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9
Acknowledgements
I would like to thank my tutor Professor David Woolfson of Queen's University of Belfast for his
expert advice, guidance and support to carry out this dissertation.
I am indebted to all participants of this study for their valuable feedback.
I would also like to thank my parents and fiancée Grace for their constant support and under-
standing during the entire masters course.
Finally, I would like to dedicate this dissertation to my late grandfather Michael Angelo Debrincat
who always encouraged me to further my studies.
11
Abstract
Title: Patient perspectives to self medication in a community pharmacy setting in Malta.
Objective: To determine the perspectives of patients regarding OTC medication, incidence of
irresponsible medication, reasons for, predisposing factors that contribute to, and methods used
to reduce these events from occurring. The misuse and abuse of OTC medications was also
discussed.
Design: Questionnaire of approximately 15 minutes duration administered using a structured
interview technique.
Setting: National Pharmacy, Hamrun, Malta.
Subjects: 200 people above the age of 16 years entering the pharmacy.
Results: Three quarters of participants visited a community pharmacy at least once a month
and over half of participants (56.5%) reported buying OTC drugs during the same period. Most
respondents (85%) preferred seeking advice from a chemist rather than a doctor when their
condition was not serious enough to visit the latter. Patients with higher managerial, administra-
tive and professional occupations were more likely to follow the directions on the packet.
Patients with manual occupations were more likely to seek the advice of a pharmacist rather
than a doctor if a given OTC product did not work within a recommended time period. Only 1%
of participants asked for an OTC product that did not correspond with the symptoms they were
treating. Three quarters of participants were knowledgeable about the potential for abuse of
some OTC drugs and most named analgesics as the most liable for abuse. Almost one third
(31.5%) of the participants came across cases of OTC abuse.
Conclusion: Participants were positive towards the health care being provided by their local
pharmacy. They felt that pharmacists play an important role in providing advice on OTC medi-
cines use. The OTC drug abuse problem needs to be tackled urgently as shown by the number
of participants witnessing such abuse. Further studies are required to determine on a larger
scale the perspectives of OTC use in Malta.
Chapter 1
Introduction
15
1 Introduction
1.1 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 316km
2
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
16
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 under-
taken 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).
1.2 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.
17
Table 1: OTC practices in EU member states
OTC practices
Price
Controls
Reimbursement
Sales outside
pharmacies
Austria Not
Free
Yes
Allowed
Belgium
Not Free
Yes
Not allowed
Czech Rep.
Not Free
Yes
Allowed
Denmark Free
No
Allowed
Finland Free
No
Not
allowed
France Free
No
Not
allowed
Germany
Free
No
Allowed
Netherlands Free
No
Allowed
U.K. Free No Allowed
Ireland Free
No
Allowed
Spain Free No
Not
allowed
Italy Free No Not
allowed
Estonia Free
No
Allowed
Hungary Free
No
Not
allowed
Malta
Free
No
Not allowed
Poland Free
No
Allowed
Portugal Free
No
Not
allowed
Slovenia
Not free
No
Not allowed
Greece
Not free
No
Not allowed
(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
18
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 appropri-
ate 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 condi-
tions 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.
1.3 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
19
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).
1.4 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 pharma-
cists 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
20
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 con-
cerns 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, includ-
ing the British Society for Antimicrobial Chemotherapy, which was concerned about the devel-
opment 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 spokes-
woman for McNeil Product said the discontinuation is because of limited consumer demand
21
(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 Shep-
herd 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 condi-
tions 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
22
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 collabora-
tion between health professionals were each member can utilise his or her clinical skills.
1.5 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
23
(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 continu-
ing 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 re-
sources (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).
1.6 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 experi-
ence 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
24
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).
1.7 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).
1.8 OTC abuse
From the definitions of misuse and abuse one can infer that all OTC medications can be mis-
used. 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).
25
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).
1.
9 Studies on OTC use (self medication)
"The nature and extent of self-medication varies in different ... [cultures] and social and educa-
tional 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 responsi-
bility 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 interac-
tions, 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
26
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 medi-
cines are more interested in the potential benefits than the possible risks" which is a phenome-
non 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 communica-
tors 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 infor-
mation (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 recom-
mended 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.
27
Simoens et al. 2009 found that patients prefer buying OTC medicines from community pharma-
cies 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).
Bradley and Bond in 1995 identified the need for a patient education campaign about the safe
and appropriate use of OTC medicines. They felt that this should be done in the context of
ordinary GP consultations and backed by media publicity and education in schools. In Malta, the
Medicines Authority (MA) launched an information campaign on medicines which was carried
out in line with results of a research done on Maltese consumers (MA 2011). The research found
that 60 per cent of consumers always or frequently read the package leaflet before taking the
medicine for the first time while more than 85 per cent of consumers were not aware of the
difference between originator and generic medicines (ibid). Throughout the campaign patients
were educated about OTC medicines including how they can be used safely (ibid). The study
revealed the necessity for patients to read the instructions and information on the pack-
age/package insert, as should the availability of further advice and information from the commu-
nity pharmacist (Blom and Rens 1989).
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