pharmacy practice final

Drug development from Lab to Market

Lab Research → Animal Studies → Investigational New Drug (IND) → Humans (Clinical Trials Phase 1-3) → New Drug Application (NDA) → FDA Review/Approval → Market (Phase 4)

Investigational New Drug (IND)

FDA determines if compound is reasonably safe to test in humans based on Animal Pharmacology/Toxicology, Manufacturing Information, and Clinical Protocols and Investigator Info

New Drug Application (NDA)

Drug Sponsor Submits to FDA: Several 100,000 pages of data, documentation of safety/efficacy, all information from development, benefits vs. risks, manufacturing process

Phase I

- 6-9 months

- Healthy, small group (20-80)

- side effects, with increasing doses

- metabolism

- excretion

Phase II

- 6 months - 3 years

- emphasis on effectiveness

- patients with condition (100-300)

- placebo controlled

- safety/side effects continue to be studied

- establish minimum/maximum dosing

Phase III

- 1-4 years

- emphasis on safety/efficacy/dosing

- expanded trails allow extrapolation

- interactions/effects/toxicities evaluated

- special trials: renal insufficiency, hepatic insufficiency, elderly vs. young, lactating women

Information that may be found in the Highlights section of the package insert

limitations, product names and date of initial approval, boxed warnings, recent changes like dosage forms and strengths, contraindications, warnings, and precautions

Contraindication

really, really should not take because risk of harm is too high

Warning

Use, but monitor closely and drug may pose a significant risk

Precaution

medicine should be used with careful assessment because the risk of adverse reaction may be increased

Key events leading to Pure Food and Drug Act

Established in 1906 by the Pure Food and Drug Act which gives the FDA authority to pursue manufactures of misbranded drugs or adulterated drugs

Key events leading to Food Drug and Cosmetic Act

Established in 1938 because of the sulfanilamide tragedy. FDA's oversight/regulation includes drugs, medical devices, and cosmetics

Key events leading to Durham Humphrey Amendment

1952 - categorized drugs into OTC and prescription

Key event leading to Drug Amendments of 1962

Thalidomide tragedy

Role of FDA in the oversight of pharmacy

Oversight on drugs, medical devices, and cosmetics

Role of State Board of Pharmacy in the oversight of pharmacy

- Protect the public from the profession and govern the practice of pharmacy on a day to day basis

- Issue licenses to pharmacies, pharmacists, interns, and technicians.

- Provide and enforce laws that govern the practice of pharmacy

- Take action on those who break the law

Role of DEA in the oversight of pharmacy

Minor responsibility in pharmacy, but major role is to fight drug trafficking, controlling the sale of large quantities of illegal drugs, apprehension of healthcare professionals who divert legal prescription drugs to the illegal market

Role of CMS in the oversight of pharmacy (Medicare)

Medicare is responsible for paying for elderly and disabled patients. It is funded by the federal government. Part A is for hospital insurance, Part B for medical insurance, and Part D for prescription insurance

Role of CMS in the oversight of pharmacy (Medicaid)

- Responsible for paying for indigent patients by state and federal government

- Funded by state and federal government

- responsible for enrolling patients, covering physician visits, and covering medications

Purpose of OBNDD in the oversight of pharmacy

Govern the dispensing of controlled medication and enforcing laws

Misbranded drug

Improperly labeled as to content or proper use

Adulterated drugs

Tampered with or contaminated with impure/foreign substances

Information that goes on the prescription label

Patient, DOB, date, refills, provider, sig, quantity, drug name, strength, form, pharmacy name, address, and phone number, prescription number

Information that goes on prescription label on a bottle

Pharmacy name, address, and phone number, date filled, patient name, drug name, strength, quantity, provider, refills, sig

Information needed for a transfer

patient, DOB, drug, sig, prescription number, pharmacy from, address, phone number, pharmacist, pharmacist license number, provider, date written, original refills, refills remaining (1+x), last refill date, controlled drug= physician's DEA#