FEDERAL LAW QUESTIONS Flashcards
(119 cards)
1
Q
What was the first law to prohibit the distribution of food and drugs that are misbranded or adulterated?
A
Pure Food and Drug Act of 1906 prohibits the distribution of food and drugs that are contaminated (adulterated) or contain labeling that is misleading or incorrect (misbranded).
2
Q
What is the system that can be used as an electronic substitute for DEA Form 222 when ordering Schedule II controlled substances?
A
Controlled Substance Ordering System or CSOS is a secure electronic substitute for a physical DEA Form 222 to order Schedule II controlled substances.
3
Q
What federal agency is responsible for overseeing the federal Controlled Substances Act (CSA)?
A
The DEA (Drug Enforcement Administration) oversees the federal CSA (Controlled Substances Act).
4
Q
Which resource determines the bioequivalence of drugs?
A
The Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations) is the primary source for determining the therapeutic equivalence of drugs.
5
Q
Which resource can be used to determine if biological products are considered biosimilars?
A
The Purple Book provides a list of biological products considered biosimilars and provides interchangeability evaluations for biologics.
6
Q
When ordering Schedule II controlled substances, who keeps the original DEA Form 222?
A
The purchaser (pharmacy) fills out and submits the DEA Form 222 to order Schedule II controlled substances and submits the original DEA Form 222 to the supplier. The supplier obtains and keeps the original DEA Form 222 for their records. The purchaser makes and retains a copy of the original DEA Form 222 for their records. These records can be physically or electronically retained by the purchaser.
7
Q
Which DEA form should be completed to report theft or significant loss of controlled substances?
A
DEA Form 106 should be filled out and submitted to the DEA upon discovery of theft or significant loss of controlled substances. A copy of the DEA Form 106 should be retained in pharmacy records. The DEA should be contacted immediately by phone, fax, or brief written message about the theft/loss. Local authorities should also be alerted.
8
Q
What is the first application that must be submitted to the FDA before a drug can be administered to humans in order to start testing?
A
An IND (Investigational New Drug Application) must be submitted to the FDA before testing can begin in humans. The IND must not have been marketed in the US prior to the application. The FDA has 30 days to approve or reject the application. If approved, human testing can begin for the new drug.
9
Q
Which phase of clinic drug trials determines efficacy?
A
Phase II
10
Q
Clinical Drug Trial Phases
A
Clinical Drug Trials are used for new drugs that have not been marketed before. Trials are conducted in 4 phases.
- Phase I assesses drug properties like pharmacokinetics and adverse effects. Conducted in a small group of healthy participants.
- Phase II assesses the efficacy of the drug compared to current standard of care or placebo.
- Phase III provides a more comprehensive understanding of potential risks and benefits of the new drug. Conducted in a larger group of participants.
- Phase IV is post-marketing surveillance of the new drug that gathers information about problems and adverse effects with the drug after it has been released and marketed.
11
Q
Which act regulates the sale and record-keeping requirements of prescription drug samples?
A
The Prescription Drug Marketing Act of 1987 (PDMA):
- regulates the sale and record-keeping requirements for prescription drug samples.
- regulates storage, distribution, and resale of drug samples.
- enforces record-keeping requirements of drug samples.
- prohibits hospitals and other healthcare entities from reselling drugs to other businesses. Hospitals get special rates for drugs.
- regulates state licensure or wholesalers.
12
Q
What application must be submitted for approval by a drug manufacturer to the FDA if the manufacturer wants to change the way a currently marketed drug is being produced?
A
A Prior Approval Supplement (PAS) must be submitted to the FDA by a drug manufacturer of a currently marketed drug if the manufacturer would like to change the way a drug is produced including:
- location of manufacturing
- processes and procedures of manufacturing
- packaging of drug
- biosynthesis of drug
13
Q
Scenarios in which Schedule II controlled substances CAN be transferred
A
- a pharmacy is closing and wants to transfer its C2 inventory to another pharmacy.
- a pharmacy decides to not renew its DEA registration and decides to transfer its C2 inventory to another pharmacy.
- a pharmacy orders the wrong C2 controlled substance and would like to transfer the incorrectly ordered C2 to its supplier.
- a pharmacy would like to transfer X amount of bottles to another pharmacy.
- researchers authorized to use C2 controlled substances for research purposes only MAY transfer C2 controlled substances to another researcher authorized to use C2 controlled substances for research purposes only
14
Q
Research and C2 controlled substances
A
- researchers must be authorized to use C2 controlled substances to conduct research.
- researchers may transfer C2 CSs to another researcher that is authorized to conduct research with C2 CSs for the purposes of research only.
- researchers CANNOT dispense C2 CSs to patients or transfer C2 CSs to pharmacies.
15
Q
A patient is not satisfied with the way a pharmacy filled their prescription the first time it was filled and demands to have the prescription back so they can fill the prescription at another pharmacy. What can the pharmacist do for the patient in this scenario?
A
- the original pharmacy that filled the prescription at the first fill MUST retain the original hard copy as once it is filled and dispensed, the original pharmacy legally owns the prescription.
- the original pharmacy may transfer the remainder of the prescription to another pharmacy if it is allowed (RX has refills remaining, state transfer laws allow it to be transferred, etc.).
