INTRODUCTION

Over-the-counter drugs (OTCs) are commonly used and most people can assume responsibility for using them on their own. We call this "self-care" and define it as "self-medication with over-the-counter drugs (OTCs), intended for use without medical supervision, diagnosis, prescriptions or monitoring of treatment."

The availability of OTCs is increasing, as several prescription drugs are being switched to non-prescription status by the regulatory body, the Swedish Medical Products Agency (MPA), after applications from the manufacturers. The MPA is one of several National Competent Authorities (NPAs), being represented in the European Medicines Agency's (EMA's) different scientific councils. In Sweden, 42 products have been switched to OTC status since 2003. That is, either a previous prescription substance, strength, dosage form or dose has become available over-the-counter. The availability of OTCs has further increased in Sweden since the Governmental re-regulation of the pharmacy market in 2009, through which outlets other than pharmacies became permitted to provide many OTCs. Non-pharmacy retailers, such as grocery stores and gas stations, wanting to sell OTCs have to send the MPA a notification. Today, they may merchandize 122 different OTCs, comprising 70% of all OTC packages, more than in several other countries in Europe. However, the non-pharmacy retailers usually select a limited stock only of the 10-15 most demanded products. The international trend of increased OTC availability has been questioned for safety reasons, including higher risks for adverse effects in the elderly.¹

In 2011, two years after the re-regulation, the pharmacy was still the preferred OTC drug retailer in Sweden, according to a Swedish Consumer Agency survey², but purchases in outlets other than pharmacies are increasing. The aspect that was considered most important was whether the OTCs had good quality, followed by advice given by pharmacy staff on the use of various OTC products. Non-prescription medicine use has been examined in several studies³,⁴,⁵,⁶,⁷,⁸,⁹,¹⁰,¹¹,¹², including the finding that many consumers need information and advice on the purchase of OTCs and that the most common problem for OTC pharmacy customers is uncertainty about the aim of the drug, resulting in an incorrect choice of product.⁹,¹¹,¹² Other common OTC drug-related problems are therapy failure and adverse reactions, overdoses and drug duplications, contraindications and practical administration issues.⁹,¹¹ Studies have also noted a lack of knowledge among the public about OTCs to treat pain and colds.⁵,¹²,¹³ Because of the increased availability of OTCs and our limited knowledge about the public's use and safety perception of OTCs, the Swedish Medical Products Agency (MPA) decided to conduct a study to increase our knowledge.

The aim of the study was to examine the adult general public's views on risks and safety, preferred purchasing and information channels, reasons for their preferences and storage and disposal of OTCs in Sweden.

METHODS

A descriptive study in which the survey agency Statistics Sweden (SCB) conducted a questionnaire survey in a web format during November 2012-February 2013 on behalf of the MPA. A paper version of the questionnaire was distributed as well in connection with two reminders. The random selection was drawn from SCB's Total Population Register (TPR).¹⁴

RESULTS

A total of 8,302 people (42%) answered the questionnaire; 57% used the paper survey, 43% the web-based version. Gender and age distributions were as shown in Table 1, while distributions by country of birth, family type and highest education are presented in Table 2.

Regarding income, the respondents were divided into four quartiles. The weighted response rates were highest among women, in the elderly, in respondents born in Sweden or in another Nordic country, in couples without children, in university/college-educated and in respondents with a higher income. Just over 6% of men and 1% of women of the respondents said they did not use OTCs.

DISCUSSION

To our knowledge, this is the first study conducted in a random sample drawn from the whole adult population of Sweden, aimed at examining consumer views on safety, purchase and information sources of OTC drugs. Half a year after our data collection, another Swedish study was however performed on consumer preferences for OTC drug retailers and reasons for their choices in a sample of a local web panel.¹⁹

The public seem to have a sound judgment of OTCs, especially families with children, who could be seen as taking both a more cautious and practical approach towards OTCs. The finding that the proportion of respondents, who think that OTCs should only be used on a health professional's recommendation, declined both with increasing education and rising income, may possibly be interpreted as the highly educated and the high income earners, often the same people, feel they have sufficient knowledge to enable them to take responsibility for their OTC drug use themselves.

