Practice and Awareness of the General Population About Common Over the Counter Analgesics Dependence and Side Effects in Al-Madinah, Saudi Arabia

INTRODUCTION:-

Background

Over the counter (OTC) medication can be defined as "the practice of using drugs that have not been prescribed, recommended, or controlled by a certified health care professional"(1). They are usually used for management of minor illness, and they are available for the patients and can be obtained from the community pharmacies. The most common over the counter medications are analgesics. Analgesics that were associated with dependence are those capable of causing tolerance. For example, codeine-containing analgesics(2),(3). The psychological aspects of addiction may occur with any substance, including OTC drugs(4). Dependency "is defined as the repeated use of an OTC drugs in which the person has a need or desire to use the OTC drug and has difficulty in voluntarily stopping or altering their use"(5). OTC analgesics are non-harmful if used appropriately. There is need for people education in order to prevent the misuse of OTC analgesics(6).

Analgesics like non-steroidal anti-inflammatory drugs (NSAIDs) and acetaminophen (paracetamol) are the most commonly used OTC drugs in the world(7),(8). Twenty-five percent of the patients who take NSAIDs, faced adverse events, even with prescription. Several cases of deaths were associated with acetaminophen overdoses(9),(10). Paracetamol is a commonly used analgesic, which is acting on the hypothalamus center, through inhibition of prostaglandin synthesis to produce an antipyretic effect, it also may work in the periphery to block the pain impulses generation by inhibiting prostaglandin synthesis in the central nervous system and increasing pain threshold. It is commonly used for analgesia and fever. Its side effects include disorientation, dizziness, gastrointestinal hemorrhage, laryngeal edema, liver failure, and nephrotoxicity(11).

NSAIDs like Diclofenac, Ibuprofen, and Aspirin have analgesic effect by inhibiting cyclooxygenase (COX 1-2). It has anti-inflammatory and antipyretic activity, and it may inhibit platelet aggregation. Its side effects include headache, abdominal pain or cramps, constipation, diarrhea, dizziness, dyspepsia, nausea, vomiting, edema, and gastrointestinal ulceration or bleeding(12).

Anti-inflammatory drugs had their origins in the serendipitous discovery of certain plants and their extracts being applied for the relief of pain, fever, and inflammation. The chemical advances of the 20th centuries lead to the development of NSAIDs(13).

Al-Madinah is a large city which is located in the west of the Kingdom of Saudi Arabia (KSA), its population is 1,700,000 according to the General Authority of Statistics at 2010(14).

Literature review

Usage of NSAIDs as analgesic is common. According to one of the studies, the top utilized medication class in KSA were analgesics specifically Diclofenac Sodium with percentage of (67%)(15).

One of the recently conducted cross sectional studies in Al-Madinah, showed that (72.5%) of the citizen reported the use of OTC drugs, and (24.3%) of the responses showed history of experiencing side effects from using OTC medication(1).

Other cross-sectional study was done on Riyadh city - KSA, showed a total of 285 medications were bought without a prescription. The most common medications dispensed without prescriptions were antibiotics (22%) and analgesics/antipyretics (19%). Also, it showed that (35%) of 538 patients does not know the side effects of the OTC drugs they use(16).

Another study done on KSA showed that the use of antibiotics and analgesics still accounted for the bulk, followed by proton pump inhibitors and anti-diabetics drugs respectively(17).

According to a systematic review on the Middle East countries, showed that these areas have a high frequent use of OTC drugs, and KSA was in the fourth place by 35.4% (83% in Iran, 68.1% in Pakistan, and 42.5% in Jordan)(18).

Another study was on Jordan showed that NSAIDs use was (69%), Diclofenac was the most common type used, and 58% reported having side effects from NSAIDs use. Gastrointestinal upset was the most reported side effect. Patient's awareness regarding NSAIDs use was poor, and pharmacist role in counseling was inadequate(19).

A cross sectional study in United Kingdom general population showed that dependence rate was more common with analgesics, sleep aids, and nicotine products(17).

Rationale

Studies showed high prevalence of OTC analgesics usage in Saudi Arabia in general. Also, there is limited data about dependence and side effects awareness of OTC analgesics especially in Al-Madinah. Also, the researchers have a clear observation of lack of awareness about common OTC analgesics dependence and its related hazards among general population, that may lead to severe side effects especially among the high-risk groups. The lack of awareness and knowledge highlighted the need for more researches in this area. This is the first paper in KSA that documented the relationship between potential side effect and awareness of dependence on OTC analgesics.

Objectives

- To measure the prevalence and describe the pattern of using OTC analgesics among Al-Madinah population.

- To assess their awareness and attitude regarding the related side effects and dependence.

METHODS:-

Through a cross sectional study focused on Al-Madinah city, KSA, started from February/2019 to Augusts/2019.

The study sample was drawn from a total of 1,700,000 individuals lives in Al-Madinah with 95% confidence interval and 5% marginal error. The calculated sample size was 384. During data collection, we collect 600 responses and stopped receiving data after that.

