PTCB LAWS AND REGULATIONS

HIPAA stands for

Health insurance portability and accountability act

HIPAA requires healthcare professionals to

-employ a designated privacy officer

-devise a system to properly secure protected info

-establish HIPAA-compliant privacy policies

-advise patients of their rights under HIPAA and how to request their own health info

-advise patients on how to file a complaint in the event their privacy is violated

-train employees how to properly maintain patient privacy

-sanction employees who don't properly follow HIPAA policies and procedures

Pure Food and Drug Act of 1906

- This law forbade the manufacture or transport or sale of mislabeled (branding is inaccurate, incomplete or misleading) or adulterated (product that fails to meet quality, strength, or purity standards) food or drugs and poisonous patent medicines.

-came after the meat-packing industry was exposed for it's unsanitary conditions, in Sinclair's "The Jungle"

- gave the government broad powers to ensure the safety and efficacy of drugs in order to abolish the "patent" drug trade.

- It paved the way for the eventual creation of the Food and Drug Administration (FDA) still in existence as the FDA.

Federal Food, Drug, and Cosmetic Act of 1938

• Known as FDCA 1938.

• Replaced the Food and Drug act of 1906.

- requires drug manufacturers to provide FDA with evidence of safety by submitting NDA before marketing them.

• Provided better clarification about misbranding definitions.

• Provided better clarification about adulteration definitions.

• Gave the FDA authority to require adequate testing of new drugs for safety.

Durham-Humphrey Amendment of 1951

• Created a distinction between "OTC" and "Legend Drugs".

• Legend Drugs can only be dispensed with a valid Prescription. Required Legend Drugs to carry the statement: "Caution: Federal law prohibits dispensing without a prescription.". The emphasis on this act was to insure safety thru qualified medical supervision.

Kefauver-Harris Amendment of 1962

• Also known as the "Drug Efficacy Amendment".

• Required drug manufacturers to provide proof of the effectiveness and safety of their drugs before approval.

- prior to this amendment, drug manufacturers only had to prove that the drug was safe (not misbranded or adulterated)

• Required drug advertising to be more closely regulated and disclose accurate information about side effects

- FDA's automatic 60 day approval time frame was invalidated with this amendment.

the joint commission

a non-profit, independent organization that certifies and accredits health care organizations throughout the US

joint commision accreditation

-seen as the standard for best care

-achieved by regular inspections of healthcare facilities

FDA purpose

to protect and promote public health by both supervising and regulating the production of

-food

-meds

-tobacco products

-dietary supplements

-vaccines

-biological drug products

-blood transfusions

-medical devices

-cosmetics

also investigates and enforces laws related to food and drug safety

commissioner of food and drugs

director of the FDA, appointed by the president

DEA (1973)

agency of the gov't that enforces laws related to drug use

main goals

-educate the public

-fund state and local law enforcement

-break up sources and suppliers of illegal drugs

Controlled Substances Act (1970)

-pertains to the manufacture, regulation and sale of certain controlled substances

- 5 controlled drug classes created under this act

Prescription Drug Marketing Act (1988)

-makes sure that all drugs being marketed to consumers were both safe and effective

-prevents risk to consumers from counterfeit meds

United States Pharmacopeia and National Formulary (USP-NF)

-all meds sold in the US must comply with the standards set by the USP-NF

-sets standards for food products and dietary supplements

US Nuclear Regulatory Committee (1975)

-creates standards to provide safety from regulation

-ensures patients receiving nuclear medicine receive the correct and proper dose of radiation

-ensures radioactive meds are controlled, stored and disposed of following use

Americans with Disabilities Act (1990)

-prohibits discrimination against people with disabilities

-requires public and commercial areas to accommodate people with disabilities

Poison Prevention Packaging Act (1970)

-empowered the Consumer Products Safety Commission to set rules about packaging that would be used in households with small children

-created child resistant caps

Consumer Products Safety Commission

-protects the public from unnecessary risks associated with manufactured products

-doesn't regulate drugs, but regulates drug vials

Orange Book

-"Approved Drug Products with Therapeutic Equivalence and Evaluations"