- the original pharmacy may provide a photocopy of the original prescription to the patient or provider if requested (this is not a valid prescription for the patient to give to another pharmacy, it is merely a photocopy of a prescription).
16
Q
What does it mean when a drug is considered adulterated?
A
Adulteration of a drug refers to the composition and integrity of the drug. If a drug’s composition or integrity is compromised, it is adulterated.
17
Q
What are some examples of adulteration?
A
- a drug is stored in unsanitary conditions
- a drug is not manufactured according to required manufacturing standards
- a drug contains an unapproved color additive
- a substance from the drug container leaches into the drug itself
- a drug contains less active ingredient than is listed on the product or is not pure
- a drug that contains a decomposed substance
18
Q
What was the first law enacted that required all new drugs to be proven safe before being marketed?
A
The Food, Drug and Cosmetic Act of 1938 (FDCA) was the first law that required all new drugs to be PROVEN SAFE for their labeled use before being marketed to patients.
19
Q
What set of regulations specify the minimum manufacturing standards for pharmaceutical products in the US?
A
GMP (Good Manufacturing Practice) specifies the minimum manufacturing standards for pharmaceutical products in the US. The purpose of GMP is to uphold and maintain the safety and quality of drug products.
20
Q
NDC
A
NDC stands for National Drug Code and is listed on pharmaceutical products. NDCs contain a set of 3 numbers.
For example: XXXX - YYYY - ZZ
- X = the first set of numbers contain 4 to 5 digits that indicate the manufacturer of the drug product
- Y = the second set of numbers contain 4 digits that indicate the specific drug product (active pharmaceutical ingredient)
- Z = the third set of numbers contain 2 digits that indicate the amount of drug in package / package size
21
Q
Schedule II (C2) controlled substance (CS) drug classes
A
C2 CSs are highly regulated due to their potential for abuse and misuse. Examples of C2 drug classes include but not limited to:
- amphetamines and dextroamphetamine salts
- methylphenidate and derivatives
- opioids and opiates
- PENTObarbital
- SECObarbital
- phencyclidine
22
Q
Federally, how many times can a prescription for lorazepam be refilled in a 6 month period?
A
On a federal level, C3 and C4 prescriptions can be refilled a maximum of 5 times within a 6 month period from the date written on the prescription hard copy.
Some states apply this rule to C5 prescription refills.
NYS DOES NOT ALLOW REFILLS ON BENZODIAZEPINES!!!
23
Q
Labeling Requirements for Manufacturer Drug/Product containers
A
Labeling requirements for manufacturer containers of drugs include:
- name and address of manufacturer, packer or distributor
- name of drug or product
- net quantity contained in package
- weights for each active ingredient
- route of administration (ROA) directions for NON-ORAL meds
- ROA DIRECTIONS ARE NOT REQUIRED ON MFR CONTAINER LABELING FOR ORAL MEDS!
- expiration date
- LOT # / MFR control #
- special storage instructions if necessary
- Federal Legend: ‘RX only’
24
Q
Maximum BUD (beyond-use date) for compounded products
A
- Water-containing ORAL formulations when stored in the refrigerator have a max BUD of 14 days
- Non-water containing formulations have a max BUD of 6 months
- Water-containing topical, dermal, mucosal liquid and semisolid compounds have a max BUD of 30 days
Drugs or chemicals known to be labile to decomposition will require shorter BUDs.
The max BUD on ANY compounded product cannot exceed the expiration date of the API (active pharmaceutical ingredient) or any other component in the product.
25
**Midlevel Practitioners**
**Midlevel practitioners** are individual practitioners that are **NOT** *physicians (including ophthalmologists), veterinarians, dentists or podiatrists.*
**Midlevel practitioners** *include, but not limited to:*
- **nurse practitioners (NP)**
- **physician assistants (PA)**
- **nurse midwives**
- **nurse anesthetists**
- **clinical nurse specialists**
- **optometrists** *(ophthalmologists are physicians)*
- **registered pharmacists (RPh)**
- **chiropractors**
- **homeopathic physicians**
26
*Standards* for **DME** *(durable medical equipment)*
- **long-term use**
- **maintain integrity with repeated use**
- **may be used at home**
- **primarily used for medical purposes**
Examples of DME: *wheelchairs, prosthetics, canes, crutches, oxygen, ventilation, hospital beds, etc.*
27
What is the **CSRPA** *(Controlled Substances Registrant Protection Act of 1984)*?
CSRPA **protects DEA registrants from certain crimes** and **provides federal investigation** if *any of the following are met:*
- **theft/loss of CSs is $500 or more**
- **an employee is seriously injured or killed during theft/loss**
- **interstate or foreign commerce is involved in execution of theft/loss**
If found guilty, perpetrators may be subject to fines or imprisonment.
