L3 - concept of medicine and dosage forms, brands & generics

Question 1

what is a medicine?

Answer 1

a drug in a dosage form.
any product used to diagnose, treat, mitigate, cure or prevent disease.

Question 2

what is a drug?

Answer 2

the active pharmaceutical ingredient (API)

Question 3

what is an excipient?

Answer 3

other components of the formulation excluding the API

Question 4

what is a formulation?

Answer 4

mixture of API and excipient

Question 5

what are the 2 types of medication names?

Answer 5

1. brand name
2. chemical/ generic name

Question 6

what is the brand name?

Answer 6

registered ®. given by pharmaceutical company

Question 7

what is the generic name?

Answer 7

the API

Question 8

examples of things which can be trademarked

Answer 8

medicinal devices, packaging, shape, colour, brand and generic name

Question 9

what are new medicines marketed as?

Answer 9

branded drugs

Question 10

when a big pharma company discovers a new drug what do they do?

Answer 10

take out a patent (which lasts 20 years but you can have additional 5 years added on) to earn money

Question 11

outline process of discovering new drug and introducing it to the market

Answer 11

• 15-20 yrs to create drug
• file a new drug application
• obtain marketing authorisation

1. 6+ yrs for discovery & preclinical studies
2. 5+ yrs for clinical development & regulatory
3. 10-15 years for marketing to make a profit before patent expires

Question 12

role of pharmaceutical research

Answer 12

to convert any synthesised compounds into candidate drugs for development

Question 13

what is product development?

Answer 13

involves converting the candidate drugs into dosage forms for registration and sale

Question 14

do drugs cost the same in different countries?

Answer 14

no drugs cost different amounts in different countries

Question 15

what is a blockbuster drug?

Answer 15

sales reach 1 billion US dollars per year (1/3 of pharma market)

Question 16

when do generic drug companies kick in and start making drugs?

Answer 16

• when leading band loses patent
• they usually make lower profits
• can become blockbusters

Question 17

if a disease is large enough what may happen to a blockbuster drug?

Answer 17

blockbuster drug loses patent protection (E.g for cardiovascular disease and respiratory disease)

Question 18

what are generic drugs?

Answer 18

• identical in dose, route of administration, same safety and efficacy as “innovator”

Question 19

prescribing generic medicines

Answer 19

• expected to prescribe these as they are generally cheaper

Question 20

word of caution surrounding generics

Answer 20

rare cases where branded + generic are diff
E.g epilepsy, modified release preparations, lithium, biological medicines