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The information provided includes the following: what is Lortab the possible side effects of Lortab what happens if you miss a dose of Lortab what happens if you overdose with Lortab the most important information about Lortab how to use Lortab other drugs that may affect Lortab what to avoid while using Lortab Generic Name: acetaminophen and hydrocodone (ah see ta MIH no fen and hye dro KOE done) Brand Names: Anexsia, Anolor DH5, Bancap HC, Dolacet, Lorcet 10/ 650, Lorcet HD, Lorcet Plus, Lortab, Lortab 10, Lortab 5/ 500, Lortab 7.5/ 500, Lortab Elixir, Norco, T-Gesic, Vicodin, Vicodin ES, Vicodin HP, Zydone What is the most important information I should know about acetaminophen and hydrocodone? • Hydrocodone is habit forming. It is possible become physically and/ or psychologically dependent on the medication. Do not take more than the prescribed amount of medication or take it for longer than is directed by your doctor. Withdrawal effects may occur if acetaminophen and hydrocodone is stopped suddenly after several weeks of continuous use. Your doctor may recommend a gradual reduction in dose. • Avoid alcohol while taking acetaminophen and hydrocodone. Alcohol can increase drowsiness and dizziness caused by the medication, possibly resulting in unconsciousness and death. Also, acetaminophen can be damaging to the liver when taken with alcohol. • Acetaminophen and hydrocodone may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, antihistamines, pain relievers, anxiety medicines, seizure medicines, and muscle relaxants. Dangerous sedation, dizziness, or drowsiness may occur if acetaminophen and hydrocodone is taken with any of these medications. Tell your doctor about all medicines that you are taking, and do not take any medicine without first talking to your doctor. • Acetaminophen and hydrocodone may cause constipation. Drink plenty of water (six to eight full glasses a day) to lessen this side effect. Increased fiber in the diet may also help to alleviate constipation. What is acetaminophen and hydrocodone? • Hydrocodone (related to codeine) is in a class of drugs called narcotic analgesics. It relieves pain. • Acetaminophen is a less potent pain reliever that increases the effects of hydrocodone. • Together, acetaminophen and hydrocodone are used to relieve moderate-to-severe pain. • Acetaminophen and hydrocodone may also be used for purposes other than those listed in this medication guide. What should I discuss with my healthcare provider before taking acetaminophen and hydrocodone? • Before taking this medication, tell your doctor if you have · a history of alcohol or drug abuse; · kidney disease; · liver disease; · asthma; · urinary retention; · an enlarged prostate; · hypothyroidism; · seizures or epilepsy; · gallbladder disease; · a head injury; or · Addison's disease. • You may not be able to take acetaminophen and hydrocodone, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above. • Acetaminophen and hydrocodone is in the FDA pregnancy category C. This means that it is not known whether it will be harmful to an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant or could become pregnant during treatment. • Acetaminophen and hydrocodone passes into breast milk and may affect a nursing infant. Do not take this medication without first talking to your doctor if you are breast-feeding a baby. • If you are younger than 18 years of age or older than 60 years of age, you may be more likely to experience side effects from acetaminophen and hydrocodone. Your doctor may prescribe a lower dose. How should I take acetaminophen and hydrocodone? • Take acetaminophen and hydrocodone exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you. • Take each dose with a full glass of water. • Take acetaminophen and hydrocodone with food or milk if it causes stomach upset. • To ensure that you get a correct dose, measure the liquid form of acetaminophen and hydrocodone with a special dose-measuring spoon or cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one. • Hydrocodone is habit forming. It is possible become physically and/ or psychologically dependent on the medication. Do not take more than the prescribed amount of medication or take it for longer than is directed by your doctor. Withdrawal effects may occur if acetaminophen and hydrocodone is stopped suddenly after several weeks of continuous use. Your doctor may recommend a gradual reduction in dose. • Acetaminophen and hydrocodone may cause constipation. Drink plenty of water (six to eight full glasses a day) to lessen this side effect. Increased fiber in the diet may also help to alleviate constipation. • Store acetaminophen and hydrocodone at room temperature away from moisture and heat. What happens if I miss a dose? • Take the missed dose as soon as you remember. Do not take a double dose of this medication. Wait the prescribed amount of time before taking the next dose. What happens if I overdose? • Seek emergency medical attention if an overdose is suspected. • Symptoms of an acetaminophen and hydrocodone overdose may include slow breathing, seizures, dizziness, weakness, loss of consciousness, coma, confusion, tiredness, cold and clammy skin, small pupils, nausea, vomiting, and sweating. What should I avoid while taking acetaminophen and hydrocodone? • Avoid alcohol while taking acetaminophen and hydrocodone. Alcohol can increase drowsiness and dizziness caused by the medication, possibly resulting in unconsciousness and death. Also, acetaminophen can be damaging to the liver when taken with alcohol. • Acetaminophen and hydrocodone may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, antihistamines, pain relievers, anxiety medicines, seizure medicines, and muscle relaxants. Dangerous sedation, dizziness, or drowsiness may occur if acetaminophen and hydrocodone is taken with any of these medications. Tell your doctor about all medicines that you are taking, and do not take any medicine without first talking to your doctor. • Use caution when driving, operating machinery, or performing other hazardous activities. Hydrocodone may cause drowsiness or dizziness. If you experience drowsiness or dizziness, avoid these activities. • Other products may also contain acetaminophen, especially over-the-counter pain, fever, cold, and allergy medications. Do not take any other products that contain acetaminophen without first talking to your doctor. Too much acetaminophen can be dangerous. What are the possible side effects of acetaminophen and hydrocodone? • If you experience any of the following serious side effects, stop taking acetaminophen and hydrocodone and seek emergency medical attention or contact your doctor immediately: · an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives); · slow, weak breathing; · seizures; · cold, clammy skin; · severe weakness or dizziness; · unconsciousness; · yellowing of the skin or eyes; or · unusual fatigue, bleeding, or bruising. • Other, less serious side effects may be more likely to occur. Continue to take acetaminophen and hydrocodone and talk to your doctor if you experience · constipation; · dry mouth, nausea, vomiting, or decreased appetite; · dizziness, tiredness, or lightheadedness; · muscle twitches; · sweating; · itching; · decreased urination; or · decreased sex drive. • Hydrocodone is habit forming. It is possible become physically and/ or psychologically dependent on the medication. Do not take more than the prescribed amount of medication or take it for longer than is directed by your doctor. Withdrawal effects may occur if acetaminophen and hydrocodone is stopped suddenly after several weeks of continuous use. Your doctor may recommend a gradual reduction in dose. • Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. What other drugs will affect acetaminophen and hydrocodone? • Do not take acetaminophen and hydrocodone if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. Dangerous side effects could result. • Acetaminophen and hydrocodone may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, antihistamines, pain relievers, anxiety medicines, seizure medicines, and muscle relaxants. Dangerous sedation, dizziness, or drowsiness may occur if acetaminophen and hydrocodone is taken with any of these medications. Tell your doctor about all medicines that you are taking, and do not take any medicine without first talking to your doctor. • Other products may also contain acetaminophen, especially over-the-counter pain, fever, cold, and allergy medications. Do not take any other products that contain acetaminophen without first talking to your doctor. Too much acetaminophen can be dangerous. • Drugs other than those listed here may also interact with acetaminophen and hydrocodone. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products. Where can I get more information? • Your pharmacist has additional information about acetaminophen and hydrocodone written for health professionals that you may read. -------------------------------------------------------------------------------- In addition, the liquid contains the following inactive ingredients: citric acid anhydrous, ethyl maltol, glycerin, methylparaben, propylene glycol, propylparaben, purified water, saccharin sodium, sorbitol solution, sucrose, with D&C Yellow #10 and FD&C Yellow #6 as coloring and natural and artificial flavoring. CLINICAL PHARMACOLOGY Hydrocodone is a semisynthetic narcotic analgesic and antitussive with multiple actions qualitatively similar to those of codeine. Most of these involve the central nervous system and smooth muscle. The precise mechanism of action of hydrocodone and other opiates is not known, although it is believed to relate to the existence of opiate receptors in the central nervous system. In addition to analgesia, narcotics may produce drowsiness, changes in mood and mental clouding. The analgesic action of acetaminophen involves peripheral influences, but the specific mechanism is as yet undetermined. Antipyretic activity is mediated through hypothalamic heat regulating centers. Acetaminophen inhibits prostaglandin synthetase. Therapeutic doses of acetaminophen have negligible effects on the cardiovascular or respiratory systems; however, toxic doses may cause circulatory failure and rapid, shallow breathing. Pharmacokinetics The behavior of the individual components is described below. Hydrocodone Following a 10 mg oral dose of hydrocodone administered to five adult male subjects, the mean peak concentration was 23.6 ± 5.2 ng/mL. Maximum serum levels were achieved at 1.3 ± 0.3 hours and the half-life was determined to be 3.8 ± 0.3 hours. Hydrocodone exhibits a complex pattern of metabolism including O-demethylation, N-demethylation and 6-keto reduction to the corresponding 6-(alpha)- and 6-(beta)-hydroxymetabolites. See OVERDOSAGE for toxicity information. Acetaminophen Acetaminophen is rapidly absorbed from the gastrointestinal tract and is distributed throughout most body tissues. The plasma half-life is 1.25 to 3 hours, but may be increased by liver damage and following overdosage. Elimination of acetaminophen is principally by liver metabolism (conjugation) and subsequent renal excretion of metabolites. Approximately 85% of an oral dose appears in the urine within 24 hours of administration, most as the glucuronide conjugate, with small amounts of other conjugates and unchanged drug. See OVERDOSAGE for toxicity information. INDICATIONS AND USAGE Lortab Elixir (hydrocodone bitartrate and acetaminophen oral solution) is indicated for the relief of moderate to moderately severe pain. CONTRAINDICATIONS This product should not be administered to patients who have previously exhibited hypersensitivity to hydrocodone, acetaminophen, or any other component of this product. Patients known to be hypersensitive to other opioids may exhibit cross sensitivity to hydrocodone. WARNINGS Respiratory Depression At high doses or in sensitive patients, hydrocodone may produce dose-related respiratory depression by acting directly on the brain stem respiratory center. Hydrocodone also affects the center that controls respiratory rhythm, and may produce irregular and periodic breathing. Infants may have increased sensitivity to the respiratory depressant effects of opioids (see PRECAUTIONS , Pediatric Use ). If use of Lortab Elixir in such patients is contemplated, it should be administered cautiously, in substantially reduced initial doses, by personnel experienced in administering opioids to infants, and with intensive monitoring. Head Injury and Increased Intracranial Pressure The respiratory depressant effects of narcotics and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions or a preexisting increase in intracranial pressure. Furthermore, narcotics produce adverse reactions, which may obscure the clinical course of patients with head injuries. Acute Abdominal Conditions The administration of narcotics may obscure the diagnosis or clinical course of patients with acute abdominal conditions. PRECAUTIONS General Special Risk Patients As with any narcotic analgesic agent, Lortab Elixir should be used with caution in elderly or debilitated patients, and those with severe impairment of hepatic or renal function, hypothyroidism, Addison's disease, prostatic hypertrophy or urethral stricture. The usual precautions should be observed and the possibility of respiratory depression should be kept in mind. Cough Reflex Hydrocodone suppresses the cough reflex; as with all narcotics, caution should be exercised when Lortab Elixir are used postoperatively and in patients with pulmonary disease. Information for Patients Hydrocodone, like all narcotics, may impair mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. Such tasks should be avoided while taking this product. Alcohol and other CNS depressants may produce an additive CNS depression, when taken with this combination product, and should be avoided. Hydrocodone may be habit-forming. Patients should take the drug only for as long as it is prescribed, in the amounts prescribed, and no more frequently than prescribed. Physicians should instruct patients and caregivers to read the patient information leaflet, which appears as the last section of the labeling. Laboratory Tests In patients with severe hepatic or renal disease, effects of therapy should be monitored with serial liver and/or renal function tests. Drug Interactions Patients receiving narcotics, antihistamines, antipsychotics, antianxiety agents, or other CNS depressants (including alcohol) concomitantly with hydrocodone bitartrate and acetaminophen oral solution may exhibit an additive CNS depression. When combined therapy is contemplated, the dose of one