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Over-the-Counter (OTC) Medications
What are OTC Medications?
OTC drugs are safe and effective, meant for general public use. There is no mandatory
requirement of doctor ’s prescription for the purchase of OTC drugs. Hence, these
are also called non-prescription or de-controlled drugs, or over-the-counter drugs.
These have beneficial pharmacological activity, required for symptomatic relief of
discomfort. These are generally used for relief of distressing undesirable symptoms,
while prescription drugs focus on underlying causes and conditions for treatment.
Significance
• Relativelylow-costdrug,maybesuggestedbychemistfortheuseofOTCdrug.
• Patientcanself-diagnose,treatandmanagethediscomfortwithOTCproduct.
• Minorillnesscanbetreatedwithoutgoingtophysicianclinic,whichsavetimeand
consultationfee.
• Simpledrugsotherearefewernumberofsideeffectscomparedtoprescription
drugs.
The 55 percent of drugs used in India are over-the-counter drug products, while
prescription drugs constitute only about 45% of the total drugs. As per market survey,
most of the OTC drugs used in India are analgesics, anticaries drugs, cough suppressants,
anti-acne drugs, NSAIDs, antimicrobial cream/ointment, decongestants, gastric
antacids, antifungal, antihistamines, smoking cessation agents (e.g. nicotine lozenges),
etc.
Examples of OTC Drugs
Topical dosage form of bactericidal antibiotics, available from the OTC, are applied to
the skin to treat or prevent infections, developed on minor cuts, scrapes, and burn due
to presence of various types of microbes.
Cough suppressants areused to prevent or stop coughing.Antitussives arecough
suppressant,whichrepressthebody'surgetocoughandusedfortreatingdrycoughs.
Thesearedifferentfromcoughexpectorants,whichhelpinthetreatmentofproductive
coughsthatproducephlegm.
Anti-acne drugs, available as creams, gels and lotions, are used in the treatment of
various acne problems like pimples, whiteheads, blackheads, etc.
Nonsteroidal anti-inflammatory drugs (NSAIDs) are used to treat mild to moderate
inflammation, and fever.
Antiseptics, in the form of lotions, creams, ointment are used to slow down or stop
the growth of germs. These are beneficial in preventing infections in cuts, scrapes, and
burns. Analgesics drugs are medicines that relieve pain.
Decongestants are used to relieve nasal congestion, which in common terms, refer
to nasal stuffiness.
Antacids, available as liquid or chewable dosage form, are used to neutralize the
stomach acids to relieve the symptoms of indigestion and heartburn.
Antihistamines are used to relieve or prevent the symptoms of allergy like hay fever,
itchy skin, sneezing, runny nose and other kinds of allergy.
Antifungal drugs are used to treat fungal infections like ringworm and yeast infection.
Smoking-cessation drugs are used to help people to stop smoking cigarettes or using
other forms of tobacco.
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Risks Associated with Use of OTC Drugs
There is a dominant ideology that OTC drugs do not require a prescription, so these
drugs must be less dangerous in comparison to prescription drugs, which are inaccessible
at pharmacy display counter but it is incorrect. There is risk factor in the use of OTC
drugs. Hence, there should be rational use of OTC drugs. Some of the risk factors with
the use of OTC drugs are given here:
For example, acetaminophen is safe OTC drug but taking acetaminophen in a higher
dose than recommended not provide more relief, but can be dangerous. Too much use
of acetaminophen causes liver damage, which may lead to death. Risk for liver damage
may be enhanced in people, who drink three or more alcoholic beverages in a day with
the intake of acetaminophen-containing medicines.
Too much intake of NSAIDs for the treatment of pain or inflammation can cause
stomach bleeding leading to ulceration. This risk increases in higher aged people,
who are taking prescription blood thinners, or are taking steroids, or have a history of
stomach bleeding or ulcers, and/or have other bleeding problems. Continuous use of
NSAIDs can also cause kidney damage. This risk may be enhanced in people, who are
over 60 years of age, are taking a diuretic drug; have high blood pressure, heart disease,
or pre-existing renal problems.
Dextromethorphan (DXM) is used to treat cough, cold and flu symptoms. It is
available in cough syrup or tablet or capsule form. Both liquid cough syrups and the
tablet or capsule forms of DXM can distort the visual perceptions and damage the
sense of judgment, when used as OTC drug. DXM at higher doses can lead to loss
of coordination, dizziness, nausea, hot flashes and hallucinations. Sometimes, OTC
cough remedies have multiple ingredients—expectorants and suppressants along with
decongestants, antihistamines, or painkillers. It is advised to select products that give
relief from the prevailing symptoms. For the symptomatic treatment of cough, use OTC
drug which give symptomatic relief from cough.
