Chapter 8_Over The Counter (OTC) Medications.pptx

Definition, need and role of Pharmacists in OTC medication dispensing
OTC medications in India, counseling for OTC products
Self-medication and role of pharmacists in promoting the safe practices during self medication
Responding to symptoms, minor ailments, and advice for self-care in conditions

1. Chapter­: 8 Over The Counter (OTC) Medications By: Mr. Vinay D. Gaikwad S.P.M.S. College of Pharmacy (Poly), Akluj.

2. Contents: Definition, need and role of Pharmacists in OTC medication dispensing OTC medications in India, counseling for OTC products Self-medication and role of pharmacists in promoting the safe practices during self-medication Responding to symptoms, minor ailments, and advice for self-care in conditions such as – Pain management, Cough, Cold, Diarrhea, Constipation, Vomiting, Fever, Sore throat, Skin disorders, Oral health (mouth ulcers, dental pain, gum swelling) 15Hrs.

3. Introduction: Medications are broadly classified in to two types 1. Prescription controlled medications 2. Prescription uncontrolled medications Prescription controlled medications: this class involves the drugs and medicines which needed a signified prescription of eligible authority that is physician or a registered medical practitioner. Prescription uncontrolled medications: this class involves all the drugs and medicines which do not require a written prescription of a physician or a medical practitioner. Such medications can be directly purchases over the chemist, so those drugs are called as an over the counter drugs or non prescribed drugs.

4. Definition: “OTC Medications are those medications that can be obtained over the counter or from the chemist bench without prescription of a RMP and consultation with a physician. It can be suggested that those having little significant pharmacological activity and therefore the physician need not to be very much concerned about these use by the patient themselves.” “Over-the-counter medicine 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 health care professional.” Examples include analgesics (pain relievers), such as aspirin and acetaminophen.

5. OTC Medication History: In 1860s the preparation of remedies at home was replaced by purchasing of patient medicines. By 1905 the market of the patent drugs was at its peak. 1920 due to intense economical and political struggle changed preference care, resulted in decline in public demand and use of patient medicines.

6. Need & Benefits of OTC Medicine: Over-the-counter (OTC) medicines are drugs you can buy without a prescription. Some OTC medicines relieve aches, pains, and itches. Some prevent or cure diseases, like tooth decay and athlete's foot. Others help manage recurring problems, like migraines and allergies. OTC medicines are a critical component in advancing consumer health because they allow people to treat or manage many health conditions conveniently and successfully. Because they enable people to self-treat, OTC medicines save health systems valuable resources and can save consumers time and money.

7. OTC Medications Reasons: Shortage of time and comfort Cheaper in price Availability Level of literacy and awareness Self care Advertisement

8. 1. Shortage of Time Comfort: Usually people in cities and towns due to their busy schedule don't get proper time for visiting the physician for getting proper medications but OTC medications are available in very less time or less consuming time and easily available. 2. Cheaper in Price: In our country like India where more than 55% of total population is just near the poverty line people majority are weak to visit physician for small health problems and hence prefer non-prescribed drugs comparatively cheaper.

9. 3. Availability: Most of the NPDS are easily available at all places. Due to the availabilities, there is easily preferred by common people for daily health problems. 4. Level of Literacy and Awareness: Many of the people have either very low awareness due to which they don't prefer to visit a physician. 5. Self Care: Now a day's people with high literacy and awareness are preferred to use of OTC medications. This is because self caring people that they can take care of their own help.

10. Role of Pharmacists in OTC Medication Dispensing: The pharmacists play a vital role in controlling the number of medications being dispensed as OTC drugs. They can also counsel and advise the consumers regarding OTC medications. Carefully read and follow all directions on the medicine bottle and box. Dispense the minimum effective dose. Call your doctor if you think you are having a problem with your medicine. Do not give a medicine if patient have had an allergic reaction to it in the past. Inform patient to take the medicine exactly as directed. Pharmacist has to be careful when dispensing more than one drug. Keep your doctor informed.

11. OTC Medications in India: In India, the medicines are listed under different schedules in the Drugs and Cosmetics Act and Drugs and Cosmetics Rule. Drugs listed in Schedules H, H1, and X should carry a label stating that these drugs are to be sold by retail only on prescription of a registered medical practitioner. It has to be stressed that in India, the phrase “OTC” has no legal recognition. Here, the term OTC is used for the way drugs are used (self-medication without prescription or allowed to be sold by pharmacists without the prescription of a Registered Medical Practitioner) rather than being a recognized official category of medicines unlike other countries.

