CHAPTER 2: FEDERAL REQUIREMENTS

Safety Data Sheet (SDS)

- are divided into 11 sections that provide information to the handler regarding the hazards associated with the product. - opics covered on an SDS include identification, hazards ID, composition/ information on ingredients, first aid measure, accidental release measures, handling and storage, exposure controls an personal protection, physical and chemical properties, stability and reactivity, and toxicological factors.

HIPPAA administration simplification provisions include

-HIPPAA electronic health care transactions and code standards -HIPPAA privacy Rule -HIPPAA security rule

The six criteria used in determining if a substance is hazardous are?

-carcinogenicity, -teratogenicity or developmental toxicity, -reproductive toxicity in humans, -genotoxicity, -and new drugs that mimic existing hazardous drugs in structure or toxicity.

How many refills are available on schedule II meds?

0 schedule II meds does not carry efills. a schedule III-V meds might carry up to 5 refills, and any medication that is not schedule drug can have PRN refills

The FDA has responsibility for all the following EXCEPT__ A. establishing requirements for labeling of medications, whether they are in a multidose vial or unit-dose container, an IV admixture, or a compound B. providing information on recent drug approvals and rug shortages and providing drug safety information C. establishing clinical trials, submissions of drug application, and the required labeling of medication D. issuing warning letters to the public regarding specific medication and conducting post-market surveillance program for newly approved med

A -The United States Pharmacopeia has the responsibility for establishing requirements for labeling of medications, whether they are in a multi dose vial or unit-dose container, an IV admixture, or compound. - the FDA is responsible for te other choices, including providing info on recent drug approvals and drug shortages and providing drug safety info; establishing clinical trials, submission of drug applications, and the required labeling of meds; and issuing warning letters to the public regarding specific medications and conducting post-market surveillance programs for newly approved meds

Which of the following drug recall description is correct? A. class I: reasonable probability that use of the product will cause or lead to serious adverse health events or death B. class II: use of product will probably not cause an adverse health event C. class III: probability exists that use of the product will cause adverse health events that are temporary or medically reversible D. class IV: use of product will not cause and adverse health event

A Class I: reasonable probability that use of the product will cause or lead to serious adverse health events or death Class II: Probability exists that use if the product will cause adverse health events that are temporary or medically reversible Class III: use of product will probably not cause an adverse health event Class IV: Does not exist

A biennial inventory is one that is completed__ a. every 2 years b. every 2 months c. twice in year d. for non-controlled substances

A a biennal inventory is required by te Drug Enforcement Administration of all controlled substances every 2 years. an accurate count of all schedule II medications must be preformed (exact amount), but schedule III, IV, V and "exempt narcotics" may be estimated.

Last night a local pharmacy had its safe broken into, and schedule II drugs were stolen. which form would need to be completed? a. DEA Form 106 b. DEA Form 41 c. DEA Form 222 d. DEA Form 22

A in the case of theft, a DEA Form 106 would need to be filled out after the police and local DEA diversion office were notified

You would expect to find all the following EXCEPT the __ on a manufacturer's drug label. a. physician's name b. name and place of business of the manufacturer, packer, or distributor c. NDC d. statement of ingredients

A on a manufacturer's drug label you would expect to find the name and place of business of the manufacturer, packer, or distributor; NDC, and a statement of ingredients. THE DOCS NAME WOULD BE ON RX LABEL

certain medications have severe side effects and are only approved or certain populations. which o the following describes stipulations or the use of clozapine (clozaril)? a. reporting of white blood cell (WBC) values and absolute neutrophil counts (ANCs) b. indicated for multiple myeloma c. blood should never be donated d. a woman can be excused from the requirements is she has no had a period 24 months in a row

A the clozaril administration registry enrollment (CARE) is a secured internet application that facilitates the reporting on WBC values and ANCs of patients taking brand clozaril (clozapine) to the clozaril national registry (CNR). CARE is design to safeguard patietn information, protect patients' privacy, and assist physicians and pharmacists with effective monitoring functionalities. the other condition are specific to thalidomide?

who is responsible for developing REMS programs? A. drug sponsor B. FDA C. Pharmacy D. all the above