Related to use of diet pills, it is initiated by trying just a few pills, but soon person
becomes addicted. Ephedrine is one of the dangerous abused stimulants that can
be found in diet pills. But even herbal or "natural" weight-loss products can often
incorporate this and other ingredients that are just as dangerous and risky. Hair loss,
insomnia, menstrual cycle disturbances, urinary tract infections, diarrhoea, vomiting,
blurred vision and anxiety are the possible side effects of diet pills.
Long-term Effects
DXM can be dangerous drug, which may lead to psychological dependency. Its use along
with intake of alcohol or other drugs, can lead to overdose, which may cause death.
The stimulants incorporated in diet pills affect the central nervous system, increase the
rate of metabolism and make the heart beat faster. All of these can be especially serious
for patient with a pre-existing heart problems or high blood pressure. Sometimes in a
healthy person, a heart attack or stroke is also reported with intake of diet pills.
LABELING REQUIREMENTS
The patients are increasingly doing self-diagnosis and are self-treating with OTC drug
products without considering the need of consulting a medical practitioner. For the
purpose of safety, all the OTC products must be labeled with an actual drug facts for
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Over-the-Counter (OTC) Medications
better understanding of patients about OTC product. These must comply with a generic
format for making better sense of understanding the product. The labels must include
information on incorporated active ingredients, indications (i.e. what the drug does),
safety cautioning, and directions for use. Understandable and logical labels always
help patient to choose the right medication and avoid unhealthy mistakes. By looking
an OTC label, patient is able to determine whether this is the appropriate drug for the
treatment of prevailing condition, know the benefits of the drug, necessary precautions,
and when to consult a pharmacist or other health professional.
What are on the New Label?
All OTC product labels should have detailed relevant and cautioning information for
the proper selection and use of products by the patient.
TheexampleofOTCdruglabelisillustratedinFig.18.1.Itcontains:
• Activeingredient.Therapeuticallyactiveingredientanditsstrengthperunit.
• Uses.Indicationsforthetreatmentorpreventionofsymptomsordiseases.
• Warnings.When not to useor apply the product; conditionsthat may require
consultationfromadoctorbeforetakingtheOTCproduct;possibledrugorfood
interactionsorsideeffects;whento stop taking theproductandwhentocontact
adoctor; if you are pregnant or breastfeeding, seek guidance froma healthcare
professional;keepproductoutofchildren’sreach.
• Inactiveingredients.Otheringredientslikecolouringorflavoringagent.
• Purpose. Product activity or category(such as antihistamine, antacid, or cough
suppressant.
• Directions.Howmuchtotake,howtotake,andhowoftentotakeandhowlongto
take.
• Otherinformation.HowtoproperlystoretheOTCproductandnecessaryinformation
aboutcertainingredients(suchastheamountofcalcium,potassium,orsodiumthe
productcontains)
± Storagecondition –Expirydate(whentothrowitout)
± Batchnumber –Nameandaddressofmanufacturer
ESTABLISHMENT OF AN OTC MEDICATION COUNTER
The OTC counter is a part of community pharmacy. The establishment of OTC counter
means establishment of community pharmacy or retail pharmacy. The retail medical
store does the dispensing, sale and distribution of OTC medications. Some OTC drugs are
placed in big medical store to attract the consumer like health-related products (vitamin
preparation, tonics, etc.), laxatives, contraceptive pills, cold relieving preparations,
pain-killers (Fig. 18.1).
Various factors which should be considered before establishing a medical store
are:
i. Selection of site: Thepremisesmaybeownedorrentedforleaseforcertainperiod
oftime.Thecostofpremisesdependsonlocation/city.Preferably,itshouldbeon
groundfloor.Thesiteofpremisesshouldbeingoodbusinessarea,meansinbig
supermarketarea,neartothehospitalorneartothicklypopulatedarea.Nowadays,
itisadvisablethatsitewhichisselectedshouldhavethegoodparkingarea.
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Textbook of Pharmacy Practice
ii. Layout of medical store: The layout/area of medical storeshould fulfilthe
requirementmentionedin the Schedule‘N’ mentionedin Drugs andCosmetics
Act(Fig.18.2).Apartfromthis,itshouldhavebigandattractivefrontdoorforeasy
approach,drinkingwaterfacility,andpublictelephonefacility.Thereshouldhave
enoughspaceforkeepingtheprescriptionandnon-prescriptiondrugs.Itispreferred
tohavetheseparatecounterforOTCmedicationtoattracttheconsumers.
