[e-drug] Substandard drugs

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E-drug: Substandard drugs
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[Copied as fair use. KM]

Lancet; 358(9291): 1463 (27 October 2001)

Substandard drugs

Sir--R B Taylor and colleagues' (June 16, p 1933)1 and Paul
Newton and colleagues' (June 16, p 1948)2 reports highlight the
issue of substandard drugs in less-developed countries.

Most studies on the quality of medicines have focused on drug
content and on the amount of impurities. However, contamination
of drugs by bacteria and fungi is also a hazard of medicines
manufactured under suboptimum conditions. Although seemingly
uncommon, contaminated medication can have serious
consequences and deserves more attention.

In July, 1999, an outbreak of postoperative eye infections occurred
at our national eye hospital because of intrinsically contaminated
gentamicin eye drops imported from an obscure company. Over a
1-month period, four patients presented to the eye hospital with a
hypopyon about a week after cataract surgery. Samples from the
eyes of three patients grew gentamicin-resistant Pseudomonas
aeruginosa. Investigation showed gentamicin eye drops to be
contaminated. P aeruginosa with an antibiogram identical to isolates
from the patients was cultured from five of six unopened vials
tested. Other bacteria of lesser virulence such as Acinetobacter sp
and Stenotrophomonas maltophilia were also found in some vials.
No organism was isolated from indometacin eye drops imported
from the same manufacturer. After the gentamicin eye drops were
removed from the hospital, no further case of P aeruginosa
postoperative infection occurred.

Substandard antibiotics can worsen the global problem of
antimicrobial resistance. As Taylor and colleagues state, antibiotics
in subtherapeutic concentrations can readily select drug-resistant
mutants. Moreover, substandard narrow-spectrum antibiotics may
create the wrong impression that the antibacterial agents
themselves are ineffective and, thus, lead prescribers to
unnecessarily opt for newer broad-spectrum antibiotics that have
not yet been copied by unscrupulous manufacturers as their
first-line treatment for many infections.

I agree with Alain Li Wan Po, in his June 16 commentary,3 that
governments which do not take action against rogue manufacturers
harm their own reputations. They also help to create an unjustified
perception that all products from their countries are likely to be
substandard.

M I Issack
Central Health Laboratory, Victoria Hospital, Candos, Mauritius
(e-mail:missack@intnet.mu)

1. Taylor RB, Shakoor O, Behrens RH, et al. Pharmacopoeial quality
of drugs supplied by Nigerian pharmacies. Lancet 2001; 357:
1933-36.

2. Newton P, Proux S, Green M, et al. Fake artesunate in southeast
Asia. Lancet 2001; 357: 1948-50.

3. Po LWA. Too much, too little, or none at all: dealing with
substandard and fake drugs. Lancet 2001; 357: 1904.


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