Final Federal law and pharmacy practice outline

Question 1

MUST and SHALL

Answer 1

Required to do so by law

Question 2

May

Answer 2

Nice to do, not a requirement

Question 3

1. Durham Humphrey Amendment- revisited:

Answer 3

• Cosponsored by two pharmacist congressmen (Senator and Representative)
• OTC vs Rx
• Dispensing written, oral and electronic prescriptions
• Prescriptive authority
• Labeling requirements
• Expiration or beyond use dating (BUD)
• Switching RX to OTC
• Third class of drugs

Question 4

a. Cosponsored by two pharmacist congressmen (Senator and Representative)-

Answer 4

1. Cosponsored by two pharmacist congressmen (Senator and Representative)- created the first statutory distinction between RX and non-RX drugs. But the focus of the bill was to authorize oral prescriptions and to authorize the number of refills as indicated in the initial prescription. (before the law no oral prescriptions and no refills)

Question 5

b. OTC vs. RX

Answer 5

b. OTC vs RX

1. FDA has authority to categorize drugs as RX that are
   
   1. Unsafe except for use under supervision of a practitioner because of: (1) the toxicity, (2) the method of use, or (3) the collateral measures necessary to use the drug
   2. Subject to the NDA approval process.

Question 6

c. Dispensing written, oral and electronic prescriptions

Answer 6

c. Dispensing written, oral and electronic prescriptions- RX drugs may be dispensed pursuant to written or oral prescription promptly reduced to writing and filed.
1. What about e-prescribing? Most states have authorized (or even mandated in certain circumstances) e-prescribing, and most states allow transmission of prescriptions by fax. Medicare prescription drug laws permits e-prescribing and preempts any state restrictions

Practice concern- prescription may not be refilled unless there is specific authorization (either orally or in writing) from the prescriber. This means a prescriber’s employee (office staff, nurse) cannot legally authorize a refill unless the state law has granted that person prescriptive authority, and a prescriber CANNOT delegate authority to an agent or employee who isn’t authorized by law to prescriber. HOWEVER, an employee/agent may (state law permitting) transmit or communicate the refill authorization or new prescription from the prescriber. This means that if a pharmacist calls a prescriber’s office for refill authorization and speaks to an employee who immediately grants authorization, the pharmacist should be suspicious

1. ii. Prescriptive authority- prescription drugs may be prescribed by a practitioner licensed by law to administer such a drug. STATES license healthcare providers, not the federal government. Each state determines if a practitioner in that state has the authority to prescribe (and may place limits on the schedule of drugs a prescriber may prescribe- think CIIs- certain providers may not be permitted to prescribe CIIs).
   
   1. Consider prescriptive authority granted by the state BUT ALSO consider scope of practice of the provider (e.g., a dentist can’t prescribe drugs for back pain, or acne; podiatrist can’t treat ADHD).

Question 7

d. Labeling requirements

Answer 7

d. Labeling requirements- without Durham-Humphrey, pharmacists would be required to label their prescription drugs for dispensing with the same requirements that manufacturers have to meet; SO, this amendment exempts dispensing pharmacists from having to meet the label requirements except that:

1. The label must not be false or misleading
2. The drug dispensed must not be an imitation drug
3. The drug must not be sold under the name of another drug
4. The packaging and label must conform to official compendia standards
5. If it is a drug liable to deteriorate, it must be packaged and labeled appropriately
6. these are federal requirements- remember states usually have additional requirements; AZ requires- on outpatient labels: Pharmacy name and address, RX number (serial number), date of dispensing, prescriber name; (for animal the name of the owner and species of the animal), directions for use and any cautionary statements.

Question 8

e. Expiration or beyond use dating (BUD)

Answer 8

e. Expiration or beyond use dating (BUD)

1. Manufacturer is required to include the expiration date on the label of its product. Many states require that the pharmacist include expiration/BUD. But this may or may not be the same as the manufacturer’s date.
   
   1. Once a manufacturer’s container is opened and the drug product is transferred to another container for dispensing or repackaging, the manufacturer’s expiration/BUD is technically no longer valid.
   2. USP states that unless specified otherwise, the BUD shall not be later than (1) the expiration date on the manufacturer’s container, or (2) 1 year from the date the drug is dispensed, whichever is earlier.
   3. Expiration of 9/2020- means last day of the month.

