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
Ethylmorphine preparations - [100 mg per 100 ml or 100 gm]
CV
Opium preparations - [100 mg per 100 ml or gm]
CV
Pregabalin - Lyrica®
CV
Lacosamide - Vimpat®
CV
Potiga - Ezogabine®
CV
It shall be the responsibility of the person, partnership, firm, or corporation holding a pharmacy practice site LICENSE to notify the Board within 10 days of the Resignation, Removal, or Death of the Pharmacist-in-charge named in the application for license.
- True
- False
False
It shall be the responsibility of the Person, Partnership, Firm, or Corporation HOLDING a pharmacy practice site LICENSE to notify the Board IMMEDIATELY of:
(1). the RESIGNATION, REMOVAL, or DEATH of the Pharmacist-in-Charge named in the application for license (or SUCCESSOR Pharmacist-in-Charge); or
(2). the DISABILITY for a period EXCEEDING thirty (30) DAYS of the Pharmacist-in-Charge named in the application for license (or SUCCESSOR Pharmacist-in-Charge).
The notice of the Resignation, Removal, or Death of the Pharmacist-in-charge named in the application for license shall include:
(1) . the NAME & SIGNATURE of the OUTGOING Pharmacist-in-Charge; (EXCEPT in the case of Death or Disability)
(2) . the EFFECTIVE DATE of the appointment of the NEW Pharmacist-in-Charge; (whether Temporary or Permanent)
(3) . the NAME & SIGNATURE of the NEW Pharmacist-in-Charge; and
(4) . the NAME & ADDRESS of the pharmacy practice site.
A pharmacist shall not be required to counsel a patient or care giver when the patient or care giver refuses such consultation and such refusal is documented.
- True
- False
True, [OBRA 90].
A pharmacist shall NOT BE REQUIRED to COUNSEL a patient or care-giver when the patient or care-giver refuses such consultation and such refusal is documented.
Which of the following drugs is classified as a “[Schedule III]” drug?
- Fioricet
- Fiorinal
- Codeine
- Lorazepam
Fiorinal [Butalbital + Aspirin + Caffeine] is classified as a “[Schedule III]” drug.
Fioricet [Butalbital + Acetaminophen + Caffeine], is NOT a schedule III controlled drug.
Manan Care Pharmacy wants to transfer 30 tablets of Oxycontin 10 mg to High Yield Care Pharmacy. The correct way to do this transfer is
I. By filling out a DEA 222 order form.
II. By taking verbal authorization and all necessary information from the pharmacist where Oxycontin is being transferred.
III. It cannot be transferred between pharmacies.
The TRANSFER of “[Schedule II]” Controlled Substances between pharmacies should be done by filling out a DEA 222 order form.
In order to obtain a license for out-of-state pharmacy practice site to conduct a business in the state of Tennessee, which of the following standards must be met?
I. A pharmacy should maintain at all times a current permit, license or registration to conduct the pharmacy practice site in compliance with the laws of the state in which the site is physically located.
II. Records of prescription orders dispensed to persons residing in Tennessee must be maintained.
III. All records of prescription orders prepared and dispensed to persons residing in Tennessee shall be readily retrievable from other records.
No OUT-OF-STATE Pharmacy Practice Site, Manufacturer or Wholesaler shall conduct business IN THE STATE of Tennessee until such pharmacy practice site, manufacturer or wholesaler obtains the required LICENSE from the Board.
In order to obtain a LICENSE for a Pharmacy Practice Site, Manufacturer or Wholesaler physically located OUT-OF-STATE the following standards must be met.
(1) . [Submit an APPLICATION for a license]: →
a. the ADDRESS of the pharmacy practice site,
b. NAME of OWNER if a sole proprietorship/partnership/titles of all officers if a corporation &
c. NAMES of ALL PHARMACISTS who practice at the site,
d. together with APPLICATION FEE
The DIRECTOR shall be notified in WRITING within thirty (30) DAYS of ANY CHANGES in the information contained on the “ORIGINAL” application for a license, including names of pharmacists practicing at the site.
(2). Comply with all statutorily authorized directions & requests for information from the Board.
(3) . [The STATE in which the SITE is PHYSICALLY LOCATED]: →
a. Maintain AT ALL TIMES a current permit, LICENSE or registration to conduct the Pharmacy Practice Site in compliance with the laws OF THE STATE in which THE SITE IS PHYSICALLY LOCATED.
b. Submit a copy of the MOST RECENT INSPECTION report resulting from an inspection conducted by the regulatory or licensing agency OF THE STATE in which THE SITE IS PHYSICALLY LOCATED.
(4) . [RECORDS on Tennessee’s RESIDENT]: →
a. MAINTAIN RECORDS of prescription orders dispensed to persons RESIDING in Tennessee.
b. All RECORDS of prescription orders prepared & dispensed to persons RESIDING in Tennessee shall be readily retrievable from other records.
(5). [REGULAR HOURS of OPERATION]: a minimum of →
a. six (6) DAYS per WEEK,
b. forty (40) HOURS per WEEK, &
c. Provide access to a pharmacist by a TOLL-FREE TELEPHONE service.
• A toll-free number shall be placed on the LABEL AFFIXED to the DISPENSING CONTAINER for EACH prescription dispensed to a person RESIDING in Tennessee.
(6). [Pharmacist-in-Charge]: →
Designate a Pharmacist-in-Charge who shall be responsible for compliance with the provisions in this section, & who shall hold a current Tennessee pharmacist license.
(7). [COMPLY with Tennessee State Pharmacy Law]: →
All out-of-state pharmacy practice sites shall comply with the requirements as set forth in Tennessee State Pharmacy Law for:
a. patient counseling,
b. patient profiling,
c. drug regimen review &
d. pharmaceutical care
Bill’s father comes to your pharmacy & asks for the medication records of his son who is a minor. The pharmacist gives him the medication records of his son. The pharmacist was in accordance with Tennessee State Pharmacy Law.
- True
- False
True
According to HIPAA, a healthcare provider CANNOT disclose medication records or the history of patients WITHOUT prior approval of patients or otherwise permitted by the law. The only EXCEPTION under this law is when the patient is designated a MINOR by the Court.
According to Tennessee State Pharmacy Law, Marijuana should be classified as a Schedule:
Schedule VI
According to Tennessee State Pharmacy Law, Marijuana should be classified as a “[Schedule VI]” controlled substance,
(1) . the commissioner of mental health &
(2) . developmental disabilities,
(3) . the commissioner of health
(1) . Marijuana
(2) . Tetrahydrocannabinolis
- Please note under Tennessee Drug Control Act of 1989, Marijuana shall be considered a “[Schedule II]” Controlled Substance ONLY for the purposes enumerated in the Controlled Substances Therapeutic Research Act*
A computerized system employed by a pharmacy practice site must, upon the request of an authorized representative of the board, send or provide a hard-copy printout of prescription order refill data to the pharmacy practice site within 72 hours of such request.
- True
- False
False,
A computerized system employed by a pharmacy practice site must, upon the request of an authorized representative of the Board, SEND or provide a HARD-COPY printout of prescription order refill data to the pharmacy practice site within FORTY-EIGHT (48) hours (excluding weekends and legal holidays) of such request.
According to Tennessee State Pharmacy Law, certified pharmacy technicians may receive new or transferred oral medical and prescription orders.
- True
- False
True
A REGISTERED pharmacy technician may, in the presence of & under the supervision of a pharmacist, perform those tasks associated with the preparation and dispensing process EXCEPT those tasks that must be personally performed by a pharmacist or pharmacy intern under the personal supervision and in the presence of a pharmacist.