Interesting differences were observed between respondents based on country of birth, as those born in Sweden in particular, but also participants born in other Nordic countries and North America, assessed OTCs as harmless to a lesser extent than mainly Africans and Asians. The reasons are unknown, but one explanation could perhaps be that OTCs generally are available under less restriction in Africa and Asia, resulting in a different appraisal. The view of traditional versus western medicine could also have an influence, which may be prominent in many population groups for a long time after emigration.

In an American study, 40% of the respondents said OTC analgesics were too weak to cause damage⁷ and two Italian studies reported low awareness and underestimation by the public about the potential risks of long-term use of certain OTCs.²⁰,²¹ The results of two other studies in the United States, one of which was a large multicenter study, showed that non-steroidal anti-inflammatory drugs (NSAIDs) are often taken incorrectly and even in a potentially dangerous manner.²²,²³ There was also a low public awareness about the potential side effects.²³ In the US multicenter study, self-medication with OTCs was however found to cause hospitalizations due to side effects to a very small extent.²³ Among those that did, NSAID-related stomach/intestinal side effects in the elderly, mainly due to aspirin, were the most common.

Our results confirm the Consumer Agency survey that the pharmacy still is the most preferred OTC drug retailer², although the proportion who buys them at the pharmacy has dropped from about 90 to 80%. In the Swedish web panel study, 76% of the participants had been to a pharmacy the last time they bought any of the OTC drugs listed in the study. According to their results, more respondents aged below 60 than 60 or above had at least once purchased OTC drugs from a non-pharmacy retailer.¹⁹ Pharmacy-monopoly on sales of OTC drugs is still the case in about half of the countries in Europe, such as in Finland, Germany, Belgium, France, Spain and Italy. Self-care customers in a study in Belgium were happy with pharmacies and hesitant to use other distribution channels of OTCs.²⁴ In a study in the Netherlands, a country with no pharmacy OTC monopoly, consumers had good confidence in the use of OTCs but still preferred non-prescription analgesics to be available in pharmacies only.²⁵

The most common reasons for the choice of OTC drug retailer were much in line with the Consumer Agency's survey.² The Swedish web panel study arrived at different results, where geographic proximity was reported as the overarching factor in the choice of retailer, followed by opening hours and range of available products, while access to counselling by trained staff was rated as the fourth most important reason.¹⁹ Our finding that opening hours was a more common motive for families with children could probably be explained by the fact that availability is a major practical issue for the families with children. Nor was it surprising that the price of the OTC was an important reason for single parents when selecting the place of purchase, considering their economic conditions. Also as expected, the price motive declined with rising income.

The pharmacy staff was the most common information source prior to choosing the product when being uncertain, which is in accordance with a study in Northern Ireland, where the pharmacist's recommendation had the greatest influence on the consumers' product selection.²⁶ In an interview study in pharmacies in Estonia, more than half of the respondents relied on the pharmacist as a drug counselor and appreciated the recommendations on OTCs.²⁷ However, in a Swedish interview study of a thousand OTC analgesics/NSAID pharmacy customers, over 90% said that they select their products without any communication with the pharmacy staff other than for payment. Furthermore, 8 out of 10 responded that they routinely chose the same OTC product as previously purchased. In the same study, 40% reported that they did not intend to read the package insert.¹² As opposed to our current study, the previous study however dealt with OTC analgesics and NSAIDs only and the respondents obviously felt confident in their product selection and therefore did not seek any advice. It may seem surprising that only 18% preferred physicians as a source of information. One plausible explanation is the easier access to pharmacists' counseling, another that it may feel more natural to ask for advice at the moment of OTC purchase than to ask at a doctor's appointment.

