TN Law Flashcards
Where a LOCAL health department does NOT employ a pharmacist what happens
All inventory controls, accountability, repackaging, security, storage and distribution of such drugs shall be under the supervision of a pharmacist at the REGIONAL level, as defined by the Department of Health.
According to Tennessee State Pharmacy Law, any INSULIN preparation shall be:
(1) . dispensed only by OR under the supervision of a pharmacist and
(2) . must be properly stored in an area NOT accessible to the general public
A drug shall be classified as MISBRANDED if:
(1). Its LABELING → is FALSE or MISLEADING in any particular way.
(2). It is in a pre-PACKAGE FORM, → UNLESS it bears a LABEL containing:
→ a). the NAME & PLACE of BUSINESS of the manufacturer, packer, or distributor; &
→ b). an accurate statement of the QUANTITY of the contents in terms of weight, measure, or numerical count.
(3). Any word, statement, or other information to appear on the LABEL that is in such terms as TO RENDER it likely to be read & understood by the ordinary individual under customary conditions of purchase and use.
(4). It is a drug & its CONTAINER →
→ a). is so made, formed, or filled as to be MISLEADING; or
→ b). It is an IMITATION of another drug; or
→ c). It is offered FOR SALE UNDER ANOTHER the NAME of ANOTHE DRUG
(5) . It is DANGEROUS TO HEALTH → when used in the dosage or manner; or with the frequency or duration prescribed, recommended, or SUGGESTED IN THE LABELING thereof.
(6) . It is a COLOR ADDITIVE → that is used for ANY OTHER PURPOSES other than being a color additive
(7) . NOT REGISTERED with FDCA→ It was manufactured, prepared, propagated, compounded, or processed in an establishment in any State NOT duly registered under section 510 of FDCA.
“[Schedule II]” Controlled prescriptions for patients in a LTCF or patients with a medical diagnosis documenting a terminal illness are valid for a period not to exceed:
60 days from the issue date
The partial filling of a prescription for a Controlled Substance listed in “[Schedule II]” is permissible if the pharmacist is unable to supply the full quantity called for in a written or emergency oral prescription and he makes “a notation of the quantity supplied” on
(1). the FACE of the written prescription, (2). written record of the emergency oral prescription, or (3). in the electronic prescription record.
The REMAINING PORTION of the prescription may be filled WITHIN 72 Hours (3 DAYS) of the FIRST PARTIAL FILLING; HOWEVER, if the remaining portion is not or CANNOT BE FILLED within the 72-hour period, the pharmacist shall NOTIFY THE PRESCRIBING Individual practitioner.
NO FURTHER QUANTITY MAY BE SUPPLIED → beyond 72 hours without a NEW Prescription.
A prescription for a “[Schedule II]” Controlled Substance written for a patient in a Long Term Care Facility (LTCF) or for a patient with a medical diagnosis documenting a TERMINAL ILLNESS MAY BE FILLED IN:
“Partial Quantities” → to include “Individual Dosage Units”.
If there is any question whether a patient may be classified as having a TERMINAL ILLNESS, the pharmacist must contact the practitioner PRIOR to PARTIALLY FILLING the prescription.
BOTH the Pharmacist + Prescribing Practitioner → have a corresponding responsibility to assure that the Controlled Substance is for a TERMINAL ILL PATIENT.
The Pharmacist MUST RECORD on the prescription whether the patient is TERMINAL ILL or an “LTCF patient.” A prescription that is PARTIALLY FILLED and does not contain the notation “terminally ill” or “LTCF patient” shall be deemed to have been filled in violation of the Act.
or EACH PARTIAL FILLING, the Dispensing Pharmacist shall record on the BACK of the prescription (or on another appropriate record, uniformly maintained, and readily retrievable) the
(1). date of the partial filling, (2). quantity dispensed, (3) remaining quantity authorized to be dispensed, and (4). the identification of the dispensing pharmacist.
If the prescription is written for an animal, what is required on the prescription?
If the prescription is for an animal, the prescription shall state the species of animal for which the drug is prescribed and the full name and address of the owner of the animal.
