Federal Law

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1. Which of the following statements is (are) true? I. Commercial herbals are categorized as dietary supplements. II. Commercial herbals may be categorized as nonprescrip- tion drugs. III. None of the herbals used in the US are recognized in the USP/NF.

(1)A (A) I only

2. A pharmacist may sell herbals provided that: I. the patient is properly counseled with respect to their use. II. the consumer is cautioned to use the product for not more than two weeks. III. there are adequate directions on the package for patient use

(2) B (B) III only

3. Upon formal request, to whom must the manufacturer of an herbal product submit data supporting the claims for the product? I. FDA or FTC II. pharmacists III. consumers

(3) A (A) I only

4- Ephedra may still be found in which of the following products? I. prescription drug products II. non-prescription drug products III. dietary supplements

(4) C (C) I & II only

5. Nomenclature for herbals is primarily based upon which one of the following reference sources? (A) Herbs of Commerce (B) Homeopathic Pharmacopoeia (C) German Commission on Herbs of Choice (D) USP (E) USP/NF

(5) A (A) I only

6. A practitioner of "Traditional Chinese Medicine" may sell ephedra-containing products if: (A) a prescription is presented. (B) there is no label claim that the product is a dietary supplement. (C) the customer is examined by the seller. (D) less than a 10 day supply is sold. (E) the product is marked for long-term use for weight loss

(6) B (B) III only

5. Which one of the following acronyms will eventually replace the AWP when calculating drug product prices under the MMA? (A) ASP (B) BDP (C) ESP (D) NARD (E) SP

(A) ASP

Hospital heath care reimbursement is most closely associated with which one of the following acronyms? (A) DRG (B) DEA (C) GMP

(A) DRG

1. Which of the following population(s) is (are) covered under the MMA? I. Medicare beneficiaries II. Medicaid beneficiaries III. nongovernmental employees (A) I only (B) III only (C) I and II only (D) II and III only (E) I, II, and III

(A) I only

11. Which group of the following individuals are ineligible to contribute to health savings accounts (HSAs)? (A) enrolled in Medicare (B) gross earnings over $100,000 (C) gross earnings over $200,000 (D) gross earnings over $500,000 (E) gross earnings over $1 million

(A) enrolled in Medicare

1. Which one of the following acronyms does NOT refer to pharmacy economics? (A) AAC (B) ATF (C) AMP (D) EAC (E) MAC

(B) ATF

8. An individual will become eligible for Medicare Plan D on July 4th of a certain year. Which of the following is the maximum time span for her to enroll in a PDP without penalty? (A) July 4th to Dec 31st (B) April 1st to Oct 31st (C) Jan 1st to December 31st (D) July 1st to July 31st (E) July 1st to September 31st

(B) April 1st to Oct 31st

2. Manufacturers would most fear the reclassification of their nonprescription product from category (A) I to II (B) II to I (C) I to III (D) III to I (E) II to III

(B) II to I

2. Which of the following conditions may preclude a pharmacist from working in a hospital pharmacy? I. alcoholism II. HIV infection III. cocaine addiction (A) I only (D) II & III only (B) III only (C) I & II only (E) I, II, & III

(B) III only

5. All of the following are exempt from tamper-evident packaging requirements EXCEPT (A) aerosols (B) drugs in first-aid kits (C) 2-piece hard gelatin capsules (D) 1-piece hard gelatin capsules (E) no exceptions

10. Mrs Stenson is about to file for social security as she is turning 65. Into which of the following portions of Medicare will she automatically be enrolled? (A) A only (B) B only (C) A and B (D) A and D (E) B and D

4. Which of the following is (are) NOT permissible under the MMA? I. Requiring a beneficiary to use a mail order pharmacy. II. Requiring a beneficiary to use a mail order pharmacy for 90-day supplies of a maintenance drug. III. Changing the price of a drug product one month after establishing a certain price (A) I only (B) III only (C) I and II only (D) II and III only (E) I, II, and III

7. Which one of the following is TRUE for a client who becomes eligible for Medicare Plan D on April 1st of the present year? (A) Cannot enroll into the program until her next birthday (B) May enroll at anytime without a penalty (C) Must enroll within a certain time span without a penalty (D) Must wait until January 1st of the following year (E) May sign up immediately but benefits will not start until April of the following year

2. At what intervals may a patient with a Medicare PDP or MA- PD card change his/her provider? (A) Every month (B) Every 6 months (C) Once a year (D) Whenever he/she desires (E) Never

9. When reviewing the choices of drugs covered in various Plan D programs, a beneficiary is likely to find only a limited choice of brand name products in which of the following categories of drugs? (A) anticonvulsants (B) antidepressants (C) antihyperlipidemics (D) antineoplastics (E) antipsychotics

1. A physician writes prescription for a nonprescription drug with no refill instructions. The pharmacist: (A) may NOT refill the prescription (B) may refill only once (C) may refill at his/her discretion (D) must contact the physician before refilling (E) should supply a one day supply of drug

1. The requirements of the ADA must be followed if what minimum number of employees is employed in a pharmacy? (A) 2 (B) 10 (C)15 (D) 50 (E) 100

4. The ADA protects an employee if an employer attempts to enforce: I. random locker room searches for illegal drugs II. IQ tests III. weight reduction programs (A) I only (D) II & III only (B) III only (C)I&.IIonly (E) I, II, & III

(D) II & III only

12. When a patient asks who has to pay the expense designated as TrOOP, the pharmacist should state it is the: (A) Drug company (B) Federal government (C) Insurance company (D) Patient (E) State government

(D) Patient

The preferred term for packaging that helps prevent contamination of nonprescription drug products is: (A) child-proof (B) occlusive (C) poison-prevention (D) tamper-evident (E) tamper-proof

(D) tamper-evident

6. The term "donut hole" refers to which of the following situations? (A) Prescription drug costs to the beneficiary before reaching the catastrophic coverage (B) The period of time during which a person may enroll in Plan D (C) The period of time during which a beneficiary may change health insurance companies (D) The portion of prescription drug costs charged to the in- surance company (E) A dollar range in which the beneficiary must pay for all prescription drugs

(E) A dollar range in which the beneficiary must pay for all prescription drugs

3. A pharmacy providing services under MMA may establish a formulary limiting the drugs to which of the following? (A) The top 200 frequently dispensed drugs (B) Only drugs available generically (C) Only brand-name drugs (D) 100 brand-name drugs plus their equivalent generic products (E) At least one drug from each of 8 therapeutic categories

(E) At least one drug from each of 8 therapeutic categories

3. An institutional pharmacy employer may NOT prevent pharmacists with which of the following conditions from working in a parenteral admixture room? I. chronic alcoholism II. HIV infection III. epilepsy (A) I only (D) II & III only (B) III only (C) I & II only (E) I, II, & III

(E) I, II, & III

2. Which one of the following acronyms directly relates to Alcohol? (A) AMP (B) ADE (C) CAM (D) GRAS (E) SDA

(E) SDA

A list of safe online pharmacies will be found in which of the following sites? (A) HPUS (B) JCAHO (C) USAN (D) VIP (E) VIPPS

(E) VIPPS

Who controls Medicaid?

-partially reimbursed by the federal government -regulated by the individual state

What are other provisions to Medicare programs?

1. All Rx benefits programs must accept participation from any pharmacy that agrees to the terms and conditions of their drug plan. This is referred to as the "any willing provider clause". 2. The sponsors cannot require beneficiaries to obtain their prescriptions through mail-order pharmacies. 3. Larger quantities, including 90-day supplies of long-term drugs, may be obtained at the participating local pharmacy. 4- If a brand-name product is dispensed, the patient must be informed of the availability of lower-cost generic versions of the drug. 5. Pharmacists are eligible to receive payment from Medicare for providing medication therapy management (MTM), if the patient is enrolled in Medicare Part D. 6. Each drug plan sponsor must establish medication therapy management (MTM) programs for enrolled individuals having high drug costs resulting from multiple chronic conditions such as asthma, diabetes, hypertension, hyperlipidemia, etc. 7. Importation of drugs from Canada and some other countries may be permitted if the HHS certifies that the importation poses no additional risk to the public health. 8. Explicitly blocking the use of Medicare's purchasing powerto negotiate prices with pharmaceutical manufacturers to obtain lower cost drugs for the elderly and disabled. 9. Bringing higher reimbursement prices paid by Medicare into a lower range. The manufacturer-reported AWP will be phased out in favor of an "ASP" - average sales price. This value will be between the actual acquisition price (AAP) paid and the present AWP. 10. Preventing a drug company from filing multiple 30-month stays to prevent competing companies from marketing a generic version of a drug product. 11. Allowing multiple manufacturers of a generic product to obtain a 180 day exclusivity period if they file their applications on the first day of eligibility.