or both agents should be reduced. The use of MAO inhibitors or tricyclic antidepressants with hydrocodone preparations may increase the effect of either the antidepressant or hydrocodone. Drug/Laboratory Test Interactions Acetaminophen may produce false-positive test results for urinary 5-hydroxyindoleacetic acid. Carcinogenesis, Mutagenesis, Impairment of Fertility No adequate studies have been conducted in animals to determine whether hydrocodone has a potential for carcinogenesis, mutagenesis, or impairment of fertility. Hydrocodone has not demonstrated mutagenic potential using the Ames Salmonella-Microsomal Activation test, the Basc test on Drosophila germ cells, and the Micronucleus test on mouse bone marrow. No adequate studies have been conducted in animals to determine whether acetaminophen has a potential for carcinogenesis, mutagenesis, or impairment of fertility. Acetaminophen has not demonstrated mutagenic potential using the Ames Salmonella-Microsomal Activation test, the Basc test on Drosophila germ cells, and the Micronucleus test on mouse bone marrow. Pregnancy Teratogenic Effects Pregnancy Category C There are no adequate and well-controlled studies in pregnant women. Lortab Elixir should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nonteratogenic Effects Babies born to mothers who have been taking opioids regularly prior to delivery will be physically dependent. The withdrawal signs include irritability and excessive crying, tremors, hyperactive reflexes, increased respiratory rate, increased stools, sneezing, yawning, vomiting and fever. These signs usually appear during the first few days of life. The intensity of the syndrome does not always correlate with the duration of maternal opioid use or dose. There is no consensus on the best method of managing withdrawal. Labor and Delivery Narcotic analgesics cross the placental barrier. The closer to delivery and the larger the dose used, the greater the possibility of respiratory depression in the newborn. Narcotic analgesics should be avoided during labor if delivery of a premature infant is anticipated. If the mother has received narcotic analgesics during labor, newborn infants should be observed closely for signs of respiratory depression. Resuscitation may be required (see OVERDOSAGE ). The effect of hydrocodone, if any, on the later growth, development, and functional maturation of the child is unknown. Nursing Mothers Acetaminophen is excreted in breast milk in small amounts, but the significance of its effects on nursing infants is not known. It is not known whether hydrocodone is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from hydrocodone and acetaminophen, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Pediatric Use Safety and effectiveness in the pediatric population below the age of two years have not been established. Use of Lortab Elixir in the pediatric population is supported by the evidence from adequate and well controlled studies of hydrocodone and acetaminophen combination products in adults with additional data which support the development of metabolic pathways in children two years of age and over (see DOSAGE AND ADMINISTRATION for pediatric dosage information). Geriatric Use Clinical studies of hydrocodone bitartrate and acetaminophen oral solution did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Hydrocodone and the major metabolites of acetaminophen are known to be substantially excreted by the kidney. Thus the risk of toxic reactions may be greater in patients with impaired renal function due to the accumulation of the parent compound and/or metabolites in the plasma. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. Hydrocodone may cause confusion and over-sedation in the elderly; elderly patients generally should be started on low doses of hydrocodone bitartrate and acetaminophen oral solution and observed closely. ADVERSE REACTIONS Potential effects of high dosage are also listed in the OVERDOSAGE section. Cardio-renal: Bradycardia, cardiac arrest, circulatory collapse, renal toxicity, renal tubular necrosis, hypotension. Central Nervous System/Psychiatric: Anxiety, dizziness, drowsiness, dysphoria, euphoria, fear, general malaise, impairment of mental and physical performance, lethargy, light-headedness, mental clouding, mood changes, psychological dependence, sedation, somnolence progressing to stupor or coma. Endocrine: Hypoglycemic coma. Gastrointestinal System: Abdominal pain, constipation, gastric distress, heartburn, hepatic necrosis, hepatitis, occult blood loss, nausea, peptic ulcer, and vomiting. Genitourinary System: Spasm of vesical sphincters, ureteral spasm, and urinary retention. Hematologic: Agranulocytosis, hemolytic anemia, iron deficiency anemia, prolonged bleeding time, thrombocytopenia. Hypersensitivity: Allergic reactions. Musculoskeletal: Skeletal muscle flaccidity. Respiratory Depression: Acute airway obstruction, apnea, dose-related respiratory depression (see OVERDOSAGE ), shortness of breath. Special Senses: Cases of hearing impairment or permanent loss have been reported predominantly in patients with chronic overdose. Skin: Cold and clammy skin, diaphoresis, pruritus, rash. DRUG ABUSE AND DEPENDENCE Controlled Substance Lortab Elixir (hydrocodone bitartrate and acetaminophen oral solution) is classified as a Schedule III controlled substance. Abuse and Dependence Hydrocodone can produce drug dependence of the morphine type and, therefore, has the potential for being abused. Psychological dependence, physical dependence, and tolerance may develop upon repeated administration of narcotics; therefore, this product should be prescribed and administered with caution appropriate to the use of other oral narcotic medications. However, psychological dependence is unlikely to develop when hydrocodone bitartrate and acetaminophen oral solution are used for a short time for the treatment of pain. Physical dependence, the condition in which continued administration of the drug is required to prevent the appearance of a withdrawal syndrome, assumes clinically significant proportions only after several weeks of continued narcotic use, although some mild degree of physical dependence may develop after a few days of narcotic therapy. Tolerance, in which increasingly large doses are required in order to produce the same degree of analgesia, is manifested initially by a shortened duration of analgesic effect, and subsequently by decreases in the intensity of analgesia. The rate of development of tolerance varies among patients. OVERDOSAGE Following an acute overdosage, toxicity may result from hydrocodone or acetaminophen. Signs and Symptoms Toxicity from hydrocodone poisoning includes the opioid triad of loss of consciousness, pinpoint pupils, and respiratory depression (Cheyne-Stokes respiration, cyanosis, decrease in respiratory rate and/or tidal volume). Convulsions may occur. The toxic dose of acetaminophen for adults is 10 grams. In adults, hepatic toxicity has rarely been reported with acute overdoses of less than 10 grams, or fatalities with less than 15 grams. Early symptoms following a potentially hepatotoxic overdose of acetaminophen may include diaphoresis, general malaise, nausea, and vomiting. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours post-ingestion. Other signs and symptoms of overdose of this product include bradycardia, cold and clammy skin, extreme somnolence progressing to stupor or coma, hypoglycemic coma, hypotension, renal tubular necrosis, skeletal muscle flaccidity, thrombocytopenia. In severe overdosage, apnea; circulatory collapse; cardiac arrest; dose-dependent, potentially fatal hepatic necrosis; and death may occur. Treatment A single or multiple overdose with hydrocodone and acetaminophen is a potentially lethal polydrug overdose, and consultation with a regional poison control center is recommended. Immediate treatment includes support of cardiorespiratory function and measures to reduce drug absorption. Vomiting should be induced with syrup of ipecac, if the patient is alert (adequate pharyngeal and laryngeal reflexes). Oral activated charcoal (1 g/kg) should follow gastric emptying. The first dose should be accompanied by an appropriate cathartic. If repeated doses are used, the cathartic might be included with alternate doses as required. Hypotension is usually hypovolemic and should respond to fluids. Vasopressors and other supportive measures should be employed as indicated. A cuffed endo-tracheal tube should be inserted before gastric lavage of the unconscious patient and, when necessary, to provide assisted respiration. Meticulous attention should be given to maintaining adequate pulmonary ventilation. In severe cases of intoxication, peritoneal dialysis, or preferably hemodialysis may be considered. If hypoprothrombinemia occurs due to acetaminophen overdose, vitamin K should be administered intravenously. Naloxone, a narcotic antagonist, can reverse respiratory depression and coma associated with opioid overdose. Naloxone hydrochloride 0.4 mg to 2 mg is given parenterally. Since the duration of action of hydrocodone may exceed that of the naloxone, the patient should be kept under continuous surveillance and repeated doses of the antagonist should be administered as needed to maintain adequate respiration. A narcotic antagonist should not be administered in the absence of clinically significant respiratory or cardiovascular depression. If the dose of acetaminophen may have exceeded 140 mg/kg, acetylcysteine should be administered as early as possible. Serum acetaminophen levels should be obtained, since levels four or more hours following ingestion help predict acetaminophen toxicity. Do not await acetaminophen assay results before initiating treatment. Hepatic enzymes should be obtained initially, and repeated at 24-hour intervals. Methemoglobinemia over 30% should be treated with methylene blue by slow intravenous administration. DOSAGE AND ADMINISTRATION Dosage should be adjusted according to severity of pain and response of the patient. However, it should be kept in mind that tolerance to hydrocodone can develop with continued use and that the incidence of untoward effects is dose related. The usual adult dosage is one tablespoonful every 4 to 6 hours as needed for pain. The total daily dosage for adults should not exceed 6 tablespoonfuls. The usual dosages for children are given by the table below, and are to be given every 4 to 6 hours as needed for pain. These dosages correspond to an average individual dose of 0.27 mL/kg of Lortab Elixir (providing 0.135 mg/kg of hydrocodone bitartrate and 9 mg/kg of acetaminophen). Dosing should be based on weight whenever possible. Lortab (pronounced LOR-tab) is used to relieve moderate to moderately severe pain. You should not take Lortab Elixir if you are allergic to hydrocodone or acetaminophen. The most common side effects of Lortab Elixir are abdominal pain, dizziness, drowsiness, light-headedness, nausea, shortness of breath, unusual tiredness, and vomiting. Take this medicine as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Uses Lortab Elixir is an analgesic used to relieve moderate to moderately severe pain. Lortab Elixir is a combination product containing hydrocodone (hye-droe-KO-done) bitartrate and acetaminophen (a-seat-a-MIN-oh-fen). Hydrocodone is a narcotic pain reliever and a cough suppressant. Acetaminophen is a non-narcotic pain reliever and fever reducer. A narcotic analgesic and acetaminophen used together may provide better pain relief than either product used alone. If you have any questions, please call your doctor or pharmacist. General Cautions Do not take this drug if you have allergies or unusual reactions to narcotic pain relievers or acetaminophen because it is likely that you may also be allergic to Lortab Elixir. This product may inhibit your mental and physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. Such tasks should be avoided while you are taking this product. This medicine may not be right for you. Check with your doctor or pharmacist, if you: are pregnant. are nursing. are taking other medications; narcotic pain relievers; allergy medicines; antidepressant medicines; acetaminophen-containing medicines or other medicines that cause central nervous system depression, including alcohol. have other medical problems: a history of drug or alcohol abuse; recent head injury; emphysema, asthma, or other chronic lung disease; liver disease, kidney disease; underactive thyroid, Addison's disease, enlarged prostate or difficulty urinating. Proper Use Take this medicine as directed by your doctor. Do not share it with anyone else. This medicine can cause drug dependence and has the potential for abuse. