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Risks of Self-Medication Practices

Article · October 2010

DOI: 10.2174/157488610792245966 · Source: PubMed

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Risks of self-medication practices

María Esperanza Ruiz

Quality Control of Medications, Department of Biological Sciences, Faculty of Exact Sciences,

National University of La Plata (UNLP). 47 & 115 (B1900AJI) – 542214235333 ext 43.
eruiz@biol.unlp.edu.ar.

Current Drug Safety, 2010, 5 (4): 315 - 323

Received : 09/17/2009
Revised : 10/14/2009
Accepted : 11/09/2009

Keywords: self-medication – drug interactions – adverse reactions to medications -

polypharmacy

ABSTRACT

Self-medication is defined as the selection and use of medicines by individuals (or a

member of the individuals’ family) to treat self-recognized or self-diagnosed conditions
or symptoms. Several benefits have been linked to appropriate self-medication, among
them: increased access to medication and relief for the patient, the active role of the
patient in his or her own health care, better use of physicians and pharmacists skills
and reduced (or at least optimized) burden of governments due to health expenditure
linked to the treatment of minor health conditions However, self-medication is far from
being a completely safe practice, in particular in the case of non-responsible self-
medication. Potential risks of self-medication practices include: incorrect self-
diagnosis, delays in seeking medical advice when needed, infrequent but severe adverse
reactions, dangerous drug interactions, incorrect manner of administration, incorrect
dosage, incorrect choice of therapy, masking of a severe disease and risk of dependence
and abuse. In this short review the author analyzes recent literature on some of the most
important dangers related to self-medication practices, particularly: polypharmacy and
drug interactions, medications abuse or dependence, misdiagnosis and incorrect choice
of treatment. The author also proposes measures that could be adopted in order to solve
or improve these issues.

1
INTRODUCTION

Self-medication involves the use of medicinal products by the patient to treat self-

recognized disorders or symptoms [1]. It also includes the selection of a medication for

a chronic or recurrent condition by the patient, after an initial diagnosis and prescription

by a physician. We may also regard as self-medication the administration of medicinal

products to family members, specially infants, children or the elderly [1] (see

Pfaffenbach et al article in this same volume).

Responsible self-medication involves the use of non-prescription, safe, quality

medicinal products for conditions that are easily self-diagnosed or for recurrent

conditions that have been previously diagnosed by a physician [2]. World Health

Organization points out that responsible self-medication requires the medicinal product

to be supported with information describing how to take the medicine, possible side-

effects, monitoring, possible interactions, warnings, duration of use, etc. It should also

be noted that since herbal medicines are regulated as over-the-counter (OTC) medicinal

products, self-medication only medicines/drugs, dietary supplements, functional or

health food in most countries [3], the use of herbal medicines also constitutes a potential

case of responsible-self medication, provided that they are supported by the appropriate,

aforementioned information (see Consolini et al article in this same volume).

There are many individual and social benefits linked to self-medication practices

[1,4,5]. It facilitates prompt access to medication providing faster relief to the patient,

which is a particularly important issue in those countries with congested (private and/or

public) health systems, where getting an appointment with a physician could be

2
problematical. This is a very important argument in favor of self-medication when

delays in access to the medication could endanger the patient or jeopardize the efficacy

of the treatment (e.g. contraception pills or asthma treatments). Thus, easy access to

medication can also provide psychological support to chronic patients, reducing anxiety

related to the possibility of running out of medication and helping to develop self-

reliance in preventing or relieving symptoms. From a social perspective, self-

medication moves patients towards greater independence in making decisions about

management of minor health conditions, which is in line with the modern ideal of a

well-informed patient actively involved in health and disease management. Self-

medication saves scarce medical resources from being wasted in minor conditions;

public expenditure in health may then be redirected to more severe disorders. It also

helps better use of physicians’ and pharmacists’ skills. From an economic perspective,

self-medication helps avoiding unnecessary medical consultations; it lowers the cost of

community-based health programs (which may be regarded as an advantage or a

disadvantage depending on the social scenario) and reduces absenteeism from work due

to minor health disorders.

However, self-medication is also linked to several risks for the self-medicated patient

and, in some cases, for the community [1,4,5]. Many of these risks are not limited to

self-medication and may also occur in the prescription situation (although they are often

less likely if correct medical protocols are observed by the physician). Other risks

constitute particular dangers of the self-medication practice. Among the dangers of self-

medication we may quote incorrect self-diagnosis; masking of an underlying severe

health condition and consequent failure to seek medical advice promptly; rare but severe

adverse effects; failure to recognize contraindications and potential drug-drug and drug

3
–food interactions; incorrect route or manner of administration; inadequate dosage; risk

of dependence or abuse; storage in incorrect conditions and; incorrect choice of therapy.