-includes all products approved by the FDA

-meds are identified by active ingredient, name, applicant and application numver

CDC

-government agency founded during WWII to prevent and control the spread of communicable diseases

-studies public health risks

compounding medications

preparing patient specific doses of meds as prescribed by a physician (can compound at pharmacies)

manufacturing medications

the bulk mixing or prep of non-patient specific medications (can NOT manufacture at pharmacies)

compounding laws

-cannot compound ahead of time

-cannot use drugs from ingredients that have been withdrawn from market

-can't use ingredients not approved by FDA

-can't compound drugs using commercial scale equipment

-can't compound drugs from third-party resale

-can't compound drugs that are otherwise commercially available

FDA Process of Drug Approval

-takes about 12 years (tested for 4 years before application is sent to FDA to begin process of human testing)

-after FDA approves testing the drug enters 3 phases of human testing

Prescription logs

-must be kept on file for at least 5 years

-must be available for inspection at any time

-records must include date dispensed, drug name/strength/dosage form, patient's name, quantity dispensed and patients address

Schedule 1 controlled substances (C-I)

-substances have no recognized medical purpose/investigational or illicit

-high potential for abuse and psychological dependence

-lack of demonstrated safety

- ex/heroin/LSD/methaqualone/marijuana *

*marijuana may have been legalized in states by DEA but CSA is still schedule 1.

Schedule 2 controlled substances (C-II)

-have accepted medical uses

-high abuse potential/psychological dependence

-stricter regulations compared to CIII onwards

-cannot be placed in automatic counting devices

-examples include most narcotics (codeine - single entity, morphine, oxycodone), stimulants (amphetamine, methylphenidate)

Schedule III controlled substances (C-III)

-have accepted medical uses

-moderate to low abuse potential, but high psychological dependence, exists but lower than in CI and CII

-examples: codeine fixed combination products, anabolic steroids, burprenorphine, ketamine, testosterone

Schedule IV controlled substances (CI-IV)

-have accepted medical uses

-low abuse potential exists but lower than in CIII

-limited physical/psychological dependence is possible, especially in combination with other substances of abuse

-examples (zolpidem, benzodiazepines, carisoprodol, tramadol, pentazocine)

Schedule V controlled substances (C-V)

-accepted medical use

-low abuse potential

-limited physical/psychological dependence

- examples include antidiarrheals (lomotil), antitussives (guaifenesin/codeine)

-cough preparations with less than 200mg of codeine/100 ml (robitussin ac), Lyrica, motofen

For CII scripts to be faxed...

pt must be

-resident in a longterm care facility

-resident in community based care

-in a hospice program

-recipient of compounded home infusion/IV pain therapy

Controlled Substances (C-II)

- no expiration per federal law, may have expiry per state law/company policy

- Cannot be refilled, must write new prescription

- cannot be transferred

- partial fill permitted as long as remainder is filled within 72 hours, if remainder not filled within 72 hours, the remainder is void and prescriber must be notified.

- Multiple prescriptions can be written at the same time, "Not to dispense before..."

- Example: patient drops off three 30-day supply prescriptions for Adderall. The issuance date (date they were written) on all three should be the same. The second prescription should state, do not fill until xxxx"

- records must be stored separately from all other Rx records.

****examples include most narcotics (codeine - single entity, morphine, oxycodone), stimulants (amphetamine, methylphenidate)

Refills, Part-fills, expiry, transfers, records

CIII-IV: can have up to 5 refills, or refills for up to six months from the date of issuance, whichever comes first.

CIII-IV: Rx valid for six months from date of issuance.

CIII-IV: partial fills are permitted with no time limit - as long as the RX is not expired.

CIII-IV: allows one time transfer between two pharmacies. Pharmacies sharing an electronic real-time, online database may transfer up to the maximum refills permitted by the law and prescriber

CIII-IV records must be stored separately from other prescriptions marked in the lower right corner with letter "C" in red ink at-least one inch high, they can then be stored in the same file with non-controlled substances prescription records. **only for hardcopies.