Question 9

f. Switching RX to OTC

Answer 9

f. Switching RX to OTC- FDA has authority to switch RX to OTC status- requires proof that the product can be adequately labeled such that the consumer can (1) self-diagnose, (2) self-treat, and that the supervision of a practitioner is not required. Also considers the potential for misuse/abuse.

1. Three ways to switch (most switches occur through NDA or SNDA):
   
   1. Manufacturers may request the switch by submitting an NDA or SNDA (only applies to manufacturer’s product not to generics or other similar drug products)
   2. The manufacturer or other parties may request an OTC switch through a citizen petition to the FDA (this was the pathway for Allegra, Claritin, and Zyrtec based on a request by BlueCross/Blue Shield)
   3. The FDA may add or amend an OTC monograph (then these would apply to all drug products)

Question 10

g. Third class of drugs

Answer 10

g. Third class of drugs- Behind the Counter- no national category, but states have implemented BTC drugs.
1. Historically this issue is one of controversy between pharmacists/pharmacies who support a third class and prescribers/medical organizations oppose it.

Question 11

Providing patients prescription drug labeling information

Answer 11

Providing patients prescription drug labeling information

1. Patient Package Inserts (PPI)-required for oral contraceptives and estrogen containing drugs
2. Medication guides- FDA wanted to be sure to provide drug information to patients- two arms: (1) MedGuides and (2) Consumer Medication Information (CMI)

Question 12

a.Patient Package Inserts (PPI)-

Answer 12

1. Patient Package Inserts (PPI)-required for oral contraceptives and estrogen containing drugs
   
   1. Manufacturers must include a PPI for each package that it intends to be distributed to the patient, and pharmacist must include a PPI with each container dispensed regardless of whether it’s an initial fill or refill.- FAILURE TO DO SO IS MISBRANDING
   2. Institution (hospital, LTCF, etc.) may provide patient the PPI each time drug is administered, OR it may provide the PPI before the first dose and at every 30 days thereafter. Institution can’t delegate this authority to the prescribing physician- they must have a protocol to provide.

Question 13

b. Medication guide

Answer 13

b. Medication guides- FDA wanted to be sure to provide drug information to patients- two arms: (1) MedGuides and (2) Consumer Medication Information (CMI)

1. CMI: FDA wanted to require that useful patient information would accompany every new prescription, ultimately relied on the private sector to produce the materials. Increased distribution of CMI, but the usefulness of the materials were questionable. FDA created action plan with criteria, similar distribution and usefulness results. There are materials to hand out, but are they useful?
2. MedGuides: FDA retained the authority to mandate a medication guide program for drugs that posed a serious and significant concern. FDA requires that Medication Guides be issued with certain prescribed drugs and biological products when the Agency determines that: certain information is necessary to prevent serious adverse effects; patient decision-making should be informed by information about a known serious side effect with a product, or patient adherence to directions for the use of a product are essential to its effectiveness. MedGuides applied to outpatients who aren’t under the direct supervision of a healthcare professional and apply to new and refill prescriptions. This is now part of the REMS (risk evaluation and mitigation strategy)
   
   1. FDA requires MedGuide when:
      
      1. Patient or patient’s agent requests one
      2. When the drug is dispensed in an outpatient setting and the patient will use the drug without the direct supervision of a healthcare professional (e.g., in a community or hospital am care pharmacy)
      3. The first time a drug is dispensed to a healthcare professional for administration to a patient in an outpatient setting such as a clinic or infusion center
      4. The first time a drug is dispensed in an outpatient setting of any kind after a MedGuide is materially changed
      5. When a drug is subject to a REMS that includes specific requirements for reviewing or providing a MedGuide.
      6. NOT REQUIRED: when the drug is administered to a patient in an inpatient setting or when administered to an established patient in an outpatient setting- clinic, dialysis, or infusion.
   2. MedGuides should be written in non-technical language, in a uniform format including the following sections: approved uses of the product, circumstances when the product should not be used, serious adverse reactions, proper use, cautions, and other general information.
   3. Manufacturers must get FDA approval before the guide is distributed with the product, and must supply a sufficient number of guides to distributors or dispensers. PHARMACIES must provide MedGuide to patient each time the medication is dispensed (other information you may provide doesn’t replace the MedGuide)

List of drugs requiring a medguide: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=medguide.page

Question 14

3. Using approved drugs for off-label use

Answer 14

1. The promotion of drugs for off-label use is controversial, and subject to restrictions- and could constitute misbranding. What is off-label- when a drug is prescribed for a use not listed in the official labeling.
   
