6-8 - New Drug Dev./Prescription

CML magic pill drug

Imatinib

What type of drug can we not make in Thailand?

• Antineoplastics

How long is a drug patent in Thailand, and what is the downside?

• 20 years

• Too long of a patent = no competition → prices stay elevated

Critical bottleneck in drug development

• Phase II to phase III

NAMs in drug discovery

• New Approach Methodologies used to test if a drug will be viable in a human. This includes organoids, organ on a chip, etc. rather than animals

What are IND and NDA?

• IND: Investigational New Drug application, submitted to transition from preclinical to clinical phases of study

• NDA: New Drug Application, submitted to begin moving from clinical trials to selling the drugs to the public

Phase 1 of clinical trials for new drug

• Who

• Amount of pt.

• Objective

• Found in Thailand?

• In healthy individuals

• 10-100

• Is the drug toxic?

• Never

Phase 2 of clinical trials for new drug

• Who

• Amount of pt.

• Objective

• A small group of patients with target disease

• 50-500

• Testing if it works in patients and seeing if there are side effects

Phase 3 of clinical trials for new drug

• Who

• Amount of pt.

• Objective

• Found in Thailand?

• Patients with the target disease; wider range of countries, races, etc.

• 500-3000

• Find out if it really works and if there are any larger scale side effects

• Very frequently

Dabigatran

• Oral anticoagulant

What is phase IV, when does it happen, and what could happen?

• After NDA is approved, and now in the real market where many things could happen like rare adverse effects in certain groups of people who weren’t represented in earlier phases

What is an indication of a drug?

A specific approved use of a drug

QALY stands for ___ and is ___

Quality adjusted life year, and is a measurement of how beneficial a treatment is in terms of quantity of years of life added along with the quality

How is a quality of a year measured, and give an example

On a utility score based calculation, so 0.2 could be a year with lots of pain, and inability to move, while a 0.8 could be a year with minimal illness

QALY formula

Life years x utility score

What is ICER and what is the equation and what’s the point?

Incremental cost-effectiveness ratio = (Cost of new treatment - cost of existing treatment) / (QALYs gained from new treatment - QALYs gained from existing treatment)

• This measures the cost per QALY added by the drug

What is Thailand’s threshold for cost/QALY?

• 160,000THB/QALY

CMA, CBA, CEA, CUA

1. Cost minimization analysis: Finding the treatment between multiple that gives equal health outcome with the least cost

2. Cost benefit analysis: Turning the benefit into a monetary value and seeing if a treatment is a gain or loss

3. Cost effectiveness analysis: Measuring natural clinical units across different treatments, like cost per mg/dL reduction in blood sugar, or cost per reduction in LDL cholesterol

4. Cost utility analysis: Same thing, but focusing on QALY only. So it’s a subtype of CEA, focusing on QALYs. Eg. this drug costs this much per QALY while this drug costs that much per QALY

Black box warning: What is it, and added when?

• A warning of a serious risk after taking the drug

• Added after it’s already been approved onto the market

What is a bioequivalence study, and when does it happen?

• It is a study of the pharmacokinetics of generic versions of a drug originally made by one company, done after the patent expires.

What does Rx stand for?

Prescription

4 Parts of a prescription

1. Superscription: Date, patient info, the Rx logo

2. Inscription: Name of drug, strength/concentration

3. Subscription: For the pharmacist and telling them form of drug and amount

4. Signatura: Instructions for the patient

30 Tab Glipizide (5mg) Sig 1 tab P.O. bid ac

• Which parts are what?

• Inscription: Glipizide (5mg)

• Subscription: 30 Tablets

• Signatura: 1 tablet per os twice a day before meals

ac

before meal

pc

after meal

PO

by mouth

hs

at bedtime

OD

bid

tid

qid

prn

OD: once daily

bid: 2x a day

tid: 3x a day

qid: 4x a day

prn: as needed

q

qd

qad

stat

q: every

qd: every day

qad: every other day

stat: immediately

1 grain to mg

60mg

How many mL is in one tsp?

5mL

How many mL is in one tbsp?

15mL

How many mL is one ounce, and how many tablespoons is that?

30mL, and it’s 2 tablespoons since 1 tbsp = 15mL

What are the levels of drugs in the Thai บัญชียาหลัก

1. B: Anyone can buy

2. S: Only w doctor’s prescription

3. Exclusive list

4. R1

5. R2