The chapter on over-the-counter (OTC) drugs begins with a discussion of FDA regulations governing OTC products
OTCs
The chapter on over-the-counter (OTC) drugs begins with a discussion of FDA regulations governing OTC products and its classifications of the ingredients found in OTC preparations. Then the authors provide discussions of many of the major categories of OTC products. The chapter covers OTC stimulants, weight-control drugs, sedatives and sleep aids. In addition, detailed discussions of the pharmacology and use of analgesics including aspirin, acetaminophen and ibuprofen are included. The chapter concludes with a brief discussion of cold and allergy medications and ingredients commonly found in them.
Over-the-counter drugs are a big business in the United States. Americans spend in excess of $7 billion annually for OTC products. OTC drugs are those which are self-prescribed and self-administered for the relief of self-diagnosed illnesses. Sometimes the doctor may diagnosis someone and then they choose to use OTC’s for the ailment, but often, people just know what’s wrong with them, such as a headache and they go get headache medicine. Yet other times, they think they know and they may misdiagnosis themselves and then take medications that make it worse.
The OTC classification for many drugs did not take effect until 1938. These products are now regulated by the FDA which classifies them as being GRAS or GRAE. OTC drugs include stimulants, weight control products, sedatives, and other products. There is a question of allowing other stimulants to be allowed as OTC drugs, as well as psychoactive products. The only OTC stimulant allowed by the FDA is caffeine and there are many “look a likes.” PPA is the only drug in weight-control products, the others pass off as “health foods.”
For sleep aide alternatives they may try herbs like Gingko Balboa or OTC’s such as antihistamines, diphenydramine is the active ingredient in most products. Internal analgesics are a much-used OTC product. There are compounds that reduce pain. Different types of pain respond to different medications. However, when it comes to talking about herbs and natural remedies there are a lot studies showing that they do not do as much as we think, yet even in a blind study with placebos – individuals report that they have relief of pain. This just shows that mind over matter does indeed play a factor. So if we believe the vitamin or pill we’re taking is healing/helping us, then we will indeed begin to feel better. Not because the pill has any real healing properties, but because we believe it does. But that does not make it so that the herbs and pills work, yet, who’s to say!
By what mechanism does aspirin produce its effects? These are Salicylates and they are the most widely used class of internal analgesics. Aspirin has three major therapeutic uses to block somatic pain, as an antipyretic agent, and as an anti-inflammatory agent. Aspirin also has some negative side effects such as increased bleeding time, gastrointestinal bleeding, the number of viruses produced in sufferers of colds, and accidental poisoning in children under five years of age. Aspirin use by children is related to the potentially lethal Reye’s syndrome. Aspirin is the oldest internal analgesic, but newer drugs are taking part of the market.
Acetaminophen is as effective as aspirin in reducing pain but can result in fatal liver damage. Ibuprofen is the ingredient in other new pain-relieving drugs. More products of this nature can be expected in the future. Tylenol and Datril are examples of drugs which include acetaminophen. Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID). It is used to reduce fever and treat pain or inflammation caused by many conditions such as headaches, toothache, back pain, arthritis, menstrual cramps or minor injury. Ibuprofen can increase your risk of fatal heart attack or stroke, especially if you use it long term or take high doses or have heart disease. Do not use this medicine just before or after heart bypass surgery. It may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using ibuprofen while you are using ibuprofen, especially in older adults.
Taking ibuprofen in the last three months of pregnancy may harm the unborn baby. They do not really know if it passes into breast milk or it could affect a nursing baby. Do not ever give ibuprofen to a child younger than two years old, preferably over six with doctor’s direction.
When taking ibuprofen regularly check with your doctor and watch for signs of stomach bleeding, blood in stool, coughing up blood. Liver problems can cause nausea, upper stomach pain, itching, tired feeling, flu-like symptoms, loss of appetite, dark urine, clay colored stools, jaundice. Sometimes it results in fatal liver damage. Kidney problems include little or no urinating, or painful urination. Some signs are swelling in feet or ankles, tired and short of breath. Anemia can also occur, skin reactions, blurry, or burning eyes. More side effects of ibuprofen can include bloating, gas, diarrhea or constipation. Watch for dizziness, nervousness, ringing in your ears.
Almost everyone suffers from a cold some time, and all treatment is symptomatic. The common cold is caused by anyone of many viruses. Interferon has been used with good results in the prevention of cold symptoms. Colds are not completely preventable, but there are ways to reduce the chances of getting them. Transmission of colds is more likely via one’s hands than through one’s nose or mouth. Choosing the correct OTC drug may mean reading the labels and doing comparisons.