   1. Health professionals prescribe and dispense drugs for indications other than those listed in the approved labeling.
      
      1. Not all uses are included in the approved labeling-(1) healthcare practice finds uses for drugs much faster than regulatory system can approve them and (2) manufacturers rush to get their product to market and might not list all uses thinking they can go back and file NDA or SNDA.
   2. FDA’s position- is that a drug may be legally prescribed and dispensed for off-label indications or dosages

Practice consideration: More about eliminating unnecessary risk- exercise professional judgment is this an unnecessary risk to the patient- call prescriber to confirm the drug, dosage, and indication for use. Also, be aware that some insurances may not cover off-label uses.

Question 15

4. Compounding vs. Manufacturing

Answer 15

a. Pharmacy
b. requirments
c. DSQA

Question 16

4. Compounding vs. Manufacturing
   a. Pharmacy

Answer 16

1. Pharmacy- historical role of preparing medications for their patients. But, drug manufacturers began producing drugs in finished form, which diminished the need for pharmacy compounding, although new products have led to a resurgence. Pharmacies are exempt from registering with the FDA as a manufacturer if they: do not manufacture, prepare, propagate, compound, or process drugs or devices for sale other than in the regular course of their business of dispensing or selling drugs.
   
   1. If a pharmacy is deemed a manufacturer they must register for FDA license, might have to apply for IND, and conform to the regulations regarding current good manufacturing practices.
   2. If a pharmacy repackages OTC drugs or in any way change the container, wrapper, or labeling of these products for resale, they must also register as manufacturers.
   3. If pharmacy repackages prescription drug products for sale to other healthcare providers must register as manufacturer.
      
      1. ISSUE: what about pharmacies that dispense to LTCF/assisted living? When the pharmacist there repackages and relabels drugs. There is no FDA guidance or opinion- some states have authorized the practice. Arizona has regulations:
         
         1. Only a pharmacist is permitted to label a drug container or alter the label of a drug container
         2. A pharmacist shall not repackage a drug previously dispensed to an assisted living facility resident

Question 17

4. Compounding vs. Manufacturing

Requirements:

Answer 17

1. Requirements: Pharmacy is exempt from adequate directions for use, CGMP, and new drug requirements IF the compounded product meets the following conditions:
   
   1. It is for an individual patient based on the receipt of a valid prescription and compounded by a licensed pharmacists or physician (THIS MEANS PHARMACY CANNOT COMPOUND FOR ANOTHER RESELLER LIKE A PHARMACY OR HOSPITAL)
   2. It is for a “limited quantity” if prepared in anticipation of receiving a prescription. The amount anticipated must be legitimately based on the established practice history between the prescriber, pharmacy, and patients.
   3. The product is not essentially a copy of a commercially available product, unless compounded only occasionally, and not in inordinate amounts. A compounded drug is not essentially a copy if there is a change made for an identified individual patient, which produces for that patient, a significant difference, as determined by the prescribing practitioner, between the compounded drug and the commercially available drug.
   4. It is compounded in compliance with the USP chapters on compounding, using bulk substances that comply with monograph standards, if one exists
   5. Compounding only with FDA approved drugs that have not been withdrawn or removed from the market because of safety or efficacy issues.

Question 18

4. Compounding vs. Manufacturing

DSQA

Answer 18

c. DSQA also created a new category of sterile compounding pharmacies under 503B known as outsourcing facilities, a status for which pharmacies can voluntarily register. Outsourcing facilities can legally compound drugs and ship them interstate without an individual prescription and without quantity limitations.

