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CORK Bibliography: Over-the-counter Drugs



94 citations. 1999 to present

Prepared: June 2008



Acocella CM. Using diaries to assess nonprescription drug use among university students. Journal of Drug Education 35(4): 267-274, 2005. (8 refs.)

Nonprescription drug use among university students was investigated using survey and behavioral diary methodologies to assess usage of nonprescription drug use and to compare survey and diary methodologies. Surveys were completed by 183 students (136 females and 47 males) that asked how often they used nonprescription drugs and what those drugs were. Of these participants, 61 (53 females and 8 males) voluntarily completed behavioral diaries for nonprescription drug use for a three week period. Survey data showed 83.1% of participants used nonprescription drugs in the past week, with pain relievers being the most common drug used. There was a significant correlation between the number of times participants reported using nonprescription drugs on the surveys and what the participants reported in their diaries, with no differences in the mean number of uses between survey and diary. This indicates that participants can recall information about their medication-taking behavior with some accuracy. Behavioral diaries were also able to show some of the misuse that is associated with using nonprescription medications. In most cases of misuse, too large a dose was taken. Students should be provided with information about the possible long- and short-term effects of these medications.

Copyright 2005, Baywood Publishing Co.


Akram G; Roberts K. Pharmacists' management of over-the-counter medication requests from methadone patients. Journal of Substance Use 8(4): 215-222, 2003. (32 refs.)

Aim: To determine how pharmacists respond to requests for over-the-counter (OTC) medicines by patients on a methadone maintenance programme. Design: Postal self-administered questionnaire distributed to all Greater Glasgow Health Board (GGHB) pharmacies. Participants: Community pharmacists involved in the GGHB methadone maintenance programme. Findings: Pharmacists are consulted most frequently for advice about colds/flu and gastrointestinal symptoms. Analgesics (by specific brand) were found to be the most often requested OTC product. Most requests (either for advice or sale of a product) were dealt with personally by the pharmacist. In most instances, pharmacists were suspicious of these requests and were reluctant to make a supply. The most common product for which sales were refused was Nytol (diphenhydramine), a sedative antihistamine. Although no statistical difference was found between gender, a greater proportion of those denying sales were female. However, no difference was found in pharmacist propensity to deny or allow a sale and their age (determined by year of registration). Conclusion: This study has given an insight into how community pharmacists deal with OTC medication requests and the nature of such requests. Pharmacists were found to be cautious when dealing with methadone patients, although requests for OTC products from this group were few in number.

Copyright 2003, Taylor and Francis Health Sciences


Almarsdottir AB; Grimsson A. Over-the-counter codeine use in Iceland: The impact of increased access. Scandinavian Journal of Public Health 28(4): 270-274, 2000. (11 refs.)

Background: The objective of this study was to test the assumption that liberalizing community pharmacy ownership in Iceland would lead to increased irrational use of over-the-counter pain relievers containing codeine. Methods. Based on this assumption we built and tested a model using an interrupted time series design that contrasts the monthly sales data for over-the-counter pain relievers containing codeine before and after the legislation took effect. Results: The total use of over-the-counter pain relievers containing codeine as well as those containing paracetamol and codeine has risen steadily throughout the period under study. The interrupted time series did not show a substantial effect From the legislative change on the use of all over-the-counter codeine pain relievers, paracetemol with codeine, and aspirin with codeine combinations. Conclusion: The assumption that increased access leads to irrational use of over-the- counter medicines is not substantiated in the case of over-the- counter pain relievers containing codeine.

Copyright 2000, Scandinavian University Press


Andersen A; Holstein BE; Hansen EH. Is medicine use in adolescence risk behavior? Cross-sectional survey of school-aged children from 11 to 15. Journal of Adolescent Health 39(3): 362-366, 2006. (32 refs.)

Purpose: To examine the association between smoking, drunkenness, and medicine use for headache, stomachache in getting to sleep, and nervousness in a representative sample of 11- to 15-year-old school-aged children. Methods: Design: Cross-sectional school-based survey. Setting: A random sample of schools in Denmark in 2002. Participants: All students in the fifth, seventh and ninth grades in these schools, n = 4824. Measurements: Self-reported medicine use for headache, stomachache, difficulties in getting to sleep, and nervousness within the last month; self-reported experience of drunkenness; self-reported smoking. Results: There was a strong and graded association between drunkenness and medicine use, even in models adjusted for the symptom for which the medicine was taken. There was a similar association between medicine use and smoking. Conclusions: The findings suggest that medicine use can be regarded as part of a cluster of risk behaviors among young people.

Copyright 2006, Society for Adolescent Medicine


Armstrong DJ; Chester N. IOC regulations in relation to drugs used in the treatment of respiratory tract disorders. IN: Mottram DR, ed. Drugs in Sport, 3rd edition. New York: Routledge, 2003. pp. 102-137. (78 refs.)

Drugs used to treat respiratory problems are of concern to both participants and those responsible for drug testing. This chapter will describe the pathophysiology of asthma, exercise-induced asthma and of coughs and colds. It will discuss the treatments of those conditions with reference to current British Thoracic Society (BTS) guidelines and to the IOC Regulations. It will also provide some historical background to the problems encountered by sportspersons as counsel to those who have used or might anticipate using these drugs, albeit inadvertently.

Copyright 2003, Routledge


Barat I; Andreasen F; Damsgaard EMS. The consumption of drugs by 75-year-old individuals living in their own homes. European Journal of Clinical Pharmacology 56(6-7): 501-509, 2000. (26 refs.)

Objective: To examine the drug consumption and the extent of polypharmacy (defined as daily intake of three or more drugs) among 75-year-old persons living in their own homes and to point out potential problems associated with it. Methods: Information on the intake of all drugs was collected from 492 subjects randomly selected. The subjects were interviewed at home, and their drug storage was examined. Information was also collected from the general practitioners (GPs) and from prescription databases. Database information comprised prescribed drugs used by the study population and the background population. Results: Eighty-seven percent of the study population received prescribed drugs and 72% used over-the-counter (OTC) drugs. Only 3% of the subjects did not take any drugs. Eighty percent of females and 60% of males used central nervous system (CNS) drugs, the most commonly used category. The subjects took on average 4.2 different prescribed drugs and 2.5 OTC drugs. Sixty percent used three or more prescribed drugs and 34% used five or more. Thirty percent used three or more OTC drugs. Seventeen percent had prescribed drugs not in use at the time of the examination in their drug storage. Twenty-five percent of the prescribed drugs were used without the GPs' knowledge. Thirty-one percent of the study population received prescribed drugs from two or more physicians. Potential drug interactions with clinical significance were found among 15.3% of the participants and were positively correlated to polypharmacy. Conclusion: Almost all 75-year-old persons receive drugs. The observed polypharmacy may increase drug-related risks. The discrepancies between the GPs' knowledge of their patients' medication and the actual intake may involve a potential risk. A better registration of the patients' total medication and the implementation of a common medication database for the use of all involved physicians may improve medication and reduce risks.

Copyright 2000, Springer-Verlag


Baume N; Mahler N; Kamber M; Mangin P; Saugy M. Research of stimulants and anabolic steroids in dietary supplements. Scandinavian Journal of Medicine & Science in Sports 16(1): 41-48, 2006. (38 refs.)

The purpose of this study was to analyze the composition of 103 dietary supplements bought on the internet. The supplements were dispatched in four different categories according to their announced contents [creatine, prohormones, "mental enhancers" and branched chain amino acids (BCAA)]. All the supplements were screened for the presence of stimulants and main anabolic steroids parent compounds. At the same time, the research was focused on the precursors and metabolites of testosterone and nandrolone. The study pointed out three products containing an anabolic steroid, metandienone, in a very high amount. The ingestion of such products induced a high quantity of metandienone metabolites in urines that would be considered as a positive antidoping test. The results have also shown that one creatine product and three "mental enhancers" contained traces of hormones or prohormones not claimed on the labels and 14 prohormone products contained substances other than those indicated by the manufacturer. The oral intake of the creatine product revealed the presence of the two main nandrolone metabolites (19-norandrosterone and 19-noretiocholanolone) in urine.

Copyright 2006, Blackwell Publishing


Bentur Y; Bloom-Krasik A; Raikhlin-Eisenkraft B. Illicit cathinone ("Hagigat") poisoning. Clinical Toxicology 46(3): 206-210, 2008. (37 refs.)

Introduction. Khat leaves (mainly cathinone and cathine) have been chewed for centuries as stimulants. Hagigat (capsules of 200mg cathinone) have been marketed in Israel as a natural stimulant and aphrodisiac. The consequences of illicit exposure to cathinone are reported. Methods. Prospective observational study of calls to the Poison Center regarding exposure to Hagigat during the course of 10 months. Demographic and clinical data were abstracted from patients' records and telephone follow up was performed. Results. Data of 34 consecutive patients aged 16-54 years were analyzed. The amount consumed was 1/2 - 6 capsules (ingestion - 32, sniffing - 2). Main clinical manifestations were headache, vomiting, hypertension, nausea, tachycardia, dyspnea, chest pain, and myalgia. Main complications were myocardial ischemia (3), pulmonary edema (2), and intracerebral hemorrhage (1), all in young subjects. Treatment was supportive; one patient underwent neurosurgery. Conclusion. Exposure to illicitly synthesized cathinone is associated with serious cardiovascular and neurological toxicity, even in young subjects.

Copyright 2008, Taylor & Francis


Black RA; Hill DA. Over-the-counter medications in pregnancy. American Family Physician 67(12): 2517-2524, 2003. (30 refs.)

Pregnant women commonly use over-the-counter medications. Although most over-the-counter drugs have an excellent safety profile, some have unproven safety or are known to adversely affect the fetus. The safety profile of some medications may change according to the gestational age of the fetus. Because an estimated 10 percent or more of birth defects result from maternal drug exposure, the U.S. Food and Drug Administration has assigned a risk category to each drug. Many drugs have not been evaluated in controlled trials and probably will not be because of ethical considerations. Of the commonly used over-the-counter medications, acetaminophen, chlorpheniramine, kaolin and pectin preparations, and most antacids have a good safety record. Other drugs, such as histamine H-2-receptor blockers, pseudoephedrine, and atropine/diphenoxylate should be used with caution. If use of smoking cessation products is desired, the intermediate-release preparations minimize the amount of nicotine while maintaining efficacy. With all over-the-counter medications used during pregnancy, the benefit of the drug should outweigh the risk to the fetus.

Copyright 2003, American Academy of Family Physicians.


Blank MD; Sams C; Weaver MF; Eissenberg T. Nicotine delivery, cardiovascular profile, and subjective effects of an oral tobacco product for smokers. Nicotine & Tobacco Research 10(3): 417-421, 2008. (17 refs.)

The tobacco industry markets potential reduced exposure products (PREPs) to smokers, including oral products that are intended to be used in situations where cigarettes cannot. For example, Ariva, marketed by Star Scientific, is a tablet made from compressed tobacco powder and is intended for "adult smokers in situations where they cannot or choose not to smoke." No objective data are available regarding Ariva's effects in smokers, including its nicotine delivery, cardiovascular profile, or subjective effects. In this single-session, clinical laboratory study, 10 overnight-abstinent cigarette smokers were administered one Ariva tablet, followed 90min later by two Ariva tablets, followed 90min later by three Ariva tablets. Participants allowed each dose to dissolve in their mouths according to package instructions. Blood was sampled, heart rate monitored, and subjective effects assessed regularly. Ariva delivered nicotine in a dose-dependent manner; mean (SD) nicotine levels increased from 2.4ng/ml (0.9) at baseline, to 3.4ng/ml (1.4) 45min post-1 tablet, 7.3ng/ml (4.0) 45min post-2 tablets, and 9.7ng/ml (4.4) 45min post-3 tablets. Heart rate increased after tablet administration, independent of dose. The tablets also significantly decreased subjective ratings of craving and urge, and increased ratings of nausea. Based on this short-term laboratory evaluation, Ariva exposes users to nicotine and may suppress some symptoms of tobacco abstinence, though its nausea-inducing characteristics may limit initial acceptability.

Copyright 2008, Taylor & Francis


Brewer C. Emergency naloxone for heroin overdose: Naloxone is not the only opioid antagonist. (letter). British Medical Journal 333(7571): 754-755, 2006. (3 refs.)

This letter is in response to the editorial in this journal by J Strang J, M Kelleher, D Best, S Mayet, V Manning, Emergency naloxone for heroin overdose, 333(7569): 714-715, 2006.

Copyright 2006, Project Cork


Broughan TA; Soloway RD. Acetaminophen hepatotoxicity. Digestive Diseases and Sciences 45(8): 1553-1558, 2000. (12 refs.)

To determine the influence of psychosocial factors in accidental and deliberate acetaminophen overdose, we reviewed the charts of 207 overdose patients, and 48 met our criteria for acetaminophen toxicity. Two patients died. A psychiatric history was present in 75%, and 25% had a previous or subsequent suicide attempt. A substance abuse history was elicited from 46%, and 36% of adolescent teenagers had a teen pregnancy. The mean time to starting N- acetylcysteine was 18.5 hr. Delayed N-acetylcysteine administration led to higher transaminase levels. Alcohol abuse was associated with a longer hospital stay. Mean AST was 8860 IU/liter in the accidental and 3013 IU/liter in the suicide groups. We concluded that management of acetaminophen toxicity can be optimized by early identification, obtaining a complete drug screen, starting N-acetylcysteine early or whenever toxic acetaminophen levels or elevated transaminases are identified, and referring patients with acetaminophen toxicity to a liver center.