A the drug sponsor is responsible for developing REMS programs; however, the FDA is responsible for reviewing and approving REMS programs

which of the following describes adulteration? a. "prepared, packed, or held under unsanitary conditions b. labeling that is "false or misleading in a particular way" c. failure to label "adequate directions for use" d. failure to carry label indicating "warning-May be habit forming" if the product is habit forming

A the other choices describe misbranding

You would find all the following EXCEPT the __ on an OTC package label a. pt name b. active ingredients c. inactive ingredients d. NDC

A PT name might be typed on a rx label that is affixed to an OTC package, but it would not be found on the OTC package label. one would find the active ingredient and inactive ingredient as well as NDC # on the package label of a OTC product

A batch of anti-arrhythmic medication is found to have no active ingredient. Which of the following would probably occur? a. class I recall b. class II recall c. class III recall d. class IV recall

A because of the danger of giving a medication that is lacking the active ingredient necessary to prevent arrhythmia, and possibly death, it is most likely that there would be a class 1 recall in this case.

The Kefauver-Harris Amendment of 1962 did not include a provision that__ a. requires all meds in the US to be pure, safe, and effective b. controlled substances are placed in one of 5 schedules c. established procedures for both drug applications and investigational drugs d. drug manufacturers are require to be responsible for good manufacturing processes

B The Comprehensive Drug Abuse and Control Act of 1970 put controlled substances in 5 categories. the other 3 choices are part of the The Kefauver-Harris Amendment of 1962

where would a pharmacy technician look to find a listing of all medication recalls on the internet? a. APHA website b. FDA website c. OSHA website d. TJC website

B a complete listing of ll medication recalls can be found on the FDA website

Which statement is true when comparing the health insurance portability and accountability act(HIPPAA) with protected health info (PHI) a. PHI requires that HIPPAA remain confidential b. HIPPAA requires that PHI remain confidential c. Prescriber order entry does not complement HIPPAA d. HIPPAA provides barriers to pt access of their health records

B HIPPAA requires that health practitioner keep PHI confidential and secure. prescriber order entry complements HIPPAA, and HIPPAA allows pt better access to their health records.

The Durham-Humphrey Act did not include a provision that__ a. separated drugs into legend and non-legend b. regulated the use of pt info c. required the supervision of a physician for prescribed meds d. refills could be phoned in from the physician's office

B The Durham-Humphrey Act of 1951 did not regulate the use of pt info; HIPPAA did that. the act did separate drugs into 2 categories, legend and non-legend, and did require the supervision of a physician for prescribed med. the act also alllowed refills to be called in from a physician's office

which organization establishes a listing of rugs that deemed to be hazardous? A. FDA B. NIOSH C. OSHA D. TJC

B The national institute for occupational safety and health (NIOSH) established a list of drugs that are deemed to be hazardous and require special handling.

prior to using the DEA's controlled substance ordering system (CSOS), what must the purchaser possess? a. CSOS digital DEA number b. CSOS digital certificate c. CSOS digital self-certification d. all the above

B an individual must enroll with the DEA to acquire a CSOS digital certificate prior to using the DEA's Controlled Substance System (CSOS)

Which DEA form must be completed to veriy the destruction of schedule II narcotics? a. DEA Form 106 b. DEA Form 41 c. DEA Form 222 d. DEA Form 22

B in the case of destruction of schedule II narcotics, a DEA Form 41 would need to be filled out.

which organization may discipline a pharm tech if he or she engages in improper conduct relating to pharm practice? a. AHPA B. BOP C. NABP D. all above

B the BOP is the regulatory state agency that oversees the practice of pharmacy in a given state. defines regulations affecting pharmacy as well as the roles, duties, and expectations of pharmacists and pharm techs in that state. the BOP authority to discipline pharmacies, pharmacists, and pharm techs for improper behavior.

Safety Data Sheet (SDS) are divided into 11 sections that provide information to the handler regarding the hazards associated with the product. which of the following is not discussed on an SDS sheet? a. composition/ information on ingredients b. cost c. hazards identification d. first aid measure

B the cost of the product in not provided on an SDS. topics covered on an SDS include identification, hazards ID, composition/ information on ingredients, first aid measure, accidental release measures, handling and storage, exposure controls an personal protection, physical and chemical properties, stability and reactivity, and toxicological factors.

