4 questions | Applied Sciences homework help

1. Gellert G, Maxwell RM, Siegel BS. Survival of breast cancer patients receiving adjunctive psychosocial support therapy: A 10-year follow-up study. Journal of Clinical Oncology 11:66–69, 1993.

Drug ProDucts The desire to take medicine is perhaps the greatest feature which distinguishes man from animals. Sir William OSler No drug is perfectly safe. Any drug powerful enough to do good is powerful enough to do harm. mOrtOn mintz the therapeutic nightmare Chapter OnePart Five Chapter Seventeen

© AARON BACALL

Part Five Other Products and Services350 or controlling diseases. They include common remedies such as pain relievers, antacids, laxatives, and cough and cold remedies, which consumer can purchase off the shelf at drugstores, supermarkets, and many other retail outlets or from online sources. A few nonprescription products are behind-the- counter (BTC) drugs, which require authorization by the pharmacist. The Combat Methamphetamine Epidemic Act of 2005 banned OTC sales of cold medicines that contain pseudoephedrine and similar ingredients that can be used to illegally manufacture methamphetamine (an addictive drug). But pharmacists can dispense limited quantities of pseudoephedrine from a locked cabinet or behind the counter to people who present photo iden- tification.1 Emergency contraception (Plan B), which is discussed in Chapter 19, is also available BTC to women 18 years or older, Under the Food, Drug, and Cosmetic Act, manufac- turers may not label or market drugs for uses that lack FDA approval. Except for products legally defined as controlled drugs, however, federal law does not limit how physicians may use approved drugs. Drugs can be marketed under a brand name or simplified chemical name of their active ingredient(s). New prescription drugs, which are marketed under brand names, are protected by patents. After the protection period ends, other manufacturers can copy and market a drug under its simplified chemical name or another brand name. Originally patents were good for 17 years from the early stages of the drug’s development. The federal Drug Price Competition and Patent Term Res- toration Act (1984) extended the protection for up to 5 more years to compensate for the time required to get FDA approval. The 1994 General Agreement on Tariffs and Trade (GATT) Act extended patent protection to 20 years from the time the manufacturer files for a patent. A

• Be sure to learn the name, purpose, dosage, and significant side effects of any drug prescribed for you and whether any special instructions must be followed.
• Ignore nonprescription drug advertising. Learn what ingredients are effective for the problem at hand and select products that contain those ingredients.
• Drug prices vary considerably, so shopping for the best price is prudent.
• A well-stocked “home pharmacy” will facilitate self-care of common problems.
• Trustworthy information about drugs is available in reference books and on Web sites.