CS prescriptions must:

*be manually signed, no stamps or computer-generated signatures. Anything printed out or faxed must be manually signed by prescriber.

* have patient full name and address. Prescriber name, address, DEA #. Drug name, strength, dosage form, quantity, date issued, directions, prescribers signature.

changes permitted:

-dosage form

-med strength

-med quantity

-directions

changes not permitted

-patient's name

-different drug

-addition of prescriber's signature

DEA form 222

*triplicate form (1st page, brown ink, retained by CS supplier) (2nd page, green ink, CS supplier sends to DEA), (3rd page, blue ink, pharmacy retains this page for at least 2 years)

used for

-ordering CIIs from a warehouse

-transferring CIIs between locations

-returning CIIs to the wholesaler

green copy sent to local DEA Office

brown copy kept at pharmacy for at least 2 years

DEA number verification

-DEA numbers have 2 letters and 7 numbers.

-The first letter identified type of prescriber. (ABF = physician, dentist, vet, hospital, pharmacies), (M = allied health, PAs and NPs), (PR = manufacturers, narcotic tx program, researchers)

-The second letter is the first letter of the prescribers last name.

- add the 1st, 3rd, 5th numbers (X). add the 2nd, 4th, and 6th numbers x 2 (Y). add X and Y . the last number of X+Y should equal the last digit (7th digit) of the DEA number

S.T.E.P.S

system for thalidomide education and prescribing safety

-pt's required to register, undergo pregnancy testing and receive mandatory counseling before receiving first prescription

IPledge Program

restricts drug distribution of isotretinoin

-pt's must register with the program, undergo pregnancy testing, commit to 2 forms of bc

Clozapine program

-program tracks the patient's WBC count and absolute neutrophil count

drug diversion

use of a med for anything other than its intended purpose

Forged prescription tells

-drug seeker provides contradicting personal info

-prescription written from a dr who would not normally prescribe this type of med

-wrong sig codes

-dosing errors

-erasures

-2 types of ink

-refills on CIIs

mailing a prescription

-prescriptions should be mailed in a special padded envelope

Poison Prevention Packaging Act of 1970

-requires all medications (legend and OTC) to be packaged in child resistant containers to prevent accidental child poisoning by "delaying" access to the content of the containers.

-note, this is not childproof, just aims to delay the access and make it difficult for children under 5 to open the medication in a reasonable amount of time.

- However, patients who sign a waiver are exempted from this regulation.

- Certain emergency medications are exempt: such as nitroglycerin sub-lingual are dispensed in non-childproof packaging, effervescent apap, effervescent aspirin, OCP

Federal Anti-Tampering Act

This act stipulates that OTC products must be in tamper resistant packaging

"Tylenol Act"

Prescription Drug Marketing Act of 1987

Banned selling, purchasing, trading of Rx drug samples

Limits distribution of drug samples only to those licensed to prescribe them, if requested.

Omnibus Budget Reconciliation Act (OBRA)

- established 3 key pharmacy provisions (DUR, patient counselling standards, patient record maintenance)

FDAMA (food and drug administration modernization act) 1997

- eliminated certain labelling requirements (....caution federal law..... replaced to RX only)

DSHEA (Dietary Supplement Health and Education Act)

Placed health foods, food supplements and herbal products into a class different from rx and OTC drugs.

Do not have to be approved by FDA

DATA 2000

*Permits physicians to prescribe and dispense CIII-V drugs to treat opioid addiction outside of opioid treatment clinic

*allows qualified prescribers to complete training and register for a NADEAN (narcotic addiction DEA number)

*CARA allowed qualified NPs and PAs to treat narcotic dependence too. Do not need to register to opioid tx program.

CMEA (Combat Methamphetamine Epidemic Act)

This federal law sets daily and monthly limits on OTC sale of pseudoephedrine and ephedrine. Because they can be used illegally to manufacture methamphetamine (METH). These products must be stored behind the counter or in a locked cabinet.

-customer must present a valid, government issued photo ID to purchasePSE containing products.

