POM vs OTC drugs
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Difference between Over-the-counter drugs and prescribed medications. Examples of OTC and POM. FDA regualtion over OTC and POM.
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2) Instructions for use, intended performance, and potential side effects.
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4) Materials used and manufacturing residuals that pose risks.
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Over-the-counter (OTC) drugs are medications that can be safely used without a prescription. In the US, the FDA regulates OTC drugs to ensure they are safe and effective for self-treatment of common health issues. The FDA reviews OTC products and establishes labeling regulations. There are two pathways for legal OTC drug marketing: compliance with an OTC drug monograph or approval under a new drug application. OTC drugs are generally low risk for abuse and allow for wider access and treatment of minor conditions. Proper labeling, safety, efficacy, and manufacturing standards are required of all OTC drugs.
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- Factors like urgent medical need or similar disease mechanisms may motivate off-label prescribing.
- Rates of off-label prescribing are high in pediatrics, psychiatry, and other areas with limited clinical trials.
- Indian law does not explicitly permit or prohibit off-label use, though some guidelines support evidence-based off-label prescribing with patient
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2. Obtain relevant background information such as medical history, medications, and lab values.
3. Determine and categorize the ultimate question being asked.
4. Develop a search strategy and conduct research in primary, secondary, and tertiary literature resources.
5. Perform evaluation, analysis, and synthesis of the data found.
6. Formulate a response to the question and provide it to the requestor.
7. Conduct follow-up documentation and communication as needed.
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The kidney plays an important role in regulating fluids, electrolytes, and removing waste from the body. Impairment of kidney function affects drug pharmacokinetics. Common causes of kidney failure include disease, injury, drug toxicity, infections, diabetes, toxins, and reduced blood flow. Acute kidney problems or trauma can lead to uremia where filtration is impaired, causing excess fluid and waste to accumulate. Uremic patients may have changes in drug absorption, distribution, and clearance. Dosage adjustments are often needed based on a patient's kidney function and drug properties to safely treat uremic patients.
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This document discusses medication history, which involves identifying and documenting a patient's current and past medications, allergies, and other medication-related information. It is an important part of pharmaceutical care that provides a starting point for medication reconciliation and review. The goals of a medication history include gaining information on prescription/nonprescription medications, perceived benefits/side effects, medication allergies/intolerances, and identifying potential medication problems. The document outlines the components, sources, aspects, and steps involved in conducting a thorough medication history interview.
Off label use of drugs
Off-label drug use involves prescribing approved medications for indications, dosages, or patient populations that are different than what is specified in the drug's approved labeling. This is common in areas where patients may not have been included in clinical trials. Some key points include:
- Off-label use can expand treatment options but also increases risks of adverse reactions.
- Factors like urgent medical need or similar disease mechanisms may motivate off-label prescribing.
- Rates of off-label prescribing are high in pediatrics, psychiatry, and other areas with limited clinical trials.
- Indian law does not explicitly permit or prohibit off-label use, though some guidelines support evidence-based off-label prescribing with patient
pharmaceutical policy - 2002
The Pharmaceutical Policy of 2002 was introduced by the Government of India to address challenges from trade liberalization and globalization. Its objectives were to ensure availability of quality drugs at affordable prices, strengthen domestic production capabilities, encourage investment and exports, promote rational drug use and R&D. Key decisions included abolishing licenses for some bulk drugs, allowing 100% FDI, price controls on essential medicines, and incentives for indigenous R&D including tax benefits and a fund to support it. The policy aimed to make India's pharmaceutical industry more competitive internationally while ensuring access to medicines.
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This document discusses types of adverse drug reactions and factors influencing them. It describes types A-E reactions, which include augmented, bizarre, chemical, delayed and end of treatment reactions. Polypharmacy, age, drug characteristics, gender, race and genetic factors can influence susceptibility. Detection methods include pre-marketing studies, post-marketing surveillance, underreporting and communicating reactions. Healthcare professionals should monitor high-risk patients and gather information to assess causality between drugs and adverse events. Underreporting is common due to various barriers but can be addressed through improved reporting systems and education.