“Certified pharmacy technician” → means an individual who is certified by a national or state agency that offers a certification program that is recognized by the board. “Certified pharmacy technician” MAY perform the following task:
(1). Receive NEW or TRANSFERED oral medical & prescription orders;
(2). RECEIVE & TRANSFER copies of oral medical & prescription orders between pharmacy practice sites; and
(3). VERIFY the contents of unit dose carts prepared by other REGISTERED technicians when an additional verification by use of bar code technology or a licensed health care professional is performed prior to administration to the patient.
“Registered pharmacy technician” → means an individual who is registered with the board by submitting an application on a form prescribed by the board. The APPPLICANT shall also:
(1). Provide a STATEMENT of GOOD MORAL CHARACTER;
(2). SUBMIT an AFFIDAVIT from his/her employer attesting that the applicant has read & understands the statutes & regulations pertaining to the practice of pharmacy in Tennessee. (A copy of this affidavit shall be retained at the place of employment);
(3). SUBMIT the appropriate APPLICATION FEE as set in Board of Pharmacy Rule.
The patient profile system must contain a complete and accurate record of the refill history of all medical and prescription orders dispensed at the pharmacy practice site. Each such profile must be maintained for a period of one year from the date of the last dispensing recorded on the profile.
- True
- False
False
The patient profile system must contain a complete & accurate record of the refill history of all medical and prescription orders dispensed at the pharmacy practice site.
Each such profile must be maintained for a period of TWO (2) Years from the date of the LAST dispensing recorded on the profile.
In which of the following instances, a dispensing of a drug shall be classified as misbranded?
- A tablet falls on a floor dispensed by a pharmacist
- A spider is found in an original manufacturer container.
- A returned drug is mixed with the drug containing a different lot number.
- A drug is compounded without properly sanitizing the compounding.
c. A returned drug is mixed with the drug containing a different lot number.
The choices A, B & d are considered to be “[ADULTERATED]”.
Which of the following drugs requires an exact count when taking inventory?
- Dalmane
- Concerta
- Halcion
- Darvon compound
The INVENTORY of “[Schedule II]” controlled drugs requires an EXACT COUNT.
Concerta [Methylphenidate] is a “[Schedule II]” controlled drug.
Dalmane, Halcion, & Darvon compound are all “[Schedule Iv]” controlled drugs.
Dr. Brook prescribed Darvocet-N to Mr. Abeyomi for his dental pain on 06/01/2001 with 5 refills. After taking the medication for a month, he didn’t take the drug for a while. On 02/19/2002, he had severe dental pain and went to the pharmacy to get a few weeks supply of the drug on the original prescription. The pharmacist most likely will say:
- I cannot refill the prescription.
- I can only refill if the physician says okay to fill remaining.
- I can only fill 3-day supply.
- You have to pay in cash for this prescription.
I cannot refill the prescription.
The prescriptions for “[Schedule III & IV]” drugs should NOT be FILLED After SIX (6) MONTH from the date of ISSUED or REFILLED more than 5 times within a 6-month period.
Darvocet-N [Propoxyphene + Acetaminophen] is classified as a “[Schedule IV]” Controlled Substance, pharmacist CANNOT fill the prescription since it is more than six months old.
In Tennessee, a pharmacist is permitted one temporary absence for a period not exceeding three hours per day.
- True
- False
False
In Tennessee, a pharmacist is permitted ONE Temporary absence for a period NOT EXCEEDING one (1) hour PER Day. During the absence of a pharmacist from the pharmacy practice site, a SIGN containing the words “pharmacist not on duty” must be conspicuously displayed in the Pharmacy Practice Site.
It shall be UNLAWFUL to fail or refuse to display the required sign in a conspicuous place when a pharmacist is ABSENT. No medical or prescription order may be COMPOUNDED or DISPENSED during the absence of a pharmacist.
Additionally, during the absence of the pharmacist the prescription department shall be closed off by PHYSICAL BARRIER from floor to ceiling.
Under CSA, can an LTCF return a resident’s unused controlled substance medication to a pharmacy?
- Yes
- No
No
There are no provisions in the Controlled Substances Act for a DEA registrant (i.e., retail pharmacy) to acquire Controlled Substances from a non-registrant (i.e., resident of an LTCF).
Most LTFCs are not licensed by their respective state to handle Controlled Substances and, therefore, are NOT registered with DEA.
LTCFs act in a custodial capacity, holding Controlled Substances that, pursuant to a prescription, have been dispensed to & belong to the resident of the LTCF.
Federal laws & regulations make no provisions for Controlled Substances that have already been dispensed to patients, regardless of the packaging method, to be returned to a pharmacy for further dispensing or disposal.
Under Controlled Substances Act [CSA], is it permissible to dispense a prescription for Controlled Substances “[Schedules III and IV]” a quantity less than the face amount prescribed resulting in a greater number of dispensations than the number of refills indicated on the prescription?
- Yes
- No
Yes
PARTIAL REFILLS of “Schedules III & IV” Controlled Substance prescriptions ARE PERMISSIBLE under federal regulations provided that EACH PARTIAL FILLING is:
(1). DISPENSED & RECORDED in the same manner as a REFILLING
(2). the TOTAL QUANTITY DISPENSED in all partial fillings DOES NOT EXCEED the total quantity prescribed, &
(3). no dispensing occurs after six (6) months past the date of ISSUE
Mr. Varsi came to the pharmacy & said that he could only pay for 30 tablets of Ritalin. The remaining he would collect next week. The pharmacist may tell him:
- Okay, but call us before you come.
- We cannot dispense this prescription.
- You have to pay us in advance for the whole supply
- No, you cannot do that.
No, you cannot do that.
Under NO CIRCUMSTANCES, the PARTIAL filling of “[Schedule II]” controlled drugs (Ritalin) should be done after 72 hours from its INITIAL filling.
Prescription or medical orders transmitted electronically shall meet which of the following criteria?
I. All prescription or medical orders shall be transmitted directly from an authorized prescriber or prescriber’s agent to a licensed pharmacist.
II. The transmission shall include the telephone number of the authorized prescriber.
III. If the transmission is delegated by the prescriber to an agent of the prescriber, the identity of the agent shall be included in the transmission.
All
(1). Prescription or medical orders transmitted electronically shall meet the following criteria:
(A). All prescription/medical orders shall be TRANSMITTED DIRECTLY from an authorized prescriber/prescriber’s agent to a licensed pharmacist/licensed pharmacy of the PATIENT’S CHOICE, with no intervening person or entity having access to the order for purposes other than transmission of the order.
A prescriber/prescriber’s agent may ELECTRONICALLY TRANSMIT medical/prescription orders to a pharmacist within an INSTITUTIONAL FACILITY for INPATIENTS and/or OUTPATIENTS “currently” under treatment at that facility.
(B). The transmission shall include:
→ (i). The TELEPHONE number of the authorized PRESCRIBER to allow verbal confirmation of the VALIDITY & ACCURACY of the order;
→ (ii). The correct TIME & DATE of the transmission;
→ (iii). The NAME of the PHARMACY to which the order is being transmitted; and
→ (iv). The PRESCRIBING practitioner’s ELECTRONIC SIGNATURE or other secure method of validation.
→ (v). If the transmission is delegated by the prescriber to an agent of the prescriber, the IDENTITY of the AGENT shall BE INCLUDED in the transmission.
“Electronic Signature” → is defined as the process that secures the user authentication (proof of claimed identify, such as by biometrics, fingerprints, retinal scans, hand written signature verification, etc.) at the time the signature is generated & creates the logical manifestation of a signature.
(2) . A HARD COPY or EXACT IMAGE of the transmitted order shall be maintained in the pharmacy and shall be deemed the ORIGINAL Prescription or medical order meeting all requirements of rule of the rules of the board.
(3) . The PHARMACIST receiving any transmitted order shall not knowingly participate in any system that RESTRICT the patient’s choice of pharmacy.
