Knowledge and Use of Over-the-counter Drugs in Italy: An Exploratory Survey-based Study in the General Population

Abstract

Background

During the past decade, the misuse of over-the-counter (OTC) medicines has become a global public health concern, especially among young people. In this study, we aimed to explore the OTC consumption and related misuse in Italy and identify the demographic characteristics of people/individuals involved in this phenomenon, understanding eventual risk factors.

Methods

The study consisted of an anonymous online survey distributed by direct contact and via the Internet between June-November 2021 to the general population living in Italy. Descriptive statistics were reported, and binary regression analyses were performed to identify risk factors for lifetime misuse of OTC. The University of Hertfordshire approved the study (aLMS/SF/UH/02951).

Results

The final sample size was composed of 717 respondents. The sample was mainly represented by female (69.3%) students (39.9%) in the 20-25 years age group (30.0%). Based on the survey responses, study participants were divided into two groups according to the presence/absence of OTC abuse/misuse (127 versus 590), which were compared for possible predictors of OTC diversion. Multivariate regression showed that OTC abuse/misuse was associated with the knowledge of the effects of OTC [odds ratio/OR = 2.711, 95%Confidence Interval/CI 1.794-4.097, p <0.001]. On the contrary, the educational level appeared to be a protective factor [OR = 0.695, 95%CI 0.58–0.94, p = 0.016].

Conclusion

Although, according to our data, the phenomenon of OTC abuse appeared to be limited, increasing attention is needed because of possible underestimation and high-risk outcomes. Preventive strategies, including simplified access to information, may play a key role in limiting OTC misuse.

1. INTRODUCTION

1.1. The ‘Pharming’ Phenomenon

Over-the-counter medicines (OTC) are drugs that can be purchased from a pharmacy, online stores and supermarkets without a prescription and are available for self-medication, including several products used for the treatments of self-limiting conditions or minor illnesses, e.g., acute sore throat, conjunctivitis, coughs/colds and nasal congestions, diarrhoea, minor pain, travel sickness, etc. They are generally considered safe medications; however, some may be harmful due to inappropriate intake, adverse drug reactions, and drug interactions, but also due to dependence and diversion issues [1-8]. In fact, OTC might be abused and diverted to reach psychoactive recreational effects through idiosyncratic reactions related to unusual routes of administration, high or very-high dosages and a combination of licit/illicit drugs to enhance effects [1, 3, 9, 10]. These issues are related to the phenomenon known as pharming [1, 11] which identifies the possibility of diversion of medicines to achieve psychoactive effects [11-13]. OTC medications may be easily diverted due to several factors: i) they are ubiquitous and easily available and may be easily purchased at local stores and on the internet; ii) they are often inexpensive; and, finally, iii) they are legal and are perceived to be harmless [3, 11]. The most commonly abused OTC include: i) antihistamines, e.g., chlorphenamine, diphenhydramine and dimenhydrinate [3, 14, 15]; ii) syrups based on codeine and/or promethazine [3, 16-18]; iii) dextromethorphan cough syrups [3, 11, 19]; iv) drugs based on ephedrine and pseudoephedrine [3, 20]; v) loperamide [3, 21, 22]; vi) and benzydamine-based anti-inflammatories [3, 23, 24].

1.2. Current Prevalence of OTC Diversion

A major problem in assessing the extent of OTC misuse is the limited research on the problem, as it is mostly focused on the abuse of illicit drugs [1, 25]. Currently, even though the problem of OTC abuse has been recognized and studied in recent decades [5, 11, 26], there is limited information on the prevalence of OTC misuse [12, 13, 27]. According to a mixed-method systematic review, the prevalence reported via survey questionnaires with pharmacy customers and the general public ranged from 3.1 to 59% for misuse, 0.8 to 4.1% for abuse and 4.2 to 17.8% for dependence, while the prevalence of OTC medicines problematic use reported through national databases was variable, with an overall pooled prevalence in the population-based studies recorded of 16.2% for misuse, 2.0% for abuse, and 7.2% for dependence [28]. The same review study described analgesics (with or without codeine), sedative antihistamines, and cough mixtures containing dextromethorphan as the groups of OTC drugs most commonly involved in problematic use [28]. It is possible that the diversion of OTC may be underestimated because of the ease of purchasing OTC, which promotes self-management, which may increase diversion to the inherent abuse potential of some of these OTC medicines [25]. Indeed, among pharmacists, there are increasing concerns about the possible inappropriate use of OTC in several countries, including the United Kingdom (UK) [4, 25, 26, 29, 30] and the United States of America (USA) [10, 31, 32]. A further issue is the impact of the CoronaVirus disease (CoViD)-19 pandemic on drug markets, which has introduced numerous changes in drug consumption habits, e.g., an increase in drug amounts used, relapse, or shifts to other substances if access to illicit or other substances previously used has become limited. These changes have been associated with increased internet drug-seeking activities, increased access to websites promoting rogue/illicit pharmaceutical products, such as benzodiazepines, or the use of alternative drugs or medications, including OTC medications [33-36].