12. Schedule K of the Drug and Cosmetics Act and its Rules includes household remedies such as paracetamol , liquid paraffin, eucalyptus oil, tincture iodine, and various formulations for the treatment of cough and cold and are the potential OTC drugs.

13. Currently, nondrug-licensed stores (e.g., nonpharmacists ) can sell a few medicines classified as “Household Remedies” in Schedule K of the D and C Rules in villages whose population is below 1000 subject to certain other conditions. Under the provision of the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 and Rules, 1955, the advertising and misleading promotion of some drugs/classes is kept under control to avoid self-medication by people. Topical or external use of certain schedule G and H category drugs (except ophthalmic and ear/nose preparations containing antibiotics and/or steroids) is exempt from the schedule. For example, topical diclofenac is not a schedule H drug though diclofenac is included in schedule H.

14. The medicines which do not fall under the category of schedule H, H1, and X can be given without prescription through pharmacists and drugstores in India. Moreover, it is a common observation that prescription drugs are also sold without a prescription akin to over the counter medicines. Ayurvedic drugs and traditional medicines are manufactured under a manufacturing licence issued by the State Licensing Authorities. These drugs are sold over the counter freely by non-pharmacists. Thus, till date, there are no specific unifying regulations related to use and sale of OTC products and this impacts both the accessibility to better health care and patients' safety due to inappropriate use.

15. Counseling for OTC Products: Patients’ use of OTC products carries both benefits and risks. When pharmacists proactively counsel patients on OTC product selection and use, the risks virtually disappear. Pharmacists should have to counsel every patient on the safe and effective use of OTC products.

16. The involvement of pharmacists in nonprescription medication counseling will increase the public stability to understand the risks and benefits of OTC remedies. It has been well documented that interactions by pharmacists through consultation and effective assessment strategies can enhance patient outcomes. In order to counsel patients efficiently, pharmacists must be able to communicate.

17. The first step in achieving optimal communication is setting the stage. By identifying potential barriers in the pharmacy that can impede good communication, pharmacists can actively take steps to overcome them. It is important to remove distractions or barriers that may affect interactions with patients.

18. The mnemonic  QuEST  means: Qu ickly and accurately assess the patient;  E stablish that the patient is an appropriate self-care candidate;  S uggest appropriate self-care strategies to the patient;  T alk with the patient about these strategies.

19. Another helpful mnemonic is SCHOLAR-MAC: S ymptoms;  C haracteristics of symptoms;  H istory of symptoms;  O nset;  L ocation;  A ggravating factors;  R emitting factors; M edications (prescription, OTC, herbal, dietary supplements);  A llergies;  C onditions (medical).

20. Self-medication: Fundamentally, the concept “self-care” puts responsibility on individuals for their own health and well-being. Many authors have described what constitutes self-care, and whilst no universally agreed definition exists, it is clear that self-care is seen as a broad concept that encompasses activities to establish and maintain health, through to preventing ill health.

21. The World Health Organization defines self-care as; “The ability of individuals, families and communities to promote health, prevent disease, and maintain health and to cope with illness and disability with or without the support of a health-care provider”.

22. What is Self Medication? “Self-medication” is just one element of self-care and can be defined as the selection and use of medicines by individuals to treat self-recognized illness or symptoms. How these medicines are made available to the public varies from country to country but all have been approved by regulatory agencies as safe and effective for people to select and use without the need for medical supervision or intervention.

23. Self-selection medicines are commonly referred to as “over-the-counter” medicines or “nonprescription” medicines. In this review, the term “nonprescription” will be adopted since different markets place varying restrictions on their availability, but all fall under the umbrella term of “nonprescription”.

24. Role of Pharmacists in Promoting the Safe Practices during Self-Medication: Pharmacies are often the first place a person visits when faced with an ailment. Pharmacists are highly skilled and trained professionals with vast knowledge about products and different conditions. They guide and advise individuals, helping them to avoid possible interactions of medicines and warning them of possible side effects.

25. As a communicator: The pharmacist should initiate dialogue with the patient. In order to address the condition of the patient appropriately. (e.g. how to take the medicines and how to deal with safety issues) The pharmacist must be prepared and adequately equipped to perform a proper screening for specific conditions and diseases, without interfering with the prescriber’s authority. The pharmacist must provide objective information about medicines. The pharmacist must be able to use and interpret additional sources of information to satisfy the needs of the patient. The pharmacist should be able to help the patient. The pharmacist must ensure confidentiality concerning details of the patient’s condition.