Copyright 2000, Plenum Press


Burak LJ; Damico A. College students' use of widely advertised medications. Journal of American College Health 49(3): 118-121, 2000. (11 refs.)

The authors describe college and university students' use of widely advertised pharmaceutical products. Four hundred seventy-one students from three institutions completed self-administered questionnaires that addressed the use of advertised medications, attention to magazine ads for medications, communications with physicians about medications, and the conditions the medications address. Results indicated that the majority of the students used at least one of the advertised products. Most students did not discuss the pharmaceutical products with their physicians or discuss the conditions for which they reported they were taking the drugs.

Copyright 2000, Helen Dwight Reid Educational Foundation


Burton SL; Gitchesll JG; Shiffman S. Use of FDA-approved pharmacologic treatments for tobacco dependence: United States, 1984-1998. MMWR. Morbidity and Mortality Weekly Report 49(29): 665-668, 2000. (9 refs.)

This study estimates the number of quit attempts using FDA-approved pharmacologic aids during 1984-1998. The availability of new products and the availability of over-the-counter products has increased pharmacologically-assisted quit attempts. By 1998, the nicotine patch accounted for 49% of assisted attempts; nicotine gum, 28%; Zyban, 21%; and nicotine inhaler and nasal spray under 3%.

Public Domain


Byrne A. Emergency naloxone for heroin overdose - Over the counter availability needs careful consideration. (letter). British Medical Journal 333(7571): 754-754, 2006. (5 refs.)

This letter is in response to the editorial in this journal by J Strang J, M Kelleher, D Best, S Mayet, V Manning, Emergency naloxone for heroin overdose, 333(7569): 714-715, 2006.

Copyright 2006, Project Cork


Camacho A; Matthews SC; Dimsdale JE. Use of GHB compounds by HIV-positive individuals. American Journal on Addictions 13(2): 120-127, 2004. (29 refs.)

Gamma hydroxybutyrate (GHB) has been used by body-builders to enhance performance and by young adults in rave parties. Warnings have been posted about its addictive potential. The use of these dietary compounds is currently banned by the Food and Drug Administration, but they are widely available through the Internet and in certain communities. The purpose of the study was to examine the use of these compounds by HIV-positive individuals and to investigate their knowledge of the addictive potential of GHB and its related dietary compounds. One hundred HIV-positive individuals from the UCSD outpatient HIV clinic responded to an anonymous survey that inquired about their knowledge, use, and effects produced by GHB containing dietary compounds. The most common reported dietary compound beside GHB was Growth Hormone Release Extract (GHRE). Fifty-two percent of individuals reported using at least one GHB containing dietary compound. Gay subjects reported the highest use of GHB compounds (76.9%; p less than or equal to 0.001). The most common effect reported by users was increased energy (71%). Only 24% of the total responders knew about GHB's addictive potential. Among reported users of GHB containing compounds, fourteen (27%) knew about its addictive potential and nine (17%) knew that the compound is illegal. This study shows that HIV-positive gay individuals attending our clinic are using GHB compounds. Reported GHB users have limited knowledge about its addictive potential and serious adverse effects. More controlled studies are needed to evaluate long-term effects of dietary compounds containing GHB, especially among HIV-positive individuals who are actively receiving antiretroviral treatment.

Copyright 2004, American Academy of Psychiatrists in Alcoholism and Addictions


Canfield DV; Hordinsky J; Millett DP; Endecott B; Smith D. Prevalence of drugs and alcohol in fatal civil aviation accidents between 1994 and 1998. Aviation, Space, and Environmental Medicine 72(2): 120-124, 2001. (8 refs.)

Background: The use of drugs and alcohol in aviation is closely monitored by the FAA Office of Aviation Medicine's (OAM's) Civil Aeromedical Institute(CAMI) through the toxicological analysis of specimens from pilots who have died in aviation accidents. Method: Frozen specimens received from local pathologists were tested and the results entered into a computer database for future analysis. The data were sorted based on the class of drug, controlled dangerous substance schedules II, and I controlled dangerous substance schedules Ill-V, prescription drugs, over-the-counter drugs, and alcohol. Results: Specimens from 1683 pilots were analyzed between 1994 to 1998. Controlled dangerous substances, CDS, (schedules I and II)were found in 89 of the pilots analyzed. Controlled dangerous substances (schedules III-V) were found in 49 of the pilots tested. Prescription drugs were found in 240 of the pilots analyzed. Over-the- counter drugs were found in 301 of the pilots analyzed. Alcohol at or above the legal limit of 0.04% was found in 124 pilots. No abused drugs were found in Class 1 air transport fatal pilots. Conclusion: This research supports the very low incidence rate of drugs found in the FAA random drug-testing program. Over-the-counter medications are the most frequently found drugs in fatal aviation accidents and many of these drugs could impair a pilot's ability to safely fly an aircraft. This data is helpful to the FAA in developing programs to reduce the usage of dangerous drugs and identify potentially incapacitating medical conditions that may cause an accident. Data collected from this research can be used to evaluate the effectiveness of the FAA drug-testing program.

Copyright 2001, Aerospace Medical Association


Centers for Disease Control. Unintentional deaths from drug poisoning by urbanization of area -- New Mexico, 1994-2003. MMWR. Morbidity and Mortality Weekly Report 54(35): 870-873, 2005. (9 refs.)

New Mexico experienced an increase in poisoning deaths during the 1990s and in 2002 was the state with the highest death rate (14.1 per 100,000 population) from unintentional poisoning, more than twice the national rate (6.1). The majority of these unintentional poisoning deaths were caused by ingestion of drugs, including illicit, prescription, and over-the-counter drugs. New Mexico is geographically diverse, with communities ranging from urban centers to sparsely populated counties. Data from the New Mexico Medical Examiner was reviewed for 1994-2003, to ascertain any differences by the nature of the community. The analysis showed that deaths from illicit-drug poisoning were twice as likely to occur in metropolitan areas than nonmetropolitan areas. However, deaths from prescription-drug poisoning were most likely to occur in micropolitan areas. Decedent characteristics (e.g., sex, race/ethnicity, and drugs causing death) were analyzed, and age-adjusted drug-poisoning death rates per 100,000 population by urbanization of area were calculated for 1994--2003. Drugs causing death were categorized as illicit drugs (i.e., heroin, cocaine, or methamphetamine), over-the-counter drugs, or prescription drugs (i.e., methadone, other opioid painkiller, tranquilizer/muscle relaxant, antidepressant, barbiturate, or other prescription drug. During 1994--2003, a total of 1,982 drug-poisoning deaths were identified in New Mexico; data on four deaths did not include county of decedent residence. Statewide, 71.3% of decedents resided in metropolitan areas, 25.3% in micropolitan areas, and 3.4% rural. Compared with decedents from micropolitan and nonstatistical areas, a significantly larger proportion from metropolitan areas died from heroin overdose (52.6% versus 48.8% and 35.3%, respectively). However, a larger proportion from rural areas died from any prescription drug (50.0% versus 37.2% and 40.2%) or from opioid painkillers other than methadone (38.2% versus 19.6% and 22.8%). Illicit drug poisonings had the highest death rate (8.1 per 100,000 population), with a higher poisoning death rate from heroin than from cocaine or methamphetamine (5.8 versus 4.4 and 0.6). The death rate from any prescription drug was 4.4, with the highest rate among prescription drugs from opioid painkillers other than methadone (2.4). Metropolitan areas had the highest rates for all drug-poisoning deaths (12.6 versus 9.5 for micropolitan areas and 7.4 for nonstatistical areas), any illicit drug (9.0 versus 6.8 for micropolitan areas and 4.4 for nonstatistical areas), heroin (6.6 versus 4.7 for micropolitan areas and 2.6 for nonstatistical areas), and cocaine (4.8 versus 3.7 for micropolitan areas and 2.4 for nonstatistical areas). Metropolitan areas also had the highest death rates from methadone (1.6) and over-the-counter drugs (1.0). rural areas had the highest death rate from opioid painkillers other than methadone (2.8); micropolitan areas had the highest death rate from alcohol and drug cointoxication (3.7).

Public Domain


Centers for Disease Control; Burt A; Annest JL; Ballesteros. Nonfatal, unintentional medication exposures among young children -- United States, 2001-2003. MMWR. Morbidity and Mortality Weekly Report 55(1): 1-4, 2006. (10 refs.)

During 2001-2003, over 53,000 children age 4 and under were treated in hospital emergency rooms for unintentional exposure to prescription and over-the-counter medicaitons. Most of these occurred in the home. These children were nearly four times as likely to hospitalized or transferred for specialized care as other children in the same age group, treated for all unintentional causes of injury (9.7% versus 2.5%). Over-the-counter preparations represented 42%, and prescription medicatons 39%. The most common medications were central nervous sysem agents (e.g. acetaminophen). those most commonly involved in hospital admissions were anticonvulsant agents, calcium-channel-blocking, and antidepressant and mood-stabilizing agents. Data is summarized in three tables.

Public Domain


Chaturvedi AK; Craft KJ; Canfield DV; Whinnery JE. Toxicological findings from 1587 civil aviation accident pilot fatalities, 1999-2003. Aviation, Space, and Environmental Medicine 76(12): 1145-1150, 2005. (24 refs.)

introduction: The prevalence of drug and ethanol use in aviation is monitored by the Federal Aviation Administration (FAA). Under such monitoring, toxicological studies for the 1989-1993 and 1994-1998 periods indicated lower percentages of the presence of controlled substances (illegal drugs) than that of prescription and nonprescription (over-the-counter) drugs in aviation accident pilot fatalities. In continuation, a toxicological assessment was made for an additional period of 5 yr. Methods: Biosamples from aviation accident pilot fatalities submitted to the FAA Civil Aerospace Medical Institute (CAMI) are analyzed, and those findings are stored in a database. This database was examined for the 1999-2003 period for the presence of controlled substances (Schedules I-V), prescription/nonprescription drugs, and ethanol in the fatalities. Results: Out of 1629 fatal aviation accidents from which CAMI received biosamples, pilots were fatally injured in 1587 accidents. Drugs and/or ethanol were found in 830 (52%) of the 1587 fatalities. Controlled substances from Schedules I-II (SI-II) and Schedules III-V (SIII-V) were detected in 113 and 42 pilots, respectively. Prescription drugs were present in 315 pilots, nonprescription drugs in 259, and ethanol in 101. SI-II substances were detected in 5 of 122 first-class medical certificate-holding airline transport pilots. In addition to the controlled substances, many of the prescription/nonprescription drugs found in the fatalities have the potential for impairing performance. Conclusions: Findings from this study were consistent with those of two previous toxicological studies and support the FAA's programs aimed at reducing the usage of performance-impairing substances.

Copyright 2005, Aerospace Medical Association


Congeni J; Miller S. Supplements and drugs used to enhance athletic performance. (review). Pediatric Clinics of North America 49(2): 435-462, 2002. (141 refs.)

This article reviews current medical knowledge of nutritional supplements and drugs used to enhance athletic performance. The article reviews the physiology, clinical usage patterns, and efficacy, dosages, and adverse side effects of the use of drugs and supplements. It also discusses strategies for prevention of the use of drugs and supplements that can be harmful, The temptation is using these substances as short-cuts is very seductive to adolescents. Education is a key component in combating misinformation or lack of information about these drugs and supplements.

Copyright 2002, W.B. Saunders Co.


Crouch BI; Caravati EM; Booth J. Trends in child and teen nonprescription drug abuse reported to a regional poison control center. American Journal of Health-System Pharmacy 61(12): 1252-1257, 2004. (29 refs.)

Purpose. Trends in child and teen nonprescription drug abuse reported to a regional poison control center over a 10-year period were examined. Methods. Human exposures to toxic substances reported to the Utah Poison Control Center between January 1990 and December 1999 were reviewed. Cases were selected for analysis if the exposure involved a nonprescription drug, the patient was 6-19 years old, and the reason for exposure was intentional abuse. Frequencies and cross-tabulations were calculated to identify trends in nonprescription drug abuse. Results. There were 2214 reports of intentional drug abuse among children and teenagers 6-19 years old. Of those, 844 (38.1%) involved nonprescription drugs. The percentage of exposures involving nonprescription products varied every year and declined over time. Exposures were slightly more common in males (51.7%). The site of exposure was a residence in 65% of cases and a school in 10% of cases. The majority of patients with exposures (68.4%) were treated in a health care facility. The most common types of nonprescription medications abused were drugs with anticholinergic properties, caffeine, dextromethorphan, and nonprescription stimulants. Conclusion. Reports of the intentional abuse of nonprescription drugs by children and teenagers were common at a regional poison control center. There was significant variation in the type of nonprescription medication most commonly abused. The knowledge of these trends may assist public health policymakers, physicians, pharmacists, and child educators in their attempts to curb nonprescription drug abuse.