(4) . The PHARMACIST may NOT provide financial or other remuneration to the PRESCRIBER for any prescription transmitted to the dispensing pharmacy.
No person or entity, including but not limited to wholesalers, distributors, manufacturers, pharmacists, and pharmacies, shall SUPPLY electronic equipment, software, devices, or modems to any PRESCRIBER in exchange for transmitting orders.
Tamper-resistant packaging provides protection against:
A: accidental poisoning
B: Intentional contamination of OTC drugs
C: Brand name of manufacturer
D: Accidental breakage of containers
Tamper-resistant packaging provides protection against intentional contamination of over the counter drugs.
Certain products such as aerosol, lozenges and OTC products used in hospitals and not accessible to the general public are exempt from this act.
In which of the following situations is patient counseling not required?
- A patient is picking up the medication from the retail pharmacy
- A patient is picking up the medication from the outpatient department of hospital
- A patient is receiving the medication at the time of the discharge from the hospital
- A patient is receiving the medication from the inpatient department of hospital
A patient is receiving the medication from the inpatient department of hospital
Upon the receipt of a medical or prescription order and following a review of the patient’s record, a pharmacist shall personally counsel the patient or caregiver “face-to-face” if the patient or caregiver is present
If the patient or caregiver is not present, a pharmacist shall make a REASONABLE EFFORT to counsel through alternative means.
(1) . Alternative forms of patient information may be used to supplement, but not replace, face-to-face patient counseling.
(2) . Patient counseling, as described herein, shall also be REQUIRED for OUTPATIENTS of HOSPITALS or other institutional facilities dispensing medical and prescription orders, and for patients when medications are dispensed ON DISCHARGE from the HOSPITAL or other institutional facility.
(3) . Patient counseling as described in this rule shall NOT BE REQUIRED for INPATIENTS of an institutional facility.
Under CSA [Controlled Substances Act], can an individual return his/her controlled substance prescription medication to a pharmacy?
- Yes
- No
No
An individual patient may NOT RETURN his/her UNUSED Controlled Substance prescription medication to the pharmacy.
Federal laws & regulations make NO PROVISIONS for an individual to return the Controlled Substance prescription medication to a pharmacy for further dispensing or for disposal.
There are NO PROVISIONS in the Controlled Substances Act or Code of Federal Regulations [CFR] for a DEA registrant (i.e., retail pharmacy) to acquire Controlled Substances from a non-registrant (i.e., individual patient).
The Code of Federal Regulations [CFR] does HAVE A PROVISION for an individual TO RETURN his/her UNUSED Controlled Substance medication to the pharmacy in the event of:
(1). the Controlled Substance being RECALLED or
(2). a DISPENSING ERROR has occurred.
An individual MAY DISPOSE of his/her own Controlled Substance medication WITHOUT APPROVAL from DEA.
Medications should be disposed of in such a manner that does not allow for the Controlled Substances to be EASILY RETRIEVED.
In situations where an individual has expired, a caregiver or hospice staff member may assist the family with the proper disposal of any UNUSED Controlled Substance medications.
Which of the following is/are TRUE about dispensing Schedule II controlled substances in the case of an emergency situations?
I. The quantity prescribed and dispensed should be limited to treat the patient during the emergency period.
II. The prescription shall be immediately reduced to writing by the attending pharmacist and contained all the information required by the law.
III. The authorized prescriber shall deliver the written prescription for the emergency quantity prescribed to the dispensing pharmacy within 7 days after authorizing an emergency oral prescription.
All
In the case of an EMERGENCY SITUATIONS:
(1). The QUANTITY prescribed & dispensed should BE LIMITED to treat the patient DURING the EMERGENCY PERIOD.
(2). The prescription shall be IMMEDIATELY reduced to writing by the attending PHARMACIST & contained all the information required by the law.
(3). The authorized PRESCRIBER shall deliver the WRITTEN PRESCRIPTION for the “emergency quantity prescribed” to the dispensing pharmacy WITHIN seven (7) days AFTER authorizing an emergency oral prescription.
Faxing a prescription for “[Schedule II]” controlled drugs may serve as the original prescription only if:
I. A licensed practitioner prescribes the Schedule II controlled substances for a patient undergoing home infusion/IV pain therapy.
II. A licensed practitioner prescribes the Schedule II controlled substances for a patient living in a LTCF.
III. A licensed practitioner prescribes the Schedule II controlled substances for a patient living in hospice care as certified by Medicare.
All
Normally, a “[Schedule II]” prescription drug order MAY BE transmitted by the practitioner or the practitioner’s agent, BUT NOT the patient or patient’s agent, to a pharmacy VIA FACSIMILE machine or equipment.
The ORIGINAL WRITTEN, SIGNED prescription drug order must be presented by the patient to the pharmacist PRIOR to the actual dispensing of the “[Schedule II]” drug.
Faxing a prescription for “[Schedule II]” Controlled drugs may SERVE as the ORIGINAL PRESCRIPTION only if:
(I). A licensed practitioner prescribes the “[Schedule II]” Controlled Substances for a patient undergoing HOME INFUSION / IV PAIN Therapy
(II). A licensed practitioner prescribes the “[Schedule II]” Controlled Substances for a patient RESIDING in a LTCF.
(III). A licensed practitioner prescribes the “[Schedule II]” Controlled Substances for a patient RESIDING in HOSPICE care certified by Medicare.
An Automated Data System must provide on-line retrieval (via CRT display or hard-copy printout) of the original medical or prescription order information, and shall include which of the following?
I. Prescription serial number
II. Identity code of the dispensing pharmacist
III. Prescriber’s name
All
An Automated Data System must provide on-line retrieval (via CRT display or hard-copy printout) of the ORIGINAL PRESCRIPTION Order information & the complete refill history of all medical & prescription orders that are currently authorized for refilling.
This shall include all the information contained in and required to be entered on each such medical or prescription order. This DATA must include:
(1) . The medical or PRESCRIPTION NUMBER;
(2) . DATE of ISSUANCE of the medical or prescription order;
(3) . PATIENT’s NAME (and ADDRESS on Controlled Substance medical and prescription orders);
(4) . PRESCRIBER’s NAME (& ADDRESS & DEA Registration Number on Controlled Substance medical and prescription orders);
(5) . Product NAME, STRENGTH, DOSAGE form, QUANTITY prescribed, DIRECTIONS for use, & LABELING instructions;
(6) . REFILLS instructions; and
(7) . DATE of DISPENSING, QUANTITY dispensed, & IDENTITY (name, initials, or identification code) of the dispensing PHARMACIST for the original dispensing and each refill.
The record produced by an Automated Data System should be preserved for at least:
two (2) YEARS from the DATE of LAST DISPENSING
Each individual Pharmacist using a computerized system or ADS Automated Data 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 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).
Such documentation shall be separately maintained at the Pharmacy Practice Site for at least two (2) YEARS from the DATE of LAST DISPENSING
Which of the following are TRUE about the Combat Methamphetamine Epidemic Act of 2005?
I. Retail sales may not exceed 3.6 grams pseudoephedrine per day per purchaser, regardless of the number of transactions.
II. Individuals are prohibited from purchasing more than 9 grams pseudoephedrine per 30-day period.
III. All non-liquid forms (including gelcaps) of PSE products must be sold in blister packs with no more than two dosages or in unit-dose packets or pouches.
All
On March 9, 2006, President George W. Bush signed into law the USA Patriot Act, Title VII, which includes the Combat Methamphetamine Epidemic Act of 2005.
The federal law applies to all COUGH & COLD products [including combination products] that contain the METHAMPHETAMINE precursor chemicals:
(1). ephedrine,
(2). pseudoephedrine, or
(3). phenylpropanolamine
(1) . Retail sales may NOT EXCEED “3.6 grams” PSEUDOEPHEDRINE per DAY per PURCHASER, REGARDLESS of the number of transactions.
