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HSCI180 CH 12-13 NHPs, OTC drugs, Opioids.docx

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Department
Health Sciences
Course
HSCI 180
Professor
Julian Somers
Semester
Fall

Description
CHAPTER 12 -NHPs&OTCDrugs Natural Health Products  Health Canada is responsible for establishing standards for the safety and quality of food and drugs sold in Canada. This mandate is exercised under the authority of the Food and Drugs Act ( FDA) and the regulatory mandate is followed under the Food and Drug Regulations.  Drug = a product intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease  NHP = Eg Vitamins and mineral supplements, herbal remedies, Chinese medicines, probiotics, EFAs o Package like drugs but classified/regulated like food  Only need to prove safe and pure – not safe & effective  Do not need to provide potential side effects/toxicities o Established Natural Health Products Directorate (NHPD) 2004  Regulate products that ‗treat disease, or modify/correct organic functions‘  Safe - Must be as safe as OTC but no need prescription  Effective - Must have evidence of effectiveness (eg clinical trail data)  If none, can rely on traditional evidence (50 years of effectiveness) – Chinese medicine – so it represent no reproductive side effects in two generations  Must have product + site license, info on active ingredients, and Natural Product Number or DIN- HM for homeopathic medicine  Today – NHPs are safe, effective and high quality  71% regularly use, 38% use daily o Most common – vitamins (57%), Echinacea (15%) Psychoactive NHPs Enzyte  US Natural male enhancement – not proven effective, ‗designed‘ to, enhance sex not enlarge penis St.John’s Wort (Hypericum perforatum) o Prevent devil possession  1) ―Relieve restlessness/nervousness, treat sleep disorders‖  2) Limited in treating anxiety  3) Useful in treating depression = Better than placebo, similar to antidepressants but fewer side effects  Concerns when interacting with various prescription drugs SAMe  S-adensyl-L-methionine – naturally in body  ―Support healthy mood balance‖  Antidepressant – better than placebo, similar to tricyclic antidepressants Ginkgo Biloba  Long history of medical use in China  ―improve memory and cognitive function‖ o Improve Alzheimer (increase circulation in brain) o Unreliable for dementia  ―improve circulation, reduce blood clotting‖ o But when combined with Aspirin (also reduce clotting) can be dangerous Caffeine  Wake-Ups, Peptime (100-200mg)  do not need, buy coffee or rest to safe money  ―temporarily restore mental alertness when experiencing fatigue‖  When NHPD started, transitioned form OTC to NHPs Weight-Control Products  No NHP or OTC license today as ―weight control‖ product  Before 2001, product with phenylpropanolamine (PPA) were considered safe and effective as anorexic agents o Eg Ayds – suppress appetite – 1970-1980 o Concerns about safety – 75mg (recommended dose) increase blood pressure, stroke  Ephedra/Ma huang – misused for weight loss – only good short term o Link to sudden cardiac death, Health Canada issued recall of all products o Today – ephedra ―relieve nasal congestion due to cold/hay fever‖  Orlistat(Xenical) – ―anti obesity agent‖ – induce enzyme to help breakdown fats o But when stopped, weight returns, o Fat remain in poop, causing loose oily stools – frequent urgent bowel movement hard to control o Only available by prescription Sleep Aids  There are OTC sleep aids, but people prefer NHPs  NHP - Eg Melatonin – a hormone = ―increasing total sleep time for people who suffer from shift work and jet lag‖ Over the Counter Drugs  Non-prescription drugs – medicines sold directly to consumer  Regulated by Health Canada/FDA – ensuring safe and effective  Evaluated by active pharmaceutical ingredients (APIs), not final product o Allowing manufacturers to formulate ingredients into proprietary mixtures  Canadians spent $3million/ year – especially for aspirin-like analgesics for cold and fever  +100,000 product, but contain fewer than 1000 total active ingredients o Many only have one active ingredients – most differ in the inactive (colourings, flavouring)  Regulations = Need Notice of Compliance – evaluate safety and effectiveness  Labelling = uniform standard, directions, precautions and warnings, clear and simple language o Developing the requirement to list non-medicinal ingredients (NMIs) OTV vs Prescription  Drugs approved for use classified into scheduling system, maintained by National Association of Pharmacy Regulatory Authorities  Schedule 1 – prescription  Schedule 2 – behind the counter  Schedule 3 – OTC o Determine by toxicity or other reasons (need to inject) o Differ in amount of active ingredient  Eg Tylenol #1 (8mg codeine); Tylenol #3 (30mg)  Recent years push to reregulate prescription to OTC – driven by: increase notion of