Patient perspectives to self medication in a community pharmacy setting in Malta.

Table of Contents

Acknowledgements

Abstract

1. Introduction
Maltese Health Care System
Maltese Classification of Pharmaceuticals
Cost of medicines in Malta – Economic Aspects
Deregulation from POM to P
Collaborative Care
Misuse vs. Abuse
OTC misuse
OTC abuse
Studies on OTC use (self medication)

2. Aims and objectives

3. Methodology
Literature Review
Modifications to questionnaire of Waizaify et al. 2005
Validity testing.
Administration of Questionnaire
Structure of questionnaire
Coding data into SPSS
Analysis of Data
Researching published studies into OTC drug related trends to aid in improving pharmaceutical care

4. Results
Reliability testing
Demographics
Patient interaction with a local pharmacy
Views on OTC use
OTC selection
OTC abuse

5. Discussion
Drug-related trends to improve pharmaceutical care
Drug adherence
Health Literacy
OTC abuse
Facilitating behaviour change

6. Conclusion

References
Appendix 1 Questionnaire
Appendix 2 Coding data into SPSS
Appendix 3 Participants responses

List of figures

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List of tables

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Chapter Introduction

1. Introduction

Maltese Health Care System

Before one can start describing the Maltese health care system it is pertinent to describe Malta geographically. The Maltese archipelago is found at the centre of the Mediterranean, consisting of three main islands: Malta, Gozo and Comino (Department of Information 2010). The total population is 412,966 covering an area of 316km² giving a population density of 1307 persons per km² which is the seventh populated density in the world (Eurostat 2010).

In the early 1950s, when Malta was still a British Colony, the Maltese Government attempted to introduce a free National Health Service similar to that created in the UK in 1948 (Azzopardi Muscat 1999). It found strong opposition by doctors who carried out a ten year strike and this in turn led the government to open several polyclinics to provide a free emergency primary care service (ibid). This polyclinic service formed the basis of the present primary health care system (ibid).

The Maltese health care system is funded from general taxation and is free at the point of delivery (Ministry of Health 2011). A highly comprehensive package of health care benefits is offered by the state health care system (Azzopardi Muscat 1999). “At a primary care level the package includes GP consultations, home visits, minor treatment, community nursing and preventive programmes including immunization and screening” (ibid:25). Health care financing in Malta is split between the statutory (60%) and private (40%) systems (ibid). The state system covers all Maltese citizens irrespective of income or ability to pay (ibid). Private financing occurs through out-of-pocket payment and private insurance (ibid).

Entitlement to free medication also differs from that in the U.K. (Cordina et al. 1998). Categories of patients who are entitled to receive free medication through the Government National Health Service include patients with chronic diseases (yellow card holders), people who have a low income and have undergone a means test (pink card holders) as well as members of the clergy, police force and armed forces (ibid). These people obtain their medication from government pharmacies that are managed independently of privately owned community pharmacies (ibid); free medication is now also being currently dispensed from the latter through a new pharmacy of your choice scheme. Patients can register with a pharmacy of their choice to collect their free medicines. “Apart from offering a personalised service and cutting down on waiting times for patients who currently have to queue for hours outside government pharmacies to pick up their medicines, the scheme is also intended to cut down on wastage” (Busuttil 2008:1). Minister for Health Joe Cassar said that, “although figures were not yet available, an auditing service already indicates that wastage is on the decline” (ibid:1 ). This service also allows continuity of care as a pharmacist-patient relationship is built up. Such a scheme is already 3 years behind in that only 40,000 of a total estimated 120,000 are benefiting from the scheme since the target date for the service to be available on a national scale was the end of 2008 (Times of Malta 2008).