What is medigap?

A Medigap policy is health insurance sold by private insurance companies to fill the "gaps" in the original Medicare Plan coverage. It is sometimes referred to as Medicare Supplemental Insurance. Health insurance companies are not permitted to sell new Medigap policies that cover drugs. However, people who already have such policies may keep them. Medigap plans without drug coverage may still be sold. Medigap supplementary insurance covers some out-of- pocket expenses not paid by original Medicare. There are about 12 different types of Medigap policies available. These policies must follow federal and state laws. A Medigap policy must be clearly identified on the cover as "Medicare Supplement Insurance." Each policy has a different set of basic and extra benefits.

Hospice

A facility or program that provides palliative and supportive care for terminally ill patients.

What is the CAN-SPAM Act regarding email use in pharmacy practice?

A federal law passed in December 2003, sometimes called the CAN-SPAM act, affects all unsolicited commercial e-mailing. The law's intent is to reduce unsolicited e-mailing (i.e. spam) from all sources. All companies that issue e-mail messages must identify themselves within the message and provide physical address contact information. In addition, the subject line of the e-mail must be truthful and not deceptive. Other requirements of this law specify that each commercial e- mail message must: • identify itself as an advertisement or solicitation. • originate from a legitimate e-mail address to which a recipient may reply. • be sent from a legitimate domain name and have correct header information that allows tracing to its origin. • have a mechanism by which a recipient may choose not to receive future messages. An added incentive for complying with the CAN-SPAM act is that the federal government is empowered to levy a fine of up to $16,000 for each separate e-mail violation of this law.

Generic Name

A name that is assigned to a specific drug structure. It is a simplified name as compared to the chemical name. Drug products may be marketed under their "generic name" or a brand name (trade name). The general perception is that a drug marketed under its generic name is usually less expensive than the brand name product.

Drug Sample

A unit of drug product not intended to be sold. Usually it is intended to acquaint a prescriber with a drug product by providing several doses for short-term or initial therapy

ADE or ADR

Adverse Drug Experience or Adverse Drug Reaction

ANDA

Abbreviated New Drug Application

AAC

Actual Acquisition Cost - the actual price a pharmacist pays when purchasing units of a drug product. This price usually represents a discounted price from the Average Wholesale Price (AWP).

Patient Protection and Affordable Care Act (Health Care Reform Act) of 2010

After contentious debate, Congress passed a major bill in 2010 that affects health care delivery to all Americans. While portions of the provisions will go into effect almost immediately, others will be phased into place over several years. Questions concerning specifics of the Act are unlikely to be included on the MPJE®, especially since many provisions are likely to be clarified and/or changed over the next few years. Among the areas of this legislation that affect pharmacist interactions with consumers, government agencies, and other health professionals include: 1. Require that all individuals have health insurance. A Health Insurance Exchange was created allowing individuals and families to purchase health coverage with credits available based upon their Federal Poverty Level (FPL). Small businesses also receive credits if they provide employee health coverage. 2. Require standards for financial and administrative transactions including timely and transparent claims using standard electronic transactions. (Previously enacted legislation required Part D pharmacy claims to be paid within 14 days after electronic submission or within 30 days if submitted by other means.) 3. Stop agreements between brand name and generic drug manufacturers that limit or delay competition from generic drugs. 4- Phase elimination of the catastrophic threshold, better known as the "donut hole" or "coverage gap", during which the patient pays all costs of prescription drugs.

ATF

Alcohol, Tobacco, and Firearms agency

What are Medicare formulary requirements?

All standard plans must include drugs within all the therapeutic categories and classes developed by the USP. Companies desiring to develop their own formularies must have a Pharmacy and Therapeutics (P &. T) Committee with the majority of members comprised of practicing physicians and pharmacists. Insurers do NOT have to include all drugs within each category. However, there are six drug classes that do require that most drug products be included.

AARP

American Association of Retired Persons

nutraceuticals

An additional term that may lead to confusion is nutraceuticals, which may be defined as food products including dietary supplements, herbals, and processed foods that provide health or medical benefits, including prevention or treatment of diseases.

Food

An article used for food or drink in humans or animals, chewing gum, and substances used as components of food or drink

Non-DI

An excipient or other substance used in the manufacture of a dietary supplement (DS).

What is SDA?

Another available form of tax-exempt alcohol is Specially Denatured Alcohol (SDA). SDAs refer to specific formulas of grain (ethyl) alcohol that have been rendered unsuitable for use as a beverage by the addition of denaturants such as sucrose octaacetate, brucine, or butyl alcohol. There are a large number of formulas for SDAs, usually designated as SDA 40A, SDA 23H, etc. SDAs are often used for pharmaceutical processing and in commercial products such as mouthwashes.

HMOs

Another form of managed care is the HMOs, which require that you generally utilize only doctors and hospitals in the plan's network, except in emergencies or special situations.

Device

Any instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent or related article which is • recognized in the USP/NF or HPUS or any supplement. • intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals. • intended to affect the structure or any function of the body of humans or animals but are not foods.

Drug

Any of the following: • Article recognized in the official United States PharmacO' poeia] National Formulary (USP/NF), or official Homeopathic Pharmacopoeia of the United States (HPUS), or any supplements of these references. • Article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals. • Article (other than food) intended to affect the structure or any function of the body of man or other animals. • Article intended for use as a component of any articles specified in the above but does not include devices or their components, parts, or accessories.

Cosmetic

Article intended to be rubbed, poured, sprinkled, sprayed on, introduced into or otherwise applied to the human body for the purpose of cleansing, beautifying, promoting attractiveness, or altering the appearance. Also, any component of the above articles is considered to be a cosmetic.

AMP

Average Manufacturer Price - average price paid by wholesalers to a manufacturer for drugs that are to be sold at retail

AWP

Average Wholesale Price - a published wholesale price for a drug product that can be used as the basis for pricing prescription drugs. Usually pharmacies are able to purchase the drug at lower (discounted) prices from the AWP.

3. The general guideline for listing ingredients on a cosmetic product label consists of listing the additives (A) and active ingredients intermixed but in the alphabetical sequence. (B) and active ingredients intermixed but ranked by decreasing concentrations. (C) and active ingredients intermixed but ranked by increasing concentrations. (D) separately from the active ingredients by increasing concentration. (E) separately from the active ingredients by decreasing concentrations.

4. A cosmetic hand lotion consists of an oil-in-water emulsion. The first ingredient listed on its label is most likely to be the: (A) oil that is present (B) water (C) coloring agent (D) surfactant (E) perfume

5. Which one of the following is the basic goal for the 2014 Sunscreen Innovation Act? (A) speed the marketing of new sunscreen products (B) speed the approval of new sunscreen ingredients (C) establish a newcode for screen efficacy (D) provide funds for developing new sunscreen ingredients (E) reduce the cost of sunscreen products

Which one of the following organizations is responsible for establishing names for ingredients used in cosmetic formulations? (A) ASHP (D) HCFA (B) AHPA (E) RDA

CDER

Center for Drug Evaluation and Research

CDC

Centers for Disease Control

CMS

Centers for Medicare and Medicaid Services - developed and currently supervises the MMA

CMS

Centers for Medicare and Medicaid Services - responsible for administering Medicare and overseeing states' administration of Medicaid; formerly known as the Health Care Financing Administration

CFR

Code of Federal Regulations - a compilation of final regulations and notices promulgated by the federal government; published annually by the US Government Printing Office; the above regulations and notices are first published in the Federal Register, a daily publication.

