Day 4: Overview History Of US Pharmacy

Question 1

What is a generic or alternative source manufacturer?

Answer 1

It’s ones that waits until a drugs patent expires and they rush to the generic form to market and they make their money off of making generic drugs

Question 2

What is a research intensive manufacture?

Answer 2

It’s a larger company that spends a lot of money on research for the discovery of novel drugs

Question 3

What were the general government themes in pharmacy before the 1950s?

Answer 3

Few laws that regulated (pharmacists had a lot of freedom to practice)

Few laws regulated drug manufactures (there was a free market to develop new products)

Fun fact: pharmacists were not commissioned officers in WWI and WWII (implied the government didn’t respect pharmacy)

Question 4

What is the Food Drug and Cosmetic act of 1938?

Answer 4

It was a law that established drug safety prior to they would be approved

Needed an NDA

**Came into place because a drug company put a sulfa antibiotic into draino and gave it to kids which ended up killing them

**sometimes death is the only thing that motivates change in laws

Question 5

How was pharmacy education before the 1950s?

Answer 5

Before 1928 it was only an apprenticeship but it was soon turned into a 4 year bachelors degree

California started to adopt a 6-year degree

• *this was frowned on by some school because the resources to run a 6 year program were higher
• *also employees didn’t want it because it would cause a demand for higher wages

Question 6

What was the first pharmacy association that represented pharmacists?

Answer 6

American Pharmaceutical association

*created in 1852

Question 7

What is the importance of the soda fountain?

Answer 7

It was a place that people could go to socialize and meet with people as well as pick up drugs. It made the pharmacists a figure and a place people wanted to go

**this built respect for the profession

Question 8

What is the focus of community pharmacy before 1950?

Answer 8

Dispensing is the focus of practice

Dispense it correctly, quickly and accurately (just dispense what the dr wrote for no questions)

Question 9

How was hospital pharmacy before the 1950s and what did they think of community pharmacy?

Answer 9

They are only really found in the largest and most established hospitals but not found in each one

**Some hospital pharmacists thought they were better than community pharmacy (even tho studies found most didn’t preform pharmacists duty and more management type jobs)

***this lead to the creation of the ASHP which started a war between hospital and community pharmacy and made a rift in the profession

Question 10

What was the 1951 amendment to the 1938 Food, Drug, Cosmetic act?

Answer 10

It dived drugs into prescription and nonprescription status

Also had to obtain consent of prescriber for refills

**also meant that you now needed an RX in order to get a drug

Question 11

Was the change of pharmacy education to the 5-year program in the 1950s welcomed or not?

Answer 11

Not it was a compromise that pleased no one

Question 12

Why was hospital pharmacy in the 1950s preferred over community?

Answer 12

They worked shorter hours and they had a better scope of practice

Could teach in nursing schools

Could work on committees

Question 13

How did a change in pharmaceutical manufacturing in the 1950s change the role of pharmacists?

Also were community or hospital pharmacists able to control manufacturers in the 1950s?

Answer 13

There was an increase in mass production. This meant that pharmacists were not compounding as many products as before

**community pharmacists could not stop laws that supported manufacturers (this means that they couldn’t get formularies and generic substitutions of products)

***Hospital pharmacies were able to do that and could make formularies and use generic substitutions (allowed them control over cost as well as ability to pick which drugs were used)

Question 14

What was the role of community pharmacy in the 1950s? What was the primary duties they preformed? What was the APhA code of ethics say>

Answer 14

it was the count and pour era

Compounding drugs was disappearing and the practice was becoming more commercialized

Also prescription volume doubled

**The APhA code even said that the role of the pharmacist was to just fill the drug and not question what the doctor wrote for

Question 15

What was the 196 amendment to the food, drug, cosmetic act?

Answer 15

It added that manufacturers not only had to prove the drug was safe but also that it had EFFICACY!!!

Question 16

What’s the difference between efficacy of a drug and if its effective?

Answer 16

For a drug to be proved efficacious its done in controlled setting and is regulated greatly

If its effective that happens in real world examples, and not everything is controlled as perfectly as in the efficacy trails

Question 17

What was the importance of Medicare and Medicaid programs being passed in the 1960s?

Answer 17

Was a major expansion into health care system

Low income patients can now have access to drugs

*****ONLY hospital pharmacies directed by RPhs were eligible for Medicare reimbursement

Question 18

How was pharmacy education changing in the 1960s?

Answer 18

It was starting to shift from being science based, even tho most teachers were still physical scientists, to shifting to being more clinical aspects of the profession

Question 19

How was community Pharmacy in the 1960s and how did the APhA codes of ethics change?

Answer 19

The count and pour era continues

**new grads were not finding many opportunities to apply the info that they have learned

***dispensisng still ruled the day and third part programs were staring to be created

APhA code of ethics: RPh should hold the health and safety of the patient first before everything else

Question 20

How was hospital pharmacy changing in the 1960s?

Answer 20

It was developmenting more into clinical pharmacy practice
**like Vanco dosing and stuff

They were moving beyond providing drug information and drug dosing and expanding their roles

Worked on patient profiles (making sure they had all the meds together of each place that the patient was being seen

Question 21

What was the importance of Nixon signing Health Mainteance Organization (HMO) act of 1973?

Answer 21

It put HMOs in place in order to try and control the costs of health care and improve quality

Question 22

What was the significance of consumer movement of the 1970s?