Copyright 2004, American Society of Health-Systems Pharmacists


Dart RC. The use and effect of analgesics in patients who regularly drink alcohol. American Journal of Managed Care 7(19 Supplement): S597-S601, 2001. (15 refs.)

Analgesic consumption poses special risks for regular users of alcohol. Among the numerous adverse health effects are acetaminophen toxicity and gastrointestinal (GI) bleeding associated with nonsteroidal anti-inflammatory drug (NSAID) use. An alcohol- acetaminophen hypothesis contends that alcohol enhances acetaminophen toxicity. Because 22% of adults use acetaminophen each week and 5% to 10% of the population is alcoholic, the healthcare implications of serious adverse interactions are considerable. However, such interactions are rare when NSAID doses remain in the therapeutic range. Although clinical studies fail to support anecdotal case reports of liver damage associated with consumption of therapeutic doses of acetaminophen by alcohol users, such reports are probably inaccurate because of the uncritical acceptance of patient history by the clinician and a lack of well-designed prospective trials. Over- the-counter (OTC) NSAIDs, such as aspirin, naproxen, and ketoprofen, are other analgesic options, but each carries the risk of Gl bleeding. Unanswered questions about the newer "second-generation" NSAIDs, such as celecoxib and rofecoxib, make them less desirable than acetaminophen and OTC NSAIDs. Because the risk of GI bleeding or ulceration may be higher in alcoholic patients, the optimal strategy in prescribing pain relievers to those who consume alcohol is to use I drug at a time and to clearly communicate its generic name. Acetaminophen is the safest OTC analgesic and is recommended as first-line treatment for osteoarthritis. OTC NSAID users should be carefully advised as to recommended dose, and all patients should be reminded to stay within the dosing limits regardless which OTC analgesic is used.

Copyright 2001, American Medical Publishing, LLC


Desai S; Aldea D; Daneels E; Soliman M; Braksmajer AS; Kopes-Kerr CP. Chronic addiction to dextromethorphan cough syrup: A case report. Journal of the American Board of Family Medicine 19(3): 320-323, 2006. (12 refs.)

Background: Serious drug abuse and addiction related to dextromethorphan-containing cough preparations has been a problem in the United States since the 1950s, but few physicians are aware of it. Physicians must be alert to the type of substances and quantities used and misused by patients in obtaining a thorough routine history of over-the-counter medication use. Methods: We describe the case of a 66-year-old clerical worker who ingested 4 to 16 oz of dextromethorphan on a regular basis over an 8-year period. We consulted with our local Poison Control Center and undertook a literature search to research previous reports of similar cases to identify the features that would aid physicians in recognition and management of this problem. Results and Conclusion: Despite the availability of a substantial number of case reports in specialty journals, there are almost no reports in the primary care literature of chronic dextromethorphan addiction. Our case highlights the difficulties in making an appropriate diagnosis and in obtaining effective help for the patient.

Copyright 2006, American Board of Family Medicine


Dickerson DL; Schaepper MA; Peterson MD; Ashworth MD. Coricidin HBP (R) abuse: Patient characteristics and psychiatric manifestations as recorded in an inpatient psychiatric unit. Journal of Addictive Diseases 27(1): 25-32, 2008. (13 refs.)

Coricidin HBP (R), a cold medication containing dextromethorphan, has become a popular agent abused among adolescents. This retrospective chart review examines the potential psychiatric manifestations of Coricidin HBP (R) misuse and patterns of use among patients treated in an inpatient child and adolescent psychiatric unit. Coricidin HBP (R) use was documented in 47 patient. The data revealed that Coricidin HBP (R) use was associated with: (a) predominantly depressive symptomatology; (b) transient substance-induced psychosis; (c) cardiac toxicity; and (d) greater quantities used per episode by Caucasians. Clinicians treating adolescents need to be aware of the abuse potential and psychiatric manifestations of this dextromethorphan-containing product.

Copyright 2008, Haworth Press


Doughty C; Walker A; Brenchley J. Herbal mind altering substances: An unknown quantity? Emergency Medicine Journal 21(2): 253-255, 2004. (13 refs.)

Herbal drugs are increasingly marketed as a "safe" alternative to illict drugs. The variety of consituents in these compounds and their potential pharmacological activity an present difficultis for the emergency physicain in management of intoxicated patients. After a case as at a recent music festival, we prsent a case report and review of herbal compounds. The cas report involved a young women who had taken herbal drugs )"road runners") and alcohol. She was conscience but hyperventilating, tachycardic with dilated pupils, who became increasingly agitated and after arrival at a festival medical station had a grand mal seizure. She was tranferred to a local emergency department. The chemical analysis of the preparation is presented, the predominant ingredients being ephedrine and caffeine.

Copyright 2004, British Medical Journal Publishing Group


Elseviers MM; De Broe ME. Analgesic nephropathy? Is it caused by multi-analgesic abuse or single substance use? Drug Safety 20(1): 15-24, 1999. (48 refs.)

Analgesic nephropathy is a slowly progressive renal disease, characterised by renal papillary necrosis. Recently, diagnostic criteria for this disease have been defined based on renal computed tomography scanning performed without contrast. The observation of a decreased renal mass of both kidneys, combined with either bumpy contours or papillary calcifications, has been found to have high diagnostic specificity and sensitivity. However, the question remains as to what kind of analgesics can cause analgesic nephropathy. In the majority of early reports about this condition, phenacetin was singled out as the nephrotoxic culprit. However, during the last decade the nephrotoxic potential of nonphenacetin-containing preparations has become apparent. It is clear that people who abuse analgesics prefer combination analgesics containing 2 analgesics combined with caffeine and/or codeine. In contrast, abuse of products containing only aspirin (acetylsalicylic acid) or paracetamol (acetaminophen) is seldom described and associated renal disease is only occasionally reported. Experimental evidence of the nephrotoxicity of analgesic preparations is not well established. The results of studies involving analgesic administration in animals remain contradictory. Clinical evidence linking high consumption of analgesic preparations with analgesic nephropathy is overwhelming. Most patients who admit to over-consuming analgesics have taken preparation containing more than one compound. In recent pears, it has become more apparent that preparations not containing phenacetin also have the potential to cause nephrotoxicity manifesting as identical renal lesions. Further epidemiological evidence of the nephrotoxic potential of analgesic combinations has come from case-control studies published during the last decade and from 2 prospective cohort studies. Effective prevention of analgesic nephropathy consists of the prohibition of over-the-counter sales of preparation containing at least 2 analgesics associated with caffeine and/or codeine.

Copyright 1999, Adis International, Ltd.


Fiocchi A; Riva E; Giovannini M. Ethanol in medicines and other products intended for children: Commentary on a medical paradox. Nutrition Research 19(3): 373-379, 1999. (20 refs.)

Carrier solvents in pharmaceuticals should be excipient. Ethanol in liquid preparations intended for children is an industry decision but it is a metabolically active substrate, sometimes found in subtherapeutic or subtoxic doses. Worst offenders in this respect are prescription drugs for long-term treatment which inevitably subject patients to chronic passive exposure. 103 such preparations were identified from the Italian pharmacopoeia with more than 20 mg/dL ethanol. OTCs and homeopathic remedies were also found to contain large amounts (up to 60% vol.) of ethanol with even less clinical need or benefit. Domestic sources other than medicinals were found to account for negligible amounts (>2mg/dL). Hepatic and extrahepatic enzyme route switching, hepatic blood flow and plasma clearance are all age-dependent and the growth process itself is increasingly thought to impact on drug pharmacokinesis. The implications for paediatric prescribers are that trademarks for the same active ingredient should be differentially assessed against expected length of treatment and ethanol amounts, preferring non-alcoholic alternatives whenever possible. Yet the medical literature has paradoxically ignored the need for a toxicological re-assessment of ethanol in children medications and acceptable risk thresholds have not been determined.

Copyright 1999, Elsevier Science Ltd.


Fleming GF; McElnay JC; Hughes CM. Development of a community pharmacy-based model to identify and treat OTC drug abuse/misuse: A pilot study. Pharmacy World & Science 26(5): 282-288, 2004. (36 refs.)

Objective: The aim of this study was to develop and pilot a harm-minimisation model for the identification and treatment of over-the-counter (OTC) drug abuse/misuse by community pharmacists. Method, Extensive consultation was conducted during the development of the model. This included an exploratory conference involving an interdisciplinary group of delegates and detailed individual consultation with a range of healthcare practitioners. Consultation with a psychologist specialising in communication skills allowed development of the communication aspects of the model. A comprehensive manual detailing the model was prepared, Results: The model is designed to be used by community pharmacists in conjunction with other healthcare professionals. It focuses on the abuse/misuse of opioids, laxatives and antihistamines and can be broadly divided into three phases, namely: patient identification and recruitment, treatment/referrals and data collection/outcome measurement. Client identification is via record-keeping which is implemented alongside an information campaign promoting safe use of OTC medicines. Once identified, the pharmacist aims to recruit clients using the developed communication strategies. Treatment depends on whether the problem is misuse or abuse and on the product. Several treatment paths are available including treatment according to an agreed protocol and referring to the GP or community addiction team (CAT). Two pharmacists were recruited and trained to pilot the model. Of the clients, 18 were identified as abusing/misusing OTC products over a one-month period. The subject of inappropriate OTC use was raised with 14 of these clients. Some success was noted in that clients agreed to stop using the product and/or to try safer alternatives. As expected, some sales had to be refused, as the client was unwilling to accept the pharmacist's intervention. Conclusion: This study represents the first reported structured attempt by community pharmacists in the UK to address the abuse/misuse of OTC medication. Work is now ongoing to modify this model in light of the pilot study findings.

Copyright 2004, Kluwer Academic Publishing


Frank C; Godwin M; Verma S; Kelly A; Birenbaum A; Seguin R; Anderson J. What drugs are our frail elderly patients taking? Do drugs they take or fail to take put them at increased risk of interactions and inappropriate medication use? Canadian Family Physician 47(June): 1198-1204, 2001. (31 refs.)

Objective: To determine whether there were discrepancies between what medications frail elderly outpatients took and what physicians thought they took and whether discrepancies put patients at risk of taking inappropriate drugs and of increasing the potential for drug interactions. Design: Case series. Setting: Day Hospital Program at St Mary's of the Lake Hospital in Kingston, Ont. Participants: One hundred twenty community-living elderly patients attending the Day Hospital Program in 1998. Three patients and two family physicians declined to participate. Main Outcome Measures: Lists of medications being taken by patients compared with lists of medications in physicians' charts. Category according to explicit criteria that each drug fell into and risk of drug interactions as determined by the Clinidata Drug Interaction Program. Results: Of the 120 patients, 115 had at least one discrepancy between their lists of medications and their physicians' lists. Of the 1390 medications on the lists, 521 (37%) were being taken by patients without their doctors' knowledge, 82 (6%) were not being taken by patients when doctors thought they were, and 133 (10%) were on both patients' and their doctors' lists but with dosages or frequency of administration that were different. More potential drug interactions were identified on patients' lists than on physicians' lists. No increase in risk of inappropriate drug use was identified. Conclusion: Family physicians are often unaware of all the medications their patients are actually taking. Medications used by patients without physicians' knowledge increase the likelihood of drug interactions. Family physicians should look at and inquire about all medications, including over-the-counter drugs, their patients are actually taking.

Copyright 2001, College of Family Physicians of Canada. Used with permission.


Gallo JJ; Lebowitz BD. The epidemiology of common late-life mental disorders in the community: Themes for the new century. Psychiatric Services 50(9): 1158-1166, 1999. (100 refs.)

Objective: The prevalence and incidence of the major mental disorders of late life that are common in the community and in primary health care are reviewed. Methods: Community-based studies in English that included older adults were identified through MEDLINE searches and were reviewed. Results: As the population ages, dementia, depression, and other mental conditions of the aged will demand more attention from clinicians and investigators to minimize their effects on disability, the use of health care services, and the quality of life for older adults and caregivers. Up to 15 to 20 percent of older adults have significant depressive symptoms, and it is estimated that as many as 45 percent of persons age 85 years and older have significant cognitive impairment and dementia. Other mental-health-related conditions, such as anxiety disorders, alcohol abuse, and prescription medicine misuse, are also important considerations but have not been as well studied as depression and dementia. Because an increasing proportion of older adults are members of minority groups, clinicians need to increase their awareness of how cultural factors relate to risk for mental disorders in late life. Conclusions: Attention to three themes may help clinicians and investigators meet the challenge of treating the common mental disorders of later life: the effect of these disorders on functioning, prevention of the consequences of mental disorders, and integration of mental health care and primary health care services.

Copyright 1999, American Psychiatric Association. Used with permission


Hanlon JT; Fillenbaum GG; Ruby CM; Gray S; Bohannon A. Epidemiology of over-the-counter drug use in community dwelling elderly: United States perspective. (review). Drugs & Aging 18(2): 123-131, 2001. (40 refs.)