The proper form to use when ordering Schedule II controlled substances for the pharmacy is DEA Form__ a. DEA Form 106 b. DEA Form 41 c. DEA Form 222 d. DEA Form 22

C for regular ordering of schedule II medications, DEA Form 222 is used

which of the following is an example of Schedule II controlled substance? a. acetaminophen + codeine b. gabapentin c. methylphenidate d. carisoprodol

C - methylphenidate (concerta or rilatin) is a schedule II - acetaminophen with codeine (Tylenol with codeine or Tylenol #3) is classified as a schedule III controlled substance

A prescriber of controlled substances may issue multiple RX authorizing the patient to receive a total of up to how many days supply of a schedule II controlled substance if specific conditions are met. a. 30 days b. 60 days c. 90 days d. 120 days

C A prescriber of controlled substances may issue mutiple RX authorizing the patient to receice a total of up to 90 day supply of a schedule II controlled subtance if the following conditions are met. - each rx must be issued on a separate rx blank. - each separate rx must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of professional practice.

The first letter of a prescriber's DEA number would definitely not be a.A b. B c. Q d. M

C A,B,F and M would be legitimate starting letters for a physicians DEA #

The US Pharmacopeia and National Formulary (USP-NF) contains standards for all the following EXCEPT a. chemical and biological drug substances b. compounded meds c. energy drinks d. dietary supplements

C The USP-NF contains standards for chemical and biological drug substances, dosage forms, compounded preparations, excipients, medical devices, and dietary supplements

certain records must be maintained in the pharmacy. which of the following would not have to be maintained in the pharmacy? a. the biennial inventory of narcotics b. change of PIC c. OTC med order d. controlled substance invoices

C The biennial inventory of narcotics, change of PIC, and controlled substance inventory must all be maintained in the pharmacy. OTC orders might be completed by the front office and maintained there.

Establishes conditions on the use and the disclosure of protected health information" describes a provisions of which law or amendment? a. FDA Safe Medical Devices Act 1990 b. dietary supplement health and education act (DSHEA) 1994 c. Health insurance portability and accountability act (HIPPAA) 1996 d. Combat methamphetamine epidemic act 2005

C The health insurance portability and accountability act HIPPAA 1996 requires that health care providers ensure that patient confidentiality be maintained; established conditions on the use and the disclosure of protected health information (PHI): and requires that patients be notified on how their PHI will be used

Which DEA form is issued by a reverse distributor to the pharmacy or the destruction of schedule II controlled substances? a. DEA Form 41 b. DEA Form 106 c. DEA Form 222 d. DEA Form 224

C a reverse distributor must issue a DEA Form 222 or its electronic equivalent to the pharmacy for the destruction of Schedule II controlled substances

which of the following medication is NOT classified as a hazardous drug? a. cisplatin b. estradiol c. lisinopril d. methotrexate

C lisinopril is not classified as hazardous drug. cisplatin, estradiol, and methotrexate are classified as hazardous drugs

For a medication or substance to be classified as being hazardous, it must meet at least one of six criteria. which of the following is NOT a criterion for a hazardous substance? a. carcinogenicity b. genotoxicity c. organ toxicity at low doses in both animals and human d. reproductive toxicity in humans

C organ toxicity at low doses in both animals and human is not a criterion for a substance to be classified as hazardous. The six criteria used in determining if a substance is hazardous are as follows: carcinogenicity, teratogenicity or developmental toxicity, reproductive toxicity in humans, genotoxicity, and new drugs that mimic existing hazardous drugs in structure or toxicity.

the HIPPAA administration simplification provisions include all of the following EXCEPT a. HIPPAA electronic health care transactions and code standards b. HIPPAA privacy Rule c. HIPPAA safety rule d. HIPPAA security rule

C the HIPPAA safety rule is not a provision of the HIPPAA administration simplification provisions. HIPPAA administration simplification provisions include HIPPAA electronic health care transactions and code standards, HIPPAA privacy Rule, HIPPAA security rule

Which organization maintains the CPE Monitor for completed continuing education or both pharmacist and pharm techs? A. APHA B. BOP C. NABP D. TJC

C the national association of the boards of pharmacy (NABP) maintains CPE Monitor for completed continuing education for both pharmacists & tchs

which of the following drugs would be classified as Schedule 1 under DEA's guideline? a. oxycodone b. hydrocodone c. peyote d. codeine