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This document provides information about over-the-counter (OTC) medications. It defines OTC medications as drugs that are safe for use by the general public without a prescription from a doctor. OTC medications have little pharmacological activity and are primarily used for symptomatic relief rather than as prescription drug substitutes. The document discusses the classification of medications as either prescription-controlled or prescription decontrolled/OTC. It also covers OTC drug labeling requirements, proper OTC drug use, common types of OTC drugs, risks of OTC drug use, and the process of counseling patients on OTC medication selection and use.
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OTC drugs are medicines that can be purchased without a prescription. They make up a large portion of the drug market, with over 100,000 products containing around 800 active ingredients across 80 categories. While convenient for self-treatment, they can also be misused or abused, especially by adolescents. Common OTC drugs that are misused include dextromethorphan (DXM) in cough medicines and stimulants like ephedrine. Clinicians can help prevent misuse by educating patients, reviewing all medications, and encouraging guidance from medical professionals when treating with OTC drugs.
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1. Secure demographics and contact information of the requestor.
2. Obtain relevant background information such as medical history, medications, and lab values.
3. Determine and categorize the ultimate question being asked.
4. Develop a search strategy and conduct research in primary, secondary, and tertiary literature resources.
5. Perform evaluation, analysis, and synthesis of the data found.
6. Formulate a response to the question and provide it to the requestor.
7. Conduct follow-up documentation and communication as needed.
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This document discusses pharmacokinetic drug interactions, which occur when one drug alters the concentration of another drug in the body. It classifies these interactions based on how a drug affects another drug's absorption, distribution, metabolism, or elimination. Key points include that absorption can be impacted by changes in gastrointestinal pH, chelation, or motility. Distribution interactions commonly involve protein binding displacement. Metabolism may be induced or inhibited by other drugs. Elimination interactions can impact renal blood flow, urine pH, active secretion, or forced diuresis. The document provides examples to illustrate each type of pharmacokinetic drug interaction.
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Action mechanisms, uses & adverse effects of cholinergic agents used in ophthalmic preparation..
Physiology of pregnancy.pptx
The document summarizes several key physiological changes that occur in a woman's body during pregnancy. It discusses changes to the cardiovascular, respiratory, urinary, and gastrointestinal systems. It also covers metabolic changes, weight gain, hormonal changes, and intrauterine physiology and circulation. The stages of labor and lactation are briefly outlined as well. In summary, the document provides an overview of the many adaptations a woman's body undergoes to support the growing fetus during pregnancy.
E_learning.docx
Computers have revolutionized education by playing an important role in student career development and making lessons more interactive. Schools now teach basic computer and internet skills, allowing students to create presentations, drawings and documents. Computer use supports lesson delivery and communication. As the world modernizes rapidly, teachers use computers to manage grades, attendance and student data, creating presentations to make lessons more understandable. E-learning through digital devices and the internet allows learning anywhere with an internet connection, though it can increase laziness and distract students from their academic paths if non-educational content is accessed.
Obesity.pptx
The document discusses obesity, its causes and health risks. It states that obesity is caused by consuming more calories than the body can use, which are then stored as fat. Obesity is linked to many health conditions like heart disease and diabetes and is the second leading cause of preventable death in the US. While not a psychiatric disorder, obesity can manifest psychological symptoms like low self-esteem. The document recommends lifestyle changes like healthy eating, exercise and medications as ways to manage obesity. Surgery may also be considered for severe cases.
Peptic ulcer.pptx
Peptic ulcer is caused mainly by infection with Helicobacter pylori bacteria or use of nonsteroidal anti-inflammatory drugs like aspirin. Symptoms include abdominal pain and discomfort. Risk factors include smoking, alcohol, family history, and certain illnesses. Complications can include internal bleeding, perforation of the stomach wall, or gastric outlet obstruction. Treatment involves eradicating H. pylori with antibiotics if present, reducing NSAID use, and medications to reduce acid production and promote healing. Prevention focuses on healthy lifestyle habits and protecting against infections.
