Review of Pharmacology - 9E (2015)

Review of Pharmacology
An orphan drug is a pharmaceutical
agent that has been
developed specifically to treat a
rare medical condition (affecting
fewer than 200,000 people)
Orphan Drugs
An orphan drug is a pharmaceutical agent that has been developed specifically to treat a rare
medical condition (affecting fewer than 200,000 people), the condition itself being referred to as
an orphan disease. Examples include deferipirone to treat iron overload in thalasemia patients,
N-acetylcysteine to treat paracetamol poisoning etc. Since the pharmaceutical companies will
not like to develop such a drug due to lack of financial benefits, a separate law known as ‘The
Orphan Drug Act’ was passed in 1983. The intent of the Orphan Drug Act is to stimulate the
research, development, and approval of products that treat rare diseases.
Essential drugs
• These are the drugs that satisfy the priority healthcare needs of a population. These
are selected with regard to
––
Incidence and pravelence of disease (public health relevance)
––
Evidence on safety and efficacy
––
Comparative cost-effectiveness
––
Assurane of quality
• Most essential drugs are formulated as single compounds
• WHO brought first essential drug list in 1977. It is updated every 2 years. The current
version is 18th WHO essential medicines list and 4th WHO essential medicines list
for children updated in april 2013.
• The first national essential medicine list of India was prepared in 1996. It was revised
in 2003, 2011 and in 2013. The latest list contains 406 drugs
General Pharmacology
Schedule of Drugs
‘Drugs and cosmetics act 1940’ along with `Drugs and cosmetic rules 1945’ and its amendments
describe various schedule of drugs. Important schedules are:
Schedule
C and C1
F and F1
G
H
M
P
W
X
Y
Deals with
Biological and special products
Bacterial vaccines
Drugs to be labelled with the word “Caution”-It is dangerous to take this preparation
except under medical supervision
Drugs that must be sold by retail only when a preseription by RMP is produced
Good manufacturing practices (GMP)
Expiry period of drug formulations
Drugs that shall be marketed under generic names only
Psychotropic drugs requiring special licence for manufacture and sale
Requirements and guidelines on clinical trials, import and manufacture of new drugs
Golden Points
1. Two drugs having opposite response via action on different receptors are called
physiological antagonists, e.g. adernaline (causes bronchodilation by actiion on b 2
receptors) is physiological antagonist of histamine (cause bronchoconstriction by acting
on H 1
receptors).
2. Two drugs having opposite response via action on same receptors are called
pharmacological antagonists, e.g. propanolol (causing bradycardia by acting on b 1
receptors) is pharmacological antagonist of adrenaline (cause tachycardia by acting on b 1
receptors)
3. Alpha 1 (α 1
) receptors act by increasing Ca 2+ whereas b 1
increase cAMP in the cell.
4. Apparent volume of distribution is more than total body fluids (very high), if the drug is
sequestered by tissues.
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