Research Paper. Abstract. Introduction. Tahir M. Khan a and Promise M. Emeka b

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1 bs_bs_banner Research Paper JPHSR 2015, 6: Royal Pharmaceutical Society Received October 16, 2014 Accepted December 15, 2014 DOI /jphs ISSN A qualitative assessment of community pharmacists views about the non-prescription sale of citalopram for the management of premature ejaculation in eastern region, Alahsa, Saudi Arabia Tahir M. Khan a and Promise M. Emeka b a School of Pharmacy, Monash University, Selangor, Malaysia, b College of Clinical Pharmacy, King Faisal University, Alashsa, Eastern Province, Saudi Arabia Abstract Objectives This study assessed the community pharmacist views about the nonprescription request for citalopram by male customers seeking assistance for premature ejaculation. Methods This was a qualitative study conducted in summer June 2012 until August 2012, in community pharmacy setting eastern province, Alahsa, Saudi Arabia. A structured interview guide was used and study sample was drawn from the community pharmacist practicing in the region. The entire interview was recorded and was transcribed by the researcher in to themes. Key findings Overall, it is found that non-prescription sale over the counters is a frequent practice. Patients requesting citalopram for premature ejaculation are mainly within the age group of years. Lidocaine was reported to be another medication given either alone or in combination with citalopram for same purpose. Conclusion These findings may be worrying for the drug regulatory authorities and might reflect a failure in implementing the safe use of medicines in the community. Citalopram is a prescribed medication and conditions such as premature ejaculation need to be examined by qualified personnel for appropriate treatment, rather than seeking pharmacist assistance to resolve the abnormality. Keywords citalopram; community pharmacist; premature ejaculation; Saudi Arabia Correspondence: Tahir M. Khan, School of Pharmacy, Monash University, Bandar Sunway, Selangor 47500, Malaysia. Introduction Sexual health has always remained a sensitive issue. Regardless of geographical distribution, every one wishes to have a good sexual health. Particularly for men, good sexual health is thought to be a marker for vitality and masculinity. In majority of the cases, such problems are due to the influence of sociocultural, religious and psychological factors. [1] However, in some situations (cases), there are true biological or organ associated conditions that should be treated to get the desired benefits. In order to ensure effective care, developed countries have taken the initiative to establish sexual health clinics. In developing nations, men approach the traditional healers or self-medicate based on the friend s advice. Premature ejaculation (PE) also termed uncontrolled ejaculation is described as the most common male sexual disorder. [2 4] Globally, it is seen that PE is a common problem faced by about 30.0% of men. [5] According to American Urological Association Guideline on Premature Ejaculation defines PE, as Ejaculation is the discharge of seminal fluid to slight stimulation, before or shortly after penetration. [6] Historically, it is seen that men have used variety of methods to counter sexual problems, that is, impotence and PE. Furthermore, some of the drugs having unlabeled indication may show beneficial effects in sexual problems such as PE. Serotonin reuptake inhibitors were used as an off label medication to treat PE. [6,7] Studies have confirmed that on-demand use of citalopram can improve PE. [4] In addition, the on-demand usage can decreases the intake dosage and consequently can lower selective serotonin reuptake inhibitors (SSRIs) side effects in comparison with daily usage method. Particularly, in a country like Saudi Arabia, where both traditional and modern concepts of medicine are practiced side by side, treatment of PE will be an important topic to address. 27

2 28 Journal of Pharmaceutical Health Services Research 2015; 6: Table 1 Demographic information of the respondents Age Education Job experience Work experience in Saudi Arabia Prescription dispensed on daily basis 24 Bachelor of Pharmacy 2 years 2 years 100 plus 29 Bachelor of Pharmacy 7 years 4 years 100 plus 32 Bachelor of Pharmacy 5 years 3 years 100 plus 26 Bachelor of Pharmacy 3 years 3 years 130 plus 30 Bachelor of Pharmacy 8 years 5 years 110 plus 28 Bachelor of Pharmacy 6 years 3 years 110 plus 25 Bachelor of Pharmacy 2 years 2 years 110 plus 38 Bachelor of Pharmacy 12 years 10 years 115 plus 25 Bachelor of Pharmacy 2 years 2 years 120 plus 26 Bachelor of Pharmacy 3 years 3 years 110 plus 28 Bachelor of Pharmacy 3 years 2 years 110 plus Moreover, in Saudi community pharmacy setting, the nonprescription sale/dispensing of medicine is a very critical issue to address. [8 11] Though regulations are in place here but patients enjoy restriction-free access to any medicine over the counter. This attitude is perhaps a mutual outcome of the consumer request and pharmacist s will to dispense without a prescription. It will be interesting to see how community pharmacist deals with this sensitive issue of PE and what management options they are utilizing, as there is no much information regarding