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Supply Chain and Inventory Management > Module 1 CE Impact > Flashcards

Module 1 CE Impact Flashcards

Entities, Acts

1
Q

Prescription Drug

A

Rx or legend drug; need a presription

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2
Q

Over the Counter

A

May be purchased w/o a prescription

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3
Q

Compounding

A

Mixing, combining, altering of ingredients to make specific product dosage form or strength nor commercially available

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4
Q

Dispense

A

Supply drug to patient pursuant to a RX or drug order from a practitioner or prescriber

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5
Q

Distribute

A

Supply a drug to entity for sale, resale, dispensing, or administration

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6
Q

Supply Chain

A

Path drug takes from manufacturer to patient. Includes: Manufacturer, wholesale distributer, 3PL, 503B Outsourcing Facility, Reverse Distributor, etc..

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7
Q

Pharmacy

A

Obtains RX product and dispenses to patients pursuant to patient-specific RX or order. Hospital, Community, outpatient, mail order, nuclear, specialty, LTC, other

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8
Q

Wholesaler

A

Obtains product from manufacturer to distribute (sell) to other wholesalers, pharmacies, practitioners, health systems, and others appropriately registered.

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9
Q

Manufacturer

A

Makes drug from active ingredients, excipients and other components. May have own facility or virtual manufacturer.

may offer health care providers product education, patient support programs, and support with navigating insurance reimbursement

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10
Q

Third Party logistics Provider

A

3PL. Possesses but not owns. Act as warehouse, recieves product sent by manufacturer distributing orders directed by manufacturer

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11
Q

Product

A

Per “DSCSA” human Rx product in finished dosage form.. Some exceptions to definition

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12
Q

Transaction

A

Product transfer between persons in which a change of ownership occurs

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13
Q

Inventory

A

What is on hand to dispense

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14
Q

Group Purchasing Organization

A

Organization joins together several facilities to purchase products at a larger volume than each could on their own generating cost savings

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15
Q

Virtual Manufacturer

A

Owns drug but not possess drug. Outsources manufacturing to a contract manufacturing organization (CMO) utilized a 3PL for distribution. Includes repackager and relabeler

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16
Q

FDA

A

ensures the safety, efficacy, and security of food, drugs, biologics (e.g., therapeutic proteins, monoclonal antibodies, vaccines), radioactive products (e.g., sodium iodide, radium), medical devices, and cosmetics. Regulating the manufacturing, marketing, and distribution of tobacco products also falls under FDA’s purview. Also plays a role in the nation’s counterterrorism capability by ensuring food supply security and fostering medical product development to respond to public health threats

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17
Q

1906 Food and Drugs Act

A

passed to protect the consumer against dangerous and mislabeled drugs) allowed for the establishment of FDA.

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18
Q

DEA

A

regulates Controlled Substances, who sells and prescribes as well
Established 1973 to enforce CSA

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19
Q

Controlled Substance Registration Certificate

A

Form 223. Renew Q 3 years. Makes so you can handle Controls

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20
Q

CI

A

No medical approved use. High abuse potential.

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21
Q

CII

A

High abuse potential. May lead to severe psych or physical dependence.

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22
Q

CIII

A

potential for abuse less than CII. may lead to moderate or low physical dependence or high psych dependence

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23
Q

CIV

A

low abuse potential compared to CIII

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24
Q

CV

A

low abuse potential compared to CIV.

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25
Q

Combat Meth Epidemic Act 2005

A

CMEA put restriction on daily and monthly purchase of certain OTCs. Required to self certify.

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26
Q

State Board of Pharmacy

A

License or register those working in pharmacy, dispensing to patients, may posess RX drugs, supply chain entities, responds to complaints

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27
Q

FD&C Act 1938

A

authorized FDA to demand safety evidence for new drugs, issue standards for food, and conduct factory inspections

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28
Q

Kefauver-Harris Amendments of 1962

A

mandated efficacy and safety data before a drug could be marketed; established stricter FDA control over drug trials; allowed FDA to regulate prescription drug advertising; established good manufacturing practices by the drug industry; granted FDA greater power to access manufacturer’s records to verify those practices

29
Q

Clinical Trial Phase 1

A

20-100 healthy volunteers or people with the disease/condition, Several months, Safety and dosage

30
Q

PDMA 1987

A

Ensure drugs safe and effective, avoid unacceptable risk to consumers from
counterfeit misbranded adulterated subpotent or expired drugs. added restrictions on sale of RX and samples. Required wholesalers be registered in the state meet uniform standards

31
Q

DCSCA

A

Title II of Drug Quality and Security Act 2013 Further protects patients from counterfit, stolen, contaminated or otherwise harmful drugs. Requires interoperable package level tracing. required FDA to establish national licensure standards for wholesalers and 3PL reporting requirements

32
Q

Track and Trace Exemption

A

Veterinary drug products; Blood or blood components intended for transfusion; Radioactive drugs or radioactive biological products; Imaging drugs; Intravenous products intended for the replenishment of fluids and electrolytes (such as sodium, chloride, and potassium) or calories (such as dextrose and amino acids); Intravenous products used to maintain the equilibrium of water and minerals in the body, such as dialysis solutions; Products intended for irrigation, or sterile water, whether intended for such purposes or for injection; Any medical gas; Homeopathic drugs; Active pharmaceutical ingredients (APIs) used in compounding; Preparations compounded by a 503A Compounding Pharmacy or a 503B Outsourcing Facility

33
Q

Active Pharmacutical Ingredient Repaker

A

API Repacker takes bulk powder APIs from the original manufacturer and packages it into smaller containers to distribute to drug manufacturers, outsourcing facilities, and compounding pharmacies.