**Loss of CSs during drug transport to pharmacy are NOT protected under CSRPA.**
28
What act *requires* that **patients are offered counseling on dispensed medications?**
**OBRA 90** *(Omnibus Budget Reconciliation Act of 1990)* **REQUIRES patients to be offered counseling on dispensed medications.** *Patients may refuse the offer of counseling*, but **must always be offered counseling on dispensed medications.**
29
**Isotretinoin**
**Isotretinoin** is *used to treat severe acne.* It is *known to cause birth defects in pregnant individuals.* Because of this, **Isotretinoin dispensing is regulated** through a **REMS program** *(Risk Evaluation and Mitigation Strategy)* called **iPledge.**
- **Physicians must be registered with iPledge to prescribe isotretinoin.**
- **Patients must be registered with iPledge to receive Isotretinoin.**
- **Pharmacies must be registered with iPledge to dispense Isotretinoin.**
- **Prescriptions for isotretinoin cannot have refills and can only be dispensed for a maximum of 30 day supplies.**
- *Patients that can get pregnant* **must use at least 2 effective forms of birth control 1 month before, during and 1 month after treatment** and **take pregnancy tests every month that show they are not pregnant during treatment.**
30
**Drug compounding rules**
*Compounded drugs:*
- **cannot be compounded, provided or sold to pharmacies, healthcare entities or other third parties.**
- **cannot be commercially available.** *In this case, you would be able to order the compounded drug as is because it is commercially available.*
- **must meet national standards.**
- **must be made at a reasonable quantity that reflects current or anticipated prescriptions.**
- **distribution cannot exceed 5% of the pharmacy’s total prescriptions filled per year.**
- **can be used to customize a medication pursuant to a valid prescription,** such as *modifying the strength of a drug, removing an allergic component, changing the dosage form, or adding flavoring to a medication.*
31
What form is *required* to **purchase or transfer C2 CSs?**
**DEA Form 222 is required to *PURCHASE* or *TRANSFER* C2 CSs.**
32
Can CS prescriptions be **mailed** to patients?
**Yes, CS prescriptions can be mailed to patients** as long as the following criteria are met:
- **must be in a package that has an *inner package* that contains the prescription with appropriate labeling.**
- **the outer package must be *plain* that does *not* contain any information about the contents of the package.**
33
What are **NTI *(narrow therapeutic index)* drugs?**
**NTI drugs** are drugs where a *small change in dose or blood concentration may lead to serious adverse reactions or treatment failure.*
**NTI drugs** *require careful titration and/or careful monitoring to ensure safe and effective use.*
The FDA recommends that *NTI drugs’ potency have a variability limit of 90% - 105% when manufactured.*
Examples of NTI drugs include **phenytoin, warfarin, levothyroxine, lithium carbonate, digoxin, cyclosporine.**
34
What act *requires* that prescription drugs, nonprescription drugs and hazardous household items have a **child-resistant closure?**
**The Poison Prevention Packaging Act** *(PPPA)* requires that **prescription drugs, nonprescription drugs and hazardous household items have a *child-resistant closure* to prevent accidental ingestion or exposure to children under 5 years of age.** *Patients may request that their prescription bottles NOT have a child-resistant closure.*
Some drugs are *exempt from PPPA* including: **SL nitroglycerin tablets, SL or chewable isosorbide dinitrate, oral contraceptives in mnemonic packaging, medications in dose packs like Medrol and ZPaks.**
35
**Drug Recalls**
There are **3 classes of drug recalls:**
1. **Class I drug recalls** occur when a **product is *likely to cause serious or irreversible adverse effects* including death.**
2. **Class II drug recalls** occur when a **product is *likely to cause temporary or reversible adverse effects* where the potential for serious adverse effects is low.**
3. **Class III drug recalls** are **voluntary drug recalls by the manufacturer** where the *potential for adverse effects from the product is low or nonexistent* but *contain issues with labeling, etc.*
36
**Clinical Trials**
Clinical trials are conducted in **4 phases:**
1. **Phase I clinical trials** are conducted in a *small group of participants without the disease.* The **goal of Phase I is to study drug properties** like *adverse effects and pharmacokinetics,* and determine **safety** of drug.
2. **Phase II clinical trials** are conducted in a *larger group of participants with the disease.* The **goal of Phase II is to determine the effectiveness/efficacy of the drug** and *further study drug safety and properties.*
3. **Phase III clinical trials** are conducted in a *larger group (100s to 1000s) of participants with the disease.* The **goal of Phase III is to determine dosing of the drug** and *further study safety and efficacy of the drug.* **If a drug passes Phase III, the FDA can approve the drug.**
4. **Phase IV clinical trials** are **post-marketing surveillance.** The **goal of Phase IV is to study the *long-term efficacy and safety* of the drug.**
37
**Reimportation of drugs back into the US**
**Reimportation of drugs back into the US** is *ONLY* permitted by the **ORIGINAL MANUFACTURER.** Reimportation of drugs back into the US is **only permitted for the purposes of emergency medical care.** *Otherwise, Reimportation of drugs back into the US is never allowed.*
38
What law required drugs to be proven **safe and effective** before the drug is approved and marketed?
