1,483
Views
30
CrossRef citations to date
0
Altmetric
Review

Abuse of over-the-counter medicines: a pharmacist’s perspective

, , &
Pages 1-6 | Published online: 19 Dec 2016

Abstract

Self-care and self-medication practices are essential components of any health care systems. The use of over-the-counter (OTC) medications is a part of the self-medication process. The popularity of OTC medication use among patients may increase the abuse potential of OTC medications. With pharmacists being as accessible as they are, they are often the first line of contact for patients, and have the opportunity to educate and counsel patients on appropriate OTC medication use. The presence of a pharmacist ensures safe and effective use of OTC medications. Pharmacists can liaise with other health care providers in the management of self-care practices by patients. However, a pharmacist has traditionally been underutilized in this role. This article provides a brief review on OTC medications with abuse potential and the effect of self-medication on OTC medication abuse. This review further describes the barriers faced by pharmacists in OTC medication abuse management, given the increased potential of prescription-to-OTC switch in recent years. In addition, the potential for a behind-the-counter drug category to boost patient–pharmacist interaction was discussed. The current review supports the positive role played by pharmacists in the management of OTC medication abuse. This review adds to the knowledge base of the barriers faced by pharmacists to prevent OTC medication abuse while developing appropriate intervention strategies. By expanding the role of pharmacists, OTC medication abuse may be controlled more effectively, thereby providing better patient medication therapy management and outcomes.

Introduction

Medications obtained by patients for treatment of common ailments, without a prescription from a physician, are known as over-the-counter (OTC) or non-prescription medications. OTC medications provide prevention and treatment for a wide range of conditions, including but not limited to headaches, common cold, musculoskeletal pain, allergies, tobacco dependence, and heartburn.Citation1 However, there is always a risk involved in using OTC medications.Citation1,Citation2 These include improper self-diagnosis, inappropriate dosage, addiction issues upon prolonged use, adverse drug reactions, and drug interactions.Citation3,Citation4 As most patients do not discuss their OTC medications with a physician, they are unaware of the risks associated with OTC medications.Citation5 In addition, direct-to-patient advertising increases the exposure of medications to patients.Citation5 As a result, there is increased product use in the absence of professional help.Citation4,Citation6 OTC medication abuse for the purpose of this review is defined as the use of non-prescription medications for non-medical purposes.Citation7 Abuse is often intentional, unlike OTC medication misuse, which may be medication used for medical purposes but used incorrectly, for example, incorrect dosage, lack of interactions knowledge, inappropriate medication use, and incorrect duration of use.Citation8

However, there is a growing concern of the potential harm associated with these medications. The objective of this article is to provide a brief review of the OTC medication abuse, extent of the OTC medication abuse, the role of pharmacists to address this issue, the concept of behind-the-counter (BTC) medications, and needed future steps that must be taken by pharmacists and the pharmacy profession to curb the issue with nationwide impact. While there have been articles studying the OTC medications and abuse, very few have reviewed the barriers faced by pharmacists and the steps to prevent abuse from a pharmacy-based approach. This review will provide pharmacists and researchers a perspective to consider the possible role played by pharmacist in reducing OTC medication abuse and how strategies can be implemented to reduce it further.

OTC medication abuse

OTC medications with most potential for abuse

Multiple OTC medications have abuse potential. Commonly abused medications include antihistamines, sleep aids, caffeine, ephedrine, pseudoephedrine, antitussives and expectorants, dextromethorphan, laxatives, anabolic steroids, and sildenafil.Citation9Citation11 Laxatives are abused for weight loss and high antihistamines doses are used for euphoria.Citation12 From the studies done across the world for OTC medication abuse, opiate-based combination products and cough/cold products containing dextromethorphan, sleep aids, antihistamines, analgesic, hypnotics, and laxatives have been highlighted as having abuse potential. Cough medicines and painkillers are most abused medications. OTC codeine or other opiate-containing products and OTC cough and cold medications are the most commonly implicated medications for abuse.Citation7,Citation13,Citation14 Codeine is not available as OTC in the US. However, it is a primary medicine with abuse potential in other countries.Citation15 Numerous studies have recorded OTC codeine analgesics as the most commonly abused medication.Citation6,Citation16,Citation17 highlights the OTC medications with high abuse potential.

