A review of pharmaceutical scheduling processes in six countries and the effect on consumer access to medicines

Abstract

Objective This analysis determined and compared pharmaceutical scheduling arrangements in six selected countries and explored how these different scheduling arrangements affect the availability of medicines to the public for self-medication.Method A comparison of the pharmaceutical scheduling requirements for medicines in six countries was undertaken in September 2003. The six countries of comparison were Australia, Canada, France, New Zealand (NZ), the United States (US), and the United Kingdom (UK). The World Self-Medication Industry website, in September 2003, listed 216 medicines available in 27 countries. Of these, 104 medicines were available in each of the six countries selected for the study. As different scheduling arrangements pertain to different forms (external, internal) or doses and pack sizes, the total number of medicines and medicine forms for comparison was 119. The scheduling of each of the 119 products was determined and compared across the six countries.Results Of the 119 medicines and medicine forms available, Australia and NZ have 38 and 34 ‘prescription-only’ medicines and 81 and 85 medicines available without a prescription respectively. UK, Canada and France have 47, 53, and 55 ‘prescription-only’ medicines and 72, 66 and 64 medicines available without a prescription. US, which has only two schedules, ‘prescription-only’ and ‘general sale’, has the highest number of ‘prescription-only’ drugs (66) and the least number of medicines available without a prescription (53).Conclusion The results indicate that there is a tendency for more products to be made available without a prescription in countries that have schedules with pharmacy involvement (Australia, NZ, Canada, France and UK) and a matching tendency for preparations to be held in ‘prescription-only’ schedules in the USA where ‘pharmacy-only’ schedules do not exist. The presence of ‘pharmacy-only’ schedules provides a structure whereby greater consumer access to medication is available.

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D-05-00015
IJPP 2006, 14: 1–10
? 2006 The Authors
Received July 21, 2005
Accepted January 31, 2006
DOI 10.1211/ijpp.14.2.00XX
ISSN 0961-7671
Quality Use of Medicines and
Pharmacy Research Centre,
University of South Australia,
Adelaide, Australia
Andrew Gilbert, director
Deepa Rao, research fellow
Neil Quintrell, project officer
Correspondence: Professor
Andrew Gilbert, Director:,
Quality Use of Medicines and
Pharmacy Research Centre,
Sansom Institute, R3–28, Reid
Building, University of South
Australia, Frome Road, Adelaide
5000, Australia. E-mail:
andrew.gilbert@unisa.edu.au
Acknowledgements: The project
was funded from money
available from the
Commonwealth Department of
Health and Ageing through the
3rd Pharmacy/Government
agreement. The authors would
also like to acknowledge Dr
Barbara Anderson for her
assistance in reviewing and
editing this article.
A review of pharmaceutical scheduling processes
in six countries and the effect on consumer access
to medicines
Andrew Gilbert, Deepa Rao and Neil Quintrell
Abstract
Objective
selected countries and explored how these different scheduling arrangements affect the availability
of medicines to the public for self-medication.
MethodA comparison of the pharmaceutical scheduling requirements for medicines in six coun-
tries was undertaken in September 2003. The six countries of comparison were Australia, Canada,
France, New Zealand (NZ), the United States (US), and the United Kingdom (UK). The World Self-
Medication Industry website, in September 2003, listed 216 medicines available in 27 countries. Of
these, 104 medicines were available in each of the six countries selected for the study. As different
scheduling arrangements pertain to different forms (external, internal) or doses and pack sizes, the
total number of medicines and medicine forms for comparison was 119. The scheduling of each of
the 119 products was determined and compared across the six countries.
Results Of the 119 medicines and medicine forms available, Australia and NZ have 38 and 34
‘prescription-only’ medicines and 81 and 85 medicines available without a prescription respectively.
UK, Canada and France have 47, 53, and 55 ‘prescription-only’ medicines and 72, 66 and 64 medicines
available without a prescription. US, which has only two schedules, ‘prescription-only’ and ‘general
sale’, has the highest number of ‘prescription-only’ drugs (66) and the least number of medicines
available without a prescription (53).