(2) . Individuals are prohibited from purchasing more than “9 grams” PSEUDOEPHEDRINE per “30-day” period.
(3) . All NON-LIQUID FORMS (including gelcaps) of PSEUDOEPHEDRINE products MUST BE SOLD in BLISTER PACKS with no more than “two dosages” or in “unit-dose packets” or pouches.
(4) . MAIL-ORDER companies may not sell more than “7.5 grams” to a customer within a “30-day” period.
All PSEUDOEPHEDRINE products must be STORED:
(1). placed behind a counter [any counter, not necessarily the pharmacy counter] that is NOT ACCESSIBLE to purchasing consumers or
(2). in a LOCKED DISPLAY CASE that is located on the selling floor
Retailers must give the product DIRECTLY to the purchaser; therefore, a retailer WITHOUT a pharmacy MAY STILL SELL the combination PSEUDOEPHEDRINE products form “behind a counter” or “locked display case”.
Retailers must maintain a LOGBOOK of information on transactions involving PSEUDOEPHEDRINE products. The logbook may be maintained in either WRITTEN or ELECTRONIC form.
The logbooks must capture the following information:
(1) . Purchaser’s SIGNATURE;
(2) . Purchaser’s NAME & ADDRESS;
(3) . DATE & TIME of sale;
(4) . NAME & QUANTITY of product sold
LOGBOOK requirements DO NOT APPLY to purchases of SINGLE SALE PACKAGES that contain no more than “60mg” of PSEUDOEPHEDRINE.
Each entry must be maintained for TWO years [Please note: Under Tennessee State Pharmacy Law 39-17-431, the log book requirement for retaining record is ONE (1) YEAR] following the DATE of ENTRY and the format may be written or electronic.
Instruments and/or devices intended for the injection of any substance through the skin shall be sold only by a pharmacist or a pharmacy intern or pharmacy technician.
- True
- False
True
Instruments and/or devices INTENDED for the INJECTION of any substance through the skin shall be STORED & SOLD:
(1). STORED in an area NOT ACCESSIBLE to the public, and
(2). shall be SOLD only on PROOF OF MEDICAL NEED by a pharmacist or a pharmacy intern or pharmacy technician under the direct supervision of a pharmacist.
Similarly, all INSULIN PREPARATIONS must be STORED & SOLD:
(1). STORED in an area NOT ACCESSIBLE to the public, and,
(2). shall be SOLD ONLY by a pharmacist or a pharmacy intern or pharmacy technician under the direct supervision of a pharmacist.
Copies of medical and prescription orders issued directly to the patient by the pharmacy practice site shall bear on the face thereof, in letters red in color and equal in size to those describing the prescription drug or device or related material, the statement: “Copy for Information Only.”
- True
- False
True
COPIES of medical / PRESCRIPTION Orders issued directly to the patient by the Pharmacy Practice Site where the order was originally compounded & dispensed pursuant to the receipt of the order shall bear on the FACE thereof, in letters RED in color & EQUAL in size to those describing the prescription drug or device or related material, the statement: “Copy for Information Only.”
Presentation of an informational written copy or label of a dispensing container shall be for INFORMATION PURPOSES ONLY & have NO LEGAL STATUS as a valid medical or prescription order.
The RECIPIENT PHARMACIST of such copy or label shall contact the Prescriber or Transferor Pharmacy Practice Site and obtain all information required by this rule, which is the SAME as obtaining an ORIGINAL PRESCRIPTION Order.
What is the difference between “night cabinet” and “emergency drug kit”?
a. Night cabinets shall be used only at night when a pharmacist is off duty, whereas an emergency kit can be used any time of the day when an emergency arises.
b. There is no difference between the two terms.
c. When an institutional facility has an institutional pharmacy, a night cabinet shall be used in case of emergency in the absence of a pharmacist, whereas when an institutional facility does not have an institutional pharmacy, an emergency kit shall be used to obtain drugs in case of emergency.
d. A night cabinet contains a numerical lock whereas an emergency drug kit contains a key lock.
c. When an institutional facility HAS AN Institutional Pharmacy, a “Night Cabinet” shall be used in case of emergency in the absence of a pharmacist, whereas when an institutional facility DOES NOT HAVE an Institutional Pharmacy, an [“Emergency Kit”] shall be used to obtain drugs in case of emergency.
In the ABSENCE OF A PHARMACIST, drugs for distribution to patients shall be stored in a LOCKED cabinet “Night Cabinet” that’s located OUTSIDE of the Pharmacy area, to which only specifically Authorized Personnel may obtain access by key or combination.
For an Institutional Facility that does NOT have an INSTITUTIONAL PHARMACY, drugs may be provided for use by Authorized Personnel by means of emergency kits LOCATED AT the institutional facility.
If a bottle of 250 mg of Cephalaxin contains 500 mg of Cephalexin, the product should be classified as:
- Adulterated
- Misbranded
Misbranded
[A drug shall be classified as “[MISBRANDED]” if]: →
(1). Its LABELING is false or misleading in any particular way.
(2). It is in a 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 required by or under authority of this Act to APPEAR ON THE LABEL or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of PURCHASE and USE.
(4). The CONTAINER of the drug is made, formed, or filled as to:
→ a. MISLEADING; or
→ b. an IMITATION of ANOTHER DRUG; or
→ c. offered for SALE UNDER ANOTHER DRUG NAME.
(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 other purposes other than being color additive
(7). It was (1) manufactured, (2) prepared, (3) propagated, (4) compounded, or (5) processed in an establishment in ANY State NOT DULY REGISTERED under section FDCA.
According to Tennessee State Pharmacy Law, which of the following mid-level practitioners may prescribe and/or dispense a Schedule II controlled substance in the course of their professional practices?
I. Physicians assistant
II. Nurse practitioner
III. Optometrists
All
The term “Mid-Level Practitioner” means an individual practitioner, other than a (1) Physician, (2) Dentist, (3) Veterinarian, or (4) Podiatrist, WHO IS LICENSED, Registered, or otherwise permitted by the United States, “TO DISPENSE Controlled Substance” in:
(1). the course of professional practice &
(2). by the state which they practice
[Mid-Level Practitioners]: → Examples of Mid-Level Practitioners include, but are NOT LIMITED TO, health care providers who are authorized to DISPENSE Controlled Substances by the state in which they practice, such as: 1. nurse practitioners (NP), 2. nurse midwives, 3. nurse anesthetists, 4. clinical nurse specialists & 5. physician assistants (PA)
For the State of Tennessee, ONLY the following Mid-Level Practitioners can EITHER Prescribe, Administer, or Both, schedule CONTROLLED SUBSTANCES.
(1). AS [Animal Shelters]: → Schedule II (sodium pentobarbital).
(2). NP [Nurse Practitioner]: → Schedule II to V controlled substances (prescribe, dispense and administer).
(3). PA [Physician assistants]: → Schedule II to V controlled substances (prescribe, dispense and administer).
(4). AMB [Ambulance Service]: → Schedule II to V controlled substances.
(5). OD [Optometrists]: → Schedule II to V controlled substances.
Which of the following is/are Schedule IV controlled substances under Tennessee State Pharmacy Law?
I. Tramadol
II. Carisoprodol
III. Pregabalin
I and II only
Effective April 7, 2011, Tramadol, Carisoprodol and products containing Tramadol or Carisoprodol will be classified as “[Schedule IV]” Controlled Substances in the State of Tennessee, and Tramadol, Carisoprodol & products containing Tramadol or Carisoprodol will become part of the CSMD submissions.
Under current CSA, can a practitioner write a prescription for controlled substances electronically?