Table 1 List of over-the-counter medications abused

One of the probable reasons for OTC abuse is increased access to medications. This is because medications for common illnesses are made accessible by prescription (Rx)-to-OTC switch.Citation16 Most switches are driven by firm’s patent expiration. However, in case of prescription antihistamines like Claritin, Zyrtec, and Allegra, Blue Cross and their parent company petitioned the switch to the US Food and Drug Administration (FDA).Citation17 Providing patients with autonomy, diagnosis of the condition on the patient’s judgment and the absence of a physician may lead to inaccurate self-diagnosis.Citation5 For example, the availability of treatment for dyspepsia masks the presence of a severe gastrointestinal disease, which may not be diagnosed by patients.Citation16 Lack of pharmacist vigilance may lead to long-term inappropriate use of OTC medications and hamper the health of patients.Citation5

Switching of drugs increases patient autonomy while encouraging them to make their health care decisions.Citation16 About $12.9 billion savings were recorded for the switch of cold/allergy, analgesics, and dermal products.Citation18 However, this increasing number of medications being switched to OTC status increased the spectrum of medications available for abuse.Citation19 For example, the switch of acetaminophen from prescription to OTC has led to increased cases of severe liver hepatotoxicity.Citation20 If abused, acetaminophen leads to withdrawal symptoms, in addition to suicidal thoughts and liver failure.

Role of pharmacist in OTC medications

Patients have easy and free access toward seeking advice from a pharmacist. Many issues faced by a patient can be easily solved by pharmacists, including product selection, OTC brand name confusion, appropriate product use, and when to take medications. Thus, pharmacists exercise a strong influence on OTC medication purchase and product selection.

Many patients find product selection confusing due to marketing strategies by manufacturers. A common marketing technique by pharmaceutical manufacturers is line extension.Citation5 A large percent of revenue is spent on OTC medication advertisements and line extensions. Once a manufacturer has an established brand name, other products are sold under the extension of the same brand. For example, the primary brand Tylenol® has many line extensions including Tylenol PM®, and Tylenol Cold and Cough®. This often leads to confusion among the minds of patients. Many times these line extensions have multiple ingredients causing more confusion. A patient–pharmacist interaction would help patients in their decision-making process during these instances.

OTC advertisements are often the driving factor in OTC medication selection by the patients. If the advertisements are misleading, a patient may be misinformed.Citation21 The advertisements focus upon the beneficial effects of the medication with bare information on the contraindications and safety concerns. With this regard, a pharmacist can also provide insight into all aspects of the drug, as well as information on the safe use of OTC medications.Citation19,Citation22

Pharmacy-based efforts to address OTC medication abuse

Pharmacist’s role in OTC medication abuse

Historically, pharmacists focused on the medication distribution system. Over the past years, with the rising incidence of chronic illness, increased need for preventive services, and complex use of medications, both pharmacists and pharmacy technicians are expected to provide broader services. They assume more clinically patient-oriented roles.Citation14 Within a hospital setting, certified pharmacy technicians have demonstrated positive impacts by obtaining medication history and conducting medication reconciliation for patients.Citation7,Citation15,Citation23Citation25 Furthermore, pharmacy technicians help with care transitions from the hospital setting to the home and community settings.Citation26 The dynamic environment of the health care system demands to expand the role of a pharmacist and pharmacy technician.

Pharmacists are the first point of contact during the purchase of OTC medications. They are required to monitor OTC medication use among a specific population.Citation7 For example, in the case of elderly patients, who take multiple medications, pharmacists should be more vigilant. Also, patients who come in with request for frequent refills must be monitored as well including OTC medications used.Citation27 Pharmacists can be more proactive in managing OTC medication abuse by utilizing their clinical skills, by providing oral and written medication information, and by developing trust among patients.Citation23,Citation28 Programs like prescription drug monitoring log information about a patient upon refills of prescription drugs. While if a similar program were set up for OTC medications, the person would have to visit the same pharmacy always. Hence, implementation of such a program may not be pragmatic.

