Pharmacists’ experience with patients suspected to be addicted to over-the-counter codeine and their attitudes towards potential remediation strategies: a cross-sectional study

Abstract

Background

Croatia is one of the European Union (EU) countries where low-dose codeine products (LDCP) can be purchased over the counter (OTC) directly from community pharmacists without a prescription. The misuse and dependence potential of OTC LDCP have raised growing public health concerns. As the first point of contact for patients seeking these medications, pharmacists play a critical role in identifying misuse and implementing harm-reduction strategies. However, little is known about the experiences and perspectives of pharmacists in Croatia regarding codeine addiction. This study aimed to examine the experience of pharmacists in Croatia with patients addicted to over-the-counter codeine and their attitudes toward potential remediation strategies.

Methods

A cross-sectional study was conducted between October 18, 2021, and December 23, 2021. Eligible participants were pharmacists, members of the Croatian Chamber of Pharmacists, employed in community pharmacies in Croatia. The data were collected via an online questionnaire that examined the attitudes and experiences of pharmacists in Croatia regarding OTC medicines containing codeine and the demographic characteristics of pharmacists.

Results

Out of 2800 active pharmacists in Croatia, 594 participated in the study (21% response rate). The majority (92%) saw patients who regularly purchased high quantities of OTC products containing codeine and for whom pharmacists suspected they could be addicted to this medicine. Most participants occasionally talked to patients about possible codeine abuse and addiction. Two-thirds of participants did not report suspected adverse reactions associated with OTC codeine use to the national pharmacovigilance system, despite patients indicating a potential link. More than half of the participants noted that codeine-containing medicines should be switched from OTC to prescription-only status.

Conclusions

This study showed that 92% of pharmacists in Croatia encountered patients who may be misusing or are dependent on OTC codeine products. However, they indicated limited engagement in formal reporting or intervention. The findings highlight the need for more precise guidelines, enhanced pharmacist education, and consideration of regulatory changes, such as reclassifying codeine-containing medicines to prescription-only status, to support pharmacists in mitigating risks associated with codeine misuse.

Supplementary Information

The online version contains supplementary material available at 10.1186/s12888-025-06881-6.

Background

Codeine is a weak opioid analgesic often found in low-dose combinations for the short-term treatment of acute pain. Croatia is one of the European Union (EU) countries where low-dose codeine products (LDCP) can be purchased over the counter (OTC) directly from community pharmacists without a prescription. In 2014, Croatia was one of 15 EU member states where codeine-containing medicines were available without a prescription [1]. While OTC availability improves accessibility, it also raises concerns about the potential for misuse, dependence, and adverse health outcomes, particularly when these products are used beyond their recommended duration or dosage.

The availability of OTC codeine-containing medicines promotes the perception that these are safe medicines, which may contribute to the abuse of these medicines [2], the development of addiction [3, 4], and other adverse effects, including the adverse reactions of acetylsalicylic acid or acetaminophen with which codeine may be combined in over-the-counter medications [5].

Very little research has been published in Croatia regarding opioids. For instance, Krnić et al. demonstrated that the consumption of all types of analgesics, including opioids, consistently increased between 2008 and 2013 [6]. Furthermore, the authors showed that Croatia is a country with low opioid consumption [6].

In 2016, MacKinnon published an article arguing for stricter regulations for OTC codeine in Canada. MacKinnon cites data from earlier research showing abuse of OTC codeine-containing medicines. A 1997 Canadian survey of regular codeine users found that 37% were dependent on codeine, 4% abused it, and half of all regular users obtained codeine without a prescription [7].

This study showed that 89% of participating pharmacists regularly or occasionally talk to patients about their concerns about the possibility of their abuse/addiction to OTC codeine-containing medicines, and may have tried to counsel them about it. Medication counseling is a key component of pharmacy care, which aims to promote the safe and effective use of medicines and achieve the best therapeutic outcomes. However, it has been shown that both patients and pharmacists are dissatisfied with the current medicines’ counseling service and that national guidelines on the further development of such services need to be made [8].

Internationally, growing evidence has highlighted the misuse and addiction potential of OTC codeine products, prompting regulatory changes in countries such as Australia, where LDCPs were reclassified as prescription-only medicines in 2018. The evaluation of the method of dispensing LDCP in Australia began in 2016, and in 2017, a decision was made to switch to a “prescription” method of dispensing. A number of other measures were gradually introduced before the change in dispensing method, including reducing the size of the package to a quantity of medicine sufficient for treatment for a maximum of five days. During the evaluation, the possibility that the availability of LDCP increases the number of intentional and accidental deaths caused by codeine was noted [9].

A 2016 study from Australia indicated that many consumers, pharmacists, and general practitioners initially opposed the upscheduling (i.e. regulatory reclassification of a medicine from a less restrictive to a more restrictive category) of OTC codeine, citing doubts about its effectiveness in reducing harm and concerns over increased financial and time burdens [10].

A 2018 survey of pharmacists in Australia regarding their views on restricting LDCP prescriptions found that 54% of surveyed pharmacists agreed that the switch would have a positive effect on patients. Perceived advantages included greater pharmacist engagement and decreased use of codeine to reduce the overall benefit-risk ratio, while fewer analgesic options and increased patient burden were cited as disadvantages. The report also indicated that pharmacists had different attitudes about changing the way of dispensing LDCP and that they recognized both the advantages and disadvantages of such a change [11].

Monitoring of the effects of the Australian national rescheduling of low-dose codeine from OTC to a prescription-only medicine indicated that codeine consumption decreased substantially afterward [12].

