CHAPTER 18 –Over the Counter (OTC) Sales

CHAPTER 18 - Over the Counter (OTC) Sales

18.1 Introduction
Nonprescription medication will play an ever-increasing role in the medical treatment.
Self-diagnosis and self-medication will continue to increase as the public becomes more
knowledgeable about diseases and drugs. This on one hand will prove to be beneficial as this will
reduce the physicians work load but at the same time will also require professional guidance. The
pharmacist who is accessible, knowledgeable and concerned, is the logical choice for the
individual on whom this responsibility should fall.

18.2 Over the Counter (OTC) Drugs

According to the Food and Drug Administration (FDA) regulations, a drug must be safe
and effective to be sold over the counter. An OTC drug is safe when it has low incidence of
adverse reactions and side effects under conditions of widespread availability. An OTC drug is
effective, if there is a reasonable expectation that when used under adequate direction for use,
which warnings will provide clinically significant relief for the ailment for which it is being
taken to a significant portion of the targeted population.

18.3 Significance of OTC Counters

For most consumers, information on non-prescription drugs comes from the label put on
the product. FDA requires that OTC labels should be more detailed as compared to prescription
drug labels. The label on which non-prescription medicine should include the following
information:
 Product name
 Active ingredients
 Inactive ingredients
 Name and address of the manufacturer
 Net quantity of ingredients
 Description of tamper resistant features
 Indication for use
 Directions and dosage instructions
 Warning and contra-indications

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 Precautions on drug interactions

 Expiry date
 Batch number

18.4 Sale and Establishment of OTC Medication

This means establishment of a medical store, which performs the functions of dispensing,
selling and distribution of non-prescription and prescription drugs. The various factors which
have to be considered before establishing a drug store are:
 Acquisition of Premises: The premises may be purchased or rented on lease for a certain
period of time. The cost of premises depends upon the location of the premises.
 Location of Premises: Generally the premises should be located on the ground floor of
the building. The outer front door of the drug store should be very attractive and build
with innovative construction techniques.
TABLE 18.1: Locations for OTC counters
Good Locations Bad Locations
Business locality, thickly populated Near hotel, school, cinema hall, or
residential areas, developing areas, play grounds, near busy roads, near
hospitals competitors

 Layout of the premises: The primary function of an OTC counter is to provide every
possible convenience and aid to the customers to make their shopping easy and less
tiring. The premises from which a pharmaceutical service is provided should inspire
confidence in the users of the service, it should be clean, hygienic, well-organized, tidy,
accessible and secure. It should provide a suitable environment conditions for both
personnel and product.
 Equipment and facilities: The equipment in the pharmacy should be suitable and
adequate for the work to be undertaken. All equipments must be maintained in an
accurate working condition. The following equipments and facilities are generally
required:
• Adequate working surface
• Supply of portable water

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• Sinks with hot and cold water taps

• Heaters / balers / burners / water baths
• Storage units for raw materials and finished products
• Type writers / labeling machines
• Electric stirrer
• Physical balances / dispensing balances
• Glass apparatus
• Temperature measuring equipments
• Storage containers
• Drug information sources
• Telephones
 Personnel: There should be an adequate number of well trained personnel, i.e. pharmacist
and technicians with expert staff members. The pharmacist should possess a degree or
diploma in pharmacy and should be registered.
 Quality control procedures: Stringent quality control procedures must be employed to
ensure safe and speedy dispensing of OTC drugs. The things which must be taken into
consideration are:
• Quality of materials: For compounding and dispensing all the raw materials
should be procured from licensed sources and must be of suitable quality. The
materials must carry a clear batch identification and expiry date. Appropriate
storage conditions must be mentioned on the label and expired material should be
discarded.
• Supervision: The compounding and dispensing of some OTC drugs should be
carried out by a pharmacist or a trainee under the supervision of the pharmacist.
• Documentation procedures: All the compounding procedures along with the
related records should be completely and carefully documented. The documented
records should contain the following details:
o Name of patient
o Master formula and its sources (IP/BP)
o Working formulae of the batch
o Method of preparation

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o Name, quantity and identification of raw materials

o Date of manufacture
o Appropriate containers and closures
o Storage conditions
All the records must be retained for at least two years for retrieval of information
about particular batch when the need arises.
• Packaging and labeling: All packaging and labeling materials must comply with
the prescribed legal standards.
• Storage conditions: To maintain the stability and shelf life of the preparation
proper storage conditions must be employed and strictly adhered to, in order to
prevent contamination, deterioration etc. Appropriate storage conditions are
usually mentioned in the official monograph of the product. For unofficial
products, the storage condition for the individual ingredients should be noted.
• Expiry date: The shelf life of the product compounded in the pharmacy must be
predicted by official methods.
 Information services: The most essential and important function of an OTC counters is to
provide information regarding drugs to the patient. So it should be stocked with good
information material like, I.P., B.P., N.F., MIMS, CIMS, and Merck Index etc.