ConclusionThe results indicate that there is a tendency for more products to be made available
without a prescription in countries that have schedules with pharmacy involvement (Australia, NZ,
Canada, France and UK) and a matching tendency for preparations to be held in ‘prescription-only’
schedules in the USA where ‘pharmacy-only’ schedules do not exist. The presence of ‘pharmacy-only’
schedules provides a structure whereby greater consumer access to medication is available.
This analysis determined and compared pharmaceutical scheduling arrangements in six
Introduction
A range of factors, such as a nation’s economic orientation, wealth, traditions and
political system, influence the manner in which medicines are distributed and sold.1In
Australia, a fundamental tenet of its National Medicines Policy is the safe and afford-
able access to medicines that consumers need, at a cost individuals and the community
can afford.2,3The scheduling of medicines (defined as any drugs or preparations used
for the treatment or prevention of disease,4is one factor that moderates direct con-
sumer access to medicines in many countries. Different countries use different terms
for classifying drugs. The term ‘scheduling’ is used in Australia, Canada and New
Zealand (NZ), while ‘classification’ is used in the UK and NZ. The US uses the term
‘classes’ while France uses the term ‘list’. We have opted to use the term ‘scheduling’ in
this article. A number of scheduling options for medicines are available, such as
prescription-only, pharmacy-only, pharmacist-only and over-the-counter (OTC).
Regulatory authorities in a number of countries have used some or all of these options
in their medicines scheduling systems.1
While consumers have been able to buy a range of medicines, for example aspirin,
without a prescription for many years,5when a new medicine is introduced into the
market, it is scheduled for prescription only. Rescheduling of medicines to a lower non-
prescription schedule by regulatory authorities relies on criteria such as low potential

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for misuse or abuse, low potential for harm, low incidence
of side-effects, efficacy of the medicine and the ability of
the consumer to diagnose and manage minor ailments or
symptoms.6The World Medical Association states that
for medicines to be available for self-medication, consu-
mers must be able to recognise the symptoms to be trea-
ted, determine that the condition is suitable for self-
medication, choose an appropriate product, understand
and follow directions, and, evaluate the balance between
risks and benefit.7
Internationally, a range of other factors are driving the
rescheduling of medicines from prescription-only to phar-
macist-only or OTC. In the UK, factors promoting the
rescheduling of drugs from prescription-only medicine
(POM) to pharmacy-only (P) include patient empower-
ment, the rise of consumerism, the decreasing power of
the professions, pharmacists’ drive to extend their role,
government policy to contain the National Health System
drug expenditure,8and the commercial gain to the phar-
maceutical industry from extending the life of the pro-
duct.9When the status of a medicine changes from
prescription-only to OTC availability, a range of issues
such as patients’ access to drugs, the cost of healthcare,
and safety and quality must be considered.10
With increased public access through the widespread
availability of non-prescription medicines, previously
available only by prescription, there has been an increas-
ing trend in self-medication.8,11–14In the US, the avail-
ability of more than 600 OTC products, containing
ingredients and dosages that were available only on pre-
scription 20 years ago, has increased the concept of self-
care.5In the US, in the third National Health and
Nutrition Examination Survey (1988–1994), 76% of
those surveyed used non-prescription products.15Other
surveys conducted in the US have reported that consu-
mers found that the switching of products from prescrip-
tion-only to non-prescription very convenient,16and that
consumers want more prescription medicines switched to
non-prescription status.17A UK study identified four fac-
tors influencing the respondents’ decision to purchase
OTC drugs. These factors were preference for OTC pur-
chase (76%), knowledge of OTC availability of products
(87%), prescription charge liability status (92%) and no
current use of other prescribed medicines (97%).18
A range of real and potential costs and benefits of
switching a medicine from prescription-only to OTC
have been identified. Costs include an increase in adverse
effects, delay in treatment of serious disease, growth in
bacterial resistance, wasted medicines and the ‘cost of
learning’ for the consumer. Benefits to society include
lower reimbursement expenses, savings in physician time
and lower dispensing costs. Benefits to the consumer
include a decrease in total price, no monetary and time
costs from physicians’ visits, no prescription fees, lower
travel costs, less waiting time in pharmacies (time cost)
and more time at work (both monetary and time cost).19
Rizzo etal (2005) assessed the net benefits of prescrip-
tion-to-OTC switches from the results of 15 studies that
considered 23 medicines-scheduling switches.20Results
indicated that 10 of the switches were determined to be
beneficial, three cases of switches were not considered to
be beneficial, and the remaining 10 switches (43%) yielded
equivocal results.