A larger number of patients are not entitled to free medicinals based on their income or disease hence the greater role of the private sector (Azzopardi Muscat 1999). There are 209 private retail pharmacies, which is approximately one pharmacy per 2000 inhabitants (DOH 2011). This ratio of pharmacies favours the increasing trend of self treatment where community pharmacists are being called upon to extend their patient education and screening roles. Therefore, if community pharmacists start utilising their clinical knowledge to assume this new role, pressures on GP drugs budgets and workloads will be reduced (MacFadyen et al. 2001). The emphasis on the delivery of care to patients and monitoring of therapeutic outcomes has not yet been undertaken in Malta with the term ‘pharmaceutical care’ being mainly interpreted as a variation of patient counselling by Maltese pharmacists (Cordina et al. 1999). The lack of patient medication records or patient profiles, limited time available for patient care due to low staffing levels, together with barriers identified in other countries need to be overcome before comprehensive pharmaceutical care becomes a reality in Malta (ibid).

Maltese Classification of Pharmaceuticals

The Maltese classification of pharmaceuticals resembles more closely that of the UK than the US system. The principle difference from the UK system is that a General Sales List (GSL) is non-existent.

Therefore, in Malta, there are only 2 categories of pharmaceuticals:

OTC medicines (also known as Pharmacy (P) medicines) do not require a prescription and must be sold by a pharmacist and supplied only from community pharmacies.

Prescription only medicines (POMs), are supplied by pharmacists on the written order of a registered medical, dental or vetinary practitioner, and supplied only from community pharmacies.

(Keen 1994)

This implies that all non-prescription medications or OTC medicines and prescription only medicines must be sold in a pharmacy with the supervision of a pharmacist. Countries in the EU which allow or do not allow the sale of OTC medicines outside pharmacies are shown in the table 1.

Table 1: OTC practices in EU member states

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(Istanbul Economics n.d.)

As can be seen from Table 1, EU countries differ with regards to OTC practices in those that a) have price controls, b) have reimbursement systems and c) allow OTC medicines to be available outside pharmacies.

In the US a pharmacist only class does not exist. Supporters claim that the more potent agents now available without prescription warrants the direct involvement of a pharmacist, while opponents on the other hand, mention increased pharmacist liability and reduced marketplace competition as reasons to dismiss this measure (Taylor et al. 2000). Adding support against this view, the US General Accounting Office in 1995 rejected the introduction of a pharmacist only class (ibid). However, in 2007, the FDA announced that it will be taking a closer look at the development of regulatory processes for a third class or behind-the-counter (BTC) class of drugs that is neither OTC nor prescription only (Sheffer 2007). This could have been a response to the new legislation that passed in 2005 which restricted the sales of pseudoephedrine containing products because of their potential for abuse in the manufacture of methamphetamine (PSW 2005).

In Canada a third class of drugs (known as Schedule II – restricted area and Schedule III – non restricted area in pharmacy) already exists in several provinces of Canada (Taylor et al. 2000). The law requires that certain OTC agents be kept behind the counter, theoretically allowing pharmacists to intervene during each transaction (ibid). Health officials believe that while these medications do not require a prescription, self-medication by the public still carries sufficient risk to preclude self-selection (ibid). Schedules II and III were adopted under the premise that either the mandatory participation or consultative availability of a pharmacist facilitates more appropriate drug use and improves patient outcomes (Dobson et al. 2004). Accordingly, provincial regulatory authorities follow standards of practice that stipulate a certain level of patient care when providing a drug from a specific schedule (ibid).

Due largely to the OTC category of drugs, Maltese community pharmacists have a traditional, well- recognized role in advising patients on symptomatic relief and treating self-limiting conditions as in the UK and Canada but probably to a greater extent since all OTCs are pharmacy only. Current examples of P medicines range from simple paracetamol to the recently approved intranasal corticosteroids for allergic rhinitis and pantoprazole for gastrooesophageal reflux.