Inclusion criteria: adults older than 18 years old, male and female, resident in Al-Madinah city. Exclusion criteria: less than 18 years old and those who lives outside Al-Madinah region.

The study tool was a modified validated questionnaire that consist of three sections: 12 questions on participant’s demography, 18 questions regarding practice and awareness of side effects, and 7 questions about practice and awareness of dependence.

Group of medical students, belonging to medical college, distrbuted electronic self-administered structured questionnaire in Arabic language to get the responses from participants through public social media (whatsapp, tweitter, and facebook), all responses met the inclution criteria for age and residency were included.

Source of the validated modified questionnaire is from these two studies: "Prevalence and Determinants of Over-the-Counter Analgesics Usage among Patients attending Primary Health Care Centers in Jeddah, Saudi Arabia - Shaza Dawood Babakor" and "Non-prescription medicine misuse, abuse and dependence: a cross-sectional survey of the UK general population - Niamh Fingleton". The consent has been taken from the authors, and the questions were translated to Arabic language and double reviewed by two doctors at Taibah University.

Statistical analysis methods

The data had been gathered through MS Excel and after data cleaning and data re-coding, it was then exported to statistical packages for social science's version 20 for further tabulation and subsequently for statistical data analyses. Both descriptive and inferential statistics had been performed where numbers and percentages were used to present all categorical variables and mean ± standard deviation for all continuous variables. A p-value cut off point of 0.05 at 95% CI used to determine statistical significance. The analyses measure the relationship between a dependent variable against independent factors by using chi square test.

Ethical considerations

An official permission was taken from the scientific ethical committee of Taibah medical college. An informed consent for this study was obtained from all participants after describing the aim of the study. The privacy and confidentiality of the participants were assured.

RESULTS:-

The total sample size was 600, 53.5% females and 46.5% males. The age range was from 18 to 73 years old (mean 32.5). Nearly all participants were Saudis (92.3%) with 51.2% of them being married. The majority of them were university degree (67.3%) and are currently working (46.7%). Parents were mostly less educated and unemployed. More than a half of them were high earner (57.8%) (Table 1).

The prevalence of OTC analgesic usage for the past 6 months was 515 (85.8%). Of those (33.8%) of them were using OTC analgesics more than 3 times. Regards pain intensity (60%) of them suffered from severe pain, 33.8% were moderate and 7.8% were mild. The commonest analgesic medication for the last 6 months was paracetamol (85.6%), followed by ibuprofen (43.9%) and diclofenac (22.1%), the least of them was aspirin (12.4%). There were (18.7%) of the participants with chronic diseases. (Table 2).

Table 3 presented the patients' knowledge about OTC analgesics, its side effects and dependency. More than (60%) of them had sufficient knowledge regarding the side effects, while (42%) of them had previously encountered side effect from OTC analgesics. When asked about the side effect of excessive use of OTC analgesics, majority of them accounted kidney toxicity (44.2%), followed by liver toxicity (38%), and gastrointestinal irritation and bleeding (25%). A high proportion of the participants (44.2%) agreed that OTC analgesics might cause dependence or addiction. Most of them did not consider themselves an OTC analgesic dependent. Few of them (14.3%) experienced withdrawal symptoms when they stopped using OTC analgesics.

When assessing the relationship between the use of OTC analgesics against the socio demographic characteristics of participants, a relationship was found between age group and the use of analgesic. Prevalence in 21 – 30 age group was higher (p-0.013). Those who were working are higher of using analgesic (p-<0.001). Those individuals who do not havea history history of chronic diseases are more using OTC analgesics (p-0.039). Other social, demographic factors were havin.no relationship. (Table 4).

We also evaluated the relationship between the awareness of OTC analgesic side effectsocial the socio demographic characteristics of participants. Female participants were aware of side effects (p-<0.001). The Saudis have more knowledge regarding the side effects (p-0.042). Those who were working and who earned more than 10,000 Saudi Arabian Riyal (SAR) monthly detected to be more knowledgeable about the side effects (p-0.028), (p-<0.001) respectively. History of chronic diseases has a relationship to the side effects awareness (p-0.036). (Table 4).

We further measured the association between the awareness of dependence on OTC analgesics and the socio demographic characteristics of participants. Those in 21 – 30 years old group and females were aware about the potential risk of dependence on OTC analgesics (p-0.038), (p-<0.001) respectively. Those who were working have lack of knowledge regarding OTC analgesic dependence.P-0.003. (Table 4).

Figure 1 described the causes for taking up self-medication. The most common causes were headache (73.7%), followed by toothache (31.3%) and the least of them was abdominal pain (16%).

The most common sources of information were self-knowledge (82.7%) and previously prescribed medication (35.2%), media was the least (9%) (Figure 2). The commonest reasons for using self-medication were a problem that wasn’t serious (65%), followed by previous experience with the same drug (51.3%), the least of them was urgency of problem (2.7%) (Figure 3). The most common side effects of self-medication with analgesics were stomachache (36.5%), followed by nausea & vomiting (34.5%), the least of them was shortness of breath and stomach ulcer (each 6.7%) (Figure 4).