this issue globally and in Saudi scenario. Therefore, the current study adopts a qualitative research design with an aim to exploring the community pharmacists views on how they manage PE problem for their patients. Methods A qualitative study design was adopted for this study. The time frame of study was from June 2012 until August Community pharmacist practicing in Al-Hofuf eastern region were approached for their participation. Study sample Study sample was drawn from the pharmacies situated in the regions. A convenience sample was used to explore community pharmacist willingness to participate in the study. In the case if one pharmacist refused to participate, the next potential pharmacy in the area was approached for interview. Interviews were done until the saturation point was achieved. Ethical approval The study protocol was approved by institutional review board at College of Clinical Pharmacy, King Faisal University and the deanship of scientific research King Faisal University. Study design A qualitative study design was adopted for a flexible exploration of respondents attitudes and experiences. A semistructured interview guide was used during the interview process. The interview was conducted in Arabic language by a trained native speaker. The interviews focused on the following issues: Non-prescription request over the counter, age group and type of sexual problems presented by patients and what drug and dose they recommend them for management of PE. In addition, pharmacist demographic data were collected using a self-administered questionnaire that was attached with the consent form. All interviewees were asked open-ended questions and were recorded using a smartphone after the consent form was signed by the respondents. Estimated time consumed by each interview was approximately min. After completing the interview, the responses were transcribed and translated into English individually and were coded with relevant themes. Results A total of 15 community pharmacists were invited for the interview, of whom 9 agreed to participate. Similarities in responses were noticed after interviewing the ninth pharmacist. Saturation point was reached after interviewing 11 community pharmacists. Two additional interviews were done to confirm the saturation point. In the end, a total of n = 11 pharmacists were interviewed and their responses were transcribed in theme. All respondents were pharmacists, holding a bachelor in pharmacy degree (B.Pharm) with a relevant experience in community pharmacy practice (Table 1). Questions regarding the use/sell of citalopram and other drugs revealed that, on a daily basis, they dispense/sell nonprescription drugs to as many as 20 patients at their request. The types of drugs usually requested without prescription include pain killers, cough/flu medication, laxatives, antibiotics and vitamin/health supplements. Theme one: non-prescription request over the counter (1) How often do people come and ask for medicine without a prescription? Pharm 1: on daily basis about 20; Pharm 2, 5, 10: many patients come to ask for medicines without prescription and we do not keep any records. Pharm 3, 4, 6, 7, 8, 9, 11: on average 5 20 patients use to come to ask for medications without prescription. (2) What common medicines do they request for? Pharm 1, 5, 9: pain killers; Pharm 2, 4 10: medications for cough and flu, Pharm 10, 11: medication for

3 Non-prescription sale of citalopram Tahir M. Khan and Promise M. Emeka 29 gastrointestinal complications, that is, laxative, medication for diarrhea, Flagyl (metronidazole). Pharm 2, 3, 4, 6, 7, 8, 9, 10, 11: some request for antibiotics and vitamin/health supplements. Theme two: age group and type of sexual problems presented by patients Results also showed that patients come with complain related to sexual health such as PE and erectile dysfunction for which they demand medication. Three-quarters of the respondents (pharmacists) put the age group of patients having this problem to be between 25 and 40 years, whereas a third of these respondents estimated their age group to be within the range of years. Also, for erectile dysfunction, about one-third of the pharmacists revealed that their age group falls within years. (1) Do people come to your pharmacy to complain about their sexual health? Pharm 4, 6, 7: Yes, some customers that complain about PE often request for medication to resolve the problem. Pharm 8, 10, 11: throughout my practice at this pharmacy, patients have been coming with complains of PE and erectile dysfunction. (2) Which age group often makes these complains particularly about the sexual health problems? Pharm 1, 5, 6, 8, 10, 11 estimated that PE is more common among the age group years. Pharm 2, 3, 4 put the age range of patients to between 35 and 50 years. Pharm 6, 9, 10 also estimated their age range of complainants to be from the age group of year or 55 years plus. Theme three: what drug and dose do you recommend for the management of premature ejaculation? There was a general consensus among the respondents that they offer treatment for both PE and erectile dysfunction without any prescriptions from physicians. On their treatment methods, a one-third of the pharmacists reported that they offer Lidocaine cream or spray or high dose of high potency vitamin. While