No drug product may be dispensed unless the prescription label discloses the:
(1). brand name & strength, or
(2). the generic name, strength, & manufacturer / distributor of the drug product dispensed
[unless the prescribing practitioner requests omission of the above information.]
notification of change of address or primary practice site within:
IMMEDIATELY!
If a pharmacist, pursuant to a prescription order that specifies a drug product by its brand name, dispenses the drug product equivalent of the drug product specified in the prescription order, the prescription label must include
BOTH the generic name of the drug product equivalent AND the brand name specified in the prescription order, (unless the prescribing practitioner requests that the brand name be omitted from the label).
A PHARMACIST convicted of any crime, including driving under the influence of alcohol or Controlled Substances, shall report such conviction to the BOARD within
ten (10) days of the conviction becoming FINAL.
According to Tennessee State Pharmacy Law, the prescription record should be kept on file for:
two years from date of dispensing; Each medical and prescription order when dispensed shall be serially numbered, filed numerically & maintained so as to be readily retrievable at the pharmacy practice site for at least two (2) years from the date the medical and prescription order was LAST DISPENSED.
INSTITUTIONAL Pharmacies shall NOT BE REQUIRED to “serially number” medical and prescription orders dispensed for administration to inpatients of that institution.
The patient profile system must contain a complete and accurate record of:
Each such profile must be maintained so as to be readily retrievable at the pharmacy practice site for at least:
a. the refill history of all medical and prescription orders dispensed at the pharmacy practice site.
b. two (2) years from the date of the last dispensing recorded on the profile.
Application for registration as a Narcotic Treatment Program is made using what form
DEA Form 363
Practitioners wishing to Administer & Dispense APPROVED “[Schedule II]” Controlled Substance [that is, Methadone] for Maintenance & Detoxification treatment must obtain:
- a separate DEA registration as a Narcotic Treatment Program
- APPROVAL & REGISTRATION of the: a. Center for Substance Abuse Treatment [CSAT] Department of Health and Human Services (HHS), as well as the b. the applicable State Methadone Authority
(4) . If a practitioner chooses to DISPENSE controlled substances, → the practitioner must maintain, separate from all other records, for a period of at least TWO (2) YEARS, all required records of receipt, storage, and distribution.
If a practitioner chooses to PRESCRIBE these controlled substances, → the practitioner must utilize their Unique Identification Number on the prescription in addition to his/her regular DEA registration number.
(5). An EXCEPTION to the registration requirement, known as the “[three day rule]”, allows a practitioner who is not separately registered as a narcotic treatment program, to administer (but not prescribe) narcotic drugs to a patient for the purpose of relieving acute withdrawal symptoms while arranging for the patient’s referral for treatment, under the following conditions:
→ a. Not more than one day’s medication may be administered or given to a patient at one time;
→ b. This treatment may not be carried out for more than 72 hours &;
→ c. This 72-hour period cannot be renewed or extended.
(6). The 72-hour exception offers an opioid dependent individual relief from experiencing acute withdrawal symptoms, while the physician arranges placement in a maintenance/detoxification treatment program. This provision was established to augment, not to circumvent, the separate registration requirement.
If a practitioner wishes to prescribe, administer, or dispense “[Schedule III, IV, or V]” Controlled Substances approved for addiction treatment (i.e., buprenorphine drug products), the practitioner must request:
a waiver (Form SMA-167) & fulfill the requirements of CSAT. If DEA approves this waiver, the practitioner will receive a → Unique Identification Number.
A C 2 Rx comes in with other non controls on the same prescription what should happen?
(a) . Pharmacists, pharmacy interns & pharmacy technicians may transfer a prescription containing a “[Schedule II]” Controlled Substance with any other drug that is a NON-Scheduled prescription drug to another prescription form under Tennessee Pharmacy Practice Act.
(b) . The transfer authorized in subsection (a) may be accomplished by scanning, photocopying or transcribing, by hand or other means, and shall include all information regarding each drug or supply being transferred.
(c) . The prescription generated in a pharmacy by the transfer process shall NOT BE REQUIRED to be on tamper-resistant prescription paper.
(d) . The prescription generated in a pharmacy utilizing the transfer process shall be recognized as a VALID, LEGAL prescription order and shall serve as the ORIGINAL PRESCRIPTION for recordkeeping and other purposes.