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If you think that this medicine is not working properly after taking it for some time, do not increase the dose. Check with your doctor or pharmacist. Dosing The dose of this medication will be different for different patients. Follow the directions provided by your doctor. The following information includes only the average doses of this medication. If your dose is different, do not change doses unless your doctor tells you to do so. BODY WEIGHT APPROXIMATE AGE DOSE Every 4 to 6 hours MAXIMUM TOTAL DAILY DOSE (6 doses per day) 12 to 15 kg 27 to 34 lbs. 2 to 3 years ? teaspoonful = 3.75 mL 4 ? teaspoonfuls = 22.5 mL 16 to 22 kg 35 to 50 lbs. 4 to 6 years 1 teaspoonful = 5 mL 6 teaspoonfuls = 30 mL 23 to 31 kg 51 to 69 lbs. 7 to 9 years 1 ? teaspoonfuls = 7.5 mL 9 teaspoonfuls = 45 mL 32 to 45 kg 70 to 100 lbs. 10 to 13 years 2 teaspoonfuls = 10 mL 12 teaspoonfuls = 60 mL 46 kg and up 101 lbs. and up 14 years to adult 1 Tablespoonful = 15 mL 6 Tablespoonfuls = 90 mL It is very important that Lortab Elixir be dosed accurately. A household teaspoon or tablespoon is not an accurate measuring device, especially when one-half or three-fourths of a teaspoonful is to be measured. Since a household teaspoon is not accurate and can be mixed-up with a tablespoon (which can cause overdosage), it is strongly recommended that you obtain and use a proper measuring device. Ask your doctor or pharmacist for help to find a dropper that can measure the needed dose properly and ask for help if you do not understand how to use the dropper. Missed Dose To avoid a possible overdose, it is important that you do not take more than a single dosage at one time, or that you don't take doses at intervals less than 4 hours apart. If you miss taking a dose of Lortab Elixir, take it as soon as you remember. However, make sure to wait at least 4 hours before taking your next dose. If you missed taking a dose, and it is almost time for your next dose, skip the missed dose and take your medicine as scheduled. Do not double the prescribed dose. Possible Side Effects Side effects you may experience include abdominal pain, constipation, difficulty urinating, dizziness, drowsiness, fear, fuzzy thinking, general feeling of discomfort or illness, light-headedness, mood changes, nausea, nervousness, rash, shortness of breath, slower reactions, unusual tiredness, and vomiting. Call your doctor if these effects continue or are bothersome. Side effects not listed above may sometimes occur. If you notice any other effects, check with your doctor. Storage Keep out of the reach of children. Store at room temperature (protect from heat, do not refrigerate). Keep in original labeled bottle. Discard medicines that are old or no longer needed. Even a single overdose of this medicine may be a life-threatening situation. If you suspect that you or someone else may have taken more than the prescribed dose of this medicine, contact your local poison control center or emergency room immediately. This medicine was prescribed for your particular condition. Do not use if for another condition or give the drug to others. This leaflet provides a summary of information about Lortab Elixir. If you have any questions or concerns, or want more information about Lortab Elixir, contact your doctor or pharmacist. Your pharmacist also has a longer leaflet about Lortab Elixir that is written for health professionals that you can ask to read. Prepared by UCB Pharma, Inc.Rev. 6E 03/2004 Current as of 05/2005 The information contained in the Thomson Healthcare (Micromedex) products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you. The use of the Thomson Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Healthcare does not assume any responsibility or risk for your use of the Thomson Healthcare products. Combination medicines containing narcotic analgesics (nar-KOT-ik an-al-JEE-zicks) and acetaminophen (a-seat-a-MIN-oh-fen) are used to relieve pain. A narcotic analgesic and acetaminophen used together may provide better pain relief than either medicine used alone. In some cases, relief of pain may come at lower doses of each medicine. Narcotic analgesics act in the central nervous system (CNS) to relieve pain. Many of their side effects are also caused by actions in the CNS. When narcotics are used for a long time, your body may get used to them so that larger amounts are needed to relieve pain. This is called tolerance to the medicine. Also, when narcotics are used for a long time or in large doses, they may become habit-forming (causing mental or physical dependence). Physical dependence may lead to withdrawal symptoms when you stop taking the medicine. Acetaminophen does not become habit-forming when taken for a long time or in large doses, but it may cause other unwanted effects, including liver damage, if too much is taken. In the U.S., these medicines are available only with your medical doctor's or dentist's prescription. In Canada, some acetaminophen, codeine, and caffeine combinations are available without a prescription. These medicines are available in the following dosage forms: Oral Acetaminophen and Codeine Capsules (U.S.) Oral solution (U.S. and Canada) Oral suspension (U.S.) Tablets (U.S. and Canada) Acetaminophen, Codeine, and Caffeine Tablets (Canada) Dihydrocodeine, Acetaminophen, and Caffeine Capsules (U.S.) Hydrocodone and Acetaminophen Capsules (U.S.) Oral solution (U.S.) Tablets (U.S.) Oxycodone and Acetaminophen Capsules (U.S.) Oral solution (U.S.) Tablets (U.S. and Canada) Pentazocine and Acetaminophen Tablets (U.S.) Propoxyphene and Acetaminophen Tablets (U.S.) -------------------------------------------------------------------------------- Before Using This Medicine In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For narcotic analgesic and acetaminophen combinations, the following should be considered: Allergies-Tell your doctor if you have ever had any unusual or allergic reaction to acetaminophen or to a narcotic analgesic. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes. Pregnancy- For acetaminophen : Although studies on birth defects with acetaminophen have not been done in pregnant women, it has not been reported to cause birth defects or other problems. For narcotic analgesics : Although studies on birth defects with narcotic analgesics have not been done in pregnant women, they have not been reported to cause birth defects. However, hydrocodone caused birth defects in animal studies when very large doses were used. Codeine did not cause birth defects in animals, but it caused slower development of bones and other toxic or harmful effects in the fetus. Pentazocine and propoxyphene did not cause birth defects in animals. There is no information about whether dihydrocodeine or oxycodone causes birth defects in animals. Too much use of a narcotic during pregnancy may cause the fetus to become dependent on the medicine. This may lead to withdrawal side effects in the newborn baby. Also, some of these medicines may cause breathing problems in the newborn baby if taken just before or during delivery. For caffeine : Studies in humans have not shown that caffeine (contained in some of these combination medicines) causes birth defects. However, studies in animals have shown that caffeine causes birth defects when given in very large doses (amounts equal to those present in 12 to 24 cups of coffee a day). Breast-feeding-Acetaminophen, codeine, and propoxyphene pass into the breast milk. It is not known whether other narcotic analgesics pass into the breast milk. However, these medicines have not been reported to cause problems in nursing babies. Children-Breathing problems may be especially likely to occur when narcotic analgesics are given to children younger than 2 years of age. These children are usually more sensitive than adults to the effects of narcotic analgesics. Also, unusual excitement or restlessness may be more likely to occur in children receiving these medicines. Acetaminophen has been tested in children and has not been shown to cause different side effects or problems in children than it does in adults. Older adults-Elderly people are especially sensitive to the effects of narcotic analgesics. This may increase the chance of side effects, especially breathing problems, during treatment. Acetaminophen has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults. Other medicines-Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking a narcotic analgesic and acetaminophen combination, it is especially important that your health care professional know if you are taking any of the following: Carbamazepine (e.g., Tegretol)-Propoxyphene may increase the blood levels of carbamazepine, which increases the chance of serious side effects Central nervous system (CNS) depressants or Monoamine oxidase (MAO) inhibitor activity (isocarboxazid [e.g., Marplan], phenelzine [e.g., Nardil], procarbazine [e.g., Matulane], selegiline [e.g., Eldepryl], tranylcypromine [e.g., Parnate]) (taken currently or within the past 2 weeks) or Tricyclic antidepressants (amitriptyline [e.g., Elavil], amoxapine [e.g., Asendin], clomipramine [e.g., Anafranil], desipramine [e.g., Pertofrane], doxepin [e.g., Sinequan], imipramine [e.g., Tofranil], nortriptyline [e.g., Aventyl], protriptyline [e.g., Vivactil], trimipramine [e.g., Surmontil])-Taking these medicines together with a narcotic analgesic may increase the chance of serious side effects Naltrexone (e.g., Trexan)-Naltrexone keeps narcotic analgesics from working to relieve pain; people taking naltrexone should take pain relievers that do not contain a narcotic Zidovudine (e.g., AZT, Retrovir)-Acetaminophen may increase the blood levels of zidovudine, which increases the chance of serious side effects Other medical problems-The presence of other medical problems may affect the use of narcotic analgesic and acetaminophen combinations. Make sure you tell your doctor if you have any other medical problems, especially: Alcohol and/or other drug abuse, or history of, or Brain disease or head injury or Colitis or Convulsions (seizures), history of, or Emotional problems or mental illness or Emphysema, asthma, or other chronic lung disease or Hepatitis or other liver disease or Kidney disease or Underactive thyroid-The chance of serious side effects may be increased Enlarged prostate or problems with urination or Gallbladder disease or gallstones-Some of the effects of narcotic analgesics may be especially serious in people with these medical problems Heart disease-Caffeine (present in some of these combination medicines) can make some kinds of heart disease worse -------------------------------------------------------------------------------- Proper Use of This Medicine Take this medicine only as directed by your medical doctor or dentist . Do not take more of it, do not take it more often, and do not take it for a longer time than your medical doctor or dentist ordered. This is especially important for young children and elderly patients, who may be more sensitive than other people to the effects of narcotic analgesics. If too much of a narcotic analgesic is taken, it may become habit-forming (causing mental or physical dependence) or lead to medical problems because of an overdose. Taking too much acetaminophen may cause liver damage. If you think that this medicine is not working properly after you have been taking it for a few weeks, do not increase the dose . Instead, check with your medical doctor or dentist. Dosing-The dose of these medicines will be different for different patients. Follow your doctor's orders or the directions on the label . The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so. The number of capsules or tablets or teaspoonfuls of solution or suspension that you take depends on the strength of the medicine. For acetaminophen and codeine For oral capsule or tablet dosage form: For pain: Adults-1 or 2 capsules or tablets containing acetaminophen with 15 or 30 milligrams (mg) of codeine, or 1 capsule or tablet containing acetaminophen with 60 mg of codeine, every four hours as needed. Children-Dose must be determined by the doctor, depending on the age of the child. Most young children will receive the oral solution or suspension, rather than tablets or capsules. For oral solution or suspension dosage form: For pain: Adults-1 tablespoonful (3 teaspoonfuls) every four hours as needed. Children younger than 3 years of age-Dose must be determined by your doctor. Children 3 to 7 years of age-1 teaspoonful three or four times a day as needed. Children 7 to 12 years of age-2 teaspoonfuls three or four times a day as needed. For acetaminophen, codeine, and caffeine Lortab Addiction Information Lortab Addiction Information Lortab is an opioid. Lortab is commonly prescribed because of its analgesic, or pain relieving properties. Lortab is the brand name for the combination of acetaminophen and hydrocodone. Many studies have shown that properly managed medical use of Lortab is safe and rarely causes addiction. Taken exactly as prescribed, Lortab can be used to manage pain effectively. Lortab acts by attaching to specific proteins called opioids receptors, which are found in the brain, spinal cord, and gastrointestinal tract. When these compounds attach to certain opioids receptors in the brain and spinal cord, they can effectively change the way a person experiences pain. In addition, opioids medications can affect regions of the brain that mediate what we perceive as pleasure, resulting in the initial euphoria that many opioids produce. They can also produce drowsiness, cause constipation, and, depending upon the amount taken, depress breathing. Taking a large single dose could cause severe respiratory depression or death. Chronic use of Lortab can result in tolerance to the medication so that higher doses must be taken to obtain the same effects. Long-term use also can lead to physical dependence—the body adapts to the presence of the substance and withdrawal symptoms occur if use is reduced abruptly. Individuals taking prescribed lortab should not only be given these medications under appropriate medical supervision, but also should be medically supervised when stopping use in order to reduce or avoid withdrawal symptoms. Symptoms of withdrawal can include restlessness, muscle and bone pain, insomnia, diarrhea, vomiting, cold flashes with goose bumps (“cold turkey”), and involuntary leg movements. Individuals who become addicted to lortab can be treated. Options for effectively treating pain killer addiction to prescription opioids are drawn from research on treating heroin addiction. Prolonged use of these drugs eventually changes the brain in fundamental and long-lasting ways, explaining why people cannot just quit on their own, and why treatment is essential. In effect, drugs of abuse take over the brain's normal pleasure and motivational systems, moving drug use to the highest priority in the individual's motivational hierarchy, thereby overriding all other motivations and drives. These brain changes, then, are responsible for the compulsion to seek and use drugs that we have come to define as addiction. This is likely the state people are in when they are reportedly "doctor shopping," feigning illnesses, and stealing from pharmacies to obtain the drug. Fortunately, we have a number of effective options to treat lortab addiction to prescription opioids and to help manage the sometime severe withdrawal syndrome that accompanies sudden cessation of drug use. Typically, the patient is medically detoxified before any treatment approach is begun. Although detoxification in itself is not a treatment for pain killer addiction, it can help relieve withdrawal symptoms while the patient adjusts to being drug free. Once the patient completes detoxification, the treatment provider must then work with the patient to determine which course of treatment would best suit the needs of the patient. For free assistance online, click here.