responsibility and self-care + companies seek increase sale + growing challenge to maintain public and private prescription plan Behind the Counter  Don‘t need prescription, but kept behind counter  Safe and effective but adverse events can happen  give pharmacist chance to counsel patients about drug‘s proper use and precautions (Reimbursed for their time through dispensing fees) o Eg - EpiPens, Polysporin eye drops, strong lice shampoos, Tylenol#1 Sleep Aids  Scopolamine (block acetylcholine) + methapyrilene (antihistamine) o FDA review panel eventually rejected scopolamine but accepted methapyrilene o Later methapyrilene was found to cause cancer in rats - no longer safe  Other antihistamine = Pyrilamine maleate, Doxylamin succinate, Diphenhydramine  Today – include diphenhydramine hydrochloride or citrate (blocking histamine) o Eg Nytol, Sleep-Eze D  Antihistamine induce drowsiness, but not very quickly – should not be used with alcohol OTC Analgesics (reduce pain)  Anaesthetics – without sensibility = unconsciousness, in surgery  Analgesics – without pain = reduce pain but is consciousness o 1) Opioids o 2) OTC internal analgesics (eg aspirin, acetaminophen, ibuprofen)  Visceral pain – arise from non-skeletal portions (eg intestinal cramps) – reduce by opioids  Somatic pain – from muscle or bone (eg sprains, headaches) – reduce by aspirin  About 35 percent of patients obtain pain relief from a placebo Aspirin  Long historical use of teas and extracts of willow and poplar bark for pain relief  1838 synthesized active ingredient salicylic acid - used to treat illness, especially arthritis o often caused gastric discomfort – upset stomach and nausea  1898 Bayer’s chemist Hoffmann synthesized acetylsalicylic acid (without stomach pain) o 1899 Patented as Aspirin o Bayer Laboratories – introduced both heroine and Aspirin o Aspirin is converted to salicylic, more potent, irritates stomach less, absorb more rapidly o Started selling as powder, then introduced tablet (non-prescription) o 1917 – patent expired, became generic name  Therapeutic Use o Therapeutic dose – 600-1000mg, but 300mg is already effective  Increase dose does not increase analgesic action  Low toxicity  Absorbed through stomach and even faster in intestines o 1)Analgesic-Block somatic pain  Pain relief experienced = one hour  Last = up to 4 hours  Can withstand continuing pain – especially headache, musculoskeletal aches  Less effective for toothache, sore throat, visceral pain, traumatic pain o 2)Antipyretic – reduce fever  Does not lower temp for non-fever  Act on hypothalamus to increase heat loss – heat production not change o 3)Anti-inflammatory (swelling, inflammation, soreness of injured area)  Use in arthritis o Over time- shell harden and active ingredient less effective o Moisture and heat decompose acetylsalicylic into SA and vinegar  if aspirin bottle smells like vinegar, discard it  Adverse Effects o Anticoagulant effect - Increases bleeding time by inhibiting blood platelet aggregation  Bad: Bleeding problems for surgical patients, don’t use 7-10 days before  Good: May prevent heart attacks and strokes by preventing clots in high-risk patients (not low) o Induces gastrointestinal bleeding (70% of people)  Perhaps due to direct eroding on gastric mucosa  Help reduce if drink lots of water or crush tablet before taking o Reye’s syndrome—rare but serious disease  Usually under age 20, after viral infection (influenza, chicken pox)  Begin vomiting, disoriented, personality changes, comas, die, brain damage – mortality rate 25%  Aspirin did not CAUSE but increase risk 25x  No one under 20 should use Aspirin to treat chicken pox/influenza or even a common cold o Accidental poisonings and suicide attempts  Mechanism of action o CNS&PNS analgesic effect – it modifies the cause of pain  Prostaglandins = local hormones - released when cell membranes are damaged/injured + mediate pain in injured areas by sensitizing neurons to stimulation  Aspirin blocks synthesis of prostag. – by inhibiting 2 forms of cyclooxygenase enzyme (COX) o Antipyretic action = prostaglandins also act on hypothalamus to decrease heat loss  Aspirin blocking it will increase heat loss Acetaminophen (Tylenol & Datril)  Phenacetin was sold for years with aspirin and caffeine APC table to fight headache pain ‗three ways‘) a now banned pain reliever  suspected for causing kidney lesions and dysfunction  withdrawn 1973 o Phenacetin rapidly convert to acetaminophen (primary active agent)  Acetaminophen compared to aspirin: o As effective in analgesic and antipyretic effects [but less gastric bleeding] o Less useful as an anti-inflammatory drug o Not safer than aspirin if recommended dose is exceeded  Overuse can cause serious liver disorders o Identified as the leading cause of overdose and acute liver failure in Canada. o Damage to liver might not be noticed until 24-48 hours