Cost of medicines in Malta – Economic Aspects

Malta is well known for its high medicine prices. According to a government study, on average, Maltese consumers are paying 40 per cent more than the EU average for their medicinal products (Grech 2010). In November 2006, a committee was set up in order to control the price of medicines whose research found that 179 medicines were being sold at a higher price than the EU average (Maltastar 2009). One of the reasons for this scenario is that the Consumer Division does not have the power to enforce price controls on importers (ibid). The Finance Minister furnished Parliament with a copy of a list of medicinals found to being sold at a higher price than the EU average (ibid). The list included medicines such as: Actifed DM Linctus 100ml sold in Malta at €5.43 (EU average = €4.26); Augmentin Duo sold in Malta at €14.16 (EU average = €13.16); Lescol where in other EU countries one can buy this medicine for €17,42 for 28 pills of 20mg, in Malta this costs €24.64 i.e. €6.9 more (ibid). This price difference increases to €8.44 for the 40mg box (ibid). It is noteworthy that in a local newspaper, a resident reported that 2 boxes of Sporanox 100mg by 15 capsules cost her €104.52. When this person was in central London, the same pills had cost her €29.43, i.e. €74.57 cheaper or four times as less than in Malta (ibid). Another individual wrote that a medicine bought in Malta for €13.08 was bought in Lisbon, Portugal, at a price of €5.23 (inclusive of 5% VAT) (ibid). Such cases show that the problem of medicine prices in Malta needs appropriate and immediate action. In fact, it must be mentioned that as of April 2011 many overpriced medicines saw their prices fall from 2% to 27% “to reflect prices on mainland Europe” (Times of Malta 2011b:1).

In response to political pressure the European Commission warned that it will monitor price developments across the EU and the compatibility of national pricing and reimbursement rules with the EU legislation (Zahra 2010). Under Article 168(7) of the Treaty on the Functioning of the European Union, EU action “shall respect Member States’ responsibility for the definition of their health policy and for the organisation and delivery of health services and medical care” (Almunia 2010:1). “This results in price variations across the European Union, but is not in itself contrary to the EU competition rules” (Zahra 2010:1). After pharmaceutical companies tried relentlessly to justify case by case their high prices they finally gave in to Government pressure and reduced the price of over 200 medicines which had been identified as higher than the EU average (ibid). Parliamentary secretary for consumers Chris Said explained that the government had achieved price reductions of 4-67% on some 91 medicines (ibid). He argued that since prices are of national competence the government was permitted to influence such prices with the necessary measures (ibid). To further curb the problem of high medicines prices, the Health Minister Joseph Cassar stated in parliament that the government was to set up a specialised agency to buy various medicines through a number of channels (Times of Malta 2011a).

Deregulation from POM to P

The first medicine to be switched from POM to P status was ibuprofen in 1983 followed by loperamide in the same year (PAGB 2011). In January 1994, certain defined packs of cimetidine and famotidine for the treatment of heartburn or dyspepsia were categorized OTC (Keen 1994). The introduction of OTC loratadine in 2002 and OTC omeprazole in 2004 brought renewed attention to the subject of prescription drug to OTC switches (Harrington and Shepherd 2002; Anon 2009a). Most drugs since then have tended to cover minor conditions (Noyce 2007). There has been a recent trend in several countries toward the deregulation of many medicines that were until recently only POMs, and in some countries, there have been moves to allow pharmacists to prescribe prescription only medicines within carefully defined limits (Anderson 2005). In Malta, pharmacist prescribing is still on the drawing board with the Maltese Doctors Association waging strong opposition (Schembri 2010). Drug policies in Western countries support self-medication with OTC drugs (Talmud 2003). For example, according to European Union Directive (92/96) a drug should be made freely available to patients unless a case can be made for its availability being restricted –“its use without medical supervision is dangerous, it is frequently used incorrectly, it is a new chemical entity or it is administered parentally” (Sihvo et al. 2000:495). The main ground for restrictions is safety which depends not only on the drug but also on the information provided to the patient (Bradley and Blenkinsopp 1996). If safety concerns can be met by providing adequate information more drugs can become available over the counter (ibid). Also, there must be a reasonable certainty that certain screening questions would be asked before supply (Langley and Wingfield 2010). In Australia, beta agonists are provided over the counter on the premise that this can be done safely by pharmacists who are required to ask certain questions and provide additional information (Bradley and Blenkinsopp 1996). Similarly, emergency contraception has been made available OTC in the UK on the predicate of the provision of better information to the patient (ibid). This has failed to materialise in Malta since emergency contraception is considered to be illegal and also due to moral aspects where the church’s influence on such laws is still very strong. In 2005 came the landmark decision to allow the first antibiotic in the UK (chloramphenicol eye drops) to be made available OTC on the advice of a pharmacist (Andalo 2010). Three years later the first oral antibiotic to be given P status for the treatment of chlamydia was azithromycin (ibid). In 2009, the UK achieved a global first when the MHRA decided that tamsulosin should be granted P status (ibid). In 2010, the first drug to be made available over the counter to treat heavy menstrual bleeding was tranexamic acid (MHRA 2010). The Medicines Control Agency in the UK “now puts great emphasis on the provision of information for patients in its assessment of applications for drugs to be switched from prescription only to pharmacy status” (Bradley and Blenkinsopp 1996:835). Unfortunately, the switches that occurred in the UK from 2005 onwards have not yet materialised in Malta.