OTC drugs have sales in the billions of dollars. People keep literally dozens of OTC medicines in their homes. We constantly see advertisements and commercials in magazines and television. Children’s medications are flavored so they will like taking them. It seems we may be a society of people who look forward to taking pills and medications and whatever else we think is going to be “good for us.”
Other related issues include the idea that Reye’s syndrome in children can be caused by aspirin, but this is not really known to be entirely true. The disease appears to be more likely to occur when children with influenza or chickenpox take aspirin. There is currently a debate whether a warning label should be placed on aspirin containers.
Nutritional supplements do not fall under the same regulations as OTC drugs because they are for nutritional purposes Yet some nutritional supplements are alleged to perform astounding feats such as helping one to lose weight while sleeping! Sounds pretty silly doesn’t it? Or the claims to bring back or save your memory, or to make you stronger, happier and so on.Some believe that there should be better regulations on these supplements.
No matter what you need to take or what you want to take or what the reasons are, pills, medications, supplements are here to stay. People are always looking to feel better, look better and so on, so just be careful, read the labels, do your research and check for interactions and possible reactions. It is not always necessary to use supplements either, there are natural foods and exercises that can help with these matters.
Opioids
The chapter on opiates begins with a rather detailed discussion on the history of opium, morphine and heroin. This discussion includes the history of use, regulations and development, legal and illegal trade for each of these drugs. In addition, the history of addiction and treatment and strategies are considered. Eras during which interesting and unique contributions to these topics were made such as the opium wars and the Vietnam War years as well as some current considerations are included. The section on the pharmacology of the narcotics includes the chemical characteristics and mechanisms of action of these drugs. The chapter ends by considering addiction from the viewpoints of abuse, patterns, toxicity of the drugs and treatment strategies.
Heroin, morphine and other opiates trace their origins to a single plant- the opium poppy.
Cultivation of the plant dates back to the earliest years of human civilization, and opium use was well known in ancient Mesopotamia. The narcotic drug has been used both recreationally and as a medicine for centuries. Opium derivatives including morphine became widely used pain relievers, particularly in the 1800’s. Heroin also was first synthesized for medical use before physicians realized its potent addictive properties.
OPIATES TIMELINE
3400 B.C. – Opium poppy is cultivated in lower Mesopotamia. The Sumerians refer to it as Hul Gil, the “joy plant”. The Sumerians would soon pass along the plant and its euphoric effects to the Assyrians. The art of poppy culling would continue from Assyrians to the Babylonians who in turn would pass their knowledge onto the Egyptians.
1300 B.C. – In the capital city of Thebes, Egyptians begin cultivation of opium thebaicum, grown in their famous poppy fields. The opium trade flourished during the reign of Thutmose IV, Akhenaton and King Tutankhamen. The trade route included the Phoenicians and Minoans who move the profitable item across the Mediterranean Sea into Greece, Carthage and Europe.
1100 B.C. – On the island of Cyprus the “peoples of the sea” craft surgical-quality culling knives to harvest opium, which they would cultivate, trade and smoke before the fall of Troy.
4600 B.C. – Hippocrates, the “father of medicine”, dismisses the magical attributes of opium but acknowledges its usefulness as a narcotic an styptic in treating internal diseases, diseases of women and epidemics.
330 B.C. – Alexander the Great introduces opium to the people of Persia and India.
400 A.D. – Opium thebaicum, from the Egyptian fields of Thebes, is first introduced to China by Arab traders.
1300’s A. D. – Opium disappears for two hundred years from European historical record. Opium had become a taboo subject for those in circles of learning during the Holy Inquisition. In the eyes of the Inquisition, anything from the East was linked to the Devil.
1500 A.D. – The Portuguese, while trading along the East China Sea, initiate the smoking of opium. The effects were instantaneous as they discovered but it was a practice the Chinese considered barbaric and subversive.
1527 A.D. – During the height of the Reformation, opium is reintroduced into European medical literature by Paracelus as laudanum. These black pills or “Stones of Immortality” were of opium thebaicum, citrus juice and quintessence of gold and prescribed as painkillers.
1600’s – Residents of Persia and India begin eating and drinking opium mixtures for recreational use.
Portuguese merchants carrying cargoes of Indian opium through Macao direct its trade flow into China.
1606 – Ships chartered by Elizabeth I are instructed to purchase the finest Indian opium and transport it back to England.
1680 – English apothecary, Thomas Sydenham, introduces Sydenham’s Laudanum, a compound of opium, sherry wine and herbs. His pills along with others of the time become popular remedies for numerous ailments.
1700 – The Dutch export shipments of Indian opium to China and the islands of Southeast Asia: The Dutch introduce the practice of smoking opium in a tobacco pipe to the Chinese.
1729 – Chinese emperor, Yung Cheng, Issues an edict prohibiting the smoking of opium and its domestic sale, except under the license for use as medicine.