- Yes
- No
Yes
DEA’s rule, “Electronic Prescriptions for Controlled Substances” revises DEA’s regulations to provide:
(1). allows PRACTITIONERS with the option of writing prescriptions for Controlled Substances ELECTRONICALLY
(2). permit PHARMACIES to Receive, Dispense, & Archive these ELECTRONIC PRESCRIPTIONS
If Ciprofloxacin pills accidentally fall on the pharmacy floor, and are unknowingly dispensed by the pharmacist to the patient, the dispensing drug should be recognized as:
- Adulterated
- Misbranded
Adulterated
[A drug shall be deemed as “[ADULTERATED]” if]: →
(1). If in WHOLE / PART:
→ a. FILTHY, PUTRID, or DECOMPOSED substance.
(2). Been Prepared, Packed, or Manufactured:
→ a. UNDER UNSANITARY CONDITIONS that are contaminated with filth & can lead to INJURIOUS TO HEALTH.
→ b. NOT in conformity with “CURRENT” Good Manufacturing Practice [GMP]
(3). If it is a DRUG that DOES NOT MEET the standards for SAFETY, IDENTITY & STRENGTH, QUALITY & PURITY characteristics, which it IS REPRESENTED TO POSSESS under:
→ a. Good Manufacturing Practice [GMP]
→ b. Official Compendium
(4). If its CONTAINER:
→ a. in WHOLE / PART, is composed of any POISONOUS or DELETERIOUS SUBSTANCE
(5). A COLOR ADDITIVE:
→ that’s being used “for the purposes of COLORING ONLY” deemed UNSAFE.
(6). A DRUG that has BEEN MIXED or PACKED therewith so AS TO REDUCE its Quality, Strength, or Substituted wholly or in part thereof.
Under Controlled Substance Monitoring Act of 2002 [CSMA], each dispenser shall, regarding each controlled substance dispensed, submit to the committee all required information at least quarterly.
- True
- False
False
Each DISPENSER shall, regarding each Controlled Substance DISPENSED, SUBMIT to the committee ALL OF THE FOLLOWING Information by a procedure & in a format established by the COMMITTEE at least MONTHLY within TEN (10) Days following the last day of each calendar month:
(1) . PRESCRIBER IDentifier;
(2) . Dispensing DATE of Controlled Substance;
(3) . PATIENT IDentifier;
(4) . Controlled Substance dispensed NAME, STRENGTH, QUANTITY, & DAYS SUPPLY;
(5) . DISPENSER IDentifier;
The principal purpose of Controlled Substance Monitoring Act of 2002 is to identify:
I. prescribing practices.
II. patterns of prescribing and dispensing controlled substances.
III. individuals receiving prescriptions for controlled substances from licensed practitioners inconsistent with generally recognized standards of dosage for that controlled substance.
All
The BOARD of Pharmacy shall maintain the Controlled Substances database in an Electronic File or by other means established by the COMMITTEE in such a manner as NOT TO INFRINGE on the LEGAL USE of Controlled Substances, and in such a manner as to facilitate use of the database for identification of:
(1). Prescribing Practices.
(2). PATTERNS of PRESCRIBING & DISPENSING Controlled Substances.
(3). individuals receiving prescriptions for Controlled Substances from licensed practitioners INCONSISTENT with “Generally Recognized Standards of Dosage” for that Controlled Substance.
A patient comes to a pharmacy with a prescription for OxyContin®. After processing the claim, the pharmacist finds out that he does not have enough quantity to dispense the full supply. Under this circumstance, the pharmacist may:
- Tell the patient to pick up partial quantities within a week
- Call another pharmacy & borrow a bottle of Oxycontin
- Reverse the claim & return the prescription back to the patient
- Call the physician & change the quantity
- Reverse the claim & return the prescription back to the patient
OxyContin® (oxycodone) → is a “[Schedule II]” Controlled Substance. When dealing with “[Schedule II]” Controlled Substance, it is better to reverse the claim & return the prescription to the patient. The other option would be to dispense the partial quantity WITHIN 72 hours (3 DAYS) of Initial Dispensing of the drug.
The compounding of cisplatin shall be performed under:
Vertical laminar flow
All oncology/cytotoxic agents shall be compounded in a vertical flow, Class II, biological safety cabinet.
A prescription for Cephalexin 500 mg has been prescribed and presented by Dr. Shah on January 20, 2005 with the direction: 1 cap po qid x 10 days. If the bulk bottle of Cephalexin has an expiration date of Jan/05, what would be the minimum quantity that should be dispensed by the pharmacist?
minimum of 40
The bulk bottle of Cephalexin has an expiration date of Jan/05, which indicates that the drug will be expiring on January 31, 2005. The prescription is presented on January 20 and is written for 10 days, therefore the pharmacist can fill the whole supply of the drug.
Which of the following are TRUE about Tamper-proof prescriptions?
I. All prescriptions written or printed by practitioners authorized to write prescriptions in Tennessee shall be written on tamper-resistant prescription paper.
II. A pharmacist shall not fill a written prescription from a Tennessee practitioner unless issued on tamper-resistant prescription paper.
III. All out-of-state prescription practices shall meet the requirement for Tamper-proof prescriptions.
I and II only.
(1). All prescriptions: →
written or printed by practitioners authorized to write prescriptions in the STATE of TN shall be written on Tamper-Resistant Prescription Paper.
(2). A Pharmacist SHALL NOT FILL: →
a written prescription FROM A Tennessee practitioner UNLESS issued on Tamper-Resistant Prescription Paper, EXCEPT that a pharmacist may provide EMERGENCY SUPPLIES in accordance with “TennCare” or other INSURANCE contract requirements.
→ NOTHING IN THIS SECTION: → shall be construed to impact regulations REGARDING Prescription Practices of: → 1. VERBAL, → 2. FAXsimile, → 3. ELECTRONIC, or → 4. OUT-of-STATE
(3). All Prescriber-Specific Information: →
shall ALSO apply to Tamper-Resistant Prescription.
(4). Unique Serial Numbers: →
may be included on Tamper-Resistant Prescription Paper for PURPOSES of:
→ 1. ENHANCING efforts TO TRACK &
→ 2. enforce any POTENTIAL FRAUD
→ Inclusion of such numbers on the prescription shall NOT BE CONSTRUED as obligating Pharmacists/Prescribers to any additional tracking, monitoring or reporting requirements and Pharmacists/Prescribers SHALL BEAR NO RESPONSIBILITY or liability with respect to the potential use of these Unique Serial Numbers for enforcement purposes.
(5). Practitioners SAFEGUARDS: →
Practitioners shall utilize reasonable safeguards to assure AGAINST
→ 1. THEFT or
→ 2. UNAUTHORIZED USE of any prescriptions.
(6). SAS 70 Audit: →
MANUFACTURERS of Tamper-Resistant Prescription Paper shall have an ANNUAL industry-approved SAS 70 audit that shall be made available by the manufacturer UPON REQUEST by the BOARD of pharmacy.
→ The BOARD of pharmacy shall maintain a list of any manufacturers WHO FAIL to show proof of such audit.
→ The list shall be made available to Pharmacists/Prescribers in the STATE of TN in a manner deemed appropriate by the BOARD of pharmacy.
(7). This section SHALL NOT APPLY to::
→ 1. prescriptions written by VETERINARIANS
→ 2. INPATIENTS of a hospital,
→ 3. outpatients of a hospital where the doctor, or other person authorized to write prescriptions, writes the order into the hospital medical record and then the order is given directly to the hospital pharmacy and the patient never has the opportunity to handle the written order,
→ 4. a NURSING HOME or an assisted care living facility or
→ 5. inpatients or residents of a MENTAL HEALTH hospital or
→ 6. individuals incarcerated in a local, state or federal CORRECTIONAL FACILITY
To improve the health of needy Tennesseans through a prescription drug redispensing program that authorizes charitable clinic pharmacies to redispense medicines that would otherwise be destroyed is known as:
Nina Norman Prescription Drug Donation Act
The PURPOSE of Nina Norman Prescription Drug Donation Act is to:
(1) . IMPROVE THE HEALTH of NEEDY Tennesseans through a prescription drug redispensing program that authorizes charitable clinic pharmacies TO REDISPENSE MEDICINES that would OTHERWISE BE DESTROYED; and
(2) . Reaffirm the existing broad latitude of the Tennessee BOARD of pharmacy TO PROTECT THE SAFETY OF PRESCRIPTION DRUG supply in this state.
