This document discusses rational use of over-the-counter (OTC) medications. It provides examples of common OTC drug categories and explains that rational use means using the appropriate medication, in the proper dose, for the right duration and indication. Irrational or improper use can lead to antimicrobial resistance, adverse reactions, financial costs, and erosion of patient confidence in the healthcare system. Factors contributing to irrational use include lack of knowledge and unethical drug promotion. Improving rational use requires guidelines, education, availability of essential medicines, and eliminating financial incentives for improper prescribing. Several examples of irrational fixed-dose drug combinations are also provided that combine drugs with different mechanisms or indications.

1. • RATIONAL USE OF OTC
MEDICATION
Submitted To :
Dr. KANCHAN VOHRA
Assistant Professor
Submitted By :
Mohd. Rafi Bhat
Department of pharmaceutical
science & Drug Research

2. RATIONAL USE OF OTC MEDICATION
OTC MEDICATION:-Over the counter medication is also
known as OTC or nonprescription medicine .All these
terms refer to medicine that you can buy without a
prescription. They are safe and effective when you
follow the directions on the label and as directed by
your healthcare.

3. EXAMPLE OF OTC DRUGS
Topical anti-bacterial, anti-fungal OTC drugs:-
Bacitracin,Clotrimazole (vaginal,topical use)Miconazole
2% ointment etc.
Pain releiver OTC drugs:
Acetaminophen,Aspirin,NSAIDs,Ibuprofen,Naproxen
etc.
Smoking cessation OTC drugs:Nicotine patch
Topical Dermatological (skin, scalp) OTC drugs: Capsaicin,
Doak tar distillate oil, Hydrocortisone ,Permethrin,
Pyrethrin, Zinc oxide ointment.

4. .Diabetes OTC drugs: Insulin OTC vials(Humulin 50/50
vial,Humulin N,Humulin R,Novolin 70/30 vial, Novolin R
vial etc)
Glucose chewable tablet.
Digestion OTC Drugs
Anti-diarrheal drug:- Loperamide
Anti-ulcer drugs:Cimetidine,Famotidine,Ranitidine
Nazitidine.
Proton pump inhibitors:-Omeprazole
Laxatives &Cathartics:-Bisacodyl,Docusate,Glycerine,
Psyllium, Sorbitol.
Other digestion drugs:-Aluminium hydroxide gel,

5. .
Antacid liquid suspension ,Calcium antacid tablets
,Simethicone drops etc.
OTC Vitamins:- Calciferol ,Ergocalciferol drops, Calcium
carbonate, Calcium carbonate 600mg+vit. D, Calcium
citrate,Ferrous fumerate ,Ferrous gluconate ,Ferrous
sulfate, Magnesium oxide, Multivitamins etc.
Eye care OTC drugs:-Artificial tears ,Refresh tears,
liquigel (15ml or 30ml bottle only), Sodium chloride
5% drops ,ointment , Systane etc.
Cough/Cold/allergy OTC drugs
Anti –histamine:-Cetrizine tab, Cetrizine-D tab,Cetrizine
sol., Diphenhydramine, Loratadine, Loratadine-D,
Anti-histamine/Decongestant Combinations:-
Brompheniramine- Pseudoephederine elixir.
Other drugs:- Nasal spray,Pseudoephedrine

6. What is rational use of drug?
Rational use of medicines refers to the correct, proper
and appropriate use of medicines. Rational use
requires that patients receive the appropriate
medicine, in the proper dose, for an adequate period
of time and at the lowest cost.
&
Use of an appropriate ,efficacious, safe and cost
effective drug given for the right indication in the
right dose and formulation, at right intervals and for
the right duration of time.

7. Irrationality
Ineffective & unsafe drug treatment.
Inappropriate self medication.
Worsening or prolonging of illness.
Consequences of irrational use of
medicine
Incorrect use of medicine ocuur in all countries,causing
harm to people and wasting resources.
Consequences include:-
Antimicrobial resistance:-overuse of antibiotics
increases antimicrobial resistance and the number of
medicines that are no longer effective against
infectious disease.

8. .
Adverse drug reactions & medication errors:- harmful
reactions to medicine caused by wrong use or
allergic reactions to medicine can lead to increased
illness, suffering and death.
Lost resources:-10-40% of national budget are spent on
medicines. out of pocket purchase of medicines can
cause severe financial hardship to individuals and
their families. if medicines are not prescribed and
used properly ,billions of dollars of public and
personal funds are wasted.

9. • Eroded patient confidence:-exacerbated by the
overuse of limited medicine, drugs may be often out
of stock or at unaffordable prices and as result erode
patient confidence. poor or negative health
outcomes due to inappropriate use of medicine may
also reduce confidence.

