Opioid Clinic and Prison Clinic Requirements

This is a licensed program to operate a narcotic substance abuse program using narcotic replacement procedures for individuals dependent on opium, morphine, heroin, or derivative:

This is a licensed program to operate a narcotic substance abuse program using narcotic replacement procedures for individuals dependent on opium, morphine, heroin, or derivative:

Narcotic treatment program; methadone clinic; methadone treatment program; opioid replacement center; opioid treatment program

This is a licensed program pharmacy designated as an on site pharmacy department of a narcotic treatment program:

Narcotic treatment pharmacy; opioid treatment program clinic pharmacy

Administer

To give one, single dose of a pharmacy prepared narcotic controlled substance

Dispense

The actions of a pharmacist when he/she fills a prescription drug order and prepares either a single dose or multiple doses in patient specific take home containers with narcotic controlled substances for an opioid treatment program

Medication dosing station

Location where doses of medications are administered

Take home dose

A quantity of a physician ordered narcotic controlled substance dispensed by opioid treatment program clinic pharmacy which an individual can take away from the OTP clinic.

Licensure and registration requirements for opioid treatment clinic:

-the full name, business address, and telephone number

- all business names or trade names

-address, telephone number, and the name of PIC

-type of ownership or operations

- must renew biennially ( June 30) of odd numbered years to the GA BOP

-License is not active upon sal, transfer, or change in mode or location of business

- Must display license on wall and the current license of each full time pharmacist: part time must display current license and pen must present upon request

This person in the OTP is responsible for all pharmacy related activities at the OTP, must be licensed by BOP and employed on a full or part time basis consistent with the need and objectives of the OTP clinic:

-Director of pharmacy services

Who can qualify as supportive personnel in the OTP clinic?

-other licensed pharmacist and personnel

This person assists with record keeping, report submission, and other administrative duties but can not dispense medications:

-secretary/clerk

How can drugs be accessed in the pharmacy if he pharmacist is not there?

-limited to authorized personnel consistent with policies and procedures of the director.

-pharmacy must be secured to deny access by unauthorized persons.

-the director develops a list of drugs to be accessible and ensure that: drugs available are properly labeled with drug names, strength, lot number, and expiration date; only prepackaged drugs are available; when pharmacy access occurs, written physician orders and proof of use for controlled substances is provided; all drugs inventoried no less than once per week.

Who determines what drugs are kept in the emergency kits?

The director and medical staff of clinic, but all must be approved by board of Pharmacy

Who may access emergency kits in the opioid treatment clinic?

Drugs may be accessed by authorized licensed. Personnel.

Where are emergency kits stored in opioid treatment clinic?

Kits are stored in limited access areas and sealed to prevent unauthorized access.

When do you have to inspect emergency kits?

Every 90 days

In the absence of the pharmacist when can you obtain medication from the pharmacy?

-Whenever drugs are not available from after hours safe or emergency kits and are required to treat the immediate needs of a patient whose health would otherwise be jeopardize

-Must obtain a physicians order

-only one authorized healthcare professional per shift can have access.( designee must be established by director prior to being permitted to obtain access to the pharmacy)

When an authorize personnel take medication from the pharmacy in absence of the pharmacist what must they record?

-Name of drug, strength, amount, date and time removed from pharmacy and their signature and title

How can medications be delivered in a OTP clinic?

By a licensed medical practitioner who writes an initial dosing medication order for each patient prior to any medication being dispensed or prepared by the OTP clinic pharmacy

In an emergency how can a medication be delivered in the OTP clinic.

-may be given verbal by the physician but must be signed by physician within 72 hours.

True/False: only licensed personnel shall administer medications

-True

What equipment is required for the OTP clinic?

•Copies of and/or electronic access to current reference materials appropriate to the practice of pharmacy related to OTP; must include the topics of drug interactions, patient counseling, compounding and pharmaceutical calculations; and generic substitution

•The telephone number of a poison control center posted or readily available in areas both inside and outside of the pharmacy where drugs are stored or patients are being cared for

•Current copies of and/or computer or electronic access to the Georgia Pharmacy Practice Act, Georgia Controlled Substances Act & Dangerous Drug Act, and the Official Rules of the Georgia State Board of Pharmacy

•Refrigerator in operating condition with a thermometer

•Sink with hot and cold running water

•Two spatulas and one oral solid counting tray

•Typewriter, word processor, or computer with label printer

•Appropriate prescription labels

•Appropriate auxiliary labels to be used in the pharmacist’s professional judgement.

•Class A Balance with an assortment of metric weights or a Class I or II electronic balance

•An adequate supply of drugs used in an OTP Clinic setting.

•Assorted sizes and types of appropriate dispensing containers.