Narcotics Anonymous is an international, community-based association of recovering drug addicts with more than 33,500 weekly meetings in over 116 countries worldwide. Development Narcotics Anonymous sprang from the Alcoholics Anonymous Program of the late 1940s, with meetings first emerging in the Los Angeles area of California, USA, in the early Fifties. The NA program started as a small US movement that has grown into one of the world's oldest and largest organizations of its type. For many years, NA grew very slowly, spreading from Los Angeles to other major North American cities and Australia in the early 1970s. In 1983, Narcotics Anonymous published its self-titled Basic Text book, which contributed to tremendous growth. Within a few years, groups had formed in Brazil, Colombia, Germany, India, the Irish Republic, Japan, New Zealand, and the United Kingdom. Today, Narcotics Anonymous is well established throughout much of the Americas, Western Europe, Australia, and New Zealand. Newly formed groups and NA communities are now scattered throughout the Indian subcontinent, Africa, East Asia, the Middle East, and Eastern Europe. Narcotics Anonymous books and information pamphlets are currently available in 27 languages, with translations in process for 16 languages. Return to top Program NA's earliest self-titled pamphlet, known among members as "the White Booklet," describes Narcotics Anonymous this way: "NA is a nonprofit fellowship or society of men and women for whom drugs had become a major problem. We … meet regularly to help each other stay clean. ... We are not interested in what or how much you used ... but only in what you want to do about your problem and how we can help." Membership is open to all drug addicts, regardless of the particular drug or combination of drugs used. When adapting AA’s First Step, the word “addiction” was substituted for “alcohol,” thus removing drug-specific language and reflecting the “disease concept” of addiction. There are no social, religious, economic, racial, ethnic, national, gender, or class-status membership restrictions. There are no dues or fees for membership; while most members regularly contribute small sums to help cover the expenses of meetings, such contributions are not mandatory. Narcotics Anonymous provides a recovery process and support network inextricably linked together. One of the keys to NA’s success is the therapeutic value of addicts working with other addicts. Members share their successes and challenges in overcoming active addiction and living drug-free productive lives through the application of the principles contained within the Twelve Steps and Twelve Traditions of NA. These principles are the core of the Narcotics Anonymous recovery program. Principles incorporated within the steps include: admitting there is a problem; seeking help; engaging in a thorough self-examination; confidential self-disclosure; making amends for harm done; and helping other drug addicts who want to recover. Central to the Narcotics Anonymous program is its emphasis on practicing spiritual principles. Narcotics Anonymous itself is non-religious, and each member is encouraged to cultivate an individual understanding—religious or not—of this “spiritual awakening.” Narcotics Anonymous is not affiliated with other organizations, including other twelve step programs, treatment centers, or correctional facilities. As an organization, NA does not employ professional counselors or therapists nor does it provide residential facilities or clinics. Additionally, the fellowship does not provide vocational, legal, financial, psychiatric, or medical services. NA has only one mission: to provide an environment in which addicts can help one another stop using drugs and find a new way to live. In Narcotics Anonymous, members are encouraged to comply with complete abstinence from all drugs including alcohol. It has been the experience of NA members that complete and continuous abstinence provides the best foundation for recovery and personal growth. NA as a whole has no opinion on outside issues, including prescribed medications. Use of psychiatric medication and other medically indicated drugs prescribed by a physician and taken under medical supervision is not seen as compromising a person’s recovery in NA. Return to top Service organization The primary service provided by Narcotics Anonymous is the NA group meeting. Each group runs itself based on principles common to the entire organization, which are spelled out in NA’s literature. Most groups rent space for their weekly meetings in buildings run by public, religious, or civic organizations. Individual members lead the NA meetings while other members take part by sharing in turn about their experiences in recovering from drug addition. Group members also share the activities associated with running a meeting. In a country where Narcotics Anonymous is a relatively new phenomenon, the NA group is the only level of organization. In places where a number of Narcotics Anonymous groups have had the chance to develop and stabilize, groups will have elected delegates to form a local service committee. These local committees usually offer a number of services. Included among them are: distribution of NA literature; telephone information services; public information presentations for treatment staff, civic organizations, government agencies, and schools; panel presentations to acquaint treatment or correctional facility residents with the NA program; and meeting directories for individual information and use in scheduling visits by client groups. In some countries, especially the larger countries or those where Narcotics Anonymous is well established, a number of local/area committees have come together to create regional committees. These regional committees handle services within their larger geographical boundaries while the local/area committees handle local services. An international delegate assembly known as the World Service Conference provides guidance on issues affecting the entire organization. Primary among the priorities of NA’s world services are activities that support young national movements and the translation of Narcotics Anonymous literature. For additional information, contact the World Service Office headquarters in Los Angeles, California. The mailing address, telephone number, fax number, and website address appear at the end of this pamphlet Return to top Positions on related issues or institutions In order to maintain its focus, Narcotics Anonymous has established a tradition of non-endorsement and does not take positions on anything outside its own specific sphere of activity. Narcotics Anonymous does not express opinions—either pro or con—on civil, social, medical, legal, or religious issues. Additionally, it does not take stands on addiction-related issues such as criminality, law enforcement, drug legalization or penalties, prostitution, HIV/HCV infection, or syringe programs. Narcotics Anonymous is entirely self-supporting and does not accept financial contributions from non-members. Based on the same principle, groups and service committees are run by NA members, for members. Narcotics Anonymous neither endorses nor opposes any other organization’s philosophy or methodology. Its primary competence is in providing a platform upon which drug addicts can share their recovery and experiences with one another. This is not to say that Narcotics Anonymous believes there are not any other “good” or “worthy” organizations. To remain free of the distraction of controversy, NA focuses all of its energy on its particular area of purpose, leaving other organizations to fulfill their own goals. Return to top Cooperating with NA Although certain traditions guide its relations with other organizations, Narcotics Anonymous welcomes the cooperation of those in government, the clergy, the helping professions, and private voluntary organizations. NA’s nonaddict friends have been instrumental in getting Narcotics Anonymous started in many countries and helping NA grow. NA strives to cooperate with others interested in Narcotics Anonymous by providing contact information, literature, and information about recovery through the NA Fellowship. Additionally, NA members are often available to make panel presentations in treatment centers and correctional facilities, sharing the NA program with addicts otherwise unable to attend community-based meetings. Return to top Membership demographics To offer some general informal observations about the nature of the membership and the effectiveness of the program the following observations are believed to be reasonably accurate. The socioeconomic strata represented by the NA membership vary from country to country. Members of one particular social or economic class start most national NA movements, but as their outreach activities become more effective, the membership becomes more broadly representative of all socioeconomic backgrounds. All ethnic and religious backgrounds are represented among NA members. Once a national movement reaches a certain level of maturity, its membership generally reflects the diversity or homogeneity of the background culture. Membership in Narcotics Anonymous is voluntary; no attendance records are kept either for NA’s own purposes or for others. Because of this, it is sometimes difficult to provide interested parties with comprehensive information about NA membership. There are, however, some objective measures that can be shared based on data obtained from members attending one of our world conventions; the diversity of our membership, especially ethnic background, seems to be representative of the geographic location of the survey. The following demographic information was revealed in a survey returned by almost half of the 13,000 attendees at the 2003 NA World Convention held in San Diego, California: Gender: 55% male, 45% female. Age: 3% 20 years old and under, 12% 21–30 years old, 31% 31–40 years old, 40% 41–50 years old, 13% over age 51, and 1% did not answer. Ethnicity: 70% Caucasian, 11% African-American, 11% Hispanic, and 8% other. Employment status: 72% employed full-time, 9% employed part-time, 7% unemployed, 3% retired, 3% homemakers, 5% students, and 1% did not answer. Continuous abstinence/recovery: ranged from less than one year up to 40 years, with a mean average of 7.4 years. Return to top Rate of growth Because no attendance records are kept, it is impossible to estimate what percentages of those who come to Narcotics Anonymous remain active in NA over time. The only sure indicator of the program's success is the rapid growth in the number of registered Narcotics Anonymous meetings in recent decades and the rapid spread of Narcotics Anonymous outside North America. In 1978, there were fewer than 200 registered groups in three countries. In 1983, more than a dozen countries had 2,966 meetings. In 1993, 60 countries had over 13,000 groups holding over 19,000 meetings. In 2002, 108 countries had 20,000 groups holding over 30,000 meetings. In 2005, there are over 21,500 registered groups holding over 33,500 weekly meetings in 116 countries. Narcotic From Wikipedia, the free encyclopedia (Redirected from Narcotics) Jump to: navigation, search This article refers to the drug classification. For the condition in scuba diving resulting from overexposure to high-pressure nitrogen, see nitrogen narcosis. A narcotic is an addictive drug, derived from opium, that reduces pain, induces sleep and may alter mood or behavior. The derivation of the word is from the Greek word narkotikos, meaning "benumbing or deadening," and originally referred to a variety of substances that induce sleep (such state is narcosis). In U.S. legal context, narcotic refers to opium, opium derivatives, and their semi-synthetic or fully synthetic substitutes as well as cocaine and coca leaves, which although classified as "narcotics" in the U.S. Controlled Substances Act (CSA), are chemically not narcotics. Many police in the United States use the word 'narcotic' to refer to any illegal drug or any unlawfully possessed drug. An example is referring to cannabis as a narcotic. Because the term is often used broadly, inaccurately or pejoratively outside medical contexts, most medical professionals prefer the more precise term opioid, which refers to all natural, semi-synthetic and synthetic substances that behave pharmacologically like morphine, the primary constituent of natural opium poppy. Contents [hide] 1 Administration 2 Effects 3 Hazards 4 Tolerance and dependence 5 External links 6 See also [edit] Administration Narcotics can be administered in a variety of ways. Some are taken orally, transdermally (skin patches) or injected. They are also available in suppositories. As recreational drugs, they are often smoked, snorted, or self-administered by the more direct routes of subcutaneous ("skin popping") and intravenous ("mainlining") injection. [edit] Effects Drug effects depend heavily on the dose, route of administration, previous exposure to the drug, and the expectation of the user. Aside from their clinical use in the treatment of pain, cough suppression and acute diarrhoea, narcotics produce a general sense of well-being known as euphoria by reducing tension, anxiety, and aggression. These effects are helpful in a therapeutic setting and contribute to their popularity as recreational drugs, as well as helping to produce dependency. Narcotic use is associated with a variety of effects including drowsiness, itching, sleeplessness, inability to concentrate, apathy, lessened physical activity, constriction of the pupils, dilation of the subcutaneous blood vessels causing flushing of the face and neck, constipation, nausea, vomiting and, most significantly, respiratory depression. As the dose is increased, the subjective, analgesic, and toxic effects become more pronounced. Except in cases of acute intoxication, there is no loss of motor coordination or slurred speech as occurs with many depressants such as alcohol or barbiturates. [edit] Hazards Among the hazards of careless or excessive drug use are the increasing risk of infection, disease and overdose. Medical complications common among recreational narcotic users arise primarily from the non-sterile practices of injecting. Skin, lung and brain abscesses, endocarditis, hepatitis and HIV/AIDS are commonly found among persons with narcotic dependencies who share syringes or inhale the drug. There has been much discussion about the dangers related to the adulterants/diluents found in street drugs, such as heroin, where rumours abound about what is used to "cut" street drugs, e.g., ground glass, talcum powder, rat poison, domestic cleaning powders, and other cutting agents. Recent evidence shows that this kind of "dangerous adulteration" is largely mythical and that far less cutting of drugs than is normally assumed actually takes place. However, since there is no simple way to determine the purity of a drug that is sold on the street, the effects of using street narcotics are unpredictable. It remains the case that the greatest risk presented by most illicit drugs relates to the drugs themselves and how they are used, e.g., in conjunction with other drugs (alcohol is a particularly risky drug to use whilst also using other street drugs), in excess (most recreational and non-excessive drug use does not result in harm), and how a drug is administered (such as the sharing of needles). HIV and hepatitis infection rates drop among opioid injectors who have access to clean syringes and take advantage of that provision. [edit] Tolerance and dependence With repeated use of narcotics, tolerance and dependence develop. The development of tolerance is characterized by a shortened duration and a decreased intensity of analgesia, euphoria and sedation, which creates the need to administer progressively larger doses to attain the desired effect. Tolerance does not develop uniformly for all actions of these drugs, giving rise to a number of toxic effects. Although the lethal dose is increased significantly in tolerant users, there is always a dose at which death can occur from respiratory depression. It is clear, however, that tolerance and dependence, both part of the conventional idea of addiction, are insufficient to explain in totality what addiction is. Addiction proper is a broader behavioural phenomena that also encapsulates nonsubstance based activity that has many of the same characteristics that substance based dependency displays, e.g., excessive and compulsive gambling, excessive and compulsive eating, and a range of other excessive and compulsive behaviours. Moreover, it isn't always the case that those with a physical dependency to opiates find it too difficult to get over their "addiction," because so-called medical addicts (those that become physically dependent on opiates given for pain relief after treatment) only have to "give-up" the physical symptoms - they don't also have the all important psychological and life-style attachment to the drug which goes to make up the all-encompassing "addiction." Physical dependence refers to an alteration of normal body functions that necessitates the continued presence of a drug in order to prevent the withdrawal or abstinence syndrome. The intensity and character of the physical symptoms experienced during withdrawal are directly related to the particular drug in use, the total daily dose, the interval between doses, the duration of use and the health and personality of the user. In general, narcotics with shorter durations of action tend to produce shorter, more intense withdrawal symptoms, while drugs that produce longer narcotic effects have prolonged symptoms that tend to be less severe. The withdrawal symptoms experienced from heroin- or morphine-like addiction are usually first felt shortly before the time of the next scheduled dose. Early symptoms include watery eyes, runny nose, yawning and sweating. Restlessness, irritability, loss of appetite, tremors and severe sneezing appear as the syndrome progresses. Severe depression and vomiting are not uncommon. The heart rate and blood pressure are elevated. Chills alternating with flushing and excessive sweating are also characteristic symptoms. Pains in the bones and muscles of the back and extremities occur as do muscle spasms and kicking movements, which may be the source of the expression "kicking the habit." At any point during this process, a suitable dose of opioid can be administered that will dramatically reverse the withdrawal symptoms. Without intervention, the syndrome will run its course and most of the overt physical symptoms will disappear within 7 to 10 days. The psychological dependence that is associated with narcotic addiction is complex and protracted. Long after the physical need for the drug has passed, the addict may continue to think and talk about the use of drugs. There is a high probability that relapse will occur after narcotic withdrawal when neither the physical environment nor the behavioral motivators that contributed to the abuse have been altered. There are two major patterns of narcotic dependence seen in the United States. One involves individuals whose drug use was initiated within the context of medical treatment who escalate their dose through "doctor shopping" or branch out to illicit drugs. A very small percentage of addicts are in this group. The other more common pattern of non-medical use is initiated outside the therapeutic setting with experimental or recreational use of narcotics. The majority of individuals in this category may use narcotics sporadically for months or even years. These occasional users are called "chippers." Although they are neither tolerant of nor dependent on narcotics, the social, medical and legal consequences of their behavior can be very serious. Some experimental users will escalate their narcotic use and will eventually become dependent, both physically and psychologically. The earlier drug use begins, the more likely it is to progress to dependence. Heroin use among males in inner cities is generally initiated in adolescence, and dependence often develops in about 1 or 2 years. Signs and symptoms of narcotic/opioid overdose include the following: euphoria, arousable somnolence ("nodding"), nausea, pinpoint pupils (except with Pethidine/Meperidine [Demerol], hypoxia, or in combination with other types of drugs), coma, and seizures. This bulletin attempts to give the most recent news on the results obtained in the control of narcotic drugs and the struggle against addiction, by Governments, by the United Nations and by the organizations established under the Conventions. It contains technical and scientific articles on narcotic drugs and articles on the legislation and administration in various countries as well as bibliographical material. The Department of State's International Narcotics Control Strategy Report (INCSR) -- due to Congress March 1st annually -- is prepared in accordance with §489 of the Foreign Assistance Act of 1961, as amended (the "FAA," 22 U.S.C. §2291). The INCSR is the United States Government's country-by-country two volume report that describes the efforts to attack all aspects of the international drug trade, chemical control, money laundering and financial crimes. [Note: The annual Narcotics Control Reports have been renamed starting with the March 2005 report to reflect the year they were released to the public. Therefore, there is no "2004 INCSR." The 2005 report covers 2004. The 2006 report will cover 2005, etc.] Narcotics are drugs that alleviate physical pain, suppress coughing, alleviate diarrhea, and induce anesthesia. Natural narcotics are derived from the Opium poppy and synthetic narcotics are made to act like the major constituents of Opium (thebaine, morphine, codeine). Legal, synthetic narcotics such as OxyContin (oxycodone) and Vicodin (hydrocodone) are prescribed as pain-relievers but are often diverted for illegitimate uses. Heroin is an illegal narcotic, derived from morphine There were no legal restrictions on the importation or use of opium until the early 1900s. In the United States, the unrestricted availability of opium, the influx of opium-smoking immigrants from East Asia, and the invention of the hypodermic needle contributed to the more severe variety of compulsive drug abuse seen at the turn of the 20th century. In those days, medicines often contained opium without any warning label. Today, there are state, federal, and international laws governing the production and distribution of narcotic substances. Although opium is used in the form of paragoric to treat diarrhea, most opium imported into the United States is broken down into its alkaloid constituents. These alkaloids are divided into two distinct chemical classes, phenanthrenes and isoquinolines. The principal phenanthrenes are morphine, codeine, and thebaine, while the isoquinolines have no significant central nervous system effects and are not regulated under the CSA. Source: DEA The Opium poppy (papaver somniferum) is the key ingredient for all narcotics. Opium is the substance that is directly extracted from the Opium poppy. Opium grows in Southeast Asia, Southwest Asia, and in the Western Hemisphere (Mexico, Guatemala, and Colombia). Opium is converted into Heroin in laboratories in the countries where it is cultivated, and then consumed locally or shipped to consumer countries. It takes approximately ten kilograms of Opium to make one kilogram of Heroin. First synthesized from morphine in 1874, heroin was not extensively used in medicine until the beginning of this century. Commercial production of the new pain remedy was first started in 1898. While it received widespread acceptance from the medical profession, physicians remained unaware of its potential for addiction for years. The first comprehensive control of heroin in the United States was established with the Harrison Narcotic Act of 1914. Heroin, an illegal opiate drug known on the street as smack, junk, brown sugar, dope, horse, skunk and other names is derived from the resin of the poppy plant which grows predominantly in southeast and southwest Asia, Mexico and now in Colombia. It is manufactured in remote laboratories using rudimentary equipment which presses the powder into bricks for bulk shipment to destination countries like the United States. Smaller amounts are smuggled by couriers who swallow heroin-filled latex balloons before boarding commercial airlines. Pure heroin is a white powder with a bitter taste. Most illicit heroin is a powder form which may vary in color from white to dark brown because of impurities left from the manufacturing process or the presence of additives. Pure heroin is rarely sold on the street. A "bag" --slang for a single dosage unit of heroin--may contain 100 mg of powder, only a small portion of which is heroin. The remainder could be sugars, starch, powdered milk, or quinine. Traditionally the purity of heroin in a "bag" has ranged from one to ten percent. More recently, heroin purity has ranged from one to ninety-eight percent, with a national average of thirty-five percent. Morphine is the principal constituent of opium and can range in concentration from 4 to 21 percent. Commercial opium is standardized to contain 10-percent morphine. In the United States, a small percentage of the morphine obtained from opium is used directly (about 15 tons): the remaining is converted to codeine and other derivatives (about 120 tons). Morphine is one of the most effective drugs known for the relief of severe pain and remains the standard against which new analgesics are measured. Like most narcotics, the use of morphine has increased significantly in recent years. Since 1990, there has been about a 3-fold increase in morphine products in the United States. Morphine is marketed under generic and brand name products including "MS-Contin®," Oramorph SR®," MSIR®," Roxanol®," Kadian®," and RMS®." Morphine is used parenterally (by injection) for preoperative sedation, as a supplement to anesthesia, and for analgesia. It is the drug of choice for relieving pain of myocardial infarction and for its cardiovascular effects in the treatment of acute pulmonary edema. Traditionally; morphine was almost exclusively used by injection. Today, morphine is marketed in a variety of forms, including oral solutions, immediate and sustained-release tablets and capsules, suppositories, and injectable preparations. In addition, the availability of high-concentration morphine preparations (i.e., 20-mg/ml oral solutions, 25-mg/ml injectable solutions, and 200-mg sustained-release tablets) partially reflects the use of this substance for chronic pain management in opiate-tolerant patients. Prescription drug abuse is on the rise and should be cause for great concern. Narcotic (analgesic) drugs are the most commonly misused of prescription drugs. Below are the three categories of prescription drugs: NARCOTICS (OxyContin, Vicodin, Percocet), also known as analgesics or opiods are drugs that are prescribed for moderate to severe physical pain. They are abused because of their euphoric, sedating, and numbing effects. Narcotic abuse causes tolerance and dependence and the withdrawal symptoms are severe. DEPRESSANTS (Xanax, Valium, Librium) are drugs that are prescribed to treat anxiety and sleep disorders. They are abused because of their sedating properties. With abuse, depressants cause tolerance and dependence and the withdrawal symptoms can be severe. STIMULANTS (Ritalin, Dexedrine, Meridia) are prescribed to treat ADD/ADHD and other conditions such as asthma. They are abused because of their energizing and euphoric effects. Stimulants do not generally cause tolerance or dependence but abuse is associated with hostility and paranoia. There is also great risk for cardiovascular failure and seizures. The Bureau for International Narcotics and Law Enforcement Affairs (INL) advises the President, Secretary of State, other bureaus in the Department of State, and other departments and agencies within the U.S. Government on the development of policies and programs to combat international narcotics and crime. The bureau is headed by Assistant Secretary Anne W. Patterson under the direction of the Under Secretary for Political Affairs. INL programs support two of the Department's strategic goals: (1) to reduce the entry of illegal drugs into the United States; and (2) to minimize the impact of international crime on the United States and its citizens. Counternarcotics and anticrime programs also complement the war on terrorism, both directly and indirectly, by promoting modernization of and supporting operations by foreign criminal justice systems and law enforcement agencies charged with the counter-terrorism mission. Narcotics Anonymous is a fellowship of men and women for whom drugs became a problem. We meet regularly to help each other remain totally abstinent from drugs in any form. The Northern California Region of Narcotics Anonymous serves 20 areas. The Northern California Regional Service Committee serves as the single point of accountability for all Regional Services within its boundaries. The boundaries are roughly from the northernmost borders of the Humboldt Del Norte, Trinity, Shasta, and Lassen Counties; on the west by the Pacific Ocean; on the east by the crest of the Sierra Nevada's; and on the south by the southernmost boundaries of Monterey, Contra Costa, Alameda, Santa Clara and Sacramento Counties. The 20 areas serve a combined total of more than 1100 weekly meetings. Each meeting sends a group service representative to a monthly Area Service meeting. Each area sends 2 regional committee members to a monthly regional service meeting. At these meetings the business of Narcotics Anonymous is conducted on behalf of the members who make up our groups and areas. The service structure is ultimately accountable to the groups making up the areas. The responsibilities for delivering services are delegated by the groups to the committees as a result of group consciences. For more information check the various committee pages. Welcome