THE IMPACT OF SELF-MEDICATION WITH NSAIDS / ANALGESICS IN A NORTH-EASTERN REGION OF ROMANIA

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1164 THE IMPACT OF SELF-MEDICATION WITH NSAIDS / ANALGESICS IN A NORTH-EASTERN REGION OF ROMANIA IOANA DANA ALEXA 1, ADRIANA GABRIELA PANCU 2, ANCA IULIANA MOROŞANU 1, CRISTINA MIHAELA GHICIUC 1, CĂTĂLINA LUPUŞORU 1, GABRIEL IOAN PRADA 3*, VASILE CEPOI 1 1 University of Medicine and Pharmacy "Grigore T. Popa" Iasi 2 Clinical Hospital Dr. C. I. Parhon Iasi 3 University of Medicine and Pharmacy Carol Davila Bucuresti *corresponding author: giprada@gmail.com Abstract Self-medication is a widespread practice to treat health problems, being involved in delayed diagnosis, worsening of disease evolution and the occurrence of adverse effects. The aim of the study was to evaluate the prevalence of the use of analgesics, anti-inflammatory and antipyretic form of medicines as self-medication in a population group in the North-eastern Romania (rural versus urban areas) and medical reasons for their administration. The questionnaire method was applied to two groups of people in rural and urban areas from north-eastern Romania. Study duration was six months (August 2013 - March 2014), while self-medication was monitored. The study was approved by the Ethics Committee of UMF "Gr. T. Popa" Iasi. Our study included 461 people aged between 20 and 90 years old, of which 55.3% were from urban areas versus 44.7% from rural areas, females being dominant (75.5%). The drugs we tracked were used by 84.8% of the surveyed population, in most cases the administration being made without prior professional advice. Of the 281 participants from urban areas, 92 % have turned to selfmedication, compared with 52.11% in rural areas. Paracetamol (46.6%), ibuprofen (30.4%) and metamizole (12.7%) are among the most widely used analgesics, both in urban and rural areas. The most frequent symptoms that required self-medication were: headache (urban and rural areas), respiratory disorders (predominantly urban) and osteo-articular problems (rural areas). Misuse of painkillers and anti-inflammatory drugs, especially in urban areas is an important concern for health care services, thus necessitating the implementation of national programs to inform and educate the population on the risks of self-medication. Rezumat Automedicaţia este o practică larg răspândită pentru tratarea problemelor de sănătate, fiind implicată în întârzierea diagnosticării, agravarea evoluţiei unor afecţiuni şi în apariţia efectelor adverse. Scopul studiului a fost evaluarea prevalenţei utilizării de analgezice, antiinflamatoare şi antipiretice sub formă de automedicaţie, într-un grup populaţional din nord-estul României (mediul rural versus urban) şi motivele medicale care au determinat administrarea acestora. S-a aplicat metoda chestionarelor pe două loturi de persoane din mediul rural şi urban. Durata studiului a fost de şase luni calendaristice

1165 (august 2013 martie 2014) fiind urmărită automedicaţia. Studiul a fost aprobat de Comisia de Etică a U.M.F. Grigore T. Popa, Iaşi. Au fost incluse 461 persoane cu vârste între 20 şi 90 de ani, din care 55,3% - urban, 44,7% - rural, dominant fiind sexul feminin (75,5%). Medicamentele urmărite au fost utilizate de 84,8% din populaţia chestionată, în majoritatea cazurilor administrarea fiind fără o consiliere de specialitate prealabilă. Din cei 281 de participanţi din mediul urban, 92% au apelat la automedicaţie, comparativ cu 52,11% din mediul rural. Paracetamol (46,6%), ibuprofen (30,4%) şi metamizol (12,7%) se numără printre cele mai utilizate analgezice, atât în mediul urban, cât şi rural. Simptomele cele mai frecvente care au impus apelul la automedicaţie au fost: cefaleea (ambele medii), afecţiunile respiratorii (predominant în mediul urban) şi afecţiunile osteo-articulare (mediul rural). Utilizarea abuzivă de analgezice şi antiinflamatoare, în special în mediul urban, trage un semnal de alarmă pentru sistemul de sănătate, fiind astfel necesară implementarea de programe de informare şi educare asupra riscurilor automedicaţiei iresponsabile. Keywords: self-medication, anti-inflammatory drugs, pain killers Introduction Self-medication has been traditionally defined as the taking of drugs, herbs or home remedies on one's own initiative, or on the advice of another person, without consulting a doctor. This is increasingly common in the world, being encouraged by governments in different countries and supported by pharmaceutical industry [1]. Family, friends, neighbours, or suggestions from advertisements in newspapers or popular magazines are common sources of self-medications as most of the patients want to play an intelligent, independent and informed role in the management of the diagnostic and therapeutic activities which concern them. The most common self-administered drugs detected in most population studies are anti-inflammatory drugs and analgesics, followed by antibiotics [2, 3]. In less developed countries, self-medication is considered "responsible" because it may help to treat diseases that do not require medical attention and may reduce overuse of medical services; selfmedication s purpose is to solve minor health issues [4]. Although the potential benefits seem to be of a financial nature, selfmedication can frequently cause unwanted side effects that would increase healthcare costs, creating an additional burden on the sanitary system [5]. Materials and Methods The study was conducted between August 2013 - January 2014 (6 months) on a population group from North-eastern Romania (rural versus urban), with the help of several General Practitioners from different areas of Moldavia: Suceava, Vaslui, and Iasi counties. Our study included 461