admitting that they also use herbal sprays, more than half of the pharmacists revealed that they give citalopram (SSRIs) as part of the management for PE. They also reported that the use of citalopram is an ideal choice and have been practicing this out their experience with such patients and that it has worked for them. According to them, citalopram is usually given for 2 weeks minimum, for a maximum of 1 month. (1) What drugs do you prescribe for routine treatment for a patient complaining of PE? Pharm 2, 3, 10: For most of my patients, I give them Lidocain cream or spray. Pharm 1: In some cases I prefer to give them some high potency vitamins (rich in iron) to help them recover from weakness if they have any. Pharm 5: I prefer giving them herbal spray that is specifically manufactured to manage the PE. Pharm 4, 6, 7, 9, 11: As per my experience, SSRIs are the ideal choice for the management of PE. Particularly, sertraline and citalopram work well in bringing relief to the patient. Pharm 4: Lidocain and Citalopram give excellent results in some cases that has been recalcitrant. (2) What duration and dose do you recommend for your patients when using Lidocain and SSRIs? Pharm 1, 2, 3: For Lidocain cream, we prefer for them to be used min before intercourse. Pharm 4, 5, 10: For spray, it is effective 5 10 min before intercourse. Pharm 6, 7: Citalopram 20 mg for minimum 2 weeks and maximum 1 month. Pharm 9, 11: Sertraline 50 mg 5 6 h before intercourse. Pharm 4: Sertraline 50 mg for 2 weeks. Discussion Citalopram (an SSRI) has been described as the most prescribed antidepressant drug in the USA with about 37.8 m prescription in 2011 alone. [12] Part of the side effect of this medication is PE and there are abundance evidence that it has been used for this condition as well. [13 16] Also equally true is the fact that there is no approval by any drug agency for the use of this medication for this disorder. [17] Several studies conducted on patients with PE indicated that their sexual performance improved markedly. [13,18,19] According to literature, the mechanism of action of citalopram includes increase in serotonin neurotransmitter activity in the brain, decrease in penile sensitivity and modulation of anxiety associated with PE. [18,20,21] It has been documented that patients who are on citalopram suffer withdrawal effect after stopping the medication by experiencing rebound PE. [15] Evidences have shown that the withdrawal effect might be due to changes in receptor function and density in the course of use. The danger therefore is not known how far the initial treatment is. It is well documented that citalopram causes sexual dysfunction as part of its side effects, of which decreased libido is one. Other effects include shortness of breath, dizziness, fainting and hepatotoxicity. [22] The hepatotoxicity effects are associated with high levels of liver enzymes. [22] Recent studies have shown that citalopram can cause abnormal changes in electrical activities of the heart at therapeutic doses. [23,24] These changes were seen as prolongation of QT interval on the electrocardiogram (ECG). This effect can, in turn, lead to abnormal heart rhythm. [25] In the USA, this has prompted the FDA to issue a safety alert, reporting that this potential risk is dose dependent. [12] The critical issue here is that patients with underlying heart conditions and those with low blood levels of potassium and magnesium will be at risk. [12,24] It is therefore required that ECG of patients receiving citalopram be done as long as they are on the medication, and to reduce the risk they may face. Therefore, nonprescription use of citalopram could present a potential problem which could lead to fatal consequences. In this regard, patient may not disclose to the pharmacist any underlying illness or use of other drugs that could increase the risk of QT prolongation in that particular patient s situation. Hence the purchase and use of citalopram for PE in this

4 30 Journal of Pharmaceutical Health Services Research 2015; 6: community could create more problems than solution. The dual effect of decreased libido and orgasmic delay could be a delicate balance for young men who want to prove themselves sexually. From our study, the pharmacists recommended this medication without any assessment of the patients. In addition, they admitted that the treatment is for 2 3 weeks and there are no follow-ups and no feedbacks from patients. Our first concern is how were the doses determined for PE? Generally, it appears that most people use same dose as in depression. Second, the treatment modalities are not defined and therefore benefits are exaggerated. Some previous studies were focused on the demand use of citalopram, which is based on what is needed, side effects and treatment cost. [4] Third concern is that the duration for use has not been clinically determined so that the benefit will be achieved without a rebound withdrawal effect. Evidence based studies are needed to properly evaluate the risks and categories of patients that are likely to benefit from this treatment. It is true that sexual health is an area where patients do not like to give out information. However, the use of non-prescription citalopram should be treated with the caution it deserves. Therefore, the consequence of