KeeP these Points in MinD as You stuDY this chaPter Key Concepts This chapter focuses on common drug products and strategies for using them wisely. It explains the differences between prescription and non- prescription products, describes the training and profes- sional activities of pharmacists, states why generic drugs usually provide good value, describes how government regulation has improved the quality of nonprescription drugs, and recommends sources of comprehensive information about individual drugs. MeDication tYPes Two basic types of medications can be legally purchased in the United States: prescription (℞ ) drugs and nonpre- scription drugs. Drugs are used medicinally to produce specific intended effects (main effects). All other effects are called side effects. Adverse reactions are side effects that are considered serious or problematic. Prescription drugs can be prescribed by a physician or other designated health professional, such as a dentist, podiatrist, or nurse practitioner, and most commonly are dispensed by registered pharmacists. They are sometimes referred to as ethical or legend drugs. They require professional supervision because (a) they are generally more potent than nonsprescription drugs, (b) they pose a greater risk of adverse side effects, and (c) the conditions for which they are prescribed are generally unsuitable for self-treatment because expert knowledge is required for their diagnosis and management. By law, a pharmacist cannot fill or refill a prescription without an order from an authorized prescriber. There are two types of nonprescription drugs. The vast majority are over-the-counter (OTC) drugs which consumers can select as they wish. Most OTC products are intended for relieving the symptoms of relatively benign, self-limiting conditions rather than for curing Chapter Seventeen Drug Products 351 federal court ruling enables 94 drugs to qualify for both extensions (up to 25 years). When a patent expires, the original manufacturer may market a mid-priced generic version (“branded generic”) under a new brand name to compete with other generic versions.2 Drugs sold under their simplified chemical name are called generic drugs. FDA regulations require them to undergo limited testing to demonstrate equivalence to their brand-name counterparts. Generic drugs cost less—often considerably less—but some controversy exists over whether they actually are equivalent. Al- though their active ingredients are identical, their inert ingredients (e.g., binders, dyes, coatings) may affect their bioavailability (the proportion that enters the circulation and thus is available to have an active effect) and bio- equivalence. Different formulations of a drug are con- sidered bioequivalent if equal doses administered under similar conditions result in no significant difference in bioavailability. Bioequivalence is assumed to result in therapeutic equivalence (equivalent medicinal value). About 75% of prescriptions are for generic drugs. PharMacists Pharmacy is concerned with procuring, storing, dis- pensing, and using medications, related substances, and appliances. Pharmacists are also trained in methods of compounding and manufacturing drugs and testing them for purity and potency, although most of the items they dispense are compounded by drug manufacturers. The Accreditation Council for Pharmacy Education accredits about 90 schools and colleges of pharmacy in the United States. Two years of prepharmacy college work are required for admission. In 1992 the American Association of Colleges of Pharmacy recommended that pharmacy schools offer a 4-year doctor of pharmacy (Pharm.D.) curriculum for their entry-level degree. As of fall 2004, all U.S. pharmacy schools do so. The Pharm.D. program includes clinical practice under fac- ulty supervision. Pharmacists who wish to do research may obtain an additional master’s or Ph.D. degree. With specialized training and passage of an examination by the Board of Pharmaceutical Specialties, certification is available in nuclear pharmacy (use of radioactive drugs for diagnosis and therapy), nutrition support pharmacy, oncology pharmacy (cancer drug treatment), pharmaco- therapy, and psychiatric pharmacy. Pharmacists practice in community pharmacies, hospitals, clinics, extended care facilities, and nurs- ing homes. All states require a license as a registered pharmacist (R.Ph.) to practice pharmacy. This requires graduation from an accredited college of pharmacy, a prescribed period of internship (in most states), and passage of an examination given by the state board of pharmacy. There are about 250,000 pharmacists in the United States. About half the states have granted limited power to prescribe drugs, but the majority of eligible pharma- cists have not exercised this privilege. Pharmacy Technicians Pharmacy technicians help with activities not requiring the professional judgment of a pharmacist. They can help fill and label prescriptions and do many other administra- tive and clerical tasks. Educational programs are avail- able, but most states have no formal requirements for training. Certification by the Pharmacy Technician Cer- tification Board (PTCB), which requires a high school Figure 17-1. Pharmacist strikes a blow for public health. Adrian Thomas, owner of the Thomas Pharmacy in Meyersville, Pennsylvania, decided it was hypocritical to give health advice in one part of his store and sell health-destroying products in another. In 1992 he burned his entire tobacco inventory, along with his license to sell tobacco products. He told reporters he was tired of seeing his customers die of cancer and heart disease. Photo courtesy of Johnstown Tribune-Democrat. Part Five Other Products and Services352 diploma and passage of an examination, entitles use of the certified pharmacy technician (CPhT) credential. As of March 2011, 16 of the 42 states that regulate pharmacy technicians require PTCB certification. Problem Areas Most pharmacists who work in retail pharmacies have a serious potential conflict of interest. On the one hand, they are professionals, expected to be knowledgeable about drugs and to dispense them in a responsible and ethical manner. On the other hand, their income depends on selling products. Before the FDA’s OTC Drug Review drove most of the ineffective ingredients out of OTC drug products, few pharmacists protested or attempted to protect their customers from wasting money on prod- ucts that did not work. Today virtually all pharmacies carry irrationally formulated dietary supplements, and many stock dubious herbal and homeopathic products in addition to drugs. Pharmacists are also the only recognized health professionals who sell tobacco products, which cause more death and years of lost life than any other consumer products. Although many pharmacists have stopped sell- ing such products (Figure 17-1), others do not consider tobacco sales unethical. The American Pharmacists Association’s code of ethics does not state that pharma- cists have a duty to prevent dubious products from lining their shelves. A few states have laws against pharmacists selling ineffective products, but these laws have never been applied to the sale of nonprescription products. Although chain-store pharmacists do not control what gets placed on their shelves, they share responsibility for the fact that their profession as a whole has made little or no effort to oppose the marketing of irrational products. Pharmacy trade publications have suggested that “natural products” offer opportunities to make up for prescription drug revenues lost as a result of man- aged care and other cost-containment programs. A few companies have marketed elaborate systems in which pharmacists advise customers to buy supplement prod- ucts to replace nutrients that their prescription drugs are supposedly depleting. These companies also encouraged pharmacists to recommend supplements, herbs, and ho- meopathic products for many diseases.3 W. Steven Pray, Ph.D., D.Ph.,4 a professor at the Southwestern Oklahoma State University College of Pharmacy, has noted that nearly every communication channel through which pharmacists receive information about these products has portrayed them more favorably than they deserve. Name and dose of drug Signa (“Write on label”)