1.3. Data Regarding OTC and Self-medication in Italy

According to the current literature available, there are several data concerning the patterns of use of certain OTC drugs in Italy, e.g., analgesic medications, including both opioids and non-opioids, used for the treatment of headache [37] or pain in general [38]. OTC inappropriate use has been recorded mainly in specific categories, such as the elderly [38] and pregnant women [39]. A recently published study highlighted the value of the regulatory switch from prescription to non-prescription medicines in Italy, showing that greater availability of non-prescription/OTC drugs could determine a positive economic impact and promote greater adherence to therapy, resulting in more effective prevention or treatment of minor pathologies, but also, conversely, be associated with the risk of the misuse, requiring patient education and training [40]. Despite of this, the current evidence relating to the prevalence of OTC misuse and dependence in Italy is still limited. Because of this, the extent of OTC misuse in Italy has not been quantified yet, and the types of drugs, modes of misuse, and total number of people affected have not been adequately determined.

1.4. The Terminology Issue Related to ‘Misuse,’ ‘Abuse’ and ‘Non-medical Use’ of OTC

Due to the heterogeneity regarding data focusing on prescription drug misuse and the issues in identifying misusing practices and misuse of medicines, in the survey, the terms non-medical use or misuse or abuse in relation to medication are considered as a single phenomenon and used interchangeably, even though referring to specific conditions. As a reference, we could consider the definitions available in the Medical Dictionary for Regulatory Activities-MedDRA (MedDRA) [41], which is a standardised medical terminology used worldwide in pharmacovigilance, where the term misuse describes the intentional use for a therapeutic purpose by a patient or consumer of a product, OTC or prescription, other than as prescribed or not in accordance with the authorised product information. Similarly, the European Monitoring Centre for Drugs and Drug Abuse (EMCDDA) indistinctly uses diversion, misuse, and non-medical use of medications, terms referring to situations where the medicinal product is intentionally and inappropriately used not in accordance with the authorised product information, e.g., a prolonged and continued use of medications, even after the original health problem for which the drug was prescribed has been resolved; or the use of a molecule in amounts exceeding the therapeutic dosage, outside the indications, and in combination with other drugs or medicines [42]. The National Institute on Drug Abuse (NIDA) uses drug misuse to distinguish improper or unhealthy use of medication as prescribed, including the repeated use of drugs to produce pleasure, alleviate stress, and/or alter or avoid reality, using prescription drugs in ways other than prescribed, or using someone else’s prescription [43]. Similarly, NIDA uses the term misuse, as it is roughly equivalent to the term abuse, which is considered a diagnostic term that professionals increasingly avoid because it can be shaming and stigmatizing [43], whereas the MedDRA considers drug abuse the habitual use of drugs that are not needed for therapeutic purposes (e.g., to alter mood); to affect a body function unnecessarily (e.g., laxative); and non-medical use of drugs [41]. Interestingly, highlighting its consequences, the UK Advisory Council on the Misuse of Drugs (ACMD) characterised problematic drug use as a condition that may cause an individual to experience social, psychological, physical, or legal problems related to intoxication and/or regular excessive consumption, and/or dependence [44]. Indeed, misusing prescription drugs involves risks associated with the drugs themselves and the general context in which they are consumed. These include side effects, interactions between licensed medicines and other unlicensed substances or products (food and environmental chemicals), and individual variation in responses (genetic differences and possible comorbidities), which might be associated with a range of severe adverse reactions and fatalities [1, 25, 42, 45, 46].