Switches of POM-to-P medicines are no longer straightforward as Neal Patel of the Royal Pharmaceutical Society states that “There are no more easy POM-to-P switches left — those days have gone” (Andalo 2010:445). Lately there has been a set back with the deregulation of antibiotics. Drug companies have withdrawn their applications to reclassify trimethoprim and nitrofurantoin as OTC medicines probably because they attracted criticism from experts, including the British Society for Antimicrobial Chemotherapy, which was concerned about the development of antimicrobial resistance and the control and prevention of Clostridium difficile infection (Anon 2010a). In the cholesterol area, Zocor Heart-Pro, the first brand of simvastatin tablets 10mg to be sold over the counter in the UK, has been discontinued (Anon 2010b). A spokeswoman for McNeil Product said the discontinuation is because of limited consumer demand (ibid). This could be that pharmacists do not feel confident treating patients OTC for cholesterol. To date, no manufacturers in Malta have applied for the switch of simvastatin from POM to P status.

The POM to OTC switch movement has further been strengthened since there is a greater demand for health information by patients and they seem to want to accept more responsibility for their own health (Keen 1994). POM to P switching allows greater choice and the ability to treat symptoms quickly (ibid). It “also has advantages for healthcare systems as it facilitates better use of clinical skills of pharmacists, increases access to medication and may contribute to reducing prescribed drug costs associated with publicly funded health programmes” (Hughes et al. cited in Wazaify et al. 2005:170). Moreover, governments are exerting pressure to contain the rising costs of health care (Keen 1994). All of these factors contribute to the favourable climate in which medicines are being recategorised from POM to P (ibid). There was no evidence that those medicines which had been deregulated had caused undue hazards hence unacceptable risk, had not been proved, although further studies are needed to substantiate the apparently favourable benefit/risk equation (ibid).

In 2007, OTC medicine purchases in the EU amounted to 25.9 billion Euro which accounted for 15% of the total pharmaceutical expenditure (Simoens et al. 2009). “The use of OTC medicines contributes to relieving the financial burden on healthcare systems: a recent analysis in seven European countries showed that a move of 5% of medicines from prescription to OTC status would generate annual savings exceeding 16 billion Euros” (ibid:451). Ryan and Yule estimated that switching loperamide from POM to P status saved the NHS Stg. 0.13 million in 1985, 0.15 million in 1986 and 0.32 million in 1987 (Ryan and Yule cited in Bradley and Bond 1995). Kline and Company “estimated that American consumers saved almost $13 billion a year by using medications switched from prescription-only availability to OTC status” (Harrington and Shepherd 2002:500). Some explain this scenario as a means of transferring “the burden of costs from third parties to consumers” (ibid:500).