A pharmacist upon initial dispensing of a medical or prescription order shall record on that medical or prescription order:
I. the date such medical or prescription order was dispensed.
II. the amount of any product dispensed.
III. the signature of the dispensing pharmacist.
I and II only
A Pharmacist upon INITIAL DISPENSING of a medical / prescription order shall record ON THAT PRESCRIPTION Order:
(1). the DATE of such medical / prescription order was DISPENSED,
(2). the QUANTITY of any product DISPENSED, and
(3). the PHARMACIST’s Initial (SIGNATURE is NOT REQUIRED).
If the Pharmacist merely INITIALS and DATES a medical/Prescription order upon INITIAL DISPENSING “without specifying the QUANTITY DISPENSED”, then the pharmacist shall be deemed to have “dispensed the FULL FACE AMOUNT” of the medical / prescription order.
At the time of removal of any drug or device or related material from an automated dispensing device, it shall automatically make a record indicating:
a. the date and time of removal of the drug or device or related material.
b. the name, strength, dosage form, and quantity of drugs or devices or related material removed.
c. the identification of the patient for whom the drug or device or related material was ordered.
d. the identification of the person authorized to remove the drug or device or related material from the device.
All
No prescription drug or device or related material shall be distributed or issued by the use of any Automated Dispensing Device UNLESS the device & the method of operation have been found by the BOARD to ensure the Purity, Potency, & Integrity of the prescription drug or device or related material, & to protect the prescription drug or device or related material FROM DIVERSION.
At the time of removal of any drug or device or related material from the device, it shall automatically make a RECORD, to be retained by the pharmacy for a minimum of TWO (2) YEARS, indicating:
(1). the DATE and TIME of removal of the drug or device or related material;
(2). the NAME, STRENGTH, DOSAGE form, & QUANTITY of drugs or devices or related material removed;
(3). the IDENTIFICATION of the PATIENT for whom the drug or device or related material was ordered; and
(4). the IDENTIFICATION of the PERSON authorized to remove the drug or device or related material from the device.
Which of the following should be part of a patient’s counseling?
I. The name and description of the drug.
II. Technique for self-monitoring of therapy.
III. Action to be taken in the event of a missed dose.
All
To optimize drug therapy, a Pharmacist shall counsel the patient or patient’s agent regarding:
(1) . the NAME & DESCRIPTION of the drug or device.
(2) . DOSAGE FORM, DOSAGE, ROUTE of ADMINISTRATION, & DURATION of therapy
(3) . any PRECAUTION for preparation, administration, and use by the patient.
(4) . common severe side or ADVERSE EFFECTS or INTERACTIONS and therapeutic CONTRAINDICATIONS that may occur with the therapy.
(5) . TECHNIQUE for SELF-MONITORING of drug therapy.
(6) . PROPER STORAGE of medication.
(7) . REFILL information.
(8) . action to be taken in the event of a MISSED DOSE.
Under Controlled Substances Act [CSA], what changes may a pharmacist make to a prescription written for a controlled substance in schedules III-V?
I. The patient’s address
II. The strength of the prescribed controlled substance
III. The quantity prescribed
All
[Schedules III-V Prescriptions]: → The pharmacist MAY ADD / CHANGE the following only AFTER consultation with & agreement of the prescribing practitioner: (1). patient's ADDRESS upon verification. (2). DOSAGE form, (3). drug STRENGTH, (4). drug QUANTITY, (5). DIRECTIONS for USE, or (6). issue DATE
Such consultations & corresponding changes should be noted by the Pharmacist on the prescription.
Pharmacists & practitioners must comply with any state/local laws, regulations, or policies prohibiting any of these changes to Controlled Substance Prescriptions.
The pharmacist is NEVER PERMITTED to CHANGE the:
(1). patient’s NAME,
(2). Controlled Substance prescribed (except for generic substitution permitted by state law) or
(3). the prescriber’s SIGNATURE
A prescription for Aldomet, with three refills, was written by a prescriber on March 31. On April 5, the prescriber passed away. In this circumstance, what should the pharmacist do?
A. Dispense the next refill as it is
B. Ask the patient to have a new prescriber name for future refills
C. Do not refill the drug
D. Dispense all the remaining balance at once
Do not refill the drug.
No prescription may be knowingly FILLED or REFILLED for a patient if the prescription was written for PRIOR USE [NEW Rx] by a PRESCRIBER who is DECEASED or NO LONGER in practice.
Please note this requirement varies State by State.
A pharmacy may perform or outsource centralized prescription processing services to another pharmacy, provided that both pharmacies MUST have the same owner.
- True
- False
False
A pharmacy may perform/outsource CENTRALIZED prescription processing services TO ANOTHER PHARMACY, provided that ALL OF THE FOLLOWING criteria are satisfied:
(1). BOTH pharmacies shall BE LICENSED by the State of Tennessee;
(2). BOTH pharmacies shall SHARE A COMMON ELECTRONIC FILE or appropriate technology to allow each other access to information that is necessary to FILL or REFILL a prescription order; &
(3). BOTH pharmacies shall HAVE THE SAME OWNER
→ (or in the event that the pharmacies DO NOT HAVE THE SAME OWNER, then the pharmacies shall enter a WRITTEN CONTRACT stating the services that will be provided BY EACH PHARMACY as well as the responsibilities of each pharmacy IN FULFILLING THE TERMS of the contract & in complying with federal and state laws and rules).
The pharmacy performing or contracting for CENTRALIZED prescription processing services shall maintain a policy & procedures manual stating how prescription orders will be filled or refilled through CENTRALIZED Prescription processing.
The pharmacies shall provide the Board with a copy of the manual & appropriate documentation of the processes for the Board’s review, upon the Board’s request.
A new application for an existing pharmacy practice site, manufacturer or wholesaler physically located within the state of Tennessee must be filed when the pharmacy practice site, manufacturer or wholesaler changes name, location or ownership.
- True
- False
TRUE
[Pharmacy Practice Site]: → An application for an EXISTING (1) Pharmacy Practice Site, (2) MANUFACTURER, or (3) WHOLESALER physically located within the state of Tennessee MUST BE FILED when the pharmacy practice site, manufacturer or wholesaler CHANGES: (1). changes NAME, (2). changes LOCATION, or (3). changes OWNERSHIP
Transactions CONSTITUTING a CHANGE OF OWNERSHIP include, but are not limited to, the following:
(1). A sole proprietor becomes a member of a partnership or corporation, which succeeds him as the new operator;
(2). A partnership dissolves;
(3). One partnership is replaced by another through the removal, addition or substitution of a partner;
(4). Two (2) or more corporations merge and the originally-licensed corporation DOES NOT SURVIVE; and
(5). Transfers between levels of government.
Transactions which DO NOT CONSTITUTE a CHANGE OF OWNERSHIP include, but are not limited to, the following:
(1). Changes in the membership of a corporate board of directors or board of trustees;
(2). Two (2) or more corporations merge and the ORIGINALLY-LICENSED corporation SURVIVES; and
(3). Corporate stock transfers or sales, even when a controlling interest.
Which of the following insulin products require a prescription for purchase?
- Humulin R
- Novolin N
- Humulin 70/30
- Humalog
Humalog® [human insulin lispro] is a Prescription Product & requires an authorized prescription to purchase it.
