Politics of Essential Drugs
Wasim Ahmed & Mohammad Iqbal
Editorial
Politics of Essential Drugs
Wasim Ahmed* Mohammad Iqbal** *Department of Biotechnology, University of Science & Technology Bannu 28100, KPK-Pakistan **Department of Otolaryngology, Head & Neck Surgery, Bannu Medical College Bannu 28100s, KPK-Pakistan
Address of correspondence Wasim Ahmed Department of Biotechnology, University of Science & Technology Bannu 28100, KPK-Pakistan
[email protected]
Essential drugs are demarcated as “The drugs that
April 2015, WHO presented its 19th list of essential
satisfy the priority health care requirements of the
medicines and 5th list of essential medicines for
people,” with the perception being that they are
children. Thirty drugs were added to the adult list
planned to be available at all the times within the
while 16 to the children list. The current list does
jurisdiction of a functioning healthcare system, in
not have a major difference from the old one.
sufficient quantity, in proper dosage formulation,
Some high cost medicines are also included in the
with high quality and at a price acceptable for an
list though the individual and the community cannot
1
Careful selection of a
afford it. Some investigational agents also included
limited range of essential medicines results in a
in the 19th list. They are Daclatasvir and dasabuvir
higher
better
and are used for the treatment of hepatitis C
management and use of medicines and more cost-
infection. Inclusion of such investigational agents
individual and country.
quality
of
care
for
effective use of health resources.
patients, 2
downfalls the rudimentary purpose of essential
The criterion for the selection of an individual drug
medicines list. Moreover, in acute hepatitis C, the
and its dosage form depends on drug stability,
rate of clearance of virus without therapy is 15–
easiness of use and the need for specific treatment
30%. Antiviral therapy is recommended if viremia
facilities. This concept although simple becomes
(documented by HCV RNA testing) persists 12
complex and difficult to implement when preparing
weeks after the initial seroconversion. Protease
a list for some selected country or region. The
inhibitors like simeprevir are indicated for HCV
WHO model list is supposed to be a gold standard
genotype 1 infection and not recommended for
and all countries compare their selection with this
other HCV genotypes. How many centers in the
model list and turn to whenever they feel any
world have facilities to measure HCV RNA levels
indecision during the process of their selection. 3 In
and HCV genotype testing?
Ann. Pak. Inst. Med. Sci. 2015; 11(2): 59-61
59
Politics of Essential Drugs
Wasim Ahmed & Mohammad Iqbal
Some drugs are included in the list for the
This can only happen if the civil society comes
indications that are off-label. The main problem
forward and promote advocacy for the stake
with using a drug for off‑label indications is that
holders.
good
(frequency,
The sequence of events leading to disappearance
quantity, route), duration, etc., is often not easily
of essential drug from the market starts when the
available. Hence, chances for their inappropriate
pharmaceutical manufacturer companies introduce
use are there. In contrast to labeled indications, the
a new “Research Product” with manifold price and
healthcare worker has to only look at the drug
hyperbolic claims. It starts its promotion for the
information sheet to know the dose, route, and
same indication side by side with the old product in
other information, and chances of the drug being
order to maintain the franchise and the good will of
used optimally are high.4 The strengths and
the prescribers. Once the so called new research
dosage forms typically included are those that are
product strengthen its roots, marketing fuel for the
extensively available in many states. In order to
old product is gradually withdrawn, sales are let to
prevent neural tube defects, folic acid 400 mcg was
dwindle and the product eventually dies off.
added to the list for women to take 2 months
According to the stipulation of Drug Act 1976,
before getting pregnant and for up to 2 months
every drug shall be produced in sufficient quantity
information
regarding
dose
This was done even in the
to ensure its regular and adequate supply in the
presence of 1mg and 5mg strengths on the list.
market. Unfortunately, no implementation of this
The inclusion of 400 mcg strength was to bring into
law exists in Pakistan so the “Drug Regulatory
line with nutritional guidelines. This particular
Authority” is unable to ensure the availability of
strength of folic acid is only available in Panama
essential medicines in the country and these are
and Switzerland and not in any other country.
often missing from the pharmacy shelves. If this
WHO seems to be under pressure to include all
shortage has been created by the manufacturers, it
drugs in the latest versions of the several WHO
is deplorable. But, if this is because of government
treatment guidelines into the WHO essential
inaction, urgent redressal should be initiated.
medicine list. The shortage of essential medicines
It has been repeatedly reported that all the drugs in
is another problem which needs to be addressed.
the list of essential medicines is not available in
Concerns are being regularly raised regarding the
many of public health institutions, private hospitals
complete disregard of the health authorities about
and clinics. It cannot be overemphasized that the
the non-availability of a large no of essential drugs
availability of these medicines is ensured and
in the market. There is a large no of such drugs
display of essential medicine’s list in prominent
going off the shelves, perhaps never to be
areas of health facilities.
after they conceived.
5
available unless there is a drastic change in the attitude of the authorities and the manufacturers. Ann. Pak. Inst. Med. Sci. 2015; 11(2): 59-61
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Politics of Essential Drugs
Wasim Ahmed & Mohammad Iqbal
References 1. 2. 3.
WHO | Essential medicines. WHO. Available from: http://www.who.int/ medicines/services/essmedicines_def/en. WHO | World Health Organization. WHO. Available from: http://www.who.int/selection_medicines/en/ WHO | Behind the Essential Medicines List. WHO.
Ann. Pak. Inst. Med. Sci. 2015; 11(2): 59-61
4. 5.
Available from:http://www.who.int/features/2013/essential_medicines_lis t/en/. Grisanti S, Ziemssen F. Bevacizumab: Off‑label use in ophthalmology. Indian J Ophthalmol 2007; 55:417‑20. Cavalli P. Prevention of neural tube defects and proper folate periconceptional supplementation. J Prenat Med 2008; 2:40‑1.
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