later – should call doctor immediately if overdose Ibuprofen and Other NSAIDs  Ibuprofen is an aspirin-like analgesic and anti-inflammatory; it also inhibits COX enzymes  Side effects: nausea, stomach pain, cramping, liver damage with high doses  Collectively referred to as nonsteroidal anti-inflammatory drugs (NSAIDs)  Originally available by prescription, but now also available OTC  Vioxx - anti-inflammatory o 2002 Withdrawn from worldwide market in 2004 because of increased risk of heart attacks. Products with Codeine  Some contain codeine (8mg per tablet) – weak pain reliever, converted into morphine  Sold behind the counter – only when formulated with two or more non-narcotic active ingredients  Co-codaprins = drugs with acetylsalicylic acid, codeine, caffeine = but some use acetaminophen instead o Caffine offset sedating codeine o Eg 222, Tylenol #1 o Anything over 8mg available by prescription only Cold and Allergy Remedies All-too-common cold  Cause by viruses, damage and kill cells – 40-60% cannot identify what specific virus  Two virus groups: rhinovirus and coronaviruses o Affected cells on the upper respiratory tract, causing irritation o Lead to coughing, sneezing, and production of fluid by the mucous membranes (runny nose)  Transmission o 100x as many viruse from nasal mucosa as from throat o Few in saliva, none in 50% of individuals o Dried virus survey on skin/palastic/wood +3 hours o Most cold viruses enter the body through the nose or eyes; usually transmitted via hands o Frequent hand washing is a good strategy to reduce the risk of contracting a cold o * pets are not susceptible to colds o Only about 50% who are exposed to a cold virus actually develop symptoms o Chill environment – BEING cold doesn‘t CATCH a cold  Treatment o No way to prevent and no way to cure once it starts o Modern cold remedies contain three common types of ingredients  Antihistamines for temporary relief of runny nose and sneezing (questionable benefits)  Eg Chlorpheniramine maleate  Nasal decongestants for temporary relief of swollen nasal membranes  Eg phenylephrine  Analgesic-antipyretics for temporary relief of aches and pains and fever reduction  Eg acetaminophen  Cough suppressant dextromenthorphan – most common active ingredient in OTC cough medicines o High school kids use large doses of cough syrup to get high o Visual and auditory hallucinations after drinking Robitussin – for hours o Side effects – itching and nausea  Should not give OTC cough and cold products to children under 2 years of age Allergy and sinus medications  Allergy relief - Rely mainly on antihistamines (slow runny nose)  Sinus medications - use nasal decongestants + analgesics – reduce swollen sinus and treat sinus headache CHAPTER 13 – Opioids History of Opium  Opioid – Naturally occurring substances derived papaver somniferum o Medical use, 6,000-year - relieve pain and suffering, reduce diarrhea, dehydration caused by dysentery o Recreational use - deliver pleasure and relief from anxiety  Cultivation - Papaver somniferum is an annual flowering plant that grows 3-4 feet high o Available for collection for only a few days of the plant‘s life o Opium harvesters use a sharp, clawed tool to make shallow cuts into the unripe seedpods, The resinous substance that oozes from the cuts is scraped and collected  get Raw Opium  Origin – Most likely the Middle East o Egypt = Papyrus (circa 1500 BC) described specific medical uses o Greece and Rome = Had an important role in Greek medicines o Arabic world = Forbad alcohol se, so opium and hashish was primary social drug (traded with india/China)  wrote widely about use of opium preparations, formed basis of medical education in Europe o Europe –16 C - Physicians used an opium extract laudanum, performed wondrous cures, spread use  Writers and Opium o Thomas De Quincey drank laudanum and wrote a widely read book (1823) about life as an ―opium eater‖ o Other authors who used laudanum included Elizabeth Barrett Browning and Samuel Taylor Coleridge History: Opium Wars 1839  1729: Opium smoking outlawed in China, but smuggling was widespread, especially from India  End of 17C, port of Canton was opened under strict rules, tea was major import  Opium was smuggled primarily, made much profit for Britain  Early 19C, government of India was actually British East India Company, had monopoly on opium (traded legally in India, but illicitly in China) - continue pouring opium into China against the wishes of the Chinese government  1839 – emperor sent Commissioner Lin to suppress opium smuggling, 6$ million worth of opium was destroyed, pressure mounted, drunken American and British sailors killed Chinese citizen, starting Opium Wars in 1839  British army came back with superior royal navy ships, won the battle, got island of Hong Kong, broad trading rights,
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