Among US community dwelling individuals aged greater than or equal to 65 years, about as many persons take nonprescription drugs as take prescription drugs. A review of US data from the last 2 decades indicates that the average number of over-the-counter (OTC) drugs taken daily is around 1.8, but varies with geographical area (highest in the Midwest) and race/ethnicity (lowest use among Hispanics. followed by African Americans, and highest use among Whites). Use has consistently been found to be higher in women than in men. While OTC use appears to be increasing over time. it also decreases with increase in age. The most common OTC classes used are analgesics, laxatives and nutritional supplements. Our ability to explain or to predict OTC use and change in use is poor, and further studies, particularly on use by elderly individuals of minority races, are needed.

Copyright 2001, Adis International Ltd.


Hasford J; Fagerstrom KO; Haustein KO. A naturalistic cohort study on effectiveness, safety and usage pattern of an over-the-counter nicotine patch: Cohort study on smoking cessation. European Journal of Clinical Pharmacology 59(5/6): 443-447, 2003. (17 refs.)

Introduction. Nicotine replacement therapies (NRT) are effective for smoking cessation. After having received over-the-counter (OTC) status in Germany, concerns grew about effectiveness, increased risks, especially of adverse cardiovascular reactions, and inappropriate use of NRT. Thus, a pharmacy-based cohort study was launched. Objectives. To assess effectiveness, safety and appropriateness of use of an OTC nicotine patch (Nicotinell, Novartis Ltd.). Every customer who bought an OTC Nicotinell patch was eligible. All data were collected by self-administered questionnaires at weeks 2, 4, 8, 12 and 24 after inclusion. Six hundred and thirty-three customers were admitted, median duration of smoking was 19 years. Of the participants, 6% smoked up to 10 cigarettes per day, 43.6% between 11 and 20, 34.3% between 21 and 30, and 16.1% more than 30 cigarettes. Twenty-four weeks later, 351 participants replied: 28% (177 of 633) had quit smoking completely. Considering replies only the proportion of complete responders raised to 50.4%. There were no serious adverse events reported; 62.9% complied with the directions for use and did not use the patch for more than 3 months. About 45% smoked simultaneously with NRT. Pharmacy-based cohort studies are feasible. This study indicates that the nicotine patch is effective and safe in an OTC setting. There is still room to improve compliance with the directions for use.

Copyright 2003, Springer-Verlag


Hawton K; Simkin S; Deeks J; O'Connor S; Keen A; Altman DG et al. Effects of a drug overdose in a television drama on presentations to hospital for self poisoning: Time series and questionnaire study. British Medical Journal 318(7189): 972-977, 1999. (25 refs.)

Objectives: To determine whether a serious paracetamol overdose in the medical television drama "Casualty" altered the incidence and nature of general hospital presentations for deliberate self poisoning. Design: Interrupted time series analysis of presentations for self poisoning at accident and emergency departments during three week periods before and after the broadcast. Questionnaire responses collected from self poisoning patients during the same periods. Setting: 49 accident and emergency departments and psychiatric services in United Kingdom collected incidence data; 25 services collected questionnaire data. Subjects: 4403 self poisoning patients; questionnaires completed for 1047. Main outcome measures: Change in presentation rates for self poisoning in the three weeks after the broadcast compared with the three weeks before, use of paracetamol and other drugs for self poisoning, and the nature of overdoses in viewers of the broadcast compared with non- viewers. Results: Presentations for self poisoning increased by 17% (95% confidence interval 7% to 28%) in the week after the broadcast and by 9% (0 to 19%) in the second week. Increases in paracetamol overdoses were more marked than increases in non-paracetamol overdoses. Thirty two patients who presented in the week after the broadcast and were interviewed had seen the episode -- 20% said that it had influenced their decision to take an overdose, and 17% said it had influenced their choice of drug. The use of paracetamol for overdose doubled among viewers of Casualty after the episode (rise of 106%; 28% to 232%). Conclusions: Broadcast of popular television dramas depicting self poisoning may have a short term influence in terms of increases in hospital presentation for overdose and changes in the choice of drug taken. This raises serious questions about the advisability of the media portraying suicidal behaviour.

Copyright 1999, British Medical Association


Hays JT; Croghan IT; Schroeder DR; Offord KP; Hurt RD; Wolter TD et al. Over-the-counter nicotine patch therapy for smoking cessation: Results from randomized, double-blind, placebo-controlled, and open label trials. American Journal of Public Health 89(11): 1701-1707, 1999. (26 refs.)

Objectives. The purpose of this study was to determine the efficacy and safety of the nicotine patch for smoking cessation in an over-the- counter environment. The years of study were 1994 to 1995. Methods. Parallel 6-week trials were conducted: a placebo-controlled trial of no-cost 22-mg, 24-hour nicotine patch therapy and an open label trial of the same therapy with patches purchased by subjects. Participants (n = 958) were is years or older, had smoked at least 15 cigarettes daily for at least 6 months, and were enrolled at 3 study sites. The main outcome measure was self-reported smoking abstinence confirmed by expired carbon monoxide measurements. Results. Smoking cessation rates in the placebo-controlled trial were 16.8% and 9.6% at week 6 and 8.7% and 4.3% at week 24 for the active patch and placebo groups, respectively. Smoking cessation rates in the open label-pay trial were 19.0% and 10.8% at weeks 6 and 24, respectively. A slight increase in adverse cardiovascular events was noted only in the open label-pay group in comparison with the placebo group. Conclusions. In an over-the-counter environment, the 22-mg, 24-hour nicotine patch is effective and safe for smoking cessation treatment.

Copyright 1999, American Public Health Association. Used with permission


Hendrickson RG; Cloutier RL. "Crystal Dex": Free-base dextromethorphan. Journal of Emergency Medicine 32(4): 393-396, 2007. (11 refs.)

Dextromethorphan (DXM) is a common component of combination cold medications that has become a popular drug of abuse for young adults. Abusers of DXM have developed a simple acid-base extraction technique to "free-base," or extract, the DXM from the unwanted guaifenesin, coloring agents, sweeteners, and alcohol that are typically included in combination cold preparations. We report a case of DXM overdose after ingestion of this purified "Crystal Dex" and discuss the "Agent Lemon" and single-phase extraction techniques that are used to free-base the dextromethorphan.

Copyright 2007, Elsevier Science


Hubbard WK. Over-the-counter drug products containing analgesic/antipyretic active ingredients for internal use, required alcohol warning, final rule, compliance date. Federal Register 64(51): 13066-13067, 1999. (11 refs.)

This presents the required alcohol warning, final rule, and compliance date for over-the-counter (OTC) drug products containing analgesic/antipyretic active ingredients. The Food and Drug Administration (FDA) has established an effective date of April 23, 1999 and a compliance date of October 22, 1999 for the regulation that was published in the Federal Register of October 23, 1998. Specifically, the regulation established warning statements that advise consumers with a history of heavy alcohol use to consult a physician for advice about the use of OTC internal analgesic/antipyretic drug products. Supplementary information in this announcement includes background information, summary of comments received, the agency's response, analysis of impacts, environmental impact, and a finding that the regulation is not subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. It is concluded that the labeling statements are a "public disclosure of information originally supplied by the Federal government to the recipient for the purpose of disclosure to the public."

Public Domain


Hughes GF; McElnay JC; Hughes CM; McKenna P. Abuse/misuse of non-prescription drugs. Pharmacy World & Science 21(6): 251-255, 1999. (25 refs.)

Aim: To investigate the abuse of non-prescription (over-the-counter; OTC) products in Northern Ireland. Method: A structured questionnaire covering various aspects of OTC drug abuse was mailed to all 509 community pharmacies in Northern Ireland. Results: 253 responses were received (response rate 49.7%) after two mailings. Pharmacists named 112 OTC products they perceived were being abused in Northern Ireland. These were classified into 8 groups, with opioids, antihistamines and laxatives the most frequently reported. The frequency of abuse of all product groups was perceived to be either increasing or static. The number of clients suspected of abuse over a three-month period ranged from 0 to 700 (median=10, mode=6) with 55% being regular customers. Pharmacists employed several methods to limit patient access to products of abuse. The most common technique was to keep the product out of sight. Others included additional client questioning, providing advice and limiting the quantity of product sold. The majority of respondents agreed their role could be extended to include other methods of dealing with abusers, including participation in harm- reduction programmes to wean abusers off products. Geographical region and location of pharmacy were not significant factors in the abuse of OTC products. Conclusions: Pharmacists in Northern Ireland perceive abuse and misuse of OTC products to be occurring in practice. Current methods employed for dealing with it are inadequate. Research into methods of effectively dealing with OTC abuse/misuse is required and has commenced on the basis of these findings.

Copyright 1999, Kluwer Academic Publishing


Hughes JR; Shiffman S; Callas P; Zhang J. A meta-analysis of the efficacy of over-the-counter, nicotine replacement. Tobacco Control 12(1): 21-27, 2003. (12 refs.)

Objective: To determine whether over-the-counter (OTC) nicotine replacement therapy (NRT) is pharmacologically efficacious, whether it produces abstinence rates similar to those in prescription settings, and to estimate the long term (that is, greater than six month) abstinence rate with OTC NRT. Method: Systematic literature review. Data sources: Medline, Psych Abstracts, bibliographies, requests of scientists. Study selection: Studies comparing OTC NRT versus OTC placebo or studies comparing OTC NRT versus prescription NRT that reported abstinence rates and for which a full study report was available. Data extraction: Two of the authors independently reviewed studies and compared results. Data synthesis: Meta-analysis was performed by first testing for homogeneity across studies, then combining odds ratios (ORs) weighting by inverse variance and proportions weighting by study sample size. Results: One OTC NRT versus OTC placebo nicotine gum study was excluded due to small sample size and different setting. The four remaining studies were randomised trials of nicotine versus placebo patch with ORs of 2.1-3.2. These outcomes were homogenous and when combined resulted in an OR favouring NRT of 2.5 (95% confidence interval (CI) 1.8 to 3.6). Among the two randomised and two non-randomised trials of OTC NRT versus prescription NRT, one small study had an OR of 0.3, two others had ORs of 1.0 and 1.4, and a fourth study had an OR of 3.6. These results were not homogenous; however, when combined via a random effects model the estimated OR was not less than 1.0-that is, OR 1.4 (95% Cl 0.6 to 3.3). The long term (that is, greater than six months) quit rates for OTC NRT was 1% and 6% in two studies and 8-11% in five other studies. These results were not homogenous; however, when combined the estimated OR was 7% (95% Cl 4% to 11%). Conclusions: OTC NRT is pharmacologically efficacious and produces modest quit rates similar to that seen in real world prescription practice.

Copyright 2001, BMJ Publishing Group


Hyland A; Bradford D; Gitchell J. Drug counselor report of adolescents abuse of nicotine replacement therapy. Journal of Addictive Diseases 24(4): 105-113, 2005. (9 refs.)

Background. Nicotine replacement products (NRT) are formulated and marketed to reduce their abuse liability among adolescents. Few studies have examined the extent of adolescent abuse. The objective of this manuscript is to describe the youth abuse rate for NRT and other over-the-counter (OTC) abusable substances. Methods. Two cross-sectional telephone surveys of Safe and Drug Free School Coordinators were conducted in 1996/7 (N = 562) and 1998/9 (N = 501). Abuse of NRT and other OTC drugs and circumstances surrounding NRT abuse was ascertained. Results. NRT abuse rates were low and did not change significantly between the two surveys (2.7% in 1996/7 to 4.6% in 1998/9). NRT abuse rates were well below those of other OTC abusable substances (e.g., diet pills and inhalants). Conclusions. Concerns over promotion of youth dependence to nicotine by offering the sale of NRT OTC to adults have not been realized and policymakers should consider reducing barriers to access these products.

Copyright 2005, American Society of Addiction Medicine


Hyland A; Rezaishiraz H; Giovino G; Bauer JE; Cummings KM. Over-the-counter availability of nicotine replacement therapy and smoking cessation. Nicotine & Tobacco Research 7(4): 547-555, 2005. (22 refs.)

In 1996, the FDA approved over-the-counter (OTC) availability of nicotine gum and two brands of nicotine skin patches. Little is known about how this reclassification has influenced the effectiveness and use of nicotine replacement therapy (NRT) and whether it has been a public health benefit. Data for the present study came from a prospective cohort study of 1,639 adult smokers surveyed by telephone in 1993, as part of the National Cancer Institute's Community Intervention Trial for Smoking Cessation (COMMIT), and resurveyed in 2001. NRT-assisted quit rates, NRT use rates, and the characteristics of NRT users were calculated before and after the 1996 OTC reclassification. Also calculated was the percentage of NRT users who quit by year. Results are presented for patch and gum separately and combined. OTC NRT use rates were lower for Hispanics and higher for those with no desire to quit at baseline. The quit rate decreased for patch-assisted quit attempts after OTC reclassification (22.5% to 18.5%, p=.05), but it did not change for gum-assisted quit attempts (11.9% to 10.5%, p=.54). NRT use rates increased for both patch and gum by about 60% following reclassification. A greater percentage of gum users had quit in the post-OTC period than in the pre-OTC period (9.7% vs. 14.6%, p=.05). Long-term quit rates in patch users were similar in both periods. Insurance coverage of NRT and concurrent attendance in a stop smoking clinic decreased for both patch- and gum-assisted attempts in the post-OTC period. The results suggest that OTC reclassification may have contributed to the increased use of NRT, compared with the pre-OTC period, whereas the efficacy for quitting decreased slightly for those using nicotine patch and remained about the same for those using the gum.