iii. Equipment and facilities: Thereshould begood working equipmentsand
appropriatefacilitiesforthepersonnelworkingandconsumers/patients.Generally,
medicalstorecontains:
(a) Adequatesalecounter
(b) Adequate dispensing section(it contains the sufficient number of physical/
dispensingbalances)
(c) Sufficientwaitingarea
(d) Drinkingwaterfacility
(e)Computerizedcashcounter
Fig. 18.1: Label for OTC drug
Active ingredient (in each tablet) Purpose
Chlorpheniramine maleate 2 mg ...................................................................................... Antihistamine
Drug Facts (continued)
Other information store at 20–25°C (68–77°F) protect from excessive moisture
Inactive informations D&C yellow no. 10, lactose, magnesium stearate, microcrystalline cellulose,
pregelatininized starch
Drug Facts
adults and children 12 years and over
children 6 years to under 12 years
children under 6 years
take 2 tables every 4 to 6 hours;
not more than 12 tablets in 24 hours
take 2 table every 4 to 6 hours;
not more than 6 tablets in 24 hours
ask a doctor
Directions
Uses
Temporarily relieves these symptoms due to hay fever or other upper respiratory
allergies: sneezing runny nose itchy, watery eyes itchy throat
Warnings
Ask a doctor before use if you have
glaucoma a breathing problem such as emphysema or chronic bronchitis
trouble urinating due to an enlarged prostate gland
Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives
When using this product
drowsiness may occur avoid alcoholic drinks
alcohol, sedatives, and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinery
excitability may occur, especially in children
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. In case of overdoes, get medical help or contact a Poison Control
Center right away.
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Over-the-Counter (OTC) Medications
Fig. 18.2: Layout of medical store
(f) Storeroomsforstoringtherawmaterialandfinishedproducts.
(g) Sufficientglassapparatus.
iv. Personnel: Thereshouldbeadequatenumberofregisteredpharmacists,assistant
pharmacist,attendantsandcashier.
v. Quality control procedure: ThisisnotestablishedinIndiaatthemedicalstorelevel.
Thequalityisjustobservedbyseeingthelabelofdrug,manufacturername,batch
numberandexpirydate.ThedispensingofOTCmedicationisdonebythequalified
pharmacistanditiswelldocumented.Thedocumentedrecordshouldcontain:
(a) Nameofpatient,age
(b) Masterformulaanditssource(IPorBP)
(c) Nameofingredientsandthequantity
(d) Directionofuseofeachingredient
(e)Storagecondition
(f) Dateofdispensing
vi. Information bulletin: ThephysicianisgenerallynotinvolvedinprescribingtheOTC
medication.So,thereshouldbeaproperguidanceabouttheuseofOTCmedication
bythe pharmacist. Toguide the patient, thereshould besufficient information
materialsliketheIP,BP,MIMS,MerckIndex,etc.Presently,internetfacilityisabest
sourcetotaketheinformationmaterialaboutanyOTCdrug.
General Advice for Using OTC Drugs
i. Use of OTC drugs during pregnancy: Self-medication is commonpractice for
thetreatmentofminorhealthproblems.Itisdonewiththeuseofapprovedsafe
medicines,designed and labeledfor use withoutprofessionalsupervision. OTC
drugshave been widely used inself-medication in the treatment of common
pregnancyrelated health problems.Pregnancy isa dynamic process inwhich
anatomicandphysiologicalchangeshappenfromfertilizationtoparturition.Use
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Textbook of Pharmacy Practice
ofOTC drugmay have differenteffectsdepending on the stage ofembryo and
fetaldevelopment.Accordingly,whenapregnantfemaletakesOTCdrugsforself-
medication,sheisrevealingherselfand/orherbabytodifferentundesirableeffects
broughtaboutbytheseOTCdrugs.Atanytimeinthegestationperiod,over90%
ofpregnantwomenusuallytakeaprescriptionorOTCmedication.Thesemaybe
usedtotreatcommonsymptomsofpregnancysuchasnausea,vomiting,heartburn,
backache,constipation,orevenmigraine,pains, and cough requiremedications.
Duringthegestationperiod,theseshouldbeselectedcarefullytoavoidsideeffects
onthefetusandmother.OTCdrugsingeneralshouldbeavoidedduringpregnancy
ifpossible.However,OTCdrugusageduringpregnancyisathighlevelbecause
ofadvertisingby the pharmaceuticalindustryand the lackofdata showing the
adverseeffectsofOTCdrugsonthefetus.
Pregnantwomen shouldconsult a pharmacist or medical practitioner before
usinganyOTCmedication.
