Pharmacy Law, FDA Regulations, HIPPA, and Prescription Labeling

How long are controlled prescriptions required to be kept on file federally?

2 years

Pharmacy Practice Act

State-specific legislation concerning the regulation of the practice of pharmacy and related matters

Food and Drug Administration (FDA)

Approves prescription and OTC meds, and enforces laws relating to them

Prescribing Information

FDA-approved scientific info for med's theraputic use

Highlight document

Lists indications, usage, dosage, administration, adverse rxns, and drug interactions, attached to stock bottle

Patient Package Inserts/MedGuides

For potentially dangerous or black-boxed meds, or meds with specific self-administration procedures

MedWatch

FDA reporting service for defects, adverse rxns, and errors for everyone

Pure Food and Drug Act of 1906

Prohibits interstate commerce of adulterated food and drugs

1938 Food, Drug, and Cosmetic Act

Pure Food and Drug Act of 1906 supplement, creates FDA under USD of Health and Human Services, determined which drugs were rx, and labeling rq for all meds

PHI

Protected Health Information, anything created or stored about pt identity or health

How long must privacy pratices/policies be stored?

6 years after creation or last effective date

Patient Rights

Obtain copies of own PHI, further restrict PHI use, and find out how pharm used PHI

Who can report HIPPA violations?

Anyone

How often are staff usually retrained on HIPAA policies?

Annually

National Provider Number (NPI)

Applied to all health care providers, including institutions like pharmacies. Must be used whenever HIPAA is in effect

Health Care Fraud and Abuse Control Program

Created by HIPAA, detects/investigates fraudulent claims

Required Prescription Elements

Prescriber Info, Pt Info, Written Date, Med Info, Sig, Prescriber Signature

Who makes "do not use" abbreviation lists?

The Joint Commission, Institute for Safe Medication Practices (ISMP)

What are the 5 rights of Medication Administration?

Patient, Medication, Strength, Route, Dose, Time

Omnibus Budget Reconciliation Act of 1990 (OBRA)

Rqs pt profiles for all used meds, for counseling to be offered to all pts, and for regular DURs to be performed

How many times can uncontrolled substance prescriptions be refilled?

Unlimited within 1 year of writing

What is required on all Manufacturer's Prescription Packaging Labels?

Established name/quantity of active ingredients, usual dose, federal legend, admin route, Lot #, dispensing procedures, name/place of manuf, exp date, habit warning

What is required on Manufacturer's Prescription Packaging Labels for controlled substances?

Controlled Substance Mark (CX) in clear, large print

What is required on Manufacturer's Prescription Packaging Labels for non-oral substances?

All inactive ingredients

What is required on Manufacturer's Prescription Packaging Labels for reconstituted medications?

Statement of New Quantity

What is required on Manufacturer's Prescription Packaging Labels for OTC medications?

Product Name, Manuf/Distributor Name/Address, Established Names of all Active and Inactive ingredients, Indications, Net Contents, Rqed Cautions and warnings, any habit forming substances, directions for use

Drug Supply Chain Security Act (DSCSA)

Requires FDA to develop tracking system to find counterfeit or poor quality drugs. Uses barcode

Bioequivalence

Found in FDA's Approved Drug Products With Theraputic Equivalence (Orange Book)

ISMP Minimum Rx Label Requirements

Pharm Name/Address/Phone #, Prescriber name, Pt name, fill date, Rx #, Exp Date, Med Name/Strength/Form/Quantity/Manuf/Sig, Auxillary Labels

Poison Prevention Packaging Act (PPPA) of 1970

Requires packaging 80% of children under 5 can't open/90% of adults can open within 5 min, unless rq by prescriber/pt, is inpatient, or rqed for proper med storage.