Aim of the study: to explore the OTC consumption and related misuse in Italy and to identify the demographic characteristics of people/individuals involved in this phenomenon, understanding eventual risk factors.

2. MATERIALS AND METHODS

2.1. Questionnaire

The questionnaire used for the survey consisted of 15 multiple-choice questions aiming at collecting socio-demographic information of the participants, investigating the use and possible abuse/misuse of OTC and eventual combination with other substances. The survey included:

i) general information, such as age, gender, occupation, level of education achieved, country of origin/residence; and ii) information regarding the information about the abuse and misuse of OTC medicines: a) their purchase without a medical indication; b) type of OTC drug, including benzydamine mouth wash, spray, tablet or gel, e.g., Difflam^®, Tantum Rosa^®, Rosalgin^®, and commercial brands; chlorphenamine-containing medicines, e.g., Piriton^®, Allercalm^®, Hayleve^®, Chlortripolon^®, Panadol^®, and commercial brands; codeine-containing medicines, e.g., Cocodamol^®, Nurofen plus^®, Adcodol^®, and brand names; loperamide, e.g., Imodium^®, and brand names; dextromethorphan-containing cough syrups, e.g., Coricidin^®, Delsym^®, Dimetapp^®, Mucinex^®, Robitussin^®, Sucrets^®, Vicks^®, and store brands; diphenhydramine and dimenhydrinate medications, e.g., Benadryl^®, Dramamine^®, and store brands; ephedrine- and pseudoephedrine- containing medications, e.g., ActiPe^®, Actifed^®, Sudafed^®, Claritin-D^®, Panadol^®, and store brands; hyoscine butyl bromide products, e.g., Buscopan^®, and brand names; syrup and tablets containing promethazine, e.g., Phenergan^®, and commercial brands; c) the effect sought, e.g. self-medication, psychoactive effects/recreational purposes, to increase/reduce the effects of concomitant drugs used; d) OTC dosage (e.g. above/below indication); e) licit or illicit concomitant substances; f) knowledge on OTC abuse/misuse potential effects and harms; etc.

2.2. Procedure

The survey was distributed to the general population by direct contact (e.g., acquaintances, students, psychiatrists working in hospitals and addiction centres) and via the internet (e.g., emails, social networks, online for, using the link https://forms.office.com/Pages/ResponsePage.aspx?id=0Lf4QSGaXEGcaaZ5hPPQ3pii9xKYZ8hBlvCtJ6rqdhx UQkFB UV dEMTdPVkZMTTFNMEdaMUZJMVlUUy4u), through the snowball sampling technique [47], consisting in inviting participants to share the survey with their contacts. Furthermore, researchers encouraged participants to send the link to other participants, helping to reach an adequate study sample. However, the engagement rate was not monitored. Formal online consent was provided for each participant to tick before starting the survey. Participation in the survey was anonymous and free of compensation. The web-based survey platform was Microsoft Forms, which was used to collect the recorded data. Post recruitment, data were securely stored as Microsoft Excel sheets at the University of Chieti (Italy), Department of Neurosciences.

2.3. Data Collection

The study was conducted between June 2021 and November 2021 and the survey was administered to the general Italian population from 15 years of age.

2.4. Statistical Analysis

All statistical analyses were performed using IBM SPSS windows version 22. Normality checking yielded adequate values. Groups of individuals (non-abusing/misusing vs. abusing/misusing) were compared using the Chi-square test with paired Z test and Fisher’s exact test, as appropriate. Binary logistic regressions were calculated to inspect how education, purchase of OTC drugs without indication and knowledge of OTC drugs misuse/abuse side effects predict the OTC drugs abuse/misuse (classified as 0, “non-abusing/non-misusing” or 1, “abusing/misusing”), controlling for age, gender, and employment status. Variables considered were dichotomized for the binary regression analysis as follows: Gender – male (1)/female (2); Employed – No (0), Yes (1); Purchase Over-the-counter drug without indication – No (0), Yes (1); Have no knowledge – have (0), No have/I have never used the previous drugs (1). Factors significant in group comparisons were later included in a single binary regression model. With a given sample size and the number of 6 predictor variables, we achieved power ranging from 0.82 to 0.99.