Copyright 2005, Taylor & Francis


Johnson KC; Klesges LM; Somes GW; Coday MC; DeBon M. Access of over-the-counter nicotine replacement therapy products to minors. Archives of Pediatrics & Adolescent Medicine 158(3): 212-216, 2004. (18 refs.)

Background: Public health policy guidelines recommend that health care providers (eg, physicians, nurses, others) counsel adolescent smokers to quit and that nicotine replacement therapy (NRT) may be considered to aid in smoking cessation for nicotine-dependent youth. This recommendation is discrepant with Food and Drug Administration-approved labeling of NRT products, stating that they not be sold to persons younger than 18 years. It is not clear how easily minors are able to purchase NRT products in retail markets. Objective: To explore youth access to NRT by conducting the first study, to our knowledge, to determine the ability of minors to purchase over-the-counter NRT products. Design: Observational case series of NRT purchase attempts and survey description of store characteristics. Setting: Retail businesses in Memphis, Tenn. Participants: Population-based sample of 165 stores that sold over-the-counter medications. Main Outcome Measure: Successfully completed purchase attempts of NRT by the minor buyer. Results: In most stores that stocked NRT products, the age of the minor was not queried at any time during the purchase attempt (79%) and the minor was able to successfully purchase the product (81%). If the minor was asked her age, the store was much less likely to sell the NRT product. Stores in which a cash register gave an age query prompt or in which alcohol was sold were more likely to inquire about the minor's age and less likely to sell NRT products. Conclusions: Nicotine replacement therapy products were successfully obtained in most purchases by a minor buyer without proof of age. While ease of purchasing NRT products is potentially beneficial to young smokers attempting to quit, these purchases are discrepant with Food and Drug Administration labeling regarding the sale of NRT products to minors.

Copyright 2004, American Medical Association


Jones G; Singer P. Miscellaneous prescription and over-the-counter medications. IN: Lebeau MA; Mozayani A, eds. Drug Facilitated Sexual Assault: A Forensic Handbook. San Diego: Academic Press, 2001. pp. 173-196. (50 refs.)

This chapter discusses the availability, pharmacodynamics, pharmacokinetics and analysis of a number of prescription and non-prescription drug that include antidepressants, antihistamines, antipsychotics, barbiturates, chloral hydrate, and other sedatives that may be involved in drug facilitated sexual assault. While having differences, the common features of the compounds used in drug facilitated sexual assault are one or more of the following properties: cause sedation, cause amnesia, are odorless and tasteless, dissolve readily in alcoholic or other beverages and are rapidly absorbed after oral administration. This chapter addresses detectability before ingestion, detection and measurement, and the pharmacokinetics of each of the major groups. While the analysis of most of these drugs is well-documented in the literature, their detection and identification poses special problems in the context of drug facilitated sexual assault. Most laboratories are designed to detect toxic concentration and may not detect the very small or trace amounts present after several hours. Detection of these requires the analysis be directed to metabolites which might not ordinarily be looked for.

Copyright 2003, Project Cork


Juhn MS. Popular sports supplements and ergogenic aids. (review). Sports Medicine 33(12): 921-939, 2003. (135 refs.)

This article reviews the evidence-based ergogenic potential and adverse effects of 14 of the most common products in use by recreational and elite athletes today. Both legal and prohibited products are discussed. This is an aggressively marketed and controversial area of sports medicine worldwide. It is therefore prudent for the clinician to be well versed in the more popular supplements and drugs reputed to be ergogenic in order to distinguish fact from fiction.Antioxidants, proteins and amino acids are essential components of diet, but additional oral supplementation does not increase endurance or strength. Caffeine is ergogenic in certain aerobic activities. Creatine is ergogenic in repetitive anaerobic cycling sprints but not running or swimming. Ephedrine and pseudoephedrine may be ergogenic but have detrimental cardiovascular effects. Erythropoietin is ergogenic but increases the risk of thromboembolic events. beta-Hydroxy-beta-methylbutyrate has ergogenic potential in untrained individuals, but studies are needed on trained individuals. Human growth hormone and insulin growth factor-I decrease body fat and may increase lean muscle mass when given subcutaneously. Pyruvate is not ergogenic. The androgenic precursors androstenedione and dehydroepiandrosterone have not been shown to increase any parameters of strength and have potentially significant adverse effects. Anabolic steroids increase protein synthesis and muscle mass but with many adverse effects, some irreversible. Supplement claims on labels of product content and efficacy can be inaccurate and misleading.

Copyright 2003, Adis International Ltd


Kanayama G; Gruber AJ; Pope HG Jr; Borowiecki JJ; Hudson JI. Over-the-counter drug use in gymnasiums: An underrecognized substance abuse problem? Psychotherapy and Psychosomatics 70(3): 137-140, 2001. (28 refs.)

Objective: Many individuals, attempting to gain muscle or lose fat, use 'dietary supplements'. Though widely available over the counter or by mail order in America and Europe, some of these 'supplements' are actually potent drugs such as androstenedione and ephedrine, We sought to estimate the prevalence of these forms of drug use in American gymnasiums. Methods: We distributed anonymous questionnaires to 511 clients entering five gymnasiums, asking about use of both supplements and anabolic steroids. Results: Among men, 18% reported use of androstenedione and/or other adrenal hormones, 25% reported ephedrine use, and 5% reported anabolic steroid use within the last 3 years; among women these rates were 3, 13 and 0%, Extrapolating from these figures to the United States as a whole, we estimated that possibly 1.5 million American gymnasium clients have used adrenal hormones and 2.8 million have used ephedrine within the last 3 years. Conclusions: Millions of men and women are currently using potent drugs, widely sold over the counter as 'supplements', despite their known adverse effects, unknown long-term risks, and possible potential for causing abuse or dependence.

Copyright 2001, S. Karger AG, Basel


Kaufman DW; Kelly JP; Wiholm BE; Laszlo A; Sheehan JE; Koff RS; Shapiro S. The risk of acute major upper gastrointestinal bleeding among users of aspirin and ibuprofen at various levels of alcohol consumption. American Journal of Gastroenterology 94(11): 3189-3196, 1999. (18 refs.)

Objective: Major upper gastrointestinal bleeding (UGIB) is the most important adverse effect of aspirin and other nonsteroidal anti- inflammatory drugs (NSAIDs). Alcoholic beverages also precipitate UGIB. This analysis was conducted to evaluate whether the deleterious effects of NSAIDs are further increased among drinkers. Methods: An interview-based, case-control study was conducted in the U.S. and Sweden; 1224 patients hospitalized with acute major UGIB due to newly occurring peptic ulcer or gastritis were compared to 2945 neighbor controls. Results: Compared with those who drank less than one drink/wk, the relative risk of acute UGIB increased with increasing alcohol consumption, rising to 2.8 among those who drank greater than or equal to 21 drinks/wk. Among current drinkers, the relative risk of acute UGIB due to the use of aspirin was raised at all levels of alcohol consumption; the estimate for aspirin taken at least every other day (regular use) at doses of >325 mg among all current drinkers combined was 7.0; for regular use at lower doses, the corresponding estimate was 2.8, and for any occasional use, it was 2.4. All estimates were statistically significant. Data for ibuprofen were more limited, but the relative risk estimates did not appear to vary consistently with level of alcohol consumption. For regular use tall doses combined), the estimate among all drinkers combined was significantly elevated, at 2.7; occasional ibuprofen use was not associated with UGIB (1.2). There were insufficient data to evaluate other NSAIDs according to alcohol consumption. Conclusions: The findings suggest that acute UGIB is similarly associated with the use of the two most common nonprescription NSAIDs, aspirin and ibuprofen, at all levels of alcohol consumption. As heavy alcohol intake independently increases the risk, the incidence of UGIB is highest among persons who are both heavy drinkers and users of aspirin or ibuprofen.

Copyright 1999, American College of Gastroenterology


Krome CN; Tucker AM. Cardiac arrhythmia in a professional football player: Was ephedrine to blame? Physician and Sportsmedicine 31(12): 21+, 2003. (30 refs.)

The use of over-the-counter dietary supplements has risen dramatically, and adverse events can be severe. Physicians should recognize the dangers that ephedrine-containing supplements present and remain vigilant for sympathomimetic symptoms in young, otherwise healthy, patients. This case illustrates how the use of a popular weight-loss supplement by a 27-year-old professional football player apparently resulted in cardiac arrhythmia requiring direct cardioversion.

Copyright 2003, McGraw-Hill, Inc


Laure P; Lecerf T; Friser A; Binsinger C. Drugs, recreational drug use and attitudes towards doping of high school athletes. International Journal of Sports Medicine 25(2): 133-138, 2004. (26 refs.)

The purpose of this investigation was to determine the substances used, and the attitudes towards doping of high school athletes. A four-page, self-completed questionnaire was designed to determine the drugs used (licit, illicit and doping substances) along with beliefs about doping and the psychosociological factors associated with their consumption. The questionnaire was distributed to all the high school students enrolled in a school sports association in the Lorraine region in Eastern France. The completed forms were received from 1459 athletes: 4% stated that they had used doping agents at least once in their life (their main source of supply being peers and health professionals). Thirty-four percent of the sample smoked some tobacco, 66% used alcohol, 19% cannabis, 4% ecstasy, 10% tranquillizers, 9% hypnotics, 4% creatine and 41% used vitamins against fatigue. Beliefs about doping did not differ among doping agent users and non-users, except for the associated health risks which were minimized by users. Users of doping agents stated that the quality of the relations that they maintain with their parents is sharply degraded, and they reported that they are susceptible to influence and difficult to live with. More often than non-doping agent users, these adolescents are neither happy, nor healthy, while paradoxically, they seem less anxious and they are more self-confident. Our findings suggest that doping prevention among young athletes cannot be limited uniquely to the list of banned drugs.

Copyright 2004, Georg Thieme Verlag KG


Lessenger JE; Feinberg SD. Abuse of prescription and over-the-counter medications. (review). Journal of the American Board of Family Medicine 21(1): 45-54, 2008. (46 refs.)

The nonmedical use of prescription or over-the-counter (OTC) medications implies that the user is using them for reasons other than those indicated in the prescribing literature or on the box label. The abuse of these medications is a national issue. Intentional drug abuse of prescribed and OTC medicines has climbed steadily. Data from the 2005 National Survey on Drug Use and Health demonstrated that 6.4 million (2.6%) people aged 12 or older had used prescription drugs for nonmedical reasons during the past month. Of these, 4.7 million used pain relievers, 1.8 million used tranquilizers, and 1.1 million used stimulants. The nonmedical use of prescription drugs in the past month among young adults aged 18 to 25 increased from 5.4% in 2002 to 6.3% in 2005, primarily because of an increase in the abusive use of pain relievers. Physicians need to watch for prescription and OTC medication abuse. Treatment strategies include (1) inquiring about prescription, OTC, and herbal drug use at the initial examination (even though many individuals are drug-abuse savvy, some are naive and do not realize that OTC medications can be problematic); (2) inquiring about drug use during office visits; (3) providing disposal containers that patients can use to dispose of their unused or unneeded prescription or OTC medications; (4) treating pain aggressively and appropriately; (5) practicing careful record keeping of prescription refills and controls over prescription blanks; (6) referring patients who are addicted to medications to 12-step programs such as Alcoholic Anonymous, Narcotics Anonymous, and Pills Anonymous; and (7) considering detoxification.

Copyright 2008, American Board of Family Medicine


Levine DA. 'Pharming': The abuse of prescription and over-the-counter drugs in teens. (review). Current Opinion in Pediatrics 19(3): 270-274, 2007. (27 refs.)

Purpose of review Prescription and over-the-counter cough and cold medication abuse is rapidly becoming a national health concern for adolescents. Increased awareness of this growing epidemic is essential toward diagnosing, treating and preventing this type of substance abuse. Recent findings Data from surveys and poison control center records demonstrate an increased nonmedical use of prescription and over-the-counter cough and cold preparations, particularly those containing dextromethorphan. The nonmedical use of prescription medications may result in serious clinical effects with potential life-threatening complications, dependence and withdrawal syndromes. Dextromethorphan causes alterations in mental status that may contribute to judgment impairment leading to injury or fatality. Coingestion of other substances found in over-the-counter medications may also cause significant morbidity. Alcohol and illicit drug use is highly associated with the abuse of these medications. The incentive for abuse, such as easy accessibility, low cost and decreased perception of potential for harm, and potential interventions are described, Summary: The recent trend of prescription and dextromethorphan-containing over-the-counter medication abuse in adolescents is alarming. Improved awareness for these readily available, seemingly benign yet highly dangerous medications is essential. Prevention and early education on substance abuse in young teens are critical in combating this recent epidemic.

