over-the-counter medicinal products
The availability of medicinal products is divided into two main
groups: medicines available Only on Prescription from doctor or
specialist (PO) and medicines available without prescription
(over-the-counter: OTC). The OTC medicinal products are better
known as over-the-counter medicines. Over-the-counter medicines may
be obtained without consulting a doctor first. The MEB has the
legal task of determining whether a medicinal product requires a
prescription (PO) or not. Over-the-counter is an important
supplement to professional care in terms of how patients can deal
with disease, complaints and discomfort, taking into account that
making medicinal products available over-the-counter also entails a
certain degree of risk. The MEB places public health interests
first and foremost in its evaluation.
People are confronted with risks in all kinds of situations. For
example, road use is associated with risks, as is dealing with
pesticides or cleaning agents; event cosmetics and foods have
health risks, albeit minor ones. The same is true for
categorization of over-the-counter medicines: on principle, there
is always some risk involved. A safety guarantee excluding any
risk, however small, cannot be provided. After all, the substance
must have the desired effect, so the risk of undesirable effects at
an effective dose of a medicinal product is inevitable,
particularly in (very) sensitive individuals. This risk is
(significantly) controlled by using the medicinal product as
indicated (normal use), based on the information in the patient
information leaflet. For example, the leaflet contains warnings for
the user, such as situations in which the medicinal product should
not be used as it would entail an elevated risk. Furthermore, the
leaflet contains recommendations on responsible use, for example
that a doctor should be consulted in the event complaints fail to
disappear following use of the over-the-counter medicinal product
in question.
Categories of legal status of supply
Since the enactment of the Medicines Act of 2007,
over-the-counter medicines have been categorized into three
categories of legal status of supply. The aim of the legislator was
to ensure a good balance between availability and risks. These
categories are:
- Pharmacy only (PH): Medicines with a relatively mild potential
risk
- Pharmacy and Drugstore only (PDO): Medicines with a relatively
low potential risk
- Without Restriction (GS): Medicines with a relatively very low
potential risk
Medicinal products in the PH category can only be obtained from
a pharmacy, medicinal products in the PDO category can be obtained
only from a pharmacy or chemist, while medicinal products in the GS
category can be obtained from other outlets as well. The last
category means these medicinal products are available not only from
pharmacists and chemists, but also via sales channels such as super
markets or service stations.
Medicinal product factors and user factors
There are two aspects important for good categorization:
- based on medicinal product properties, or medicinal product
factors
- characteristics of (individual) users or patients, also
referred to as user or patient factors.
These two aspects are closely related and cannot always be
distinguished clearly.
Medicinal product factors are inherent risks of the medicinal
product's active substance. Patient factors relate to the risks
caused or affected by use of a medicinal product (as well as
patient behaviour).
In determining legal status of supply, medicinal product
factors are weighed more heavily. The number of units per pack
and dosage will contribute to the MEB decision on which category
the medicinal product in question will fall under. Medicinal
products in the PH category may be dosed relatively higher and be
available in larger units per pack, while medicine in the GS
category will be relatively lower dosed and contain fewer doses per
pack.
In determining legal status of supply, user factors are
also considered. The packaging and information leaflet for
medicinal products in the PDO category and in particular the GS
category will have to, insofar as applicable, contain warnings for
certain high-risk situations, including warnings for specific
groups of users, in order to promote good and safe use of the
medicinal product.
Potential risks relating to use by the patient (user or patient
factors) are:
- off-label use
- addiction/dependence
- development of resistance to the medicinal product
- interactions
- relatively serious undesirable effects
If relevant, medicinal products with GS or PDO legal status of
supply will list potentially high-risk situations in which users
are advised to seek guidance from a doctor or pharmacist first.
Potential high-risk situations may develop in case of:
- serious organ dysfunction (kidney/liver)
- having other disease "co-morbidity" (e.g. diabetes,
cardiovascular disease, depressive disorders)
- the use of other medicines "co-medication" (e.g. coumarins or
other medicinal products with a narrow therapeutic range, such as
digoxin)
- masking conditions that require other treatment, e.g. the use
of analgesics while antibiotic or surgical treatment is
required.
- Specific patient groups:
-
- Children up to a certain age
- Pregnant women (or women who wish to become pregnant)
- Lactation (breastfeeding)
- Elderly over a certain age
- An elevated risk of certain (serious) undesirable effects due
to the patient's abnormal genetic predisposition (e.g. deficiency
in a specific protein or enzyme)
- long-term treatment, as over-the-counter medicines are
generally intended for short-term treatment
5 years later: a look back at the new legislation
When the Medicines Act was enacted in 2007, the MEB was given
the legal task of reclassifying the existing group of
over-the-counter medicines in a responsible manner. The law did not
provide for a transitional phase. Upon shifting to the new legal
framework, medicinal products with OTC status were temporarily
classified as PDO from 1 July 2007, as NP medicinal products were
previously only available from pharmacies and chemists. The
categorization process was intensive, as in addition to the legal
criteria, other risk minimization principles had to be taken into
account (including pack size, dosage, properties of the active
substance, intended treatment duration and method of use). During
this process, various rounds of consultation, objections and
(legal) appeals from various involved parties (industry, chemists,
pharmacists) resulted in the categorization process and rationale
for decisions being assessed and, where required, adjusted and
fine-tuned. The MEB values contributions of the parties involved in
this phase of looking for the best approach to determining legal
status of supply for over-the-counter medicinal products.
This intensive process is now almost complete, and the MEB has
developed a considered system for determining legal status of
supply. Until October 2011, there were still over-the-counter
medicines classified based on the changes to the Medicines Act in
July 2007. This process is now almost complete, although a few
procedures are in their final stages. Parties involved are aware of
this. The MEB shall not initiate any new procedures for changing
legal status of supply in response to the changes to the Medicines
Act in 2007. However, legal status of supply for medicinal products
is not static; new data continue to be collected on use and safety
for existing medicinal products, and it may be necessary to
re-evaluate and if required change legal status of supply based on
new data or scientific findings. The MEB will continue to monitor
over-the-counter medicines. Additionally, a marketing authorization
holder may also request a different legal status of supply based on
available data. The MEB will evaluate such an application and issue
a new judgement on legal status of supply.
In order to ensure transparent, careful and supported
decision-making, the MEB involves stakeholders (marketing
authorization holders, professionals and umbrella organization) in
the decision-making process where possible and necessary.