Several methods employed by pharmacists to reduce OTC medication abuse have been suggested in the past.Citation28 The top three methods used by pharmacists to control OTC medication abuse were keeping the implicated products out of sight, questioning on the purchase of these products by pharmacists, and refusal to sell the implicated product.Citation3,Citation29 It was demonstrated that 62% of pharmacists reported certain measures being taken to curb OTC medication abuse, for instance, not displaying medicines, refusing sales, and associated policies including pharmacist’s conducting an interview of the patient. The interview may include asking additional questions to patients at the time of purchase and providing advice to patients as necessary to reduce abuse of potential products.Citation24 Some other techniques used and reported by pharmacists to reduce OTC medication abuse were referral to a physician, referral to a drug and alcohol abuse team, and/or involvement of pharmacists in harm reduction programs.Citation17 lists the strategies that can be adopted in different locations and scenarios to curb OTC abuse.

Table 2 Common strategies used by pharmacists to control over-the-counter medication abuse

Barriers for pharmacists to prevent OTC medication abuse

There are multiple challenges faced by pharmacists and their pharmacies in monitoring OTC abuse. Due to lack of consistent data with OTC medications, identification of drug-related problems may become difficult. Pharmacists usually never keep any record or monitor patient medication profiles for OTC medication use, which creates a vacuum in the information necessary to make appropriate counseling decisions.Citation30

An individual seeking to abuse an OTC medication could probably obtain it from the same pharmacy at different times or visit different pharmacies for the same medication. However, considering this potential to abuse medications, specifically pseudoephedrine, US federal government passed the Combat Methamphetamine Epidemic Act of 2005 (CMEA). This act was passed to monitor the amount of pseudoephedrine which an individual can purchase in a pharmacy in the US.Citation31 The aim of this act was to curb illegal consumption of methamphetamine which can be bulk produced using drugs like ephedrine and pseudoephedrine that are commonly found in OTC cough and cold medications. The CMEA has placed a purchase limit of no more than 9 g of pseudoephedrine in a 30-day period.Citation31 Although this act has successfully helped reduce the issue of OTC medication abuse of pseudoephedrine-containing products, adaptation of this process for other medications proactively by pharmacists has been non-existent in the US.

In addition, the lack of pharmacist’s proactive initiatives to monitor patient’s OTC medication use has led to many abuse opportunities. Pharmacists are usually overworked and the continuous high stress prescription processing workload also reduces the potential opportunities to be pharmacovigilant. Further, the legal requirements associated with medication distribution have not kept up with the abuse potential nor are the laws for the practice of pharmacy revised or kept up with patient or pharmacist needs.Citation30

For example, a study conducted in a community pharmacy indicated that pharmacists were overworked.Citation32 The lack of workforce in a pharmacy led to reduced attention and problem identification among the patient’s OTC decisions.Citation32 Further, the role of pharmacy technicians has not been adequately utilized to improve the practice of pharmacy. Due to limited number of pharmacists, pharmacy technicians are an important aspect in preventing OTC medication abuse as well. Pharmacy technicians provide an extra layer for patient safety. They can help pharmacists with roles like drug dispensing, obtaining patient information, and processing order entry. Their vigilance during these processes may further help in reducing OTC medication abuse.Citation32

There are several programs in place to counter prescription drug abuse; OTC medication abuse has been overlooked. Pharmacy take back programs, drug monitoring programs as well as vigilance of professional pharmacy programs like the American Pharmacists Association (APHA) have been notable in the past few years and little focus has been provided for OTC medication abuse.

BTC medications: a promising third class

BTC medications are defined as “a third category of drugs available without a prescription; placed BTC, they are available only after consultation with a pharmacist.”Citation33 BTC medications are widely adopted in many countries including the UK, Ireland, Canada, New Zealand, France, and Australia.Citation34Citation36

The need for a BTC category was first assessed in 1995 by the Government Accountability Office (GAO) in the US while it was rejected by the FDA at that time. In 2007, the idea was re-proposed by the FDA and then reevaluated by GAO in 2009, without any conclusive statement. The FDA requested comprehensive evidence about the role that a potential BTC category would play in the US since 2007.