In Tennessee, inventory records must be maintained for a period of at least:
2 years
Inventory records must contain
(1) . the NAME & ADDRESS of the pharmacy practice site;
(2) . the NAME, STRENGTH, DOSAGE FORM, & QUANTITY of each Controlled Substance ON HAND;
(3) . the DATE OF INVENTORY; and
(4) . whether the inventory was taken as of the OPENING OR CLOSE of business on that date.
A prescription for Buprenorphine prescribed for addiction requires which of the following on the prescription?
x DEA number
Central fill pharmacies shall NOT BE AUTHORIZED to prepare prescriptions for a controlled substance listed in what category upon receiving an oral authorization from a RETAIL pharmacist “or” an individual practitioner.
schedule 2
A Pharmacist MAY DISCLOSE patient information to a third party WITHOUT the patient’s consent in the following situations:
(1) . When a pharmacist is performing PROSPECTIVE DUR.
(2) . To assist prescribers in obtaining a comprehensive drug history on a patient.
(3) . To prevent abuse or misuse of any drug or device and the diversion of Controlled Substances.
(4) . Provide a MEDICATION THERAPY MANAGEMENT program or a quality assurance program.
Under Tennessee State Pharmacy Law, a RECORD of the DESTRUCTION of Controlled Substances previously dispensed to or for patients shall be maintained so as to be readily retrievable for at least:
and should include:
two years
(1) . the IDENTIFICATION of PATIENT;
(2) . the NAME, STRENGTH, DOSAGE form, & QUANTITY of each the drug
(3) . the DATE & METHOD of destruction; &
(4) . the IDENTIFICATION of AUTHORIZED PERSONNEL WITNESSING the destruction & its record
In tennessee pharmacy permits, licenses and certificates should be renewed every:
2 years
A Pharmacist/Pharmacy Technician SERVING in the UNIFORMED SERVICES of the United States SHALL NOT BE REQUIRED to:
(1) . pay license or registration RENEWAL FEES during the period of active duty &
(2) . the Pharmacist SHALL NOT BE REQUIRED to complete Continuing Pharmacy Education requirements during the period of active duty.
A PHARMACY must register as a DISTRIBUTOR if it distributes more than:
5% of ALL Controlled Substances to another registrant within 1 year period.
A PHARMACY “registered” to dispense Controlled Substances MY DISTRIBUTE Controlled Substances “EVEN WITHOUT BEING REGISTERED as a [DISTRIBUTOR]” provided that:
(1). The Pharmacy or Physician to which the Controlled Substance IS DISTRIBUTED “must be registered” under the Act TO DISPENSE Controlled Substances.
(2). The DISTRIBUTING PHARMACY must keep accurate RECORD of distributing Controlled Substances including:
→ a. Name, Dosage form & Quantity of the Controlled Substance distributed.
→ b. Name, Address & DEA registration number of the RECEIVING Pharmacy / Physician.
(3). If the transferred Controlled Substance is either a “[Schedule I or II]” controlled drug, the transfer must be made on a DEA 222 order form.
(4). The TOTAL NUMBER of Controlled Substances distributed by the pharmacy to another registrant must not exceed 5% of all controlled substances dispensed by the pharmacy within a 12-month period.
In Tennessee, a pharmacist should not dispense any drug or device if the prescription is presented __________ days AFTER the date of issuance
> 365 days
A pharmacist may release a confidential report only to:
(1) . The patient or the patient’s agent;
(2) . A Practitioner or another Pharmacist if, in the pharmacist’s professional judgment, the release is necessary to protect the patient’s health and well-being;
(3) . The BOARD or to a person or another state or federal agency authorized by law to receive the confidential record;
(4) . A LAW ENFORCEMENT AGENCY “engaged in investigation” of a “suspected violation”;
(5) . A person employed by a STATE AGENCY that licenses a practitioner, if the person is performing the person’s official duties; or
(6) . An INSURANCE CARRIER or other third party payor “authorized by the patient” to receive the information.