18.5 General advice about prescribing OTC drugs

 Prescribed only when necessary and when benefits are likely to outweigh the risks.
 Be particularly careful when recommending non-prescription drugs.
 Watch out for potential drug-drug interaction and remember to take into account
prescribed medication.
 Some drugs may be excreted in breast milk in sufficient amounts to cause distress in
nursing.
 When recommending proprietary or branded medication, ensure that the patient is not
receiving the same drug under a different name.
 Discourage chronic use of non-prescription drugs.
 Watch out for drug abuse.

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18.6 Rational Use of Common OTC Medications

Rational Use of Drugs (RUD) is at the core of pharmaceutical best practice. 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 in addition to this 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.
Irrationality is:
 Ineffective & unsafe drug treatment.
 Inappropriate self-medication.
 Worsening or prolonging of illness.
Incorrect use of medicine occurs 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.
 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: Most 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.
 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.
18.6.1 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

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 Overworked health personnel

 Unaffordable medicines
18.6.2 What can be done to improve rational use of medicines?
WHO advices countries to implement national programs 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.
 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.
 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
18.6.3 Example of OTC Drugs
 Topical anti-bacterial, anti-fungal OTC drugs: Bacitracin, Clotrimazole (vaginal, topical
use), Miconazole 2% ointment etc.
 Pain reliever 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.

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 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.
 Anti-diarrheal drug: Loperamide
 Anti-ulcer drugs: Cimetidine, Famotidine, Ranitidine, Nazitidine.
 Proton pump inhibitors: Omeprazole
 Laxatives & Cathartics: Bisacodyl, Docusate, Glycerin, Psyllium, Sorbitol.
 Other digestion drugs: Aluminium hydroxide gel, Antacid liquid suspension, Calcium
antacid tablets, Simethicone drops etc.
 OTC Vitamins: Calciferol, Ergocalciferol drops, Calcium carbonate, Calcium carbonate,
Calcium citrate, Ferrous fumerate, Ferrous gluconate, Ferrous sulfate, Magnesium oxide,
Multivitamins etc.
 Anti-histamine: Cetrizine, Diphenhydramine, Loratadine.
 Anti-histamine/Decongestant combinations: Brompheniramine - Pseudoephedrine elixir.
18.6.4 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.
 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.
 Ciprofloxacin + Metronidazole, Norfloxacin + Tinidazole and Ofloxacin + Ornidazole:
This is very 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

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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.
 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.
 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.
 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)
 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.
 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

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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.
 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.

REVIEW QUESTIONS
MULTIPLE CHOICE QUESTIONS
1. According to FDA regulations, a drug must be ______to be sold over the counter.
A) Safe B) Effective C) Both A& B D) None of these

2. An OTC drug is safe when it has low incidence of ______under conditions of

widespread availability.
A) adverse reactions B) side effects C) Both A& B D) None of these

3. The cost of premises depends upon the _______of the premises.

A) Location B) Design C) Surroundings D) None of these

4. All the records related to Drugs must be retained for at least ____ years for retrieval
of information about particular batch when the need arises.
A) Three B) Two C) Five D) Six

5. Which of the following is not an example pain reliever drug?

A) Bacitracin B) Aspirin C) Ibuprofen D) Naproxen

6. Which of the following is Anti-Ulcer drug?

A) Cimetidine B) Ranitidine C) Famotidine D) All

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7. Which of the following is an example of Anti-histamine drug?

A) Loratadine B) Aspirin C) Metformin D) Bacitarcin

8. Which of the following is an example of Proton pump inhibitor?

A) Omeprazole B) Ranitidine C) Loratidine D) Ibuprofen

KEYS
1. C 2. C 3. A 4. B 5. A 6. D 7. A
8. A

SHORT ANSWER QUESTION

1. What is the primary function of OTC counter?
Ans: The primary function of an OTC counter is to provide every possible convenience and aid
to the customers to make their shopping easy and less tiring.

2. Enlist the factors which contribute to incorrect use of medicines.

Ans:
• 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

3. Give the examples of Topical anti-bacterial, anti-fungal OTC drugs.

Ans: Bacitracin, Clotrimazole (vaginal, topical use), Miconazole 2% ointment etc.

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4. Give the examples of plain reliever OTC drugs.

Ans: Acetaminophen, Aspirin, NSAIDs, Ibuprofen, Naproxen etc.

5. Give the examples of Anti-ulcer drugs.

Ans: Cimetidine, Famotidine, Ranitidine, Nazitidine.

LONG ANSWERS QUESTION

1. Give the significance of OTC counters.
Ans: Refer Point 18.3
2. Add a note on irrational drug combinations.
Ans: Refer Point 18.6.4
3. What can be done to improve rational use of medicines?
Ans: Refer Point 18.6.2

VERY LONG ANSWERS QUESTION

1. Explain various factors which have to be considered before establishing a drug store.
Ans: Refer Point 18.4
2. Add a detailed note on Rational Use of Common OTC Medications.
Ans: Refer Point 18.6

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