OTC – What is itOTC – What is it??Over the Counter”Non-prescription medicinesMedicinal products marketed as drugs -

regulatory approval (marketing authorization) is needed .

In broader sense all non-prescriptional medicines including traditional herbal medicines or nutritional supplements (pharmaceutical care meaning)

Criteria for OTCCriteria for OTC : :Low toxicity and low risk of serious

adverse reactionsNot to mask any underlying condition or

increase resistanceDrugs are usually approved as

prescription only first and just after they prove safety in clinical use they are recategorized as OTC

The categories of drugsThe categories of drugsIN USA :in the United States an OTC drug product is allowed to

be marketed either (1) FDA(Food and Drug Administration) monograph (2) NDA( New Drug Application)IN UK :Prescription Only Medication (POM), legally available

only with a valid prescriptionGeneral Sales List (GSL), available off the shelf with

no pharmacy .Pharmacy Medicines (P) are medicines which are

legally neither a POM or GSL medication.

SwitchingSwitching(Move from prescriptional category into OTC)(Move from prescriptional category into OTC)

Over the last 30 years , 700 drugs were switched from prescription only to OTC category.

Advantages Advantages you don't have to go see the doctor

every time you have a little sniffle or an ache or pain.

A 2008 study of heartburn sufferers estimated that if OTC medications were not available, there would be an annual increase of approximately 6 million heartburn- related doctor office visits !

OTC drugs are cheaper

DisadvantagesDisadvantagesDisadvantages of these types of drugs are

not the drugs themselves - it's the people “1 pill is good then 2 pills should be twice as good”

90% to 95% of consumers not read the Drug Facts label.

What drugs are most common :What drugs are most common :

OTC Medication Use by CategoryOTC Medication Use by Category::Most common uses include:◦ Pain relief ◦ Cough, cold, flu◦ Allergy and sinus◦ Heartburn, stomach◦ Constipation, diarrhea ◦ Skin problems◦ Vitamin and Mineral Supplements

For Example:For Example:Pain relief◦ Most common ingredients:

Acetaminophen (Tylenol aka, APAP) Aspirin (Many) Ibuprofen (Motrin IB, Advil) Naproxen (Aleve) and ketoprofen (Orudis) Caffeine Buffers, coatings, long acting, strongest pain reliever

you can buy without a prescription….

It’s used toIt’s used to : :Pain, HeadacheFeverInflammation◦ Severe muscle aches◦ Aching joints◦ Arthritis

How many people take How many people take AnalgesicsAnalgesics??

McNeil Pharmaceuticals, Annual Report to FDA

Cough, cold&fluCough, cold&fluPharmacotherapy depends on type of coughProductive – mucolyticsNon-productive – antitussics◦ Opioid◦ Non-opioid

Mucolytics and antitusics shall not be used togetherFDA issued public health statement promoting

cautious use of cough medicines in children under 4 years

AllergiesAllergiesAnihistaminesH1 antagonists Often used to relieve allergic rhinitis (hay fever). Neither

loratadine nor cetirizine are causing sedationLoratadine CLARITINECetirizine ZODAC, ZYRTEC, CETIRIZINE-SANDOZ

CorticosteroidsBeclometazone OTC products as nasal spray BECLOMET NASAL AQUA

Gastric AcidityGastric Acidity AntacidsBuffering gastric acid > raising acidityAluminium hydroxide - MAALOXCalcium carbonate - TUMS

H2 antagonistsDecrease acid productionRanitidine – ZANTAC, RANISANFamotidine – FAMOTIDIN, QUAMATEL

Constipation, DiarrheaConstipation, DiarrheaLactuloseDisaccharide that draw water into bowel – osmotic

actionDUPHALAC

BisacodylActs by irritating of colonBISAKODYL-K, FENOLAXSodium picosulfateGUTTALAX, REGULAXLoperamidedecreasing smooth muscles motility IMODIUM

Skin problemsSkin problemsSkin, nails, vaginal fungal infectionsNystatinePolyene antifungal used also in combinationsFUNGICIDINImidazolesinhibition of ergosterol synthesisClotrimazole – CANESTEN, CANDIBENEKetoconazole – NIZORALOthers: Miconazole, Bifonazole, OxiconazoleAllylaminesTerbinafine - LAMISIL

Vitamin and Mineral SupplementsVitamin and Mineral Supplements

Many preparations are on the market, some of them are marketed as drugs others as nutritional supplements

CENTRUM, GERIAVIT PHARMATON, REVALID

Many nutritional supplements are associated with various health claims but efficacy is not required .

10 Tips on OTC use10 Tips on OTC use1. Read the label2. Treat only the symptoms you have3. Know what to avoid while taking OTCs –

beware of interactions4. ASK before you buy5. Use as directed on the label6. Be careful if you take > 1 OTC 7. Don’t mix Rx and OTCs including herbals8. Give your doctor a list of ALL meds9. For kids, use pediatric formulas10. Throw meds away if they are expired

the 3 R’s for Safe Medicine Usethe 3 R’s for Safe Medicine Use

1. Risk - All medicines (prescription & nonprescription) have risks as well as benefits;.

2. Respect – Respect the power of your medicine and the value of medicines properly used.

3. Responsibility - Take responsibility for learning about how to take your medicine safely.

Accidental Overdoses with OTC Accidental Overdoses with OTC Drugs at Poison Control CentersDrugs at Poison Control Centers

Under supervisionUnder supervision

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