Meds that require specific packaging

Sublingual Nitroglycerin, chewable isosorbide, methylprednisolone, pancrilipase, cholestyramine powder, unit-dose potassium

Occupational Safety Act of 1970

Created Occupational Safety and Health Administration (OSHA)

Sharps

Anything that can penetrate skin (includes trash such as broken glass)

Sharps containers must:

Be rigid, puncture resistant, red, have biohazard symbol, be leakproof on sides and bottom, not allow retrieval after disposal, closable, able to stand upright, away from patients, and easily accessible to staff.

How to Recap a Needle

Don't unless strictly necessary. Use mechanical device or needle itself to pick up cap, then push against hard surface for tight fit.

To Clean Up Broken Glass:

Use brush/dustpan, tongs, or forceps

Hazardous Drugs

Have serious side effects in animal or human testing, cause organ damage, cancer, or harm to a pregnant person

Who Regulates Hazardous Meds?

OSHA, USP 800

USP 800 Hazardous Drug Requirements

HD must be stored seperately, admin by closed-sys transfer, prepared with PPE, and spills must be cleaned specific to environment they occured in and placed in yellow HD-specific receptacle.

OSHA Hazardous Drug Requirements

SDS must be maintained for all stored/used hazardous substances, training for employees who handle HD, and appropriate disposal of biologic materials in red bag w/biohazard symbol

Fraud

submitting false claim, using someone else's insurance card for your own coverage, and forging/altering/stealing + filling/selling scripts.

Fraud indications

lack of accepted abbrevs, multiple ink colors, photocopied appearance, unusually neat writing, unusually large or visibly altered quantity, unfamiliar prescriber/pt

Reasons for Waste

Pt nonadherence, unecessary brand dispensing, therapy changes, care transition

Abuse

Excessive charging, unecessary billing, drug abuse

Opioid Rapid Response Program

To reduce risk of overuse death. Minimizes interruption in therapy due the facility closures, prescriber-pt relationship ending, pt incarceration, etc.

Patient Profiles include:

demographics, ssn, rx history, allergies/intolerances, chronic conditons, insurance info, misc notes

Controlled Substance Act

Regulates manuf, import, possession, use, and distrib of substances with potential for abuse and dependence. Enforced by DEA of Dept of Justice

C-I

no accepted medicinal use and cannot be prescribed

C-II

prescribable, high abuse potential

C-III

Medical use, moderate phys dependence and high psychological abuse potential

C-IV

Low Abuse/Dependence Potential

C-V

low abuse potential, limited dependence risk

What is a valid first letter of a DEA number?

A, B, F, M, X

Does a DEA # need to be present in an inpatient setting

No

Required Parts of Controlled Substance Prescription

Pt full name/full address, Prescriber name/address/phone#/DEA#, date rx issued, # refills, prescriber signature

C-II refilling

No refills. 30 day supply, though prescribing 3 different scripts with different start dates for 90 day supply allowed.

C-II Partial Fills

Allowed if full quantity not avaliable, must be completed within 72 hrs unless pt or prescriber request.

Comprehensive Addiction and Recovery Act of 2016

Permits partial fills to be completed within 30 days at pt or provider rq state law allows. Total quantity can't be greater than original prescribed quantity.

C-II Formatting

Must be physical or electronic. Faxing and phoning in allowed for long term care/hospice pts and parenteral narcotics if original sent within 7 days.

C-II Transfers

must be between 2 licensed pharms, must be electronic, not altered during transfer, and allowed under state laws

C-II mailing

Allowed if outer container does not describe contents, and inner container labeled with pharm name and address

Pseudophedrine Limits

3.6g per day, 9g per 30 days

C-II Order Form

DEA Form 222, valid for 60 days

Pseudophedrine record logs kept for

2 years

C-II Disposal Form

DEA Form 41

C-II Loss/Theft

DEA Form 106

Inventory of Controlled Substances

Every 2 years after initial stock. Records must be kept for 2 years

Controlled Substances Dispensing Records

CII seperately, others can be seperate or with other dispensing records

Lending Controlled Substances

If both pharms registered with DEA, DEA Form 222 filled out, and total quantity <5% of recieved in a year.