Switches that have resulted in savings to individuals
and health systems in terms of reductions in both direct
and indirect costs and reductions in general practitioner
(GP) visits, have been shown in relation to H2antago-
nists,21second generation antihistamines,22and nicotine
replacement therapy,23and for 16 medicines switched to
non-prescriptionsale in
Australian study found that savings may not be univer-
sally enjoyed. When vaginal antifungals were shifted from
prescription-only, they were subsequently delisted from
the Pharmaceutical Benefits Scheme (a Commonwealth
Government scheme whereby a wide range of prescription
medic ines are made available to Australians at subsidised
costs), with the result that pensioners and health conces-
sion card-holders had to pay more. Particularly economic-
ally vulnerable groups were severely disadvantaged.25
Indeed, the perspective from which the analysis is carried
out plays a critical role in assessing the net benefits of
prescription-to-OTC switches. From the payer perspec-
tive, most studies have shown positive net benefits; how-
ever the benefits are not as clear for analyses conducted
from the perspective of the consumer. Societal and provi-
der perspectives have not often been addressed.20
Switching has quality and safety implications, such as
consumer perceptions of risk, information provision/
health professional engagement and post-marketing sur-
veillance/pharmacovigilance. While self-care and respon-
sible self-medication can be beneficial for patients and
health systems,26the increased availability of medications
may also have risks, associated with their use to treat
illnesses that have been wrongly self-diagnosed, and result
in the excessive use of inappropriate medications.5In US
studies, respondents reported favouring non-prescription
status despite the possibility of considerable risks.27In the
UK, consumers rarely referred to the risks or dangers of
the non-prescription medicines, focusing rather on their
benefits, as there seemed to be the widely held belief that
regulatory authorities would not allow ‘dangerous’ medi-
cines to be available from community pharmacy.28
Responsible self-medication must be accompanied by
appropriate health information.7,11Consumers appear to
use pharmacists in a variety of ways: as a ‘first port of call’
when treating minor ailments; as facilitators, either con-
firming their choice of self-care or as an agent, referring
them to a GP;29as a resource for self-care,30and ‘an
important’ source of drug information.31,32As consumers
assume greater responsibility for their healthcare, phar-
macists can play an important role by serving as an addi-
tional information source for consumers and helping them
to make informed decisions.33,34The impact of pharma-
cist advice-giving on the outcomes of self-medication in
patients suffering from dyspepsia has been shown to result
in a significant improvement in health-related quality of
life.35
A number of studies have addressed the issue of post-
marketing surveillance/pharmcovigilance. One study in
developing methods for pharmacovigilance studies for
Sweden.24
However,one
2
The International Journal of Pharmacy Practice, June 2006

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ibuprofen, surveyed pharmacy customers and found that
ibuprofen was used by 15% of customers with an active or
past history of peptic ulcer. Seventeen per cent of those
surveyed reported experiencing dyspepsia or heartburn
after purchasing ibuprofen but did not seek advice.36
Another study compared reported adverse effects from
proton pump inhibitors with the H2antagonists ranitidine
and famotidine which had been recently switched to OTC
status. The authors reported that the switching did not
affect the number of reported adverse reactions to these
drugs.37
A study assessing smoking cessation rates
achieved with nicotine gum and patches in simulated
OTC and actual prescription settings concluded that
OTC success rates were consistently higher than prescrip-
tion rates for both gum and patches.38
While the literature acknowledges the different classi-
fication or scheduling arrangements that may be adopted
and addresses a range of issues associated with switching,
it would appear that no studies have been carried out that
determine how the different scheduling arrangements
affect availability of medicines to the public. The search
strategies used for this review are listed in Appendix 1.
Aim
The aim of this analysis was to determine and compare the
pharmaceutical scheduling arrangements (or legal classifi-
cation of medicines) in six selected countries, and to
explore how these different scheduling requirements affect
the direct access of the public to medicines for self-treat-
ment.