At the community level, improper self-medication produces an increment in drug-

induced disease with the consequent increase in public health expenditure.

In this short review we will attend three of the most important dangers connected to

self-medication practices, namely: multiple drug use and risk of drug interactions; OTC

drug abuse and; misdiagnosis and incorrect choice of therapy. We will concentrate on

recent literature on these issues and we will discuss general and particular solutions to

these subjects.

MULTIPLE DRUG USE AND THE RISK OF DRUG INTERACTIONS

A drug interaction is defined as the modification of the effect (therapeutic effect and/or

toxicity) of a drug by concomitant or previous administration of another drug or food

[6]. The probability of prejudicial drug-drug interactions is expected to increase

exponentially with the number of drugs taken simultaneously by a patient [7,8].

Because of several reasons of physiological nature, the elderly are particularly exposed

to potential drug interactions. Firstly, since a larger number of co-morbid conditions are

present in this age group, the number of medications taken by older persons tends to be

large (see figure 1) [9,10]. Secondly, reduced renal drug elimination, decreased hepatic

drug clearance, reduction of the body water content and increment of body fat content

make drug interactions more likely at old age [11]. As a result, adverse drug reactions

occur two to three times more frequently in patients over 65, and when taking 10

medications simultaneously elder patients have a 100% chance of an adverse drug

4
interaction [11,12,13]. As we may note in several of the studies cited below this

paragraph, OTC medications (including OTC herbal medicines and dietary supplements

containing herbal drugs) are frequently implicated in drug-drug interactions and tend to

increase the mean number of medications administered to old patients, raising the

chances of a negative drug-drug interaction.

Fig.1. The prevalence of one or more (DP ≥ 1) and five or more (DP ≥ 5) dispensed drugs
related to gender and age groups in Sweden, 2006. Note how the proportion of polymedicated
patients increases with age (graph taken from Hovstadius et al., 2009).

While observation of advice on package inserts and labels contributes to the safe use of

OTC medicines and even though labels and package inserts clearly refer potential drug

and food interactions and advise against long-term intake of OTC drugs, impairment of

cognitive functions (memory, concentration, recognition, vision, comprehension) in the

elderly is an additional factor that makes this particular group vulnerable to adverse

interactions due to misinformation [9]. Furthermore, old people tend to have lower

general and health literacy skills, which increases the probability of an old person not

reading, understanding or remembering the advice of the label or insert [14-17]. Lay

5
beliefs about OTC medications can also influence the level of disclosure regarding OTC

drugs consumption between the patient and the physician. A cross-sectional study

conducted by the US National Council on Patient Information and Educational on 1011

American adults revealed that OTC medications are frequently wrongly regarded as too

weak to cause health problems [18]. Sleath et al. taped 414 primary care medical visits

and found out that only half the patients that had used OTC analgesics (the most used

OTC medications) 30 days before the visit reported it to the physician, while physicians

inquired about OTC medication consumption in only 37% of the visits [19]. The level

of disclosure regarding complementary and alternative medicines such as herbal

medicines can be expected to be similar or even lower [20-22], preventing the physician

to detect potential harmful interactions and adopt the correspondent preventive

measures. We may add that most of the studies cited here took place in developed

countries; the situation regarding polypharmacy1 in emergent countries, where drug use

is less regulated, enforcement of existent regulations is deficient and health literacy

tends to be lower, is understandably even worst. Figure 2 summarizes the reasons of

increased chances of drug-drug interactions in self-medicated patients and possible

solutions to this problematic.

Chagas Bortolon et al. reported a cross-sectional descriptive study based on the

administration of a semi-structured survey to women of 60 or more years old assisted at

the Universitary Hospital of the Catholic University at Brasilia (Brazil) [23]. From 218

elderly women participating in this research, 30.8% admitted practicing self-medication.

The therapeutical categories most used in self-medication practices were analgesics,

1
There is no clear definition of polypharmacy or multiple medication. Depending on the author,
polypharmacy may be defined as the concomitant consumption of three, four, five or more drugs.
However, most of the current literature agrees that five is an adequate threshold value to refer
polypharmacy (see the work from Viktil et al., Br J Clin Pharmacol 2007; 63: 187-95).

6
gastrointestinal tract medications, vitamin or mineral supplements, cardiac medications

and antialergics. Potential severe drug-drug interactions were identified with the help of

WHO Model Formulary [24]. The potential risk of administering certain medications to

the elderly was assessed through Fick and collaborators’ update to Beers’ criteria [25-

26]. From 10 interactions found involving OTC medications; 5 were classified as highly

severe and 1 was classified as moderately severe. 9 of the drugs used in self-medication

were considered inappropriate for administration in the elderly according to Beers’

updated criteria. Similar findings were obtained in another cross-sectional study in

Porto Alegre, Brazil [27]. The study comprised men and women aged 60 and more.