34
Q

Reverse Distributor

A

unsaleable products from dispensers such as damaged products or expired products.

A reverse distributor does not sell or distribute products to wholesale drug distributors or dispensers. The reverse distributor may obtain credit for unsaleable products from the manufacturer and destroy the unsaleable products or send unsaleable products for destruction.

35
Q

503A Compounder

A

preparations for patient-specific prescriptions and is not allowed to compound commercially available products unless there is a clinically significant difference required.

36
Q

503B Outsourcing Facility

A

compounds preparations for office use. An outsourcing facility may NOT compound any commercially available product unless the product is documented as being in short supply. This is to alleviate shortages. An outsourcing facility must compound at least one sterile product but is allowed to compound both sterile and nonsterile products. The outsourcing facility must comply with CGMP

37
Q

Compounding Quality Act

A

CQA Title I of the Drug Quality and Security Act (DQSA) of 2013. The CQA separates out compounding for patient-specific prescriptions from compounding for office use or administration.

38
Q

current Good Manufacturing Practices

A

a standard required of manufacturers and much more stringent than USP sterile and nonsterile compounding standards.

39
Q

Transaction Data

A

T3 Transaction Information, History, Statements

40
Q

Transaction Information

A

Product name, strength, dosage form, NDC number, container size, number of containers, lot number, transaction date, shipment date (if >24 hours after the transaction date), business name and address of the original and new owner

41
Q

Transaction History

A

Statement including the transaction information for each prior transaction which can be traced back to the manufacturer

42
Q

Transaction Statement

A

States that the entity transferring ownership received the product, received transaction information and a transaction statement from the product’s prior owner, did not knowingly ship a suspect or illegitimate product, had systems and processes in place to comply with verification requirements, and did not knowingly provide false transaction information or alter transaction history

43
Q

Exemptions from Transaction Data

A

Intracompany distribution of products; Distribution of products among healthcare entities under common control; Distribution of products for emergency medical reasons or public health emergencies (does not include drug shortages); eDispensing a product to a patient; Distribution of product samples; Distribution of minimal quantities of product from a pharmacy to a practitioner for office use. “Minimal” is interpreted as less than or equal to 5% and may not be allowed by a state board of pharmacy. Pharmacies distributing larger quantities may also require licensure as a wholesaler and then transaction data requirements will apply.; Certain charitable organizations; Sale or merger of trading partners for the actual transfer of product ownership (transaction data received for those products originally must still be kept); Certain kits or devices that may include products

44
Q

Clinical Trial Phase 2

A

Up to several hundred people with the disease/condition, Several months to 2 years, Efficacy and adverse effects

45
Q

Clinical Trial Phse 3

A

300-3,000 volunteers with the disease/condition, 1-4 years, Efficacy and monitoring of adverse effects

46
Q

Clinical Trial Phase 4

A

Several thousand volunteers with the disease/condition, Post Marketing, Safety and efficacy

47
Q

New Drug Application

A

If early tests and preclinical and clinical research indicate that a drug is safe and effective for its intended use, This is filed with results from pre-clinical and Phase 1-3 clinical trials, Mist include: proposed labeling, safety updates, drug abuse information, patent information, any data from studies conducted outside the U.S., Institutional Review Board, compliance information, directions for use

48
Q

abbreviated new drug application

A

ANDA contains data which is submitted to FDA for the review and potential approval of a generic drug product. generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness. Instead, generic applicants must scientifically demonstrate that their product performs in the same manner as the innovator drug . To be approved, must demonstrate bioequivalence.

49
Q

Medical Product Safety Network

A

(MedSun) monitors medical device safety and effectiveness. requires hospitals, nursing homes, and outpatient treatment and diagnostic centers to report medical device problems that result in serious illness, injury, or death. Once an individual reports a problem, MedSun researchers work with each facility’s representatives to clarify and understand the problem. Each month, FDA publishes the MedSun newsletter to share information about medical device safety so clinicians can take preventive actions

50
Q

FDA Adverse Event Reporting System

A

(FAERS) is a database that contains adverse event reports, medication error reports, and product quality complaints resulting in adverse events that were submitted to the FDA. The database is designed to support the FDA’s post-marketing safety surveillance program for drug products. Based on an evaluation of the potential safety concern, the FDA may take regulatory action(s) to improve product safety (e.g., updating labeling information, restricting the use of a drug, communicating new safety information to the public, removing a product from the market). Health care professionals and consumers can submit electronic reports on a voluntarily basis, while manufacturers are required to report to FAERS

51
Q

Sentinel Initiative

A

launched in 2008, FDA is developing a new national system to identify possible safety issues more quickly. The system uses large existing electronic health databases (e.g., electronic health records, insurance claims databases) to monitor the safety of approved medical products in real time. will add to, not replace, FDA’s existing post-market safety assessment tools.