The expansion of the OTC armamentarium is not without concern. Promotion of OTCs may encourage patients to believe in a system of a ‘pill for every ill’, that is, that there is some form of medical treatment for every condition or complaint. Patients may also start to obtain such medicines freely through the state by requesting for prescriptions from their GPs (Bradley and Bond 1995). Another concern is that patients may delay the diagnosis of certain serious conditions by using OTC medicines for a prolonged period and thereby masking symptoms and delaying further intervention (ibid). Other potential problems are that: patients may select the incorrect drug for the condition they are suffering from; the dose, dosage regimen and/or route of delivery may be incorrect (ibid). Furthermore, patients may not refer or delay referral to GPs when they should (ibid).

These hurdles would be minimised if patients complied with instructions and advice given by a pharmacist or provided on the package/ package insert (ibid). “However, it is not realistic to expect that patients are so attentive to details and are willing to be so regimented” (ibid: 555). Hence, one may doubt about patient’s competence in self care (ibid).

One must not forget that although rarely, an OTC medication could have its status changed to POM. For example, a recommendation has been made for topical ketoprofen to be switched to POM status by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) (CHMP 2010). The CHMP recommendations follow a scientific review of reports of cutaneous adverse reactions, including photoallergic reactions to topical ketoprofen which include serious reactions leading to hospitalisation (ibid).

Despite this, all the indications are that POM to OTC switches will continue (ibid). This might create additional drug related morbidity if not dealt with correctly by pharmacists and GPs (ibid). “In order for patients to gain the benefits of drug reclassification and yet avoid the pitfalls it is important that GPs respond to the new challenges presented by the emerging liberalization of drug classifications” (ibid: 555). Pharmacists are highly trained people with valuable skills who can manage patients self medication to maximise benefits and minimise risks (Keen 1994). Unfortunately, they are underused in primary care and therefore there should be close collaboration between health professionals were each member can utilise his or her clinical skills.

Collaborative Care

Collaborative care can be defined as:

“...the positive interaction of two or more health professionals, who bring their unique skills and knowledge, to assist patients/clients and families with their health decisions.”

(EICP n.d.:3)

Collaborative care involves utilising the expertise of the relevant health care professional for a certain medical scenario. This new setup of health care provision can help to offer improved outcomes for patients and enhance the efficiency of the health care system overall. With regards to doctors and pharmacists and the POM to OTC switch scenario, one can say that collaboration between the two will be critical for the success of such switches (Bradley and Blenkinsopp 1996). GPs should exploit this change by focusing their practices on diagnosis and advice whilst transferring the monitoring of chronic treatments and medical tests to other health professionals (Keen 1994). For example, once a doctor has made a diagnosis where long term or recurrent treatment is required, this treatment could be available OTC at the patient’s request (Bradley and Blenkinsopp 1996). The pharmacist will in effect be offering a ‘repeat dispensing’ system and at the same time will be able to monitor the patient’s condition/s until the next medical review which is stipulated by the doctor (ibid). This in effect is collaborative care, where continuing treatment of patients with chronic conditions is delegated by doctors to others (ibid). Such care should include all health carers, including informal carers, and be jointly managed to an agreed plan (ibid). Patients would need to take a greater share of the responsibility for their care and this would lead to more cost effective practice management and better use of NHS resources (ibid). In addition, professional bodies and consumer and patient groups need to look closely at how they can build stronger alliances (Bradley and Blenkinsopp 1996).

Misuse vs. Abuse

The majority of OTC drugs are used appropriately by patients; however, a small minority of patients can misuse or abuse these products (Hughes et al. 1999). “The terms ‘misuse’ and ‘abuse’ are often used interchangeably, but they have precise meanings in this framework” (Wazaify et al. 2005: 170). For example, an individual suffering from a genuine medical condition may avoid seeking medical advice if symptoms persist, and as a result, may continue to use the OTC product for a prolonged period (Fleming et al. 2004). In other cases, individuals may increase the dosage in order to obtain improved symptom relief (ibid). Another possible scenario is that of an individual intentionally consuming high doses of an OTC product in order to experience its psychoactive effects (ibid). It is clear that the two situations are different; hence, the following definitions have been employed:

OTC drug misuse: the use of an OTC product for a legitimate medical reason but it is used incorrectly, usually in terms of dosage or duration of use (e.g. taking a higher than recommend dosage of a painkiller to treat headache).