CAM

Complementary and Alternative Medicine

CPSC

Consumer Product Safety Commission

Low Sodium Labeling

Contains 140 mg or less of sodium in the lableled maximum daily dose

Very Low Sodium Labeling

Contains 35 mg or less of sodium in the labeled maximum daily dose

Sodium Free Labeling

Contains 5 mg or less of sodium in the labeled maximum daily dose

CSOS

Controlled Substance Ordering System - electronic substitute for DEA Form 222 when ordering Schedule I and/or II substances.

2. A client in a pharmacy complains about her hypersensitivity to many ingredients found in cosmetic lotions. When reading the label of a sunscreen lotion, which one of the following ingredients is not required to be listed by the manufacturer? (A) antimicrobial preservative (B) coloring agent (C) sunscreen agent (D) perfuming oil (E) water

DHHS

Department of Health and Human Services - department which includes the Food and Drug Administration (FDA).

DRG's

Diagnosis Related Groups - a classification system for hos- pital inpatients based on the principal diagnosis; reimbursement is usually based on days of stay.

Dietary Supplement - an over-the-counter product, containing one or more dietary ingredients, that is taken to improve upon a health condition, or simply enhance health, well being (mental and physical), or perhaps cosmetically to improve appearance.

DSHEA

Dietary Supplement Health Education Act

What is DSHEA?

Dietary Supplement Health Education Act (DSHEA)

DSHEA

Dietary Supplement Health Education Act (DSHEA) SHEA places health foods, food supplements, and herbal products into a class different from prescription and nonprescrip- tion drugs. Included in the class are herbals, amino acids, vitamins, minerals, and related supplements. Among the major provisions of the original act and later additions are: • Products may be marketed without their efficacy proven. The FDA or FTC would have to challenge products after they had been introduced onto the market if evidence surfaced that they are ineffective for the advertised or labeled use. • Products currently on the market do not have to be proven safe. It is the responsibility of the FDA to prove that a product is unsafe. However, the manufacturer must provide "reasonable" assurances that no ingredient in the product presents a significant or unreasonable risk for illness or injury. • The USP has published the "Manufacturing Practices for Dietary Supplements" in USP General Chapter 2750. Effective in 2007, the FDA regulations for Good Manufacturing Practices (GMP's) for dietary supplements were published. These regulations make distinctions between: A. Dietary Supplement (DS) - i.e. the final Product. B. Dietary Ingredient (DI) - i.e. a vitamin, mineral, herb or other botanical, an amino acid, or a dietary substance to supplement the diet. C. Non-DI - i.e. an excipient or substance used in the manufacture of a DS. The complete definition in the Federal Food, Drug and Cosmetic Act reads: "A dietary ingredient is a vitamin, mineral, herb, or other botanical, amino acid, a dietary substance to supplement the diet by increasing the total dietary intake, or a concentrate, metabolite, constituent, extract, or combination of any of the aforementioned ingredients". Under this Act, most of the new requirements fall upon the manufacturer of the dietary supplement with respect to testing and record-keeping. The GMP rules do not provide specific guidelines or requirements for tests that a company needs to conduct to verify identity, purity, strength, and composition of ingredients and finished products. Instead, the company may establish its own testing procedures. Also the company could either test every batch of finished products or a subset of finished batches. The company may perform tests on the non-DI or it may rely on a Certificate of Analysis (C of A) obtained from the supplier of the non-DI. The manufacturers must establish and follow written procedures for their operations and facilities. They must keep written product records for one year past the expiration date (if such a date has been determined,) or two years beyond the date of distribution of the last batch of supplements. Suppliers of dietary ingredients are not required to conform to the new GMP rules since the responsibility of determining DI quality belongs with the manufacturer of the finished DS product. The exception occurs when a company manufactures a DI that is then simply repackaged as a final product. In these cases, the company is subjected to the GMP rules. Violations of the GMP rules will result in the product being considered "adulterated".

DEA

Drug Enforcement Administration - administration responsible for the federal Controlled Substances Act (CSA). It is part of the U.S. Department of Justice.

DQSA

Drug Quality and Security Act

DUR

Drug Utilization Review - a review of prescription drug use, prescribing patterns or drug utilization by patients. Its purpose is to determine if appropriate drugs are being prescribed and if those drugs are being used appropriately.

What is a drug-free workplace?

Drug'free Workplace According to the Federal Anti-Drug Abuse Act of 1988 • The unlawful possession of controlled substances by employees is prohibited in the workplace. • If an employee is convicted of criminal possession of drugs, he/ she must inform the employer of the conviction within five days. • Employers may take appropriate action.

Can the formulary change during the year?

Drugs in any category must be for a medically accepted indication. Therefore, research drugs are not covered but "off-label" use drugs may be acceptable. The insurer may change or remove specific drugs after giving timely notice to enrollees and health professionals. Plans may alter their therapeutic categories and classes of drugs only at the beginning of each plan year unless a change is needed to accommodate newly approved drugs or new uses of an existing drug. Maintenance changes to formularies such as removing a branded drug and replacing it with a newly available generic is allowed at any time. Advance notice must be given to the CMS for its approval. Pharmacies and beneficiaries must also be notified before changes are made. If a specific drug is not covered by a plan, the patients may appeal for exceptions if his/her doctor can show that the non-formulary drug is medically necessary.

Durable Medical Equipment - equipment that meets three standards: 1. It can stand repeated use. 2. It is primarily for a medical purpose (i.e., it is not useful to a person if they have no illness or injury). 3. It is appropriate for use in the home. Examples of DME's include wheelchairs, oxygen tanks, and walkers.

EHR

Electronic Health Records - HHS requirements to encourage health professionals to share clinical information.

EOB

Electronic Orange Book

EAC

Estimated Acquisition Cost - an estimated cost of a drug to a pharmacy based upon information collected by the DHHS (Department of Health and Human Services). Such costs are often based upon the quantity purchased.

Who regulates prescription drug advertising?

FDA

Who regulates nonprescription (OTC) advertising?

FTC

T/F Soap is considered a cosmetic

False

FTC

Federal Trade Commission - responsible for investigating unfair business practices including misleading advertising, etc.

What must be on the OTC label for pregnant and nursing mothers?

Federal regulations mandate labeling for nonprescription drug products intended for systemic use. The general warning states: "As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product". Exceptions to this labeling will include those drugs intended to benefit the fetus or nursing infant and those products intended exclusively for pediatric use. Some OTC drugs, such as oral or rectal products containing aspirin, must have the warning: "It is especially important not to use this product during the last three months of pregnancy unless specifically directed to do so by a doctor".

OTC Sodium Content

Federal regulations require that the labeling for OTC products intended for oral administration must indicate the sodium content per dosage unit (i.e., per teaspoonful, tablespoonful, etc.), if the amount present exceeds 5 mg per single dose. This total refers to all sources of sodium whether present in active or inactive ingredients. If the amount of sodium present in the labeled maximum daily dose of the product is more than 140 milligrams, a warning on the label must state: "Ask a doctor before use if you have a sodium- restricted diet".

FDA

Food and Drug Administration

FDCA

Food, Drug and Cosmetic Act (FD & C Act or FDCA)

Ban on Sales of Ephedra and Ephedrine Alkaloids

For centuries ephedra has been used for several indications including asthma. However, in 2004 the FDA banned the sales of all dietary supplements containing this drug, citing that its use posed an unreasonable risk of illness or injury to consumers. Based upon the DSHEA (Dietary Supplement Health and Education Act), the FDA claimed that dietary supplements containing ephedra or its alkaloids are adulterated since they present an unreasonable risk of illness or injury based upon their recommended use. The ban does not apply to prescription or nonprescription drug products or to conventional foods such as herbal teas. It also does not apply to products that are prepared or used for "Traditional Chinese Medicine" since this practice uses ephedra for temporary respiratory conditions, not for chronic, long-term use for weight loss. In addition, the product labels must not have any indication that the product is a dietary supplement.