In contrast, data on the impact of OTC LDCPs in Croatia are scarce. To date, no comprehensive studies in Croatia have examined the experiences of pharmacists regarding OTC codeine misuse or their attitudes toward potential strategies to mitigate misuse, despite anecdotal reports and regulatory actions such as a 2011 directive of the Croatian Agency for Medicinal Products and Medical Devices (HALMED)recommending a 3-day use limitation [13].

Adverse drug reactions (ADRs) have been reported to HALMED [14]. However, addiction-related ADRs are rarely reported, possibly reflecting underreporting or a lack of pharmacist engagement with pharmacovigilance systems. Furthermore, the Croatian Institute of Public Health does not specifically track codeine addiction, limiting epidemiological insights.

Since community pharmacists are often the first point of contact for individuals seeking LDCPs, they are uniquely positioned to identify misuse and offer interventions.

To interpret these issues more robustly, we frame our investigation using the Health Belief Model (HBM), which provides a theoretical lens to understand how healthcare professionals, here, pharmacists, engage in health-promoting behaviors [15]. Within this framework, pharmacists’ beliefs about the severity and susceptibility of OTC codeine misuse, their perceived responsibilities and roles in mitigating this issue, and systemic factors such as time constraints and regulatory policies influence whether they provide counseling or report ADRs. This conceptual approach enables us to understand pharmacists’ behaviors not merely as individual choices, but as responses shaped by broader cognitive and structural factors.

The pharmacists’ role in managing codeine-related harm has not been clearly defined or evaluated in Croatia. Addressing this gap is essential for informing evidence-based regulatory and educational initiatives.

This study aimed to examine the experience of pharmacists in Croatia with patients addicted to over-the-counter codeine and their attitudes towards potential remediation strategies.

Methods

Study design

This was a cross-sectional study.

Ethics

The study protocol was approved by the Ethics Committee of the Catholic University of Croatia on February 9, 2021 (Classification no. 641-03/21 − 01/02; Registration no. 498-03-02-06-02/1-21-02) and the Croatian Chamber of Pharmacists’ management board. The study was conducted in accordance with the institutional Codes of Ethics. All methods were performed in accordance with the relevant guidelines and regulations. Informed consent was obtained from all study participants in the online survey system.

Reporting

The study was reported in line with the Checklist for Reporting Results of Internet E-Surveys (CHERRIES) [16].

Participants

Eligible participants were pharmacists, members of the Croatian Chamber of Pharmacists, employed in community pharmacies in Croatia.

Inviting participants

The Croatian Chamber of Pharmacists sent a newsletter inviting the participants to participate in the study. The invitation was sent on October 18, 2021, and a reminder was sent on December 23, 2021. The invitation contained detailed information about the study and a link to the online survey administered via SurveyMonkey. We did not offer any financial or non-financial incentives to the participants. Participation in the study was voluntary and anonymous.

Survey

We developed a new survey for this study because we could not find a similar survey in the literature. While the overall structure and thematic focus were original, the development of some questions was informed by existing literature, particularly a previous survey conducted among pharmacists in Australia [11]. This ensured some degree of content alignment with prior research while tailoring the survey to the local context.

The survey was developed collaboratively by a multidisciplinary team comprising two pharmacists (one specialized in pharmacovigilance), a nurse, a psychiatrist, and a research methodologist. This diverse team composition contributed to the face and content validity of the questionnaire, as the team members brought professional expertise relevant to both the subject matter and the methodological rigor required for survey development.

The survey was developed and administered in the Croatian language. The original version of the survey in the Croatian language is publicly available on Open Science Framework (link: https://osf.io/jfbzm/). An English translation of the full questionnaire is available in Supplementary file 1 and on Open Science Framework (link: https://osf.io/jfbzm/).

The survey used a structured, self-administered survey to explore pharmacists’ experiences with and attitudes toward OTC codeine-containing medicines. The survey consisted of 28 items, organized across multiple thematic sections. It included a combination of closed-ended and open-ended questions.

The first section assessed pharmacists’ direct experience with patients suspected of codeine misuse, including the frequency of such encounters, the types of codeine-containing products involved, and whether pharmacists discussed their concerns with the patients. Further questions examined reasons for not engaging in such discussions, the content of advice given, and any negative experiences during those interactions.

Subsequent sections focused on pharmacists’ practices regarding the substitution and denial of OTC codeine products, their experience with reporting adverse events to the national pharmacovigilance system (HALMED), and their attitudes toward the potential reclassification of codeine-containing medicines from OTC to prescription-only status. Multiple Likert-scale items assessed agreement with the potential benefits and drawbacks of such a policy change for patients, pharmacists, and the healthcare system. Attitudes were examined using a five-item Likert scale, ranging from “strongly disagree” to “strongly agree”. In addition, two questions on attitudes were inspired by a survey of pharmacists conducted in Australia [11].

The final section collected demographic data, including age, sex, years of work experience, and characteristics of the pharmacy where the respondent was employed. The questionnaire was pilot-tested for clarity and logical flow before dissemination.

The survey was shown to the participants on 11 pages in SurveyMonkey. In the survey, we used skip logic to present different questions to different responders, i.e. some follow-up questions depended on the answer to a previous question. Participants were allowed to review and change their answers by going through a back button. We did not use cookies to assign a unique user identifier to each computer. The survey did not collect data about the participants’ names or e-mail addresses. Information about the IP address was not collected. We did not use any techniques to try to prevent duplicate entries because we considered that perhaps multiple pharmacists might be using the same computer in a pharmacy. Participants were not asked for any kind of registration. The survey was not password-protected.