DEA# AB1234567

DEA number (required for controlled substances) Dosage form and number of dosage units Directions for use Number of refills permitted Dale Z. Smith, M.D. Medical Arts Building Anytown, US 12356 (803) 222-3330 naMe ____________________________ age __________ aDDress __________________________ Date _________ Refill ____ times Signature of practitioner Figure 17-2. Anatomy of a prescription. This one prescribes one tablet daily at bedtime of simvastatin (a drug to improve cholesterol levels). Simvastatin 20 mg Tabs #100 Sig: i hs Kyle Rogers 10/24/1120 University Ave. 29 2 Dale Z. Smith, M.D. Chapter Seventeen Drug Products 353 If asked directly whether an ineffective product is worthwhile, most pharmacists will answer to the best of their ability. However, many are poorly informed. In 1987 two pharmacy school professors sent a question- naire to 1000 pharmacists in the Detroit metropolitan area and received 197 responses. Among the 116 who identified their five most-common reasons for recom- mending vitamins or minerals, 66 (56%) listed fatigue and 57 (49%) listed stress.5 (Neither reason is valid.) Homeopathic products have no therapeutic value (see Chapter 8), but a study at the University of Minnesota School of Pharmacy published in 2006 found that only 26% of faculty members and 3% of senior Pharm.D. students considered homeopathy ineffective and 23% of faculty members and 35% of students said they had no opinion.6 Bruce Bouts, R.Ph., M.D.,7 an adjunct professor of clinical pharmacy at Ohio Northern University, has expressed concern about inappropriate compounding of drugs. Compounding (creation of a drug product by mixing ingredients) has legitimate uses and is most often done honestly at physician request. However, some compounding pharmacists are networked with “alternative” practitioners to provide products that lack scientific substantiation, and some compounders are marketing such products independently. Quality control is also a significant problem. Bouts advises consumers to avoid compounded products that are sustained-release, administered by injection or inhalation, or available in brand-name or generic form. The FDA8 advises against using compounded prod- ucts that are essentially copies of a commercially avail- able FDA-approved product. In 2007, the agency noted that since 1990 it had received reports of more than 200 adverse events involving 71 compounded products. PrescriPtion Drugs Prescriptions drugs are often used incorrectly by the patient, and many hospital admissions and deaths can be traced to drug-induced problems. Many people fail to fill prescriptions they receive, take doses that are too small or too large, take their medication at the wrong intervals, forget to take one or more doses, or discontinue medication too soon. Cramer and others9 studied the compliance of 26 epileptic patients who used special bottles equipped with a microprocessor that recorded when the bottles were opened and closed. Even though the patients had a serious disease and were closely monitored, they took an average of only 76% of their medication doses as prescribed. It is useful to know how to read a physician’s pre- scription. Figure 17-2 illustrates the typical format for prescriptions, and Table 17-1 provides the common abbreviations used by doctors. It is also helpful to be familiar with prescription labels and to understand them. Labels should state:

• Patient’s name • Physician’s name • Pharmacy name, address, and telephone number • Name of the medication • The number of units (tablets, capsules, ounces, etc.) • The amount of each active ingredient in each unit • How often and when to take the medication • How much to take each time • Any special instructions for use • Pertinent warnings regarding sedation or allergy • Number of refills permitted

