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 He is not alone. Shortages of essential drugs, mostly generic
medicines whose patents have long expired, are becoming increasingly
frequent globally, prompting the World Health Organization (WHO) to
suggest minimum prices may be needed to keep some products on the
market.
Drug shortages are due to a variety of factors from manufacturing,
quality and raw material problems to unexpected spikes in demand,
but such upsets are aggravated when there are few suppliers.
"It can be really problematic," said Aubrey.
The rise in shortages has gone hand in hand with a wave of
consolidation among the companies making generic drugs - which range
from global pharmaceutical giants to smaller firms in countries such
as India - reducing the number of manufacturers making individual
product lines.
Downward pressure on generic drug prices is good news for healthcare
systems in the short term, but it may fuel disruption if a supplier
hits production problems. While the lack of a patent means other
suppliers could also make the same drug, they would still need
regulatory approval and that can take years.
The result, according to experts, is a worryingly fragile supply
chain, particularly for injectable medicines such as chemotherapy
treatments and certain antibiotics.
Benzathine penicillin, for example, a vital drug for preventing
transmission of syphilis from mother to child, has been in short
supply for years because of manufacturing problems, inconsistent
demand and a relatively low price.
"Medicines can be too cheap," said Hans Hogerzeil, professor of
global health at Groningen University in the Netherlands and a
former director for essential medicines at the WHO. "For a viable
market model you need at least three and preferably five different
manufacturers."
The idea of minimum prices for certain essential medicines contrasts
sharply to traditional pricing debates about how to reduce the
sky-high cost of new patented drugs for diseases such as cancer and
hepatitis C.
Drug shortages will be discussed as a specific topic for the first
time at this year's WHO World Health Assembly in May, and U.S. and
European regulators told Reuters more needed to be done to address
the problem.
Shortages in the United States hit a peak in 2011 due to
manufacturing outages, yet the American Society of Health-System
Pharmacists still lists 155 products as being in short supply.
The European Association of Hospital Pharmacists says more than four
out of five of its members face regular shortages, while doctors in
Canada have been grappling this year with tight supply of a
widely-used epilepsy drug.
COUNTERFEIT RISK
Shortages in developing countries can go unreported for months or
even years, increasing the risk of counterfeits entering the supply
chain, according to Lisa Hedman, a procurement and supply chains
expert at the WHO.
Hedman was an author on a WHO report released earlier this year
setting out possible ways to tackle the problem.
These include a global notification system for supply problems,
increased collaboration between regulators and potential advanced
purchase commitments for priority drugs, as well as action on
pricing.
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Low-cost generic manufacturing has produced huge benefits in
increasing drug affordability but the report warned: "Too low
prices, however, may drive manufacturers out of the market."
Valerie Jensen, associate director of the U.S. Food and Drug
Administration's drug shortage program, believes global action could
complement national measures, such as a new FDA policy to speed
reviews of generics competing with only one other product.
"We know that internationally this is a problem and we need to think
of ways to address it," she said.
Drug regulators themselves have limited scope for action, since
while they can keep a drug off the market, they cannot require a
company to make a product.
"We need to sweet talk manufacturers to get them to think about best
practices," said Brendan Cuddy, head of manufacturing and quality
compliance at the European Medicines Agency.
Brendan Shaw, assistant director general at the International
Federation of Pharmaceutical Manufacturers and Associations in
Geneva, argues that recognising the need to keep generic drugmakers
financially viable is essential.
"Companies don't like stock-outs either, so it is in everyone's
interest to find a way forward," he said.
In London, medicines buyer Aubrey has now resolved the supply
difficulties he faced over the HIV/AIDS treatment nevirapine, after
one generic supplier eventually fixed its production problems, but
he is still struggling to get supplies of other important drugs.
These include the bladder cancer therapy BCG and even diamorphine,
or heroin, the powerful painkiller sometimes given to end-stage
cancer patients.
As the man holding the purse strings, Aubrey needs to get a good
deal on price but he worries that a couple of hundred medicines in
Britain now have only one supplier.
"We need a balance," he said. "It’s not good news if there is a
shortage and patient care is compromised."
(editing by David Stamp)
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