OTC drug abuse: the use of an OTC product for a non medical purpose. OTC products are usually abused to achieve mind-altering effects or in some cases to achieve weight loss (e.g. laxative abuse).

(Fleming et al. 2004 and Wazaify et al. 2005)

Studies on the misuse and abuse of OTC drugs are limited, “partly due to the perception that misuse/abuse of OTC drugs is not as problematic as other types of drug abuse” (Wazaify et al. 2005: 170-171). Studies carried out in the UK and Australia have focused on the perceptions of pharmacists and doctors with regards to misuse and abuse. On the other hand, work carried out on the public has not studied the inappropriate use of OTC drugs (ibid).

OTC misuse

Sihvo et al. (2000:497) found in a study on OTC misuse that “the concurrent use of several OTC medicines as well as continuous daily use was related mainly to vitamins and not to other OTC drugs”. Simultaneous use of different OTC NSAIDS or analgesics was infrequent while the simultaneous use of such OTC drugs with Rx drugs was more common (ibid). One explanation could be that people use painkillers simultaneously for different purposes, as found in a Finnish interview study of people with pain (ibid). In the same study, many patients mentioned that they used painkillers only in cases of ‘extreme need’, even though the use had already continued for years on a regular basis (ibid).

Morra et al. (cited in A. Douzenis et al. 2006) described a case of OTC misuse were a patient developed severe sensory and a mild motor neuropathy due to prolonged overuse of vitamin B6. An Australian study found that even children are being put at risk of medicines misuse by over-use and incorrect dosing of over-the-counter medicines for fever, coughs and colds (Anon 2010c). The study revealed that 61 per cent of adults would give children an incorrect dose of medicine based on a scenario situation (ibid). The researchers said that “dosing errors and inappropriate use of [OTC] medicines lead to a large number of calls to poison centres [in Australia] as well as emergency hospital admissions” (Moles cited in Anon 2010c:1).

OTC abuse

From the definitions of misuse and abuse one can infer that all OTC medications can be misused. On the other hand, some medications have a higher abuse potential than others (Hughes et al.1999). Drugs identified as having a high abuse potential include those containing opiods, antihistamines, sympathomimetics and laxatives (ibid).

Several authors have focused on the fact that the long-term use of stimulant laxatives can have serious negative health consequences (Fleming et al. 2004). They are often abused in the mistaken belief that their use will either prevent calorie absorption and weight gain or maintain good health for those who believe that daily bowel evacuation is healthy (Hughes et al. 1999). Abuse of stimulant laxatives may lead to a number of complications including diarrhoea with associated sodium and water loss, potassium loss and hypokalaemia, possibly hypocalcaemia and hypomagnesaemia which can result in tetany (ibid). These combined effects have been referred to as “metabolic madness” and can result in renal damage (ibid).

Fleming et al. (2004:282) stated that “with regard to antihistamines, reports of abuse have centred around older, sedating products such as dimenhydrinate, diphenyhydramine and cyclizine”. In high doses, they can cause euphoria, hallucinations, disorientation and ataxia with reports often involving teenagers seeking euphoric effects (ibid).

Sympathomimetics have also been a target for abuse causing paranoid psychosis, where the user may experience auditory and visual hallucinations similarly seen with amphetamine abuse (sympathomimetics have a similar structure to amphetamines) (Hughes et al. 1999). The symptoms usually disappear with cessation of the drug and supportive treatment (ibid).

With regards to opiods there have been reports of cardiac glycoside toxicity with opiod-containing cough mixtures which resulted from the consumption of the cardiac glycoside scillarin A and B, found in squill oxymel contained in the formulation as an expectorant (Fleming et al. 2004). In another case, an individual died after prolonged ingestion of high doses of kaolin and morphine mixture (ibid).