To distinguish from OTC medications, the characteristics of BTC medications are dispensing only with professional supervision. This ensures the safety, appropriateness, effectiveness of the dispensed medication, and increased control over medications with high clinical risk.Citation37 However, implementation of BTC medication requires pharmacists and technicians to be qualified to perform initial assessments and screenings, medication reviews, patient counseling, and medication monitoring.

Some of the medications potential for transition to BTC category include those used for high blood pressure, high cholesterol, asthma, gastrointestinal reflux, allergies, and pain.Citation37 To name a few as examples, aspirin/hydrocodone and nabilone (antiemetic) are listed as schedule II drugs in Canada, the counterpart of a BTC category, and children’s cough and cold medications were recommended to be included into BTC by pharmacists for safety consideration.Citation38 A similar class is required within the US. The current OTC medications with high abuse potential should be included under this medication class. provides a list of medications that could be moved to BTC.

Table 3 Medications potential for transition to behind-the-counter category

Despite the seemingly attractive prospects of BTC medication, including the potential to reduce medication abuse, the implementation of BTC medication category is controversial among primary stakeholders. Considering the safety and effectiveness of BTC medications, the Consumers Union and the National Consumers League argued for supportive evidence to make a national move to develop a third category, while the Consumers Healthcare Products Association (CHPA) opposed it. Physician organizations questioned the adequacy of pharmacists to provide clinical services, with a primary concern about the impact of BTC on physician–patient relationship. However, majority of pharmacy organizations provided a strong backing to the implementation of BTC medication.Citation39

To facilitate the implementation of BTC medication category, the following recommendations were made: demonstration of benefits outweighing the risks, evidence for positive outcomes, financial savings to society, sufficient allocation of resources, and appropriate compensation systems.Citation37 The BTC medication class provides adequate opportunities for pharmacists to reduce OTC medication abuse. The FDA should consider the BTC medication category to reduce OTC medication abuse.

Role of pharmacists in BTC medications

The presence of a pharmacist would be essential to purchase a BTC medication. These medications should be provided only upon a pharmacist’s recommendation. Upon performing the necessary tests, initial screenings and appropriate counseling a BTC medication can be dispensed. Some of the potential candidates could be patients with high blood pressure, gastrointestinal reflux, asthma, severe allergies, and pain.Citation5,Citation37 All current OTC medications with high abuse potential can be included as BTC medications. If the pharmacists work collaboratively with their patients, it will lead to informed decision making and safer use of medications. Once a pharmacist disapproves a particular medication, they should refuse to dispense it. BTC medication is a bridge between OTC and prescription medications, with a potential to increase access of health care while efficiently using the knowledge and expertise of a pharmacist.

Conclusion

This review concludes that pharmacists need to be well informed of the OTC medications which have an abuse potential. Better communication strategies between pharmacists and patients may help pharmacists understand the issues of OTC medication abuse. OTC medicine abuse was identified in many countries. The implementation of a new class of BTC medications will help improve patient monitoring while curbing potential OTC medication abuse.

Pharmacists do play an essential role in counseling patients. Pharmacist vigilance can help reduce OTC medication abuse. The current health care system calls for more regulation on OTC medications, especially those with identified abuse potential. We need to strike a balance between providing the required access to medications and at the same time managing the risk of OTC medication abuse. Finally, the data collection and reporting for OTC medication abuse can be standardized with distinctive reporting for medication misuse, abuse, and addiction.

Disclosure

The authors report no conflicts of interest in this work.