C Peyote is a hallucinogenic and is classified a schedule 1. the other drugs would fall between schedules II and V depending on their dosage form

what is the maximum day supply is isotretinoin that may be dispensed at one time? a 7 days b. 14 days c. 30 days d. 45 days

C The maximum days supple of isotretinoin that may be dispensed at one time is 30 days

Which organization is responsible for requiring safety data sheets to be maintained in the pharmacy for medications an hazardous substances? A. FDA B. NIOSH C. OSHA D. TJC

C the occupational safety and health administration (OSHA) is responsible for requiring safety data sheets to be maintained in the pharmacy for medications and hazardous substances.

National Drug Code (NDC) numbers have 11 digits. in the NDC # 00007-1234-56 a. the 1234 represents the med b. the 56 represents the quantity or package size c. the 00007 represents the drug manufacturer d. all statements are correct

D

a class III is issued for a medication, which of the following scenarios would most likely match the recall severity? a. a drug is found to significally increase death because of cardiac complications b. a medication causes a rash that sometimes leads to anaphylaxis c. a drug is discovered to cause severe vomiting in 10% of pt d. a batch of tablets is a lighter green that usual but of the same composition.

D a class III recall is for medications that will probably not cause a severe event

which of the following is an example of a schedule IV controlled substance? a. amphetamine/ dextroampetamine b. meperidine c. pseudoephedrine d. tramadol

D - tramadol (Ultram) is schedule IV - amphetamine/ dextroampetamine (Adderall) & meperidine (Demerol) are schedule II - Pseudoephedrine is classified as a scheduled listed chemical product (SLCP)

which of the following is not a goal of the Drug Supply Chain Security Act? a. allow verification of the authenticity of the drug product identifier down to the package level. b. improve detection and notification of illegitimate products in the drug supply chain c. make possible more well-organized recalls of drug products d. provide testing of meds to ensure they are not adulterated.

D Drug Supply Chain Security Act does not call for testing of medications to ensure they are unadulterated. goals of the drug supply security act allow for allow verification of the authenticity of the drug product identifier down to the package level, improve detection and notification of illegitimate products in the drug supply chain, allowance for more well-organized recalls for drug products.

All the following have to do with the use of isotretinoin EXCEPT a. it is prescribed only for severe recalcitrant nodular acne unresponsive to other therapies b. it might produce depression and psychosis c. it might produce suicidal ideation and suicide d. it is indicated for multiple myeloma

D Isotretinoin is a very powerful medication used to treat acne. unfortunately, the medication has been found to cause severe birth defects; induce spontaneous abortions; and produce adverse psychiatric efects, including depression, psychosis, suicidal ideation, suicide attempts, and suicide. it is only to be used for severe recalcitrant nodular acne unresponsive to other meds

When must personal protective equipment (PPE) be worn when handling hazardous drugs? a. receiving hazardous drugs b. compounding hazardous drugs c. transporting hazardous drugs d. all the above

D Personal Protective Equipment (PPEs) must be worn when receiving, storing, transporting, compounding, deactivating/decontaminating, cleaning and disinfecting, and during spill control of hazardous drugs

All the following describe the Orphan Drug Act EXCEPT___ A. it defined orphan drugs as medications that treat a condition for which there are fewer than 200,000 cases worldwide B. it passed in 1983 C. it provides tax incentives and exclusive licensing of products for drug manufacturers who are not expected to recover the costs of developing and marketing a treatment drug D. it makes provisions for the use of drugs abandoned by a pharmaceutical company's research and development team

D The orphan act of 1983 established advantages for the manufacture of drugs for treatment of diseases or conditions of which there are fewer than 200,000 cases in the world, and provides tax incentives and exclusive licensing of products for manufacturers to develop and market orphan medications

" placed ephedrine, pseudoephedrine, and phenylpropanolamine in the controlled substances act category ' scheduled listed chemical products' describes ta provision of which law or amendment? a. FDA safe medical devices act 1990 b. dietary supplement health and education act (DSHEA) 1994 c. Health insurance portability and accountability act (HIPPAA) 1996 d. combat methamphetamine epidemic act of 2005