1. Outsourcing facility is a facility registered with the FDA for that has one geographical location engaged in the compounding of sterile drugs (compounding and shipping batches of sterile products to other healthcare licensees like hospitals and clinics- not based on individual patient prescriptions) and complies with all 503B requirements:
2. All sterile compounding:
   
   1. Complies with cGMP standards
   2. Permits FDA inspections according to a risk based schedule
   3. Prohibits the sale or transfer of compounded products by an entity other than the outsourcing facility
   4. Complies with labeling requirements for each container
   5. Meets other conditions- reporting adverse events and providing FDA with product compounding information.

Question 19

5. Generic substitution and the role of the FDA

Answer 19

1. All states have passed generic drug substitution laws- which permit pharmacists to substitute a generically equivalent drug for the prescribed drug, subject to certain requirements and restrictions
2. Use of Orange Book in generic substitution
3. The coding system for therapeutic equivalence evaluations
4. Look at the image in the outline
5. Arizona: if a medical practitioner prescribes a brand name drug and DOES NOT indicate an intent to prevent substitution, a pharmacist may fill the prescription with a generic equivalent drug.
6. Look at the image in the outline
7. Narrow therapeutic index (NTI) drugs/Narrow Therapeutic Ratio (NTR) drugs
   
   1. A drug where there is less than a twofold difference between the median lethal dose and the median effective dose, or where there is a less than twofold difference between the minimum concentration and the minimum effective concentration in the blood.
8. Bioequivalence requirements are not adequate for NTI/NTR drugs Advisory committee voted that FDA accept new guidelines for NTI/NTR drugs narrowing the potency range to 95 to 105%

Question 20

All states have passed generic drug substitution laws-

Answer 20

1. All states have passed generic drug substitution laws- which permit pharmacists to substitute a generically equivalent drug for the prescribed drug, subject to certain requirements and restrictions.
   
   1. Mandatory substitution states- pharmacists must substitute less expensive generic drug for the brand name drug unless prescriber writes dispense as written, brand necessary, or a similar notation on the prescription
   2. Permissive substitution states- pharmacy may choose to substitute if the prescriber issues prescription in such a way that permits the substitution (Arizona)

Question 21

b. Use of Orange Book in generic substitution

Answer 21

1. Drug products are considered to be therapeutically equivalent only if they meet these criteria:
   
   1. They are pharmaceutical equivalents (contain the same active ingredient(s); dosage form and route of administration; and strength.)
   2. They are assigned by FDA the same therapeutic equivalence codes starting with the letter “A” To receive a letter “A”, FDA designates a brand name drug or a generic drug to be the Reference Listed Drug (RLD). FDA assigns therapeutic equivalence codes based on data that a drug sponsor submits in an ANDA to scientifically demonstrate that its product is bioequivalent (i.e., performs in the same manner as the Reference Listed Drug).
   3. A RATING VS. B RATING (A= bioequivalent; B= NOT bioequivalent) detailed table in outline

Question 22

The coding system for therapeutic equivalence

Answer 22

1. The coding system for therapeutic equivalence evaluations allows users to determine whether FDA has evaluated a particular approved product as therapeutically equivalent to other pharmaceutically equivalent products (first letter) and to provide additional information on the basis of FDA’s evaluations (second letter). Sample TE codes: AA, AB, and BC FDA assigns therapeutic equivalence codes to pharmaceutically equivalent drug products.
   
   1. A drug product is deemed to be therapeutically equivalent (“A” rated) only if:
      
      1. A drug company’s approved application contains adequate scientific evidence establishing through in vivo and/or in vitro studies the bioequivalence of the product to a selected reference listed drug.
      2. Those active ingredients or dosage forms for which no in vivo bioequivalence issue is known or suspected.
      3. Those products which the FDA does not deem to be therapeutically equivalent are “B” rated.
   2. Some drug products have more than one TE Code.
   3. Over-the-counter drugs are not assigned TE codes.
      
      1. Therapeutic equivalence DOES NOT equal therapeutic substitution- which refers to substituting different therapeutic agents that may be used for the same condition.