All the other choices are available as OTC agents:
(1) . Humulin R (Regular)
(2) . Novolin N (NPH)
(3) . Humulin 70/30 (NPH/Regular)
At the time of dispensing of the sterile product for a patient admitted in a hospital, the dispensing container must bear a label which contains:
I. patient’s name.
II. pharmacy practice site name, address, and phone number.
III. identification of the pharmacist who compounded the sterile product.
III only
At the time of dispensing of the STERILE PRODUCT, the DISPENSING CONTAINER LABEL must contains the following information:
(1). If for OUTPATIENT use [for inpatient this is NOT Required]:
→ a. PATIENT’s name
→ b. PRESCRIBER(s)
→ c. pharmacy practice site NAME, ADDRESS, & PHONE number
(4). identification of the PHARMACIST who compounded the sterile product;
(5). when applicable, identification of the PHARMACY INTERN or PHARMACY TECHNICIAN who assisted in the compound
According to the Tennessee State Pharmacy Law, the central pharmacy license shall expire three years from the date of issuance.
- True
- False
False
“Central pharmacy” - means the central pharmacy practice site licensed by the Tennessee Board of Pharmacy located within a federally qualified health center that is connected through computer link, video link, & audio link to one (1) or more satellite clinics.
“Satellite clinic” - means a clinic location located within federally qualified health center where any prescription dispensed at the central pharmacy shall be issued to the patient or patient’s agent through Telepharmacy.
“Tele pharmacy” - means the METHOD of providing pharmaceutical services through a remote site connection between a CENTRAL pharmacy “and” a SATELLITE clinic.
The CENTRAL pharmacy license shall expire TWO (2) years from the date of ISSUANCE. All licenses shall be renewed “ON or BEFORE” the last day of the two (2) - year license cycle.
The CENTRAL pharmacy may RENEW its license within SIX (6) MONTHS AFTER the license expiration date with payment of the renewal fee & late renewal PENALTY FEE. After the SIX (6) MONTH grace period, the licensee may REAPPLY for licensure.
Which of the following should be part of Drug Utilization Review [DUR]?
I. Drug-food interaction.
II. Duplication of therapy.
III. Direction for use.
All
Based on [OBRA-90], a Drug Utilization Review [DUR] may include:
(1). known ALLERGIES.
(2). rational THERAPY-CONTRAINDICATIONS
(3). reasonable DOSE, DIRECTION for use & ROUTE of administration.
(4). DUPLICATION of therapy.
(5). drug-drug, drug-food & drug-disease INTERACTIONS.
(6). ADVERSE REACTIONS
(7). OVERutilization or UNDERutilization of prescribed drugs.
Which Act emphasizes the SECURITY & SAFETY of health related information?
HIPAA = [Health Insurance Portability & Accountability Act]
It emphasizes the SECURITY & SAFETY of Health Related Information.
The MAJOR OBJECTIVES of the HIPAA are:
(1). To ASSURE HEALTH INSURANCE PORTABILITY.
→ This will help a person who has preexisting health conditions & wants to change jobs. Before the HIPPA, a person would think twice before changing jobs, if they had preexisting health conditions, because of insurance problems.
(2). To PREVENT or Reduce HEALTHCARE RELATED FRAUD & ABUSE.
(3). To ENSURE the SECURITY & SAFETY of each patient’s Health Related Information. This will help to keep a patient’s condition CONFIDENTIAL.
(4). To ENFORCE the STANDARD FOR HEALTH
A home care kit may contain:
I. Sodium Chloride for Irrigation
II. Epinephrine injection
III. Naloxone
All
A HOME CARE KIT is a kit containing certain drugs, as determined by the BOARD, to be kept in the HOME of the patient FOR USE BY HEALTHCARE PROFESSIONAL engaged in home healthcare of a patient as necessary to meet the therapeutic needs of patients & which ARE NOT AVAILABLE FROM ANY OTHER SOURCE “in sufficient time” to prevent risk of harm to patients.
[Home Care Kit]: → A home care kit may contain: (1). Sodium Chloride for Injection 0.9% Bacteriostatic (2). Sterile Water for injection Bacteriostatic or Preservative Free (3). Epinephrine injection 1mg/ml (4). Diphenhydramine (5). Heparin Flush ≤ 100units/ml (6). Naloxone (7). Sodium Chloride for Irrigation (8). Sterile Water for Irrigation (9). Dextrose 50% (10). Urokinase 5000units
Drugs contained in home care kits ARE TO BE USED FOR EMERGENCIES ONLY. Maintenance of a CENTRAL VENOUS CATHETER is considered an emergency if confirmed with the patient’s physician or his/her designee.
Under CSA, a prescription written for Ativan for “office stock” should only be filled by the pharmacist-in-charge.
- True
- False
False.
A prescription may NOT BE ISSUED in order for an Individual Practitioner to OBTAIN A SUPPLY of Controlled Substances for the Purpose of GENERAL DISPENSING to his/her patients.
Therefore, a prescription written for (1) “office stock” or (2) “medical bag” use is NOT VALID.
Which of the following classes of Schedule controlled substances CANNOT be issued using the Satellite clinic under the Tennessee State Pharmacy Law?
I. Schedule I controlled substances
II. Schedule III controlled substances
III. Schedule IV controlled substances
All
“Central pharmacy” - means the central pharmacy practice site licensed by the Tennessee Board of Pharmacy located within a federally qualified health center that is connected through computer link, video link, and audio link to one (1) or more SATELLITE clinics.
“Satellite clinic” - means a clinic location located within federally qualified health center where any prescription dispensed at the CENTRAL pharmacy shall be issued to the patient or patient’s agent through TELEPHARMACY.
“Telepharmacy” - means THE METHOD OF PROVIDING PHARMACEUTICAL SERVICES through a remote site connection between a CENTRAL pharmacy & a SATELLITE clinic.
As a CONDITION FOR LICENSURE, the “CENTRAL PHARMACY” participating in this program shall meet ALL OF THE STANDARDS established in Tennessee State Pharmacy Law & shall also meet the FOLLOWING MINIMAL OPERATING REQUIREMENT:
(1). shall be CONNECTED to the “SATELLITE” clinic through computer link, video link, and audio link;
(2). shall have a computer system that is connected to the satellite clinic’s computer system that SHARES COMMON ELECTRONIC FILES;
(3). shall have ITS OWN COMPUTER(s) that is/are NOT ACCESSED by others employed by the federally qualified health center, scanner(s), printer(s), and fax machine(s); &
(4). shall have a LICENSED PHARMACISTS at the “CENTRAL” pharmacy location.
→ (a). OPERATIONAL AT ALL TIME -> The “Pharmacist-In-Charge” shall ensure that the “CENTRAL” pharmacy’s connection with the satellite clinic through computer, video link, and audio link is operational at all times that the satellite clinic is open.
→ (b). IF NOT OPERATIONAL -> If the computer, video link, or audio link connection is not operational, the pharmacist-in-charge shall ensure that the “SATELLITE” clinic shall CEASE TO OPERATE relative to the issuance of prescriptions supplied by the central pharmacy until the links are reconnected.
→→ NO PRESCRIPTION SHALL BE DISPENSE -> Whenever an interruption of data, video, or audio link occurs between the CENTRAL pharmacy & the SATELLITE clinic, and a sign shall be posted noting the closure with an estimated time until a resumption of services can be expected.
→ (c). NOT TO BE ISSUED FROM THE SATELLITE CLINIC -> The “pharmacist-in-charge” shall ensure that prescriptions for controlled substances schedules [I, II, III, or IV] are not issued from the satellite clinic.
→ (d). FEDERALLY QUALIFIED -> The pharmacist-in-charge shall ensure that only the pharmacists and pharmacy technicians employed by the FEDERALLY QUALIFIED health center AND working in the satellite clinic shall have keys to the satellite clinic
Which of the following is/are TRUE regarding destruction of controlled substances by using authorized reverse distributors?