Similarly,breast-feedingmothershouldconsultthepharmacistbeforetakingOTC
drugasitmayenterthebreastmilkandinadvertentlypasstothenursingbabyaswell.
ii. Use of OTC drugs by children: Togeteuphoriceffect,teensaretakingOTCpain
relieversandcoughandcoldsuppressant.Theyfindthesedrugseitherfromtheir
ownhomes, or the homes of other relatives and friends. Infact, nearly half of
percentage(about47%)ofteenssaytheygetthesedrugsforfreeofcostfromarelative
orfriend.Nearly,tenpercentclaimthattheypurchasepainkillersfromafriendor
relative,andanother10percentofteensaythattheyaretakingdrugswithoutany
permission.Itissortofabusedphenomenon,whichisdifficulttomonitor.Onlythe
parentscandoitbyobservingthem.
iii. Chronic use of OTC drugs: Duetoaccessibilityofover-the-counterdrugwithout
prescription,one shouldnot considerthat these drugs arecompletely safe.The
consumershouldalwaysconsultthedoctororpharmacistbeforetakingitasthese
mayalsobeharmful.Forexample,chronicuseofpainkillersovermanyyearscan
causerenalor liverfailureand taking tabletsto self-treat afever may maskthe
symptomsofcertainillnessessuchastuberculosisormalaria.Similarly,consumption
ofOTCmedicines over alongperiodmay develop newproblems,forexample,
totaldependenceonchronicuseoflaxativesortranquilizers.Self-medicationcan
bereasonableandbeneficial,butonlyifusedintelligently.Donotjustdependon
aneighborsorfriend’sadviceoronchemist’ssuggestions:AlwaysdiscussOTC
drugswiththeproperdoctor/pharmacist.
iv. Use of OTC drugs with prescription drugs: CertainOTCdrugsmayaffecttheactionof
prescriptiondrugsbymakinginfluenceonmechanismofaction.Forexample,people
whotakewithtetracyclinealongwithantacid(OTCdrugs),maynotbebenefitted
byantibacterialactionoftetracycline.Itisduetothefactthatantacidinterferewith
thebody’s absorption of the tetracycline, thereby causing hinderance in efficacy.
Consequently,patientmustknowpreciselywhichcategoryofOTCdrugsheistaking,
andaccordinglyheshouldconsultthedoctor/pharmacistaswell.
Inthepresentscenario,varioustypesofhomeopathicandayurvedicmedicines
arealsoavailableasover-the-counterproduct.It isgeneralpredictionthatthese
medicinesare ‘naturallyoccurring’, so they arecompletely safe. It is nottrue;
alwaysrememberthatevery medicinecanhave side-effects. The samecommon
senseprincipleisappliedtotheseayurvedic/homeopathicOTCdrugs.
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Over-the-Counter (OTC) Medications
v. Miscellaneous: Unfortunately, the leaflet/labelof OTC drugs does not inform
aboutcomplete aspectsof drugsto patient.Something remainshidden because
manufacturesdo notwant to keep their customers away fromgiving business.
Completerequiredinformationcanonlybeacquiredbyconsultingthedoctoror
pharmacist.Read the packageinsertor labelbeforeleavingthe counterofdrug
store.Donothesitatetoaskaboutanydoubtfromthepharmacisttoclarify.Here
aresomebasicruleswhichmustbefollowedbeforetakingOTCdrugs:
(a) Takethesmallpossiblequantityofdrugfordesirableoutcome.
(b) UsemultisymptomsremedialOTCproduct(whichcontainsamixtureofmany
drugs)onlyiftherearemorethanonetypeofsymptomswhicharetobetreated.
Therearethe greaterchances of adverse reactionsand interactions in multi-
ingredientproduct.
(c)Toprevent thechances of interaction with food,which may decrease their
absorptionandeffectiveness,itisadvisedtotakemostofOTCdrugseitherone
hourbeforeortwohoursaftereating.
(d) AvoidintakeofOTCdrugswithalcoholandothermedications.
(e)IfbyusingOTCdrugs,symptomsdonotimprove,becomeworse,orclearsup
andthenreturns,consultadoctor.Somemedicationscanmakesymptomsworse
iftakenforalongtime.
(f)Before buying or usingOTC drugs,check the label date alongwith other
information.
EXERCISE
Multiple ChoiCe Questions
Tick mark the appropriate choice
1. What are OTC drugs?
(a) Righteous drugs (c) Controlled drugs
(b) Righteous or controlled drugs (d) De-controlled drugs
2. Which one of these is OTC drug?
(a) Paracetamol (b) Digoxin (c) Phenytoin (d) Clopigrel
3. What is true for OTC drugs?
(a) Comparatively cheaper (c) Time saving medications
(b) Consumers are able to self manage (d) All of the above
short Questions
4. What are OTC medications? Mention its significance.
5. Illustrate labeling requirements for OTC medicines.
long Questions
6. Discuss the general advice to be given for the use of OTC medicines.
7. Discuss the various components to be considered for establishment of an OTC medication
counter.
Answer to MCQs
1. (d) 2. (a) 3. (d)
UNIT
V
19. Drugstore Management and Inventory Control
20. Investigational Drugs
21. Interpretation of Clinical Laboratory Tests