Copyright 2007, Lippincott, Williams & Wilkins


Lo A; Shalansky S; Leung M; Hollander Y; Raboud J. Patient characteristics associated with nonprescription drug use in intentional overdose. Canadian Journal of Psychiatry 48(4): 232-236, 2003. (12 refs.)

Objective: Over-the-counter (OTC) medications remain freely available to suicidal patients, despite their potential lethality and common use in suicide. The study's main objective was to identify patient characteristics, particularly psychiatric diagnosis associated with the use of OTC medications in intentional overdose. Methods: We retrospectively reviewed 95 charts from patients who presented to St Paul's Hospital from August 1, 1997, to July 31, 1998, with a discharge diagnosis of intentional drug overdose. Univariate analysis was carried out to identify potential risk markers for OTC medication use, and logistic regression was performed using these variables. Results: When the variables age, sex, and concurrent psychiatric diagnoses were controlled, use of OTC medications in overdose was significantly lower in patients with a DSM-IV diagnosis of substance abuse (OR 0.11, P = 0.005) and in those who possessed prescription medications at the time of overdose (OR 0.18, P = 0.007). Most patients in this cohort (82%) had at least 1 of these 2 traits. Although not statistically significant, younger patients appeared more likely to choose OTC medications for overdose. Conclusion: Suicide-prone patients with a diagnosis of substance abuse and who possess prescription medications are unlikely to use OTC medications in overdose. For this cohort, this represents a relatively small proportion of patients whom clinicians should consider to be at greater risk for attempting suicide when using OTC medication, especially acetaminophen.

Copyright 2003, Canadian Psychiatric Association


Mahadevan S; Park Y. Multifaceted therapeutic benefits of Ginkgo biloba L.: Chemistry, efficacy, safety, and uses. (review). Journal of Food Science 73(1): R14-R19, 2008. (83 refs.)

The new age of nutraceuticals is now embracing the centuries old herbal extract of Ginkgo biloba (Mantissa Plantarum Altera, 1771, Ginkgoceae). The standardized preparation of the Ginkgo leaf extract (EGb 761) contained 2 main bioactive constituents, flavonoid glycosides (24%) and terpene lactones (6%), along with less than 5 ppm of the allergenic component, ginkgolic acid. The Ginkgo leaf extract has been reported to have neuroprotective, anticancer, cardioprotective, stress alleviating, and memory enhancing effects and possible effects on tinnitus, geriatric complaints, and psychiatric disorders. The therapeutic mechanisms of action of the Ginkgo leaf extract are suggested to be through its antioxidant, antiplatelet, antihypoxic, antiedemic, hemorrheologic, and microcirculatory actions, where the flavonoid and the terpenoid constituents may act in a complementary manner. Toxicity studies show that the Ginkgo leaf extract is relatively safe for consumption, although a few side effects have been reported, that is, intracerbral hemorrhage, gastrointestinal disturbances, headaches, dizziness, and allergic skin reactions. The use of Ginkgo leaf extract may be promising for treatment of certain conditions, although its long-term use still needs to be evaluated.

Copyright 2008, Blackwell Publishing


Matheson C; Bond C; Pitcairn J. Misuse of over-the-counter medicines from community pharmacies: A population survey of Scottish pharmacies. Pharmaceutical Journal 269(7206): 66-68, 2002

AIM: To identify trends in the extent and nature of local misuse of OTC medicines as suspected by community pharmacists over a five-year period. DESIGN Two identical cross-sectional postal questionnaires were used in 1995 and 2000. The questionnaire was developed and piloted before the 1995 survey. The questionnaire was anonymous and used a return card system allowing non-responders to be followed up while responders remained anonymous. SUBJECTS AND SETTING: All community pharmacies in Scotland in 1995 (1,091, which excludes 51 which took part in the pilot study) and 2000 (1,162). RESULTS: A 79.1% response was achieved in 1995 and 83.4% in 2000. In 1995, 67.8% of responders suspected OTC medicine misuse compared with 68.5% in 2000. Patterns of products used remained similar although there were subtle differences. An antihistamine containing product (Nytol) was the most frequently mentioned product in both 1995 and 2000. Suspected misuse of codeine-containing products was high, although suspected codeine linctus misuse fell from 27.6% to 14.9%. There was significantly more suspected misuse in urban and city centre areas compared with rural areas (P=0.001). CONCLUSIONS The suspected misuse of OTC medicines appears widespread and constant. An antihistamine product remains the most frequently mentioned product and although misuse of codeine-containing products is consistently high there is some change in particular products. There is some variation between rural and urban locations.

Copyright 2002, Royal Pharmaceutical Society of Great Britain


McBride AJ; Pates R; Ramadan R; McGowan C. Delphi survey of experts' opinions on strategies used by community pharmacists to reduce over-the-counter drug misuse. Addiction 98(4): 487-497, 2003. (30 refs.)

Aim: To explore the views of experts within the fields of pharmacy and addiction on the value of current strategies and possible alternatives and to reach an agreement on best practice in the sale of over-the-counter (OTC) medicines which are liable to misuse. Design Using a modified Delphi approach, an anonymous, international, three-stage, postal questionnaire was conducted that generated both qualitative and quantitative data. Participants: Of those contacted by telephone (164) from the United Kingdom, Canada, Australia, New Zealand and United States, 109 experts (66%) agreed to take part. Forty-three per cent (47/109) completed all three stages of the study. Measurements: A Delphi technique was employed to gather data. The second and final questionnaires were constructed from the responses to the preceding questionnaires. Content analysis of the qualitative data was carried out at each stage. Statistical analyses of the influence of demographic factors, degree of shift in overall opinion between the first and second stages and degree of agreement between respondents at each stage were also conducted. Findings: A consensus was reached on the strategies considered the most important and effective. Key areas include improving access to current information, improved staff training, addressing the issues of non-pharmacy outlets and Internet pharmacy sites. Concerns were expressed regarding the possible conflict between commercial and customer interests. Conclusions: The consensus view presented offers practical and realistic guidance for policy-makers and community pharmacists on the sale of OTC products. It reflects the best evidence to date of expert views in this area and accords with current UK guidelines. The effective implementation of these strategies can only be achieved with improved communication and coordination at local and national level.

Copyright 2003, Society for the Study of Addiction to Alcohol and Other Drugs


Metzger KB; Mostashari F; Kerker BD. Use of pharmacy data to evaluate smoking regulations' impact on sales of nicotine replacement therapies in New York City. American Journal of Public Health 95(6): 1050-1055, 2005. (26 refs.)

Objectives. Recently, New York City and New York State increased cigarette excise taxes and New York City implemented a smoke-free workplace law. To assess the impact of these policies on smoking cessation in New York City, we examined over-the-counter sales of nicotine replacement therapy (NRT) products. Methods. Pharmacy sales data were collected in real time as part of nontraditional surveillance activities. We used Poisson generalized estimating equations to analyze the effect of smoking-related policies on pharmacy-specific weekly sales of nicotine patches and gum. We assessed effect modification by pharmacy location. Results. We observed increases in NRT product sales during the weeks of the cigarette tax increases and the smoke-free workplace law. Pharmacies in low-income areas generally had larger and more persistent increases in response to tax increases than those in higher-income areas. Conclusions. Real-time monitoring of existing nontraditional surveillance data, such as pharmacy sales of NRT products, can help assess the effects of public policies on cessation attempts. Cigarette tax increases and smoke-free workplace regulations were associated with increased smoking cessation attempts in New York City, particularly in low-income areas.

Copyright 2005, American Public Health Association


Monroe ML; Doering PL. Effect of common over-the-counter medications on blood alcohol levels. Annals of Pharmacotherapy 35(7/8): 918-924, 2001. (28 refs.)

This study assessed the clinical and legal significance of the potential pharmacokinetic interaction between common over-the-counter (OTC) medications and alcohol that may result in increased blood alcohol levels (BALs). A MEDLINE search (1966-February 2000) of English-language articles was performed using the terms aspirin, acetaminophen, histamine (H2)-receptor antagonist, ethanol, and blood alcohol level and then supplemented by a bibliographic review of relevant articles. Two H2-receptor antagonist studies using methodologies representative of other published trials and a meta-analysis of 24 H2-receptor antagonist trials were chosen for detailed review. All identified studies examining aspirin and acetaminophen were addressed. More than 30 studies have examined the potential interaction between OTC drugs and blood alcohol. Because this issue has important medical and legal implications for patients, prescribing physicians, and pharmaceutical manufacturers, a critical analysis of the literature addressing this potential interaction is presented. Numerous factors arguing against a clinically significant interaction were identified. First, data from the relevant studies cannot be extrapolated to the general population because of the multitude of variables that determine an individual's BAL. Also, a publication bias for small studies (< or = 10 subjects) finding a statistically significant increase in peak BAL was observed. In addition, study results supporting an increase in BAL were often irreproducible when these trials were repeated under similar conditions. Finally, although some studies detected statistically significant increases in peak BAL, these changes were often clinically irrelevant.

Copyright 2001, Harvey Whitney Books Co.


Myers B; Siegfried N; Parry CDH. Over-the-counter and prescription medicine misuse in Cape Town: Findings from specialist treatment centres. South African Medical Journal 93(5): 367-370, 2003. (11 refs.)

Objective. To provide community-level public health surveillance information on over-the-counter (OTC) and prescription medicine misuse. Methods. A retrospective study of OTC and prescription medicine misuse among 9 063 patients from 23 specialist substance abuse treatment centres in Cape Town, South Africa, between 1998 and 2000. Results. OTC and prescription medicine misuse places a burden on health and social services in South Africa. This is evidenced through the constant demand for treatment for OTC/prescription medicine misuse. Benzodiazepines are the class of medicines for which users most often receive treatment, followed by analgesics. Analgesic misuse is most often accounted for by the use of codeine-containing medicines, many of which are available over the counter. Patients using OTC/prescription medicines as their primary drug of abuse are significantly more likely to be female, and aged over 40 years. In contrast, patients using OTC/prescription medicine as an additional drug of abuse tend to be male and over 40 years of age. Conclusions. This study points to the need to develop primary health care protocols for detection, management and referral of patients misusing OTC/prescription drugs and the need to debate the re-scheduling of codeine as a prescription-only substance. The study also points to the need for further community-based research on the nature and extent of OTC/prescription drug misuse among the general population.

Copyright 2003, Medical Association of South Africa


Neafsey PJ; Shellman J. Knowledge and self-efficacy of community health nurses concerning interactions of prescription medicines with over-the-counter agents and alcohol. Journal of Gerontological Nursing 28(9): 30-39, 2002. (64 refs.)

Knowledge and self-efficacy concerning interactions of prescription medications with alcohol and over-the-counter agents were assessed in community health nurses. Three convenience samples of community nurses were recruited to complete the instruments. The first was a sample of 20 experienced nurses working for a local visiting nurse agency. The second was a sample of 20 Bachelor of Science in nursing students (graduate nurses) completing their final rotation with the visiting nurse agency. The third was a sample of 31 nurses enrolled in a graduate program training nurses for advanced practice. There were no significant differences in overall mean self-efficacy scores among the groups of community health nurses. The mean scores indicated moderate self-efficacy about interactions between prescription drugs and alcohol and over-the-counter agents. Post-hoc analyses determined visiting nurses had significantly greater knowledge scores than nurses enrolled in advanced practice training. Overall mean self-efficacy was not correlated with mean knowledge scores. Inspection of the knowledge item responses revealed nine general misconceptions about alcohol and over-the-counter medications held by many community nurses in the sample. The data can guide the development of continuing education programs about interactions between prescription drugs and alcohol and over-the-counter medications aimed at community health nurses.

Copyright 2002, Slack Inc.


Neutel CI; Appel WC. The effect of alcohol abuse on the risk of NSAID-related gastrointestinal events. Annals of Epidemiology 10(4): 246-250, 2000. (24 refs.)

PURPOSE: Non-steroidal anti-inflammatory drugs (NSAIDs) are known to increase the risk of gastrointestinal (GI) complications. Excessive alcohol consumption may further increase this risk and the FDA is requiring warnings on over-the-counter (OTC) NSAIDs. Our objective is to evaluate the risk of NSAID-related GI events for persons with a history of alcohol abuse. METHODS: This case control study used data from Saskatchewan Health. Cases consisted of 1083 patients hospitalized for severe GI events, whereas the control group consisted of 14.754 persons without such hospitalizations. RESULTS: Five percent of cases (n = 54) and 1.9% of controls (n = 273) had a history of treatment for alcohol abuse. The presence of either NSAID use or a history of alcohol abuse led to an odds ratio (OR) of 2.9* for severe GI events, whereas the presence of both risk factors simultaneously led to an OR of 10.2* (additive would be 5.8). Similarly, the presence of ibuprofen and naproxen use, which are OTC in the USA, without alcohol abuse led to an OR of 1.9*, whereas alcohol abuse by itself led to an OR of 2.4*. The presence of both OTC NSAIDs and alcohol abuse simultaneously, led to an OR of 6.5 (additive would be 4.3). Thus with both risk factors present, the resulting risk ratio, is greater than the additive risk of the separate risk factors. CONCLUSIONS: The Food and Drug: Administration (FDA) warning concerns concurrent use of alcohol with NSAIDs, whereas the present study presents the effect of long term alcohol abuse. Further research is needed to separate these two issues to allow physicians to provide the best advice to their patients. *Statistically significant at p < 0.05.