References

  • AndersonJGDemographic factors affecting health services utilization: a causal modelMed Care19731121041204688477
  • WazaifyMShieldsEHughesCMMcElnayJCSocietal perspectives on over-the-counter (OTC) medicinesFam Pract200522217017615710640
  • HughesCMMcElnayJCFlemingGFBenefits and risks of self medicationDrug Saf200124141027103711735659
  • BondCHannafordPIssues related to monitoring the safety of over-the-counter (OTC) medicinesDrug Saf200326151065107414640771
  • SansgirySSPatelHKNonprescription DrugsSwarbrickJEncyclopedia of Pharmaceutical Science and TechnologyFourth EditionBoca Raton, FLCRC Press2013
  • AronsonJOver-the-counter medicinesBr J Clin Pharmacol200458323123415327581
  • CooperRJ‘I can’t be an addict. I am.’ Over-the-counter medicine abuse: a qualitative studyBMJ Open201336e002913
  • HallGCSauerBBourkeABrownJSReynoldsMWLoCasaleRGuidelines for good database selection and use in pharmacoepidemiology researchPharmacoepidemiol Drug Saf2012211110
  • WilliamsJFKokotailoPKAbuse of proprietary (over-the-counter) drugsAdolesc Med Clin2006173733750 abstract xiii17030289
  • TsengYLHsuH-RKuoF-HShiehMHChangCFEphedrines in over-the-counter cold medicines and urine specimens collected during sport competitionsJ Anal Toxicol200327635936514516489
  • TinsleyJAWatkinsDDOver-the-counter stimulants: abuse and addictionMayo Clinic Proc19987310977982
  • SansgirySSNadkarniADoanTMisuse of over-the-counter medications among community-dwelling older adults and associated adverse drug eventsJ Pharmaceutical Health Serv Res201014175179
  • MurphyJCAmericans make choices about self-careAm J Health-SystPharm200158161494
  • DerrySMooreRAMcQuayHJSingle dose oral codeine, as a single agent, for acute postoperative pain in adultsCochrane Database Syst Rev20104CD00809920393966
  • McBrideAJPatesRRamadanRMcGowanCDelphi survey of experts’ opinions on strategies used by community pharmacists to reduce over-the-counter drug misuseAddiction200398448749712653818
  • SollerRWEvolution of self-care with over-the-counter medicationsClin Ther199820C134C1409915100
  • EickhoffCHämmerleinAGrieseNSchulzMNature and frequency of drug-related problems in self-medication (over-the-counter drugs) in daily community pharmacy practice in GermanyPharmacoepidemiol Drug Saf201221325426021953893
  • SollerROTCness: Then and nowPharm Med Pack News1998616
  • BrassEPChanging the status of drugs from prescription to over-the-counter availabilityN Engl J Med20013451181081611556302
  • LarsonAMPolsonJFontanaRJAcetaminophen-induced acute liver failure: results of a United States multicenter, prospective studyHepatology20054261364137216317692
  • CovingtonTSelf-care and nonprescription pharmacotherapyAm J Pharm Association2000314
  • MercolaJDroegeRSeven common misconceptions about Tylenol and other OTC drugs2004 Available from: http://www.mercola.com/2004/feb/7/over_the_counter.htmAccessed November 23, 2011
  • RoussinABouyssiAPouchéLLapeyre-MestreMMisuse and dependence on non-prescription codeine analgesics or sedative H1 antihistamines by adults: a cross-sectional investigation in FrancePLoS One2013810e7649924098516
  • RomanelliFSmithKMDextromethorphan abuse: clinical effects and managementJ Am Pharm Assoc (2003)2009492e202519289333
  • ReedKBondAWittonJThe changing use of prescribed benzodiazepines and z-drugs and of over-the-counter codeine-containing products in England: a structured review of published English and international evidence and available data to inform consideration of the extent of dependence and harmLondonThe National Addiction Centre, Kings College London2011
  • Abuse (drug, alcohol, chemical, substance or psychoactive substance) Available from: http://www.who.int/substance_abuse/terminology/abuse/en/Accessed May 16, 2016
  • American Pharmacists Association2006Avoiding Medication Errors Available from: http://www.pharmacist.com/AM/Template.cfm?Section=Search1&template=/CM/HTMLDisplay.cfm&ContentID=3546Accessed November 25, 2011
