A qualitative exploration of the non-prescription sale of drugs and incidence of adverse events in community pharmacy settings in the Eastern Province of the Kingdom of Saudi Arabia
- Correspondence toTahir M Khan, College of Clinical Pharmacy, King Faisal University, PO Box 400, Al-Ahsa 31982, Kingdom of Saudi Arabia;
- Received 6 June 2012
- Revised 6 August 2012
- Accepted 10 August 2012
- Published Online First 12 September 2012
Background In Saudi Arabia, the non-prescription sale of drugs has threatened patient safety for at least a decade. It has been reported that community pharmacists often dispense medicines based solely on consumer request. The current study investigated consumers' non-prescription requests for prescription medicines, community pharmacists' efforts to ensure the correct dispensing of medicines and pharmacists' views on the incidence and reporting of adverse events in their practice.
Method A qualitative study using a structured interview format with pre-defined themes was conducted among 10 hospital-affiliated and 10 non-hospital-affiliated community pharmacies in Al-Hofuf, Eastern Province, Kingdom of Saudi Arabia.
Results Consumer requests were highest for analgesics (eg, Panadol and Voltaren) followed by cough preparations and antibiotics. Augmentin and ciprofloxacin were the antibiotics most frequently requested over the counter. In hospital-affiliated pharmacies, non-prescription dispensing was mostly carried out for regular customers. Nearly 30% of consumers were familiar with the names of the medicine they requested, while 30–35% normally brought empty bottles or boxes. However, pharmacists sometimes guessed (eg, based on shape, colour and/or price) the correct medicine. Stomach pain, urticaria, nasal bleeding, indigestion and mouth dryness were recently observed adverse events. However, due to lack of awareness of suitable websites or contact numbers for regulatory authorities, no pharmacist had ever reported an adverse event.
Conclusions Analgesics and antibiotics were frequently dispensed without prescription with pharmacists often using their personal judgment to ensure the right medicine was dispensed. Adverse events in community pharmacy settings in the eastern region of Saudi Arabia were under-reported.
The non-prescription sale of drugs is a major challenge faced equally by developed and developing nations. In recent years, the over the counter (OTC) sale of drugs has increased markedly and emerged as a major economic activity.1 In developed nations like the USA, the non-prescription sale of drugs in 2009 was reported to be worth over US$30 billion.2 It was also estimated that about 75% of American residents were using non-prescribed OTC medicines. Similarly, the Proprietary Association of Great Britain reports that approximately 976 million non-prescription medicines are sold annually.3 Very similar trends were seen among Australians, with annual sales of more than AU$2.9 billion4 and 1.63 million weekly cases of self-medication.5–7 Particularly in underdeveloped/developing countries, self-medication or the non-prescription sale of medicines is huge challenge.8–11 High doctor consultation fees, low socioeconomic status and personal experience are some consumer-related factors that may promote self-mediation, while, from the pharmacist's viewpoint, price mark-up and economic benefit can encourage the dispensing of a non-prescribed drug.11
There are generally two schools of thought regarding self-medication, with one highlighting the benefits of self-medication and the other focusing on its drawbacks. The first group believe that, by self-medicating, the consumer/patient is taking greater responsibility for their own health. In other words, they emphasise the social and financial benefits of self-medication.12 They also believe that self-medication is economically beneficial: consumers treat their illness themselves and, as they do not miss work for medical appointments, the employer also gains economically. Furthermore, in terms of broad societal benefits, self-medication reduces unnecessary visits to doctors, thus ensuring better utilisation of public health budgets.13 The second group hold opposite views and associate self-medication with higher risk. In their opinion, the self-medicating consumer takes huge responsibility for their own health as drug administration is unsupervised, greatly increasing the chances of incorrect medicine use. It is not known how much consumers understand about disease symptoms or how capable they are of selecting an effective regimen. In such circumstances, a consumer/patient is at very high risk of drug interactions and unsupervised adverse events.14 ,15
Globally, medical and drug practice vary by region. Pharmacists have dispensing rights in some developing countries but not in others. However, in some Asian nations (ie, Malaysia, Singapore, Hong Kong, Taiwan, India and Pakistan) dispensing right to the physician portrays a different situation in terms of supply of medicines to the community.16 ,17 In most developing nations, a shortage of pharmacy personnel, poor implementation of pharmaceutical/drug policies, and lack of supervision by regulatory authorities are some of the main factors that favour the non-prescription sale of drugs. Nevertheless, the community pharmacist is considered the main professional responsible for the safe delivery of medicines to consumers. In the Kingdom of Saudi Arabia, pharmacists offer quality services in individual and chain pharmacies and there is strict enforcement of rules and regulations by the Ministry of Health (MOH). However, many consumers still self-medicate by purchasing medicines without a prescription. Earlier studies have highlighted higher non-prescription sales of antibiotics in certain areas of Saudi Arabia.16 ,17 By law, pharmacists are not authorised to dispense antibiotics and other drugs that may need supervision after administration. However, previous studies have reported frequent violations of the Saudi drug law prohibiting the dispensing of medicines without prescription. In the eastern region of Al-Hofuf, few efforts have focussed on the non-prescription sales of drugs OTC. In light of community and clinical effects, the current study aimed to investigate the non-prescription sale of medicine in Al-Hofuf in eastern Saudi Arabia. The study also explored pharmacists' attitudes toward the reporting of adverse effects.