Cell structures.docx
The document summarizes the structures and functions of the major cell organelles. It describes the cytosol, cell membrane, nucleus, cell cytoskeleton, ribosomes, mitochondria, endoplasmic reticulum, Golgi apparatus, lysosomes, peroxisomes, transport vesicles, and secretory vesicles. The cell membrane forms the boundary of the cell and is selectively permeable. The nucleus houses genetic material and controls cell functions. Other organelles such as mitochondria, endoplasmic reticulum, and Golgi apparatus work together to synthesize proteins and modify other molecules. Vesicles like lysosomes and peroxisomes perform digestive and detoxification roles within the cell.
Computer Generations.docx
The document describes the five generations of computers from 1940 to present. The first generation used vacuum tubes and consumed a lot of electricity. The second generation introduced transistors which decreased the electricity used. Each generation brought improvements like increased storage, decreased costs, improved user interfaces, faster operating speeds and processing power, and smaller sizes. The latest fifth generation is based on artificial intelligence and can process data at femtosecond speeds and trillions of instructions per second.
Sudan Medical Council.pptx
The Sudan Medical Council is the regulatory body that grants medical licenses in Sudan. It was established in 1955 and monitors medical practice in the country. Some of its key roles include establishing standards for medical education, providing training for new doctors, administering licensing exams, accrediting medical schools, and enforcing codes of conduct for doctors. It aims to protect public health and safety by ensuring high professional standards.
Renal System Anatomy
The renal system consists of the kidneys, ureters, urinary bladder, and urethra. The kidneys filter waste from the blood to produce urine. The ureters then transport urine from the kidneys to the urinary bladder, where it is stored. When full, the bladder empties through the urethra, which exits the body. The kidneys are bean-shaped organs located in the abdominal cavity that contain millions of nephrons to filter blood. The ureters are muscular tubes that carry urine from the kidneys to the bladder. The bladder is a hollow organ in the pelvis that expands as it fills with urine before emptying through the urethra.
Heat In Medicine
This document discusses the use of heat in medicine. Thermal therapy uses heat for pain relief and health benefits. Hyperthermia raises body temperature to make cancer cells more vulnerable to other treatments like chemotherapy and radiation. Thermal ablation uses high heat to destroy tumors and abnormal tissues. Hyperthermia is often used with chemotherapy and radiation therapy to increase their effectiveness by damaging cancer cells and improving drug delivery. Heat therapies can precisely target tumors while minimizing harm to normal tissues. They are used to treat various conditions like cancer, heart arrhythmias, varicose veins, and more. Maintaining normal body temperature is also important for recovery from surgery.
Networks
The document discusses computer networks and internet security. It defines local and wide area networks and explains how the internet connects both computers and people globally. It lists benefits of the internet like knowledge, communication, and shopping. The final section outlines some key aspects of internet security including access control to minimize unauthorized access, using anti-virus software to detect and prevent malware, and securing email accounts and content.
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- 2. OBJECTIVES: What are Over-the-counter(OTC) medications? What are prescription only medications(POMs)? What are the differences between both? What are the examples of POMs and OTC medications?
- 3. What’s prescription only medications (POMs)? Medications that require prescription from Doctor or other healthcare professional. Doctor prescribing medication to patient Patient shows Dr’s prescription to pharmacist to get those medication.. 1 2 Syeda Aiman
- 4. What’s Over-the-counter (OTC) Medications? Medications that can be purchased without a medical prescription. She can buy medicine for headache without any prescription from doctor 1 2 Syeda Aiman
- 5. Syeda Aiman
- 6. Over-the-counter (OTC) Medications Bought off-the-shelf at drug stores or groceries. No need of prescription. Not intended for specific individual. Prescription Only Medications Bought at a pharmacy Prescribed by licensed practitioner. Intended to be used by one person. VS Syeda Aiman
- 7. Over-the-counter (OTC) Medications Unlike POM, they are not strictly monitored by FDA. Prescription Only Medications They must pass through many clinical trial phases approved by FDA and must be monitored even after drug is on the market. VS Food and Drug Administration: Decides which drug require prescription. Syeda Aiman
- 8. OTC medications Smoking cessation drugs Anti-acne drugs Antiseptics Syeda Aiman
- 9. • Tranquilizers Prescription Only Medications (POMs) Blood pressure tablets Syeda Aiman
- 10. Syeda