Pharmaceutical equivalent: drug product that have the same form, route, strength, and active ingredient

Therapeutic equivalent (federal terminology)- Pharmaceutically equivalent and bioequivalent

Generic equivalent (Arizona)- a pharmacist may fill the prescription with a generic equivalent

Question 23

6. Prescription drug marketing act of 1987 (PDMA) amends the FDCA to

Answer 23

6. Prescription drug marketing act of 1987 (PDMA) amends the FDCA to
7. Require states to license wholesale distributors of prescription drugs
8. Ban the reimportation of prescription drugs, except by the manufacturer or for emergency use
9. Ban the sale, trade, or purchase of drug samples
10. Mandate storage handling, and recordkeeping requirements for samples
11. Ban the trafficking in or counterfeiting of drug coupons
12. Prohibit the resale of prescription drugs purchased by hospitals or health care facilities with certain exceptions.

Question 24

7. PDMA: Drug sample regulations

Answer 24

1. To prevent historical abuses of the use of drug samples- the Prescription Drug Marketing Act (PMDA)- this act prohibits the sale, purchase or trade of drug samples. Same restrictions also apply to coupons used to redeem the drug at no cost or at a reduced rate.
   
   1. Sample- defined as unit of drug intended not to be sold but rather to promote the sale of the drug
      
      1. May only be distributed to practitioners licensed to prescribe or to pharmacies of hospitals or health care entities at the written request of the prescriber on a form that includes the information specified by law:

Question 25

1. PDMA: Drug sample regulations
   
   1. To prevent historical abuses of the use of drug samples- the Prescription Drug Marketing Act (PMDA)- this act prohibits the sale, purchase or trade of drug samples. Same restrictions also apply to coupons used to redeem the drug at no cost or at a reduced rate.
      
      1. Sample- defined as unit of drug intended not to be sold but rather to promote the sale of the drug
         
         1. May only be distributed to practitioners licensed to prescribe or to pharmacies of hospitals or health care entities at the written request of the prescriber on a form that includes the information specified by law:

Answer 25

1. Practitioners must make the request each time- standing request is not acceptable
2. If sample is shipped or mailed, recipient must execute a written receipt for the sample on deliver and receipt must be returned to the manufacturer or distributor
3. Regulations under this act, do not permit retail pharmacies to receive samples, but hospital or health care entity pharmacies may receive samples at the request of a licensed practitioner, provided there is a receipt containing:
   
   1. The name and address of the requesting prescriber
   2. The name and address of the hospital or health care entity designated to receive the drug sample
   3. The name, address, title and signature of the person acknowledging delivery of the drug sample
   4. The proprietary or established name and strength of the drug sample
   5. The quantity and lot or control number
   6. The date of delivery
4. Starter packs distributed by manufacturers free to pharmacies are not considered samples because they are not labeled as such and could be sold.

Question 26

8. Purchases and re-sales by hospitals and health care entities

Answer 26

1. History- diversionary markets didn’t involve only drug samples, congressional investigations discovered that prescription drugs were diverted when hospitals and health care entities resold their excess purchases.

Question 27

1. Purchases and re-sales by hospitals and health care entities
   
   1. History- diversionary markets didn’t involve only drug samples, congressional investigations discovered that prescription drugs were diverted when hospitals and health care entities resold their excess purchases.

Answer 27

1. Some hospital and health care entities are able to purchase drugs at lower prices than community pharmacies.
2. Concerns regarding adulteration and misbranding.
   
   1. Improper storage
   2. Repackaging – from larger containers to smaller mislabeled containers
3. PMDA prohibits the sale, purchase or trade (or offer to do so) of prescription drugs that have been purchased by a hospital, health care entity or charitable organization. Except when
   
   1. A hospital purchases from a group purchasing organization or from other member hospitals for its own use.
   2. Sales or purchases to nonprofit affiliates
   3. Sales or purchases among hospitals or health care entities under common control
   4. Sales or purchases for emergency medical reasons (e.g., transferred allowed between health care entities or from a health care entity to a community pharmacy to alleviate temporary shortage of prescription drug)
   5. Selling or dispensing prescription drugs pursuant to prescription.

Question 28

9. Product returns

Answer 28

1. Under PMDA there was a question whether hospitals and health care entities could legally return mistakenly ordered and outdated prescription drug products to wholesalers and manufacturers. FDA has agreed to permit returns provided the drugs are properly stored and handled and proper records are kept

Question 29

10. Wholesale distributors

Answer 29

1. Wholesale distribution is distribution to anyone other than the consumer.
2. PDMA- all persons engaged in the wholesale distribution of prescription drugs must be licensed by the state in accordance with prescribed guidelines.
   