26. As a quality drug supplier: The pharmacist must ensure that the products he/she purchases are from reputable sources and of good quality. The pharmacist must ensure the proper storage of these products.

27. As a trainer and supervisor: To ensure up-to-date quality service, the pharmacist must be encouraged to participate in continuing professional development activities such as continuing education. The pharmacist is often assisted by non-pharmacist staff and must ensure that the services rendered by these auxiliaries correspond to established standards of practice.

28. As a collaborator: It is imperative that pharmacists develop quality collaborative relationships with: Other health care professionals National professional associations The pharmaceutical industry Governments (local/national) Patients and the general public In so doing, opportunities to tap into resources and expertise, and to share data and experiences, in order to improve self-care and self-medication, will be enhanced.

29. As a health promoter: As a member of the health-care team, the pharmacist must: Participate in health screening to identify health problems and those at risk in the community Participate in health promotion campaigns to raise awareness of health issues and disease prevention Provide advice to individuals to help them make informed health choices

30. Responding to symptoms, minor ailments, and advice for self-care: 1. Pain management: Pain  is a very common condition. The occurrence of pain rises as people get older, and women are more likely to experience pain than men. Pain may be anything from a dull ache to a sharp stab and can range from mild to extreme. You may feel pain in one part of your body or it may be widespread.

31. Types of pain There are 2 main types of pain: Acute pain – a normal response to an injury or medical condition. It starts suddenly and is usually short-lived. Chronic pain – continues beyond the time expected for healing. It generally lasts for longer than 3 months.

32. Pain management strategies Studies suggest that a person’s  emotional wellbeing  can impact the experience of pain. Understanding the cause and learning effective ways to cope with your pain can improve your quality of life. Key pain management strategies include: Pain medicines Physical therapies (such as heat or cold packs,  massage , hydrotherapy and  exercise ) Psychological therapies (such as  cognitive behavioral therapy , relaxation techniques and  meditation ) Mind and body techniques (such as  acupuncture ) Community support groups.

33. Managing pain without medicines Many non-medicine treatments are available to help you manage your pain. A combination of treatments and therapies is often more effective than just one. Some non-medicine options include: Heat or cold – use ice packs immediately after an injury to reduce swelling. Heat packs are better for relieving chronic muscle or joint injuries. Physical therapies – such as walking, stretching, strengthening or aerobic exercises may help reduce pain, keep you mobile and improve your mood. Massage   – this is another physical therapy. Relaxation and stress management techniques – including  meditation  and  yoga . Acupuncture  – a component of traditional Chinese medicine.

34. Pain medicines Many people will use a pain medicine (analgesic) at some time in their lives. The main types of pain medicines are: Paracetamol – often recommended as the first medicine to relieve short-term pain. Aspirin – for short-term relief of fever and mild-to-moderate pain (such as  period pain  or  headache ). Non-steroidal anti-inflammatory drugs (NSAIDs) , such as ibuprofen – these medicines relieve pain and reduce inflammation (redness and swelling).

35. 2. Cough and Cold: Non-medication treatment for cough or cold: Get plenty of rest and drink plenty of fluids. Try to breathe moist air. Use a humidifier or take a steamy shower. Consume warm fluids (soup or tea) to provide relief for a stuffy nose and to loosen phlegm. Eat a well-balanced diet. If you cannot, ensure you are getting enough nutrients by taking a daily multivitamin. Avoid dairy products, as they can thicken phlegm. Avoid alcohol, as it impairs your body’s immune system.

36. Contact your doctor if you experience any of the following: High fever (Temperature > 101F for > 72 hrs) Ear pain Sinus-type headache Unusually severe cold symptoms Cough that gets worse while other cold symptoms improve Flare up of any chronic lung problem, such as asthma No improvement in symptoms for more than 10 days

37. Recommended non-prescription medications by symptom: Cough, Non-productive (not coughing up phlegm) Cough suppressant containing dextromethorphan ( TusQ -DX Syrup) Cough, Productive (coughing up phlegm) Cough suppressant (see above) Expectorant: Cof Q tablets or plain guaifenesin syrup, also known as ( Zedex Plus Syrup)

