This document discusses prescription drugs, over-the-counter drugs, and drug scheduling in various countries including the United States, United Kingdom, Australia, and Nepal. It provides details on Nepal's drug classification system including groups "Ka", "Kha", and "Ga" and explains the differences between prescription drugs and over-the-counter drugs. Key points covered include principles of over-the-counter drugs, analysis of advertising claims, examples of group "Ga" drugs in Nepal, and public health concerns related to prescription and over-the-counter medications.

1. Prescription Drugs &
Over The Counter Drugs
For BPH 1st Year
Dr. Pravin Prasad
Resident 3rd yr, MD Clinical Pharmacology
Maharajgunj Medical Campus
18th May, 2017 (Jestha 4, 2074) Thursday

2. Introduction
Drugs:
Beneficial Effect
Non-beneficial effects (Side Effects,
Adverse Reactions, Adverse Events,
Toxicity, Death)
Should all drugs be freely
available?

3. Scheduling of Drugs:
Basis
Depending upon
Drug’s acceptable medical use, and
Drug’s abuse or dependency
potential.
Describes the basic or parent
chemical

4. Drug Schedules
Country Drug Classification
United States 5 Schedules (Schedule I, II, III,
IV, V)
United
Kingdom
3 Categories (Prescription
Medicine, Pharmacy Only
Medicine, General Sales List)
Australia 10 Schedules (Schedule 1-9,
Unscheduled Substances)
Nepal 3 Schedules (समुह क, ख, ग)

5. औषधि स्तर
नियमावली २०४३
औषधि ऐि २०३५ को दफा ४० अिुसार
नियम १० मा:
ऐि को दफा १७ बमोजिम औषधिहरु
समुहीकृ त गिे प्रयोिि को लाधग
औषधिहरुलाई समुह “क” “ख” र “ग” मा
ववभािि गररएका छि ् ।
प्रत्येक समुहमा उप-समुह रहि सक्िेछि् ।

6. Drug Standard Rules 2043
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Joj;foLsf] pkl:ylt clgjfo{ x'g] 5}g

7. Prescription Drugs
 High abuse potential medicines
 Prior assessment of the patient to
administer
 Legal prescription mandatory
 Group “ka” and “kha” in Drug Standard
Rules, 2043 in Nepal.
 Prescribing without a prescription is a
punishable act.

8. Prescription Only &
Prescription Drugs
 Concept not prevalent in Nepal
 Prescription Only Drugs:
Cannot be sold without a prescription
Must be sold by a Registered pharmacist
 Prescription Drugs:
Prescription preferred
Must be sold by a Registered pharmacist

9. Over The Counter Drugs
 Drugs that have minimal or no abuse
potential
 Can be sold without a proper prescription,
and even in the absence of pharmacist:
 Involves Drugs enlisted in Group “ga” in Drug
Standard Rules, 2043 in Nepal.
 Prescribing without a prescription is not a
punishable act.

10. Over the counter Drugs:
Principles
 Simplest in formulation
 Product should contain therapeutic effective dose
 Read Drug Facts:
 Allegra Allergy; Allegra Anti-D; Allegra Anti-itch cream
 Recommend a generic product
 Critical analysis of advertising claims
 Children: dose, dosage form, palatability

11. Over the counter
Drugs
Being Reviewed by FDA (US) and there
has been two major outcomes:
Ineffective drugs have been removed
Some Prescription Drugs have been
made OTC Drugs

12. Over the counter
Drugs
Today’s Prescription Only drugs that
have potential for tomorrow’s OTC:
Oral Contraceptives
Nicotine Replacement Therapy
Proton Pump Inhibitors
Levocoetrizine, desloratadine

13. Group “ka” Drugs

14. Group “kha” Drugs

15. Group “ga” Drugs
Drug Percentage
Belladona Alkaloids 0.15%
Dhatura 0.15%
Codiene 1%
Dextromethorphan 1.5%
Amino Alcohol 10%
Opium 0.2%

16. Group “ga” Drugs
 Ibuprofen, Paracetamol
 Chlorpheniramine
 Mebendazole
 Diethylcarbamazepine
 Amodiaquine
 Ascorbic Acid

17. Group “Ga” Drugs

18. OTC Drugs: Should Read
Drug Facts!

19. OTC Drugs:
Critical
Analysis of
Advertising
claims

20. OTC Drugs: Critical Analysis of
Advertising claims

21. OTC Drugs: Critical Analysis of
Advertising claims

22. Over the counter Drugs: Red
Flags
 Avoided or Use cautiously:
OTC products (analgesics, allergy, cough, cold
preparations) containing sympathomimetics
Aspirin in children and adolescents for viral
infections
Cimetidine: avoided in patients using
phenytoin, theophylline, warfarin

23. Over the counter Drugs:
Red Flags
 Overuse or misuse
Regular use of decongestants nasal sprays for
more than 3 days : Rebound congestions
Antacids (Aluminium hydroxide): constipation,
impaction of stool
Analgesic containing caffeine: rebound
headache
Analgesic: interstitial nephritis

24. Prescription Only and OTC
Drugs: Public Health Concern
 Group “ka”
Includes drugs that presently have no medical uses
High potential for physical and psychological
dependence : increased crime rates, decreased
productivity, abusers rather become counter-
productive
Highly toxic
Increase healthcare costs: at both individual and
national level

25. Prescription Only and OTC
Drugs: Public Health Concern
 Group “kha”
Mild to Moderate potential of abuse,
physical and psychological dependence
Threatening global health: AMR
resistance, doping during games
Increase healthcare costs: at both
individual and national level
Delayed Diagnosis if sold without proper
workup of the patient

26. Prescription Only and OTC
Drugs: Public Health Concern
 Group “ga”
Minimal to Low potential of abuse, physical and
psychological dependence
Lack of awareness at various levels: providers,
consumers
“All that glitters is not gold”
High potential for overuse and misuse: may
increase morbidity and mortality