A qualitative study design was adopted for this study. Respondents were pharmacists practicing in community pharmacies. Descriptive statistics (numbers, percentages, means and SDs) were used to present the results where necessary. Most of the results were presented according to pre-defined themes explored in an interview format.
This study was conducted in Al-Hofuf, the major urban centre in the eastern region (Al-Ahsa) of the Kingdom of Saudi Arabia.
Twenty pharmacists practicing in community pharmacies were approached for interview. Respondents were divided into two groups: one based in non-hospital-affiliated community pharmacies and the other in hospital-affiliated community pharmacies (private hospitals). To ensure balanced selection, Al-Hofuf was divided into 10 sectors and from each sector a non-hospital-affiliated community pharmacy and a hospital-affiliated community pharmacy were selected. If a pharmacy refused participation, other nearby pharmacies were contacted instead. Overall, 33% of non-hospital-affiliated community pharmacies and 40% of hospital-affiliated community pharmacies declined participation. Selection continued until 20 pharmacists had agreed to participate.
A qualitative study design was adopted to allow flexible exploration of respondents' attitudes and experiences.18 A semi-structured interview guide with pre-defined themes was developed based on the literature on non-prescribed medicines and used during the interview.14–17 In total, 20 community pharmacists were interviewed, consisting of 10 from hospital-affiliated community pharmacies (pharmacies affiliated with private hospitals) and 10 from non-hospital-affiliated pharmacies (ie, chain/independent pharmacies).
The interviews focused on three main issues: (1) medicines routinely dispensed without prescription, (2) adverse events in the community pharmacy, and (3) reporting of adverse events. The interview guide was validated with five pharmacists. Participants' demographic data were collected using a self-administered questionnaire, which was attached to the consent form. The same open-ended questions were asked of all interviewees and more detailed questions were used where necessary to elicit additional information from respondents. Each interview lasted approximately 20–30 min and was conducted at a place and time convenient for the pharmacist. All interviews were audiotaped, verified for accuracy and then manually transcribed according to theme.
The College of Clinical Pharmacy, King Faisal University approved the study protocol. Approval was also provided by the Deanship of Scientific Research at King Faisal University. Information revealing the identities of interviewees was not disclosed. Verbal consent for participation was obtained from community pharmacists and relevant hospitals during the interview.
All pharmacists who participated in the interview were male, the majority were Egyptian, followed by Jordanians, and most were middle aged, ranging from 34 years to 47 years of age. Only two held a master's degree in pharmacy, both of whom were practicing in a non-hospital-affiliated pharmacy (table 1).