I. A pharmacy may at any time forward controlled substances to DEA registered reverse distributors who handle the disposal of drugs.
II. When a pharmacy transfers Schedule II substances to a reverse distributor for destruction, the distributor must issue an Official Order Form (DEA Form-222) to the pharmacy.
III. A DEA Form-41 along with DEA Form-222 should be used to record the transfer of controlled substances between the pharmacy and the registered reverse distributor
I and II only.
A Pharmacy may AT ANY TIME forward Controlled Substances to DEA registered Reverse Distributors who handle the DISPOSAL of drugs.
When a Pharmacy TRANSFER “[Schedule II]” Controlled Substances to a Reverse Distributor for DESTRUCTION, the DISTRIBUTOR must issue an Official Order Form (DEA Form-222) to the Pharmacy.
When “[Schedule III-V]” Controlled Substances are TRANSFERRED to a Reverse Distributor for Destruction, the Pharmacy should DOCUMENT IN WRITING the following:
(1). drug name, dosage form, strength, quantity &
(2). DATE transferred
The DEA registered Reverse Distributor WHO WILL DESTROY THE CONTROLLED SUBSTANCES is responsible for submitting a “DEA Form-41” to the DEA when the drugs HAVE BEEN DESTROYED.
A “DEA Form-41” should NOT BE USED to record the TRANSFER of Controlled Substances BETWEEN the Pharmacy & the registered Reverse Distributor.
According to the Tennessee State Pharmacy Law, pharmacy technicians working at the satellite clinic may be supervised by a pharmacist without a pharmacist being physically present.
- True
- False
True
According to the Tennessee State Pharmacy Law, pharmacy technicians working at the SATELLITE clinic may be supervised by a pharmacist WITHOUT a pharmacist being physically present.
“Central pharmacy” - means the central pharmacy practice site licensed by the Tennessee Board of Pharmacy located within a federally qualified health center that is connected through computer link, video link, and audio link to one (1) or more SATELLITE clinics.
“Satellite clinic” - means a clinic location located within federally qualified health center where any prescription dispensed at the CENTRAL pharmacy shall be issued to the patient or patient’s agent through TELEPHARMACY.
“Telepharmacy” - means THE METHOD OF PROVIDING PHARMACEUTICAL SERVICES through a remote site connection between a CENTRAL pharmacy & a SATELLITE clinic.
In which of the following situations is a PDR not required?
I. A patient visits a physician in the physician’s office & receives a prescription. The patient has the prescription filled in a retail pharmacy.
II. A pharmacist in a hospital pharmacy fills an outpatient prescription for a hospital employee.
III. A pharmacist fills a prescription for a patient who lives in a personal care home.
IV. A pharmacist fills a prescription for a patient in a nursing home.
Based on [OBRA-90], the PDR = [Prospective Drug Review] is required for both prescriptions in:
1. RETAIL &
2. OUTPATIENT
The Prospective Drug Review [PDR] does NOT EXTEND to the following:
(1). An order for a drug for an INPATIENT of an institution.
(2). A drug DISPENSED IN an EMERGENCY ROOM.
(3). A drug DISPENSED BY a Medical Practitioner.
(4). A drug DISPENSED BY a Pharmacist to a Medical Practitioner WHO WILL ADMINISTER IT to a patient.
The following are examples of situations in which a Prospective Drug Review [PDR] is REQUIRED”:
(1). A patient visits a physician in the physician’s office & receives a prescription. The patient has the prescription filled in a RETAIL pharmacy.
(2). A pharmacist fills a prescription for a patient who lives in a PERSONAL CARE HOME
(3). A pharmacist in a hospital pharmacy fills an OUTPATIENT prescription for a hospital employee.
(4). A patient is treated on a non-emergency basis in an OUTPATIENT clinic of a hospital & is given a prescription.
(5). The patient has the prescription filled either in the HOSPITAL PHARMACY or in a RETAIL pharmacy.
The following are examples of situations in which a Prospective Drug Review [PDR] is “NOT REQUIRED”:
(1) . A Pharmacist fills a prescription for a patient in a NURSING HOME
(2) . A Pharmacist in a hospital dispenses a drug that “will be administered” to a patient in the hospital.
(3) . A Physician dispenses a drug to a patient being treated in the EMERGENCY ROOM
(4) . A Pharmacist dispenses a RADIOPHARMACEUTICAL to a Physician WHO WILL ADMINISTER IT to a patient.
who is responsible for appointing the members of the board
the governor
how many members must be >/= 60 yo
1
how many members must be of racial minority
1
how many members are on the board
7 - 6 rah and 1 civil member
how much experience is a pharmacist required to have to be eligible to serve on the board
5 years in TN
the citizen member must have lived in TN for how long
5 years and must currently live in tn
T/F - a citizen member can own a health care facility or business or be a health care provider
false
how long is a term on the board
6 years
how many members must be present to constitute a quorum
a simple majority - the board may divide into groups of 3 to conduct hearings and handle disciplinary matters, in this case 3 members constitute a quorum
what are the responsibilities or the executive director of the board
to supervise, conduct research, represent the board and perform other functions
T/F - your license as a pharmacist may be suspended if you default on student loans
true
T/F - your license to practice pharmacy may be suspended if you fail to pay child support
true
A PIC must be on duty at least X of the time the pharmacy is open
50%
note - the maximum average of 40hrs/wk ( if pharmacy maintains business for 90hrs/wk, the PIC must be on duty 40hrs/wk)
what info should be recorded in a patient profile?
pt name/address/phone number birthdate gender dz states known allergies h/o drug reactions complete list of CURRENT medications and relevant medical devices any pertinent pharmacist's comments
is it required for the pharmacist to extend the offer to counsel the patient
no, the pharmacist can designate an employee to extend the offer
how often are controlled substance registrations renewed
annually
in order to do business with a controlled substance (obtaining, possessing, administering) an entity must first obtain a:
controlled substance registration
does the controlled substance registration = DEA registration
no - these are two different registrations, in TN both must be obtained
the controlled substance registration is associated with TN law only
What act requires pharmacists to record prescription info to a database when dispensing C2-5
the controlled substance monitoring act of 2002
how frequently must the information be reported into the controlled substance database
every 7 days
what information must be reported into the controlled substance database
prescriber patient dispenser drug, strength, quantity and estimated days supply date issued new rx or refill payment source
tramadol
CIV
carisoprodol
CIV
Third Party contracts must specify what?
- method and amount of reimbursement
- frequency of payment to pharmacy
- method of handling complaints/disputes
How is third party program cancellation handled?
notify 30 days before cancellation; administrator of program responsible for getting cards back.
Who can prescribe abortifacients?
only physicians - not nurse practitioners or PAs
Rx if the prescriber is now deceased
- for new Rxs - good for 90 days from date of death
2. for RFs - good for another 90 days on CIII-V, or 180 days for non controls
Who schedules controlled substances in TN?
The commissioner of mental health and substance abuse services (upon agreement of commissioner of health)
Certified pharmacy techs can
receive oral rx
receive/transfer rx
tech-check-tech
T/F - if a pharmacy has the same business hours as the store it is located in, a floor to ceiling physical barrier is still required
F - if they are open the same hours, the physical barrier is not required
in TN any new pharmacy must be equipped with a
consultation area for patient privacy
pharmacies in tn are required to post 1 or more signs at their main entrance that provide the toll-free hotline phone number to what people
- elderly victims of abuse, neglect, or exploration
- victims of domestic violence
- teens involved in relationships that include dating violence/abuse
the pharmacy department must be
clean orderly and sanitary and at least 180 square feet
the pharmacy department must have
hot and cold running water and a fridge