Methods
The World Self Medication Industry website,39which is a
comprehensive database providing information on legal
scheduling of medicines in different countries, was used to
obtain the list of countries. The website lists three tables:
the table of OTC ingredients in 14 EU countries; the table
of OTC ingredients in 7 new EU and 3 non-EU European
countries; and the table of OTC ingredients in 11 selected
countries worldwide. A systematic analysis of scheduling
processes, which included the identification of guidelines
for scheduling, was undertaken for all the countries listed
in the tables. To be included in further analyses, countries
had to have sufficient similarity to Australia’s processes
with respect to:
. the presence of substantial pharmacovigilance processes
. the use of a similar range of medicines
. access to detailed descriptions of scheduling decision-
making processes and guidelines
. access to experts in each of these countries who could
verify the scheduling arrangements in their countries
and answer queries related to scheduling arrangements.
An online search was conducted to obtain information
on the pharmacovigilance processes and for descriptions
of scheduling decision-making processes and guidelines
for each country (refer to Appendix 2 for the search
strategy). The available relevant documents were then
read by one of the authors (NQ) to assess similarities
with Australian documents. An attempt was made to
contact representatives from relevant committees in each
country. Using the search terms detailed in Appendix 2,
we were able to find links to the regulatory authority
website for all 35 countries. For six countries the websites
were not in English, and attempts to establish contacts
with the authorities were not successful. For 15 countries,
information was available in English but no relevant
information on scheduling processes was found, and
again we were not able to establish contact with the rele-
vant authorities. For 13 countries we were able to find
relevant information in English. We were able to establish
contact with a representative from the relevant commit-
tees in five countries, namely Canada, France, New
Zealand, UK and US, to verify the information. As
these five countries satisfied all inclusion criteria, they
were included in the analysis. Other countries such as
Germany, Sweden and Switzerland satisfied the first
three criteria, however we were not able to establish per-
sonal contacts in these countries within the time frame of
the project.
A comparative analysis of the scheduling of medicines
in the six countries was undertaken with a view to devel-
oping an understanding of the ways different scheduling
requirements might affect the availability of both prescrip-
tion and non-prescription medicines to the public. In
order to compare the scheduling processes of the selected
countries, a list of both prescription and non-prescription
medicines available in all six countries and their schedul-
ing requirements was obtained from the World Self-
Medication Industry website.39The list of medicines was
obtained from the table of OTC ingredients in 14 EU
countries and the table of OTC ingredients in 11 selected
countries worldwide. The two tables listed 216 ingredients
available in 25 countries in September 2003. It also lists
combinations of ingredients that are available in the dif-
ferent countries. The website also provides information on
the schedules through which these ingredients are avail-
able to the public. The main table lists whether an ingre-
dient is available through a prescription or non-
prescription route. Footnotes for ingredients provide
additional information on whether the ingredient is avail-
able through pharmacy schedules. The terms ‘ingredients’
and ‘medicines’ are used interchangeably in this article.
Of the total of 216 ingredients, 104 were identified as
being available, either on prescription or non-prescrip-
tion, in all six countries. Ingredients that were not avail-
able in all of the six countries were excluded. As different
scheduling arrangements pertain to different dose forms
(external, internal) or doses and pack sizes, the total num-
ber of ingredients and dose forms included in the analysis
for comparison was 119. For example clotrimazole, an
antifungal agent, is available as a topical as well as a
vaginal preparation in all the six countries. Other exam-
ples of ingredients available in different dosage forms
include terbinafine, econazole, nystatin, tioconazole (all
June 2006, The International Journal of Pharmacy Practice
3

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antifungal agents), nitroglycerine (cardiovascular agent)
and nicotine. Prochlorperazine, an anti-emetic agent, is
available as non-prescription in smaller packs, while lar-
ger packs need a prescription. Other examples of ingredi-
ents available in different doses and pack sizes include
diclofenac, ketoprofen (both anti-inflammatories), cetiri-
zine (antihistamine), hyoscine or scopolamine (antimus-
carinic agent), dextromethorphan (cough suppressant),
famotidine (gastro-intestinal agent). Epinephrine (adrena-
line), a sympathomimetic agent, is available as either non-
prescription or prescription in different countries depend-
ing on its use. The scheduling of each of the 119 medicines
was determined and compared across the six countries.