38. Fever/Headache/Muscle Aches Acetaminophen ( Ultracet / Calpol ) Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as ibuprofen ( Combilam ) or naproxen ( Naxdom ) Nasal Stuffiness Saline nasal spray or a Neti Pot. Nasal steroid sprays: Fluticone -FT or Solvin Nasal Spray Decongestants: Topical spray: Oxymetazoline ( Sinarest New Nasal Spray); limit to 3-4 days maximum Oral medication: Pseudoephedrine ( Ambrodil -Plus RF Syrup)

39. Runny and/or Itchy Nose/Sneezing Nasal steroid sprays: Flonase ® or Nasacort® Antihistamine: Benadryl®, which will likely cause drowsiness, or Loratadine ( Alavert ®), which is not as likely to cause drowsiness Sore Throat Pain Relief Suck on throat lozenges, hard candy or popsicles Gargle with warm salt water (1/4 tsp. salt per 8 oz. of water); and eat soft, bland foods. Take acetaminophen (Tylenol®) or ibuprofen (Advil®). Try throat sprays ( Chloraseptic ®).

40. 3. Vomiting and Diarrhea: Vomiting and diarrhea can make you feel awful. Your stomach and bowels are reacting to an irritant. This might be food, medicine, or a virus. Vomiting and diarrhea are 2 ways your body tries to remove the problem from your system. Nausea is a symptom that prevents you from eating. This can give your stomach and bowels time to recover. Self-care can help to ease your discomfort.

41. Drink liquids Drink or sip liquids so you don't lose too much fluid (dehydration). To do this: Choose clear liquids such as water or broth. Don't have drinks with a lot of sugar in them. This includes juice and soda. These can make diarrhea worse. If you have severe vomiting or diarrhea, don't drink sports drinks or electrolyte drinks. These don't have the right mix of water, sugar, and minerals. They can make the symptoms worse. Try an oral rehydration solution.  Suck on ice chips if nausea makes it hard for you to drink.

42. Medicines When considering medicines: Don't use medicines to stop diarrhea or vomiting unless your healthcare provider tells you to do so. Vomiting and diarrhea can help your body get rid of harmful substances. Some medicines can cause vomiting and diarrhea. Talk with your provider about all medicines you take. Ask which ones may cause these symptoms Any medicine with aspirin can bother your stomach. So don't use them when you have an upset stomach. Some OTC antihistamines can help control nausea. Other medicines can help soothe an upset stomach. Ask your healthcare provider which medicines may help you.

43. When to call your healthcare provider Call your healthcare provider care right away if you have any of these: Bloody or black vomit or stools Severe, steady belly pain Vomiting with a severe headache or stiff neck Vomiting after a head injury Vomiting and diarrhea together for more than 1 hour Can't sip liquids after more than 12 hours Vomiting that lasts more than 24 hours Severe diarrhea that lasts more than 2 days Fever of 100.4°F (38.0°C) or higher, or as advised Yellowish color to your skin or the whites of your eyes Can't urinate

44. 4. Constipation: Constipation is when you do not pass stool as often as you normally do. Your stool may become hard and dry, and it can be difficult to pass.

45. Signs, Symptoms, and Causes You might feel bloated and have pain, or you might have to strain when you try to go. Some medicines, and even some vitamins, can make you constipated. You can get constipated if you do not get enough fiber, drink enough water, or get enough exercise. You can also get constipated if you put off going to the bathroom even though you have the urge to go. Try to get to know your normal bowel movement pattern, so that you can prevent constipation and keep it from getting worse.

46. How to Relieve Constipation Exercise regularly. Drink more water and eat  more fiber . Try to walk, swim, or do something active at least 3 or 4 times a week. If you feel the urge to go to the bathroom, go. Do not wait or hold it in. You can also train your bowels to be more regular. It may help to go to the bathroom every day at the same time. For many people, this is after breakfast or dinner.

47. Laxatives, Stool Softeners, and Other Products You can buy stool softeners at any pharmacy. They will help you pass stool more easily. Your provider may prescribe a laxative to relieve your constipation. It may be a pill or liquid. Do not take it if you have severe stomach pain, nausea, or vomiting. Do not take it for more than 1 week without consulting your provider. It should start to work in 2 to 5 days. Only take a laxative as often as your provider recommends. Most laxatives are taken with meals or at bedtime. You can mix powder laxatives with milk or fruit juice to make them taste better. Always drink plenty of water (8 to 10 cups, or 2 to 2.5 L a day) when you are using laxatives. Store your laxative medicine safely in a medicine cabinet, where children cannot get to it. Do not take any other laxatives or medicines before talking with your provider. This includes mineral oil.