The **Kefauver Harris Amendment** required **manufacturers to prove their drug was both *safe* and *effective* before drug approval and marketing.**
Before, the *FDCA only required manufacturers to prove drug safety before drug approval and marketing.*
39
**DEA Form 222**
Used by *pharmacies* to **order and transfer CI and CII CSs.**
40
**DEA Form 106**
Used by *DEA registrants* to **report theft/loss of CSs.**
41
**DEA Form 224**
Used by *pharmacies* to **register with DEA to be able to possess and dispense CSs.**
42
**DEA Form 225**
Used by *manufacturers, distributors, exporters, importers and researchers* to **register with DEA to conduct business with CSs.**
43
**DEA Form 363**
Used by *Narcotic Treatment Programs* to **register with DEA to conduct business with CSs.**
44
What information is *required* in **transaction reports** when drugs are *sold by manufacturers and received by pharmacies?*
Information required in a *transaction report* is **transaction history, transaction information, and a transaction statement** *(THIS).*
The **Drug Supply Chain Security Act** *requires manufacturers to provide a transaction report to pharmacies for every product sold.*
*Pharmacies are required to retain the transaction report and pass it along if the drug is further distributed* in order to **track the drug.**
**The transaction report** *must contain 3 parts:* **transaction history, transaction information and a transaction statement.** *(THIS)*
45
**Class I Drug Recall**
Drug is likely to cause **serious adverse effects or health consequences including death.**
46
**Class II Drug Recall**
Drug has a **low likelihood of causing serious adverse effects or health consequences** but may cause *temporary or reversible adverse effects or health consequences.*
47
**Class III Drug Recall**
Drug is **not likely to cause adverse effects or health consequences.**
48
What act *requires* **healthcare facilities to report patient deaths or injuries *caused by or suspected to be caused by* a medical device?**
The **Safe Medical Device Act *(SMDA)* of 1990** *requires* **healthcare facilities to report death or injury *caused by or believed to be caused by* a medical device.** *The purpose of this is to **track the medical device** and **possibly recall the product** to prevent further death and injury.*
49
What is **misbranding?**
*Misbranding* occurs when there is **inaccurate labeling on the drug container** such as *information is missing, untrue or inaccurate.*
50
What are some *examples* of **misbranding?**
False or misleading information.
Unreadable material.
Omitting a medication guide.
Inadequate directions or warnings.
Omitting required information.
51
**Methadone dispensing**
- **Retail pharmacies** can stock and dispense methadone *ONLY* if it is **prescribed for analgesia.**
- **Registered narcotic treatment programs** can stock and dispense methadone *ONLY* if it is **prescribed for maintenance or narcotic detoxification.** Dispensing at a narcotic treatment program can be for **short-term detoxification** *(up to 30 days)* or **long-term detoxification** *(30 to 180 days).*
52
**Orphan drugs**
*According to the FDA,* an **orphan drug** is a drug that is *intended to cure or treat* **rare diseases or conditions that affect less than 200,000 people.**
Manufacturers can achieve orphan drug designations if the cost to research, study and develop the drug is not expected to be regained by sale of the drug.
53
**Ingredients that have *special* labeling requirements**
The following ingredients have special labeling requirements because they have an *increased likelihood of cause adverse events like allergic reactions.*
**FD&C yellow no. 5 *(tartrazine - color additive),* wintergreen oil, mineral oil, alcohol, salicylates, aspartame, sulfites, ipecac syrup.**
54
**FAXED** *C2 prescriptions*
Faxed C2 prescriptions are *never* allowed **except** in the following cases where **faxed C2 prescriptions are permitted and serve as the original prescription:**
1. **Patient is in a LTCF** *(long-term care facility)*
2. **Patient is in hospice**
3. **Drug is to be compounded for direct patient administration** via *parenteral, IM, IV, SC, intraspinal infusion (including home infusion therapy)*
55
**Voluntary Adverse Event Reporting Systems**
**FAERS** *(FDA Adverse Event Reporting System)* is a *voluntary* database to *report adverse events* caused by **medications** to provide *post-marketing surveillance.*
**VAERS** *(Vaccine Adverse Event Reporting System)* is a *national vaccine safety surveillance program run by the CDC and FDA* to *report adverse events* caused by **vaccines.**
56
**Oral *(Telephone/Called-In)* C2 Prescriptions**
Telephoned in C2 prescriptions are *allowed* in **emergency situations only.**
**The pharmacist must immediately reduce the order to writing. The quantity should be enough to cover the emergency.**
**A hard copy from the provider that authorized the emergency order must be received by the pharmacy *within 7 days* of the emergency telephone order.** *Hard copies postmarked within the 7 day period are allowed.*
*Once the hard copy is received,* **the pharmacist must write on the front *”AUTHORIZATION FOR EMERGENCY DISPENSING”* and the date of the oral telephone order.**
**If a hard copy is not received within 7 days, the pharmacy must report the provider to the DEA.**
57
**Orange Book**
The **Orange Book** provides information about **therapeutic equivalency and interchangeability ratings between drugs that are not biologics.**
58
**Purple Book**
The **Purple Book** provides information about **bioequivalence and interchangeability ratings between biologics.**
59
**Red Book**
The **Red Book** provides information about **drug pricing and packaging information.**
60
**Yellow Book**
The **Yellow Book** provides information about **international travel health concerns** like *vaccines, diseases and health risks when traveling.*
61
**Pink Book**
The **Pink Book** provides information about **immunizations** like *vaccine safety, vaccine-preventable diseases, etc.*
62
**Exact Inventory Counts**
**Exact inventory counts** are *required* when:
- **all CI and CII CSs**
- **any CS in a bottle that contains 1000 or more tablets/capsules**
- **any unopened/sealed CS stock bottle**
63
*Who* is responsible for the **scheduling for controlled substances?**
At a *federal level*, the **US Attorney General** *(as the US AG is the head of the US DOJ which the DEA is part of),* is **responsible for adding, deleting and rescheduling CSs** *with recommendations from the FDA.*