Banned laxatives

For example, in 2002, the FDA banned the use of aloe and cascara sagrada as laxative ingredients in over-the-counter drug products. These two groups of ingredients are deemed as not being GRASE (generally recognized as safe and effective). This effectively placed these ingredients into Category II. Laxative products containing any form of aloe or cas- cara sagrada are, therefore, now considered to be misbranded.

How can a formulary change be completed?

Formulary changes by plans, such as drug removal or reduction to a less favorable tier must be done with CMS approval. A 60-day notice must be given to CMS, state prescription plans, pharmacies, and plan enrollees. The exception is a formulary drug that has a new black-box warning, which may be removed at any time. If an enrollee is taking the drug being "switched", he or she must be allowed to obtain the drug without penalty for the rest of the plan year

GRAS

Generally Recognized As Safe - refers to a large number of relatively inert ingredients that are permitted to be used in pharmaceutical and food products as excipients or adjuvants because of their relatively high degree of safety.

GRASE

Generally Recognized as Safe and Effective - Term usually used when considering the safety and effectiveness of nonprescription product ingredients.

GMP

Good Manufacturing Practice

HCFA

Health Care Financing Administration - formerly responsible for policies relating to Medicare (federally managed) and Medicaid (controlled by individual states under the supervision of HCFA). Now referred to as Centers for Medicare and Medicaid Services (CMS).

HIPAA

Health Insurance Portability and Accountability Act

HMO

Health Maintenance Organization

HSA

Health Savings Account

HHA

Home Health Agency - an organization licensed or certified by the government to provide home health care services

HSD

Home-use Sterile Drug products

HP/HPUS

Homeopathic Pharmacopoeia of the United States

USP/NF Designations

If a drug is listed by its official name in the USP/NF or HPUS, it must meet the requirements specified in either book. Otherwise, it must have the designation "not USP/ NF". Without this designation the drug is considered to be either misbranded or adulterated. If a drug is official in both the USP/NF and HPUS, it must meet the standards established in the USP/NF monograph unless it is distinctly marketed and labeled as a homeopathic drug.

Food, Drug and Cosmetic Act of 1938

In 1937, 107 deaths caused by the mistaken use of diethylene glycol (automobile anti-freeze), as a vehicle in a sulfanilamide elixir resulted in the passage of a landmark piece of federal regulation, the Food, Drug and Cosmetic Act (FDCA) of 1938. This law required, for the first time in the US, that any new drug could not be marketed unless it had first been proven to be safe when used according to directions on the label. It also required that labels include adequate directions for use and warnings about habit-forming drugs that were Section B I Sources of Laws, Rules and Regulations 11 contained in the product. It was also the first law that applied to cosmetic products and medical devices as well as to food and drug products. Drug products marketed prior to 1938 were exempted or "grand' fathered" and did not, therefore, have to be labeled or proven safe under this law. The FDCA became the backbone of many subsequent laws and amendments that further strengthened drug control in the US.

OTC Labels & Other Electrolytes

In 2004, the FDA issued rules for labeling other electrolytes present in OTC products. The label must indicate the presence of each of the following minerals if the level of the mineral in each dose is equal to or exceeds the threshold amount indicated: Mineral Threshold Amount Calcium 20 mg Magnesium 8 mg Potassium 5 mg In addition, label warnings intended for individuals on electrolyte-restricted diets are required if the maximum daily intake of a mineral will exceed the threshold amounts indicated below. Mineral Threshold Amount Sodium 140 mg Calcium 3-2 g Magnesium 600 mg Potassium 975 mg

In 2008 which part started covering immuniztions?

In 2008 Medicare Part D began to cover the cost of vaccines and their administration, which formerly was covered by Part B.

Medicaid Tamper-Resistant Prescription Requirement

In 2008 the Centers for Medicare & Medicaid Services (CMS) issued a requirement that specified that all written, non-electronic prescriptions for Medicaid outpatient drugs that were to be reimbursable by the federal government must contain at least three tamper-resistant features. They must be designed to • prevent unauthorized copying of a completed or blank prescription form; • prevent the erasure or modification of information written on the prescription by the prescriber • prevent the use of counterfeit prescription forms. The tamper-resistant requirement does not apply to durable medical equipment, prosthetics, orthotics, and supplies such as diabetic testing strips? Since the individual states are responsible for implementing Medicaid regulations, each state Medicaid Agency has issued its own guidance on this requirement. In preparing for the MPJE®, candidates are advised to become aware of these state requirements.

What else can be included on an OTC label?

In addition, the OTC label will generally have the following additional information: • Expiration date, when applicable • Lot or batch code (manufacturer information to help identify the product). • Name and address of manufacturer, packer, or distributor. • Net quantity of contents (how much of the product is in each package). • What to do if an overdose occurs.

What is the Medical Device Amendment of 1976

In order to protect the American public against potentially dangerous or useless medical devices, Congress enacted the Medi- cal Device Amendment of 1976. This amendment to the FDCA Act provides for better classification of medical devices according to their specific function, establishment of performance standards for these devices, pre-market approval requirements, conformance with GMP standards, and requirements for adherence to record and reporting requirements.

IND

Investigational New Drug

What is unfair competition?

It is unlikely that questions concerning the economic aspects of pharmacy will be asked on the MPJE®. However, one should be aware of two major laws in this area.

JCAHO

Joint Commission on Accreditation of Health Care Organizations

Labeling for Herbals and Dietary Supplements

Labels for herbal products must contain the standard common names as listed in the reference source, Herbs of Commerce, published by the AHPA (American Herbal Products Association). This reference source contains standardized common herbal names as well as corresponding Latin binomial designations for thousands of herbal species. In 2006 this publication was incorporated officially into federal regulations for the labeling of botanical ingredients in dietary supplements. The standardized common herbal names must be used, but inclusion of the Latin names is optional. For example, the name of Eleuthero for the herb Eleutherococcus senticosus must be used rather than "Siberian ginseng". If an herb is not listed in the Herbs of Commerce, the manufacturer must include the herb's Latin name on the label. Manufacturers are permitted to make structure or function claims on labels if the statements do not indicate that the product will diagnose, cure, treat, or prevent a disease. Some claims related to the product's ability to affect body structure or function are permitted if they are truthful and not misleading. For example, a claim that saw palmetto will "improve urinary flow" or that it is "for the prostate" is acceptable. However, a statement that it "will cure or reduce the size of an enlarged prostate" is not acceptable. While the manufacturer must substantiate the product claims, they do NOT have to be reviewed or approved by the FDA. This fact must be stated on the product label. Often the warning will read, "These claims have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease."

LVP

Large Volume Parenteral

What special packaging is required for some cosmetics?

Many cosmetic products, especially those intended for use in body cavities (e.g. mouthwashes and vaginal products), must be packaged in tamper-resistant packaging.

What is the Durham-Humphrey Amendment of 1951?

Many of the drug products covered by the 1938 FDCA Act were not safe to use without medical supervision. The Durham-Hum- phrey Amendment of 1951 was enacted to further regulate these products. This was an amendment to the FDCA that established two classes of drugs. Those that required medical supervision to be used safely did not have to list "adequate directions for use" but were required to include the legend "Caution: Federal law prohibits dispensing without a prescription" on the manufacturer's label. The requirement for "adequate directions for use" was satisfied by the pharmacist placing directions provided by the prescriber on the label of the dispensed product (e.g. Take one tablet twice daily). Such products became known as prescription or "legend" drugs. Products that did not require medical supervision for their use had to have adequate directions for use on their label and were referred to as "over-the-counter" (OTC) or nonprescription drug products. In addition to distinguishing between legend and nonpre- 12 Guide to Federal Pharmacy Law I 9th Edition scription drug products, this legislation also provided for oral prescriptions and prescription refills.

MAC

Maximum Allowable Cost - the highest price allowed under a specific plan for a specific drug (usually multi-source drugs). If a person wants a more expensive version, he/she must pay the difference.

The federal law controls Medicare or Medicaid?

Medicare

Medicare Advantage - plans that cover everything the original Medicare covered but may offer lower costs and extra services.

MA-PD

Medicare Advantage Prescription Drug Plan.

What four programs were part of the Medicare Prescription Drug Improvement and Modernization Act (MMA)of 2003?