1166 people aged between 20 and 90 years. The research was carried out using questionnaires concerning self-administered drug consumption on a period of six months prior to the interview. The questionnaires were anonymous and the data obtained were used exclusively for statistical processing. They were sent by post and we recorded an 87% response rate. The study had the approval of the Ethics Committee of the University of Medicine and Pharmacy Gr.T. Popa Iasi. The collected data were analysed by the SPSS 18.0 software, using the paired T test for quantitative analyses and Chisquare test for differences in proportions. Results and Discussion From the total of 461 subjects, 281 were from urban area - students from various universities from Iaşi and 180 were randomly selected from several rural areas: Putna and Dragomirna from Suceava county, Micleşti from Vaslui county and Leţcani from Iaşi county. The analysis of the demographic data showed that more than 70% of the study population was under 30 years old (Figure 1) and, regardless of the origin, most of our participants were females (75.48 %). % Figure 1. Study population distribution by age The number of persons who used self-medication increased proportionally with the duration of time: 45.55% were recorded in the first month versus 80.55% in the total of 6 months of our study. Analysing selfadministered drug consumption in relation with residence area, we found that there was no significant difference between urban (92%) and rural (80.55%) areas, but the most commonly used drug was paracetamol (46.6%), followed by ibuprofen (30,4%) and metamizole (12.7%) (Figure 2).

1167 Figure 2. The incidence of the drugs used The most frequent symptoms that required self-medication were: - rhinorrhoea and cough, significantly increased in urban areas (67%) compared to rural areas (27.9%, p = 0.002); - headache, in similar proportions in both areas (46.4% in rural versus 40% in urban areas); - abdominal pain, in similar proportions in both areas (46.4% in rural versus 44% in urban area) (Table I). Table I. Symptoms for which the drugs were used in rural area and urban area Symptoms Rural Urban Rhinorrhoea cough Area Percent Statistical % differences 27.9% χ 2 =9.91 p=0.002 Headache 46.4% χ 2 =11.98 Abdominal pain 46.4% χ 2 =11.98 area Statistical differences 67% χ 2 =8.36 p=0.004 Percent % 40% χ 2 =90.5 44% χ 2 =111.4 χ 2 - Chi square test; df - degrees of freedom; p - level of statistical significance; - the mean difference is significant at the 0.05 level Over the past years there has been a push-back against the paternalistic model of health, towards a more person-centric approach involving self-care and responsible self-medication with non-prescription

1168 (or over-the-counter, OTC) medicines. The new approach in this domain consists in accepting the switching from prescription to non-prescription status due to the fact that modern patients wish to take a greater role in the maintenance of their own health and are often competent to manage uncomplicated or/and recurrent illnesses after proper medical diagnosis and with only occasional professional advice [6]. Studies carried out on self-medication state that this is a very common practice, especially in economically deprived communities. In a study conducted in Croatia, self-medication was a common practice and anti-inflammatory drugs (97%) were the most commonly used by far in the study [7]; similar data were published by studies carried out in Sudan [8], Nepal [9] and Jordan [10]. In all the studies, the most used drugs in the practice of self-medication were analgesics, anti-inflammatory drugs, and antibiotics. Our study explored the risk of self-medication in the North-eastern region of Romania, and our population group had representatives from all groups of age, equally distributed according to gender and residence area. We focused mainly on young, educated people from urban area (mostly students from various universities) and elderly people from agricultural rural zones. Our data showed that there were no significant differences based on education, gender, residence area considering self-medication as all people implied in the study were exposed equally to advertisements and availability of drugs from pharmacies. Self-medication was equally found in rural and urban areas (80.55% vs 92%), our group having predominantly female gender (75.48%) and young population (70.06%). We focused on three drugs related to self-medication: paracetamol, ibuprofen (one of the safest non-steroidal anti-inflammatory drugs) [3] and metamizole, as they are currently part of the composition of a large number of drugs used to treat headaches, colds and transient pain [11]. Our data showed that paracetamol was used in 46.6% cases, being preferred in headaches, different types of pains and general symptoms of cold indiscriminately. The second place was occupied by ibuprofen, 30.4%, very popular in the treatment of cold and headaches, followed by metamizole, 12.7%, and different associations of the three (10.3%). Symptoms that required more frequently this medication were rhinorrhoea and cough, significantly increased in urban areas (67%) versus rural areas (27%, p = 0.002), followed by headache and abdominal pain, equally found in both residence areas. There is a general agreement that self-medication has benefits on individuals and community [12]. On the individual level, self-medication has an active role in people s own health care, especially in preventing or