From a sample of 215 subjects, 33% admitted having consumed medications without

medical advice. The average number of medications taken per person was 3.2 (SD=2.5).

Again, analgesics, gastrointestinal and metabolic (including supplements) and

cardiovascular agents were among the most consumed drugs.

In another cross-sectional descriptive study involving 14 rural health settings and 143

immobile patients above 64 years old from the district of Guadalquivir, Spain, Gavilán

Moral et al. reviewed the medicine cabinet of the participants and inquired about the

origin of the prescription of each drug [28]. According to the patients’ reports, a very

low proportion (1.5%) of the medications found had not been prescribed by a physician

This is quiet lower than the rest of the studies analyzed here, but this difference might

be related with the fact that participants in this study were immobile and therefore their

autonomy was deeply diminished. A mean of 6.8 (SD=3.4) medications per patient was

found, as well as 63 (4.6%) potentially inappropriate medications according to Beers’

criteria.

7
Yoon applied the Herbal Information Questionnaire developed by him to investigate

CAUSES SOLUTIONS

Lay people tend to belief OTC and Educational interventions to

herbal drugs are innocuous instruct the patient on the risks of
Low level of disclosure of OTC and OTC medications and the
herbal drugs consumption to the importance of disclosing OTC and
physician herbal drugs consumption to the
Low level of inquiry on OTC and healthcare providers
herbal drug consumption from the Receptive health providers’ attitude
physician towards information shared by the
Certain groups (the elderly) are patient regarding OTC and
particularly sensitive to interactions alternative medications. Healthcare
due to several concomitant health professionals should strive to ask
conditions and altered physiology the patient for information on OTC
(impaired liver metabolism and consumption
renal excretion, etc) Medication regimes designed to
Difficulties reading, understanding avoid polypharmacy
and/or remembering the label and Development of online systems that
package inserts contents due to assure permanent assess to
impaired cognitive functions and updated medical records
low health literacy Involvement of pharmacists in
medical records updating
Guidelines to improve management
of older adults’ medications
Improved labeling and package
inserts. Inclusion of larger print,
pictograms, graphic displays,
simpler language

Fig.2. Causes of and some of the potential solutions to the increased probability of drug-drug
interactions due to consumption of OTC medications.

potential drug-drug interactions among 65 year old women residing in Florida [29].

From a total sample of 143 patients, he identified 58 women that reported concomitant

use of at least one herbal medication and at least one OTC or prescription drug. A mean

of 8.7 (SD=3.9) medications per patient was found. The mean number of prescription,

OTC and herbal medicines per patient were, in that order, 2.8 (SD=2.1), 3.7 (SD=2.0)

and 2.2 (SD=1.8). Note that according to this study, the mean number of OTC

8
medications consumed by those patients taking an herbal medication is quite above the

mean number of prescription medications. At least 1 potential moderate or high risk

drug-drug interaction was found in 43 (74%) of the participants. Among those 43

participants, 136 interactions were found. 52% (71) of those interactions involved OTC

medications, from which 63% (45) involved non-steroidal anti-inflammatory (NSAIDs)

drugs. 56 interactions were categorized high risk; from those, only 4 involved two

prescription drugs. These results seem to indicate that high risk interactions appear to be

more frequent, in the population studied, when self-medication is practiced. The general

percentage of identified interactions taking into account prescription, OTC and herbal

medications were also significantly higher than in previous studies that only considered

interactions between prescription drugs [30,31]. Potential interactions involving

NSAIDs are a major concern among the elderly due to the higher incidence of severe

gastrointestinal bleeding in this group [32]. Another important medication involved in

drug-drug interactions in this group are calcium supplements, usually administered to

elderly women to treat osteoporosis.

Neafsey et al. examined a sample of 51 adults aged 60 and older taking antihypertensive

medication and attending a blood pressure clinic [33]. Assessment of knowledge and

self-efficacy (confidence) of the patients on adverse drug interactions between

antihypertensives and OTC drugs and alcohol was performed to previously developed

and validated instruments [34]. The participants developed a rather low to moderate

performance in the tests: they obtained a mean of 2.0 points (SD=0.8) (40%) out of a 5

point scale in the self-efficacy test, while a mean of 43.1% (SD=15.4) was obtained in

the knowledge instrument. It is interesting to note that no correlation was found

between the performances in both tests, i.e. the participants that were more confident are

9
not those that attained the best scores in the knowledge tests. In other words, those who

think they had a better knowledge on interactions between alcohol and OTC

medications and antihypertensive medications are not the ones that actually have it. No

correlation was found between the performance in the knowledge test and the level of

education; apparently, the level of education is not necessarily correlated with health

literacy. Only 53% of the participants selected acetaminophen as the best analgesic for a

hypertensive patient and only 51% knew that administration of NSAIDs could raise

blood pressure. Only 25% manifested that an OTC analgesic could damage the kidney.