Medicare Part A - Provides hospitalization insurance. Medicare Part B - Provides medical insurance for physician services. Medicare Part C - Medicare managed care (Medicare Advantage) Medicare Part D - Medicare prescription drug program

What are the two major medical reimbursement programs in the US?

Medicare and Medicaid

Medicare Part D Overview

Medicare contracts with private insurance companies to provide drug-only coverage OR coverage through Medicare Advantage local and regional managed care plans, the MA-PD. The cost to the beneficiary depends on the beneficiary's income. If the beneficiary is not in a low-income category, they will pay a monthly premium, have an annual deductible, and have co-payment responsibilities. The PDP benefits include the cost of any prescription drug, biological product, and insulin if it is presently covered by Medicaid and is intendd for a medically accepted indication

MTM

Medication therapy management

What is MTM and how does it work?

Medication therapy management, also referred to as MTM, is a term used to describe a broad range of health care services provided by pharmacists. It is defined as a service or group of services that optimize therapeutic outcomes for individual patients. Medication therapy management services include medication therapy reviews, pharmacotherapy consults, anticoagulation management, immunizations, health and wellness programs and many other clinical services. Pharmacists generally provide medication therapy management to help patients get the greatest benefits from their medications by actively managing drug therapy and by identifying, preventing and resolving medication-related problems. The Centers for Medicare and Medicaid Services (CMS) has stated that MTM programs must "evolve and become a cornerstone of the Medicare prescription drug benefit". CMS has committed itself to increasing access to MTM and reducing eligibility restrictions for beneficiaries. As of 2016, CMS has increased requirements for Part D sponsors to provide MTM programs.

If any information (1-7) is missing, the nonprescription drug is considered what?

Misbranded

NABP

National Association of Boards of Pharmacy (creates the NAPLEX® and MPJE*).

NDC

National Drug Code - a classification system for identifying a specific drug product; used nationally for reimbursement and for identification of drug products.

NIH

National Institutes of Health

NPI

National Provider Identifier

NDI

New Dietary Ingredient. Any substance that was not marketed as a dietary supplement ingredient in the U.S. prior to October 15, 1994. A manufacturer intending to market a New Dietary Ingredient must submit to the FDA, at least 75 days before introduction of the product into commerce, documented evidence establishing that the NDI is reasonably expected to be safe as used in the dietary supplement.

NDA

New Drug Application

Are sponsors required to provide interactive consultations to LTC residents?

No!

OSHA

Occupational Safety and Health Administration - responsible for monitoring the work environment to assure worker safety.

OBRA

Omnibus Budget Reconciliation Act - act passed each year by Congress to fund many activities; each OBRA is known by the year it was enacted.

Drugs@FDA

One of the most useful drug information resources is a website produced by the FDA, Center for Drug Evaluation and Research, known as Drugs@FDA. This is a searchable website that contains information about approved and tentatively approved prescription, nonprescription, and discontinued drugs. It also includes links to drug approval letters, labels, and scientific reviews. The primary uses of Drugs@FDA are to: • find labels for approved drug products. • find generic drug products for a brand name product. • find all drug products with a specific active ingredient. • view the regulatory history of an approved drug. • find consumer information for drugs approved after 1998. • find therapeutic equivalent drug products for a brand name or generic drug product.

What is the Orphan Drug Act of 1983

Orphan drugs are those that are used to treat diseases that are relatively rare, i.e. they affect relatively few people. Prior to 1983 the cost of developing and marketing such drugs was prohibitive for most drug manufacturers because of their limited potential for profitability. In 1983, Congress enacted the Orphan Drug Act. This provided various tax and licensing incentives to manufacturers, thereby making development of such drugs more appealing. A rare disease is usually considered one that affects less than 200,000 persons in the United States.

OTC

Over-the-Counter - refers to drugs and drug products, which are available without a prescription; also referred to as "nonprescription".

OTC info

Over-the-counter (OTC) or nonprescription status is granted to drugs and drug products that have been shown to be safe for use without a physician's supervision, are for conditions suitable for self-diagnosis, and have adequate written directions for self-use. Of major importance with OTC products is appropriate labeling. The FDA has, over the past decade, focused considerable attention on the development of legislation that would improve the safety and efficacy of OTC products.

Package Insert

PPI

Patient Package Insert

PBM

Pharmacy Benefits Management - organization that manages pharmaceutical benefits for managed care organizations or employers.

PPPA

Poison Prevention Packaging Act

PPO

Preferred Provider Organization - a group of health professionals who are contractually favored to provide health services to individuals under a specific insurance plan.

PDP

Prescription Drug Plan - Medicare prescription drug plans that cover only outpatient drugs and are intended for people in original Medicare who have no other drug coverage. Patients cannot enroll in both a PDP and a MA plan.

PFFS

Private fee-for-service plans that allow you to go to any doctor or hospital that accepts their terms.

PHS

Public Health Service

Who regulates cosmetic advertising?

Regulation of advertising and labeling of cosmetics basically falls under the jurisdiction of the Federal Trade Commission (FTC). The labels of cosmetic products must contain the names of ingredients listed in descending order of predominance (that is why water may be listed as the first ingredient, while the "active ingredient" is listed further down in the ingredient list). Ingredients present in quantities of one percent or less may be listed at the bottom, in random order. Perfumes and flavoring oils may simply be listed by name. Coloring agents must be those accepted for cosmetic use. A minor exception to the above ingredient-listing requirement is cosmetics used in professional settings such as by professional hair- dressers (i.e. cosmetics not intended for retail sales).

Prescription to OTC Reclassification

Requests for the reclassification of a prescription-only drug to OTC status are accomplished by one of the following four mechanisms: • If the drug is now a prescription drug, a full NDA (New Drug Application) requesting OTC status may be submitted to the FDA for its evaluation. • The FDA may grant an exemption if it deems that prescription-only status is unnecessary for the protection of the public health. • A supplement to the NDA may be filed. The FDA will then review the relative safety of the drug based upon previous marketing experience and lack of a history of adverse effects. • The Nonprescription Drug Advisory Committee may recommend that a particular ingredient be converted to nonprescription status

REMS

Risk Evaluation and Mitigation Strategy - FDA requirement for drug manufacturers to develop strategies to assure safe use of a specific drug

What drugs were grandfathered into the Food, Drug and Cosmetic Act of 1938?

Several drug products still sold in pharmacies (e.g. levo- thyroxine, digoxin, nitroglycerin, and phenobarbital) were on the market prior to 1938 and are, therefore, still "grandfathered" from this law.

SNF

Skilled Nursing Facility - a site that treats patients especially in need of rehabilitation or a lower level of medical care than is needed in a hospital.

SNP

Special Needs Plan - a category of Medicare Advantage plan designed for people living in long-term care facilities and receiving both Medicaid and Medicare or who have certain disabling chronic illnesses.

SDA

Specially Denatured Alcohol

Can you fill prescriptions at "out-of-network" pharmacies?

Sponsors of Part D plans must ensure that the beneficiary will be able to obtain prescription drugs when traveling outside of the geographic area of their pharmacy or when the pharmacy they normally use is either closed or the drug is out of stock. When it is necessary to patronize an "out-of-network pharmacy", the beneficiary must pay the new pharmacy's usual and customary price when purchasing the prescription. The beneficiary will then submit a claim to their plan for reimbursement. The beneficiary is responsible for any difference in the new pharmacy's charge and that allowed by the plan sponsor.

Sterile Product or Supervising Pharmacist

SNDA

Supplemental New Drug Application

TRP

Tamper Resistant Packaging

What are alcohol regulations for a pharmacy?