3. RESULTS

3.1. Demographic Characteristics

All 717 subjects responded to the survey and were included in the study. About two-thirds (n= 497/717) of the participants were females (69.3%). In addition, about a third (n= 215/717) of the participants belonged to the 20-25 age group. Participants were mostly represented by students (39.9%) or workers (47.3%) and had a high-school diploma (50.9%). Based on the survey responses, study participants were divided into two groups according to the presence/absence of OTC abuse/misuse (127 versus 590), which were compared for possible predictors of OTC diversion. Thus, similar characteristics were reported when dividing the whole sample into the two groups considering the presence of OTC abusing/misusing issues (127/717: 17.7%). Detailed socio-demographical data are reported in Table 1.

Table 1.

Demographic characteristics of study participants.

-	Total	Non Abusing/ Misusing	Abusing/ Misusing	χ2	P
	N=717	N=590	N=127
Age				14.527	.024
15-20 yrs.	53(7.4%)	42(7.1%)	11(8.7%)	-	-
20-25 yrs.	215(30.0%)	170(28.8%)	45(35.4%)	-	-
25-30 yrs.	133(18.5%)	114(19.3%)	19(15.0%)	-	-
30-35 yrs.	76(10.6%)	67(11.4%)	9(7.1%)	-	-
35-45 yrs.	94(13.1%)	86(14.6%)	8(6.3%)	-	.012
45-65 yrs.	125(17.4%)	94(15.9%)	31(24.4%)	-	.022
Over 65 yrs.	21(2.9%)	17(2.9%)	4(3.1%)	-	-
Gender				5.476	.019
Male	220(30.7%)	170(28.8%)	50(39.4%)	-	-
Female	497(69.3%)	420(71.2%)	77(60.6%)	-	-
Occupation				6.760	.080
Student	286(39.9%)	229(38.8%)	57(44.9%)	-	-
Worker	339(47.3%)	291(49.3%)	48(37.8%)	-	.019
Unemployed	51(7.1%	40(6.8%)	11(8.7%)	-	-
Retired	41(5.7%)	30(5.1%)	11(8.7%)	-	-
Employed				5.571	.018
No	378(52.7%)	299(50.7%)	79(62.2%)	-	-
Yes	339(47.3%)	291(49.3%)	48(37.8%)	-	-
Education				12.957	.004
Middle school diploma	65(9.1%)	46(7.8%)	19(15.0%)	-	.011
High school diploma	365(50.9%)	293(49.7%)	72(56.7%)	-	-
Degree	235(32.8%)	203(34.4%)	32(25.2%)	-	.045
Postgraduate qualification	52(7.3%)	48(8.1%)	4(3.1%)	-	.048
Purchased an otc drug without indication				4.111	.043
No	150(20.9%)	115(19.5%)	35(27.6%)	-	-
Yes	567(79.1%)	475(80.5%)	92(72.4%)	-	-
Familiar	248(43.7%)	207(43.6%)	41(44.6%)	0.030	.861
Acquaintance/friend	123(21.7%)	99(20.8%)	24(26.1%)	1.248	.264
Web page	49(8.6%)	42(8.8%)	7(7.6%)	0.149	.700
Forum online	9(1.6%)	7(1.5%)	2(2.2%)	0.242	.644
Concomitant substance use				0.626	.429
No	625(87.2%)	517(87.3%)	108(85.0%)	-	-
Yes	92(12.8%)	73(12.4%)	19(15.0%)	-	-
Alcohol	63(8.8%)	54(9.2%)	9(7.1%)	0.557	.456
Prescription drugs	44(6.1%)	36(6.1%)	8(6.3%)	0.007	.933
Over-the-counter medications	34(4.7%)	24(4.1%)	10(7.9%)	3.352	.067
Cannabis	19(2.6%)	15(2.5%)	4(3.1%)	0.149	.759
Cocaine	3(0.4%)	2(0.3%)	1(0.8%)	0.504	.443
Opioids	2(0.3%)	0(0.0%)	2(1.6%)	9.317	.031
Ketamine	1(0.1%)	0(0.0%)	1(0.8%)	4.652	.177
Knowledge of otc drugs misuse/abuse side effects				32.896	<.001
Yes	473(66.0%)	417(70.7%)	56(44.1%)	-	-
No	244(34.0%)	173(29.3%)	71(55.9%)	-	-