Development and testing of the survey

The survey was developed in SurveyMonkey and pilot-tested within the research team. The pilot confirmed the clarity, logical flow, ease of flow and functionality of skip logic in the SurveyMonkey platform. Individuals who were later invited to participate in the main study did not participate in the pilot test. Feedback from the pilot testing was used to make final adjustments before dissemination. While a formal pilot study with external participants was not conducted, the internal pilot ensured that the survey was comprehensible and logically structured for the intended audience. Although no formal statistical reliability testing (e.g., Cronbach’s alpha) was performed, the combination of expert input and structured pilot testing provided assurance of the survey’s conceptual coherence and usability.

Data cleaning

Data cleaning was performed after the survey responses were exported from the SurveyMonkey platform. All submitted responses were retained for analysis, including partially completed surveys and those terminated early, as our goal was to capture as much information as possible from all participants. No responses were excluded based on the time spent completing the survey.

The dataset was reviewed for completeness, internal consistency, and the presence of duplicate or invalid entries. However, no identifying information (e.g., names, email addresses, or IP addresses) was collected, and cookies or user authentication mechanisms were not used to prevent duplicate submissions. As such, we relied on participants’ voluntary and anonymous participation and did not exclude any entries based on potential duplication.

For quantitative questions, responses were checked for out-of-range or implausible values (e.g., extremely high numbers for age or years of experience), but no such anomalies were detected. For open-ended responses, free-text fields were screened for irrelevant content or responses unrelated to the question. These were not categorized in the qualitative analysis. Additionally, all free-text responses were examined for potentially identifying information. Although redaction was planned in such cases, no identifiable data were present in the submitted responses. The cleaned dataset was then used for descriptive statistical and qualitative analyses.

Data analysis

Quantitative data were analyzed using descriptive statistics, including frequencies and percentages for categorical variables (e.g., gender, pharmacy location, responses to closed-ended questions). Continuous data were first tested with the Shapiro-Wilk test for normality. Data were not distributed normally, so they were shown as the median and interquartile range (IQR). For data analysis, we used the MedCalc statistical program (MedCalc Software, Mariakerke, Belgium).

The open-ended questions were analyzed using a qualitative description (QD) method [17]. This method allows for the identification and categorization of patterns and themes in textual data without imposing a highly abstract or theoretical interpretation, which aligns with the exploratory nature of this study. Responses to each open-ended question were reviewed independently by two members of the research team (ZMK and LP), who were trained and experienced in qualitative analysis. Initial coding involved identifying recurring ideas, phrases, and expressions within the responses. These were then grouped into descriptive categories that captured the main concepts expressed by the participants. Discrepancies in coding were resolved through discussion and consensus among the research team members. Thematic saturation was not a goal, as the aim was to provide a descriptive overview rather than to develop a formal theory. Representative quotes for each identified category were selected to illustrate the range and depth of the participants’ perspectives.

Results

Participants’ characteristics

Of 2800 active pharmacists in Croatia, 594 participated in the study (21% response rate). Their median age was 36 years. The majority were women, working in pharmacy for a median of 9 years, employed in a community pharmacy in a city (Table 1).

Table 1.

Characteristics of study participants (N = 377)*

Characteristic	Result**
Age (years), median and IQR	36 (27 to 47)
Sex, N (%)
Man Woman Do not wish to answer	15 (14) 322 (85) 4 (1)
Years working in the pharmacy, median and IQR	9 (2 to 20)
Location of the pharmacy where they work, N (%)
Village City	66 (18) 311 (83)
Type of the pharmacy where they work, N (%)
Privately owned pharmacy Pharmacy owned by the city, county or state Another type of pharmacy	248 (67) 111 (30) 11 (0.3)

*377/594 (63%) of participants provided information for sociodemographic data

**Percentages may not amount to 100% due to rounding

Acronym: IQR = interquartile range

Most (92%) participants had experience in their pharmacy with patients buying large quantities of OTC codeine-containing medicines that might be addicted to those medicines, based on the participants’ judgment (Table 2).

Table 2.

Participants’ experiences with patients potentially addicted to OTC codeine-containing medicines

Questions/responses	N (%)*
Do you have experience in the pharmacy where you work with patients who repeatedly buy larger quantities (2 boxes or more) of over-the-counter codeine-containing medicines for which you consider that there is a reasonable suspicion that they might be addicted to these medicines? (N = 594)
Yes No	548 (92) 46 (8)
In your experience, which codeine-containing medicines were most often purchased by such patients (please state the proprietary name of the medicine)? (N = 479)
Caffetin and/or Plivadon Caffetin Plivadon Plivadon, Caffetin and Kofedon Pholcodin capsules	333 (70) 87 (18) 57 (12) 1 (0,2) 1 (0,2)
Have you ever talked to such patients about your concerns about the possibility of their abuse/addiction on over-the-counter codeine-containing medicines and perhaps tried to advise them about it? (N = 494)
Yes, always Yes, sometimes No	107 (22) 333 (67) 54 (11)
If you have not talked to such patients in terms of questioning the use of these medicines and giving advice, please state the reasons (multiple answers allowed), (N = 50)
I don’t have time for such patient counselling I have not been educated for such patient counselling I am not motivated for such patient counselling I don’t know what exactly I would advise them I am not comfortable talking about it with patients if there are other patients in the pharmacy Some other reason	3 (6) 0 (10) 10 (20) 14 (28) 23 (46) 8 (16)
Did you experience anything unpleasant from patients while talking to them about the use of over-the-counter codeine-containing medicines and / or trying to advise them on the matter? (N = 391)
Yes No	178 (46) 213 (54)
Do you ever recommend to patients looking for over-the-counter codeine-containing medicines that they should take another, non-codeine-containing medicine? (N = 476)
Yes, always Yes, sometimes No	155 (33) 269 (57) 52 (11)
Have you ever denied a patient an over-the-counter codeine-containing medicine because you suspect they are not using it according to the medication instructions, or you suspect that the patient is addicted? (N = 476)
Yes No	117 (25) 359 (75)
Have you ever reported adverse reactions resulting from use outside the terms of approval (i.e. overdose) related to over-the-counter codeine- containing medicines to the Agency for Medicinal Products and Medical Devices of the Republic of Croatia (HALMED)? (N = 476)
Yes No I do not remember	20 (4) 367 (77) 89 (19)