The Bureau of Alcohol, Tobacco and Firearms controls the sale of alcohol. Pharmacies may purchase 95% ethanol (190 proof grain alcohol) for routine compounding by using Form ATF-11. If a pharmacy is selling alcohol in the form of a beverage, it must obtain a retail liquor dealer's stamp. Institutions that have a need for greater volumes of alcohol may choose to purchase tax-free alcohol, since it is much lower in cost (tax on regular alcohol purchases is very high). Such pharmacies must purchase alcohol by using Form ATF-144 7. The following are federal statutes that relate to the use of tax-free alcohol: • Its use is limited to medicinal or scientific use, or in patient treatment. • The alcohol may not be sold or loaned to other pharmacies or physician's offices. • The alcohol, either by itself or as a component of other products, may not be sold to outpatients. An exception to this requirement permits nonprofit clinics to dispense medicines made with tax-free alcohol provided the client is not charged for the medication. • A running, accurate inventory must be kept for all alcohol in stock. • Containers of alcohol, usually supplied in 10 or 5 5-gallon drums, must be stored in a securely locked, fire-resistant storeroom How may a prescriber's order for an alcohol-containing beverage (e.g. brandy at bedtime) for an institutionalized client be handled? Either the • institution may buy the alcohol-containing beverage, furnish it to the client, and then bill the patient, or • the hospital pharmacy may give the patient's relatives permission to bring in alcohol for the patient.

Labeling OTC for rectal use and sodium

The labeling of OTC drug products intended for rectal administration containing dibasic sodium phosphate and/or monobasic sodium phosphate must contain the sodium content per delivered dose if the sodium content is 5 milligrams or more.

FAERS

The FDA Adverse Event Reporting System (FAERS) is a database that contains information on adverse event and medication error reports submitted to FDA. The database is designed to support the FDA's post-marketing safety surveillance program for drug and therapeutic biologic products. Reporting of adverse events and medication errors by health care professionals and consumers is voluntary in the United States. FDA receives some adverse event and medication error reports directly from health care professionals (such as physicians, pharmacists, nurses and others) and consumers (such as patients, family members, lawyers and others). Health care professionals and consumers may also report adverse events and/or medication errors to the products' manufacturers. If a manufacturer receives an adverse event report, it is required to send the report to FDA. The reports received directly and the reports from manufacturers are entered into the FAERS system. FAERS is a useful tool for FDA for activities such as looking for new safety concerns that might be related to a marketed product, evaluating a manufacturer's compliance to reporting regulations and responding to outside requests for information. The reports in FAERS are evaluated by clinical reviewers in the Center for Drug Evaluation and Research (CDER) and the Center for Biologies Evaluation and Research (CBER) to monitor the safety of products after they are approved by FDA. If a potential safety concern is identified in FAERS, further evaluation is performed. Based on an evaluation of the potential safety concern, FDA may take regulatory action(s) to improve product safety and protect the public health, such as updating a product's labeling information, restricting the use of the drug, communicating new safety information to the public, or, in rare cases, removing a product from the market.

FDA requirements for OTC

The FDA requires that all nonprescription, over-the-counter (OTC) medicine labels have detailed usage and warning information, in a "Drug Facts" section, so consumers can properly choose and use the products. Below is an example of what elements an OTC "Drug Facts" section must have, in the order in which the information must appear on the label: (1) Active Ingredient - Indicates the active therapeutic substance in the product as well as the amount of active ingredient per unit (i.e.. per capsule, per teaspoonful, etc.) (2) Uses - Symptoms or diseases the product will treat or prevent. (3) Warnings. May include • when not to use the product; • conditions that may require advice from a doctor before taking the product; • possible interactions or side effects; • when to stop taking the product and when to contact a doctor; • The statement "If you are pregnant or breast feeding, seek guidance from a health care professional"; • The statement "Keep product out of children's reach". (4) Inactive Ingredients - Lists substances such as colors or flavors. (5) Purpose - Indicates the product's action or category (e.g. antihistamine, antacid, cough suppressant, etc.) (6) Directions - Lists • Specific age categories that may use the product • How much to take • How, how often, and how long to take. (7) Other Information - May include • How to store the product properly • Required information about certain ingredients (such as the amount of calcium, potassium, or sodium the product contains).

Homeopathic Drug Products

The Federal Food, Drug and Cosmetic Act of 1938 recognized the Homeopathic Pharmacopoeia of the United States (HPUS) as an official compendium. Drug products that use an official name designation found in the HPUS must meet all of its compendial standards. Otherwise the drug product is misbranded or adulterated. The basic elements of homeopathic medicine include individualized dosing of patients by homeopathic physicians, based upon a patient's symptoms. The dose of drug administered is usually extremely low; often dilutions of 1:1,000 or 1:1,000,000 are used with frequent drug administration. These drug products must meet the usual drug labeling requirements including ingredient names, amounts, and directions for use. While many of the drugs were originally labeled by their Latin name, it is now required that their English name be provided. Some of the drugs found in homeopathic formulas are also official in the USP/NF. In these situations, the drug must meet the stricter standards found in the USP/NF. If the drug product is intended for nonprescription use, its label must include appropriate warning statements, if needed. While homeopathic drugs must be manufactured under GMP standards, they do not have to have an expiration date on their package.

Americans with Disabilities Act (ADA)

The Federal Rehabilitation Act of 1973 prevents an employer from discriminating against a person who is physically or mentally handicapped, but who is otherwise qualified to perform the functions of a job. The Act applies only to those companies receiving federal assistance. The Americans with Disabilities Act (ADA) became effective in 1992. This Act expands the original Rehabilitation Act by greatly increasing the number of individuals covered and by covering companies even if they are not receiving federal financial assistance. Any company employing 15 or more people is covered. In both acts, the term "disabled" is used since it has less of a negative connotation than the term "handicapped". These acts provide civil rights protection to individuals with disabilities similar to those provided to individuals on the basis of race, color, sex, national origin, age, and religion. Among those covered under the ADA are individuals with epilepsy, paralysis, HIV infections, AIDS, mental retardation, and alcoholics. Those NOT both acts is that employers must make a "reasonable effort" to accommodate a disabled employee. The following are additional elements of these laws: • The employer must make reasonable accommodations for disabled individuals whether those individuals are employees or members of the general public. For the general public, "reasonable accommodations" include providing ramps leading into a building, providing elevator service to all floors of a building, and constructing restroom facilities that are accessible to disabled individuals. • For an employee, "reasonable accommodations" might include a reduced-height workbench. • An employer may not ask about disabilities during an employment interview, but may ask if the prospective employee has the ability to perform the work. • An employer may not require a prospective employee to undergo a medical examination before offering a position. However, the employer may require a medical examination as a condition of employment if this is a requirement for all new employees

What is the Kefauver-Harris Amendment of 1962?

The Kefauver-Harris Amendment was adopted as a result of public concern about thalidomide, a sedative-hypnotic drug. This drug was marketed in Europe but was not approved by the FDA for the US market. In 1961, it was determined that thalidomide had caused serious birth defects in the offspring of many women in Europe who had used the drug. While there were few birth defects seen in the US, Congress enacted the Kefauver-Harris Amendment to protect the public in the future. This amendment to the FDCA Act (also referred to as the Drug Efficacy Amendment) required that all new drugs marketed in the US had to be shown to be not only safe, but also effective. This requirement was also extended to products that had been approved between 1938 and 1962. In addition to this efficacy requirement, the Amendment also included provisions that placed the authority for regulating prescription drug advertising into the hands of the FDA. It also required informed consent for individuals who were research subjects in clinical investigations, reporting of adverse drug reactions, and creation of Good Manufacturing Practice (GMP) requirements that clearly defined the conditions under which drugs could be manufactured in the US.

What is the Med Part D Coverage Gap?

The Medicare Part D coverage gap, often coined the "Medicare donut hole", describes the financial gap between the Part D Rx initial coverage limit and the catastrophic-coverage threshold. This gap is when the patient pays the largest amount for prescriptions until reaching the the catastrophic-coverage level During the gap limit (the donut hole) the patient had to pay most of the cost (but with 50% discount on brand-name drugs and 35% discount for generics). When out-of-pocket reaches $4,700, the plan paid for most costs.

Nonprescription Drug Advisory Committee

The Nonprescription Drug Advisory Committees were originally established to evaluate the numerous nonprescription products and individual ingredients currently on the market. The committees or panels, subdivided by therapeutic categories, submitted their conclusions to the FDA. As a result of their deliberations, OTC ingredients were classified into one of three categories.

What is the Sherman Antitrust Act?