Results
Pharmaceutical scheduling arrangements
in the six countries
In general, there are four schedules through which medi-
cines are available to the public – general sale, pharmacy-
only, pharmacist-only and prescription-only. The first
three schedules are referred to as non-prescription sche-
dules in this paper. Table 1 summarises the different sche-
duling systems in the six countries.
The decision-making process for scheduling switches in
the six countries is outlined below.
Australia
Australia has four schedules through which medicines are
made available to the public: schedule four or prescription
only; schedule three or pharmacist-only; schedule two or
pharmacy-only and general sale. The scheduling applies
according to the ‘Standard for uniform scheduling of
medicines andpoisons’ (SUSDP).40
Medicines and Poisons Schedule Committee (NDPSC)
makes decisions relating to switches of medicines from
prescription-only to pharmacist-only or pharmacy-only
sale, or to general sale.40The decision to switch schedules
depends on safety, abuse potential, level of diagnosis
required, level of management required, incidence of
side-effects or adverse effects, capacity to mask disease
or compromise management, patient choice and accessi-
bility, public health issues (e.g. antibiotic resistance), har-
monisationand scheduling
Zealand, and therapeutic index. Safety and levels of diag-
nosis and management required are key markers for mak-
ing decisions about scheduling or scheduling switches.
The National
consistencywith New
Canada
In Canada, medicines are divided at the federal level into
prescription and non-prescription.41The provinces adopt
further subdivisions into: schedule one prescription med-
icines; schedule two pharmacist assist (behind the coun-
ter); schedule three pharmacy self-selection; unscheduled
general sale – all retail outlets. The key concepts in deter-
mining the scheduling of medicines are safety and efficacy.
When consideration is given to the transfer of medicines
from prescription to non-prescription schedules, Barbara
Wells, Executive Director, National Association of
Pharmacy Regulatory Authorities (personal communica-
tion September 9, 2003) indicated that the following major
questions must be addressed: does removal of physician
control endanger the public, and/or increase the risk of
significant adverse effects; is the medicine safe; have
potential adverse effects been overlooked in randomised
controlled trials; is there evidence of good compliance in
Table 1
The legal scheduling status of drugs in the six selected countries
CountryMedicines available
for general salea
Medicines available
from pharmacies
without prescriptionb
Total medicines available
without prescriptionc
Medicines for which a
prescription is requiredd
New Zealand
Australia
All outlets
All general
sale outlets
All general sale
outlets (GSL)
All retail outlets
–
All general sale outlets
Pharmacy medicine
S2
Restricted medicine
S3
Prescription medicine
S4
UK– Pharmacist supervision
required (P)
Schedule II
–
Only for certain
controlled substances
and only in some states
Prescription only (POM)
Canada
France
US
Schedule III
non-prescription
–
Schedule I
Prescription list
Prescription only
– The country does not have this schedule for drugs.
aSubstances (medicines) available from general sale outlets such as pharmacies and supermarkets.
bSubstances (medicines), the safe use of which may require professional advice from a pharmacist and which should be available from a
pharmacy or where a pharmacy service is not available from a licensed person. No prescription is required.
cSubstances (medicines), the safe use of which requires professional advice and which should be available to the public from a pharmacist
without prescription.
dSubstances (medicines), the use or supply of which should be by or on the order of persons permitted by the state or territory legislation
(usually doctors or veterinarians) to prescribe, and should be available from a pharmacist on prescription.
4
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adhering to labelled instructions and warnings; what are
the patterns of consumer use and misuse?
New Zealand
New Zealand has four schedules matching those of
Australia: prescription-only, pharmacist-only, pharmacy
medicine, and general sale.
New Zealand regulations state that:
[m]edical products which may be available without pre-
scription shall show a substantial safety in use in the treat-
ment of minor ailments or symptoms usually capable of rapid
and spontaneous relief which are easily identifiable by users
and do not justify a medical consultation’.42(p175)
In order to achieve schedule changes, the NZ Medicines
Classification Committee considers whether there are: con-
sumer and public benefits; ease of self-diagnosis, or phar-
macist diagnosis; relevant comparative data for like
compounds; local data or special considerations; significant
interactions with other medicines; significant contraindica-
tions; likelihood for the development of resistance; poten-
tial serious adverse effects; potential for misuse or abuse.