*percentages calculated from the number of individuals who responded to each question

Most pharmacists regularly (33%) or sometimes (57%) recommend another medicine without codeine to patients. A minority of pharmacists (25%) denied codeine-containing medicine to a patient for which they suspected potential abuse/addiction (Table 2). Among pharmacists who suspected some of their patients had potential abuse/addiction to OTC codeine, the median number of such patients encountered in the past month was 4 (IQR: 2 to 5).

494 (83%) participants answered the question of which codeine-containing medicines were most often bought by such patients (proprietary product name) according to their experience. Most respondents stated that such patients most often buy “Caffetin and/or Plivadon” (Table 2). One of the respondents added a comment to the answer: “Caffetin or Plivadon, but they ask for one of them exclusively. Some patients always buy one, and other patients another medicine”.

Counseling patients regarding codeine-containing medicines

The majority of participants sometimes talked with such patients in terms of counseling them regarding the potential abuse or addiction to codeine-containing medicines (Table 2).

Pharmacists (N = 377) described that they conveyed the following information to the patients during counseling: medicine should be used for 3 days only, a medicine contains opioids, there is a potential for addiction, medicines should not be used regularly (not every day), there is a high risk of adverse reactions, patients should consider lowering the dose if using the medicine long-term, suggestion to use another medicine and suggestion to seek counseling with a physician.

There were 378 participants who provided information about the feedback they received from the patients they counseled. Patient feedback can be narrowed down to 13 categories. The most common feedback was that patients indicate they are aware of the problem, nothing else helps them, and they buy medicine for someone else. Table 3 lists all the categories of the patients’ feedback, as well as representative quotes.

Table 3.

Feedback received by pharmacists from patients they counseled regarding codeine-containing medicines (N = 378)

Feedback category	N (%)
Patients indicate they are aware of the problem (quote: “I know, I can’t help myself, just give it to me”)	135 (36)
Patients say nothing else helps them (quote: “I tried other medicines, but this is the only thing that works”).	79 (22)
Patients say they do not buy it for themselves, but for somebody else (quotes: “I buy it for my relatives from abroad”; “It’s for the whole family and neighbours”).	60 (16)
Patients are silent and ignoring me (quote: “They refuse communication on that topic.”)	44 (12)
Patients are not interested (quotes: “Patients are disinterested”; “They say they are not worried”; “They say they do not care”.)	40 (11)
Patients say they take it only sometimes, when needed (quote: “I don’t take it often, there will be no problems”).	31 (8.2)
Patients deny being addicted (quote: “I’m in control of this and I’m not an addict”).	29 (7.7)
Patients say they need it for the headache (quote: “I just take it for the headache”).	25 (6.6)
Patients report long-term use without consequences (quote: “I have been using it for years and nothing ever happened”).	19 (5.0)
Patients attack, react negatively, threat they will go to another pharmacy (quotes: “They yell at me to leave them alone”; “They say– don’t you tell me what should I do with my life”; “If I do not give them more than 2 boxes, they say they will go to another pharmacy.”;	9 (2.4)
Patients sy they were not aware about the problem (quote: “Most often, patients complain and do not understand that an addiction has developed, they say that they know better because they have been taking this medicine for years. However, the feedback from patients who take such medicines really occasionally is excellent. They sincerely thank you if they did not know about the limitation of use and the possibility of addiction, therefore I believe that the emphasis should be on the prevention of addiction.”).	5 (1.3)
Patients say they will try to quit and talk to their physician (quote: “This is my last box for sure”; “I will talk to my physician”, “They express a good will to discontinue the medicine”)	4 (1.1)
Patients say they failed to stop taking the medicine (quote: “I tried to stop multiple times, but had to go back to the medicine due to the withdrawal symptoms”)	2 (0.5)

About half of the pharmacists who provided patient counseling regarding codeine-containing medicines experienced unpleasant feedback from patients (Table 2). When asked to describe such unpleasant experiences, 164 participants responded. Those experiences can be grouped into six general categories, whereas the most common answer was that patients express anger, aggression, hurt, and they insult the pharmacist. Categories of responses with representative quotes are shown in Table 4.

Table 4.