1750 – The British East India Company assumes control of Bengal and Bihar, opium-growing districts of India. British shipping dominates the opium trade out of Calcutta to China.
1753 – Linnaeus, the father of botany, first classifies the poppy, Papaver Somniferum – “Sleep inducing”, in his book Genera Plantarum.
1767 – The British East India Company’s import of opium to China reaches a staggering two thousand chests of opium per year.
1793 – The British East India Company establishes a monopoly on the opium trade. All poppy growers in India were forbidden to sell opium to competitor trading companies.
1799 – China’s emperor, Kia King, bans opium completely, making trade and poppy cultivation illegal.
1800 – The British Levant Company purchases nearly half of all the opium coming out of Smyrna, Turkey strictly for importation to Europe and the United States.
1803 – Friedrich Sertuerner of Paderborn, Germany discovers the active ingredient of opium by dissolving it in acid then neutralizing it with ammonia. The result: alkaloids- Principium somniferum or morphine.
Physicians believe that opium had finally been perfected and tamed. Morphine is lauded as “God’s own medicine” for its reliability, long lasting effects and safety.
1805 – A smuggler from Boston, Massachusetts, Charles Cabot, attempts to purchase opium from the British, then smuggle it into China under the auspices of British smugglers.
1812 – American John Cushing, under the employment of his uncles’ business, James and Thomas H. Perkins Company of Boston, acquires his wealth from smuggling Turkish opium to Canton.
1816 – John Jacob Astor of New York City joins the opium smuggling trade. His American Fur Company purchases ten tons of Turkish opium then ships the contraband item to Canton on the Macedonian. Astor would later leave the China opium trade and sell solely to England.
1819 – Writer John Keats and other English literary personalities experiment with opium intended for strict recreational use- simply for the high ad taken at extended, non-addictive intervals.
1821 – Thomas De Quincey publishes his autobiographical account of opium addiction, “Confessions of an English Opium-eater”.
1827 – E. Merck & Co. of Darmstadt, Germany, begins commercial manufacturing of morphine.
1830 – The British dependence on opium for medicinal and recreational use reaches an all time high as 22,000 pounds of opium is imported from Turkey and India.
1837 – Lin Tse-Hsu, imperial Chinese commissioner in charge of suppressing the opium traffic, orders all foreign traders to surrender their opium. In response, the British send expeditionary warships to the coast of China, beginning the First Opium War.
1840 – New Englanders bring 24,000 pounds of opium into the United States. This catches the attention of U.S. Customs which promptly puts a duty fee on the import.
1841 – The Chinese are defeated by the British in the First Opium War. Along with paying a large indemnity, Hong Kong is ceded to the British.
1843 – Dr. Alexander Wood of Edinburgh discovers new technique of administering morphine, injection with a syringe. He finds the effects of morphine on his patients instantaneous and three times more potent.
1856 – The British and French renew their hostilities against China in the Second Opium War. – China is forced to pay another indemnity. The Importation of opium is legalized.
1874 – English researcher, C.R. Wright first synthesizes heroin or diacetylmorphine, by boiling morphine over a stove. – In San Francisco, smoking opium is banned and is confined to Chinatown opium dens.
Prior to 1890 laws concerning opiates were strictly imposed on a local city or state-by-state basis. One of the first was in San Francisco in 1875 where it became illegal to smoke opium only in opium dens. It did not ban the sale, import or use otherwise. In the next 25 years different states enacted opium laws ranging from outlawing opium dens altogether to making possession of opium, morphine and heroin without a physician’s prescription illegal.
The first Congressional Act took place in 1890 that levied taxes on morphine and opium. From that time on the Federal Government has had a series of laws and acts directly aimed at opiate use, abuse and control.
1906 – Pure Food and Drug Act
1909 – Smoking Opium Exclusion Act
1914 – The Harrison Act
1919 – Supreme Court ratified the Harrison Anti-Narcotic Act
1920 – Holding that doctors may not prescribe maintenance supplies of narcotics to people addicted to narcotics. But they could use it to wean them off of drugs.
1922 – Narcotic Drug Import and Export Act: To insure proper control of importation, sale, possession, production and consumption of narcotics.
1924 – Heroin Act: Prohibited manufacture, importation and possession of heroin illegal.
1932 – Uniform State Narcotic Act
1938 – Food, Drug and Cosmetic Act
1951 – Boggs Act: Criminal penalties imposed for violations of import/export of drugs, with mandatory prison sentences
1956 – Narcotics Control Act
1965 – Drug Abuse Control Amendment: To deal with problems caused by abuse of depressants, stimulants, hallucinogens. Restricted research into psychoactive drugs such as LSD.