to the Narcotics Anonymous Hawaii website. On this site you will find meeting schedules for the Hawaiian Islands and the island of Guam. We also post information on how to contact NA in Hawaii. Communications will be forwarded to the proper trusted servants. We post the most recent information on the Hawaii Regional Convention and individual island "Gatherings". Other fellowship information is posted on our Downloads page. If you are new to Narcotics Anonymous, please check out our "What Is NA?" page first. You may contact our service committees and trusted servants by utilizing our "Feedback" page or through the contact information presented on the "Contact Info" page of this web site (postal address, telephone or email). Technical questions or suggestions about the website should be directed to the Web Page Work Group through our "Feedback" page. Information on Narcotics Anonymous world-wide can be found at Narcotics Anonymous World Services' website: www.na.org. This site is administered on behalf of the Narcotics Anonymous groups in Hawaii through the Hawaii Regional Service Committee's Web Page Work Group. Why is IRS Involved in Narcotics Investigations? One look at the daily newspaper is proof enough that crimes dealing with or motivated by money make up the majority of current criminal activity in the nation. Tax evasion, public corruption, health care fraud, and even drug trafficking are all examples of the types of crimes that revolve around money. In these cases, a financial investigation often becomes the key to a conviction. Traditional law enforcement relies on investigative tools such as crime scene analysis, physical evidence, fingerprint identification or eyewitness accounts. The limitations of these techniques become obvious to those who are trying to prove wrongdoing in a sophisticated financial crime. With no proof, there is no conviction. When the Internal Revenue Service astounded Public Enemy Number 1, Alphonse Capone by obtaining a conviction for tax evasion and demanding millions of dollars in back taxes, Capone said, "They can't collect legal taxes from illegal money." But it's really pretty simple: No matter what the source of income -- all income is taxable. And this creates a real problem for drug dealers. What are they going to do with their money -- so that IRS won't find it? For the IRS, money laundering and narcotics investigations are the compliance effort to address criminal violations of the Bank Secrecy Act, the Money Laundering Control Act of 1986 and section 6050(I) of the Internal Revenue Code. Why a Financial Investigation? Financial investigations are by their nature very document intensive. Specifically, they involve records, like bank account information and real estate files, which point to the movement of money. Any record that pertains to, or shows the paper trail of events involving money is important. The major goal in a financial investigation is to identify and document the movement of money during the course of a crime. The link between where the money comes from, who gets it, when it is received and where it is stored or deposited, can provide proof of criminal activity. Criminal Investigation's contribution to the war on narcotics is vital but sometimes difficult to recognize, because the work of IRS special agents usually doesn't make the headlines. The long hours of tracking down and documenting financial leads isn't glamorous, but it does allow an investigation to go right to the door of the leader of the narcotics organization. A complete financial analysis and reconstruction of a drug organization's financial activity as it relates to unreported income on tax returns and money laundering can often be critical to making the conviction. History Criminal Investigation (CI) was established in 1919 and commenced its first narcotics investigation of an opium trafficker in Hawaii in the early 1920's, obtaining tax evasion charges against the leader of that organization. The CI Narcotics Program's goal is to utilize the financial investigative expertise of its special agents to disrupt and dismantle, through investigation, prosecution and asset forfeiture, the country's major drug and money laundering organizations. Federal Statutes, Task Forces and Strategies Regarding IRS Narcotics Investigations Definition of Terms Currency Transaction Report (CTR) - Form 4789: Filed by financial institutions that engage in a currency transaction in excess of $10,000. Suspicious Activity Report (SAR) - Form TD F 90-22.47: Filed by financial institutions on transactions or attempted transactions involving at least $5,000 that the financial institution knows, suspects, or has reason to suspect the money was derived from illegal activities. Report of Foreign Bank and Financial Accounts (FBAR) - Form TD F 90-22.1: Filed by individuals to report a financial interest in or signatory authority over one or more accounts in foreign countries, if the aggregate value of these accounts exceed $10,000 at any time during the calendar year. Report of Cash Payments Over $10,000 Received in a Trade or Business -Form 8300: Filed by persons engaged in a trade or business who, in the course of that trade or business, receive more than $10,000 in cash in one transaction or two or more related transactions within a twelve month period. Report of International Transportation of Currency or Monetary Instruments (CMIR) - Form 4790: filed by persons who physically transport, mail or ship currency or other monetary instruments in an aggregate amount exceeding $10,000 at any one time into or out of the United States. Federal Statutes Internal Revenue Code – CI has sole jurisdiction for criminal violations of the Internal Revenue Code (IRC), Title 26 of the United States Code. The IRC, Section 61(a) defines gross income as ". . . all income from whatever source derived." This has been held by the courts to include income earned from illegal activities such as drug trafficking. The primary criminal statutes violated include evasion of income tax, false income tax returns, and failure to file tax returns, among others. Additionally, IRC, Section 6050(i), requires anyone involved in a trade or business, except financial institutions, to report currency received for goods or services in excess of $10,000. This requirement has provided a significant impediment to the use of illicit profits by narcotics traffickers for the purchase of luxury items such as vehicles, jewelry and boats. Financial institutions report similar information on a Currency Transaction Report. A new law, Title 31, Section 5331 of the United States Code, was passed in 2001 as a result of the USA Patriot Act and duplicates the reporting provisions of IRC, Section 6050(i). Dual reporting of this information will now be made to both the IRS and the Treasury Department's Financial Crimes Enforcement Network (FinCEN). Money Laundering Control Act of 1986 – CI investigates and recommends criminal prosecution for violations of Title 18, United States Code, Sections 1956 and 1957. These statutes make illegal certain financial transactions constituting laundering, hiding, or use of proceeds generated through specified unlawful activities, such as narcotics trafficking and embezzlement, among others. Bank Secrecy Act – The Currency and Foreign Transactions Reporting Act, Public Law No. 91-508, Title II, along with financial institution record-keeping requirements, became known as the Bank Secrecy Act (BSA). The BSA mandates the reporting of certain currency transactions conducted with a financial institution, (Form 4789), the disclosure of foreign bank accounts (TD F 90-22.1), and the reporting of the transportation of currency exceeding $10,000 across United States borders (Form 4790). Asset Forfeiture – The asset forfeiture program is one of the federal government's most effective tools against drug trafficking, money laundering, and organized crime. In conjunction with other federal, state, and local law enforcement agencies, CI uses asset forfeiture statutes to dismantle criminal enterprises by seizing and forfeiting their assets. Most of CI's seizures and forfeitures are the result of Title 18 and Title 31 money laundering and currency investigations. Criminal Investigation (CI) Supports National Strategies and Initiatives: Criminal Investigation supports national law enforcement strategies and initiatives by investigating and recommending prosecution of domestic and international narcotics traffickers and related money-laundering organizations. CI follows the money trail, tracing the profits from the illegal activity back to the criminal. To focus our resources against major money laundering organizations, CI participates in inter-agency task forces in High Risk Money Laundering and Related Financial Crimes Areas (HIFCAs); intensifies the use of federal criminal and civil asset forfeiture laws; and enhances intra-agency, inter-agency, and international coordination of money laundering investigations. High Intensity Money Laundering and Related Financial Crime Area (HIFCA) Task Forces Mandated in the National Money Laundering Strategy, HIFCAs occupy the flagship role in the nation's efforts to disrupt and dismantle large-scale money laundering systems and organizations. The designation of a HIFCA is intended to concentrate law enforcement efforts at the federal, state, and local level on combating money laundering in high-intensity money laundering zones, whether based on drug trafficking or other crimes. The 2001 Money Laundering Strategy announced the designation of two new HIFCA locations: Northern District of Illinois (Chicago) and Northern District of California (San Francisco). The four HIFCAs named in the 2000 strategy were: New York/New Jersey; San Juan/Puerto Rico; Los Angeles; and a "systems HIFCA," designed to address cross-border currency smuggling in Texas/Arizona to and from Mexico. HIFCAs are composed of all relevant federal, state, and local enforcement authorities; prosecutors; and federal financial supervisory agencies as needed. They work closely with the High Intensity Drug Trafficking Areas (HIDTA) and Organized Crime Drug Enforcement Task Forces (OCDETF) and focus on collaborative investigative techniques. Office of National Drug Control Policy (ONDCP) As part of the Anti-Drug Abuse Act of 1988, the President established the Office of National Drug Control Policy to oversee the nation's effort to combat illegal drugs. As part of that oversight authority, the Director of the ONDCP established a National Drug Control Strategy. This strategy directed agencies involved in counter-narcotics activities to focus their efforts on reducing the demand for drugs through treatment and prevention and by attacking and disrupting the drug supply through aggressive law enforcement and increased international cooperation. Organized Crime Drug Enforcement Task Force (OCDETF) The Organized Crime Drug Enforcement Task Force (OCDETF) Program was created and is managed by the Department of Justice "to identify, investigate, and prosecute members of high-level drug trafficking enterprises, and to destroy the operations of those organizations." IRS CI is substantially reimbursed for the resources it commits to the war on narcotics trafficking and has been a participating member of OCDETF since its inception in 1982. During FY 2001, CI participated in 38% of the OCDETF investigations. High Intensity Drug Trafficking Area (HIDTA) The High Intensity Drug Trafficking Areas (HIDTA) Program was established by the Anti-Drug Abuse Act of 1988, to provide assistance to federal, state and local law enforcement agencies operating in areas most adversely affected by drug trafficking. The Director of the Office of National Drug Control Policy (ONDCP) has oversight authority over the HIDTA Program . There are 28 locations designated as HIDTA. HIDTA initiatives focus on the investigation of money laundering violators and the identification and confiscation of the profits derived from the illegal sale of narcotics. Criminal Investigation supports HIDTA by dedicating special agents and other resources to the initiatives. CI provides the financial investigative perspective necessary to meet the goals of the National Drug Control Strategy. Narcotics Enforcement Statistics Criminal Investigation continues to commit financial investigative expertise to investigations involving highly complex narcotics related financial crimes Examples of Narcotics Related Investigations Examples of narcotic related investigations are excerpts from public record documents on file in the court records in the judicial district in which the cases were prosecuted. IRS Special Agents participated in the financial investigative aspect of these cases. How Do You Report Suspected Tax Fraud Activity? If you have information about an individual or company you suspect is not complying with the tax law, report this activity. WHEREAS, federal, state and city narcotics laws declare the habitual use of narcotics to be a crime, while narcotics addiction is considered by the medical profession to be an illness and by many psychiatrists and social scientists to be a personality disorder rooted in psycho-social factors; and WHEREAS, narcotics addicts are forced by such laws to the illegal procurement of narcotics at exorbitant prices to ease their suffering, which leads to crime to make such procurement possible, and encourages and supports the illegal traffic in narcotics; and WHEREAS, the flourishing illegal traffic in narcotics depends on, and actively works to develop, new addicts to maintain and expand the market; BE IT THEREFORE RESOLVED: That the Unitarian Universalist Association urges changes in existing narcotics laws in order to provide for: The establishment of intake-referral centers to which all addicts apprehended by law-enforcement agencies would be taken in order that they be placed in rehabilitation centers; A choice between imprisonment or a rehabilitation center for the addicted "pusher," the "pusher" to be on probation if he chooses rehabilitation; A severe sentence to imprisonment for non-addict "pushers" and accomplices. BE IT FURTHER RESOLVED: That the Association be directed and its members urged to take action to support this resolution whenever possible and that there be further study by the Association on this subject.