Categorized unpleasant experiences experienced by pharmacists that provided patient counseling regarding codeine-containing medicines (N = 164)

Categories of unpleasant experiences	N (%)
Patients express anger, aggression, hurt and they insult the pharmacist (quotes: “Patients abuse me verbally”, “They felt insulted that I was even trying to talk to them about it, they said I should just sell it to them and not ask anything”, “Patients swear at me”, “Insulting, scolding, defending that they are not addicts, that they are adults who know what they are doing”).	102 (62)
Patients say this is none of the pharmacists’ business (quotes: “Why do you care”; “Mind your own business”; “They try to silence me and tell me– I should know what helps me”)	49 (30)
Patients say they know it all, they know better (quote: “I know everything about it, I’m not an addict, why are you telling me that, why can’t I get 5 boxes.”).	18 (11)
Patients threat that they will go to another pharmacy (quote: “I can just go to another pharmacy and they will sell it to me.”).	14 (8.5)
Patients ignore me (quote: “They don’t want to listen, they just want to pay and be left alone.”)	5 (3.0)
Patients say that they do not like to be told that they are doing something wrong (quote: “People really don’t like it when they are told that they are doing something wrong, especially when that person has been using something for many years. Aggression is always one of the defense mechanisms.”	2 (1.2)

Reasons for not counseling patients

Participants who did not engage in patient counseling regarding codeine-containing medicines mostly did not do it because they were uncomfortable discussing such issues with other patients present in the pharmacy (Table 2).

Fifteen participants indicated that there was another reason for not providing such counseling. Those reasons are shown in Table 3. Their answers can be sorted into three groups, including problems with patients who were unkind and hostile, discouragement due to failed prior attempts, and belief that such effort would be futile (Supplementary Table 1).

Reporting adverse reactions to the regulatory authority

There were 20 (4%) pharmacists who indicated that they ever reported ADRs resulting from use outside the conditions of approval, i.e. overdose related to over-the-counter medicines containing codeine to the HALMED (Table 2). There were 296 pharmacists who responded to the question about not reporting such reactions. The most common reasons for non-reporting were that patients did not report any adverse reactions, lack of time, negligence and lack of knowledge. Categories of responses with representative quotes are shown in Supplementary Table 2.

Pharmacists’ attitudes towards upscheduling codeine-containing medicines

The majority of pharmacists agreed or completely agreed (67%) that OTC codeine-containing medications should be upscheduled to ‘prescription only’ and that such upscheduling would be positive for both patients and pharmacists (Supplementary Table 3).

Advantages of upscheduling the over-the-counter medicines containing Codeine to ‘prescription-only’

The most commonly suggested advantages for patients of upscheduling the OTC codeine-containing medicines to ‘prescription-only’ recognized by the participants were prevention of new addiction/reduction of abuse, better control over medicine and more difficult access to those medicines. The most common proposed advantages for pharmacists were more control (less abuse, less addiction, better safety), easier communication with the patients, and relief from guilt and responsibility. When asked about the advantages for the health system, most participants mentioned prevention of addiction/abuse, better treatment and protection of patients, and fewer expenses in healthcare (Supplementary Table 4).

Disadvantages of upscheduling the over-the-counter medicines containing Codeine to ‘prescription-only’

The most common disadvantages for patients of upscheduling the OTC codeine-containing medicines to ‘prescription-only’ recognized by the participants were less availability of medicine, none or inadequate treatment of individuals who use the medicine rationally, need to visit a physician, and lack of availability of a physician. Disadvantages for pharmacists were most often recognized as conflicts with patients, financial loss, and listening to explanations from patients that they cannot live without a recipe. Most pharmacists indicated that disadvantages for the health system would be a financial burden if medicine would be paid by the national health insurance, a higher burden on physicians, and fewer sales in pharmacies (Supplementary Table 5).

Final participants’ comments

When asked if they had anything else to add on the topic of OTC codeine-containing medicines, for example, something they thought was important, but that was not covered in the previous questions, most of the responses were covered with feedback that was obtained in previous questions. Some new suggestions were that pharmacists could be authorized to issue a prescription, and some wondered why these medicines are still on the market. Some also warned that their use is deeply rooted in society and that mostly older patients use it (Supplementary Table 6).

Several pharmacists expressed an opinion that they should remain OTC and that they are helpful for some patients. One pharmacist indicated additional questions related to this topic that would be worthwhile investigating, such as the awareness of physicians, healthcare insurance, the magnitude of the codeine addiction problem and the assumption of taxpayers’ costs (Supplementary Table 6).

Discussion

This study found that an overwhelming majority of community pharmacists in Croatia (92%) reported encountering patients who regularly purchase large quantities of OTC codeine-containing medicines, raising justified concerns about potential addiction. These findings highlight pharmacists’ significant role in identifying possible medicine misuse at the point of sale.

Today, pharmacy practice goes beyond dispensing medication; it includes counseling patients to ensure the safe and appropriate use of medicines [18]. In our study, most pharmacists reported counseling patients suspected of codeine misuse, i.e., providing advice on risks, proper use, and suggesting alternatives. Although some pharmacists avoided such discussions due to the sensitive nature of the topic or the presence of other patients, very few felt unprepared or unqualified to offer this type of counseling. This suggests that pharmacists are both aware of the issue and actively trying to address it within their scope of practice.

However, these conversations are not without challenges. Many pharmacists reported unpleasant interactions with patients, including aggression, denial, or verbal insults. This finding is consistent with previous literature, where pharmacists have reported patient conflict as one of the most frequent stressors in community settings [19]. Addressing this issue may require better communication training and structural support to reduce the emotional burden on pharmacists.

A notable finding of this study is that a majority of pharmacists (67%) agreed or strongly agreed that OTC codeine-containing medicines should be reclassified as prescription-only. This widespread support likely reflects growing concern among pharmacists about the potential for misuse and addiction associated with codeine, a mild opioid commonly used for pain relief but with well-documented risks of dependence and overuse, particularly when easily accessible. Of note, a study conducted in 2020 showed the majority of pharmacists (70%) in Croatia indicated that codeine is a strong opioid and that the risks of addiction outweigh the benefits of using codeine preparations (73%) [20].