Barat et al. studied the consumption of drugs of 75-year old individuals living in their

homes in the municipality of Aarhus, Denmark [35]. 492 people participate in the study.

Subjects were interviewed at home and their drug storage was examined. Drug

interactions of major and moderate clinical significance were identified. 32.6% of the

total drugs stored corresponded to OTC medications. The mean number of medications

in use was 5.4 (range 1 to 24, SD not reported); the mean number of OTC agents in use

per person was 2.5 (range 1 to 16, SD not informed). The general practitioners were

unaware of 25% of the prescription medications possessed by the subjects; most of

these drugs unknown to the general practitioner were prescribed by another doctor and a

positive correlation was observed between polypharmacy (defined here as concomitant

use of three or more drugs) and number of prescriptors (p=0.01). 72% of the

participants of the Barat et al study had OTC drugs and 40% were using alternative

medicines and dietary supplements. 113 potential drug interactions were found in 15.4%

of the subjects.

10
In a retrospective study on 833 patients over 64 years old discharged from home care

(returned to self-care or care of the family, or hospitalized), Flaherty et al. found a mean

of 6.6 (SD=3.9) and 5.7 (SD=3.4) drugs per patient (including both prescription and

OTC medications) in the hospitalized and self-care/care of the family groups,

respectively [36]. Five of the top 10 medications used by the participants were OTC

medications (salycilates, H2 blockers, laxatives, vitamins and acetaminophen). The

percentage of inappropriate medications found in the hospitalized group was 20%,

while it rose to 27% in the self-care/care of the family group (the criteria used to

identify them was previously developed by consensus by a group of 13 experts in

geriatric pharmacology).

As a part of the Medical Research Council Cognitive Function and Ageing Study, Chen

and collaborators carried on a cross-sectional study comprising three urban (Newcastle,

Nottingham, Oxford) and two rural (Cambridgeshire, Gwynedd) centers in England and

North Wales [37]. 12489 people aged 65 and over were interviewed. The mean number

of drugs taken by participants 65-74 years old was 2.03 (SD=1.95); among the

participants ≥75 years old, the mean value was 2.47 (SD=2.02). Fairly consistent with

some of the reports previously described, the most frequently used drug categories were

cardiovascular, central nervous system (including non-narcotic analgesics),

gastrointestinal, musculoskeletal, haematology/dietetic, endocrinal and respiratory

drugs.

Linjakumpu et al performed two cross-sectional studies on people aged 64 years old or

over (the first in 1990-91, N=1131; the second in 1998-99, N=1197) from the

municipality of Lieto, Finland [38]. The most commonly used medications were , again,

11
cardiovascular and central nervous system agents. The mean number of medications per

person increased from 3.1 (SD=2.8) to 3.8 (SD=3.1) during this period and

polypharmacy, defined as concomitant consumption of five or more medications,

increased from 19 to 25%.

Table 1 summarizes some of the described reports. Some general conclusions may be

drawn from the reviewed literature. Due to physiological reasons, older adults are more

sensitive to drug-drug interactions. Simultaneously, due to the fact that old age is

associated to a major prevalence of multiple, simultaneous health conditions,

polypharmacy is more common in this age group. The mean number of medications in

this age group ranges from 2 to 9, depending on the study and considering results from

different locations [9,27-29,35-40]. Many of the most used medications among the

elderly are OTC medications (including herbal medicines and dietary supplements).

OTC medications are frequently involved in sever drug-drug interactions. OTC NSAIDs

appear among the most frequently used medications among the elderly. These drugs,

alone or associated to other drugs and/or health conditions (hypertension, impaired renal

function) are well known to elicit severe adverse drug reactions such as gastrointestinal

bleeding, hepatotoxicity, nephrotoxicity and hypertension. The low disclosure to the

physician on OTC and herbal drugs consumption prevents the physician from designing

a rational medication scheme. So does the existence of unknown prescription co-

medications from other prescriptors.

Table 1. Summary of the reviewed studies on drug consumption among the elderly.