52
Q

MedWatch

A

medical product safety and adverse event reporting program to promote public safety.

publishes safety alerts for FDA-regulated products including OTC and prescription medications, biologics, combination products, medical devices, nutritional products, cosmetics, and food. website allows reports for serious adverse events, product quality problems, product use/medication errors, or therapeutic inequivalence/failures. Manufacturers are mandated to report adverse events through MedWatch; reporting by consumers, patients, and health care professionals is voluntary but strongly encouraged by FDA. Individuals can file reports online or by mail

53
Q

Controlled Substances Act of 1970

A

CSA bring those involved in the illegal growing, manufacturing, or distribution of controlled substances to the criminal and civil justice systems.14 DEA also recommends and supports programs aimed at reducing the availability of illicit controlled substances on the domestic and international markets

54
Q

Form 224

A

To register with DEA

55
Q

Form 223

A

Certificate of Registration

56
Q

Form 224A

A

Used to renew reg with DEA q 3 years
renewal notifications via email to registrants approximately 60 calendar days prior to their registration expiration date.

57
Q

Form 224b

A

Same as 224a but for chains

58
Q

Resource Conservation and Recovery Act in 1976

A

address increasing problems the nation faced from the growing volume of municipal and industrial waste

59
Q

EPA

A

authority to control the generation, transportation, treatment, storage, and disposal of hazardous waste by imposing strict standards through tracking and permitting. EPA authorizes states to operate their own hazardous waste programs when those programs are at least equal to and consistent with federal standards.

60
Q

Procedures for Non-Creditable Hazardous Waste

A

waste that is sent to a facility for incineration instead of a reverse distributor

place its hazardous waste pharmaceuticals in containers that are structurally sound, compatible with the contents, and prevent any leaks or spills.

If incompatible hazardous waste pharmaceuticals are commingled in a container, must manage the container so it doesn’t: have the potential to generate dangerous heat and/or pressure; emit any toxic or flammable substances; damage the container’s structural integrity; otherwise endanger human health and/or the environment

must be protected from unauthorized access and marked with the phrase “Hazardous Waste Pharmaceuticals.”

must ship hazardous waste to a designated facility via a hazardous waste transporter. EPA and DOT require all shipments accompanied by a manifest form.

61
Q

Hazardous Waste Manifest form

A

form is designed to track hazardous waste from the time it leaves the health care facility until it reaches the off-site waste management facility where it will be disposed of.

If signed copy of the shipping document from the owner of the facility within 60 days, must notify EPA. must provide a copy of the manifest along with an explanation of efforts taken to locate the hazardous waste and the results of those efforts.

must keep a copy of the signed shipping document for 3 years when hazardous waste is removed from the premises.

62
Q

Procedures for Creditable Hazardous Waste

A

waste that is unopened, undispensed, and unexpired or within 1 year of expiration and has a reasonable expectation of receiving manufacturer credit

EPA does not impose specific standards for how containers of creditable waste must be managed or labeled because they are in the original manufacturer packaging which is already labeled.

EPA believes that the risk of environmental release of creditable hazardous waste pharmaceuticals during transport is relatively low because of the form and packaging

63
Q

Country of Manufacture

A

FDA, the country where the final formulation of a drug occurs, including where it is packaged, is the drug’s country of manufacture

64
Q

Country of Origin

A

CBP, the country in which the active pharmaceutical ingredient is made is the country of origin

65
Q

FDCA

A

Requires only that a manufacturer’s drug label bear the name of the manufacturer and any address associated with the company
The address does not have to be where the drug was made (eg, the address can be a manufacturer’s corporate headquarters instead of the country of the factory where the drug was made)

66
Q

Tariff Act

A

Requires imported products to be labeled with the country of manufacture
A drug manufacturer cannot list a US address alone without including the country of manufacture for a drug with a foreign made active pharmaceutical ingredient
A drug labeled solely with a US address would be considered, by the FDA and the CBP, to be manufactured domestically

67
Q

FTC Act

A

Stipulated it was illegal to market a product with the phrase “Made in the USA,” unless “all or virtually all” the contents of the product are domestically manufactured
A drug with a domestically manufactured active pharmaceutical ingredient, labeled only with a US address, cannot make the claim “Made in the USA’’ if any of its inactive ingredients are imported

68
Q

Trade Agreement Act

A

TAA limits the US Government procurement to domestic products or products made in designated countries. Such products are called TAA compliant. Examples of designated countries that are not TAA approved are China, India, Indonesia, Iran, Iraq, Malaysia, Pakistan, and Russia

Supply Chain and Inventory Management (4 decks)

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