The pharmacy technician to pharmacist ratio shall not exceed
2:1;
the tech to RPh ratio may be increased up to a maximum of 4:1 by the
pharmacist in charge BASED UPON PUBLIC SAFETY considerations but only if the additional pharmacy technicians are certified pharmacy technicians.
Pharmacist-in-Charge may request a MODIFICATION OF THE RATIO from the Board in writing which addresses:
(1) . the pharmacy technician’s experience, skill, knowledge & training; &
(2) . the workload at the practice site; &
(3) . detailed information regarding the numbers of pharmacy technicians & the specific duties & responsibilities of each of the pharmacy technicians; &
(4) . justification that patient safety and quality of pharmacy services & care can be maintained at the pharmacy.
Each individual pharmacist using a computerized system in the refilling of a medical or prescription order shall certify that the information entered into the computer for such a refill is correct by:
how long should documentation be retained at the practice site:
- verifying, dating, and signing a hard-copy printout of each day’s medical or prescription order refill data or in lieu of such a printout, by signing a statement in a book or file each day attesting that the refill information entered that day has been reviewed by the pharmacist and is correct as shown.
- at least two (2) years from the date of the last dispensing.
a printout, if requested by the board, regarding the records of prescriptions filled must be readily available and include the following:
and must be obtained within:
(1) . the medical or prescription order serial number;
(2) . patient’s name (and address on controlled substance medical and prescription orders);
3. name of prescriber;
4. name, strength, and dosage form of the product; and
5. the date of each refill, quantity dispensed on each refill, and
6. the name or identification code of the dispensing pharmacist.
Controlled substance data contained on such a printout must be separated, asterisked, or in some other manner visually identifiable apart from other items appearing on the printout.
48 hours
What information is required on a prescription for a controlled substance?
(1) . DATE of issue;
(2) . Patient’s NAME & ADDRESS;
(3) . Practitioner’s NAME, ADDRESS, & DEA registration number;
(4) . Drug NAME, STRENGTH, DOSAGE form, & QUANTITY prescribed
(5) . DIRECTIONS for use;
(6) . Number of REFILLS (if any) authorized; and
(7) . MANUAL SIGNATURE of prescriber.
A prescription for Controlled Substance must be written in
ink or indelible pencil or typewritten and must be MANUALLY SIGNED by the practitioner.
Can an individual prepare the prescription for the controlled substance who is not the prescribing practitioner
An individual may be designated by the practitioner to prepare the Controlled Substance prescriptions for his/her signature BUT it is the PRACTITIONER who’s responsible for making sure that the prescription conforms in all essential respects to the law & regulation.
Prescriptions for Schedule II controlled substances must be written & be signed by
the practitioner.
a prescription for a Schedule II controlled substance MAY be TELEPHONED to the pharmacy & the prescriber must follow up with a WRITTEN prescription being sent to the pharmacy within:
7 days
Prescriptions for Schedules III through V controlled substances may be delivered in what ways
(1) written, (2) oral or transmitted by (3) fax.
The required THIRTY (30) HOURS of continuing pharmaceutical education shall consist of at least FIFTEEN (15) hours obtained through LIVE contract programs. In order to fulfill the fifteen (15) LIVE contact hour requirement, a pharmacist shall obtain the hours from a program designated as “live” by:
(1) . the ACPE-approved provider,
(2) . from a program that is approved by the BOARD prior to the expiration of the pharmacist’s license or
(3) . from an out-of-state program that is approved by the BOARD of pharmacy IN THE STATE WHERE the program was presented.
No pharmacist shall be required to complete any Continuing Pharmaceutical Education during a two-year license cycle if that pharmacist presents proof that during ALL or PART of the license cycle the pharmacist was ENROLLED in an:
(1) . ADVANCED or GRADUATE DEGREE in a health-related science; or
(2) . participating in a pharmacy RESIDENCY or FELLOWSHIP program; or
(3) . engaged in a course of study leading to certification as a nurse practitioner [NP] or a physician assistant [PA].
Which DEA Form is required to order Schedule I & Schedule II controlled drugs?
DEA 222
Each DEA 222 form contains THREE copies (i.e. Copy 1, Copy 2 & Copy 3):
The PURCHASER:
completes the form & submits the Copy 1 & Copy 2 of the form to the SUPPLIER, and retains Copy 3 for his/her own record.
