THE Pharmacy

Policy and Procedure Manual

1|Page
 JOB DESCRIPTIONS

PHARMACIST- IN CHARGE

 The pharmacist-in-charge shall have responsibility for, at a minimum, the following:

A. education and training of pharmacy technicians and pharmacy technician
trainees;

B. supervising a system to assure appropriate procurement of prescription drugs

and
devices and other products dispensed from the Class A pharmacy;

C. disposal and distribution of drugs from the Class A pharmacy;

D. storage of all materials, including drugs, chemicals, and biologicals;

E. maintaining records of all transactions of the Class A pharmacy necessary to

maintain accurate control over and accountability for all pharmaceutical
materials
required by applicable state and federal laws and sections;

F. supervising a system to assure maintenance of effective controls against the theft

or
diversion of prescription drugs, and records for such drugs;

G. adherence to policies and procedures regarding the maintenance of records in a

data processing system such that the data processing system is in compliance
with
Class A (community) pharmacy requirements;

H. legal operation of the pharmacy

PHARMACIST

2|Page
The pharmacist shall have responsibility for, at a minimum, the following:
A. Pharmacists shall directly supervise pharmacy techs and techs in training

B. receiving oral prescription drug orders and reducing these orders to writing, either
manually or electronically;

C. interpreting prescription drug orders;

D. selection of drug products;

E. performing the final check of the dispensed prescription before delivery to the
patient to ensure that the prescription has been dispensed accurately as prescribed;

F. communicating to the patient or patient's agent information about the prescription

drug or device which in the exercise of the pharmacist's professional judgement,
the
pharmacist deems significant, as specified in §291.33(c) of this title;

G. communicating to the patient or the patient's agent on his or her request

information concerning any prescription drugs dispensed to the patient by the
pharmacy;

H. assuring that a reasonable effort is made to obtain, record, and maintain patient
medication records;

I. interpreting patient medication records and performing drug regimen reviews;

  
    (A) Non-Sterile Preparations. All pharmacists engaged in compounding non-sterile
preparations shall meet the training requirements specified in §291.131 of this title
(relating to Pharmacies Compounding Non-Sterile Preparations).

PHARMACY TECHNICIAN AND TECHNICIAN IN TRAINING

Pharmacy technicians and pharmacy technician trainees may perform only nonjudgmental
technical duties associated with the preparation and distribution of prescription drugs, as
follows:
A. initiating and receiving refill authorization requests;

B. entering prescription data into a data processing system;

3|Page
 C. taking a stock bottle from the shelf for a prescription;

D. preparing and packaging prescription drug orders (i.e., counting tablets/capsules, measuring
liquids and placing them in the prescription container);

E. affixing prescription labels and auxiliary labels to the prescription container;

F. reconstituting medications;

G. prepackaging and labeling prepackaged drugs;

H. loading bulk unlabeled drugs into an automated dispensing system provided a pharmacist
verifies that the system is properly loaded prior to use;

I. compounding non-sterile and sterile prescription drug orders; and

J. bulk compounding.

4|Page
5|Page
 GENERAL PROCEDURES
PRESCRIPTION PROCESSING
A. All prescriptions shall be processed following applicable regulatory agency
guidelines including, but not limited to STATE BOARD, Drug
Enforcement Agency (DEA), Department of Public Safety and Centers for
Medicare & Medicaid Services (CMS).
B. Pharmacy staff shall process all prescriptions in accordance with Third
Party specified guidelines.
C. All prescriptions processed in the ambulatory main dispensing pharmacy
shall follow the guidelines at each of the different points of service as
described in Attachment A.
D. Prescription Transfers
1. Prescriptions shall be transferred as per STATE BOARD guidelines.
2. When transferring a prescription from another pharmacy, the
pharmacist or technician shall determine if the item is in stock prior
to transferring.
3. If the medication is temporarily out of stock, the patient shall be
notified before the transfer is executed.

COUNSELING AND EDUCATION

A. All new prescriptions require counseling.
B. Counseling shall be offered on all refill prescriptions.
C. Counseling shall be notated on the prescription bag.
D. All counseling shall be documented according to the current guideline
(electronically captured signature via cash management system) on the
Dispensed Medication Log. The log shall contain the patient-signed
prescription sticker for each medication
E. The Indian Health Services (IHS) method shall be the recommended
counseling method and consists of the following questions:
1. What did the doctor tell you the medication is for?
2. How did the doctor tell you to take this medication?
3. What did the doctor tell you to expect while on this medication?