64
**DEA number verification**
AB1234567
1. Add the 1st, 3rd and 5th digits in the DEA number.
2. Add the 2nd, 4th and 6th digits in the DEA number. *Then, multiply this number by 2.*
3. Add together the products from steps 1 and 2. *((1st+3rd+5th)+((2nd+4th+6th)x2))*
4. **If the DEA number is valid, the last digit from step 3 *should* be the 7th digit in the DEA number.**
*The first letter indicates the type of DEA registrant and the second letter indicates the first letter of the DEA registrant’s last name/first letter of healthcare facility.*
65
*Who* is *authorized* to **sign and execute a DEA 222 form in a *community* pharmacy?**
In a *community pharmacy,* **the most recent signer of the DEA registration, or DEA registration renewal, is authorized to sign, date and execute a DEA 222 form *(usually a pharmacist or the pharmacy manager)* to order C2 CSs.**
This person **may *grant power of attorney (POA)* to others so they can also sign, date and execute 222 forms.**
**The most recent signer of the DEA registration renewal grants POA to others** *by signing the POA themselves, the person being granted POA signing, and 2 witnesses.*
66
Who **regulates advertising of OTC drugs?**
The **Federal Trade Commission** *(FTC)* **regulates OTC drug advertising.**
67
Who **regulates advertising of RX drugs?**
The **FDA regulates advertising of RX drugs.**
68
What **records** *may be kept* at a **central location** that is *not the address registered with the DEA?*
**Shipping and financial data records for CSs may be kept at a central location** that is not the location listed on the pharmacy’s DEA registration *only after notifying the local DEA Diversion Field Office.*
69
What **records** *must* be **retained at the location that is registered with the DEA** *(not at a central location that is not on the DEA registration)?*
The following records **must be retained by the pharmacy** *(location on DEA registration)* and **NOT** *at a central location:*
• **CS inventories**
• **CS prescriptions**
• **Executed DEA Form 222 orders**
70
A patient is hospitalized and does not remember the medications they are currently taking. A hospital nurse calls the patient’s local pharmacy to obtain a medication list. **Does this violate HIPAA?**
**No. PHI *(protected health information)* may be shared among people directly involved in the patient’s care *without receiving verbal or written consent* from the patient.**
71
The *warning* **”Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed”** is **required on labels** of which prescriptions?
The **Federal Transfer Warning** is **required only on *C2, C3 and C4* prescription labels.**
*Most pharmacies affix this warning to **all prescription labels** (C5 and non-control prescription labels also), but is only required on C2, C3 and C4 prescription labels.*
72
What can pharmacies that register with *FDA* as an **outsourcing facility** do?
Pharmacies that register with the *FDA* as an **outsourcing facility** *(503B entity)* **can compound sterile products *without a patient-specific prescription order* from a prescriber.**
**Outsourcing facilities** are *regulated by the FDA* and **must follow current good manufacturing practices.**
**Products compounded at OSFs can *only* be distributed to healthcare facilities or directly to a patient or prescriber.**
Products compounded at OSFs **cannot be sold to wholesalers for redistribution.**
73
According to *Federal law,* how can **paper prescriptions be filed?**
*Federal law* allows 3 ways to file paper prescriptions:
1. **C2 paper RX file, C3-C5 paper RX file, C6 paper RX file**
2. **C2-C5 paper RX file** *with red ‘C’ markings on C3-C5 prescriptions*, **C6 paper RX file**
3. **C2 paper RX file, C3-6 paper RX file** *with red ‘C’ markings on C3-C5 prescriptions*
*Follow state paper prescription filing laws if they are stricter.*
**Electronic prescriptions may be stored electronically and be readily retrievable.**
74
What is the purpose of **USP chapters**?
USP chapters detail the **requirements for compounding** including *responsibilities of personnel, training, facility management, storage of compounds, environmental monitoring and testing.*
75
**USP 795**
**USP 795** details requirements for **nonsterile compounding.**
76
**USP 797**
**USP 797** details requirements for **sterile compounding.**
77
**USP 800**
**USP 800** details requirements for the **safe handling of hazardous drugs.**
78
Who is **required** to **register with the DEA?**
**Any person or entity that is involved in *distributing, dispensing or manufacturing CSs* must register with the DEA.** *(Manufacturers, physicians, pharmacies, distributors, etc.)*
*Pharmacists do not need to register with the DEA as the pharmacy is registered with the DEA.*
79
**Clozapine REMS Program**
**Clozapine** can cause *severe neutropenia which can lead to fatal infections and death.* **There is a REMS program for clozapine to ensure patients receiving clozapine are not neutropenic and are taking the drug safely.**
**Prescribers *must* be certified in the Clozapine REMS Program to prescribe clozapine.**
**Pharmacies *must* be certified in the Clozapine REMS Program to dispense clozapine.**
80
What is **DEA Form 41** used for?