The University of Colorado School of Pharmacy offers the Doctor of Pharmacy (PharmD) degree for working pharmacists in a part-time format. All didactic courses are delivered online, via the Internet. Online courses provide maximal accessibility and flexibility to working pharmacists, and provide opportunities for interaction with the faculty and with the other pharmacists in the program, and for active participation in learning. Experiential training is also very flexible. Some clerkships can be challenged for academic credit based on your experiences as a pharmacist. Others are available part time, or can be performed where you work. (See "Experiential Training" for more information.) The Nontraditional PharmD program (NTPD) is fully accredited by the Accreditation Council for Pharmacy Education (ACPE). It is designed to offer excellent, contemporary pharmacy education in a format that will fit into your professional and personal life. Each pharmacist determines his or her own course load each semester, to find their best personal balance. No campus visits are currently required. Program Outcomes: The ability to demonstrate a comprehensive knowledge of pathophysiology, pharmacotherapeutics and pharmacokinetics. The ability to observe and understand the signs and symptoms of disease as they relate to and impact drug therapy. The ability to develop an adequate data base from information extracted the patient, the patient's medical and pharmacy records, and other health care practitioners in the process of evaluating drug therapy. The ability to organize and present an assessment of the patient's health-related problems. The ability to define realistic therapeutic objectives, identify subjective and objective outcomes of drug therapy and recommend a pharmacotherapeutic plan based on patient-specific information. The ability to identify, prevent and solve drug therapy problems by recommending the use of an appropriate drug or dosage regimen. The ability to effectively assess drug efficacy and safety through the evaluation of appropriate physical and laboratory parameters. The ability to communicate effectively with patients and other health care practitioners. The ability to develop effective professional relationships with patients and other health care practitioners. The ability to select, critically evaluate and apply information from the medical and pharmacy literature. The ability to evaluate clinically relevant research. The ability to demonstrate a high level of professional maturity, commitment and ethics. Program Description: Through your computer, you will typically obtain lecture handouts and readings, view slide shows, listen to audio lectures from faculty, participate in office hours and discussion groups with faculty and classmates, submit assignments, take exams, view grades, link to the medical library, and receive and send messages. The NTPD program requires the completion of 35 semester credit hours of didactic coursework (11 courses) and 30 hours of experiential training in advanced pharmacy practice experiences (APPEs) or clerkships (six 5-week rotations), for a total of 65 semester credit hours. Students may be able to receive credit for up to four clerkships by preparing portfolios that document relevant work experience. Six Advanced Disease State Management (ADSM) courses form the core of the didactic curriculum. Each course addresses the pathophysiology, advanced pharmacotherapeutics, pharmacokinetics, and professional skill development for two to three body systems. For example, one course contains cardiovascular and renal modules. As an illustration, the programmed learning experiences within the cardiovascular section include: The pathophysiology of common cardiovascular disorders such as hypertension, myocardial infarction, congestive heart failure, and dysrhythmias; Pharmacotherapeutic management of patients with these disorders, including design of patient-specific individualized drug therapy treatment plans; Pharmacokinetics of drugs used to treat cardiovascular disorders; Basic cardiovascular physical assessment skills such as blood pressure monitoring; Problem-based case discussions of patients with cardiovascular disorders; Other appropriate clinical skills development activities. The Advanced Disease State Management (ADSM) courses are 3.5-4 credit hours each. Each ADSM course is delivered in a format which will require about four hours of "class time" online per week. Readings and other course preparation or assignments are likely to add about another 4 hours weekly for 4 credit hour courses. About one-half of ADSM class time is allocated to clinical skills development. ADSM courses may be taken in any sequence. Other course work supports the ADSM courses and develops skills that are important to the effective functioning of clinical pharmacy practitioners: The NTPD includes six 5-credit advanced pharmacy practice experiences (APPEs, or rotations). If taken on a full-time basis, each APPE is five weeks. On a part-time basis, each APPE requires 200 contact hours. Three practice areas are required: acute care medicine, ambulatory care, and drug information. All pharmacists enrolled in the NTPD program must either perform these APPEs, or successfully challenge these practice areas for credit. Each pharmacist also selects three elective APPEs. Electives may be selected from a wide variety of medicine subspecialties such as neurology, oncology, nutrition, infectious diseases, critical care, psychiatry, and pediatrics. Other elective choices include pharmaceutical care projects, community pharmacy, education, administration, industry, managed care, and clinical research. APPEs are critical in permitting the faculty to assess the pharmacist’s clinical application and integration of didactic material. However, the Postgraduate Professional Education and Clerkship Committees recognize that the time commitments of performing several traditional APPEs are not workable for most practicing pharmacists, and also present serious scheduling challenges for employers. To make the experiential components as flexible and feasible as possible, several accommodations have been implemented: The experiential component of the NTPD is shorter than that of the full time on-campus program (30 weeks maximum, compared with 44 weeks). This is possible because pharmacists enrolled in the NTPD have greater pharmacy practice experience before entering the program than most students enrolled in full time on-campus programs. You also have greater opportunity to apply your new didactic knowledge to your clinical practice while you are taking classes. Pharmacists may apply for credit by challenge of one to four APPEs, based on their professional experiences. Time limits apply. Challenges require preparation of portfolios that describe and document how you have met the expected outcomes for specific practice areas. They require a narrative, and documentation of clinical experiences, interventions, presentations, programs, etc. Tuition is not currently charged for successful APPE challenges, although a challenge fee applies. Some APPEs may be performed at the pharmacist's usual practice site with approval of the experiential programs director. Approval depends on factors such as the size of the institution, the availability of qualified preceptors, potential conflicts of interest, and many other factors. Many APPEs are available on a part-time basis. APPEs need not be taken consecutively. NTPD students may begin taking APPEs only after completing four Advanced Disease State Management classes; however, students can prepare a challenge to a clerkship at any point in the program. The drug information APPE is available through distance learning. Nontraditional clerkship models are available. Examples include "distance preceptorships" or design and implementation of a pharmaceutical care project. Every attempt will be made to arrange APPEs at sites near the pharmacist's home or usual workplace. New ACPE accreditation standards specify that required APPEs be performed within the US. Application Process: The NTPD program is open to pharmacists who have graduated from accredited colleges or schools of pharmacy in the United States or Canada, or who have passed the Foreign Pharmacy Graduate Equivalency Exam. Pharmacists must be licensed to practice pharmacy in the U.S. or Canada and be in good standing with the regulatory agency issuing the license. Admission is inclusive; there is no minimum GPA. Preference may be given to Colorado residents. The Admissions Committee reserves the right to consider exceptions to these guidelines on a case-by-case basis. Three recommendations written on standard University of Colorado School of Pharmacy recommendation forms. These are available from the same sources listed above. The reference forms should be given to people who know you and your recent pharmacy career well, and can speak to your self-motivation and professional attributes. References will usually be employers, supervisors, former faculty, preceptors, or professional colleagues. See guidelines on the application form. One-page personal statement that describes your reasons for seeking a PharmD degree and for applying to this program. Current curriculum vitae (CV) or resume that includes your pharmacy practice experiences since graduation from pharmacy school. Official transcripts from the School of Pharmacy from which you graduated and from any degree program(s) in which you have been enrolled since obtaining your BS in Pharmacy. Usually you will request these transcripts from the registrar's office of your School or College of Pharmacy. Copies will be sent directly from your school to the to the Chair of the Admissions Committee (NTPD). Please request transcripts at least 2-4 weeks before the application deadline. Non-refundable application fee of $50.00 (US dollars). Checks or money orders should be made out to the University of Colorado School of Pharmacy. Applications are accepted at any time for the Nontraditional PharmD program. However, the application must be complete at least 30 days before the beginning of a semester to be considered for admittance that semester: June 30* for admission in Fall semesters, and November 15 for admission beginning in Spring semester. Fall classes begin the last week in August, and spring classes begin in the middle of January. Pharmacists may begin the PharmD program in any spring or fall semester. Please request transcripts and letters of reference at least one month before the application deadline to ensure that your application file is complete by the application deadline! Application materials will be reviewed by the School of Pharmacy Admissions Committee. The committee reserves the right to require a telephone or in-person interview. Acceptances to the Nontraditional PharmD program will be honored for one year from the start date of the semester for which admission was requested. Pharmacists who fail to enroll in any course within that year may be required to reapply. NOTE: Applications to the NTPD program will be accepted at least through November 15, 2006, with a start date for January 2007. Extension of admissions to the NTPD program will be determined annually, based on demand. Tuition, Fees, and other Costs: Tuition per credit hour for the 2006-2007 academic year is $400 for Colorado residents and $440 for non-residents. New tuition rates are established each spring, and go into effect with summer classes. Many employers offer a tuition reimbursement benefit that can be applied to the costs of professional education programs. Tax benefits (life long learning credit) may also apply. All tuition and fees are in US dollars A one-time matriculation fee of $140 is required of any student enrolling for classes at the University of Colorado for the first time. A computer technology fee of $65 per course helps defray the costs of delivering courses online, and a $75 academic support fee is assessed each semester. There is a $75 APPE fee, which is charged for each APPE in which you enroll. The credit by challenge fee for clerkships is $450 per clerkship (however, tuition is currently waived for successful challenges). Textbook requirements are determined by individual instructors, but are limited, since much of the required instructional materials will be provided online. Textbooks may be ordered online through the University of Colorado Health Sciences Bookstore. Computer Equipment Needed: To take full advantage of the interactivity of the NTPD courses, the following setup is required: IBM compatible PC strongly recommended with pentium® processor (90MHz minimum), most but not all components of the delivery system will perform with Macintosh with PowerPC processor (604 PowerPC minimum) Windows 2000 or XP or MacOS 9.1or later 28.8 kbps modem (56K recommended). High speed Internet access such as "cable modems" or "DSL lines" are recommended to improve the speed and function of online course delivery, but are not required An Internet connection and Internet service provider (ISP) An e-mail account Speakers and a sound card (Soundblaster® or equivalent) Web browser such as Microsoft’s Internet Explorer R (preferred) or Netscape CommunicatorR, the newest version of either. (download free, see below). Internet Explorer 6 or Netscape 7 are recommended browsers for PC Netscape 7 or Internet Explorer 5.2.2 are recommended browsers for Mac OS-X RealPlayerR for audio and video, newest version (download free, see below) Microsoft OfficeR 97 or newer (or Microsoft OfficeR 98 for Macintosh), Standard Version or better (available at excellent discounts through the HSC bookstore to enrolled students) Printer Please visit the following website for more detailed information on required technical features,http://strata.ecollege.com/index.learn?action=technical_info. - (Click into the Technical Info. Tab). Also, the website offers downloads for the newest browser versions, free of charge. It is also recommended that you have a second phone line installed in your home for dedicated use with your computer, or use a high speed internet service such as cable or DSL. This will decrease the inconvenience for other members of your household when you are online and will reduce the time it takes to download files. Frequently Asked Questions about the Nontraditional PharmD Program You may ask additional questions by sending them to NTPharmD@UCHSC.edu Thank you, and we hope to hear from you soon! Carol Balmer, PharmD, BCOP Assistant Dean, Postgraduate Professional Education EC PHARMACY UPDATE EC pharmacy access legislation, SB 849, was introduced in the 2005 legislative session (bills can only be introduced every other year). Amendments were made to SB 849 to add a physician assistant as an authorizer and to address record-keeping and rule-making.EC pharmacy access legislation, SB 849 For the past several years the Board of Pharmacy and the Oregon State Pharmacists Association (OSPA) have been involved in efforts to simplify the restrictions on collaborative protocols and thereby permit pharmacists to initiate