-daily limit 3.6g/day/customer

- not more than 9g/per 30 days if purchased in store

- pharmacies must keep a written record or electronic record of all OTC sales of PSE and ephedrine products. Maintain for 2 years, include the following: product name, quantity sold, name, address and signature of purchaser, date of the sale.

- annual certification for training of all pharmacy employees to be compliant with regulations.

class 1 recall

-most serious

-drugs affected can cause serious health conditions or death

class II recall

-slightly less serious

-temporary health problems may occur from drugs affected

class III recall

-used when drug has violated an FDA regulation

-adverse health consequences unlikely to occur

medication disposal techniques

-don't flush meds down toilet unless package says to

-disposed in trash with coffee grounds/cat litter and placed in a sealed bag to prevent leakage

-destroy med label

DEA take back program

national event in which pharmacies, community partners and law enforcement agencies are encouraged to host collection sites where consumers can bring back expired or unneeded meds

ratio of pharm techs: pharmacists

2:1 or 3:1 depending on state laws

preceptor reqs

-1 to 2 years of full time employment

-fully licensed and in good standing

-desire to mentor

-desire for honest assessments

-desire to have their performance assessed by students

National Association of the Board of Pharmacy (1904)

-assists and supports the individual state boards of pharmacy

-facilitates the transfer of pharmacy licenses across state lines

Safety Data Sheets

provide info about the following materials and chemical compounds

Detailed Spill Response Plan

-immediately warn everyone

-remove contaminated clothing and flush skin

-refer to SDS for more info about the chemical

-put on personal protective equipment

-use absorption spill kit for small or medium spills

-once spill is absorbed, dispose of it in appropriate bags

-decontaminate area

-report spills to supervisor

Examples of hazardous waste in the pharmacy

-expired meds

-meds that have been incorrectly compounded

-chemotherapy

-products contaminated with bodily fluids

-items used to dispense or compound hazardous materials

First degree Burn

-least serious

-skin is red, swollen, painful

-outer layer of skin still intact

-run cool water over the area

Second degree burn

-outer layer of skin is damaged

-blisters

-same treatment as in first degree unless the burn is large

Third degree burn

-extremely serious

-skin and underlying tissue are burned through

DEA Form 41

Documents disposal and destruction of scheduled drugs

DEA Form 104

Reporting pharmacy closure or surrender of pharmacy permit

DEA Form 106

Reporting loss or theft of controlled substances

DEA form 222a

Used to order more 222 Forms

DEA Form 224

Application for New Registration for a DEA number

DEA form 224a

Renewal Application for Registration (every 3 years)

MSDS (Material Safety Data Sheet)

Standardized form that provides detailed information about potential environmental hazards and proper disposal methods associated with various computing components

OVERSEEN BY OHSA.

Medicare

A federal program of health insurance for all citizens 65 years of age and older, as well to younger citizens who are blind, widowed, disabled due to long term illness

Medicare Part A(Inpatient)

Medicare part A will pay for the following "medically necassary " services:

-inpatient hospitalization(including inpatient psych)

-hospice care

-home health care

-skilled nursing facility

Medicare Part A will not pay for custodial care(nursing homes, retirement homes)

Medicare Part B

The part of the Medicare program that pays for preventative care, physician services, outpatient hospital services, durable medical equipment, and other services and supplies.

Medicare Part C (Medicare Advantage)

Managed by private health plants.

Medicare—Part D Prescription Drug Coverage

a United States federal-government program to subsidize the costs of prescription drugs and prescription drug insurance premiums for Medicare beneficiaries.

Medicaid eligibility

Low income, single parents with dependants, blind, disabled

TRICARE

A government health program that serves dependents of active-duty service members, military retirees and their families, some former spouses, and survivors of deceased military members; formerly called CHAMPUS.

Wholesale Acquisition Cost (WAC)

represents the "list price" at which the manufacturer sells the drug to the wholesaler

AWP (Average Wholesale Price)

The average price at which drugs are purchased at the wholesale level. It is mainly used to determine third-party reimbursement.