The finding that young people in our study ask both family and doctors to a greater extent than middle-aged and older people could possibly be because they still have limited experience in OTC use. It is not surprising that they also seek information on various websites to a higher degree, given that they have a greater habit than older people of using the internet. The fact that even low-income people in the study to a larger extent use the same sources of information as the young, may be because they are partly the same people, i.e., younger who have not yet reached a higher income, and that several of these information sources are free of charge. The reason why it was more common among respondents born outside the Nordic countries to turn to doctors/health care could possibly be a cultural issue.

It was expected that analgesics and various cold remedies, followed by OTCs to treat dyspepsia, would be common in the home medicine cabinet. In one of the studies in Northern Ireland, analgesics were clearly the most common OTCs found in the home, followed by vitamins and minerals and products for dyspepsia²⁶ In the Dutch study mentioned earlier, over 80% used OTCs in the past year, virtually all analgesics/antipyretics and three quarters cold medications.²⁵ Analgesics and antipyretics represented 76% of the OTC drugs used in the Swedish web panel study, followed by nasal sprays for cold relief (35%) and antacids and anti-reflux drugs (18%).¹⁹

The finding that almost half of the respondents in our study said that they used the bathroom cabinet for storage purposes, pointed to a need to inform about the unsuitability of such storage given some drugs' moisture sensitivity. It is surprising that 17% of respondents throw their OTC leftovers in the trash or flush them down the toilet, considering both that pharmacies have propagated for decades a return of unused OTCs to the pharmacy and the general increase in environmental awareness in society. However, according to a systematic review, covering the literature on medication disposal around the world in 2005 through 2015, Sweden and Germany were the only countries where returning drugs to pharmacy was practiced to a larger extent. According to the review, the most common method for disposal of unused medications in households is disposal in the garbage.²⁸ Hence, the practice of medication disposal in Sweden may still be good in an international comparison.

A limitation of our study is the low response rate, but due to both the stratification sampling and the weighting procedure the distribution of demographic variables of the study population is believed to be similar to the adult population in Sweden. As it however is not known how representative the reported consumer views on safety and preferred drug retailers and information sources are, the questionnaire results should be generalized to the adult population of Sweden with great caution. Although, possible reasons for differences among different groups of respondents are discussed, chi square tests would not have been sufficient to establish causal relationships but a more thorough statistical analysis would have been necessary. A limitation that made age-related comparisons more difficult was the finding that the older age group marked the response options "No opinion" and "Do not know" more frequently than the younger respondents, as well as generally fewer options in questions where multiple responses were possible. The reasons are unknown, but it is not likely to be due to the web-based survey medium, as they had the possibility to choose the paper-based format instead. One possible explanation could be that some people think of "OTC drugs" as a heterogeneous collective term for products which are more or less safe to use. The answers might therefore depend on the product in question and respondents may have found it hard to generalize to OTCs as a whole.

Like in questionnaire studies in general, there is also a risk of a selection bias through which the most interested respond. Additionally, there is a possibility of both a recall and a social desirability bias, the latter perhaps reinforced by the fact that the study was run by the regulatory authority. Another limitation is the fact that the data collection took place three years after OTCs were permitted to be sold by non-pharmacy retailers and changes may have taken place during the more than three years that have passed since the data collection, such as an increase in e-commerce. Hence, the results are limited to the point in time when the questionnaires were answered

Despite the limitations and the cautious generalization of the results to the adult population of Sweden, the findings may be of value for future research, such as in generating hypotheses.

CONCLUSIONS

In conclusion, the study population does not consider OTC drugs to be harmless regardless of how they are used, but on the other hand feels they should not be taken on health professionals' recommendation only. The majority buys OTCs at the pharmacy and close to all have OTC drugs at home, most frequent of which are drugs to treat pain and fever. Pharmacy staff is the most common sources for advice on OTC use and a quarter say they read the package information. The storage and disposal of OTCs can be further improved.