1169 relieving minor symptoms or conditions; it is convenient, since medical consultations will be reduced or avoided. On the community level, selfmedication can save scarce medical resources from being wasted on minor conditions, can reduce absenteeism from work due to minor symptoms and could increase the availability of health care to populations living in rural or remote areas. However, one should keep in mind that self-medication has, in the same time, potential risks. On the individual level, incorrect diagnosis and therapy choice, and failure to recognize or report adverse drug reactions are the most redoubtable. On the community level, improper self-medication could result in an increase in drug-induced diseases and in wasteful public expenditure [12, 13]. Based on these observations it becomes obvious that preventing risks of self-medication should become the main concern of health professionals, as they are responsible for information, therapeutic advice and education of population. Whenever health professionals are prescribing drugs, they should give proper instructions for the patient to understand and make his own decisions. Given information should be at patient's comprehension level so that it will be helpful for them to understand its management. Proper health education should be given to the patients. By regularly adopting an educational attitude we can have an effect on large sectors of the population, on people who, in turn, may directly influence their friends and family. This aspect is of particular importance with respect to the selfmedication of children by their parents or relatives [6, 13]. Conclusions Self-medication is a widely-used practice and health professionals should make it safe by providing the people who are using it with sufficient knowledge about the main characteristics of the preferred drug: dose, treatment duration, side-effects; the lack of information can cause serious negative effects such as antibiotic resistance, skin problems, hypersensitivity and allergy. Hence, for developing countries like Romania where the education status is poor, the risks of self-medication are higher. People do not have enough knowledge regarding risks associated with their self-medication so it is unsure whether to promote self-medication or not. We consider that holistic approach should be taken to prevent this problem, which includes proper awareness and education regarding self-medication and pharmaceutical products advertising.

1170 References 1. Taylor J.S., The value of autonomy and the right to self-medication. J. Med. Ethics., 2012; 38(10): 587-588. 2. Bennadi D., Self-medication: A current challenge. J. Basic Clin. Pharm., 2013; 5(1): 19-23. 3. Drăgănescu D., Popa D.E., Lupuleasa D., Burcea Dragomiroiu G.T.A., Miron D.S., Roşca A.C., Chivu R.D., The in vitro release mechanism of ibuprofen from conventional and special dosage forms. Farmacia, 2013; 61(4): 811-819. 4. Zaffani S., Cuzzolin L., Benoni G., Herbal products: behaviors and beliefs among Italian women. Pharmaco. Epidemiol. Drug Saf., 2006; 15(5): 354-359. 5. Talevi A., The new patient and responsible self-medication practices: a critical review. Curr. Drug Saf., 2010; 5(4): 342-353. 6. Hughes C.M., McElnay J.C., Fleming G.F., Benefits and risks of self-medication. Drug Saf., 2001; 24: 1027 1037. 7. Aljinović-Vucić V., Trkulja V., Lacković Z., Content of home pharmacies and selfmedication practices in households of pharmacy and medical students in Zagreb, Croatia: findings in 2001 with a reference to 1977. Croat Med. J., 2005; 46(1): 74-80. 8. Elzubier A.G., Ansari E.H., el Nour M.H., Bella H., Knowledge and misconceptions about malaria among secondary school students and teachers in Kassala, Eastern Sudan. J. R. Soc. Health., 1997; 117(6): 381-385. 9. Shankar P.R., Partha P., Shenoy N., Self-medication and non doctor prescription practices in Pokhara valley, Western Nepal: a questionnaire-based study. B.M.C. Fam. Pract., 2002; 3: 17. 10. Al-Bakri A.G., Bustanji Y., Yousef A.M., Drugs within the Jordanian population: sources, patterns and appropriateness. Int. J. Antimicrob. Agents, 2005; 26: 389-395. 11. Enache F., Mircioiu I., Corlan G., Sandulovici R., Mircioiu C., Estimation of therapeutic equivalence using bioequivalence statistical methods for algopirin tablets versus excedrin analgesic formulations. Farmacia, 2012; 60(2): 227-239. 12. Geneva: WHO; 2000. Guidelines for the regulatory assessment of medicinal products for use in self-medication. 13. Ruiz M.E., Risks of self-medication practices. Curr. Drug Saf., 2010; 5(4): 315-323. Manuscript received: April 2014