6|Page
 4. How you are going to take this medication?
F. The pharmacist shall provide education to members of the health care team
and/or patients upon request or as deemed necessary. In-services shall be
documented accordingly.
G. The supervisor shall conduct an audit of the counseling logs to ensure
compliance with OBRA’90. The percentage of counseling performed shall
be determined by taking the total number of new prescriptions versus the
total number of prescriptions counseled.

7|Page
 Records Retention

DEFINITIONS

A. Records – All documents, papers, books and electronic media created

B. Retention – The process of storing records for a determined amount of time.

C. Record label – A descriptive item that is affixed or written on each box

containing records.

D. Record destruction – Records that have satisfied their legal, administrative,

and archival requirements and may be destroyed. Records shall be
destroyed to ensure protection of patient sensitive information.

GENERAL PROCEDURES

A. All pharmacy records shall be retained in accordance with the rules and
regulations of the Board of Pharmacy (STATE BOARD), Federal
Controlled Substance Act (FCSA), Drug Enforcement Administration
(DEA), Centers for Medicaid and Medicare Services (CMS).
B. All boxed records shall have a specific record label affixed or written on
each box, as well as the beginning and ending date of the records. The
record destruction shall be determined by comparing the current date to the
ending date on the record label. If the period of time is in excess of the
length of time detailed in the record retention guidelines, (Section II.D.) the
box shall be destroyed. Otherwise, the record box shall be maintained for
the prescribed time.
C. Record Retention Guidelines: The following guidelines have been
established for maintaining pharmacy records:

8|Page
Type of Record Record Label Length of Time Agency

Ambulatory Ambulatory 10 years1 CMS

Prescriptions Prescriptions

Schedule II Schedule II 10 years1 CMS

Prescriptions

Schedule III-V Schedule III-V 10 years1 CMS

Prescriptions

Medicaid Prescriptions (Filed with above) 10 years2 CMS

Signature Logs Daily Log Sheets 2 years

STATE BOARD

Purchasing Records Invoices 10 years1 CMS

Expired, Wasted, Controlled Substance 2 years DEA/STATE

BOARD
and Recalled Controlled Sheet
Substance Report

Controlled Substance Controlled Substance 2 years STATE BOARD

Perpetual Inventory Sheet
Records

Compounding Records Sheet

Annual Inventory Inventory 2 years STATE

BOARD

9|Page
 SAFETY
GENERAL OVERVIEW

A. Safety shall include those policies, procedures, regulations, standards

and educational efforts that are specifically directed towards the creation
and maintenance of safe working conditions and/or practices.
B. All employees shall receive general safety education during
orientation and training reviews at least annually to keep their knowledge
current.
C. Any defective equipment(s), unsafe condition(s) and/or act(s) of
safety hazards shall be reported immediately to the manager..

MEDICATION SAFETY

A. The pharmacy shall be properly sized and equipped to store medications

according to state and federal regulations.
B. All drugs shall be properly stored to promote safety and efficiency.
C. No unidentified drugs shall be stored in the pharmacy.
D. All drugs shall be labeled appropriately, including the addition of
cautionary statements, as required.
E. Discontinued, outdated, beyond use or unusable drugs shall be disposed
of properly.
F. Only a pharmacist or authorized pharmacy personnel, under the direct
supervision of a pharmacist, shall dispense medication, make label
changes or transfer medication to different containers.
G. Prescription/medication labels shall be checked prior to dispensing to
avoid medication errors.

10 | P a g e
 EMPLOYEE SAFETY

A. Pharmacy personnel shall recognize the hazards of the job and take
necessary precautions to ensure the safety of themselves and others.
B. All accidents and incidents occurring within the DOP shall be reported
to the pharmacy manager/supervisor immediately. The employee
involved shall seek medical care

WORK AREA SAFETY

A. Pharmacy personnel shall employ general safety practices.

B. Only authorized personnel shall be allowed in the pharmacy.
C. All doors must remain secured/locked at all times.
D. Pharmacy work areas shall be kept clean and orderly.
E. Pharmacy personnel shall use sharps containers or puncture resistance
boxes for the disposal of needles.
F. Proper protective wear shall be worn when preparing bio-hazardous and
other hazardous substances.
G. Appropriate containers shall be used to dispose of bio-hazardous and
other substances.
H. The pharmacy manager or designee shall ensure the pharmacy area is in
proper sanitary condition and has a working sink with hot and cold
water.
I. The pharmacy manager or designee shall ensure that appropriate lighting
and ventilation is functional in the work area at all times.
J. The pharmacy manager or designee shall ensure that the pharmacy room
temperature be maintained within a range compatible with proper storage of

11 | P a g e
 pharmaceuticals and a suitable environment for employee working
conditions.
K. Spills and overflows shall be cleaned immediately with appropriate spill
kits.
L. Gloves shall be worn when handling soiled/moist prescriptions or refill
containers and when re-stocking emergency medication boxes/trays.