The Sherman Antitrust Act prevents restraint of trade or the establishment of monopolies. Originally, the Sherman Antitrust Act was intended to curtail the large monopolies that operated in the early 1900's. The concept of the Act is to prevent restraint of trade and/or the establishment of monopolies. Companies or groups may not have agreements, either formal or informal, among themselves, which would unreasonably restrain trade. For example, three independent pharmacies in a given area may not agree to a common drug mark-up of 40% or a professional fee of $15.00. These actions would probably be classified as price fixing. Other examples could be the distribution of suggested retail prices for certain prescription drugs by a pharmaceutical organization or the boycott by a group of pharmacies of a third party payer because of its low reimbursement rate. In addition, a group of pharmacies may not agree as a group to reject a third-party prescription plan, nor can they collectively bargain for better reimbursement rates. However, a chain consisting of several pharmacies may do so.

United States Pharmacopoeia/National Formulary (USP/NF)

The US government does NOT publish this reference. It is published by a private organization known as the US Pharmacopoeia Convention (USPC). The USP/NF contains monographs of recognized drugs. Each monograph includes the drug's chemical characteristics and standards of quality. Proposed changes of the USP/NF are published in the Pharmacopoeia1 Forum (PF), a bimonthly publication available in print and online. While printed as one bound book, the USP and NF are still considered to be two separate entities.

Official Status of Herbals

The USP/NF has developed monographs for some botanicals that appear to have therapeutic efficiency. To be admitted into the official compendium, the herb must have an FDA approved use or a USP Dl Panel recognized use. The monographs describe the portion of plant used, its botanical characteristics, and appropriate assay procedure for ingredients. The monographs do not describe the therapeutic use of the herbs. Among the herbs with monographs are chamomile, cranberry liquid preparations, feverfew, garlic, ginger, ginkgo, milk thistle, St John's wort, saw palmetto, and valerian.

What is the Sunscreen Innovation Act of 2014?

The approval of new ingredients for sunscreen products has been very slow in the past. This act requires the FDA to respond quickly to requests for approval of pending ingredients for OTC sunscreen products.

Can you use brand name ingredients in cosmetics?

The ingredient names listed on labels must be the generic names listed in the USP/NF. If an ingredient is not of USP/NF quality or is not listed in these two official books, other relevant sources such as the CTFA Cosmetic Ingredient Dictionary may be used. This book has been compiled by the Cosmetic, Toiletry, and Fragrance Association (CTFA) and contains many ingredients commonly used in cosmetics (e.g. surfactants).

What is the Robinson-Patman Act?

The intent of the Robinson-Patman Act is to prevent the hindering of competition. A seller is not allowed to practice price discrimination when dealing with similar purchasers. For example, the wholesale price for 100 x 1,000 tablet bottles may not favor one pharmacy over another. Likewise, this issue arises when individual states allow hospitals to dispense prescriptions for walk-in clients if the hospital has a community pharmacy permit. In this case, however, the price of the prescription may not be based upon the special, reduced price that the hospital receives from the pharmaceutical manufacturer. Nor can the hospital sell drugs or medical devices to affiliated groups such as a home health care business at the special, reduced price. Hospitals and similar institutions do have the right to extend their special prices to employees, inpatients, emergency room patients, etc. This is known as "own use". Institutions are not permitted to provide prescription refills for former patients unless the take- home drugs are intended as continued care or are supplementing treatment administered in the hospital (e.g. continuing a treatment with parenteral antibiotics). While physicians on the hospital staff may be supplied with drugs for personal use, drugs may not be sold to physicians for use in their private practice, especially if the drugs are being sold to patients.

Cosmetics vs Drugs

The legal distinction between cosmetics and drugs is somewhat muddled. For example, some cosmetics, such as fluoridated toothpaste, medicated mouthwash, or anti-dandruff shampoos are on the borderline between being classified as cosmetics or as non- prescription products. The overriding factor in determining a product's status may not be its ingredients, but what claims are made for the product, especially on the label. Unlike drugs, cosmetics do not require premarketing approval from the FDA.

Refilling Prescriptions Written for Nonprescription Drugs

The pharmacist may refill prescriptions written for nonprescription drugs without prescriber authorization unless: 1. The dose requested is greater than the recommended dose on the label of the commercial OTC product. 2. The prescriber has limited the number of refills on the original prescription. 3. The drug is a Schedule V controlled substance where the number of refills must be designated by the prescriber. 4. The individual state has set a time period limit for refills

What are Med D's premiums based upon?

The premiums, deductibles, and percentages are based upon an individual. Therefore, a husband and wife must each have their own plans. Part D deductibles may be reduced or waived by a health insurance company, but a company may charge a higher premium for this benefit. Other insurance company options include charging a higher co-payment. Co-payments (co-pays) may be based on a three or four level tier system developed by each health coinsurance company. The tiers often consist of: Tier 1: least expensive generic drug Tier 2: preferred brand name drug Tier 3: non-preferred brand name drug Tier 4: rarer, high cost drugs Once the beneficiary has enrolled, the premium and deductible cannot change between January 1 and December 31. The co-pay amount may change if the drug is moved to another tier. The beneficiary may change plans only once a year unless he/she moves out of the plan's area, into a nursing home, or the plan stops service in the area.

FDA Modernization Act of 1997

This Act is a far-reaching piece of legislation that touches virtually every aspect of FDA's activities. Included in this legislation are the following: • Provisions for the fast-track review of some New Drug Application submissions. The intent is to expedite the approval ofnew drugs used to treat serious or life-threatening conditions. • Clarification of the conditions under which pharmacies may perform extemporaneous compounding of prescriptions. One premise is that individual states should regulate compounding. Also, pharmacies are exempt from the strict regulatory federal GMP standards and the requirements for submission of new drug applications. • The prescription drug legend "Caution: Federal law prohibits dispensing without a prescription" is replaced by "Rx only". • The provision that required certain substances to be labeled "Warning - May be habit forming." has been eliminated. • Encouragement for manufacturers to conduct research for new uses of drugs and to submit supplemental NDAs for these uses. The manufacturers may publicly disseminate limited information about these unapproved uses provided a statement is included specifying that the use has not been approved or cleared by the FDA. • Encouragement for drug manufacturers to perform pediatric studies of drugs by providing them with an additional six months of marketing exclusivity.

Prescription Drug Marketing Act of 1987

This bill was enacted in order to place more stringent controls on the distribution of prescription drug products and samples. Elements of this legislation include: • Requiring that prescription drug wholesalers be licensed by states under federal guidelines. • Banning re-importation of prescription drugs produced in the United States. • Banning the sale, trade or purchase of prescription drug samples. • Specifying precise storage, handling and recordkeeping requirements for drug samples. • Prohibiting, with certain exceptions, the resale of prescription drugs purchased by hospitals or health care facilities.

Homeopathic Pharmacopoeia of the United States (HPUS)

This is also published by a private organization or convention that updates information about homeopathic products or remedies on a regular basis.

What are the medicare enrollment guidelines?

Those individuals who become eligible for Medicare have an initial enrollment period that begins three months before and lasts three months after the month of their birthday. In other words, a time span of seven months. After enrollment, clients are "locked" into their specific plan until the next general enrollment period. At that time, they may switch to another plan. Failure to enroll in a plan may result in a late-enrollment penalty. A beneficiary's monthly premium is based upon the individual coverage they have chosen and may be paid directly each month or deducted from monthly Social Security checks. Anyone enrolling in Medicare may no longer contribute to health savings accounts (HSAs). This is a medical savings account intended to ease the cost of medical care for working individuals. It is available to taxpayers in the United States who are enrolled in a high-deductible health plan (HDHP). The funds contributed to such an account are not subject to federal income tax at the time of deposit.

TCAM

Traditional, complementary, and alternative medicine

TrOOP

True Out-of-Pocket expense to the individual. The sum of an individual's deductible and cost sharing expenses in Medicare Part D.