**DEA Form 41** is used to **document the destruction of CSs.**
Oftentimes, *pharmacies will transfer CSs they would like to destroy* to an **authorized reverse distributor.** In this case, the **authorized reverse distributor will fill out the DEA Form 41 to document the destruction of CSs.**
81
What act **set the requirements for tamper-evident packaging** *on some OTC products?*
The **Federal Anti-Tampering Act** *requires* some **OTC products and cosmetics to have tamper-evident packaging to avoid contamination of the product and minimize access.** With this, *if a product has been tampered with, it would be obvious with the tamper-evident packaging.*
*Examples of tamper-evident packaging include tamper-evident closure caps, tape, linings.*
82
**Schedule I CSs**
**Schedule I CSs currently have no accepted medical use and have a high potential for abuse and dependence.**
Examples include *heroin, LSD, mescaline, methaqualone, etc.*
83
**Required information on *OTC product* container labeling**
Information that is **required** to be on OTC product container labeling by Federal Law:
• **identity of product (active ingredient)**
• **inactive ingredients**
• **purpose**
• **uses**
• **directions**
• **warnings**
• **storage information**
Information that is *usually* on OTC labeling but **not required by Federal Law:**
• net quantity of ingredients
• name/address of manufacturer/packager/distributor
• lot #/batch code
• **expiration date** *is **not required** to be on OTC product labeling*
• instructions in case of overdose
• **Poison Control Center phone number** is **not required on OTC labeling**
84
**Patient Package Inserts (PPIs)**
**PPIs are *required* for *patients in acute care settings and LTCFs* prior to first administration and every 30 days thereafter.**
**PPIs are required for oral contraceptives and estrogen-containing products.**
85
**How long are DEA registrations to possess CSs valid?**
**DEA registrations to *possess CSs* are valid for *36 months* (pharmacies, distributors, manufacturers, importers, exporters, researchers).**
*Renewal notices are sent out by DEA **60 days prior** to expiration.*
86
**DEA Form 222 Rules and Procedures**
- **Executed copies of DEA Form 222 must be maintained separately from all other records per record keeping requirements.** *If copies of executed DEA Form 222 are filed **electronically,** these electronic copies are deemed **separate if they are readily retrievable** from all other records.*
- **Defective DEA Form 222 / DEA Form 222s with errors *cannot be corrected* and *must be replaced with a new DEA Form 222* in order to place an order for C2 CSs.**
- *When filling out a DEA Form 222,* **only 1 item may be entered per numbered line.**
87
**What does *HIPAA* stand for?**
**Health Insurance Portability and Accountability Act**
88
If a pharmacy would like to mail refill reminder communications to patients for a fee of $2/month, *would this be a violation of HIPAA?*
**No. Under the *HIPAA Privacy Rule,* a communication to an individual *is not considered marketing* if it is for treatment of the patient. Therefore, *a refill reminder for a medication a patient is currently taking (or a medication that has not lapsed over 90 days)* is NOT considered marketing and is NOT a violation of HIPAA.**
*Patients may be charged a fee for this service if the fee charged to the patient is a reasonable amount for the pharmacy to cover the cost for this service.*
**Mailed and electronic communications such as refill reminders or anything related to the treatment of a patient is *NOT* a violation of HIPAA.**
*The **HIPAA Privacy Rule defines *marketing* as a communication about a product or service that encourages the recipient of the communication to PURCHASE the product or service.** An entity would need to get authorization from an individual to send out marketing communications.*
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What do **prospective DURs *(Drug Utilization Reviews)* consist of?**
A **prospective DUR** consists of **reviewing a prescription** for **adverse effects, therapeutic duplication, drug-disease interactions and contraindications, drug dosing and regimen, drug allergies, clinical misuse or abuse, drug interactions, medication appropriateness, overutilization, underutilization and pregnancy/lactation alerts.** *Compliance with prescription labeling requirements is not part of a prospective DUR.*
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**Federal Hazardous Substances Act** *(FHSA)*
FHSA was enacted to **protect consumers from hazardous or toxic household products and certain OTC drugs. FHSA *requires* the precautionary statement *”Keep out of reach of children”* to be on the immediate packaging of hazardous household products and *certain OTC drugs like Tylenol.* This precautionary statement is *only required on certain OTC drugs* and not FDA regulated RX drugs.**
91
What is the **5% Rule**?