DISCUSSION:-

Main findings

The current study investigated the practice and awareness of the general population about common OTC analgesics dependence and their side effects. In this study, the practice of OTC analgesics for the past 6 months was high (85.8%). Several published papers documented the usage of OTC analgesics was highly prevalent among people with minor health issues(20),(21). In Saudi Arabia, OTC analgesics usage among medical students has a range of (55% - 77%)(22),(23),(24). Among patients attending primary health care (PHC) center the prevalence was (84.4%)(20). In abroad the prevalence of OTC analgesics usage has a range of (45% - 65.5%)(25),(26). However, one paper showed a prevalence of OTC analgesics usage of (47%) only in a week duration(21).

Type of OTC analgesics

In our study, (85.6%) of the participants indicated the usage of paracetamol in the past 6 months. Various articles reported paracetamol as the most common OTC analgesic being used to treat many different kind of illnesses, Babakor reported (86.1%) of patients attending PHC centers in Jeddah used paracetamol for self-medication(20). In Jazan University (62%) of the female students used paracetamol as headache treatment(22). In India (47.2%) of the medical students used paracetamol as self-medication(27). In Norway they reported (40%) of paracetamol usage. The availability of paracetamol in many convenience stores helps many patients in the treatment of minor illness ignoring the risk of dependence or overuse. Moreover, ibuprofen and diclofenac were the secondary choice of the general population among OTC analgesics. The finding is concurrent from the study published by Babakor and Alghamdi as well as Shivamurthy et al(20),(27). It is mostly used for more sever pain like toothache and pain that dose not responde to paracetamol.

Reason for the use of OTC analgesics

The most common reasons for taking OTC analgesic were “the problem was not serious” and “it was previously prescribed medication.” This is consistent from the study published both local and abroad(20),(24),(25),(27). In Bangladesh, the most common reason were the “remedy is known” and “high fee of doctor”(28), which could be related to the health care system there. Albasheer reported “sufficient information” and “previous experience” were the most common reasons for students to take self-medication(26).

Common symptoms

Headache and toothache were the most common symptoms being identified by the participants in this study, which is similar to most of the published papers. Different papers documented headache as the most common reason for OTC analgesics usage(20),(24),(25),(27). Menstrual pain was the most common symptoms being indicated by the female students in Jazan University(22). Aashi as well as Ira reported fever as the most common reason for self-medication(23),(28). Albasheer, documented that pain management was the main reason for medical students to take self-medication like sedatives(27).

Common side effects

The knowledge of participants regarding the potential side effects of taking OTC analgesics was sufficient, where stomachache as well as nausea and vomiting were widely prevalent among them, this is expected by high level of educated participants. Shivamurthy, detected (61.2%) of the undergraduate medical students were aware of the side effect of analgesic self-medication(27). Similarly, Albasheer reported that undergraduate medical students were knowledgeable about the harmful effect of self-medication(26).

Factors associated with OTC analgesics

Young adult (21 – 30 years) detected to be more associated with the use of OTC analgesic. We further determined that those who were working and without history of chronic diseases were more associated with the use of analgesics self-medication. Babakor revealed those illiterate and highly educated were associated with the highest prevalence of OTC analgesic usage(20), because they are more liable for minor work injuries or headache that mey need analgesics. Ibrahim reported age group, educational year, residual status and father occupation were the significant factors of self-medication with analgesics in the past 6 months(24). Subhashini accounted gender, locality and socio economic status were having relation with self-medication(27).

Factors associated with OTC side effects and drug dependency

Females, Saudis, those who were working, those who were high earners, and those without history of chronic diseases have higher knowledge of the side effects. Concerning to the awareness of dependence on OTC analgesics, females and young adult were more agreed of the potential cause of drug dependency. Those who were working were more disagreed of the potential effect of drug dependency. Females are more attractable to details especially in health, young and high earners are more likely to have assistned technology and health awearness materials.

Study limitation

Using retrospective style and distributing questionnaires by web-based link was because of limited time and recourses.

CONCLUSION:-

Despite the fact that the majority of the general population in this study have sufficient knowledge about the side effects of OTC analgesics and that it may cause dependence or addiction, however, OTC analgesic used in the general population was still high. Paracetamol was the most common OTC analgesic. Headache was the most common symptoms. Stomachache and vomiting were the most common side effects. Age group, occupation, and history of chronic disease are the predictors of OTC analgesics usage.

Recommendation

Medical practitioners' effort is necessary in order to educate the general population about the proper medication for a certain illness to allow safe use of OTC analgesics. Also, the knowledge, attitude, and practice of OTC analgesics misuse should be further investigated in the future studies.

ACKNOWLEDGEMENT:-

We want to acknowledge the survey participants.

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