10. Factor contribute to incorrect use of
medicines
• Lack of skills and knowledge
• Inappropriate unethical promotion of
medicines by pharmaceutical companies
• profit from selling medicine
• Unrestricted availability of medicines
• Overworked health personnel
• Unaffordable medicines

11. What can be done to improve rational
use of medicines?
WHO advices countries to implement national
programes to promote rational use of medicines
through policies , structures , information and
education. These include:-
• A national body to coordinate policies on
medicine use and monitor their impact
• Evidence based clinical guidelines for supervision
and supporting decisions making about
medicines
• List of essential medicines used for medicine
procurement and insurance reimbursement

12. .• Drug (medicines) and therapeutics committees in
districts and hospitals to monitor and implement
interventions to improve the use of medicines;
• Problem-based training in pharmacotherapy and
prescribing in undergraduate curricula;
• Continuing medical education as a requirement of
licensure;
• Publicly available independent and unbiased
information about medicines for health personnel and
consumers;
• Public education about medicine

13. .
• Elimination of financial incentives that lead to
improper prescribing, such as prescribers selling
medicines for profit to supplement their income;
• Regulations to ensure that promotional activities
meet ethical criteria; and
• Adequate funding to ensure availability of medicines
and health personnel.
• The most effective approach to improving medicines
use in primary care in developing countries is a
combination of education and supervision of health
personnel, consumer education, and ensuring an
adequate supply of appropriate medicines. Any of
these alone have limited impact

14. IRRATIONAL DRUG COMBINATIONS
If the combination of drugs is illogical in terms of
plasma half-life and pharmacokinetics of the drug,
the combination should be termed as irrational drug
combination. Large numbers of such irrational drug
combinations are available in the market which
unnecessarily increase the cost of medication and
add to the side effects of the therapy.

15. IRRATIONAL DRUG COMBINATION
Ampicillin + Cloxacillin
Ampicillin is effective against Gram negative bacilli
but Cloxacillin is an Anti-staphylococcal penicillin and
not effective against Gram negative bacilli. Mixed
Gram negative and Staphylococcal (Gram positive)
infection rarely coexists. So, in a patient with a single
infection, one of the drugs of the combination would
be useless. In addition to the cost of therapy it would
add to adverse side effects and resistance of bacteria
to the drug. On the other hand the combination
would reduce the dose of effective drug to the half
and the patient would need longer course of
therapy.

16. .
Antibacterial + Antiamoebic Combinations:
Ciprofloxacin + Metronidazole, Norfloxacin +
Tinidazole and Ofloxacin + Ornidazole are such
commonly available fixed dose drug combinations. In
bacterial diarrhoea only anti-bacterial drug is
effective and antiamoebic drug is useless. Similarly,
in intestinal amoebiasis only antiamoebic drug is
effective while antibacterial drug is useless.
Amoebiasis and bacterial diarrhoea rarely coexist.
The therapy should be based on the diagnosis to
reduce the cost of treatment since in a given case,
only one drug of the combination would be effective
and the other one would be useless.

17. .
NSAIDs Combinations Nimesulide, diclofenec,
ibuprofen and Paracetamol are some non-steroidal
anti-inflammatory drugs (NSAIDs). There is no
justification in combining one NSAID (nimesulide,
diclofenec, ibuprofen) with another NSAID
(paracetamol) having same pharmacological actions.
The increased risk of hepatotoxicity has been
reported due to the use of combination of
nimesulide with paracetamol. There is increased risk
of nephrotoxicity with NSAIDs combinations.

18. .
H2 Blocker + Domperidone Ranitidine and
Famotidine are H2 blockers. H2 blockers reduce
gastric acid production in peptic diseases and give
symptomatic relief. The combination of these drugs
with antiemetic drug (Domperidone) is an irrational
drug combination as peptic ulcer is not always
associated with vomiting. Even in gastro-esophageal
reflux disease (GERD), the domperidone is less
effective as compared to metoclopramide, so
combining H2 blockers with domperidone seems to
be an irrational choice.

19. .
H2 Blocker (Ranitidine) + Antispasmodic Drug
(Dicyclomine)
The pain of peptic ulcer is due to high level of gastric
acid but not due to spasm of smooth muscles and
will subside only with reduction in gastric acid in
stomach by use of H2 blocker (Ranitidine) or proton
pump inhibitor drugs (Omeprazole, Pantoprazole or
Lansoprazole). So there is no justification in
combining H2 blocker (Ranitidine) with
antispasmodic drug (Dicyclomine)

20. .
Mucolytic Agent + Antibacterial
Ambroxol + Ciprofloxacin or Cefadroxil or
Roxithromycin. Ambroxol is a mucolytic agent used
to liquefy thick respiratory secretions. There is no
justification in combining mucolytic agent with
antibacterial, as thick secretions in respiratory tract
are always not due to respiratory infections. Also the
antibacterial therapy always does not require an
associated dose of mucolytic agent.

21. .
Metformin + Glimepiride + Pioglitazone
Metformin is indicated drug in obese type -2
diabetes mellitus whereas Sulfonylurea (Glimepiride)
is indicated drug in non-obese type-2 diabetes
mellitus. As per pharmacological principle, other
drug should be added only when monotherapy fails.
Metformin (biguanide) is to be administered after
meal whereas Glimepiride (sulfonylurea) drug is to
be administered before meal, therefore even when
both the drugs are required, it would be better to
administer them separately. Pioglitazone is indicated
in suspected cases of insulin resistance. So, the
combination of all these drugs in one formulation is
an irrational drug combination.

22. .
Codeine+NSAID (paracetamol)
This combination is used to treat severe pain or to
inhibit pain perception but these combinations can
cause excessive sedation which can be dangerous.
Needs further examination.
Multi vitamin preparations
Multivitamin combination is considered to be irrational.
Excessive use may leads to several side effects.

23. .
Expectorant+central cough suppressants
antihistaminics + bronchodilator+mucolytic agent
Bromhexine Hydrochloride 8 mg + Terbutaline
sulphate 2.5 mg + Guaiphenesin 100 mg + Menthol 5
mg, this combination of expectorants is a costlier
way of helping a condition which is often self-
resolving. Expectorant given in effective doses are
often not tolerated and produce adverse drug
reaction.