1970 – Controlled Substance Act: Controlled Substances Import and Export Act
1973 – Drug Enforcement Agency: The DEA was formed by Executive Order
1974 – Narcotic Addict Treatment Act of 1974
1986 – Anti-Drug Abuse Act
1988 – Anti-Drug Abuse Act: Here’s the school based drug prevention program efforts.
2000 – The Drug Addiction Treatment Act
2004 – The Confidentiality of Alcohol and Drug Abuse patient records regulation and the HIPAA privacy rule:
2005 – Public Law 109-56, Amends the Controlled Substances Act.
2006 – President Bush signed the Bill H.R. 6344. For doctors to prescribe drugs for the treatment of opioid dependence.
2016 – HHS augments regulations concerning the 30/100 patient limit by raising it to 275.
There you have it, a basic timeline on the rise, fall, rise, fall, rise of Opiates! And the story continues.
NARCOTIC ADDICTION
Addiction increased as a result of opiates in patent medicines, development of hypodermic needle, importation of Chinese laborers, and use during the Civil War. Physician’s dispensed opiates a great deal in their practice and this too contributed to high rates of opiate addiction. The 1914 Harrison Act curtailed legal use of narcotics by addicts by limiting access and eventually eliminating access to addicts. Narcotic addiction went from being a medical problem to a legal problem. The typical opiate addicts were women, ages 30 to 50 years old. You can guess why!
This all changed after the Harrison Act, addicts were viewed as degenerate, vile individuals rather than as poor people worthy of sympathy.
After WWII, heroin use increased in slum areas of large cities: gradually prices increased and quality ceased. During the Vietnam conflict thousands of service personnel in Southeast Asia were using heroin: Many of them were addicts. After returning to the United States almost all heroin use by veterans stopped,…. almost. Some of them were treated and detoxed in hospitals state side, but some could not stop and even became homeless because of it.
Pharmacology of narcotics: Heroin is capable of penetrating the blood brain barrier more easily than morphine, thus making heroin more potent. Synthetic narcotics such as fentanyl and sufentanyl are vastly more potent. Narcotic antagonists such as naloxone and naltrexone block the action of narcotics. Enkephalins and endorphins are morphine like substances which are naturally present in the brain. These drugs are used primarily with surgical anesthesia. Antagonists can reverse the depressed respiration resulting from a narcotic overdose. Endorphins have been linked to the so-called runner’s high.
Benefits and drawbacks of narcotics: The major benefit of narcotics is that they reduce the physical and emotional response to pain. Tolerance to narcotics occurs although some of the tolerance may be learned. Physical and Psychological dependency results from prolonged narcotic use and cross dependency among narcotics can occur. Some narcotic users are so-called needle freaks who simply like the rush derived from injecting; nausea and vomiting are the most common reaction to shooting narcotics into the veins. Another major issue with narcotics is that they depress the respiratory centers in the brain and death can follow if enough of it is used.
Unclean needles can represent another danger, since hepatitis and AIDS can be contracted though the use of sharing needles with others who are infected. HIV/AIDS refers to a set of symptoms and illnesses that occur at the final stage of HIV infection. Human immunodeficiency virus infection and acquired immune deficiency syndrome otherwise known as HIV/AIDS.
2.1 million children worldwide are living with HIV. Most of these children were infected by their HIV positive mothers during pregnancy, childbirth or breast feeding. There are approximately 36.7 million people worldwide living with HIV/AIDS. Yet, only 60% of them know that they have it, the rest are out spreading it around, though unprotected sex and dirty needles.
Withdrawal symptoms are not the excruciating experience the media portrays them to be. It’s more like bad flu symptoms with nausea, diarrhea, sweats and discomfort in the bones. New derivatives of opiates, such as China White are synthetic heroin that have even worse consequences than the original drug.
Therapeutic approaches to narcotic addiction were established in Lexington Kentucky and Fort Worth Texas. There is methadone, buprenorphine, 12 step programs and naltrexone. Naloxone is used for overdose, parents and loved ones are encouraged to carry this with them.
In 2013 opioid use disorders affected about .4% of people. About 16 million people have been affected at one point in time. It resulted in 122,000 deaths worldwide in 2015, up from 18,000 deaths in 1990. In the United States in 2015 there were 33,000 deaths due to rug overdose involving opioids. Of those 33,000 deaths, about 15,000 were from prescribed opioids and 13,000 from heroin.
As we can see, opioids, morphine, heroin has a very long and difficult history. It has been the source of pain and troubles for many people throughout the years. Likewise, it’s been a source of pleasure, a cure a dream. It’s highly addictive and will destroy a family in no time. Yet, save a life. This is certainly not a drug to take lightly or be tampered with.
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Answer preview to the chapter on over-the-counter (OTC) drugs begins with a discussion of FDA regulations governing OTC products
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