This person is responsible for the safe and efficient distribution, control , and accountability of drugs in the OTP pharmacy

-director

What must be established in the written policies and procedures for the distribution of medications/emergency kits?

-the drug must be identified up to the point of administration.

-the pharmacy must receive a direct, electronic or mechanical copy of a physician’’s order before the first dose of medication is dispensed as defined by the clinic stat order policy.

-pharmacy must maintain a patient profile for prospective and retrospective drug reviews, for comparing with the central registry as required and to report violators, for discharge from another OTP, and for urine or blood tests to check for drug positive test results.

Which form from the DEA do all drug invoices be attached to?

-DEA 222

When does the controlled substances inventory be taken /

-every two years from the date of the pharmacy opening for business

True/False: An TOP clinic pharmacy may not dispense or administer prescriptions medications other than OTP program medications

-True

How long must records be maintained?

-for 2 years

In an OTP clinic pharmacy when can the pharmacy make on premises destruction of small quantities of controlled substances prepared for oral administration?

-it is the remainder of a single dose unit

-single dosage unit from which the ordered dose was prepared is the nearest possible size to the dose ordered.

When does inspections by the BOP take place for an OTP clinic?

-once every 2 years

-director must maintain copy of the inspection report and submit a copy of the report to the DHR methadone Authority

-any discrepancies or deficiencies must be corrected within 30 days of the inspection

Prison clinic pharmacy

•The portion of a prison correctional facility engaged in the distribution of drugs, medications, devices, and other materials used in the prevention, diagnosis, and treatment of injury, illness, and disease which is registered with the Board

This is considered when an inmate who is confined to an infirmary bed and is in the custody of an assigned to an institution operated under the authority of the GA department of corrections, or any cunty or municipal political subdivision:

-inpatient

This is an inmate who is in custody of an assigned to an institution operated under the authority of the GA department of corrections, or any county or municipal political subdivision:

-outpatient

Who can work in the prison pharmacy?

•Director of Pharmacy/Director

• A pharmacist licensed to engage in the practice of pharmacy in the state, and who is knowledgeable in and thoroughly familiar with the specialized functions of prison clinic pharmacies.

• Responsible for all activities of the prison clinic pharmacy

• Must work full-time or part-time

•Supportive personnel

• DOP must be assisted by a sufficient number of additional pharmacists and ancillary personnel in ratios consistent with state laws and regulations.

•Secretary/Clerk

• May assist with the record keeping, report submission, and other administrative duties

• NO dispensing duties

What are the rules in a prison pharmacy when accessing night cabinets in the absence of the pharmacist?

-access to drugs by locked cabinets or other enclosures and located outside the pharmacy area ( access only by specifically authorized personnel by key or combination)

-prepackaged drugs only that properly labeled ( drug name, strength, lot number, and expiration)

-when access occurs, written physician’s order and proof of use for controlled substances must be provided

-all drugs therein are inventoried not less than once per week

What is the physicals space requirements for the OTP clinic and prison pharmacy?

-minimum 150 square feet

•Storage and receiving area

•Manufacturing and packaging area

•Office space area

What are the equipment requirements for the prison pharmacy?

•A refrigerator in operating condition with a thermometer (biological refrigerator preferred)

•A sink with hot and cold running water

•A Class A balance and an assortment of metric weights if using a Class A Balance or a Class I or II electronic balance (If compounding onsite using components that must be weighted)

•Graduates of assorted sizes

•Two spatulas and a counting tray

Type writer, word processor, or computer with a label printer

Reference requirements for the prison pharmacy:

•Copies of and/or computer/electronic access to:

• Current reference materials appropriate to the individual pharmacy practice (shall be authoritative on at least the topics of drug interactions, patient counseling, compounding and pharmaceutical calculations, and generic substitution.

• The Georgia Pharmacy Practice Act

• The Georgia Controlled Substances Act-

• The Rules of the Georgia State Board of Pharmacy

•Compatibility charts if IV solutions are being prepared in the pharmacy

•Current antidote information and the telephone number of a poison control center conspicuously displayed

•Other reference materials as may be determined by the Board to meet the current practice standards.

Storage requirements for the prison pharmacy:

•All drugs shall be stored in designated areas with proper sanitation, temperature, light, ventilation, moisture control, segregation, and security.

•Drug storage cabinets and unit dose carts in the medication area are locked when the area is not attended by medical staff personnel.

•Controlled drug storage for schedule II drugs should be an enclosed room with limited access capable of showing forced entry.

•Safe or metal cabinet adequately locked that is permanently affixed to the structure is acceptable

•Whenever any area of a prison clinic pharmacy is not under the personal and direct supervision of authorized personnel, such areas are locked.