Abbreviations: OTC: over-the-counter; yrs: years

3.2. Drug Knowledge and Use

Overall, a significant percentage of respondents (567 subjects: 79.1%) purchased OTC medicines without any licensed indication. Of these, approximately 43.7% had been advised to use the medicine by a family member and 21.7% by an acquaintance/friend, while others had found the suggestion on a web page (8.6%) or an online forum (1.6%). About 12.8% of the respondents used OTC combined with one or more other substances. The substances most used in combination with OTC medicines were alcohol (8.8%), prescription-only medicines (6.1%), other OTC products (4.7%), and cannabis (2.6%). Results regarding cocaine, opioids and ketamine were not statistically significant. Finally, the majority (66.0%) of the participants declared that they knew the side effects of OTC abuse/misuse. Of the entire sample, 17.7% (n=127 subjects) declared having made an abuse/misuse of OTC drugs. In the abusing/misusing group, data recorded were similar; however, interestingly, only one respondent and four responded that he had used or abused other substances than OTC medicines, such as cocaine and cannabis. The percentage of respondents who stated that they did not know the side effects of OTC drug abuse was significant (55.9%). Full data of the participant sample and the two groups of subjects are shown in Table 1.

3.3. Regression Analysis

Logistic regression on OTC drug abuse/misuse [classified as 0, “non-abusing/non-misusing” or 1, “abusing/misusing”] in the model included: i) education; ii) the purchase of OTC drugs without indication (0, “no”; 1, “yes”); iii) knowing OTC drugs side effects (0, “have knowledge”; 1, “have no knowledge”); iv) age; v) gender; and vi) employment status. OTC abuse/misuse was associated with the knowledge of the substance use side effects, with an odds ratio (OR) = 2.711, 95% Confidence Interval (CI) 1.79–4.10, p < 0.001. OTC drug abuse/misuse almost doubled when individuals purchased OTC without indication [OR = 1.54, 95% CI 1.02–2.34, p = 0.042]. Education was also significant. Indeed, high levels of education were minimally related with OTC drugs abuse/misuse [OR = 0.695, 95% CI 0.58–0.94, p = 0.016] (Table 2).

Table 2.

Logistic regression model of factors associated with OCT abuse/misuse.

Total N=717 (Non abusing/ misusing: n = 590)/ Abusing/ misusing: n = 127)	Variables		OR	CI			p
				Min	Max
	Age		.994	.878	1.125		.923
	Gender		.822	.534	1.265		.373
	Employed		.767	.477	1.235		.275
	Educational level		.695	.517	.935		.016
	Purchase of OTC drugs without indication		1.542	1.017	2.339		.042
	Knowledge of OTC drugs misuse/abuse side effects		2.711	1.794	4.097		< .001
	Constant		.410	-	-		.122

Abbreviations: CI: Confidence Interval; Odds Ratio: OR; OTC: over-the-counter

Note: Gender – male (1)/female (2); Employed – No (0), Yes (1); Purchase over-the-counter drug without indication – No (0), Yes (1); Have no knowledge – have (0), No have/I have never used the previous drugs (1).

4. DISCUSSION

To the best of our knowledge, this is the first study in Italy to explore this topic. Given the limited research in this area, the present study provided preliminary findings on the misuse of OTC in Italy. Indeed, the aim of the present study was to explore OTC consumption and related misuse in Italy and to identify the demographic characteristics of individuals involved in this phenomenon through a cross-sectional observational design. The main aspects investigated were the frequency of use, type of OTC used, and risk for abuse/misuse. Predictors and eventual factors which might constitute a risk for OTC abuse/misuse were also explored.