USAN

United States Adopted Names

USP DI

United States Pharmacopoeia Dispensing Information - a set of three volumes containing a variety of information, including: • Volume I - Drug Information for the Health Care Professional - contains information about individual drugs. It is written specifically for health professionals. • Volume II - Advice for the Patient - contains drug information in lay language and includes information intended for the general public about the use of drugs (side effects, etc.) Individual pages may be photocopied and provided to patients as part of the counseling process. • Volume III - Approved Drug Products With Therapeutic Equivalence Evaluations - contains information from The Orange Book, USP/NF definitions and regulations, portions of the Federal Controlled Substances Act, plus other information.

USP/NF

United States Pharmacopoeia/National Formulary

Pure Food & Drug Act of 1906

Up to 1906 there were relatively few controls on the distribution of foods, drug-containing products, cosmetic products and medical devices. Products were often contaminated, were not consistent in strength and were poorly labeled. In 1906 Congress passed the Pure Food and Drug Act. This law prohibited foods and drugs that were distributed through interstate commerce to be adulterated or misbranded. The law fell short of protecting the public since it did not require manufacturers to list on the label the ingredients or directions for use of a product. The law also did not regulate cosmetic products or medical devices.

VIPPS

Verified Internet Pharmacy Practice Site - List of relatively safe online pharmacies.

Do cosmetics have to meet FDA GMP?

While cosmetic manufacturers do not have to meet the rigorous requirements of the FDA's Good Manufacturing Practice (GMP) program, they are still obligated to manufacture these products under sanitary conditions. Otherwise, the products could be considered to be adulterated. While the Federal Food, Drug, and Cosmetic Act of 1938 does not specifically state that cosmetics have to be tested for safety, any cosmetic that poses a safety problem to the general public will be considered as being misbranded. If an unapproved color additive is used in the formulation, the product will be classified as being adulterated.

Drug Price Competition and Patent-Term Restoration Act or Hatch-Waxman Act

attempted to resolve a dispute between generic drug and brand name drug manufacturers. Prior to the enactment of this amendment to the FDCA, generic drug manufacturers had to go through most of the lengthy drug approval process that was required of manufacturers of newly developed drugs. New drug manufacturers were concerned about limited periods of exclusive patent rights for their innovative products. In enacting this bill, Congress streamlined the drug approval process for generic products by requiring submission of only an abbreviated new drug application (ANDA). This generally does not require costly clinical testing for approval of a generic product. It only requires proof of bioequivalence with its brand-name counterpart. Brand name drug manufacturers were provided with incentives to develop new drug products by being awarded up to five additional years of patent protection to compensate them for the lengthy time it takes to go through the FDA approval process.

ACA 2012, The Women's Preventive Health Care Amendment

began providing services to women including • well woman visits • gestational diabetes screening • Human papillomavirus screening • STD counseling • HIV counseling and screening • contraceptive counseling • etc. These services are provided periodically without patient cost sharing.

Tamper-resistant Packaging Act

ercial nonprescription drug packages on store shelves, the Tamper-resistant Packaging Act was passed. The intent of this Act is to prevent the intentional contamination of OTC products. Some exemptions from the requirement include: • aerosol products. • nonprescription products not accessible to the general public (such as those in hospitals and other institutions). • lozenges, and drugs in first aid kits. In November 1998, the Act was clarified by using the term "Tamper-evident Packaging". It is intended to heighten consumer awareness of potential tampering, without implying that a particular package is difficult to open or that it is "tamper- proof'. This legislation also requires that two-piece hard gelatin capsules must be sealed using a tamper-evident technology and that the packages containing the capsules have at least one tamper-evident feature.

ACA 2018 Implementations

• An excise tax would be imposed on so-called "Cadillac plans" that generally provide more than $27,500 worth of coverage for a family.

ACA 2017 Implementations

• Businesses that have more than 100 employees would be allowed to participate in the state insurance exchanges, if the state government allows it.

3 Categories of OTC

• Category I - Generally recognized as safe and effective (GRASE) for the claimed therapeutic indication. • Category II - Not generally recognized as safe and effective or having unacceptable indications. • Category III - Insufficient data available to permit final classification.

ACA 2014 Implementations

• Exchanges are created so individuals without employer-pro- vided health care (e.g. employees of small businesses) can shop for health care coverage • Insurance companies are barred from denying coverage on the basis of pre-existing conditions. • The insurance industry is required to pay an annual fee to help pay for the exchanges that cover all citizens that cannot otherwise receive insurance. • In addition to providing subsidies and guaranteed coverage for most citizens, the new health care hill requires that most people have health insurance. There is a fine for not carrying some health insurance . • An independent Medicare board is created to help curb Medicare costs if the costs rise more quickly than inflation.

ACA 2010 Implementations

• Insurance companies are no longer allowed to deny coverage to children with pre-existing illnesses. • Children are able to stay on their parent's health insurance policies until they turn 26 years old, i.e. through the age of 25. • Individuals who have not had health insurance for six months receive a subsidy to enroll in high-risk insurance pools run by the states. • All new insurance plans sold must exempt preventative care and screenings from deductibles. • Small businesses with fewer than 25 employees receive up to a 35 percent tax credit for providing health insurance to their employees.

ACA 2013 Implementations

• Many of the new taxes and fees that pay for the health care bill become effective. These taxes include new Medicare taxes on individuals who earn more than $200,000 a year. The wage tax, dividends and interest tax, and a small tax on medical devices are also implemented.

What are MTM requirements?

• Part D sponsors must automatically enroll qualified beneficiaries, unless they opt-out. • Beneficiaries must be targeted for enrollment at least quarterly. Part D sponsors must target beneficiaries who — have multiple chronic disease states - usually 2-3 or more. — are taking many Part D medications - sponsors may set the minimum number of drugs from 2 to 8. — are predicted to incur a predetermined annual cost from Part D medications. NOTE: the cost threshold for 2016 is $3507 per year. • Sponsors cannot require more than three chronic illness and MUST target at least four of the following seven core chronic disease states: — Hypertension — Heart failure — Diabetes — Dyslipidemia — Respiratory disease (e.g. asthma, COPD, etc.) — Bone disease - arthritis (e.g. osteoporosis, osteoarthritis, rheumatoid arthritis, etc.) — Mental health (e.g. schizophrenia, depression, bipolar disorder, etc.) • Offer interventions for beneficiaries and prescribers • Report specific outcomes data to CMS. Reports should include — The number of CMRs — The number of targeted medication reviews — The number of prescriber interventions — The change(s) in therapy directly resulting from the MTM interventions. • Minimum interventions must include — Comprehensive medication review (CMR) - this must include a review of medications, offering interactive consultation, and providing consultation summaries face-to-face or by telephone. — Targeted medication review - may be done person-to-person or by computer. — Reviews must be done at least quarterly for each participating beneficiary. — Interventions targeted to prescribers may be either passive (fax, mail, etc.) or interactive. • Sponsors may include passive interventions such as — Educational newsletters — Drug utilization review (DUR) edits — Refill reminders — Medication lists

ACA 2011 Implementations

• Senior citizens that fall into the "medicare donut hole" (a coverage gap) receive a 50% discount on some drugs. • Employers also start to include the cost of health care on employee's W-2 forms.

ACA 2012 Implementations

• The US Department of Health and Human Services (HHS) initiates the preparation of meaningful requirements for increasing the use of electronic health records (EHRs) and sets goals for 2013 and 2014. Stage 1 of this process establishes basic methods to enable electronic capture of patient data and provides electronic copies of health information to patients. Stage 2 extends beyond simple data capture to sharing of information between providers. It also promotes the patient's ability to access their health information. Stage 3 focuses on improving health outcomes through greater use of clinical decision support, increases patient engagement, and widens sharing of clinical data.

ACA 2015 Implementations

• The new health care bill continues the new coverage, taxes and fees that were created in previous years.

ACA 2016 Implementations

• The penalty for individuals who do not purchase health insurance rises to a minimum of $695.

What are the 6 drug classes that Medicare mandates all drugs in the class must be included?

• anticonvulsants • antidepressants • antineoplastics • antipsychotics • antiretrovirals • immunosuppressants

What are some classes of drugs that are generally not covered?

• barbiturates • benzodiazepines • weight loss or weight gain drugs • hair growth drugs • drugs that increase fertility • prescription vitamins except prenatal and fluoride products • outpatient drugs for which the manufacturer requires monitoring

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