The PARTIALLY FILLED order form of DEA 222 must be filled within
60 DAYS from the date of issuance. The order form is NO LONGER VALID after 60 days from the time it was executed by PURCHASER.
A pharmacist is adding 1000 mg of pure codeine powder to 100 cc of Tylenol with codeine Elixir (120 mg/12 mg/5 cc). The resultant mixture should be classified as:
he compounded mixture should be classified as a Schedule III controlled drug.
The amount of Codeine present in the final mixture is 1.24 gms (1000 mg plus 240 mg).
It has been stated under CSA that if a mixture contains LESS than 1.8 gms of Codeine per 100 cc, it should be classified as a Schedule III controlled substance.
Anabolic steroids
schedule 3
Buprenorphine (Buprenex, Temgesic)
schedule 3
Butalbital (Fiorinal, Butalbital with aspirin)
C III?????
Codeine combination product (Empirin, Fiorinal, Tylenol, ASA or APAP w/codeine)
CIII???? fiorinal does this have codeine in it? no?
Hydrocodone combination product (Tussionex, Tussend, Lortab, Vicodin, Hycodan, Anexsia)
CIII - not true
Lysergic acid amide
C III
Opium combination product (Paregoric)
C III
Pentobarbital & noncontrolled active ingredients
C III
Secobarbital & noncontrolled active ingredients
C III
Testosterone (Android-T, Androlan, Depotest, Delatestryl)
C III
Thiopental (Pentothal)
C III
The owner or pharmacist in charge of a pharmacy practice site shall return or destroy all outdated, defective, or deteriorated prescription drugs and devices and related materials within 6 months of discovering them.
- True
- False
False
The owner or pharmacist-in-charge of a pharmacy practice site shall IMMEDIATELY return or destroy all OUTDATED, defective, or deteriorated PRESCRIPTION DRUGS and devices and related materials; EXCEPT that the DESTRUCTION of controlled substances listed in ANY schedule shall be performed by a BOARD approved agent or vendor
According to Tennessee State Pharmacy Law, a nuclear pharmacy practice site may furnish radiopharmaceuticals for office use to authorized practitioners for individual patient use.
- True
- False
True
According to Tennessee State Pharmacy Law, a NUCLEAR pharmacy practice site can FURNISH radiopharmaceuticals for OFFICE USE to authorized practitioners for individual patient use.
In ADDITION to any LABELING requirements of the Board for NON-radioactive drugs, the IMMEDIATE OUTER CONTAINER of a Radioactive drug to be dispensed shall also be LABELED with:
(1) . the standard RADIATION SYMBOL;
(2) . the WORDS → “Caution - Radioactive Material”;
(3) . the RADIONUCLIDE;
(4) . the CHEMICAL form;
(5) . the AMOUNT of radioactive material contained, in MILLIcuries or MICROcuries;
(6) . if a liquid, the VOLUME;
(7) . the CALIBRATION TIME for the amount of radioactivity contained;
(8) . the EXPIRATION TIME; and
(9) . the NAME, ADDRESS, & TELEPHONE number of the NUCLEAR pharmacy practice site.
??[Radioactive Drug LABEL → IMMEDIATE CONTAINER]: →
(1) . the standard RADIATION SYMBOL;
(2) . the WORDS → “Caution - Radioactive Material”;
(3) . the NAME of the drug; &
(4) . the medical or PRESCRIPTION NUMBER.
A pharmacist MAY NOT compound products that are commercially available, UNLESS
the Board/FDA has given PRIOR approval to compound a commercially available product that is TEMPORARY in short supply/unavailable.
Codeine preparations - [200 mg per 100 ml or 100 gm (Robitussin AC®, Phenergan w/ Codeine®)]
CV
Difenoxin preparations - [0.5 mg Difenoxin + 25mcg Atropine sulfate (Motofen®)]
CV
Diphenoxylate preparations- [2.5 mg Diphenoxylate + 25mcg Atropine sulfate (Lomotil®, Logen®)]
CV
Dihydrocodeine preparations - [100 mg per 100 ml or 100 gm]
CV