Our findings are consistent with international research on pharmacists’ perspectives regarding codeine regulation and misuse. For example, in Australia, where codeine-containing medicines were upscheduled to prescription-only status in 2018, studies reported that while many pharmacists supported the change due to public health concerns, they also cited significant barriers to implementation, including patient dissatisfaction, increased workload, and limited communication with prescribers [10, 11].

Similar to our findings, Australian pharmacists also desired more straightforward guidelines and enhanced training to navigate patient interactions during this transition [21]. In 2017, McKenzie et al. surveyed pharmacy practices in Australia on switching codeine-containing medicines to the prescription status. More than half of respondents (59%) indicated that codeine would be safe if they were only available by prescription. In the mentioned period, there were changes related to the method of dispensing codeine-containing medicines, but 64% of the respondents declared that they did not undertake any additional activities related to education in the mentioned area [21].

In the UK and Ireland, research has shown that pharmacists recognize the risks associated with OTC codeine but often face challenges in counseling, particularly due to lack of privacy, patient hostility, and concerns over damaging customer relationships [22, 23]. Carney et al. conducted a study to compare pharmacists’ attitudes regarding the OTC use of codeine in South Africa, Ireland, and Great Britain. They showed that pharmacists had not received (additional) education regarding the use of codeine. The authors conclude that the education of the pharmacy staff is necessary, which would cover the topics of addiction, prevention of mental health, how to deal with acute pain, and similar issues [22].

MacKinnon posited that, despite requests for counseling on purchasing OTC codeine-containing medicines, significant barriers in community pharmacy practice prevent this from happening effectively [7]. MacKinnon suggested using a prescription monitoring program to deliver real-time alerts to pharmacists about potential abuse at the time of purchase [7].

Research on prescription monitoring programs in Canada and the USA showed that dual treatment and polypharmacy are reduced after the implementation of these programs [24]. This indicates that such programs can help reduce the inappropriate prescribing and dispensing of opioids and other controlled drugs. It is not clear whether this ultimately leads to a reduction in abuse and addiction [24].

Some pharmacists highlighted that the disadvantage of switching to prescription status would lead to less sales in the pharmacy. It has been addressed previously that business objectives of pharmacy practice may stand in the way of pharmacists’ professional obligations to counsel patients due to economic, social, and technological changes in pharmacy practice [25]. Harm reduction efforts in community pharmacies are often constrained by the tension between commercial priorities and professional responsibilities. In privately owned pharmacies, pharmacists may hesitate to confront patients about suspected misuse due to fear of losing customers or causing conflict, particularly when sales and client satisfaction are tied to business survival [25].

Additionally, pharmacists’ dual roles as healthcare providers and retail staff create relational challenges. Many participants reported unpleasant encounters when counseling patients, which may discourage future interventions. Pharmacists may feel ill-equipped to engage in consistent harm-reduction practices without institutional support, training, or private space for sensitive conversations [23].

When making decisions about the codeine on the market, patient welfare should be considered before the business goals of the pharmacies. It was suggested in the study that it should be calculated would be the cost for the taxpayers in case codeine-containing medicines that are currently available OTC would be scheduled. However, there is also an option that patients would still be required to pay for these medicines, even if they are switched to the prescription regimen.

The finding that only 4% of pharmacists reported suspected adverse reactions related to OTC codeine use to the national regulatory agency (HALMED) is particularly striking. Despite widespread recognition of potential misuse, this extremely low reporting rate suggests a critical underutilization of pharmacovigilance mechanisms in community pharmacy settings. Responses from participants indicate barriers such as time constraints, perceived futility of reporting, lack of patient cooperation, or uncertainty about how or when to report. This underreporting may hinder national surveillance of codeine misuse and limit timely public health responses. Addressing this issue will require not only targeted continuing education for pharmacists, but also simplified and incentivized reporting systems to improve engagement with national safety monitoring processes.

A pharmacist suggested multiple ideas for further research, including exploring the awareness about this problem among different stakeholders in the healthcare ecosystem, such as physicians and healthcare insurance. Also, it was suggested to explore the magnitude of the codeine addiction problem; however, this is not possible under the current methods of collecting data about addiction in Croatia. Those topics are worth addressing in future studies.

Implications for practice, policy, and education

This study has relevant implications for practice. Our findings underscore that pharmacists frequently encounter patients who may be misusing OTC codeine-containing medicines and often engage in patient counseling despite limited formal guidance and support. This highlights the need to strengthen the role of community pharmacists in early detection and intervention in cases of potential medicine misuse. Pharmacists are uniquely positioned to identify concerning use patterns and provide front-line education and referral. However, the observed discomfort and negative experiences during counseling and limited adverse reaction reporting suggest that practice protocols, communication tools, and support mechanisms should be developed and made available to pharmacists to improve confidence and safety in managing such interactions [26].

The striking underreporting of suspected adverse reactions, despite widespread exposure to potentially addicted patients, indicates a major gap in the pharmacovigilance system. From a policy perspective, this highlights the need to formally recognize and support the pharmacist’s role in post-market surveillance. Simplified digital reporting tools could be explored to reduce time burden and reporting complexity. In parallel, relevant educational interventions should be developed and embedded into continuing professional development programs. These steps could enhance the responsiveness and completeness of pharmacovigilance data, particularly for substances like codeine that are available without prescription but carry substantial risk.