Average
Most consumed
Type of study number of
Authors Participants therapeutic
(instrument) medications per
categories
patient (SD)
Chagas Bortolon 218 women Cross-sectional Not reported Analgesics,

12
 et al [23] from Brasilia (semi-structured gastrointestinal,
(Brazil), ≥60 personal survey) dietary
years old supplements,
cardiovascular,
antialergics
Analgesics,
215 men and
Cross-sectional gastrointestinal,
women from
(personal metabolics
Flores et al [27] Porto Alegre 3.2 (2.5)
structured (including dietary
(Brazil), ≥60
interview) supplements),
years old
cardiovascular
Cross-sectional
143 immobile
(reviewing of
men and women Analgesics,
medicine cabinet
Gavilán Moral et from antiacids,
and non- 6.8 (3.4)
al. [28] Guadalquivir antihypertensives,
structured
(Spain), ≥65 NSAIDs
personal
years old
interview)
58 women from
Florida (USA)
Data extracted
concomitantly
from two
consuming at
different cross-
least one herbal
Yoon [29] sectional studies 8.7 (3.9) Not reported
drug and one
(personal
OTC or
structured
prescription
interviews)
drug, 65 years
old
Cardiovascular,
492 men and Cross-sectional
central Nervous
women from (reviewing of
5.4 (not System,
Barat et al [35] Aarhus drug storage and
reported) gastrointestinal,
(Denmark), 75 personal
alternative
years old interview)
medicine
833 men and 6.6 (3.9) Cardiovascular,
women from (hospitalized analgesics,
Flaherty et al Missouri (USA) Retrospective patients) gastrointestinal
[36] discharged from chart review 5.7 (3.4) (self- (antiacids,
home care, ≥65 care/care of the laxatives), dietary
years old family) supplements
Cardiovascular,
12489 men and
central nervous
women from
Cross-sectional 2.03 (1.95) (≤ 74 system (includes
three urban and
(personal years old) non-narcotic
Chen et al [37] two rural centers
structured- 2.47 (2.02) (≥75 analgesics),
from England
interview) years old) gastrointestinal,
and Wales, ≥65
musculoskeletal,
years old
dietetic
1197 men and Cross-sectional
Cardiovascular,
Linjakumpu et al women from (personal
3.8 (3.1) central nervous
[38] Lieto (Findland), structured-
system
≥64 years old interview)

13
Several measures can be proposed to manage this problematic. Most authors agree that

educational interventions to either (or both) the patients and the health providers are one

of the best options to deal with the problematic of multiple medications [9,41-44]. In

light of the conclusions, it is fundamental to inform the patient that OTC status is not

synonym of risk-free, especially if other medications are consumed simultaneously.

Education of the patients on the importance of disclosing information regarding OTC

and herbal drugs consumption to their healthcare providers (physicians, nurses,

pharmacists) is a key strategy to help designing rational and safe medication schemes.

Government should assure that advertisement on OTC drugs deliver well-balanced

information (including potential adverse reactions) to the patients. Health providers

should proactively inquire about OTC consumption, and they should also adopt an

open, receptive attitude towards the information shared by the patient (particularly,

information regarding alternative therapies). The least complex drug regimen as

possible should be prescribed to the patient, above all to the old patient, considering his

or her medical condition. Optimized pharmaco-vigilance programs should be

developed. Online systems providing 24-hour access to update medical records could be

developed; pharmacists, as the only health professional often aware of OTC

consumption2, should be involved in medical records updating. Guidelines for an

improved management of older adults’ medication have been developed [45]; they

provide assessments and interventions to decrease polypharmacy and reduce

inappropriate prescribing. Finally, it has been suggested that the use of alternative

methods of information display in labels and package inserts could lead to more

2
This is not always true: depending on the country (or even the state) OTC medicines can be purchased
without any health professional’s surveillance. Some countries or states allow selling drugs in commercial
circuits that exclude pharmacists or physicians. Internet drug sales are often unregulated. Herbal drugs
and dietary supplements are often under-regulated. All this provides a complex scenario; anyway,
pharmacists’ involvement in medical record updating could be a step towards improvement of the
polypharmacy problematic.

14
adequate interpretation of risk and proper manner of use of medications in patients,

which is particularly important in the case of patients with impaired cognitive functions

or vision or poor literacy (and health literacy) skills [9,46-48]. Graphical displays,

pictograms, the use of larger print, clearer identification of the active ingredient and

simpler instructions should be considered as possible improvements, and the label

information should be supplemented by pharmacists’ advice.

SELF-MEDICATION AND OTC MEDICATIONS ABUSE

Drug abuse has been defined as (persistent or sporadic) excessive drug use inconsistent

with or unrelated to acceptable medical practice. The intentional use of excessive doses

or the intentional use of therapeutic doses but for purposes other than the indication of

the drug constitute drug abuse [49]. We will review recent literature and reports on OTC

drug abuse. Since the purpose of this review is to describe risks connected to self-

medication, we will not focus on abuse of OTC medications by patients with a story of

illicit drug dependence or abuse that resort to OTC drugs when their drug of choice is

not available. This is a consequence of the availability of OTC medications and may

trigger a discussion on the need to revise the OTC status of certain drugs, but is not a

consequence of a genuine self-medication practice (selection of a medication by the

patient to treat a self-recognized health condition). We are not interested in describing

non-medical use (e.g. recreational use or use as ergogenics or anabolics) of OTC drugs

here. For an extensive description of abuse of prescription and OTC drugs for non-

medical purposes the reader may refer to the recent review from Lessenger & Feinberg

[50].