Theme 1: routine dispensing of prescription and non-prescription drugs in hospital-affiliated and non-hospital-affiliated pharmacies
The interviews sought information on the top five commonly dispensed products in the last 2 weeks. Sales records have shown that analgesics, cough and flu medicines, and antibiotics were the most commonly sold drugs in this period (figure 1). In order to identify those products routinely requested by consumers, a records sheet was given to the pharmacists on which they noted non-prescription requests and provided information about the pharmacy, name of the medicine, dose and quantity. These records showed that antibiotics, pain killers, antihistamines and multivitamins were routinely dispensed in community pharmacies in the Al-Ahsa region (table 2). A slight difference was observed in the pattern of non-prescription drug sales between hospital-affiliated and non-hospital-affiliated pharmacies. Augmentin was the antibiotic most commonly requested by consumers. However, the non-prescription sale of ciprofloxacin was higher in the non-hospital-affiliated pharmacies. Over 2 weeks, the non-prescription sale of drugs accounted for 10.2% of drug sales in hospital-affiliated pharmacies and 21.8% of drug sales in non-hospital-affiliated pharmacies.
Theme 2: how pharmacists ensure that they are dispensing the right medicine
The main aim of this theme was to explore the strategies adopted by pharmacists to ensure that they have given the correct medicine to the consumer. Different strategies were adopted in non-hospital-affiliated pharmacies and hospital-affiliated pharmacies (table 3).
Theme 3: incidence of adverse events in pharmacies and reporting procedure
The main aim of this theme was to inquire about any adverse events that were reported in the pharmacy in last 2–3 weeks. Responses are given in table 4.
The non-prescription sale of medicines in community pharmacies is a significant problem. Particularly in developing nations, it is one of the main causes of under-reported adverse events and antibiotic resistance. In Saudi Arabia, the non-prescription sale of drugs has always been a challenge for regulatory bodies such as the MOH and the Saudi Food and Drug Administration (SFDA). Previous studies have explored this issue in Riyadh, the capital of Saudi Arabia,19 but the situation in the eastern region of Al-Ahsa has not been investigated. Furthermore, the incidence of adverse drug events and factors affecting drug selection are still inadequately understood. To our knowledge, the current study was the first to focus on these particular issues in the eastern region of Saudi Arabia. It is seen that analgesics (Panadol and Voltaren) were the most commonly requested non-prescription medicines. Previous findings in the Riyadh region reported higher non-prescription sales of analgesics OTC than in other regions.16 In addition, the other most commonly dispensed non-prescription medicines were cough preparations followed by antibiotics. As in other parts of Saudi Arabia, inhabitants of the Al-Ahsa region can easily access any medicine OTC.17 This is a clear violation of the Saudi drug law of 1978 which states that a registered pharmacist can only dispense drugs OTC that can be dispensed without a prescription.20 In the current study, analgesics, antibiotics and a variety of cough/flu medicines were dispensed without consideration of the consequences of non-prescription dispensing.16 ,17 ,20 The current sample of pharmacists reported a higher demand for non-prescription Augmentin in hospital-affiliated pharmacies, while the non-prescription dispensing of ciprofloxacin was higher in non-hospital-affiliated pharmacies. These results confirm the findings of Bin Abdulhak et al who reported more dispensing of non-prescription Augmentin20 and higher resistance to Streptococcus pneumonia in Saudi Arabia.16–21
In spite of previous research, it is difficult to identify the factors encouraging the non-prescription sale of drugs. Perhaps lack of interest by stakeholders in implementing the law, as well as their own financial interests, support the non-prescription sale of drugs.20 Results have shown that the non-prescription sale of analgesics, common cold and cough medicines, and vitamins was higher in independent pharmacies than in hospital-affiliated pharmacies, presumably because hospital administrations restrict non-prescription dispensing in these pharmacies. In addition, none of the pharmacists were Saudi nationals and all practiced in the way they would in their own country. The current study design limits our ability comment on this issue. Future studies should explore the factors responsible for the non-prescription dispensing of drugs OTC.