48. 5. Fever : For healthy human beings, the body temperature should be around 98.4°F (37°C). Any rise in temperature above one degree more than the normal is considered as fever. However , fever by itself may not be something to worry about until the temperature reaches very high levels and fever episodes occur often, but it always requires medical attention to find and treat the cause. Infections are one of the main causes of  fever , but fever is mostly a body response to fight off these infections.  However , you can manage it with some self care treatment tips for fever at home before consulting the doctor.

49. Symptoms: Body temperature ranging from 100 to 102°F (37.8 to 39°C) is considered as low-grade fever, whereas body temperature of more than that is considered as high-grade fever. In either condition, some major associated symptoms are: Chills Sweating Headache Muscle ache Appetite loss Fatigue Lethargy Sometimes, a very high fever can cause  seizures .

50. Causes: Severe physical exertion Infection (bacteria, virus, parasites, and fungi) Heat exhaustion Autoimmune disorders  Inflammatory disorders  A malignant tumor Blood pressure and seizure medications Some immunization vaccines, like  diphtheria ,  tetanus , and pneumococcal vaccine Drug abuse or side-effect of medications  Hormone disorders

51. Home Remedies for Fever: Fever  causes continuous unease, but some self-help remedies can quickly give you relief. Follow the following home remedies and tips: Drink a lot of water/hydrate well:  With a fever, our body needs more water to compensate for the high temperature because there is more water loss in the body. It is called  dehydration . Drinking lots of water can help in rehydrating the body. Along with water, have coconut water, orange juice, lime juice, and oral rehydration solution(ORS). Rest:  Our body requires a lot of energy to fight off fever. A person having a fever should take an adequate amount of rest until the fever is gone. Any physical stress can have ill effects.  Have a warm bath:  Have a bath with lukewarm water as it is soothing and relieves the pain in the muscles and joints.

52. Use OTC medicines: Over-The-Counter (OTC) medicines are available to relieve fever. Some of them are ibuprofen and paracetamol. However, for infants or children, give medicines according to a doctor’s prescription.

53. When to See a Doctor ? If you feel feverish and do not subside even after following the home remedies mentioned above or any other concerns, consult your doctor for further diagnosis and treatment.

54. 6. Skin disorders: Skin diseases are conditions that affect your skin. These diseases may cause rashes, inflammation, itchiness or other skin changes. Some skin conditions may be genetic, while lifestyle factors may cause others. Skin disease treatment may include medications, creams or ointments, or lifestyle changes.

55. What are skin diseases ? Your   skin  is the large organ that covers and protects your body. Your skin has many functions. It works to: Hold in fluid and prevent  dehydration . Help you feel sensations, such as temperature or pain. Keep out bacteria, viruses and other causes of infection. Stabilize your body temperature. Synthesize (create) vitamin D in response to sun exposure.

56. How are skin diseases treated? Many skin diseases respond well to treatment. Depending on the condition, a  dermatologist  (doctor specializing in skin) or other healthcare provider may recommend: Antibiotics . Antihistamines . Laser skin resurfacing . Medicated creams, ointments or gels. Moisturizers. Oral medications (taken by mouth). Steroid  pills, creams or  injections . Surgical procedures.

57. You may also reduce symptoms of skin conditions by making lifestyle changes: Avoid or limit certain foods, such as sugar or dairy, if your healthcare provider suggests it. Manage  stress . Practice good hygiene, including proper skin care. Avoid excessive alcohol use and smoking.

58. 7. Oral health : Dental and oral health is an essential part of your overall health and well-being. Poor oral hygiene can lead to dental cavities and gum disease, and has also been linked to heart disease, cancer, and diabetes. Maintaining healthy teeth and gums is a lifelong commitment. The earlier you learn proper oral hygiene habits — such as brushing, flossing, and limiting your sugar intake — the easier it’ll be to avoid costly dental procedures and long-term health issues.

59. Types of dental and oral diseases: Cavities Gum disease (gingivitis) Periodontitis Cracked or broken teeth Sensitive teeth Oral cancer

60. Treating dental and oral problems: Cleanings Fluoride treatments Antibiotics Fillings, crowns, and sealants Root canal Probiotics Changing daily habits