EQUIPMENT SAFETY

A. All equipment shall be maintained in safe working order.

B. Pharmacy personnel shall check equipment periodically for inspection and
expiration/maintenance dates.
C. All refrigerators/freezers/warmers shall be maintained within the approved
temperature range as mandated by regulatory requirements.

FIRE SAFETY

A. All staff shall be aware of where the fire extinquisher is stored.

B. All staff shall be oriented on proper use of fire extinquisher.
C. If the fire can not be contained staff shall evactuate building and call 911.
D. Smoking is prohibited.

INFECTION CONTROL

A. Pharmacy personnel shall wash hands after any patient contact, before and
after patient contact and returning back to work after breaks.
D. Pharmacy employees shall not eat or drink in work areas or store food in
medication refrigerators.

12 | P a g e
 SECURITY

GENERAL

A. Access to the pharmacy shall be restricted to pharmacy personnel. Before

employees enter the pharmacy premises the pharmacist on duty must be
present.
B. The doors to the pharmacy dispensing area must remain locked at all times.
C. The opening and closing of the pharmacy is permitted only by an
authorized pharmacist and is done by activating and deactivating the alarm
system.
D. Unauthorized personnel entering the pharmacy areas to perform services
(e.g. cleaning) shall be supervised by a pharmacy employee.
E. Purses, backpacks, etc are not allowed in the dispensing area. They shall be
stored in a designated area to be determined by the pharamcy manager.
These items shall remain stored until the end of the employee’s shift and
should only be removed when the employee is ready to exit the pharmacy at
the end of the shift.
F. All passwords shall be considered confidential and not shared with other
employees.

ALARM SYSTEM

A. An alarm system equiped with a siren and door contact senors has been
installed at THE Pharmacy for added security.

13 | P a g e
 B. The alarm system is monitored by XXXX Security.
a. Contact information: 1-888-XXX-XXXX

C. The alarm system has a panic trigger in case of emergency. The panic
button
is to be used only if the employee is in danger.

CAMERA SYSTEM

A. A video surveillance camera system with DVR has been stalled in THE
Pharmacy to monitor the dispensing area, outside of the back door of the
pharmacy, and the back office/kitchen area to:

a. Prevent medication diversion

b. Monitor activity when pharmacy is closed
c. Monitor dispensing area when owers are away

B. The camera will be reviewed on a weekly basis by the PIC or owner.

C. The DVR is set record 24 hours a day without interruption.

D. If the DVR stops due to technical difficulties, the pharmacist shall prepare a
report to include but not limited to:

a. The date the DVR stopped

b. The exact time it stopped
c. The exact time it started running again
d. The reason for the interruption
e. Details of the pharmacy activity while DVR was down

E. The PIC shall be notified immediately, if not on duty at the time.

F. The DVR shall be deleted every two weeks after being reviewed by both
owners for increminating activity.
14 | P a g e
 DRUG SECURITY

A. All medications shall be stored in a secure location.

B. All controlled substances not dispensed shall be stored in the safe.
C. Beyond use/expired medications shall be handled as follows:
1. All controlled substances shall be placed in a labeled bag or bin.
Those bags shall be kept in the safe until vendor pickup.
2. All legend/dangerous medications shall be removed from the
dispensing/stock areas and stored in a separate, designated area until
vendor pickup.

D. All Schedule II medications, if available in the pharmacy, must be

stored in a separate and secured safe/cabinet at all times.
E. The safe/cabinet will be locked at all times and must only be opened
by the pharmacist. Only the PIC and staff pharmacist will have the
combination to the safe.
F. All other controllled medications (Schedule III – V) will be stored in
a locked safe/cabinet separate from the Schedule II medications.
G. The PIC shall leave instructions on accessing the pharmacy,
prescription area and safe for relief pharmacist(s).

15 | P a g e