OVER THE COUNTER (OTC)
SALES
BY: Dr. Tanvi H. Desai
(M.Pharm, Ph.D)
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.
• Over the counter (OTC) medications, while readily accessible without a
prescription, are still potent substances that can have significant effects on the
body.
• 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.
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:
• Purchase 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.
Good Locations Bad Locations
Business locality thickly Near hotel, school, cinema hall, or play
populated residential grounds, near busy roads, near competitors.
areas, developing areas,
hospitals.
• Layout of the premises: The primary function of an OTC counter is to provide every
possible convenience and help to the customers to make their shopping easy.
• 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, neat, manageable and safe.
• It should provide a suitable environmental 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 equipment must be maintained in an accurate working condition.
• The following equipment and facilities are generally required:
• Adequate working surface.
• Supply of portable water.
• 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 equipment.
• 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: Strict quality control procedures must be employed to
ensure safe and speedy dispensing of OTC drugs.
• The things which must be taken into consideration are:
1. 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
2. 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.
3. 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:
• Name of patient.
• Master formula and its sources (IP/BP).
• Working formulae of the batch.
• Method of preparation.
• Name, quantity and identification of raw materials.
• Date of manufacture.
• Appropriate containers and closures.
• Storage conditions.
• All the records must be retained for at least two years for retrieval of information about
particular batch when the need arises
4. Packaging and labeling: All packaging and labeling materials must fulfil the
prescribed legal standards.
5. Storage conditions: To maintain the stability and shelf life of the preparation
proper storage conditions must be employed and strictly adhered 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.
6. Expiry date: The shelf life of the product compounded in the pharmacy must be
predicted by official methods.
7. 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, NF and Merck
Index, etc
Rational use of common OTC medications
• Rational use of medicines refers to the correct, proper and appropriate use of
medicines to maximize their benefits and minimize potential risks or harm.
• Rational use requires that patients receive the appropriate medicine, in the
proper dose, for an adequate period of time and at the lowest cost.
• Key Principles for Rational Use
• Right Indication: OTC medications should be used only for the indications they are approved for and listed on
the label.
• Right Dose: Always adhere to the recommended dosage. Taking a dose larger than recommended doesn't
necessarily enhance efficacy and may increase the risk of side effects.
• Right Duration: OTC medications should be used for the recommended duration. Continuous or prolonged use
can lead to complications, such as tolerance or even adverse reactions.
• Right Patient: Some OTC drugs might not be suitable for all age groups, pregnant women, or individuals with
specific health conditions. Always read the label for contraindications.
• Factors Promoting Rational Use of OTC Medications
1.Educated Consumers: Public awareness campaigns can educate consumers
on the appropriate use of OTC medications.
2.Clear Labeling: Manufacturers should ensure clear, concise labeling that lists
indications, correct dosages, potential side effects, and contraindications.
3.Pharmacist's Role: Pharmacists play a crucial role in guiding consumers on
the proper use of OTC drugs.
4.Regulation and Monitoring: Regulatory bodies need to continuously monitor
and evaluate the safety and efficacy of OTC drugs.
• 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 and 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 and 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
• Damaged patient confidence: Impaired by the overuse of limited medicine,
drugs may be often out of stock or at unaffordable prices and as result
damage patient confidence.
• Poor or negative health outcomes due to inappropriate use of medicine may
also reduce confidence.
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.
• Overworked health personnel.
• Unaffordable medicines.
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 repayment.
• 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 programs.
• 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 reasons 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.
• 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.
3. Examples 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.
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• Topical dermatological (skin, scarp) OTC drugs: Capsaicin, Doak tar distillate
oil, Hydrocortisone, Permethrin, Pyrethrin, Zinc oxide ointment.
• 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 and 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 citrate,
Ferrous fumerate, Ferrous gluconate, Ferrous sulfate, Magnesium oxide,
Multivitamins, etc.
• Anti-histamine: Cetrizine, Diphenhydramine, Loratadine
• Anti-histamine/Decongestant combinations: Brompheniramine -Pseudoephedrine
elixir.
4. Irrational Drug Combinations
• If the combination of drugs is illogical in terms of plasma half-life and
pharmacokinetic 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
1. Ampicillin + Cloxacitlin: 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, 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.
• 2. NSAIDs Combinations: Nimesulide, diclofenac, ibuprofen and paracetamol
are some non-steroidal anti-inflammatory drugs (NSAIDs).
• There is no justification in combining one NSAID (nimesutider diclofenac,
ibuprofen) with another NSAID (paracetamol)as they 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.
3. 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, another 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.
4. 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.