  • MajorCVinczeZConsumer habits and interests regarding nonprescription medications in HungaryFam Pract201027333333820067976
  • HughesCMMonitoring self-medicationExpert Opin Drug Saf2003211512904120
  • HämmerleinAGrieseNSchulzMSurvey of drug-related problems identified by community pharmaciesAnn Pharmacother200741111825183217925500
  • MurtySSansgirySSPseudoephedrine laws in the US – are we doing enough?Ann Pharmacother20064061213121416735651
  • WesterlundTAlmarsdóttirABMelanderADrug-related problems and pharmacy interventions in community practiceInt J Pharm Pract1999714050
  • SegaTSullivanDLAssessment of pharmacists’ opinions toward the behind-the-counter category of medicationsJ Am Pharm Assoc (2003)201151453553821752777
  • RoerigJLSteffenKJMitchellJEZunkerCLaxative abuse: epidemiology, diagnosis and managementDrugs201070121487150320687617
  • BenrimojSIGilbertAEmmertonLA cost-benefit analysis of Pharmacist Only (S3) and Pharmacy (S2) Medicines and risk-based evaluation of the standards2005
  • EmmertonLThe ‘third class’ of medications: sales and purchasing behavior are associated with pharmacist only and pharmacy medicine classifications in AustraliaJ Am Pharm Assoc (2003)2009491313719196594
  • RiedLDHustonSAKucukarslanSNSogolEMSchafermeyerKWSansgirySSRisks, benefits, and issues in creating a behind-the-counter category of medicationsJ Am Pharm Assoc (2003)2011511263921247824
  • LeslieSRGwadry-SridharFThiebaudPPatelBVCalculating medication compliance, adherence and persistence in administrative pharmacy claims databasesPharma Prog2008111319
  • SweilehWMArafatRTAl-KhyatLSAl-MasriDMJaradatNAA pilot study to investigate over-the-counter drug abuse and misuse in PalestineSaudi Med J200425122029203215711697
  • GriffithsRRJohnsonMWRelative abuse liability of hypnotic drugs: a conceptual framework and algorithm for differentiating among compoundsJ Clin Psychiatry200566Suppl 9314116336040
  • BakerSDBorysDJA possible trend suggesting increased abuse from Coricidin exposures reported to the Texas Poison Network: comparing 1998 to 1999Vet Hum Toxicol200244316917112046973
  • MiechRAJohnstonLDO’malleyPMBachmanJGSchulenbergJE“Monitoring the future – National survey results on drug use, 1975–2014Bethseda, MDNational institute on Drug Abuse; National Institutes of Health; US Department of Health and Human Services2007
  • LessengerJEFeinbergSDAbuse of prescription and over-the-counter medicationsJ Am Board Fam Med2008211455418178702
  • PomeranzJLTaylorLMAustinSBOver-the-counter and out-of-control: legal strategies to protect youths from abusing products for weight controlAm J Public Health2013103222022523237149
  • Albsoul-YounesAWazaifyMYousefA-MTahainehLAbuse and misuse of prescription and nonprescription drugs sold in community pharmacies in JordanSubst Use Misuse20104591319132920509736
  • Paulose-RamRHirschRDillonCLosonczyKCooperMOstchegaYPrescription and non-prescription analgesic use among the US adult population: results from the third National Health and Nutrition Examination Survey (NHANES III)Pharmacoepidemiol Drug Saf200312431532612812012
  • RiedLDHustonSAKucukarslanSNSogolEMSchafermeyerKWSansgirySSRisks, benefits, and issues in creating a behind-the-counter category of medicationsJ Am Pharm Assoc (2003)2011511263921247824
  • SenakMBehind-the-Counter Drug AccessAm Health Drug Benefits2008125657
  • PrayWSPrayGEBehind-the-counter products: a third class of drugsUS Pharm20113691115
  • HustonSAPorterKBClementsTShepherdGPharmacists’ attitudes towards pediatric cough and cold products and behind the counter statusJ Pediatric Pharmacol Ther2010152126137
  • Nonprescription drugs: considerations regarding a behind-the-counter drug classOfficeGAWashington, DCGovernment Accountability Office2009
  • Alphabetical list of medicines for human useRoyal Pharmaceutical Society2010