   1. Intent is to prevent individuals who can obtain drugs at lower prices from reselling those drugs unless they are licensed as a wholesaler.

Question 30

11. Counterfeiting
12. Section 503(e)(1)(A) of the PDMAct establishes the pedigree requirement for prescription drugs.

Answer 30

i. Pedigree:
ii. Who:
iii. Increase in counterfeit drugs has influenced FDA and state boards of pharmacy to propose legislation that would require pedigree tracking by everyone in distribution chain including pharmacies at some future date
iii. Proposed under FDAAA to prioritize and develop standards to identify, authenticate, and track and trace prescriptions drugs and develop a standardized numerical identifier to be applied to the drug by the manufacturer. Not implemented yet.

Question 31

11. Counterfeiting
12. Section 503(e)(1)(A) of the PDMAct establishes the pedigree requirement for prescription drugs.

i . Pedgree:

Answer 31

1. Pedigree: A drug pedigree is a statement of origin that identifies each prior sale, purchase, or trade of a drug, including the date of those transactions and the names and addresses of all parties to them.

Question 32

11. Counterfeiting
12. Section 503(e)(1)(A) of the PDMAct establishes the pedigree requirement for prescription drugs.
    ii. Who:

Answer 32

ii. Who: each person who is engaged in the wholesale distribution of a prescription drug in interstate commerce, who is not the manufacturer or an authorized distributor of record for that drug, must provide to the person who receives the drug a pedigree for that drug. The PDMA states that an authorized distributor of record is a distributor that has an “ongoing relationship” with a manufacturer to distribute that manufacturer’s drug products.

Question 33

12. Reimportation of prescription drugs

a.

Answer 33

1. Generally reimportation of drugs from another country is illegal; importation of drugs that lack FDA approval- including foreign made versions of US approved drugs that have not been manufactured in accordance with and pursuant to FDA approval

Question 34

12. Reimportation of prescription drugs

b.

Answer 34

b. PMDA allows for the reimportation of prescription drugs, but only by the original manufacturer or for emergency use.

Question 35

12. Reimportation of prescription drugs

c.

Answer 35

c. Medicare Prescription Drug Improvement and Modernization Act allows secretary of HHS to promulgate regulations that facilitate the wholesale importation of prescription medications from Canada.
1. May only do so if the secretary can certify the program would pose no additional risk to public health or safety and would significantly reduce cost. To date, secretary has refused to recognize any certification

Question 36

12. Reimportation of prescription drugs

d.

Answer 36

d. FDA has permitted personal importation of small amounts of drugs, but only if when 1) the intended use [of the drug] is unapproved and for a serious condition for which effective treatment may not be available domestically either through commercial or clinical means; 2) there is no known commercialization or promotion to persons residing in the U.S. by those involved in the distribution of the product at issue; 3) the product is considered not to represent an unreasonable risk; and 4) the individual seeking to import the product affirms in writing that it is for the patient’s own use (generally not more than 3 month supply) and provides the name and address of the doctor licensed in the U.S. responsible for his or her treatment with the product; OR (1) provides evidence that the product is for the continuation of a treatment begun in a foreign country/area and (2) they are not approved in the US and are used for the treatment of a serious condition for which no satisfactory treatment is available in the US

1. Foreign made versions of US approved drugs would not generally be considered a candidate for entry under this guidance.
2. But, FDA has determined that using its resources to provide comprehensive coverage and enforcement of drug important for personal use is generally not justified. Different entity patrols border entry. (Immigration and Customs Enforcement/Customs and Border Patrol/Department of Homeland Security)
   
   1. Department of Homeland Security Appropriations Act of 2007 individual patient may import an FDA approved prescription drug from Canada
      
      1. Individuals transporting the drug on their person
      2. In a quantity not to exceed 90 day supply and not to exceed a total combined quantity of 50 dosage units.
      3. Not a controlled substance or biologic product
      4. Dispensed in original container and declared at customs
3. Penalties- up to 10 years in prison and or up to $250,000.