When dispensing a generic drug, some pharmacists indicate which brand-name drug is equivalent. coMMon PrescriPtion abbreviations* Table 17–1 Latin ad libitum ante cibos bis in die capsule gutta hora somni per os post cibum pro re nata quaque 4 hora quaque die quater in die ter in die ut dictum

Metric units:

Quantity:

Abbreviation ad lib ac bid cap gt hs po pc prn q4h qd qid tid ut dict cc mg ml g i, ii, iii Meaning freely, as needed before meals twice a day capsule drop at bedtime orally after meals as needed every 4 hours daily four times a day three times a day as directed cubic centimeter milligram milliliter gram (1000 mg) 1, 2, 3 *The R in the symbol is an abbreviation of the Latin verb recipte, meaning “take thou.” The thou refers to the pharmacist. The “tail” on the R is a contraction of the sign of Jupiter. Thus the symbol is an order to the pharmacist to “take in the name of Jupiter,” with the physician invoking the name of Jupiter to ensure that the pharmacist does not make a mistake in carrying out the instructions. Part Five Other Products and Services354 generic vs branD-naMe Drugs Drugs may be identified by generic or brand name. The term generic refers to the name of the active chemical or chemicals in a drug. Generic names are written in lowercase letters. The brand name (trade name) is the manufacturer’s exclusive property, usually by reason of trademark rights. The first letter of a brand name is capitalized. Some drugs are marketed under only one brand name, whereas others are marketed under more than one. Brand-name manufacturers also market most of the generic drugs, whereas a few hundred smaller companies make the rest. The fact that identical drugs are marketed under different names is a potential source of confusion for consumers and possibly even for physicians. All drug products must meet FDA requirements for form, strength, route of administration, safety, purity, and effectiveness. The official standards of identity, strength, and purity are set forth in the United States Pharmacopeia and the National Formulary (USP-NF), which is continuously revised by experts. The compen- dium is published by the United States Pharmacopeial Convention, an independent organization that establishes officially recognized standards for medicines and related products. The 2009 update, USP32-NF27, contains more than 4000 monographs on drug substances and dosage forms for medicines and dietary supplements. Product labels sometimes contain the term USP or NF to indicate that the active ingredient meets USP or NF standards. Therapeutic equivalence is established by demonstrating bioequivalence. If the rate of absorption and the blood levels achieved are allowably close to those of a brand-name drug in the same dosage, a generic substance is considered bioequivalent. The Drug Price Competition and Patent Term Res- toration Act requires the FDA to expedite approval of generic drugs. To approve a generic drug for marketing, the FDA does not have to judge the safety and effective- ness of its active ingredient(s), since the same chemical substance(s) has already been approved for use in the drug’s brand-name counterpart. However, the FDA must test for and approve the bioequivalence of generic drugs. FDA officials state that properly evaluated generic drugs are therapeutically equivalent to their brand-name counterparts.10 More than 7500 different generic drugs have FDA approval. All states let pharmacists substitute a generic product if authorized by a physician. Some states require that when a generic version of a prescribed drug is available, it must be dispensed unless the physician’s prescription forbids substitution. Generic drugs are usually less expensive than brand- name drugs. Table 17-2 compares the retail prices of several commonly prescribed products. For consumers to realize savings it is necessary for doctors and phar- macists to make generic drugs available. Pharmacies pay less for generics than for brand-name prescription drugs, but they do not always pass these savings to the consumer; in some stores, consumers have paid higher coMParative cost oF coMMonlY PrescribeD branD-naMe anD generic Drugs Table 17–2 Brand Name Ativan Calan SR Flexeril Lasix Prozac Valium Zantac Zithromax Zocor Zovirax Drug Type or Purpose Antianxiety agent Calcium-channel blocker (for high blood pressure) Muscle relaxant Diuretic Antidepressant Antianxiety agent, muscle relaxant H2 blocker (for ulcers and acid reflux) Antibiotic Cholesterol-lowering agent Antiviral (for herpes infections) Generic Name lorazepam verapamil cyclobenzaprine furosemide fluoxetine diazepam ranitidine azithromycin simvastatin acyclovir Dosage Brand Generic 1 mg $105.12 $ 44.97 120 mg 89.97 49.97 10 mg 176.60 18.97 40 mg 57.97 16.20 10 mg 588.95 26.97 5 mg 321.95 13.95 300 mg 684.94 24.97 250 mg 915.92 285.99 40 mg 459.97 73.97 400 mg 603.30* 51.65* Price per 90 *prices are for 100 tablets. Source: Drugstore.com Web site, June 2011. Chapter Seventeen Drug Products 355 prices for generics. Because prices vary from store to store, it is advisable to shop for drugs. Many pharmacists are willing to quote prices over the telephone. Some manufacturers try to frighten consumers away from generics because brand-name drugs generally are priced higher and yield larger profits. These companies claim that generics are not as safe, that they don’t do the job as well and take longer to act, and that patients may suffer side effects. The FDA Consumer11 has reported that all of these claims are myths, and Consumer Re- ports has also criticized this tactic. However, authorities generally agree that if a generic drug is used over a long period