Table 2 presents a summary of articles linked to abuse of OTC medications.

15
Table 2. Summary of studies on abuse of OTC medications.

Authors Drug Description

Hagler Orlistat Case report of a 45-year old normal-weight woman
Robinson abusing orlistat with an eating disorder. The woman took
[51] orlistat more frequently and in larger doses than indicated
in the label. She did not limited the fat ingest per meal to
15 g, but purposefully ate large amounts of food when
taking orlistat.
Fernández- Orlistat Report of two cases of normal-weight women with a
Aranda et al. previous diagnosis of bulimia nervosa, using orlistat as
[52] their only purging mechanism after binge episodes.
Cochrane & Orlistat Case report of abuse of orlistat by a normal-weight
Malcolm woman with eating disorder and stimulant dependence.
[53]
Orriols et al. Codeine, Cross-sectional pharmacy-based study performed in the
[54] dextromethorphan, Midi-Pyrénées (France) based in self-administration of an
pseudoephedrine, anonymous questionnaire. Patients requesting one drug
H1 receptor from a list of psychoactive drugs used in self-medication
antagonists were included in the study. A control group composed by
patients requesting anti-acids was used. Statistical
significant differences on misuse/non-medical use were
found in the codeine group compared to the antiacids
groups.
Barrington Diphenhydramine Cross-sectional pharmacy-based study with a self-
et al. [55] administered questionnaire completed by 304 purchasers
of Nytol or Sleepeaze revealed that 33.8% of participants
had used the product continuously for more than indicated
in the label (two weeks); 8.2% took more of the
recommended maximum dose.
Phelan et al. OTC sleep aids Cross-sectional pharmacy-based study with a self-
[56] administered questionnaire completed by 86 purchasers of
OTC sleep aids. 49% were classified as inappropriate
users (daily use for more than 30 nights, weekly use
starting using sleep aids more than two years ago, use of
the OTC sleep aid to treat severe sleep disorders).
Lagerløv et OTC analgesics Cross-sectional study based in administration of a survey
al. [57] to 367 15-16 year old teenagers. 26% used OTC
analgesics on a daily or weekly basis. Analgesics were
commonly used to treat headache and muscle pain. Pain
or discomfort were related to long time spent in front of
different screens, tight time schedules, drinking too little
and much noise in the classroom.
Mäntyselkä Prescription and Cross-sectional multi-center study based in a self-
et al. [58] OTC analgesics administered questionnaire to 358 patients diagnosed
musculoskeletal pain, aged 20-75 years old. The General
Health Questionnaire was used to assess mental distress;
Beck’s Depression Inventory was used to assess
depression. 28% had used drugs daily due to pain and
29% has used multiple drugs simultaneously due to pain.
OTC drug use was associated to living alone. Depression
and mental distress were associated to daily use and

16
 multiple drug use.
Myers et al. Prescription and Analysis of data collected by 23 specialist substance
[59] OTC drugs abuse treatment centers in Cape Town (South Africa). A
standardized one-page form is completed on each person
treated. 710 forms collected during 1998-2000 referred to
abuse of prescription and OTC medications. 33.7% used
medications as primary drug of abuse. 107 patients (15%)
abuse of analgesics; 2.3% corresponded to codeine-
containing OTC preparations.
Goniewicz OTC nicotine Analysis of current studies reveals 0.4-17% of patients
et al. [60] replacement use the NRT for more time than recommended. Research
therapy (NRT) to assess particular dependence symptoms (subjective
sense of dependence, occurrence of withdrawal
symptoms, difficulties in ceasing using therapy) does not
reveal them.
Hughes et OTC NRT Two cross-sectional study based on telephone surveys to
al. [61] smokers recruited through newspaper ads. Study 1
(N=266) revealed that among long term users (≥90 days)
20% attributed their use to addiction. Study 2 (on 100
smokers or ex-smokers that reported addiction to nicotine
gum) showed that 66% met DSM-IV and 74% met ICD-
10 criteria for dependence.
Schiffman et OTC NRT Analysis of OTC NRT purchase patterns in data from a
al. [62] population based panel of 40000 US households that
electronically scanned all household purchases between
1997-2000. 2690 households recorded NRTs. Among 805
households that purchased nicotine gum, 5.2% of new
purchase incidents led to continuous monthly purchase of
gum for ≥3 months, and 2.3% ≥6 months. For nicotine
patches (2050 households) these percentages were 2.9 and
0.9%. Allowing one month gaps within a "continuous"
purchase run resulted in increased estimates (for gum:
11.2% ≥3 months and 6.7% ≥ 6 months; for patch: 5.7%
and 1.7%, in that order).