non-prescription use of citalopram for PE is risky. In the light of recent evidence that it prolongs QT interval, therefore its use for PE should be viewed seriously. The erroneous idea that it is a safe drug should also be addressed. Also on a worrying some note, Koyuncu et al. reported that escitalopram, an isomer of citalopram, affects sperm quality. [26] We advise that for patient safety, an assessment be done for those who seek this medication over the counter. Conclusion These findings may be worrying for the drug regulatory authorities and might reflect a failure in implementing safe use of medicines in the community. Citalopram is a prescribed medication and conditions such as PE need to be examined by qualified personnel for appropriate treatment, rather than seeking pharmacist assistance to resolve the abnormality. Limitation of study Authors did not differentiate between daily usage and on-demand use of Citalopram which bothers on episodic treatment. Daily treatment of PE will be more practical for evaluating the effectiveness of drugs, although side effects will be the major concern. Declarations Conflict of interest The Author(s) declare(s) that they have no conflicts of interest to disclose. Funding This research received no specific grant from any funding agency in the public, commercial or not-for-profit sectors. Authors contributions All Authors state that they had complete access to the study data that support the publication. References 1. Richardson D et al. A qualitative pilot study of Islamic men with lifelong premature (rapid) ejaculation. J Sex Med 2006; 3: Montorsi F. Prevalence of premature ejaculation: a global and regional perspective. J Sex Med 2005; 2(Suppl.2): Basile Fasolo C et al. Premature ejaculation: prevalence and associated conditions in a sample of men attending the andrology prevention week 2001 a study of the Italian Society of Andrology (SIA). J Sex Med 2005; 2: Farnia V et al. On-demand treatment of premature ejaculation with citalopram: a randomized double-blind study. Acta Med Iran 2009; 47: Goldstein I. Premature to early ejaculation: a sampling of manuscripts regarding the most common male sexual dysfunction published in the IJIR: the journal of sexual medicine. Int J Impot Res 2003; 15: Montague DK et al. AUA guideline on the pharmacologic management of premature ejaculation. JUrol2004; 172: Assalian P. Clomipramine in the treatment of premature ejaculation. J Sex Res 1988; 24: Emeka PM et al. Public attitude and justification to purchase antibiotics in the Eastern region Al Ahsa of Saudi Arabia. Saudi Pharm J 2014; 22: Promise E et al. A qualitative study exploring role of community pharmacy in the irrational use and purchase of non-prescription antibiotics in Al Ahsa. Eur J Genet Med 2012; 9: Khan TM. The consequences of nonprescription medication sales in Saudi Arabia s community pharmacies: regulations without implementation. Ther Adv Drug Saf 2014; 5: Khan TM, Ibrahim Y. A qualitative exploration of the nonprescription sale of drugs and incidence of adverse events in community pharmacy settings in the Eastern Province of the Kingdom of Saudi Arabia. Eur J Hosp Pharm 2013; 20: FDA. Drug Safety Communication: Abnormal heart rhythms associated with high doses of Celexa (citalopram hydrobromide) MedWatch 13. Atmaca M et al. The efficacy of citalopram in the treatment of premature ejaculation: a placebo-controlled study. Int J Impot Res 2002; 14: Atmaca M et al. Serum leptin levels in patients with premature ejaculation before and after citalopram treatment. BJU Int 2003; 91: Adson DE, Kotlyar M. Premature ejaculation associated with citalopram withdrawal. Ann Pharmacother 2003; 37: Montejo AL et al. Incidence of sexual dysfunction associated with antidepressant agents: a prospective multicenter study of 1022 outpatients. Spanish Working Group for the Study of Psychotropic-Related Sexual Dysfunction. J Clin Psychiatry 2001; 62(Suppl.3): Wang WF et al. Selective serotonin reuptake inhibitors in the treatment of premature ejaculation. Chin Med J 2007; 120: Safarinejad MR, Hosseini SY. Safety and efficacy of citalopram in the treatment of premature ejaculation: a double-blind placebo-controlled, fixed dose, randomized study. Int J Impot Res 2006; 18:

5 Non-prescription sale of citalopram Tahir M. Khan and Promise M. Emeka Dadfar MR, Baghinia MR. Salvage use of citalopram for treatment of fluoxetine-resistant premature ejaculation in recently married men: a prospective clinical trial. Urol J 2010; 7: Xin ZC et al. Penile sensitivity in patients with primary premature ejaculation. JUrol1996; 156: Tian L et al. Effect of renewed SS-cream on spinal somatosensory evoked potential in rabbits. Asian J Androl 2004; 6: Solomons K et al. Toxicity with selective serotonin reuptake inhibitors. Am J Psychiatry 2005; 162: Deshmukh A et al. Prolonged QTc interval and torsades de pointes induced by citalopram. Tex Heart Inst J 2012; 39: Cooke MJ, Waring WS. Citalopram and cardiac toxicity. Eur J Clin Pharmacol 2013; 69: Castro VM et al. QT interval and antidepressant use: a cross sectional study of electronic health records. BMJ 2013; 346: f Koyuncu H et al. Escitalopram treatment for premature ejaculation has a negative effect on semen parameters. Int J Impot Res 2011; 23:

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