and appears to be working, it is best to not switch to another source when refilling the prescription. Using a single brand will avoid the possibility of potency varia- tion from one manufacturer to another. Drug interactions Two or more products taken at the same time may inter- fere with each other’s absorption into the bloodstream, distribution within the body, metabolism (biochemical reactions), or excretion.12 A drug may also multiply the effect of another drug. For example, aspirin increases the clot-preventing ability of anticoagulants and can cause someone on anticoagulant therapy to have a hemorrhage. Thousands of people who combine alcohol with other drugs are treated in hospital emergency rooms yearly, and some die. Alcohol depresses the central ner- vous system, as do narcotics, barbiturates, tranquilizers, sedatives, and certain prescription painkillers. Alcohol causes drowsiness, and, depending on the amount con- sumed, can affect walking, talking, and driving. When mixed with another depressant drug, the combined effect may be greater than the sum of the two drug actions.13 Many OTC cough, cold, and allergy medicines con- tain antihistamines, and some also contain alcohol. When these products are taken with alcoholic beverages, they can increase drowsiness and be dangerous to someone driving an automobile or operating machinery. Other drugs with adverse interactions with alcohol include oral antidiabetic drugs, certain antibiotics, and certain classes of drugs used against angina pectoris (chest pain) and high blood pressure. Foods can interact with drugs, making them work faster or slower or preventing them from working at all. For example, the calcium in dairy products interferes with the absorption of tetracycline (an antibiotic), and carbonated beverages and fruit juices with a high acid content can cause some drugs to dissolve in the stomach rather than in the intestine. Grapefruit juice can block the action of certain en- zymes in the intestinal wall and liver that are needed to absorb and detoxify drugs. As a result, grapefruit juice increases the body’s absorption of certain drugs and slows their breakdown in the liver, causing the drugs to have higher-than-desirable blood levels and remain longer in the body. More than 30 commonly prescribed drugs carry a warning not to consume grapefruit or grapefruit juice when using them. The Grapefruit-Drug Interactions Web site (www.powernetdesign.com/grape- fruit) has comprehensive information on this topic. Many herbs and dietary supplements can have unfavorable interactions with drugs. The most notable include St. John’s wort, vitamin E, ginseng, and ginkgo biloba.14 An interaction checker is available to subscrib- ers to the Natural Medicines Comprehensive Database www.naturaldatabase.com and ConsumerReportsHealth. org. Patients can minimize the likelihood of taking an ad- verse combination of products by telling their physician when they are taking drugs (including herbal products) from another source and by carefully following the directions when using any drug product. Drug recalls Drug recalls are actions taken by a manufacturer to remove a product from the market. Recalls may be con- ducted on a firm’s own initiative, by FDA request, or by FDA order. Since 1997, the FDA has banned or restricted distribution of more than a dozen popular drugs. In some cases, widespread use led to the discovery that they could cause severe adverse effects that had not been detected during the research before the FDA approved the drug for marketing. In others, problems arose because doctors ignored safety warnings and prescribed them for patients who did not meet appropriate criteria. Drug recalls are listed at www.recalls.gov. In a 1999 interview, FDA Commissioner Jane Henney, M.D., advised consumers that if a doctor wishes to switch them to a newly marketed drug, they should ask how it is different and indicate that just being new is not sufficient reason.15 counterFeit Drugs The FDA has expressed concern about a rise in the num- ber and sophistication of drug counterfeiting operations. Since 2000, the agency has investigated more than 20 per year, a sharp increase from an average of 5 per year —Text continued on page 358 Part Five Other Products and Services356 6 Historical Perspective The “Evolution” of Patent Medicines Patent medicines were also known as nostrums and pro- prietary medicines. Nostrums are remedies recommended by their preparers without scientific proof of effectiveness. Strictly speaking, patent medicines are those for which patents have been obtained from the U.S. Patent Office to deter other manufacturers from copying them. (A patent permits a monopoly for at least 17 years.) However, many products referred to as “patent remedies” were actually not patented. A proprietary medicine is one whose name, composition, or manufacturing process is protected from use by competitors. Thousands of patent medicines were produced and distributed in the United States, with sales reaching their peak during the 19th century and part of the 20th century. The 19th century has been called the “patent medicine era” because of the extensive variety of materials sold to the public. Toxic substances could be legally marketed. Some products were said to be for specific ailments, whereas others were supposedly cure-alls. They were claimed to affect afflictions such as “female weakness,” “worn-out kidneys,” yellow fever, goiter, cancer, paralysis, and “piles” (hemorrhoids). Tonics, bitters, and other sub- stances were widely used, but their ingredients were kept secret. The worse a product tasted, the greater its curative powers were assumed to