4.1. Considerations on OTC Consumption and Related Misuse in Italy

As shown by the data presented here, the abuse and misuse of OTC are a considerable problem associated with a substantial risk of harm in the Italian scenario. Consistently with previous European studies [48-50], people/individuals who were here involved in this phenomenon were mainly represented by female (69.3%) students (39.9%) in the 20-25 years age group (30.0%). Data from international surveys, such as the National Surveys on Drug Use and Health in the US, showed similar trends with increasing misuse of medications, prescription psychotropics, and OTC medicines, especially in the age range 18-25 years during 2019-2020 [51]. A relevant part of our sample declared to misuse OTC with other substances [3, 11, 25, 52], possibly for recreational purposes (high) or to relax and relieve anxiety. However, many other reasons for the problematic use of OTC medicines were previously described [2, 11, 31], and included the need to manage frequent headaches and chronic pains with OTC analgesics, or the management of opioid withdrawal symptoms with codeine-based medications or loperamide. Among OTC medicines, opiate-based and cough/cold products containing dextromethorphan, sleep aids, sedative antihistamines, analgesics, hypnotics, and laxatives have been highlighted as having abuse potential [2, 42]. The OTC codeine or other opioid-containing products and OTC cough and cold medications have been identified as the most commonly implicated medications with abuse potential [26, 53]. Moreover, together with opioids, dextromethorphan, some antihistamines such as chlorpheniramine or promethazine, and pseudoephedrine prolonged use and overdosing might result in physical, phycological, and social life consequences, but also in full substance dependence [2, 23, 26, 54] and severe outcomes which might lead to life-threatening or fatal conditions, such as the serotonin syndrome [3, 23, 55]. All these consequences might clearly involve an economic cost to the health care system due to increasing hospitalisation and multiple admissions [42]. Therefore, this supports the need for interventions reducing the risk of OTC medicines’ problematic use, including drug up-scheduling, e.g., codeine was rescheduled as a prescription only medicine in some countries [56], or size and type sale limits, e.g., loperamide has been restricted to no more than 48 mg and requiring unit-dose blister packaging in the USA by the Food and Drug Administration (FDA) [57].

4.2. Risk Factors Involved in OTC Diversion in Italy

Our study showed that purchasing OTC without licensed indications and having an eventual knowledge about their side effects are factors that might influence OTC medicines' use and diversion, which is consistent with previous studies recording users' knowledge about OTC medication uses, indications, side effects, and safety risks with prolonged use [5, 6, 31, 32]. A survey previously conducted in Italy collected data regarding the use of OTC medications from 1,206 adults aged 18 years and older through a self-administered questionnaire, finding uncertain results regarding the non-medical use of OTC medicines (around 42% confused the concept of ‘contraindications’ with that of ‘side effects’) and potential side effects, e.g., most respondents were aware of the OTC general potential for side effects, but 64.3% did not know about potential harms related to the use of painkillers in people with high blood pressure and the risks of long-term use of laxatives and codeine-based nasal decongestants (58). On the other side, the educational level here appeared a protective factor [OR: 0.695], confirming previous research clearly identifying that high school dropouts and in general educational attainment have a significant relationship with substance use disorders [28, 53, 59].

4.3. Prevention and Intervention Approaches

Prevention approaches should first focus on education in general and health education to support people to learn the appropriate use of OTC drugs while eliminating their misuse. Schools or other educational settings should establish programs to raise awareness among students about drug and alcohol abuse risks. Considering a common perception among youngsters that OTC drugs are safer than prescription and illegal street drugs, being unaware of the potential risks associated with their misuse, promoting the safe and proper use of OTC drugs is essential. Furthermore, the present research has shown alcohol to be the most used substance in conjunction with OTC. This result might be related to several reasons, including its wide availability, relatively low cost and dose-dependent psychoactive effects. Alcohol use might cause both short-term and long-term effects, including respectively accidental injuries, poisonings, risky sexual behaviours (which may result in unintended pregnancy or sexually transmitted diseases) and chronic diseases, such as hypertension, strokes, liver diseases, digestive problems, mental health problems, e.g., depression and anxiety, social/family/job-related problems, alcohol use disorders, or alcohol dependence. Moreover, normally alcohol interacts with many drugs, including medications, OTC medicines and illegal drugs, increasing or reducing their effects, depending on the type of drug, e.g., alcohol can increase the risk of drowsiness when mixed with other depressant drugs such as benzodiazepines or opioids [60].

