
Must have other references needed for pharmacists to furnish information to patients
and practitioners concerning drugs
Must have access to current copy of Washington laws and regulations relating to
pharmacy; electronic version is permitted and on-line access satisfies this requirement
✔✔What are the Inspection & Grades of a pharmacy? - ✔✔Class A: 90-100
Conditional: 80-89
60 days to improve to Class A
Unsatisfactory: <80
14 days to improve to Class A
5 pts + taken off for violation of ancillary personnel rules automatic Unsatisfactory grade
Self-inspection procedures
,✔✔What are considered Non-Resident Pharmacies (Pharmacies not located in
Washington State)? What are their requirements? - ✔✔Sell or ship drugs to patients in
WA
Must register with WA Pharmacy Commission
Registered & regulated by home state
Must put 800-number on label for patients to receive consultation
Must maintain patient profiles
Must provide patient information
May be disciplined or fined by WA if home state doesn't investigate a complaint within
45 days.
✔✔What are Hospital Pharmacy Requirements - ✔✔040 - Must have director of
pharmacy
Appropriately qualified by education, training, and experience
Each decentralized unit of a hospital pharmacy must have a pharmacist supervisor
050 - Must have 24 hour pharmacy services
Policy for after-hours nurse access
060 - Plan for emergency outpatient meds
080 - Distribution of drugs
090 - Administration of drugs
100 - Investigational drugs
110 - Additional responsibilities
Authenticated - authorized in writing in the record by means of signature containing at
least first initial, last name, and title
Drug administration - an act in which a single dose is given to a patient
-Removing dose from previously dispensed container
-Reviewing the order
-Properly recording time and dose given
Protocol - written set of guidelines
-Workflow that you will follow
-HOWEVER A CDTA: authorizes the pharmacist to change therapy, whereas the
protocol just explains the process.
Self-administration of drugs" - patient administers his or her own meds from properly
labeled containers (not same as PCA)
-Patient's responsibility to take, however institution must document if they were taken or
not... this is done through a policy
✔✔What are Hospital: Drug distribution and control - ✔✔MUSTS
Control of all drugs throughout hospital
-Ultimately the responsibility of director of pharmacy
Monthly inspections of all areas where drugs are stored or used
Monitoring of drug therapy
Provision of drug information
-Patients (counseling)
-Monthly inservices
, -Providers calling pharmacy
SHOULDS
Obtaining and recording drug use histories (med rec upon admit)
Preparation of all sterile products
Distribution and control of all radiopharmaceuticals
Administration of drugs
Prescribing
Director maintains policies, with annual updates
-i.e. receiving inventory, inspections, nurse access to pharmacy while closed
Labeling (see textbook) (4.1 and 4.2 page 123)
Pharmacist must see copy of order before drugs dispensed, except according to
policies developed to handle emergencies
Controlled substance accountability
-Policies in place for inventory and control
Handling of recalls, ADRs, and error reporting
✔✔What are Hospital: Verbal Orders - ✔✔Commission Rule: Verbal orders shall be
issued in emergency or unusual circumstances, and countersigned within 48 hours.
"Interpretive Guideline:"
Allows for "passive authorization" of certain verbal orders. These order can be
authenticated by review and monitoring undertaken by other health professionals, such
as nurses or pharmacists.
Orders not subject to the passive authorization policy must be countersigned by the
prescriber. Exclusion from the policy must be spelled out in the policy (e.g.,
chemotherapy)
A quality assurance program must be in place to monitor and improve the passive
authorization program.
✔✔What are policies for Drugs brought into hospital by patients/familes - ✔✔Written
policy must be in place.
Such drugs may be administered only if properly ordered.
Prior to use a pharmacist must examine them and assure they meet quality standards
If not use, remain sealed and are returned to patient or family.
By policy, hospital may choose to not return certain drugs if it would be dangerous to
the patient
Non returned drugs must be destroyed.
✔✔Are patients allowed to perform Self-administration of Medicines (SAM) - ✔✔May be
done under a policy and approved protocols in a program of self-care or rehabilitation.
Policy must be developed by Director of Pharmacy, and be approved by the
administration, and medical and nursing staffs
✔✔What are Assisted Living Services: Med-packs - ✔✔Bingo cards and dosage
cassettes, prepared under immediate supervision of a pharmacist
Original bulk Rx container stays in pharmacy