Abuse of OTC medications is probably an under-researched and neglected area [63].

However, table 2 seems to indicate that several OTC preparations can lead to abuse

and/or dependence. It should be noted that some of the case-reports and studies on OTC

drugs dependence show a subjacent psychological condition that seems to predispose to

medication abuse (eating disorders, depression). Abuse and/or dependence of NRT may

be attributed not to the medication itself but to the previous-developed dependence of

the smoker subjected to the treatment. Nevertheless, a revision of OTC status may be

necessary in the case of some drugs object of abuse for either medical or non-medical

17
reasons. Among them we may mention orlistat, OTC sleep aids and OTC cough and flu

medications. Lessenger and Feinberg have discussed some general strategies that the

physicians may adopt to reduce medications abuse [50], among them inquiring about

prescription, OTC and herbal drug use at the initial examination. A cross-sectional

study developed in North Ireland reveals the inconsistent fact that, although 80% of the

surveyed population agree or strongly agree that some OTC medicines can cause

dependence if used for a long period of time, more than 47% of the sample indicated

that non-prescription medicines are totally safe to use3 [64]. This inconsistent risk

perception may be the fundamental problematic regarding non-safe self-medication

practices, and educational interventions on the patients to change these societal

perspectives on OTC medications might be the most important approach to handle the

issue. Sharpening communicational skills of healthcare providers might improve

communication at the patient/healthcare professional encounter, allowing for a better

and joint approach to this topic.

MISDIAGNOSIS AND INCORRECT CHOICE OF TREATMENT

Many non-specific symptoms are common to wide array of health conditions.

Treatment of minor, non-specific symptoms with OTC medications can mask a severe,

underlying disease (especially when the treatment is taken for a longer period than

recommended in the label or package insert) and delay an appointment with the

physician. Misdiagnosis is also a very common and important issue in the case of

infectious diseases, which can have different causes (bacteria, virus, fungus, parasites)

each them requiring a specific treatment. Incorrect choice of treatment of an infectious

3
It is worth mention that analgesics are among the most liable for abuse drugs according to the surveyed
population.

18
disease can aggravate the health condition of the patient and help to spread resistant

strains of bacteria (an important public health concern).

After clinical diagnosis, Ferris and collaborators found that, from 95 women who

purchased and presented with an OTC medication for vulvovaginal candidasis (VVC),

only 33.7% were actually diagnosed VVC. The remaining women presented bacterial

vaginosis, mixed vaginitis, trichomonas vaginitis, other conditions or no infection at all

[65]. Women with a previous clinically based diagnosis were not more accurate in

diagnosing VVC. Neither were those who read the label compared to those who did not.

In another study from Ferris et al. 552 women completed a 63-question survey

instrument designed to assess their knowledge of the symptoms and signs of pelvic

inflammatory disease, bacterial vaginosis, acute cystitis, vaginal trichomoniasis, and

vulvovaginal candidiasis. Only 34.7% of participants who had received a previous

diagnosis of VVC (N=365) was accurate in diagnosis VVC, compared to 11% of the

participants that had not received a previous diagnosis (N=154) and 83.7% of a control

group of 49 medically-trained women [66]. In Africa, over 70% of malaria cases do not

present initially to health facilities but diagnose and manage it at home with traditional

or OTC medicines, even though effective treatment is recommended within 24 hours of

the onset of the disease [67]. Several current studies from both developed and emergent

countries show high frequency of self-medication with aminopenicillins for the

treatment of non-specific upper respiratory tract symptoms (which are often of viral

origin) [68-75]. Table 3 summarizes these articles. Since oral antibiotics are prescription

drugs, self-medication with these therapeutic agents come from leftover from previous

prescriptions or from drugs illegally acquired without prescription. Dispensation of the

exact number of doses for a prescribed treatment and enforcement of current laws are

19
therefore proposed as solutions to self-medication with antibacterials. Evidence-based

guidelines for the self-diagnosis of infectious diseases (e.g. VVC) and educational

interventions have also been recommended [66,68,72,76].

Table 3. Summary of recent articles on self-medication with antibiotics.