The **5% Rule** states that a **pharmacy *does not need to register with the DEA as a distributor* if the *total quantity of CSs distributed in a 12 month period* does *not* exceed 5% of the pharmacy’s total amount of CSs dispensed or distributed.**
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What is **OSHA *(Occupational and Safety Health Administration)*?**
**OSHA** *requires* that **employers meet the *Hazardous Communication Standard* which includes having a *Hazardous Communication Plan* that *lists all of the hazardous chemicals in the workplace* and *ensuring all hazardous chemicals are appropriately labeled and have a Safety Data Sheet*.**
**OSHA** also *requires* that **employees are *trained on the hazards of chemicals, appropriate protective measures and where to find more information*.**
**OSHA is meant to protect employees.**
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*Which agency administers* the **PPPA (Poison Prevention Packaging Act)** which **requires *certain RX and non-RX drugs* to have *child-resistant containers*?**
The **Consumer Product Safety Commission** is responsible for administering **PPPA.**
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If a **pharmacy** were to **order bulk bottles of ibuprofen *to compound ibuprofen suppositories* and *sell the ibuprofen suppositories to pharmacies* that need to fill ibuprofen suppository prescriptions but do not have the ability to make them, *what would the original pharmacy be considered*?**
The **pharmacy *compounding ibuprofen suppositories in bulk quantities* and *selling the product to other pharmacies without a patient-specific prescription* would be considered *MANUFACTURING* which is *regulated by the FDA*.**
*This would be considered **COMPOUNDING** if the pharmacy was making ibuprofen suppositories **pursuant to a patient-specific prescription** and **only compounding enough product to satisfy the need for that prescription** (not in large quantities). **Compounding pharmacies are regulated by state boards of pharmacy**.*
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**Purchasing and Selling Prescription Drug Samples**
The **PDMA** *(Prescription Drug Marketing Act)* **bans most pharmacies from purchasing, trading, selling or possessing prescription drug samples.**
The **only exception** to this ban is for **pharmacies that are run by a *charitable organization* or a *city, county or state government that is part of a healthcare entity that provides care to indigent or low-income patients at reduced or no cost*. These pharmacies *may provide prescription drug samples to patients at no cost*.**
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**Is there a DEA form needed for a pharmacy to order C3-C5 CSs?**
**No.** *Ordering of C3-C5 CSs does not require a DEA form. C3-C5 CSs may be purchased via the pharmacy’s drug supplier (in no way different than how a pharmacy would order non-CS prescription drugs). The pharmacy would acknowledge the receipt and quantities of C3-C5 CSs received on the supplier’s invoice for the pharmacy’s order.*
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**DEA Form 222**
**DEA Form 222 is *required by pharmacies* to *order and transfer C2 CSs*.**
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**DEA Form 224**
**DEA Form 224** is **required by pharmacies to *dispense CSs*.**
99
Which *OTC drug products* **do NOT require tamper-evident packaging?**
*Most OTC drugs require tamper-evident packaging.* **Exceptions to the anti-tampering evident packaging for OTC drugs are *dermatologic and dental products, insulin and lozenges*.**
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**Changes that *CAN BE* made to C2 prescriptions**
**With *verbal authorization from the prescriber*, a pharmacist *may change the drug quantity, drug strength, directions for use and drug form* to a C2 prescription with an annotation on the original prescription.**
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**Changes that *CAN NOT* be made to C2 Prescriptions**
A pharmacist **CAN NOT CHANGE** *patient name, drug name or prescriber name* on a C2 prescription even with a prescriber’s verbal authorization.
102
**How much time** *does a pharmacy have to complete a patient’s request for their PHI (like pharmacy records)?*
*A pharmacy has **30 days** to complete a patient’s request for their PHI (like pharmacy records).*
*If a pharmacy cannot complete the patient’s request within 30 days, the pharmacy must notify the patient of the delay and reason for the delay and are able to have an additional 30 days to complete the request.*
Most pharmacies are able to provide PHI to patients (like pharmacy records) at the time of the request.
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**Thalidomide**
**Thalidomide** is an immunomodulatory and chemotherapy drug that can cause a *high frequency of birth defects in pregnant female patients.* **Thalidomide has a REMS program** to ensure safe use and monitoring.
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**Which law *requires new drugs* to be *proven both safe and effective before approval*?**
The **Kefauver-Harris Amendment** *requires that new drugs be proven **both safe and effective** before approval.*
This amendment is also known as the *Drug Efficacy Amendment*.
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**Kefauver-Harris Amendment**
The **Kefauver-Harris Amendment:**
- *requires that new drugs be proven both safe and effective before drug approval*
- *AKA ‘Drug Efficacy Amendment’*
- *allows FDA to establish GMP (good manufacturing practices)*
- *gives FDA control of prescription drug advertising that must include accurate information regarding a drug’s side effects*
- *controls marketing of generic drugs so they are not sold under a different trade name for more money $$$$*
106
**Anabolic steroids** are classified under which *CS schedule under Federal Law?*
*Anabolic steroids like testosterone **under Federal Law are C3 CSs**.*
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What is the **Durham-Humphrey Amendment**?
The **Durham-Humphrey Amendment** separated drugs into **prescription (legend)** and **OTC** drugs.