In order to avoid such complications, pharmacists in Malta as in the UK are directed by their Code of Ethics to use their professional judgement to prevent the supply of unnecessary and excessive quantities of OTC products and where necessary, to refuse the sale (Fleming et al. 2004).

Studies on OTC use (self medication)

“The nature and extent of self-medication varies in different ... [cultures] and social and educational influences may be greater than medical practice influence” (Hussain et al. 2010:32). In common with the findings of other researchers, patients appear to be confident to take responsibility for their own treatment of their minor conditions (Hughes et al. 2002). Severe side effects, “prolonged use, excessive dosages, habituation, drug-drug interactions, drug-disease interactions, food drug-interactions, misdiagnosis and delayed treatment are possible risks of self-medication” (Sihvo et al. 2000:496).

It has been found that medicines information is obtained from a variety of sources, some of them potentially more reliable than others (Hughes et al. 2002). Patients mentioned the use of books, friends and colleagues, magazines, television and the Internet in one particular study (ibid). “The use of friends, relatives and colleagues was an important information source for a number of patients, and other researchers have likewise found that patients use this information source” (ibid:247). It has been shown that patient information leaflets (PILs) can increase knowledge of side-effects of a drug (ibid). What is of concern is that a particular patient said that “they did not expect there to be any side-effects as they did not consider it to be a powerful drug” since it was provided over the counter (ibid:246). An explanation to this could be that “users of OTC medicines are more interested in the potential benefits than the possible risks” which is a phenomenon identified by Bissell and colleagues (ibid:246). These authors discovered that patients are of the opinion that all OTC medicines are safe since if they were not they would not be allowed to be sold over the counter (ibid). In fact, in the Australian study Dr Moles said that “We were surprised and concerned to find that some people thought that medicines must be safe because you can buy them without prescription” (Moles cited in Anon 2010c:1). “For example, one parent said to us that if it [paracetamol] is available over the counter, administering a double dose couldn’t do any harm and asked: What could be the worst that could happen?” (ibid:1).

Pharmacists have been viewed as a convenient source of good advice, although there were concerns about the lack of privacy in community pharmacies (Hughes et al. 2002). On a positive note pharmacists were viewed as easier to access compared to doctors and better communicators of health information (ibid). “Clearly information about potential side-effects should be provided to patients, but problems in understanding the leaflets, and ‘scaring’ patients with long lists of side-effects need to be addressed” (ibid:247). To help this situation, health professionals should explain detailed printed information in a simple and easy to understand manner and to offer reassurance to patients about the safety of their medicines (ibid).

Studies have shown that patients’ lack knowledge about the adverse and toxic effects of their medicines including POMs for chronic conditions (ibid). This could lead to under reporting of ADRs since they will not be identified and reported (ibid). Therefore, it is important to examine whether patients are knowledgeable about their medication and also the source of this information (ibid).

Past studies on self-medication have largely been descriptive (Sihvo et al. 2000). These have focussed on healthcare professionals’ views on OTC medicines; OTC practices of pharmacists; change in prescribing behaviour and physician services vis-à-vis prescription-to OTC switches; drug interactions, adverse drug events and misuse of OTC medicines (Simoens et al. 2009). Some questions which have remained unanswered include: What are the sources of drug information regarding OTC medicines? What do patients believe is the role of the community pharmacist regarding OTC medicines use? Do patients follow the directions on the packet of OTCs? What action do patients take when their OTC medication does not work within a recommended period? What are patients’ perspectives with regards to safety, side-effects, tolerance, abuse and dependency to OTC medication? These are some of the questions which this study attempts to answer.

Simoens et al. 2009 found that patients prefer buying OTC medicines from community pharmacies since this is where they can obtain information about these medications. Patient feel that a community pharmacy is well suited to providing such medication information especially if it has a separate consultation room for private communication with the patient (Mobach cited in Simoens et al. 2009). They also felt that a high pharmacy to inhabitant ratio improves “patient access to OTC medicines and diminishes the need for other distribution channels” (Simoens et al. 2009:455).

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