OTCs - Safety comes first
All medicines, whether they are OTC or prescription only (POM)
products, are subject to the same strict licensing procedures
laid down by the Medicines Act 1968 and EU legislation. These
are enforced by the Medicines Control Agency (MCA) and the Committee
on Safety of Medicines (CSM).
A product can only be sold if it has a marketing authorisation
and this is only issued once a medicine has been evaluated and
proven to meet strict criteria in terms of safety, efficacy and
In considering a product for a move from prescription only (POM)
to pharmacy status (P), the CSM considers the clinical issues
first and then the criteria for legal status, as set out in the
legislation (see criteria for Legal Status).
Evidence of efficacy and safety needs to be demonstrated from
randomised, controlled clinical trials and the CSM also looks
for evidence that the product has been shown to be safe in wider
use as a prescription only medicine.
A risk/benefit consideration is also part of this approval process
and for a medicine to receive approval, any benefits must far
outweigh any associated risks. This includes an assessment of
the consequences of any side effects or misuse of the product.
If the product passes...
Medicines which pass this stringent scrutiny are then granted
an OTC marketing authorisation. This stipulates the ailments and/or
symptoms that can be treated with the medicine, the circumstances
in which the medicine should not be used, how to take it and at
Should the product's manufacturer wish to change any part of
the medicine or its information then they must first have the
marketing authorisation altered by going through the approval
channels of the MCA.
The CSM also considers a product's label and/or information leaflet
to be an integral part of the safety of the medicine, as it acts
as a substitute for medical supervision and protects the consumer
from accidental misuse. The information on the medicine's label
and leaflet is also assessed by the MCA as part of the marketing
The work of the MCA in safeguarding the public does not stop
with the issuing of the marketing authorisation. It continues
to monitor medicines when they are in use, keeping records of
any reported side effects.
Manufacturers also have a legal obligation to report any new
information on the safety profiles of their products to the MCA.
The monitoring of OTCs has been extended to community and hospital
Support for self-medication
Evidence indicates that growing numbers of both GPs and consumers
are in favour of increased self-medication. Positive support by
GPs for self-medication is growing and research shows that more
than half of GPs expect to increase their levels of OTC recommendation
over the next 12 months - the reason most frequently given being
the availability of more products OTC (1).
83% of GPs say they are comfortable about referring patients
to the pharmacist (1), and the Department of Health supports this
by promoting the pharmacist as the first port of call for people
suffering from minor ailments. More than half of consumers (56%)
agree that it is useful to be able to buy some of the stronger
medicines without having to go to the doctor (2).
However, when problems arise with OTC products and the media
pick up the story, the public's confidence in self-medication
is seriously undermined, for example, when the MCA addressed safety
issues relating to the pack sizes of OTC analgesics such as paracetamol
and aspirin, and when they questioned the availability of the
hayfever treatment terfenadine. The proposal in each case was
to restrict access to the products in question, to help avoid
the consequences of inappropriate use by a small number of people,
compared with the millions who use these products safely.
The reality is that many millions of people have used, and still
use, these medicines safely. Even though very few people are at
risk, this can lead to people losing confidence and naturally
questioning the safety of other OTC medicines.
The industry, health professionals, consumer representatives
and the regulatory bodies ail wish to ensure that medicines are
used safely. When there is new information about side effects
and contra-indications, everyone wants to ensure that it is acted
upon. The challenge is to achieve the necessary high level of
consumer safety for the few at risk, while not restricting access
to the product for the many who continue to use it without problems.
More targeted consumer information must be the way forward. Professor
Richard Eiser, of the University of Exeter, maintains that for
people to make sensible decisions about their health they need
to be helped to acquire the necessary knowledge, confidence and
competence to make such decisions more independently (3).
Both GPs and pharmacists have a role to play in helping people
assess the risk of using medicines, and appropriate labelling
information on the medicine also allows the individual to take
steps to ensure his or her own safety.
Every day, people use household products such as flammable liquids,
bleaches and appliances which have safety instructions - people
are expected to take sensible steps to look after themselves.
Is the risk/benefit decision process for medicines really all
- BMRB Everyday Healthcare Study, 1997.
- PMSI poll, commissioned by the PAGB, 1997.
- Bradley C.R. et al, Family Practice 1998; 15: 44-50
Criteria for Legal
Following the requirements of the
Medicines Act 1968, the natural status of a medicine is
Pharmacy only (P). If the product falls into one or more
of the following categories, it will be designated a prescription
only medicine (POM).
- Could present danger, directly
or indirectly, even if used correctly, without medical
- Are frequently used incorrectly
and could present a danger to human health directly or
- Contain substances, the activity
or side effects of which require further investigation
- Are normally given by injection.
- The other issues taken into account
when considering legal status are:
- The presence of narcotic or psychotropic
substances in non-exempt quantities
- The risk of medicinal abuse, possibility
of addiction or illegal misuse
- Novel substances with properties
requiring full investigation
- Where the usage is confined to
hospitals or for conditions diagnosed in hospitals
- Where the use is intended for
outpatients but requires specialist/special supervision.