**Prescription drugs** *require* a **prescription** and *can only be dispensed under medical supervision.*
**OTC drugs** *do NOT require a prescription or medical supervision.*
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**FDA Bioequivalence Rating System**
The **FDA Orange Book** uses a **2-letter coding system to indicate the bioequivalence and interchangeability between 2 drug products. *The first letter is key* in interpreting the bioequivalence and interchangeability of 2 drugs.**
*If the **first letter is ‘A’,** the 2 drug products are considered to be **pharmaceuticals and therapeutically equivalent and can be interchanged**.*
*If the **first letter is ‘B’,** the 2 drug products are **NOT equivalent** and therefore **should *NOT* be interchanged**.*
The **second letter indicates the dosage form.** *For example, a rating of AT is a topical product that is therapeutically equivalent and interchangeable with the drug it is being compared to.*
A rating of **’AB’** indicates *there are known or potential equivalency issues* but **there is adequate scientific data to support the safe and appropriate interchangeability between the products being compared.**
109
If a bottle’s labeling states loratadine 10mg tablets but there are loratadine 5mg tablets inside the bottle, is this product considered *adulterated, misbranded or both?*
**Both adulterated and misbranded.**
An **adulterated** product is any product that’s **strength or quality *differs from what it represents*.** (The bottle states 10mg tablets are inside the bottle but there are actually 5mg tablets inside the bottle. The strength differs from what it says is in the bottle and what is actually in the bottle, therefore this is **adulterated.**)
A **misbranded** product is a product that’s **labeling is false or misleading.** (The bottle’s labeling states 10mg tablets are inside but there are actually 5mg tablets inside the bottle which is *both false and misleading*, therefore this is also **misbranded.**)
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**Easy Open Cap Requests on Prescription Bottles**
**Only patients can provide a *blanket* request that all their prescription bottle have an easy open cap.** *If a patient makes this request, the pharmacy should document it in case an issue arises later.*
*Providers can also make a verbal or written request that a prescription have easy open caps on a patient’s behalf*, but **a provider’s request that a patient’s prescription is ONLY VALID FOR THAT SINGLE PRESCRIPTION - PROVIDERS CANNOT MAKE A BLANKET REQUEST FOR EASY OPEN CAPS on a patient’s behalf.**
111
What is the *purpose* of **REMS?**
**REMS** *(Risk Evaluation and Mitigation Strategies)* are **strategies to manage known or potential serious risks associated with a drug.**
*REMS has nothing to do with the affordability of a drug.*
112
What is the **maximum amount of tablets allowed in OTC 81 mg ASA chewable tablets (1.25 grain)?**
**36 tablets of 81mg (1.25 grain) ASA chewable tablets is the maximum amount of tablets that can be in an OTC bottle as 36 tablets is the maximum amount that a child could accidentally ingest and it would be considered nontoxic.**
Federal regulations require labeling on OTC aspirin and other salicylate products of the potential of Reye’s Syndrome in children and warnings like “Keep out of reach of children. In case of overdose, get medical help, or contact a Poison Control Center right away.
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**DEA Registration Number Letters**
DEA Registration numbers start with *2 letters*.
The **first letter indicates practitioner status.** *For example, a first letter of A or B is a physician, and a **first letter of M is a mid level practitioner**.*
The **second letter is the *first letter of the practitioner’s last name, the first letter of the pharmacy name or the first letter of the hospital name*.**
**How to verify *7 digits in a DEA number*:**
1. Add first, third and fifth digits.
2. Add second, fourth and sixth digits. Multiply this product by 2.
3. Add products of step 1 and step 2 (step 2 being multiplied by 2).
4. The second digit of the product of step 3 should be the seventh digit in the DEA number if it is valid.
114
The **FDA requires Medication Guides (Med Guides) are provided with certain prescription drugs and biologics** *for what reasons?*
*The FDA requires Med Guides for certain prescription drugs and biologics are provided if they determine that:*
- **a drug has has serious risks over benefits**
- **patient adherence is crucial to the effectiveness of a drug**
- **there are known serious side effects of a drug**
- **providing information about a drug can prevent serious adverse effects**
**FDA Med Guides do *not* replace pharmacist counseling of a drug.**
115
What *information can be gathered* from an **NDC number**?
**NDC numbers** are *comprised of **3 sets of numbers**:*
The *first set of numbers* indicates the **drug manufacturer.**
The *second set of numbers* indicates the **specific drug.**
The *third set of numbers* indicates the **packaging/package type/package size.**
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**Drugs that are *exempt* from child-resistant packaging requirements**
• **sublingual nitroglycerin tablets**
• **methylprednisolone containing no more than 84mg per package** (Medrol dose packs = 4mg x 21 tablets per dose pack)
• **preparations in containers intended for inhalation** (inhalers)
• **prednisone containing no more than 105mg per package**
• **effervescent ASA or APAP tablets** (ASA and APAP tablets that are not effervescent are not exempt from child-resistant packaging)
117
According to *Federal Law*, **how long must prescription records be kept for?**
**Federal law requires that prescription records be kept for a minimum of *2 years*.**
*If state law requires that prescription records be kept longer than 2 years, follow state law.*
118
What is the **HIPAA Breach Notification Rule**?
The **HIPAA Breach Notification Rule** is part of the *HITECH Act (Health Information Technology and for Economic and Clinical Health Act)* which promotes health information technology to advance healthcare, especially electronic health records.
The *HIPAA Breach Notification Rule* **requires entities to notify affected individuals of health information breaches with no reasonable delay and no later than 60 days after the discovery of the breach.**
**Breaches of 500 or more records must be reported to the US Department of Health and Human Services (HHS) within 60 days of discovery of the breach and a notification to prominent media outlets in the state or jurisdiction in which the breach occurred.**
**Smaller breaches of 500 records or less require the HHS to be notified within 60 days of the end of the calendar year in which the breach occurred.**
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**How often** must *pharmacists perform DURs on long term care patients to comply with CMS (Centers for Medicare and Medicaid Services) requirements?*
To comply with CMS requirements, pharmacist must perform DURs on long term care patients **at least once a month.**
