Introduction - Uppsala Monitoring Centre

John Abraham and Helen Lawton Smith, Palgrave Macmillan.
2. Countries needs and capabilities. Inevitably new drugs are more expensive than
the alternatives, the knowledge of the safety of a drug improves, usually, with the
passage of time, the medical problems vary from country to country, the
experience and expertise of the regulatory authorities varies greatly between
countries, the degree of corruption also varies between countries.
3. Country idiosyncrasies. It is not known why Japan was specifically hit by SMON.
The annual rate/per million/years for agranulocytosis 2.9 in Ulm Germany; 1.6 in
Israel and 0.6 in Budapest Hungary (IAAAS, 1986) and the reason for this
difference is not known.
Countries that were the first to take regulatory action
France and the USA were the first on 10 occasions, Japan on 8 occasions, Canada
on 7 occasions, Germany on 6 occasions, the UK, Norway and Italy on 3 occasions
and Denmark and Turkey on 2 occasions. Those which were only first on one
occasion were: Australia, Austria, Brazil, Cuba, Domenica, Egypt, Finland,
Hongkong, Malaysia, Panama, Singapore, Spain, Sweden and Yemen. Possibly
those that were the first on only one occasion were those authorities that had a
single enthusiastic expert.
Availability in some countries after withdrawal in others.
There are several reasons why a drug might remain in some countries despite
withdrawal in other countries:
1. The ADR frequency may be different, e.g. SMON in Japan.
2. A poor country may allow a cheap, but toxic drug, to remain if the alternatives
are too expensive for the bulk of the population, i.e. different countries will
have different ‘toxic thresholds’.
3. Pharmaceutical company pressure
4. Patients may be unaware of the adverse effect of drugs because of
differences in labelling.
5. ‘Analysis of the pharmaceutical section indicates that a country’s capacity to
restrict dangerous drugs depends heavily on its wealth, as illustrated by the
strong correlation of restrictions with per capita gross national product (r =
0.65, n = 162, P < 0.001).’ (Menkes, 1997).
6. ‘Poor countries with notable restrictions (including Bangladesh and Ethiopia)
lack administrative machinery to police them.’ (Menkes, 1997).
Delay
The time between the first report of an ADR and the drug’s removal from the market
varies with the type of ADR. Type ‘A’ ADRs tend to be common and dose-related
and therefore likely to be discovered during clinical trials or shortly after marketing.
On the other hand type ’B’ ADRs are rare and, therefore, unlikely to be discovered