The low rate of ADR reporting among pharmacists may be shaped by institutional and cultural factors. Time constraints in busy pharmacy environments, particularly where pharmacists work alone or under commercial pressure, can deprioritize reporting. Additionally, several participants indicated a low perceived utility of reporting, suggesting a cultural gap in understanding the role of community-based pharmacovigilance. Some pharmacists also described discomfort with collecting personal or sensitive information from patients, particularly in the absence of formal protocols or legal protections, highlighting potential fear of conflict or negative reactions. These findings suggest that underreporting is not merely a matter of awareness but is also tied to systemic disincentives and organizational culture, which should be addressed through targeted training, leadership support, and institutional incentives.

Furthermore, regarding policy implications, pharmacists’ strong support for reclassifying codeine-containing medicines from OTC to prescription-only status reflects a perceived need for tighter regulatory control. Policymakers may consider these findings in ongoing deliberations about the risk-benefit balance of codeine availability, particularly in light of international trends toward stricter regulation [27]. Additionally, several participants raised the possibility of authorizing pharmacists to prescribe certain medications or participate in shared-care models, which could be further explored in the policy context to reduce unnecessary physician visits while maintaining safe access to essential medicines.

In terms of implications for education, our findings reveal gaps in pharmacists’ preparedness to counsel patients on substance misuse, with some citing a lack of time, knowledge, or confidence. This suggests a need to enhance training in addiction awareness, pharmacovigilance, and communication skills in undergraduate pharmacy curricula and continuing professional development programs [23]. Educational interventions should be aligned with evolving practice expectations, especially as pharmacists are increasingly recognized as key contributors to public health and safe medicine use.

The findings underscore the need to strengthen the pharmacist’s role in early identification and intervention for codeine misuse. Practice should be supported by national guidelines that define when and how pharmacists should counsel patients, recommend alternatives, or refuse sales. On a policy level, regulatory authorities should consider revising prescribing and dispensing guidelines to ensure consistent limits on the sale and use of OTC codeine, including pack-size restrictions, labeling improvements, and mandatory documentation of repeated purchases. Structured interprofessional collaboration and formal referral mechanisms between pharmacists and prescribers could also enhance continuity of care.

The implications of our findings resonate with several Development Goals of the International Pharmaceutical Federation (FIP), particularly Development Goals (DG) 5 (Competency Development) and DG 9 (Continuing Professional Development) [28]. Based on DG 5, it would be useful to create formalized networks where pharmacists can share patient concerns with prescribers or addiction specialists, reducing the burden of confrontation and enhancing care continuity. Meanwhile, aligning national CPD programs with DG 9 could ensure that pharmacists are regularly equipped with evidence-based strategies for recognizing and addressing substance misuse. These global standards offer a roadmap for translating our findings into structured national strategies that enhance pharmacist capacity and patient care.

Theoretical framing of findings

The findings of this study can be better understood when viewed through the lens of established public health and behavioral models. The HBM provides a useful framework to interpret pharmacists’ behaviors and attitudes [15]. In our study, pharmacists perceived a high prevalence of misuse and addiction to OTC codeine (perceived severity), recognized their own unique role as a frontline defense (perceived benefits), but often encountered barriers such as fear of confrontation, lack of privacy, or uncertainty about proper guidance (perceived barriers). Some pharmacists chose not to engage in patient counseling due to past negative experiences or a belief that such conversations would be ineffective—aligning with the concept of low self-efficacy.

In parallel, our findings align with the harm reduction model, a public health strategy that seeks to minimize the negative consequences associated with drug use without necessarily requiring abstinence [29]. Pharmacists in this study often recommended alternative medicines, provided information about risks, and attempted to counsel patients about misuse. These actions are consistent with harm reduction principles. However, these efforts were constrained by systemic limitations, such as absence of formal training, limited privacy in the pharmacy setting, and a lack of institutional support. These constraints suggest that while pharmacists are willing to engage in harm-reduction activities, they require enhanced structural support to do so effectively.

Furthermore, the results can be interpreted within the context of health systems responsiveness [30], which emphasizes the ability of the health system to meet the population’s legitimate expectations regarding communication, respect, confidentiality, and prompt attention. Our findings indicate that pharmacists often feel isolated in dealing with codeine misuse, highlighting a gap in systemic responsiveness. Without clear guidelines, coordinated care pathways, or feedback mechanisms, pharmacists are left to manage a complex public health issue mainly on their own. A responsive health system would empower pharmacists through training and protocols and integrate them into a broader continuum of addiction care.

Together, these theoretical perspectives offer a more robust understanding of the pharmacists’ experiences and suggest specific directions for intervention, including behaviorally informed education, harm-reduction toolkits, and enhanced health system engagement.

Strengths and limitations

This study has several strengths. First, it addresses an important and underexplored topic using a comprehensive and structured approach. A multidisciplinary team developed the survey, which allowed for a nuanced understanding of pharmacists’ experiences and perspectives. Qualitative data were analyzed systematically using the QD method, providing insight into participants’ attitudes and reasoning. The study followed established methodological standards, including ethical approval, informed consent, and adherence to the CHERRIES checklist for reporting internet-based surveys.

However, several limitations should be acknowledged. The study had a modest response rate (21%). While this response rate is within acceptable limits for online surveys among healthcare professionals, it raises questions about the representativeness of the sample. The sample may not fully represent the entire population of community pharmacists in Croatia. Although participation was voluntary and the survey was disseminated through the national professional body (Croatian Chamber of Pharmacists), we did not have access to detailed demographic data for the whole pharmacist population, which limits our ability to assess representativeness directly.