Authors Type of study Main findings

Dreser et al. Review Between 70 and 80% of recommendations given by
[68] pharmacies staff in Mexico for the treatment of acute
respiratory and gastrointestinal infections are
inappropriate.
Basualdo et al. Personal surveys to According to physician’s perceptions, self-medication
[69] 700 antibiotic with antibiotics is an extended practice. The most
consumers and usually self-prescribed antibiotics are amoxicillin,
interviews to 28 tetracycline, ciprofloxacin and cephalosporin.
physicians from
Paraguay
Grigoryan et Cross-sectional based Throat symptoms, teeth symptoms and bronchitis were
al. [70] in administration of a the most frequent reasons for self-medication with
questionnaire to antibiotics. Penicillins were the most self-prescribed
15548 people across antibiotics.
19 European
countries
Sarahroodi et Cross-sectional study Respiratory conditions were the most frequent
al. [71] on 160 college indication for self-medication with antibiotics
students in Tehran (73.3%). Amoxicillin was the most self-prescribed
(Iran), based in self- antibiotic (40%).
administered
questionnaire
Richman et al. Prospective survey 17% of participants had used leftover antibiotics,
[72] on 1363 American mostly for the treatment of cough (11%) or sore throat
patients enrolled in (42%).
an emergency
department
Raz et al. [73] Cross-sectional study Amoxicillin was the antibiotic most commonly used
based in (32.7%); around 10% of antibiotics were obtained
administration of a without a prescription; 24.4% of the respondents
questionnaire to 467 stored leftover antibiotics at home.
people in northern
Israel
Papaioannidou Cross-sectional study Four out of ten participants have antibiotics at home
et al. [74] based in and one out of four people use them without a
administration of a prescription, against fever (44%), flu (32%), sore-
questionnaire throat (19%) and cough (16%).
Nounou et al. Cross-sectional study 53% of the respondents at least occasionally consume
[75] based in antibiotics without prescription. Sore throat (48%) and
administration of a fever (18%) are among the main reasons for practicing
personal survey to self-prescription of antibiotics. Amoxicillin is the most
482 people from La consume antibiotic (70%).
Plata (Argentina)

20
Myers et al. Prescription and Analysis of data collected by 23 specialist substance
[59] OTC drugs abuse treatment centers in Cape Town (South Africa).
A standardized one-page form is completed on each
person treated. 710 forms collected during 1998-2000
referred to abuse of prescription and OTC
medications. 33.7% used medications as primary drug
of abuse. 107 patients (15%) abuse of analgesics;
2.3% corresponded to codeine-containing OTC
preparations.
Goniewicz et OTC nicotine Analysis of current studies reveals 0.4-17% of patients
al. [60] replacement therapy use the NRT for more time than recommended.
(NRT) Research to assess particular dependence symptoms
(subjective sense of dependence, occurrence of
withdrawal symptoms, difficulties in ceasing using
therapy) does not reveal them.
Hughes et al. OTC NRT Cross-sectional study based on two telephone surveys
[61] to smokers recruited through newspaper ads. Study 1
(N=266) revealed that among long term users (≥90
days) 20% attributed their use to addiction. Study 2
(on 100 smokers or ex-smokers that reported addiction
to nicotine gum) showed that 66% met DSM-IV and
74% met ICD-10 criteria for dependence.
Schiffman et OTC NRT Analysis of OTC NRT purchase patterns in data from
al. [62] a population based panel of 40000 US households that
electronically scanned all household purchases
between 1997-2000. 2690 households recorded NRTs.
Among 805 households that purchased nicotine gum,
5.2% of new purchase incidents led to continuous
monthly purchase of gum for ≥3 months, and 2.3% ≥6
months. For nicotine patches (2050 households) these
percentages were 2.9 and 0.9%. Allowing one month
gaps within a "continuous" purchase run resulted in
increased estimates (for gum: 11.2% ≥3 months and
6.7% ≥ 6 months; for patch: 5.7% and 1.7%, in that
order).

FINAL CONCLUSIONS

Although regarded as totally safe by many patients, consumption of OTC medications

always involves some degree of danger to the consumer. This is especially true in the

case of those patients that do not follow the instructions given by the label of package

insert. Educational interventions aimed to make the patients conscious of potential risks

of OTC medications and the importance of disclosing OTC and alternative medicines

21
consumption to the physician and/or pharmacist are among the most popular measures

proposed to reduce the dangers linked to self-medication practices. Interventions should

also educate lay people on the importance of observing label or inserts instructions on

dosage, indication, duration of the treatment and necessity of consulting a physician in

case of symptoms persistence. Improving the understanding of the label and inserts by

the patient (true pictograms, graphs, larger typography, simpler instructions) and

supplementation of this information by oral instructions given by the healthcare

professionals are other possible strategies towards safe self-medication, particularly for

old or low literate patients having difficulties when dealing with the label written

instructions.

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