The second important aim of the study was to document pharmacists' efforts to ensure the correct medicine was dispensed. It was previously reported that community pharmacists in Riyadh did not usually solicit information before dispensing non-prescription medicines such as antibiotics.20 Therefore, in this research emphasis was placed to exploring the strategies adopted by community pharmacists to ensure the appropriate dispensing of non-prescription drugs. Findings demonstrated that nearly 30% of consumers knew the exact name of the medicine sought. The majority of consumers were middle aged and familiar with the medicines requested and many asked for medicines based on their previous experience. Therefore, the chance of errors was limited. On the other hand, in the hospital-affiliated pharmacies, most non-prescription dispensing was for regular customers, so pharmacists knew in advance the type of medicines they needed and could better ensure that the correct medicines were dispensed. Furthermore, in 30–35% of cases, consumers brought the empty bottle or box when requesting a non-prescription medicine. For those without an empty box or bottle, the pharmacist tended to ask about the size, shape and colour of the medicine to ensure that the correct drug was dispensed. However, pharmacists from hospital-affiliated pharmacies relied less on the appearance of medicines and rather asked about symptoms and chief complaints. In general, pharmacists said that the majority of patients requested non-prescription painkillers for physical pain, antibiotics for treatment or for prophylaxis, and multivitamins to maintain good health and physical well-being.
The last and perhaps most important section of this study enquired about the incidence of adverse drug reactions (ADRs) in the community pharmacy setting, as under-reporting of ADRs has been a critical issue for over a decade. Many consumers may experience ADRs in developing nations with a high incidence of non-prescription dispensing in community pharmacies. In both developed and developing countries, physicians are considered important for documenting and reporting adverse events in their practices.22–24 However, in recent years, hospital and community pharmacists have also been encouraged to take part in the adverse events reporting process.22–24 Therefore, community pharmacists from hospital-affiliated and non-hospital-affiliated settings were asked about any adverse events that were noticed shortly after dispensing. Recently observed adverse events due to the use of non-steroidal anti-inflammatory drugs (NSAIDs), ampicillin, warfarin and Prozac included stomach pain, urticaria, nasal bleeding, indigestion and mouth dryness. However, none of the respondents had reported any of these adverse events, mainly because of lack of information about the reporting process. Some pharmacists also mentioned that they were unfamiliar with the contact numbers or websites of the MOH or SFDA where they could report such events. These findings agree with those of Bawazir who reported that community pharmacists in Riyadh city were unaware of the ADR reporting process approved by the MOH.25
Saudi Arabia is one of the very few developing countries to have targeted the effective reporting of adverse events. In 1998, a postmarketing programme was established to ensure the timely detection and recording of adverse events.25 In addition, it is illegal for a pharmacist to dispense a non-OTC product without prescription. However, even after more than a decade, the regulatory authorities have failed to achieve the goals of the postmarking programme, as community pharmacists are not aware of the ADR reporting process. Furthermore, there is no control of the non-prescription dispensing of drugs. Future studies should explore whether this behaviour is due to lack of supervision by the MOH or whether the ADR reporting process is not properly promoted. An efficient ADR reporting system should be established to enable community pharmacists to report and record ADRs for the benefit of the community.
Non-prescription requests for analgesics and antibiotics were highest in the community pharmacy setting in the Al-Ahsa region. In most cases, consumers requested non-prescription medicines they had used previously. Community pharmacists often relied on their own judgment to ensure that they were dispensing the right medicine. Some pharmacists observed adverse events among consumers who had recently used NSAIDs and antibiotics, but none of these events was reported due to a lack of awareness among community pharmacists of the ADR reporting process. Future research should focus on the factors affecting consumers' requests for non-prescription drugs. In addition, strategies encouraging an ADR reporting culture among community pharmacists should be promoted.
The small study sample is one of the main limitations of this study as it affects our ability to draw a firm conclusion. However, a qualitative study is an effective study design to identify areas for future research. Furthermore, as all interviewees were non-Saudi nationals, these findings cannot be generalised to Saudi pharmacists.
The current study highlights routine non-prescription sale of analgesics and antibiotics over the counter in the Eastern region Al-Ahsa.
Moreover, the adverse event associated with the use of non-prescription medicines are not reported or informed to the related authorities.
The authors thank Dr Mansour Alturki, Clinical Pharmacist, Al-Jaber ENT, Al-Ahsa Hospital for his support and final year student Maitham Almuslim, College of Clinical Pharmacy, King Faisal University, for help with communicating with the pharmacist who did not speak English.
Contributors TMK drafted the manuscript and developed the themes. YI classified the data into themes and wrote the discussion section.
Competing interests None.
Ethics approval The College of Clinical Pharmacy, King Faisal University and the Deanship of Scientific Research, King Faisal University approved this study.
Provenance and peer review Not commissioned; externally peer reviewed.