Copyright 2000, Elsevier Science Ltd.


Office of Applied Studies, Substance Abuse and Mental Health Services Administration. The NSDUH Report: Misuse of over-the-counter cough and cold medication among persons aged 12-25. (January 10, 2008). Rockville MD: Substance Abuse and Mental Health Services Administration, 2008. (8 refs.)

The cough suppressant dextromethorphan (DXM) is found in more than 140 over-the-counter (OTC) cough and cold medications. Dextromethorphan is generally safe when taken in recommended doses but in large amounts can cause dangerous side effects and has led to increased poison control calls involving dextromethorphan. Based on SAMHSA's National Survey on Drug Use and Health, in 2006 about 3.1 million persons aged 12 to 25 (5.3%) reported having ever used an over-the-counter cough or cold medication to get high, i.e., used it nonmedically. Nearly 1 million persons aged 12 to 25 (1.7%) had done so in the past year. Those ages 18 to 25 were more likely than youth aged 12 to 17 to have used OTC cough and cold medications nonmedically in their lifetime (6.5% vs. 3.7%) but less likely to do so in the past year (1.6% vs. 1.9%). Among those 12 to 25 years old, non-medical use of cough and cold medications use is more common among Whites (2.1%) than Hispanics (1.4%) and blacks (0.6%). There are differences in use based on gender. Among those aged 12 to 17, females nonmedical use of these products is more common among females. However, for those ages18 to 25, males were more likely to have misused these preparations. Among persons aged 12 to 25 who had misused an OTC cough and cold medication in the past year, 30.5 percent misused a NyQuil(r) product, 18.1 percent misused a Coricidin(r) product, and 17.8 percent misused a Robitussin(r) product.

Public Domain


Office of Applied Studies, Substance Abuse and Mental Health Servicese; Ball J; Garfield T; Morin C; Steele D. Emergency Department Trends from the Drug Abuse Warning Network: Final Estimates 1995-2002. DAWN Series: D-24. Rockville MD: NIDA, 2003. (24 refs.)

This issue of ED Trends From DAWN examines the nature of U.S. trends in drug-related ED episodes and focuses almost exclusively on the final estimates for 2002 with statistical comparisons to 2001. Semi-annual estimates for the 10 half years from 1998 through 2002 are provided for reference, but are not discussed. In the full-year tables, statistical tests are used to compare final 2002 estimates with those for 2001, 2000, and 1995. For half years, estimates for the latest half-year period are compared with those for the previous 2 half years. Each table displays the percentage change for statistically significant differences. The presentation of ED findings in this publication is divided into the following sections: (1) Trends in major substances of abuse, such as alcohol-in-combination, cocaine, heroin, and "club drugs;" (2) Trends in other substances of abuse, such as prescription and OTC drugs; (3) Trends for the 21 metropolitan areas oversampled in DAWN; (4) Trends in demographic characteristics of patients treated in drug-related ED episodes; (5) Trends in characteristics of the episodes themselves; and (6) Discussion of results. Population-based rates are discussed within these sections by topic, because the rates are best used to supplement the other estimates of episodes and mentions. By considering the estimates of drug mentions and episodes relative to the size of the population at risk, the rates yield standardized measures that can be compared across selected drugs, metropolitan areas, and gender and age groups.

Public Domain


Office of Applied Studies, Substance Abuse and Mental Health Services Administration. The DAWN Report. Emergency Department Visits Involving Dextromethorphan. Issue 32. Rockville MD: Substance Abuse and Mental Health Services Administration, 2006. (6 refs.)

Dextromethorphan is a cough suppressant approved by the Food and Drug Administration found in many over-the-counter (OTC) remedies. Taken in large amounts it can produce hallucinations and a "high" similar to psychotropic drugs. Side efffects can include blurred vision, loss of coordination, abdominal pain and rapid heartbeat. In recent years it has become available over the internet in bulk powdered form and concern has grown over the nonmedical use by teannagers. This issue focuses upon data from the 2004 Drug Abuse Warning Network (DAWN) survey of emergency-department visits involving dextromethorphan. In that year, an estimated 12,584 visits involving dextromethorphan. The rate of ED visits resulting from nonmedical use for that ages 12-20 was 7.1 visits per 100,000, compared to 2.6 visits or fewer per 100,000 for other age groups. Those age 12-20 accounted for nearly half of all ED visits for the drug. The rate of ED visits resulting from any type of DXM in that age group was 10.3 per 100,000 compared with 4.3 visits for the overall population. Alcohol was implicated in about a third (36%) of ED visits involving nonmedical use of DXM for those aged 18-20 and in 13 percent of visits for those aged 12-17.

Copyright 2006, Project Cork


Office of Applied Studies. The New DAWN Report: Emergency Department Visits Involving Dextromethorphan. Issue 32. Rockville MD: Substance Abuse and Mental Health Services Administration, 2006. (6 refs.)

This issue is part of an occasional series based on information gathered as part of the Drug Abuse Warning Network (DAWN) that monitors drug related morbidity and morality, by monitoring emergency department visits in selected metropolitan areas. This issue focuses upon the emergency department visits that involve dextromethorphan (DXM), an ingredient commonly found in over-the-counter cough and cold remedies. When taken in large amounts dextromethorphancan induce a "high" similar to those produced by hallucinogens, and have side effects including blurred vision, loss of coordination, rapid heart beat. These side effects can be amplified by the other ingredients found in cold products, such as antihistamines, or acetaminophen, or psuedoepedrine. Recently DXM has been sold over the Internet in bulk form, leading to increased concern about nonmedical use. Data from the DAWN system shows that in 2004 there were an estimated 12,584 emergency medicine visits involving DSM; this represented 0.7% of all drug-related ED visits. Those age 12 to 20 had the highest rate of DXM visits, at 7.1 for each 100,00 persons in the population. This rate was two and a half times higher than the rate for other age groups. Those age 12 to 20 accounted for virtually half (48%) of all ED visits for non-medical use of DXM. The reasons for DXM-related visits were attributable to non-medial use (48%), adverse reactions associated with medical use accounted for about 30% of all DXM-related emergency department visits. Suicides attempts accounted for 14% of visits. Visits related to accidental ingestion were very rare and were almost exclusively among children under age 12.

Copyright 2006, Project Cork


Office of Applied Studies; Ball J; Mallonee E; Steele D; Morin C. Drug Abuse Warning Network, 2003: Area Profiles of Drug-Related Mortallity. DAWN Series D-27. Rockville MD: Office of Applied Studies, Substance Abuse Mental Health Administration, 2005. (0 refs.)

This volume introduces the new DAWN system, which profiles drug-repated deaths reported by participating medical exaiminers and coroners for 2003. A total of 122 jurisdictions in 35 metropolitan areas and 6 states submit data to the DAWN netork. The key features of the report are described. These changes do not allow comparisons to earlier DAWN reports. Deaths associated with substance abuse, both intentional and accidental are included, and drugs with therapeutic uses as well as illict drugs. The profile for each reporting area is provided in seven different tables/graphs. The informaion provided includes: map with the jurisdictions within the metropolitan area indiated, the totoal of drug-related deaths, total area population; mix of cases (e.g. accidental, homicide, suicide); place of death; five most common drugs reported to DAWN.

Copyright 2005, Project Cork


Office of Applied Studies; Steele D; Mallonee E. Mortality Data from the Drug Abuse Warning Network. DAWN Series D-25. Rockville MD: Office of Applied Studies, Substance Abuse Mental Health Administration, 2004. (0 refs.)

This publication presents information on deaths related to drug abuse based on data collected through the Drug Abuse Warning Network (DAWN) for calendar year 2002. This ongoing national surveillance system collects data from 31 major metropolitan areas on drug abuse deaths from medical examiners and coroners. Deaths include those directly caused by drugs as well as those in which drug use in a contributing factor. Among the significant findings is that (1) as previously, the typical case involved between two and four different drugs. (2) Three drugs were among those most commonly reported, heroin/morphine, cocaine, or alcohol-in-combination with another substance, in all among three of the areas these were the most common. (3) There are geographical differences, with methamphetamine most commonly reported in the west and midwest; marijuana mentions, are much lower and among the top 3 drug mentions in only 3 areas. Beyond describing the methodology and the "drug vocabulary" used, the bulk of the report provides detailed data on each of the metropolitan area. These presentations provide information on area population, deaths by sex, age, and race/ethnicity, the top ten drugs mentioned, the mentions by drug category for a five year period, and drugs involved by sex and age groups, and manner or death (suicide, accident, drug-induced, drug-related, and number of drugs involved.

Copyright 2004, Project Cork


Olivier P; Marechal K; Llau ME; Lapeyre-Mestre M; Damase-Michel C; Montastruc JL. Use of codeine and non-codeine cough suppressants: A survey among a French network of community pharmacists. Clinical Drug Investigation 22(6): 399-402, 2002. (11 refs.)

Oral codeine is used extensively worldwide in medical practice for the treatment of cough and pain. In France, codeine antitussive preparations are non-prescription-only medicines (NPOM). One of these preparations, Neocodion[sup (r)] tablets, Use of tradenames is for product identification only and does not imply endorsement. (Laboratoire du Docteur Bouchara) is known to be misused by opiate addicts since codeine is partially demethylated to morphine by the genetically polymorphed cytochrome CYP2D6. Although this misuse is often decried, few studies have been published about the characteristics of codeine users or misusers.Since 1992, the French Medicine Agency had requested that the French Network of the 'Centres d'Evaluation et d'Information sur les Pharmacodˇpendances' (CEIP) monitor patterns of codeine misuse. We present the results of a survey investigating codeine use and misuse in the context of a community network of pharmacists in the southwest of France, with a special interest in drug misuse among young people.

Copyright 2002, ADIS International Limited


Pates R; McBride AJ; Li SL; Ramadan R. Misuse of over-the-counter medicines: A survey of community pharmacies in a South Wales health authority. Pharmaceutical Journal 268(7184): 179-182, 2002. (22 refs.)

AIM To investigate community pharmacists' perceptions of the extent of the suspected misuse of over-the-counter (OTC) medicines in South Wales; to identify the OTC preparations that are involved and the factors that alert pharmacists to suspected misuse; and to discover the ways in which pharmacists handle the suspicion of misuse. DESIGN A confidential questionnaire survey. SUBJECTS AND SETTINGS 180 community pharmacies in Bro Taf, a health authority in South Wales. RESULTS A response rate of 89% (161/180) was achieved. 66% (105/161) of respondents believed that there was current OTC misuse in their areas. A list of 36 products suspected of misuse is reported, but attempts to determine a "typical" misuser were less successful. CONCLUSIONS All findings were in line with previous studies, suggesting a widespread OTC drug misuse problem in the UK. The need for standardised policies focusing on particular OTC products is highlighted.

Copyright 2002, Royal Pharmaceutical Society of Great Britain


Peters RJ; Kelder SH; Markham CM; Yacoubian GS; Peters LA; Ellis A. Beliefs and social norms about codeine and promethazine hydrochloride cough syrup (CPHCS) onset and perceived addiction among urban Houstonian adolescents: An addiction trend in the City of Lean. Journal of Drug Education 33(4): 415-425, 2003. (15 refs.)

In the current study, we used a qualitative approach to investigate relevant beliefs and norms associated with codeine and promethazine hydrochloride cough syrup (CPHCS) consumption, initiation, and perceived addiction among 48 alternative school students who identified themselves as current CPHCS users. In general, both boys and girls believed that CPHCS addiction started during an individual's initial consumption. A majority of both groups reported that their second CPHCS event was initiated during the same or next day after their first event. Our findings suggest that friends and an innovative form of hip-hop music called "screw" are strong reinforcers of CPHCS use.

Copyright 2003, Baywood Publishing Co., Inc.


Pierce JP; Gilpin EA. Impact of over-the-counter sales on effectiveness of pharmaceutical aids for smoking cessation. Journal of the American Medical Association 288(10): 1260-1264, 2002. (39 refs.)

Context Successful smoking cessation is a major public health goal. In controlled clinical trials, nicotine replacement therapy (NRT) and the antidepressant bupropion have been shown to significantly increase cessation rates only for moderate to heavy smokers ( greater than or equal to15 cigarettes/d). Nicotine replacement therapy is heavily promoted to the general population by both the pharmaceutical industry and tobacco control advocates. Objective To examine trends in smoking cessation, pharmaceutical cessation aid use, and success in cessation in the general California population. Design, Setting, and Participants The large population-based California Tobacco Surveys of 1992, 1996, and 1999, including 5247 (71.3% response rate), 9725 (72.9% response rate), and 6412 (68.4% response rate) respondents, respectively. Main Outcome Measures Rates of cessation attempts ( greater than or equal to1 day) among smokers in the last year, use of pharmaceutical aids (mostly over-the-counter products since 1996), and cessation success. Results: Between 1992 and 1999, cessation attempts among California smokers increased 61.4% (from 38.1% to 61.5%),and NRT use among quitters increased 50.5% (from 9.3% to 14.0%). A total of 17.2% of quitters used NRT, an antidepressant, or both as an aid to cessation in 1999. In 1996 and 1999, the median duration of aid use (14 days) was much less than recommended, and only about 20% of users had adjuvant one-on-one or group behavioral counseling. Use of NRT increased short-term cessation success in moderate to heavy smokers in each survey year. However, a long-term cessation advantage was only observed before NRT became widely available over-the-counter (August 1996). In 1999, no advantage for pharmaceutical aid users was observed in either the short or long term for the nearly 60% of California smokers classified as light smokers (<15 cigarettes/d). Conclusion: Since becoming available over the counter, NRT appears no longer effective in increasing long-term successful cessation in California smokers.