Answer 22

It lead to consumers causing repeals of laws against generic product selection

The pharmacists and the consumer became allies against the drug companies

**Patient interest in self-care is growing

Question 23

What was the change that happened in the 1970s to pharmacy educations?

Answer 23

Pharmacy stated to become more diverse (more women and minorties)

Also the curriculum was changing leading to the Pharm. D programs, programs are becoming more clinically oriented

Question 24

What was community pharmacy changing in the 1970s? As well as hospital pharm?

Answer 24

Changes were happening for community
They start to market themselves as consultants

Increase use of computers

Increasing use and review of patient profiles

Hospital:
Continues to expand and go on rounds and do clinical PK as well as manage dosing

Question 25

How did pharmacy education change in the 1980s?

Answer 25

ACPE Ann comes that they want pharmacists to pursue clinical roles and only start to accept the Pharm D. Programs

Question 26

How did the role of community pharmacy change in the 1980s?

Answer 26

Number of independent pharmacies begin to decline (chains are growing)

Mail order pharmacies starting to grow

Question 27

How did hospital pharmacy change in the 1980s?

Answer 27

Starting to use more computers and found a way to expand pharmacy services

*** Payers want to control utilization - decrease length of stay in the hospital (great way to save money)

Hospital pharmacies develop serviced that save $$ by decreasing the LOS of patients (was a way to get more pharmacists hired into hospitals since they can save a lot of money)

Question 28

How did the philosophy of pharmaceutical care change in the 1990s?

Answer 28

A pharmacist accepts responsibility for using drug therapy appropriately to improve patient outcomes

Question 29

What is the primary responsibility of pharmacists in pharmaceutical care?

Answer 29

Find and fix ALL types of drug-related problems

Question 30

What is the acceptable standard of practice for pharmacist in pharmaceutical care?

Answer 30

Improve patient outcomes

Question 31

What was a change in pharmacy education the in the 1990s?

Answer 31

It is now required for COP grads to have earn a PharmD in order to practice pharmacy.

**Pharmaceutical care becomes mission for pharm education

Question 32

How did pharmaceutical manufacturers change n the 1990s?

Answer 32

FDA allowed them to directly market RX drugs to consumer**** (know this)

Manufactures start to buy PBM in order to try and make more money by controlling prices

Question 33

How did hospital pharmacy change in the 1990s?

Answer 33

Increase use of techs

Lots of use of tech

Pharm services are available 24/7 in a good number of pharmacists

Question 34

What did the Omnibus Budget Reconciliation Act of 1990 (OBRA 90) do for community practice? What was the pharmacists primary role and standard of practice

Answer 34

It gave new opportunities for community practice by required “offer to counsel” Medicaid patients

Also Pharmacists required to maintain and review patients profiles

Primary job: prevent drug duplications, drug-drug interactions, allergies etc

Acceptable standard practice: Counsel patent, identify and prevent drug-drug interactions and adverse drug reactions

***BIG ISSUE! Medicaid didn’t increase RPh’s reimbursement!

Question 35

What was added in the 1990s that gave community pharmacy a much larger role in the health care world?

Answer 35

Disease state management: Target specific diseases- asthma, diabetes, HTN, cholestrol

Goal to improve and manage disease states

MTM
Improve pat care and control cost

***THIS WAS HUGE, reduced costs on insurance and the PHARMACY GETS PAID!

Question 36

What did the Medicare Part D being passed in 2003 have an impact? Who qualified for Part D?

Answer 36

Expands RX drug benefit coverage and requires MTM services

Who qualified:
Pt with multiple chronic diseases

Take many drugs covered under med part D

Who will injure annual costs to part D

In 2013 they needed annual comprehensive review and interventions as needed PT must receive a written summary of the review

***DOES NOT NEED TO BE DONE BY PHARMACIST

Question 37

Why do the pharmacists continue to lobby the fed government to be recognized as “providers” under the Social Security Act?

Answer 37

Once pharm are federally recognized as “providers” it will make it easy for them to be reimbursed for providing clinical pharmacy services

Question 38

How did manufactures change from 2000-present?

Answer 38

New regulations on marketing drugs to health care workers (concerns over conflicts of interests)

Concerns about the need to improve post-marketing surveillance
Some drugs that were approved are now removed from market after being seen as having to much adverse events

Opioid crisis (marketing practices played a role in the crisis coming)

Inc in drug prices (not technically illegal to buy and increase price of certain drugs)

Question 39

How is pharmacy education changing from 2000-present?

Answer 39

All COP is Pharm D

Increased value on post-pharmD education
Residency
Certificate in competence in certain area of pharmacy, asthma, diabetes
Board Pharmacotherapy specialist

**LOTS OF NEW SCHOOL BEING OPENED

Question 40

How did pharmacy education change in the late 2000s to present?

Answer 40

Applicant pool decreases - most are accepted into COP

Demand for pharmacy residency position greatly increases - the number of applications fo residency positions exceeds the number of positions available

Question 41

What is the importance of Pharmacists receiving Current Procedural Terminology Codes (CPT) in 2006?

Answer 41

Allows for pharm to bill Medicare part D plans for MTM using these codes and can bill other payers for clinical services

Question 42

What are the workforce issues of pharmacy practice in 2000-present>

Answer 42

Early 2000s : demands for Pharmacists exceeds supply

Late 2000s: demand for pharmacists = supply

**tech plays a very important role in pharmacy