TEXTBOOK Chapter 3 -- the Pharmacist and the Pharmacy profession Flashcards
the predominant forces shaping pharmacy and medication use today took effect largely during what century?
20th century (1900s)
before the 20th century, those who practiced pharmacy were trained via____
apprenticeship
what was the 1st major piece of legislation to affect medication use in the 20th century?
the pure food and drug act of 1906
why did the government pass the food and drug act of 1906?
before it was passed, many medicines sold at the time through apothecaries or pharmacies were ineffective, mislabeled, or even unsafe
this law enabled authorities to enforce penalties for mislabeling and adulteration (mixing something with something else – could be unsafe)
why was the pure food and drug act of 1906 still not perfect?
the law wasnt well written – many found loopholes to evade punishment
also, the act didnt address the issue of EFFICACY in drug products
due to the loopholes and lack of addressing efficacy, many people pushed the government to strengthen the pure food and drug act of 1906.
when did this happen?
it took tragedy — the ingestion of toxic elixir sulfanilamide in 1937 (caused at least 73 deaths)
gave the impetus (push) for the gov to pass the
“FOOD, DRUG AND COSMETIC ACT OF 1938” FDCA
what was the name of the federal agency in charge of enforcing the food, drug, and cosmetic act of 1938? (FDCA)
the FDA (food and drug administration)
in 1938, when the FDA was established, what was their job?
- to enforce the food, drug, and cosmetic act of 1938 (FDCA) – SAFETY AND EFFICACY
- to approve new drugs and indications of drugs before they could be marketed
explain why the 1937 elixir sulfanilamide incident happened
the sulfa antibiotic was safe for many years – that wasn’t the issue.
new oral preparation was made with antifreeze “diethylene glycol” – issue
how many deaths were caused by thr 1937 elixir sulfanilamide incident
73-107 (some were kids)
the manufacturer of the elixir sulfanilamide that killed 73-107 people faced what penalty and why?
the manufacturer was only fined for improper labeling (elixir instead of solution) because there was no substantial law prohibiting their actions
the FDCA had been in congress for _____ years without action
6
During the early 1900s, was there any legislation categorizing drugs into prescription and nonprescription products
NO
in the early 1900s, explain the doctors role in medications
people did NOT have to visit a physician to get medicine.
explain how it can be argued that pharmacists had “INDIRECT PRESCRIBING AUTHORITY” in the early 20th century
there were no formal restrictions on dispensing, pts did not have to visit a doctor to get medicine — just went right to the pharmacy/pharmacist.
pharmacist was expected to counsel and give advice to people getting medicine.
pharmacists were the FIRST SOURCE OF HEALTHCARE ADVICE and medication recomendations
in the early 1900s, who said that pharmacy isnt a profession and why did he say that?
what was the response?
abraham flexner. he said pharmacy isn’t a profession bc their only responsibility is to carry out orders given by physicians.
in response, AACP commissioned a study that served as the basis for AACP to require a 4 year bachelor program for all colleges of pharmacy
what years were the “era of expansion” and explain why it was called that
1940s-1970s
at this time there were significant changes in how healthcare was organized, delivered, and financed
The hospital survey and construction act was also known as _______
what did it do?
the Hill-Burton Act
provided money for the renovation and expansion of existing hospitals AND the construction of new ones (primarily in underserved inner-city and rural areas)
what lead to the passaged of certain amendments in the 1935 social security acts?
what were these amendments called and what did they do?
mounting pressure from the growing number of people who were unable to access healthcare lead to the passage of….
titles 18 and 19 amendments (year = 1965)
-ESTABLISHED MEDICARE AND MEDICAID
the _____ program, in particular, resulted in a dramatic shift in the use of pharmaceuticals and significantly increased the number of prescriptions dispensed
(medicare or medicaid?)
medicaid
during this time period (1940s-1970s) other healthcare professionals’ roles were growing, but the role of pharmacists in medication use management was diminishing.
give 2 reasons for this
- large apothecaries were transformed into large-scale MANUFACTURERS for drugs. previously, the majority of products dispensed by pharmacists were the result of their own compounding
- technology advancements along with the increasing number of compounds and the demand of society for products to be exactly uniform in composition resulted in manufacturers premaking standard dosage forms (ie: syrups, tablets, capsules, etc)
**PHARMACISTS WERE NO LONGER COMPOUNDING
what was the most influential legislation that affected the medication use process?
The durham-humphrey amendment to the FDCA act
created the prescription drug (or “legend” drug)
the Durham-humphrey amendment required what warning to be on prescription drugs?
“CAUTION: FEDERAL LAW PROHIBITS DISPENSING WITHOUT A PRESCRIPTION”
with the passage of the Durham-Humphrey amendment of 1951, were pharmacists allowed to counsel?
NO
the APHA prohibited it – pharmacist had to suggest speaking to practitioner when faced with questions