United Kingdom
The UK has three schedules of medicines: prescription-only
medicine (POM), pharmacy only (P) and general sale (GSL).
Before a medicine can be switched from POM to P, ministers
must be satisfied that it would be safe to allow it to be
supplied without a prescription. Similarly, before a medicine
can be switched from P to GSL, ministers must be satisfied
that it ‘can with reasonable safety be sold or supplied other-
wise than by or under the supervision of a pharmacist’.43
The government authority responsible for the regulation of
medicines in the UK, the Medicines and Healthcare pro-
ducts Regulatory Agency, specifies the criteria for switching
a drug from POM to P schedule.43These are: indications
suitable for self-medication, including self-diagnosis (for
example a recurrent attack of a condition which had been
physician diagnosed on first attack); the medicine has an
acceptable margin of safety during unsupervised use, includ-
ing safety in overdose or following accidental misdiagnosis;
the medicine is not a new drug substance for which further
post-marketing evidence of safety is required; the medicine
does not present a hazard to the community (indirect dan-
ger) from unsupervised use as might occur with development
of resistant flora to antibiotics; the medicine has no major
abuse or dependence potential and is not for parenteral use.
France
France has four drug schedules: prescription, list A (list
I) – this includes substances or preparations and medi-
cines presenting high risks for health. The prescriptions
are non-refillable by a pharmacist without written
authorisation of the prescriber; prescription, list B –
this includes substances with addictive risks such as
controlled narcotics and certain psychotropics; prescrip-
tion, list C (list II) – this includes substances or prepara-
tions and medicines presenting direct or indirect risks for
health, these prescriptions are refillable by a pharmacist,
examples include the non-steroidal anti-inflammatory
drug aceclofenac, the antihistamine ketotifen eye drops
and insulin; non-prescription – this includes all other
medicines which, with the exception of aspirin, must be
sold only in pharmacies. In rural areas where there is no
pharmacy, physicians may be authorised to dispense
drugs. Safety, efficacy, and quality are the factors con-
sidered when a drug approval decision is made.44
United States
The US has only two relevant schedules for medicines:
prescription or non-prescription. However there are sev-
eral exceptions to the two-schedule system. In some
states, selected schedule V controlled substances, such
as the narcotic buprenorphine or the stimulant pyrova-
lerone, are available without a prescription but must be
dispensed by a pharmacist. Insulin is a non-prescription
product in some states, but can be dispensed only by a
pharmacist. In Florida pharmacists can prescribe a lim-
ited list of prescription drugs without a prescription
having been written by another health professional. In
some states pharmacists have a ‘dependent’ prescribing
authority in which typically they can prescribe drugs
under protocols established by supervisory physicians.44
The crucial question that determines whether medicines
are available to consumers without prescription is whether
patients alone can achieve the desired medical results with-
out endangeringtheirsafety. Keyconcepts of USlegislation
include:9safety – including toxicity, potential for misuse,
minimal side-effects; effectiveness – effective for short-term
treatment; diagnosis – can the consumer self-diagnose;
management – are routine tests needed; information – can
patients understand correct use.
In general, all the countries consider the criteria of
safety, potential for abuse, adverse effects and level of
diagnosis, for making decisions about rescheduling.
Table 2 provides a comparison of the scheduling
requirements of the 119 ingredients (including different
dose forms) available in the selected countries.
The results show that of the six selected countries, NZ
had the highest number of the identified medicines avail-
able without a prescription, 85, followed in descending
order by Australia, UK, France, Canada and the US,
which had the smallest number (53). Conversely, New
Zealand had the lowest number of identified medicines
for which a prescription was required (35), followed in
ascending order by Australia, UK, Canada, France and
the USA, which had the greatest number (66).
Discussion
The decision-making process for scheduling switches in the
six countries appear to be based on a relatively consistent
set of principles. The analysis of the placement of medicines
within available schedules in the countries of comparison
indicates that there is a greater tendency for preparations to
be made available without prescription in countries that
have ‘pharmacy-only’ schedules (France, UK) and ‘phar-
June 2006, The International Journal of Pharmacy Practice
5