Question 37

13. Inspections under the FDCA

Answer 37

1. FDA does not routinely inspect pharmacies, but FDCA permits FDA inspectors to inspect facilities where drugs are held at reasonable times, within reasonable limits and in a reasonable manner, but pharmacies that don’t manufacture, prepare or compound drugs or devices for sale other than in the regular course of business are exempt.
   
   1. Courts have held that FDA can inspect pharmacy to determine whether it is engaging in manufacturing and if the FDA has probably cause to believe the pharmacy is manufacturing, FDA can extend its search to the pharmacy’s records
   2. FDA agents do not need a warrant under the statute, but merely must show their credentials and a notice of inspection- don’t need to state the reason for the inspection.
   3. Fine for refusing entry to FDA inspector could result in a penalty of up to 1 year in prison and or a $1,000 fine.

Question 38

14. Use of alcohol in pharmacy practice

Answer 38

1. Use of denatured alcohols, ethyl alcohols and isopropyl alcohols in pharmacy practice vs. ethyl alcohol (beverage liquor) sold in liquor stores, grocery stores and some pharmacies.
   
   1. Selling beverage alcohol at retail must conform to the licensing and tax requirements established by Bureau of Alcohol Tobacco and Firearms and IRS.
   2. Community pharmacies that use alcohol to compound prescriptions commonly use tax-paid ethyl alcohol, purchased from an authorized retail or wholesale outlet.
      
      1. Cannot legally obtain or use tax free alcohol.
   3. Some entities use tax-free ethyl alcohol that is not federally taxed:
      
      1. State or political subdivisions for scientific and mechanical purposes
      2. Educational institutions for scientific and mechanical purposes
      3. Laboratories for scientific research
      4. Hospitals, blood banks for scientific, mechanical, and medicinal purposes and in the treatment of patients
         
         1. Medicines made with tax free alcohol may not** be sold to **outpatients.
      5. Pathology laboratories in connection with hospitals for scientific, mechanical, and medicinal purposes and in the treatment of patients
      6. Nonprofit clinics for scientific, mechanical, and medicinal purposes and in the treatment of patients.
         
         1. Outpatient charity clinics may furnish medications made with tax-free alcohol if they do not charge.
   4. Tax free alcohol must be stored in securely locked storeroom with the labels and markings on the containers intact. When containers are empty, the labels and the markings must be obliterated before discarding. Records of use must be kept.

Question 39

15. Omnibus Budget Reconciliation Act of 1990 (OBRA 90)

Answer 39

a. background
b. OBRA framework

Question 40

15. Omnibus Budget Reconciliation Act of 1990 (OBRA 90)
    a. Backgroud

Answer 40

1. Background
   
   1. First federal law that directly addressed pharmacist practice standards
   2. Recognizes a public expectation of pharmacists to detect and resolve problems with drug therapy
   3. Establishes a federal policy requiring drug use review (DUR) to ensure that drug therapy is as safe and effective as possible.
      
      1. Difficult since states, not federal government regulate professional practice.
      2. Avoid this issue by making it a condition of participation in Medicaid that states must establish expanded standards of practice for pharmacists.
         
         1. Some states- state board of pharmacy promulgates regulations imposing the expanded requirements for pharmacists
         2. Other states have left the responsibility to state Medicaid agency

Question 41

15. Omnibus Budget Reconciliation Act of 1990 (OBRA 90)
    b. OBRA framwork

Answer 41

1. Three main areas:
   
   1. Rebates
      
      1. Requires manufacturers to provide pharmaceuticals to Medicaid at their “best price”, the lowest price at which they sell the product to any consumer (42 U.S.C. §1396r-(a).
   2. Demonstration projects
      
      1. address pharmacist-provided DUR services and patient care outcomes and effectiveness, efficiency, and cost-effectiveness of online computerized DURs and face to face consultation
   3. DUR- drug utilization review- three parts are all ongoing elements of continuous quality improvement

Question 42

15. Omnibus Budget Reconciliation Act of 1990 (OBRA 90)
    b. OBRA Framework:
16. DUR- drug utilization review- three parts are all ongoing elements of continuous quality improvement

Answer 42

1. Retrospective review
   
   1. DUR Board, composed of both physicians and pharmacists oversees retrospective review. 42 U.S.C. §1396r-8(g)(2)(B).
      
      1. Review data concerning the use of medications over a particular period of time and compare those data with criteria for medication use previously developed by DUR board.
         