Furthermore, users can take steps to ensure that they use prescription/OTC medications appropriately by i) following the directions as explained on the label or by the pharmacist; ii) being aware of potential interactions with other drugs as well as alcohol, iii) never stopping or changing a dosing regimen without first discussing it with the doctor; iv) never using another person’s prescription; v) never giving their prescription medications to others; vi) and safely storing prescription stimulants, sedatives, and opioids [61]. Healthcare professionals should be trained to identify and treat problematic use and know how to address signs of non-medical use of medicines optimising the appropriateness, use and safety of OTC drugs [62]. Moreover, offering support in primary care settings may be appropriate for people with problems associated with the non-medical use of medicines who are reluctant to seek help from traditional drug treatment services, such as professionals or non-regular drug users. Good clinical practice, supported by clear guidelines, can lower the risk of diverting and misusing medicines. In addition, pharmacists should play an increasing role in preventing the inappropriate use of medicines and reducing the associated risks and potential harms and should therefore be included in educational programmes [2, 8]. Finally, public awareness and knowledge should be increased about the safe use of medications in people who might be identified as most vulnerable or at risk. Developing and implementing such responses, whether at the EU, national, local, or individual level, should involve several steps, such as the identification of the nature of the drug problems to be addressed; the selection of potentially effective interventions to tackle these problems; and the implementation and monitoring of these interventions [42].

4.4. Limitations

Despite the novelty of the study, it presented several limitations. Firstly, in being an explorative study, enrolling a self-selected sample through an online questionnaire, the generalisability of the findings could be reduced. A further limitation is related to the terminology used with regard to the definitions of abuse, misuse, and non-medical use of OTCs, which have been interchangeably used in the survey. Moreover, the engagement rate was not monitored. However, all the participating respondents provided data sufficient for the analysis of the study variables. Also, due to the cross-sectional nature of the data, no causal relationship can be drawn between the variables. Finally, using an Italian-only sample could reduce the applicability of our findings to different cultural settings.

CONCLUSION

The misuse of OTC medicines is a matter of increasing concern in Europe and is associated with acute health harms and chronic problems, such as dependence. Despite the limitations, the present study can provide important insight into the phenomenon of OTC abuse and misuse in Italy. Social education about the risks deriving from misuse of OTC drugs should play a key role in preventing strategies, particularly among those individuals at increased risk as the youngest. Policies to prevent the diffusion of OTC without prescription through the web may also be improved. Comparative data for other countries across the European Union and beyond are needed to extend and generalize our findings and improve common preventive strategies.

LIST OF ABBREVIATIONS

OTC

Over-The-Counter

EMCDDA

European Monitoring Centre for Drugs and Drug Abuse

MedDRA

Medical Dictionary for Regulatory Activities

NIDA

National Institute on Drug Abuse

AUTHORS’ CONTRIBUTIONS

S.C., G.M., M.D.G., and F.S focused on conceptualization. A.M., F.C., and S.C. prepared and wrote the original draft. J.B. did the statistical analysis; S.C., G.M., F.D.C, N.S., M.P., M.D.G., A.G., and J.C. wrote, reviewed and edited the manuscript. All authors have read and agreed to the published version of the manuscript.

ETHICS APPROVAL AND CONSENT TO PARTICIPATE

The Human Sciences Ethics Committee approved the study at the University of Hertfordshire (HSK/SF/UH/ 00104); protocol number is aLMS/SF/UH/02951 [2].

HUMAN AND ANIMAL RIGHTS

No animals were used for study. All experiments involving human participants were in accordance with the Declaration of Helsinki and the European General Data Protection Regulation.

CONSENT FOR PUBLICATION

Not applicable.

AVAILABILITY OF DATA AND MATERIALS

Not applicable.

FUNDING

None.

CONFLICT OF INTEREST

F.S. was a member of the UK Advisory Council on the Misuse of Drugs (ACMD; 2011–2019) and is currently a member of the EMA Advisory Board (Psychiatry).

J.C. is a member of the ACMD’s Novel Psychoactive Substances and Technical Committees.

G.M. has been a consultant and/or a speaker and/or has received research grants from Angelini, Doc Generici, Janssen-Cilag, Lundbeck, Otsuka, Pfizer, Servier and Recordati.

S.C., F.C., A.M., F.D.C., M.P., A. Mi., A.G., N.S., and J.B. have nothing to declare.

M.D.G. has been a consultant and/or a speaker and/or has received research grants from Angelini, Janssen-Cilag, Lundbeck, Otsuka, Pfizer, Servier, and Recordati.