Copyright 2002, American Medical Association


Poole C; Jones D; Veitch B. Relationships between prescription and non-prescription drug use in an elderly population. Archives of Gerontology and Geriatrics 28(3): 259-271, 1999. (19 refs.)

This paper explores, at an epidemiological level, the relationship between categories of over-the-counter (OTC) and prescribed (Rx) drugs in a community-resident elderly population. A total of 2818, randomly selected, older adults were interviewed at home about their use of prescribed and non-prescribed medication and other health- related factors. For comparative purposes OTC drugs were classified into 16 therapeutic groups-identical to those used by other researchers; prescribed drugs were classified into 45 British National Formulary (BNF) therapeutic sub-categories. Analyses revealed significant association between certain BNF categories and OTC categories, which may have a clinical explanation. These include a 3-fold increase (P < 0.01) of OTC laxative use by those prescribed an antidepressant, and a 4-fold increase (P < 0.001) in OTC antacid use among those prescribed oral corticosteroids. Our findings may indicate an attempt by older people to control side effects of prescription medicines with OTC preparations. This study, in part, supports the call by the Royal College of Physicians for further research to determine the effect of interactions (be they pharmacological, behavioural or otherwise) between OTC and prescribed medicines.

Copyright 1999, Elsevier Science Ireland Ltd.


Pyle KR. FDA v. ephedra: Is it time to lift the ban? Food and Drug Law Journal 61(4): 701-751, 2006. (557 legal refs.)

After more than a decade of deliberation, FDA issued its Final Rule on February 6, 2004, prohibiting the sale of all dietary supplements containing ephedrine alkaloids. The regulation went into effect on April 12, 2004. Ephedra, then, became the first dietary supplement to be banned by FDA under the Dietary Supplement Health and Education Act (DSHEA), a 1994 amendment to the FDCA. The rulemaking process to regulate ephedra began in June of 1997, when FDA published a proposed rule that declared a dietary supplement that contained more than 8 mg of ephedra alkaloids per serving, or a dosage that resulted in 24 mg or more to be consumed in a 24-hour period, according to either labeling or recommended conditions of use, to be adulterated. The rule also proposed that: 1) claims or uses requiring long-term intake be prohibited and that ephedra should not be used for more than seven days; 2) that ephedrine alkaloids not be combined with other stimulants (e.g., caffeine); 3) that warning labels be used to advise consumers of possible drug interactions, particularly those who may be at risk because of certain pre-existing medical conditions; and 4) claims encouraging short-term, higher than usual intakes be accompanied by a warning statement of possible serious side effects. In reaching its Final Rule, FDA had used a "risk/benefits" standard to determine whether ephedra supplements posed an "unreasonable risk of illness or injury under the conditions of use recommended or suggested in labeling, or ... under ordinary conditions of use (in the absence of labeling)" under the Dietary Supplement Health and Education Act (DSHEA). The district court deemed this standard "improper," and also stated that "FDA's requirement that ephedrine-alkaloid dietary supplements (EDS) demonstrate a benefit is contrary to the clear intent of Congress." The note review the peer-reviewed scientific literature, reported adverse events,

Copyright 2006, Food Drug Law Institute


Rastegar DA; Fingerhood MI. Addiction Medicine: An Evidence-Based Handbook. Baltimore: Lippincott Williams & Wilkins, 2005. (Chapter refs.)

This handbook, intended for those in clinical medicine, provides practical and evidence-based guidelines for evaluating, treating, and managing patients with substance abuse problems. It is organized into 17 chapters. The initial four chapters provide an overview of basic constructs, responding to addictions in the primary care setting, the medical interview and an overview of treatment. This discussion includes consideration of different models for understanding addiction problems, the natural history of addiction and the recovery process, the basic clinical skills around screening, the use of drug testing, motivational interviewing, and responding to denial, and a introduction to the basic elements of treatment and the settings in which it is provided. The bulk of the book (10 chapters) are directed to the examination of a specific drug, its epidemiology, acute effects, diagnostic considerations, associated medical complications, and drug-specific treatment elements. Individuals chapters are devoted to alcohol, sedative-hypnotics, opioids, tobacco, cocaine and other stimulants, hallucinogens, marijuana, inhalants, and steroids. The final four chapters consider medical care for the addicted patient, including issues such as problems associated with the route of administration, issues around pain management, and "the difficult" patient. Another chapter is devoted to prescription drug abuse -- markers of abuse, strategies to avoid prescription drug abuse, the products most commonly abuse, as well as discussion too of over-the-counter products. The concluding chapters consider special populations -- women, the elderly, adolescents, prisoners -- as well as issues related to co-occurring mental illness.

Copyright 2006, Project Cork


Roehrs T; Hollebeek E; Drake C; Roth T. Substance use for insomnia in metropolitan Detroit. Journal of Psychosomatic Research 53(1): 571-576, 2002. (15 refs.)

Objective: People with insomnia are not typically treated medically for their insomnia. Studies have reported approximately 30% of insomniacs self-medicate with alcohol or over-the-counter (OTC) medications. This study was done to identify determinants and risks of different insomnia therapeutics. Methods: A random-digit-dial, computer-assisted survey of a representative sample of adults in Metropolitan Detroit, aged 18-65 years, is being conducted. A sample of all respondents over an 18-month period was collected (n=1324) with a 68% response rate. Exclusive past-year use of alcohol for sleep was reported by 10% (n=132), prescription medications by 8% (n=108), and OTC medications by 10% (n=135). Five percent used both alcohol and sleep medications. The three exclusive-use groups formed the comparison groups of the study. Results: The prescription drug group used medications for more consecutive nights and for more total nights than the alcohol and OTC users. Alcohol users were predominately male, while OTC and prescription drug users were predominately female. Alcohol users were more likely to be single than the others, and prescription drug users were older than the others. Prescription drug users had more severe insomnia and had greater disability, neuroticism, and daytime fatigue than the others. In contrast, the alcohol users had greater daytime sleepiness than the others. Conclusions: In Metropolitan Detroit, insomniacs receiving medical treatment have more severe insomnia and greater disability than those who self-treat. However, while the insomnia of those self-treating is less severe, it is still associated with some risks.

Copyright 2002, Pergamon Press


Saseen JJ. Does acetaminophen affect liver function in alcoholic patients? (editorial). Journal of Family Practice 52(3): 187-188, 2003. (1 refs.)


Scher CS; Anwar M. The self-reporting of psychiatric medications in patients scheduled for elective surgery. Journal of Clinical Anesthesia 11(8): 619-621, 1999. (10 refs.)

Study Objective: To determine by survey the percentage of patients, over the age of 21 years, reporting for elective surgery who also are taking psychotropic medications. Design: Institution-approved, anonymous survey. Setting: Teaching hospital. Patients: 169 patients who were scheduled for elective surgery. Interventions: After completion of the preoperative evaluation by members of the anesthesia care team, all patients were given an institution-approved survey of medications. They survey listed 33 drugs known to affect central nervous system neurotransmitters, and included the most commonly prescribed antidepressants, antipsychotics, benzodiazapines, and lithium. Over-the-counter drugs known to affect mood, such as melatonin, also were included in the survey. Patients were not asked the indications for the medications, and no psychiatric question were asked of the patients. Measurements and Main Results: 300 surveys were distributed, and 169 patients completed the survey for a response rate of 53%. Forty-three percent of all patients who completed the survey admitted to taking one or more of the psychotropic medications. Of these patients, 35% were taking antidepressants, 34% were taking benzodiazapines, 19% were taking combination therapies, and 11% took antipsychotics, lithium, or over-the-counter drugs such as melatonin. Conclusion: The number of patients taking psychotropic medications and who present for elective surgery is high. The anesthetic implications of this drug usage are essentially unknown. Additional study of these medications and their impact on anesthetic care is warranted.

Copyright 1999, Elsevier Science, Inc.


Shiffman S; Hughes JR; Di Marino ME; Sweeney CT. Patterns of over-the-counter nicotine gum use: Persistent use and concurrent smoking. Addiction 98(12): 1747-1753, 2003. (18 refs.)

Aims: To examine the occurrence of persistent use (i.e. use beyond 12 weeks) and concurrent use of nicotine gum with cigarettes among consumers who purchase nicotine gum over-the-counter (OTC). Design: Assessment of gum use was conducted in the context of a smoking cessation trial among smokers who purchased Nicorette gum and enrolled in the optional Committed Quitters smoking cessation program. Eligible participants were contacted by telephone 6 weeks and 12 weeks following their self-selected target quit date. Those who reported gum use at 12 weeks were contacted again at week 24. Participants: A total of 2655 current smokers who purchased nicotine gum and enrolled in a clinical efficacy trial of the Committed Quitters program. Measurements: Detailed information on smoking and gum use, including frequency of use, amount used and reasons for use was obtained at each of the three follow-up assessments. Findings: At the 24-week assessment, 6% of participants reported current use of nicotine gum (i.e. persistent use). Those engaging in persistent use averaged 4.7 (SD = 2.5) days of gum use per week and 3.2 (SD = 3.5) pieces of gum per day. Sixty-six per cent of persistent users reported at week 24 that they were not currently smoking, and 67% of persistent users reported they were using gum to establish or maintain abstinence. At the 6-, 12- and 24-week assessments, 14%, 10% and 2% of participants, respectively, reported current use of nicotine gum and current cigarette smoking (i.e. concurrent users). Those concurrent users reported at the 12-week follow-up that they did so an average of 4.4 (SD = 2.1) days per week, that they chewed an average of 2.6 (SD = 3.5) pieces of nicotine gum per day and that they smoked an average of 8.7 (SD = 8.6) cigarettes per day. Conclusion: Extended use of nicotine gum is rare. Concurrent use with cigarettes is uncommon. In both cases, the amount of gum use is small. OTC marketing of nicotine gum does not appear to have increased use contrary to labeling nor resulted in patterns of use that should warrant clinical or public health concerns.

Copyright 2003, Society for the Study of Addiction to Alcohol and Other Drugs


Shiffman S; Sweeney CT. Ten years after the Rx-to-OTC switch of nicotine replacement therapy: What have we learned about the benefits and risks of non-prescription availability? Health Policy 86(1): 17-26, 2008. (69 refs.)

Objective: Review the history of the Rx-to-OTC switch of nicotine replacement therapy (NRT) in the US, outlining concerns expressed before the switch, discussing how concerns were addressed, and presenting data on the actual experience in the decade following the switch. Methods: Literature review of studies examining trends in NRT utilization pre- and post-switch, the efficacy and safety of NRT in the OTC setting, and patterns of OTC NRT use. Results: OTC availability of NRT increased access to and utilization of treatment. Studies show that OTC NRT has been used safely and effectively, without substantial misuse or abuse, and with continued physician engagement and wide access to proven behavioral treatment. Conclusions: With other medications that challenge the traditional OTC paradigm being proposed for OTC switch, the NRT case study serves as a useful example in highlighting the potential role that Rx-to-OTC switch can play in addressing public health challenges. The NRT experience suggests that advance identification and analysis of concerns, implementation of plans to manage concerns, including appropriate marketing and post-marketing surveillance, can ensure that OTC switch of medications for behavior change and disease prevention can help minimize risks and maximize public health benefits.

Copyright 2008, Elsevier Science


Sihvo S; Klaukka T; Martikainen J; Hemminki E. Frequency of daily over-the-counter drug use and potential clinically significant over-the-counter-prescription drug interactions in the Finnish adult population. European Journal of Clinical Pharmacology 56(6-7): 495-499, 2000. (18 refs.)

Objective: To explore the frequency of continuous use of over-the- counter (OTC) drugs among the Finnish adult population and the potential for harmful interactions between OTC drugs and prescribed (Rx) drugs. Methods: Data were extracted from a 1995-1996 population-based interview survey on health care (n = 10,477, response rate 86%). The drug interaction classification system from the Swedish Drug Compendium FASS 1997 was used to identify OTC drugs likely to have clinically significant interactions with prescription drugs. Logistic regression was used to study factors related to continuous use and risks for interactions. Results. Seventeen percent of the population had used OTC drugs and 15% had used OTC vitamins during the 2 days prior to the interview. Daily use of OTC drugs and of vitamins was reported by 7% and 9%, respectively. Continuous use of OTC drugs was related to older age, female gender, higher education, poor health status, long-term morbidity, psychosomatic symptoms (fatigue) and use of prescription drugs, but not to poor lifestyle. Four percent of the OTC drug users had taken drug combinations with potential for clinically significant interactions. Interactions were mos