EC. Similar legislation, SB 677, was proposed in the 2003 session but died. Health advocates had a major role in attempting to move this legislation and the Board of Pharmacy and Pharmacists Association were less visibly involved. In April 1999 the Oregon Board of Pharmacy and the Oregon Medical Association explored the concept of a pilot project where pharmacies would initiate EC. However, the Oregon Pharmacy Act did not provide the appropriate framework to support this type of project, and the concept died. During the 2001 legislative session, OSPA proposed broad enabling legislation similar to Washington State that would allow pharmacists under protocol to initiate drug therapy including EC. This legislation was opposed by the Oregon Medical Association, Kaiser Permanente and the Oregon Association of Hospitals and Health Systems. In November 2002, representatives from the Oregon Office of Family Health, the Oregon Health and Science University, and Columbia University School of Public Health presented at the American Public Health Association’s 130th Annual Meeting on Improving Access to Emergency Contraception using Oregon PRAMS (Pregnancy Risk Assessment Monitoring System) data. They highlighted that one barrier to increased use of EC in Oregon has been that very few retail pharmacists were stocking EC. They concluded, “Many women would benefit if mores states passed laws allowing pharmacist counseling, referral, and prescription of emergency contraception.” EC awareness training aimed at health care professionals occurred in the Portland metropolitan area. The State Department of Human Services also contracted with Population Services International to train providers throughout the state including 36 agencies and 128 clinics. Planned Parenthood of the Columbia/Williamette (PPCW) in Portland, OR, offers women a way to access EC through the PPCW website. A nurse practitioner contacts the patient by phone to review the information submitted and answer questions. Since the program’s launch in 2002, almost 600 women have received an EC prescription. Additional papers from the Oregon Department of Human Services, Office of Family Health, on the need for advance prescriptions, knowledge of EC and pregnancy intendedness, and EC in emergency departments have been or will be published. Jeanne Atkins Manager, Women's and Reproductive Health Services, Office of Family Health PROTOCOL ENVIRONMENT Possible Environment: Revision to Existing Authority Required This state permits collaborative practice agreements or a similar agreement between physicians and pharmacists. However, some modification of existing statutes and/or regulations is required to allow pharmacists to initiate EC for the general community. Pharmacist initiation of EC would require: Modifying the requirement for patient-specific protocols Modifying the requirement that only prescribers may initiate drug therapy PHARMACY PRACTICE ACT Pharmacy Practice Act Regulatory and Statutory Authority Note: The text presented below has been prepared by the American Pharmacists Association for the Pharmacy Access Partnership and reflects legislation or regulation promulgated as of June 15, 2003. Pharmacists with special training, working in any practice setting, may engage in patient-specific protocol agreements with physicians or other prescribers. No external Board review is required. Collaborative drug therapy management must be initiated by prescription order for each individual patient by the participating practitioner. Training requirements for the pharmacist are stated in the protocol, which is valid for two years. Therapeutic substitution is not allowed. The scope of practice is defined within the protocol and must include – a detailed description of the collaborative role the pharmacist shall play; specific drugs the pharmacist may base drug therapy management decisions on; and a description of the mechanism for communication and circumstances under which the pharmacist will initiate communication with the practitioner, including the need for new prescription orders and reports of patients’ therapeutic responses or adverse effects. Pharmacists who complete other required training may administer immunizations, by any route of delivery, to those 18years and older. Pharmacists must follow written protocols approved by the Oregon Health Division for administration of vaccines and the treatment of severe adverse events, keep detailed records, and provide information to the Board. Statutory authority: Or. Rev. Stat. § 689.005, § 689.015, § 689.645 Regulatory authority: Or. Admin. R. 855-041-0400, 855-041-0500, 855-006-0010 (1) “Administer” means the direct application of a drug or device whether by injection, inhalation, ingestion, or any other means, to the body of a patient or research subject by (a) A practitioner or the authorized agent thereof; or (b) The patient or research subject at the direction of the practitioner. 689.015 “Practice of pharmacy” defined. The “practice of pharmacy” means the interpretation and evaluation of prescription orders; the compounding, dispensing, labeling of drugs and devices (except labeling by a manufacturer, packer or distributor of nonprescription drugs and commercially packaged legend drugs and devices); the administering of vaccines and immunizations pursuant to ORS 689.645; the administering of drugs and devices to the extent permitted under ORS 689.655; the participation in drug selection and drug utilization reviews; the proper and safe storage of drugs and devices and the maintenance of proper records therefor; the responsibility for advising, where necessary or where regulated, of therapeutic values, content, hazards and use of drugs and devices; the monitoring of therapeutic response or adverse effect to drug therapy; and the offering or performing of those acts, services, operations or transactions necessary in the conduct, operation, management and control of pharmacy. [1979 c.777 §4; 1999 c.350 §3 ivision 41 - Operation Of Pharmacies (Retail And Institutional Drug Outlets) Consulting Pharmacists And Operation Of Drug Rooms The Oregon Administrative Rules contain OARs filed through July 15, 2002 Collaborative Drug Therapy Management (1) A pharmacist shall engage in collaborative drug therapy management only under a written protocol that includes; (a) The identification, either by name or by description, of the participating pharmacist(s); (b) The identification, by name, of the participating practitioner(s); (c) The name of the principal pharmacist and practitioner who are responsible for development, training, administration, and quality assurance of the arrangement; (d) A detailed description of the collaborative role the pharmacist(s) shall play, including but not limited to: (A) Written protocol for specific drugs pursuant to which the pharmacist will base drug therapy management decisions for an individual patient. (B) Circumstances which will cause the pharmacist to initiate communication with the practitioner, including but not limited to the need for new prescription orders and reports of patients' therapeutic responses or adverse effects. (C) Training requirement for pharmacist participation and ongoing assessment of competency, if necessary. (D) Quality assurance and periodic review by a panel of the participating pharmacist(s) and practitioner(s). (e) Authorization by the practitioner(s) for the pharmacist(s) to participate in collaborative drug therapy. (f) A provision for the collaborative drug therapy arrangement to be reviewed and updated, or discontinued at least every two years; and (g) A description of the mechanism for the pharmacist(s) to communicate to the practitioner(s) and for documentation of the implementation of the collaborative drug therapy. (2) Collaborative drug therapy management is valid only when initiated upon the prescription order of a participating practitioner for each individual patient. (3) Nothing in this rule shall be construed to allow therapeutic substitution. (4) The collaborative drug therapy protocol must be kept on file in the pharmacy and made available to the Board of Pharmacy and to the Board of Medical Examiners upon request. The state comparison information above was adapted from a study conducted by the American Pharmacists Association and commissioned by the Pharmacy Access Partnership. About Us • EC & Pharmacies • State Profiles • Legislation • Resources • Get Involved • Home • Site Map © 2006 Pharmacy Access Partnership Hosting Donated by eZigma, Inc. Edited by Professor Christine Bond from the Department of General Practice and Primary Care, University of Aberdeen, UK, the International Journal of Pharmacy Practice (IJPP) publishes reviews and original research on all aspects of the use of medicines and the practice of pharmacy. Published quarterly the IJPP has a respected international editorial board and publishes work from academics and practitioners worldwide. Topics covered by the IJPP include: Primary and secondary care Health economics, health policy and medicines usage Medicines information Pharmaceutical services provision Pharmacy education and practice Medicines utilisation Health improvement Pharmaceutical public health Research methods The first of two review articles by Watson et al. in IJPP June, discusses the use of simulated patients (i.e. mystery shoppers) – those who are trained to test pharmacists or pharmacy staff in specific scenarios – as a ‘methodological tool’ for pharmacy practice research. The authors aimed to provide a definitive review and identify the important characteristics that should be considered for inclusion in any study that uses this method. The review retrieved relevant studies from electronic databases (MEDLINE, EMBASE, CINAHL), as well as additional studies that were found in the references of retrieved articles, and a notice was also published in the Pharmaceutical Journal. Criteria was defined with articles being included in the review if ‘primary reports of trials conducted in the community pharmacy and drug store settings’. The review was restricted to publications from 1976 to May 2005; whilst articles were excluded if computer-, telephone, or laboratory-based simulations. It is also noted that the review’s purpose ‘was to assess the research method used in primary studies, rather than the results of the individual studies per se’. Of the 46 studies included in the review, these included nine randomised controlled trials (RCTs), three controlled clinical trials (CCTs) and 30 cross-sectional studies. The review details the randomisation, blinding and follow-up used in the studies; and how validity in the studies was achieved. Several studies used formal scenarios for the simulated patients in order to achieve some standardisation in the visits, and it was noted that simulated patients may require ‘face validity’ in order that pharmacy staff did not become suspicious and alter their behaviour. The purpose of the studies was also detailed; as was the characteristics and training of the simulated patients. Watson et al. note that their results demonstrate a growth in the use of simulated patient methodology during the past 30 years, stating that ‘this can be a rigorous and robust method of measuring practice’. However, the review was limited by variable reporting such as studies from developing countries making it difficult to classify the setting; while others did not state if staff were pharmacists or not. Future studies using simulated patients should present sufficient data and information to allow assessment. The review also discusses quality, validity and ethics. The authors summarised their findings by noting that simulated patient methodology is an internationally applicable tool with which to derive outcome measures in pharmacy practice research. Models and frameworks for implementing cognitive services in community pharmacy Roberts et al. carried out a literature search which contained discussion of models or frameworks for the implementation of cognitive pharmaceutical services (CPS) in pharmacy practice. It is noted that community pharmacy practice has been documented along a ‘continuum’ from manufacturing, compounding and distribution to pharmaceutical care and CPS. There have been very few studies which have evaluated the implementation process for pharmaceutical care or CPS, and the authors’ objective was to review the literature on practice change models so that approaches for implementing CPS could be investigated. Only a small number of papers met the criteria for inclusion. However, many of the papers were either conceptual, descriptive or non-empirical and so did not have methods sections. Thus, the authors divided the papers into two categories, conceptual and empirical. Within both categories the papers could be separated into two broad areas: models relating to specific services; general models which focused on implementation or change management process. The papers in these categories were discussed in further detail. Roberts et al. conclude that emphasis is still placed on the skills, knowledge and attitudes of individual pharmacists, assuming that improving those areas will ‘automatically result in successful change’. Many models identified overlooked the importance of the organisational process, and whilst some included elements such as business plans and external support, the authors feel that ‘it is of concern that the majority of models in which business and financial aspects were included remain conceptual in nature’, and in practice were not utilised. Furthermore, organisational models for implementing CPS that existed had not been tested thoroughly. Many studies used small groups of pharmacists; whilst most studies contained participants who had actively chosen to be involved. It is accepted that ‘the characteristics of innovators are different from those of later adopters’ and can affect the generalisability of findings. Roberts et al. find it clear that improving the generalisability and applicability of the models requires larger samples to be used in future research. Individual factors are important but the authors highlight that the implementation process is complex and involves both internal and external factors. Literature from other healthcare settings have been faster to adopt key concepts in organisational change management, and cognitive services ‘should no longer be presented in the absence of a clear framework’ for implementation. A documentation system to support pharmaceutical care of day-case oncology patients between hospital and community pharmacists Fisher et al. discuss ensuring that appropriate pharmaceutical care continues with increasing numbers of day-case cancer patients. The increa