Additionally, the sample was mainly composed of women (85%), reflecting the gender distribution in the profession but limiting the potential for gender-based comparisons. Because the study was designed as exploratory and descriptive, no inferential statistical analyses were conducted, and subgroup comparisons (e.g., by gender or years of experience) were not performed. The reliance on self-reported data introduces the potential for recall and social desirability bias. Furthermore, using an anonymous online survey without mechanisms to prevent duplicate entries, while appropriate for protecting respondent anonymity, may limit data reliability. Although the survey was pilot-tested internally for clarity and logic, a formal external pilot study was not conducted.

Finally, incomplete surveys were included in the analysis. While this could be seen as a limitation, we opted for that to maximize the use of available data and provide a more comprehensive understanding of the research question. Excluding incomplete surveys can lead to significant data loss, especially if the incomplete responses still contain valuable information on key variables. This can reduce the sample size and potentially bias the results if the excluded respondents differ systematically from those who completed the survey. Furthermore, including incomplete responses helps maintain the sample’s representativeness. If incomplete surveys are excluded, the final sample may not accurately reflect the target population, leading to skewed conclusions. Finally, excluding participants who did not complete the entire survey might be seen as disregarding their effort and time. Including their partial responses respects their contribution, even if incomplete.

Future research

The findings of this study highlight several important directions for future research. First, while this study focused on descriptive analysis, future studies could explore comparative analyses across demographic or professional subgroups (e.g., age, gender, years of professional experience, or urban vs. rural pharmacy settings) to better understand potential differences in pharmacists’ experiences and attitudes regarding OTC codeine-containing medicines. Such analyses would benefit from more extensive and balanced samples to better understand how these factors influence engagement in patient counseling or support for regulatory changes.

In addition, the low rate of adverse reaction reporting to regulatory authorities observed in this study suggests a need for further investigation into pharmacists’ knowledge, attitudes, and perceived barriers toward pharmacovigilance in the context of OTC medicine misuse. Qualitative studies or structured interviews could provide more in-depth insight into why underreporting occurs and how it might be addressed through policy or educational initiatives.

Several participants raised novel and relevant issues in their free-text comments, such as the role of physicians, access to healthcare, and even the possibility of authorizing pharmacists to issue prescriptions under certain conditions. These ideas merit formal exploration in future work, ideally involving other key stakeholders such as physicians, public health authorities, and patients.

Further research could also examine public perceptions and patient behavior related to codeine use, including misuse patterns, motives, and awareness of addiction potential. A population-level or mixed-methods approach may be useful to complement pharmacists’ perspectives and offer a more comprehensive view of codeine use in the community.

Finally, as regulatory changes regarding the availability of OTC codeine-containing medicines are being considered in many countries, longitudinal studies following any future policy changes could help evaluate the impact of such reforms on patient behavior, pharmacist workload, public health outcomes, and healthcare system costs. Researchers could explore the effectiveness of pharmacist-led interventions, the outcomes of codeine upscheduling, and patient experiences with such regulatory changes.

Conclusions

The majority of community pharmacists see patients in their pharmacy for whom they suspect they are addicted to OTC codeine-containing medicines. Further research is needed about the magnitude of OTC codeine addiction in Croatia. Upscheduling from non-prescription to the prescription regimen could be considered in Croatia for codeine-containing medicines in a step-wise manner allowing to implement appropriate support network for addiction issues related to OTC codeine-containing medicines and educate all stakeholders involved– patients, general practitioners and pharmacists.

Electronic supplementary material

Below is the link to the electronic supplementary material.

Abbreviations

ADRs

adverse drug reactions

CHERRIES

Checklist for Reporting Results of Internet E-Surveys

EU

European Union

HALMED

Croatian Agency for Medicinal Products and Medical Devices

HBM

Health Belief Model

HZJZ

The Croatian Institute of Public Health

IQR

interquartile range

KPPKFS

caffeine/paracetamol/propifenazone/codeine phosphate sesquihydrate

LDCP

low-dose codeine products

OTC

over-the-counter

QD

qualitative description

Author contributions

Study design: ZMK, ZK, AS, LPData collection: ZMK, BP, LPManuscript writing and data interpretation: ZMK, LPFinal approval of the manuscript: ZMK, BP, ZK, AS, LP.

Funding

The authors did not obtain any grants to support this work.

Data availability

Based on the study protocol approved by the Ethics committee and the Croatian Chamber of Pharmacists, and information given to participants, raw data collected within the study will be used for the purpose of this study only, and only study researchers will have access to the data. Corresponding author can be contacted for any queries regarding the raw data collected within this study.

Declarations

Ethical approval and consent to participate

The study protocol was approved by the Ethics Committee of the Catholic University of Croatia on February 9, 2021 (Classification no. 641-03/21 − 01/02; Registration no. 498-03-02-06-02/1-21-02) and the Croatian Chamber of Pharmacists’ management board. The study was conducted in accordance with the institutional Codes of Ethics. All methods were performed in accordance with the relevant guidelines and regulations. Informed consent was obtained from all study participants in the online survey system.

Consent for publication

Not applicable.

Competing interests

The authors declare no competing interests.

Disclaimer

The views expressed in this article are the personal views of the author(s) and may not be understood or quoted as being made on behalf of or reflecting the position of the regulatory agency/agencies or organisations with which the author(s) is/are employed/affiliated.

Clinical trial registration

Not applicable. This study was not a clinical trial.