be. Many of the products were neither helpful nor toxic, but some were as hazardous as the ministrations of the doctors practicing “heroic” medicine of the period. Whiskey was considered the all-purpose remedy on the frontier. It was used as an antiseptic, painkiller, and courage builder. Tonics and cough medicines were popular because of their alcoholic content, as illustrated by these products: Hood’s Sarsaparilla (18%), Hotstetter’s Bitters (44%), and Parker’s Tonics (42%). Most hard liquors today are about 40% to 45% alcohol. The home-remedy books of this era promoted pat- ent medicines as well. These volumes included Indian Doctor’s Dispensatory, Dr. John Williams’ Last Legacy, A Useful Family Herbal, Dr. Chase’s Recipes, Gunn’s Do- mestic Medicine, and Poor Man’s Friend in Pain and Sick- ness. Most patent remedies had ingredients derived from the leaves, flowers, seeds, bark, and roots of plants. Notable Promoters and Remedies In 1796 Samuel H.P. Lee, a doctor from Windham, Con- necticut, became the first American to prepare a patent medicine, which he called Bilious Pills. The ingredients were gamboge, aloe, soap, and nitrate of potassium. The pills supposedly would cure biliousness (indigestion attrib- uted to too much bile production), yellow fever, jaundice, dysentery, dropsy (edema), worms, and female complaints. The patent medicine business was very lucrative. Thomas W. Dyott, king of America’s nostrum makers, marketed products that contained large amounts of alcohol. He assumed the title of M.D. and fabricated experience as a doctor. By 1830 his income was $25,000 per year, which was a fortune at that time. During the early 1800s Samuel Thomson, a New Hampshire farmer, devised a treatment system intended to make people their own physicians. He believed that the diminished “power of heat” and water caused an imbal- ance of body elements. The cure was to restore heat with a 30-minute steam bath, which was followed by washing the body with cold water, taking a powerful vomitive con- taining herbs mixed in brandy, drinking warm water until vomiting occurred, taking another bath, resting in bed, and taking two herbal enemas.16 This treatment was repeated for several days. Thomson was labeled “the sweating and steaming doctor.” The idea of cleaning out the patient’s system and strengthening the patient with tonics was common to both orthodox and folk medicine at that time and is still common among nonscientific practitioners and products today. Lydia E. Pinkham’s Vegetable Compound was advertised in 1873 for female weaknesses, irregular menstruation, inflammation, and ulceration of the womb. The Bureau of Investigation of the American Medical As- sociation could find no medical evidence to support these claims. The compound originally contained 18% alcohol. Eventually vitamins and minerals were added and the alcohol content was reduced. The company appealed to women disenchanted with their doctors by suggesting that the grandmotherly Mrs. Pinkham was compassionate and understood their needs. The Pinkham Guide for Women, a publication important to the product’s success, had over 1 million copies distributed. In 1890 Dr. Samuel Brubaker Hartman produced Pe- runa, which he claimed could cure catarrh (mucus buildup) of the lungs; disorders of the stomach, head, kidneys, blad- der, and pelvis; and other conditions. Peruna contained 25% alcohol. For 25 years no other patent medicine in the United States devoted as much newspaper space to testimonials. Rampant Narcotic Use Brecher17 described 19th-century America as a “dope fiend’s paradise.” Opium was sold legally at low prices. Morphine was commonly used, and heroin was marketed toward the end of the century. These opiate (narcotic) drugs could be purchased as easily as aspirin is today. Physicians dispensed them in prescriptions, drugstores sold them over the counter, grocery and general stores made them available, and they could be ordered by mail. More than 600 patent medicines and other products Chapter Seventeen Drug Products 357 The “Evolution” of Patent Medicines — Cont’d. contained opium. They were widely advertised in news- papers and on billboards as effective against pain, cough, and other problems. Physicians prescribed them for pain, cough, diarrhea, and other illnesses for which they actu- ally were effective. Opiates were also used as a substitute for alcohol. They apparently helped to calm rather than excite the baser passions and hence were considered less conducive to violent or criminal behavior. Many physi- cians converted alcoholics into narcotic addicts because morphine addiction was thought to be far less damaging than chronic alcoholism. During the Civil War, men who had been injured in battle were given large doses of opium to ease their pain. Soldiers often left hospitals cured of their wounds but addicted to opiates. This affliction acquired the name “soldier’s sickness.” However, addiction was more wide- spread among civilians. Federal narcotics laws passed after the turn of the century ended the inclusion of opiates in nonprescription remedies (see Chapter 25). Marketing Strategies Advertising played an important role in the patent medi- cine business. By 1860 there were 4000 newspapers, in- cluding 400 dailies. By 1900 there were 100 magazines in production. In 1804 about 100 patent medicines were marketed. By 1858 more than 1500 were advertised, not only in newspapers and magazines but also on handbills, buildings, steamboat decks, and the surfaces of rocks. During the 19th century no laws controlled advertis- ing, and product claims by manufacturers were never modest. The main advertising techniques included:

• Making the product’s name memorable: Burdock’s Blood Bitters, Swift’s Sure Specific.
• Distributing books and pamphlets giving medical advice.
• Using cures from afar (e.g., China, Turkey). • Stating that a product was a powerful remedy used by

the American Indians. • Invoking mythology (Hygeia, the Minerva pill for syphilis). • Indicating that diseases may cause pain and death. • Using biblical quotations and testimonials from ministers. • Using testimonials from supposedly satisfied cus- tomers. Some of these people later died from the disease the medicine was supposed to have cured.

• Using a doctor’s name or picture on the label. • Distributing free items such as an almanac or booklet;

offering a money-back “guarantee.” During this period, patent medicine promoters often met their customers face-to-face. They went to towns and villages, especially during fairs, setting up platforms, putting on shows, delivering spiels, selling their wares, and then moving on. The performances evolved into full evenings of drama, vaudeville, musical comedy, bands, parades, and other spectacles. This was all considered re- spectable, as were the sidewalk exhibits in store windows that lured young men to “free exhibits” inside, where they were terrified into believing they suffered from some strange disease. The men were then spirited into examining rooms, where “doctors” asked a few hasty questions and pressured them into buying secret remedies. Often the cost was the exact amount of money found in their wallets. Perhaps the greatest spectacle of the day was produced by John A. Healy and Charles Bigelow and their Kickapoo Indian Medicine Company.18 The entertainment consisted of Indians and Wild West performers who were profes- sional actors. Healy’s “liver pads” supposedly contained a mixture of roots, bark, gum, leaves, oils, and berries prepared by the Kickapoo Indians. Actually they contained sawdust, red pepper, and glue. Dudley J. LeBlanc, a Louisiana state senator, in- troduced Hadacol to the public in 1943. It was an elixir containing 12% alcohol, B-vitamins, iron, calcium and phosphorus, diluted hydrochloric acid, and honey. An 8- oz bottle sold for $1.25, and a 24-oz bottle cost $3.50. A pamphlet entitled “Good Health—Life’s Greatest Bless- ing,” produced by LeBlanc in 1948, contained testimonials by people supposedly cured of conditions such as anemia, arthritis, asthma, diabetes, epilepsy, heart trouble, and high and low blood pressure. It was also claimed that a 13-year-old boy who lacked the energy to ride his bicycle took Hadacol and became a center on his football team. LeBlanc revived the old-time medicine show. In 1950 a caravan of 130 vehicles, including steam calliopes, toured 3800 miles through the South. LeBlanc’s medicine troupe played one-night stands in 18 cities with an average of 10,000 people attending. Hadacol boxtops were accept- ed as admission to hear a Dixieland band play “Hadacol Boogie” and “Who Put the Pep in Grandma?” In August 1951, shortly after LeBlanc claimed sales of $75 million, he sold his business for $8 million plus a $100,000-a-year salary as sales manager. The new owners, however, soon filed for bankruptcy, charging that LeBlanc had concealed $2 million in unpaid debts and grossly inflated the amount owed from previous sales. The broad reach of medicine shows has given way to the even broader reach of radio and television. The spectacular productions have given way to talk shows and infomercials, and the products have been replaced by a myriad of questionable vitamin products, herbs, homeopathics, and exotic “dietary supplements.” Historical Perspective Part Five Other Products and Services358 through the late 1990s. Increasingly, these investigations have found well-organized criminal operations seeking to introduce finished drug products that may closely resemble legitimate drugs yet contain only inactive ingredients, incorrect ingredients, improper dosages, or subpotent or superpotent ingredients, or that may be con- taminated. In 2004 the agency issued a comprehensive report19 outlining the problem and steps to combat it. internet PharMacY sales Many Web sites sell prescription products directly to the lay public. Although these outlets may enable consumers to save money, it should not be assumed that prices are actually lower. In 1999 Bloom and Ian- nacone20 located 46 Web sites, 37 of which required a prescription or online physician consultation and 9 (located outside of the United States) that did not. The investigation also found that the two most commonly offered medications, Viagra (for impotence) and Propecia (for hair growth) cost 10% more than they did at five Philadelphia phar- macies. On the other hand, comparison shopping, par- ticularly for expensive drugs, may result in significant savings. Most online pharmacies operating in the United States are either established national chain pharmacies (or companies that have agreements to dispense through those pharmacies) or sites that offer only a limited number of “lifestyle” or “popular” prescription drugs. Many Web sites offer online consultations and do not require an original prescription. These sites are usually more expensive than local pharmacies and may not be staffed by competent practitioners. PharmacyChecker. com has noted that companies of this type may operate sites under many different names. The National Association of Boards of Pharmacy has developed a voluntary Verified Internet Pharmacy Practice Sites (VIPPS) program. To earn the right to display the VIPPS logo, companies must be appropriately licensed and have written policies and procedures for drug utilization review, patient counseling, patient confidentiality, and quality improvement programs. Buying from companies outside of the United States may be risky because the quality of the medications may not meet U.S. manufacturing standards. However, several reputable companies operate from Canada and Israel. The Consumer Tip box offers additional warnings and tips for buying drugs online. ® Buying Drug Products Online √ Consumer Tip Online pharmacies may offer lower prices, privacy, convenience, and access to more generic drugs. On the other hand, companies can be unlicensed, fail to protect your personal and financial information, and/ or dispense drugs that are inappropriate or dangerous. The following strategies can help to protect you. Precautions • Purchasing from an illegal Web site is risky. You may receive a contaminated or counterfeit product, the wrong product, an incorrect dose, or no product.

• Getting a prescription drug by filling out a question- naire without seeing a doctor poses serious health risks. A questionnaire does not provide sufficient information for a health-care professional to deter- mine if that drug is for you or safe to use, if another treatment is more appropriate, or if you have an underlying medical condition for which using that drug may be harmful.
• Don’t buy from sites that offer to sell prescription drugs without a prescription.
• Don’t do business with sites that have no access to a registered pharmacist to answer questions.
• Avoid sites that do not identify with whom you are dealing and do not provide a U.S. address and phone number to contact if there’s a problem.
• Prices can change quickly. Temporary lowball prices are common to attract new customers.
• Look for privacy and security policies that are easy to find and understand. Don’t provide any personally identifiable information (Social Security number, credit card, and health history) unless you are con- fident that the site will protect it. Make sure the site does not share your information with others without your permission.

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