D This act placed ephedrine, pseudoephedrine, and phenylpropanolamine in the controlled substance act category " scheduled listed chemical products" products containing ephedrine, pseudoephedrine, and phenylpropanolamine are subject to sales restrictions, storage requirements, and record keeping requirements

which piece of legislation permits and individual to return unused controlled substances to designated pharmacies? a. poison prevention packaging act b. occupational safety and health act c. resource conservation and recovery act d. secure and responsible drug disposal act

D Under the secure and responsible drug act, an individuals is able to return unused controlled substances to designated pharmacies

certain medications have severe side effects and are only approved or certain populations. which o the following describes stipulations or the use of thalidomide? a. CARE is designed toe stream line the process. b. the system is used to detect agranulocytosis c. the ANC is one of the measures that determine if a patient may take the medication or not d. a woman must be negative pregnancy test result withing the 24 hours before beginning treatment

D a woman must have a negative pregnancy test result within the 24 hours before beginning treatment with thalidomide. in addition, she will needs to be testes for pregnancy in a laboratory weekly during the first 4 weeks o her treatment and then once every 4 weeks if she has regular menstrual cycles or once every 2 weeks if she has irregular menstrual cycles. the other 3 choices represent stipulations using clozaril

which of the following tasks is an example of an extended responsibility for a pharm tech? a. assisting the pharmacist in performing medication reconciliation activities b. counseling a patient picking up RX c. creating pt profile d. participating in Tech-check-tech activities

D in some states, pharm techs are permitted by the state BOP to check the work of other pharm techs. tech-check-tech is considered an expanded responsibility. Assisting the pharmacist in performing medication reconciliation and medication therapy activities an creating pt profile are not considered extended pharm tech activities. only pharmacists are permitted to counsel pt on their RX

all the following are example of schedule IV controlled substances EXCEPT A. alprazolam B. eluxadoline C. eszopiclone D. lisdexamfetamine

D lisdexamfetamine (Vyvanse) is schedule II med - alprazolam (Xanax), eluxadoline (Viberzil), and eszopiclone (Lunesta) are schedule IV controlled substance

Which controlled substance schedules can be ordered using the Controlled Substance Ordering System (CSOS)? a. schedule 1 b. schedule II c. schedules III-V d. schedules I-V

D schedules I-V can be ordered using CSOS

which organization established compounding standards for both sterile and non-sterile products. a. FDA b. NABP c. TJC d. USP

D the USP established standards for non-sterile compounding (USP<795>) and sterile compounding (USP <797>)

what is the maximum number of different controlled substances that may be ordered using the DEA's Controlled Substance Ordering System? a. 10 b. 15 c. 30 d. unlimited number of items

D there is no limit to the number of different controlled substances that may be ordered using the DEA's Controlled Substance ordering system

how many days is a paper DEA Form 222 valid? a. 7 days b. 14 days c. 30 days d. 60 days

D a paper DEA Form 222 is valid for 60 days

when must a medication guide be given to a patient? a. when the patient request a guide b. when a drug is dispense in an outpatient setting c. when a drug is subject to a REMS that include specific requirements for reviewing or providing a medication guide as part of an element to assure safe use d. all the above

D A medication guide must be provided to the patient or the patients agent - when the patient request a guide - when a drug is dispense in an outpatient setting (eg retail pharm, hospital) ad the product will then be used by the patient without direct supervision by a health care professional -first time a drug is dispensed in an outpatient setting of any kind after medication guide is materially changed (e.g after addition of a new indication or new safety information - when a drug is subject to a REMS that includes specific requirements for reviewing or providing a medication guide as part of an element to assure safe use (possibly in conjunction whit distribution; the medication guide must be provided in concordance with the terms of REMS)

while compounding hazardous medications, some of the medication is spills in the techs eye. how long should the tech flood the affected eye with water or isotonic eyewash? \ a. 1 min b. 5 min c. 10 min d. 15 min

D For eye exposure to hazardous drugs, the affected eye should be flooded at an eyewash fountain or with water or isotonic eyewash designated for that purpose for at least 15 min

patient package inserts are required to be given to all patients receiving which medication? a. Estrogen b. metered-dose inhalers c. oral contraceptives d. all the above

D patient package inserts are required to be given to all patients receiving metered-dose inhalers, oral contraceptives, estrogens, and progesterone products.