         1. Ideal therapy and determines whether actual medication use conforms to the ideal.
            
            1. Find duplications, drug/drug interactions, or continuing therapy for too long, or not long enough.
2. Educational program
   
   1. Targets- physicians, pharmacists or both
   2. Face to face, symposia, written materials
   3. Goal: improve the way medications are used.
3. Prospective review
   
   1. Pharmacists consider prescribed drug therapy and apply professional expertise.
   2. DUR board can review new data developed as a result of prospective DUR
4. Components of a prospective DUR:

Question 43

15. Omnibus Budget Reconciliation Act of 1990 (OBRA 90)
    b. OBRA Framework:
16. DUR- drug utilization review- three parts are all ongoing elements of continuous quality improvement
    d. Components Perspective DUR

Answer 43

1. Three required components: (1) SCREEN PRESCRIPTIONS BEFORE DISPENSING; (2) PATIENT COUNSELING BY PHARMACIST; (3) PHARMACIST DOCUMENTATION OF RELEVANT INFORMATION.
   
   1. Screen of prescriptions before dispensing
      
      1. Pharmacists, using their professional judgment (probably don’t want to just rely on computer programs), must detect potential problems
      2. Review of drug therapy before each prescription is filled or delivered to an individual
      3. Screening for: potential drug therapy problems due to therapeutic duplication, drug-disease contraindication, drug-drug interaction (including serious interactions with nonprescription or over the counter drugs), incorrect drug dosage or duration of treatment, drug allergy interactions and clinical abuse/misuse. 42 U.S.C. §1396r-8(g)(2)(A)(i).
2. Patient counseling by the pharmacist
   
   1. Standards, must offer to discuss with each patient or caregiver matters that in the pharmacist’s professional judgment are significant, including and not limited to:
      
      1. Name and description of medication
      2. The dosage form, dosage, route of administration, and duration of drug therapy
      3. Special directions and precautions for preparation, administration, and use by the patient
      4. Common severe side effects, adverse effects, or interactions and therapeutic contraindications that may be encountered, including ways to prevent them and the action required if they do occur
      5. Techniques for self-monitoring drug therapy
      6. Proper storage
      7. Prescription refill information
      8. Action to be taken in case of a missed dose (42 U.S.C. §N1396r-8(g)(2)(A)(ii)(I).
   2. Waiver- patients have the right to refuse counseling
      
      1. But, refusal is only effective if the patient truly understood the offer and really did not want the counseling- i.e., asking them if they want to wait 45 minutes to be counseled
3. Pharmacist documentation of relevant information- requires pharmacists to maintain a written record that contains information about patients and the pharmacist’s impressions of the patient’s drug therapy:
   
   1. Reasonable effort must be made to obtain record and maintain patient profile including
      
      1. Name, address, phone number, date of birth, (or age) and gender
      2. Individual history, - known diseases and medical conditions, known drug allergies or drug reactions, comprehensive list of current medications, list of medical devices.
      3. Pharmacist comments relevant to the individual’s drug therapy
      4. Documentation should be complete enough to (1) serve as a reminder to the Pharmacist writing the information; (2) provide information for other pharmacists working in the same pharmacy; (3) show a record of what was done, so that someone may be able to connect an action with an outcome; (4) establish compliance with OBRA 90 and state requirements.

IF IT ISN’T DOCUMENTED IT WASN’T DONE!

Question 44

16. Health Insurance Portability and Accountability Act of 1996 (HIPAA)

Answer 44

sorry, read the outline too long to post here and break down

Question 45

17. Medication management under Medicare

Answer 45

1. Medicare Part D- Medicare Prescription Drug Improvement and Modernization Act of 2003 (MMA) requires coverage for disease management programs, termed MTM. Pharmacists may receive fees for providing MTM services to those patients with multiple chronic diseases who take multiple covered drugs and who will likely exceed annual drug costs as determined by HHS.

Question 46

18. Federal regulation of long term care and pharmacist responsibilities in skilled nursing facilities

Answer 46

Sorry too long to create flashcards or breakdowns. Read outline