Contrasting the functions of the National Association of Boards of Pharmacy and the state board of pharmacy(BOPs), which of the following is correct? a. the national boards of pharmacy accredit professional degree programs b. the state BOPs are responsible for insuring safe working conditions c. the national boards of pharmacy rely on the state BOPs for assistance d. the state BOPs rely on the national boards of pharmacy for assistance

D the states BOPs rely on the national boards of pharmacy for assistance. OSHA is responsible for insuring safe working conditions, an the ACPE accredits professional degree programs.

certain practitioners may prescribe medications. which of the following practitioners would least likely have the right to write a prescription?

Doctors of Pharm (PharmDs) Generally, MDs, PAs, and NPs write RX. Under certain conditions, a PharmD may be able to author rx, but this is the exception, not the rule.

DEA Form 41

Documents disposal and destruction of scheduled drugs

Laws and amendments regarding drugs in the US, which was the most recently passed?

The kefauver-Harris amendment passed in 1962

The national institute for occupational safety and health (NIOSH) established

a list of drugs that are deemed to be hazardous and require special handling.

What does this NDC # 00007-1234-56 indicate?

a. the 1234 represents the med b. the 56 represents the quantity or package size c. the 00007 represents the drug manufacturer

ACPE (Accreditation Council for Pharmacy Education)

accredits professional degree programs in pharmacy and providers of continuing pharmacy education, and assures and advantages the quality of continuing pharmacy education

American Society of health system pharmacist (ASHP)

advocates for the practice of pharmacy to various organizations to include the Joint Commission, federal and state regulatory agencies, a other health care organizations, and establishes regulations and standards for pharmacy tech programs to include curriculum an clinical expectations

which organization ensures that specific standards are met for the licensing of pharmacists, permits are issued for pharmacies, and pharmacy techs meet requirements?

board of pharmacy

Which of the following describes misbranding? a. "prepared, packed, or held under unsanitary conditions b. prepared containers "composed, in whole or in part, of nay poisonous or deleterious substance" c. failure to label "adequate directions for use" d. containing unsafe color additives

c other choices describe adulteration

Orphan Act of 1983

established advantages for the manufacture of drugs for treatment of diseases or conditions of which there are fewer than 200,000 cases in the world, and provides tax incentives and exclusive licensing of products for manufacturers to develop and market orphan medications

The Food and Drug Administration (FDA) has the responsibility to oversee the safety of

food, drugs, medical devices, vaccines, blood, biologics, veterinary products, cosmetics, radiation-emitting produts, and tobacco are safely produced for public.

The United States Pharmacopeia has the responsibility

for establishing requirements for labeling of medications, whether they are in a multi dose vial or unit-dose container, an IV admixture, or compound.

Goals of the Drug Supply Chain Security Act?

goals of the drug supply security act allow -allow verification of the authenticity of the drug product identifier down to the package level -improve detection and notification of illegitimate products in the drug supply chain -allowance for more well-organized recalls for drug products.

Isotretinoin (Accutane)

is a very powerful medication used to treat acne. unfortunately, the medication has been found to cause severe birth defects; induce spontaneous abortions; and produce adverse psychiatric efects, including depression, psychosis, suicidal ideation, suicide attempts, and suicide. it is only to be used for severe recalcitrant nodular acne unresponsive to other meds

OSHA (Occupational Safety and Health Administration)

is responsible for insuring safe working conditions

American Pharmacists Association (APhA)

is the organization whose goal is to improve medication use and advance patient care, and advocate for the practice of pharmacy regardless of the setting

What is the difference between (USP<797>) and (USP<795>)

non-sterile compounding (USP<795>) and sterile compounding (USP <797>)

the USP established standards for?

non-sterile compounding (USP<795>) and sterile compounding (USP <797>)

The Comprehensive Drug Abuse and Control Act of 1970

put controlled substances in 5 categories. schedule 1 through 5

DEA Form 222

regular form when ordering schedule II medications

DEA Form 106

report of theft or loss of controlled substances

Kefauver-Harris Amendment of 1962

• Also known as the "Drug Efficacy Amendment". - established procedures for both drug applications and investigational drugs - rug manufacturers are require to be responsible for good manufacturing processes