Transcript Generic SIGN Presentation

Could the WHO Model List of Essential
Medicines do more for the Rational and Safe
Use of Injections?
Logez S, Hutin Y, Holloway K, Robin G, Hogerzeil H
Abstract
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Problem Statement: A national drug policy addressing the rational and safe use of injections is an
important element in preventing overuse and unsafe use of injections. Over the past 25 years the WHO
model list of essential medicines has led to a global acceptance of the concept of essential medicines as
one crucial element to ensure access and rational use of medicines. Because the model list is a keystone
of national drug policies, we examined the way it addresses injection practices.
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Objectives: To examine opportunities to build the safe and rational use of injections into national drug
policies, we reviewed the eleventh model list to describe the injectable medicines that it includes and to
examine how it addresses the issue of safe and rational use of injectable medicines.
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Design: Descriptive analysis through the development of a database of all injectable medicines included
in the model list. We reviewed the injectable medicines included in the eleventh WHO model list of
essential medicines (revised December 1999) to identify how the model list may better promote injection
safety and more rational use of injections. We presented the results to the 2002 WHO Expert Committee
for the selection and use of essential medicines.
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Outcome Measures: Proportion of injectable medicines and their characteristics in the model list;
proportion of injectables that need diluents; estimated needs of syringes for injectable medicines;
estimated price for injectable medicines on the model list.
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Results: Of 306 active ingredients on the list, 135 (44%) are listed as injectable medicines in 173
instances. Of these, 41 (30%) need diluents for reconstitution. The results of the analysis suggests that
the model list could address more clearly the need to use injections safely and rationally. First, it includes
many injectable medicines, some of which may not be justified. Second, there is no clear mention that of
the injectable medicines that need to be reconstituted, single-dose diluent vials are needed. Finally, the
model list makes no clear reference of the need to procure safe injection devices and safety boxes to
administer injectable medications safely.
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Conclusions: The main results were presented to the Expert Committee in 2002, which agreed to
recommend that a review of all injectables on the model list be carried out. The aim of such a revision
would be to reduce the number of injectable formulations on the basis of evidence. This is now in
process. In addition, the committee recommended that when injectable mediations are being supplied,
the necessary injectable devices should also be supplied.
Background
• 16 thousand million injections are administered
in developing and transitional countries each
year, 90% of these for curative purpose.
• Worldwide, unsafe injections may account for:
– 30% of new HBV infections
– 41% of new HCV infections
– 5% of new HIV infections
• Most medications used in primary care can be
administered orally
• WHO Model List of essential medicines is one
crucial element to ensure medicines access and
rational use of medicines.
• In 1999, 156 (81%) WHO Member States had
a national list of essential medicines.
Study Aims
• Examine opportunities to build the
safe and rational use of injections
into national medicine policies
• Describe the injectable medicines
included in the WHO 11th model list
of essential medicines
• Examine how the model list
addresses the issue of safe and
rational use of injectable medicines.
Methods
• Construction a database of injectable
medicines included in the WHO 11th
model list:
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–
–
–
–
type of essential medicines
therapeutic section
joint presence of an equivalent oral form
indicated dosage forms and strengths
presentation and the diluent requirement
• Inclusion of information on:
– documented routes of administration
– expected size of syringes needed
– median price per unit of the injectable medicine
Results
• WHO model list includes 306 active ingredients
• 135 (44%) active ingredients are in injectable
form. Of these :
– 29 (21%) come in various dosages and volumes for
a total of 171 injectable formulations;
– 46 (34%) contain active ingredients also included as
an oral form;
– 41 (30%) are mentioned as a powder for injection
that needs to be reconstituted with a diluent.
• The list includes 7 (5%) active ingredients
present in multi-dose vial presentation
(including anaesthetics)
Characteristics of Injectable Medicines
of the Model List (ML)
Number
%
135
44%
“Essential”
116
86%
“Complementary”
14
10%
“Reserved”
5
4%
With oral form in the ML
46
34%
Diluents required
41
30%
Solely IM-formulation
24
18%
Solely IV-formulation
63
46%
Both IM- and IV-formulation
49
36%
SC-formulation
14
10.3%
Solely spinal formulation
3
2.2%
Injectables on the ML
Characteristics of Injectable Medicines
on the Model List
Model List
Others
Injectables
10%
44% Injectables
Complementary
86% Essential
4% Reserved
Injectables with oral equivalent on model list
34%
Injectables which require diluents
30%
Estimated Needs of Syringes
for Injectable Medicines
• No mention of the need to procure diluents,
single use injection devices and safety boxes to
administer injectable medicines safely
• Of the 97 formulations with indication of the
volume:
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–
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7% would require 1 ml syringes,
51% would require 2 ml syringes,
19% would require 5 ml syringes,
11% would require 10 ml syringes,
4% would require 20 ml syringes,
8% would require a perfusion placement set
• Impossible to estimate the type of syringes
needed for 74 (43%) of the 171 formulations.
• 8 formulations are only available as multi-dose
vials in the different price indicator guides
Estimated Price for Injectable Medicines on
WHO Model List
• For 104 (61%) formulations, the median
price was US$ 0.5 (Mean: US$ 2.8, range US$
0.023 - 27.5)
• A median international price could not be
estimated for 67 (39%) because:
– size or volume indicated was not
available in the price indicator guides
(n=4, 2%),
– dosage indicated was not available (n=7,
4%)
– formulations were not listed in the price
indicators of the main international lowcost procurement agencies (n=56, 33%).
Discussion
The model list could address more
clearly the need to use injections
safely and appropriately.
• Many injectable medicines are included, some of
which may not be justified
• No mention that single-dose diluent vials were
needed for injectable medicines that need to be
reconstituted
• Some injectable medicines are solely available in
the international market as multi-dose vials
Discussion
• No clear reference of the need to procure single use
injection devices and safety boxes to administer
injectable medications safely
• Insufficient information regarding the volume of vials
which made the forecasting of single use injection
devices needs more difficult.
Recommendations
• High number of injectables on the model list:
– re-examine, based on evidence, if 86% of
injectables are “essential”
• Evidence should be generated of which injectable
medicines could be replaced by an oral alternative
• List should state where diluents are required
• Volume of injectable vials and size of syringes should
be specified
• Inclusion of multi-dose vials should be discouraged
• Need for matching supplies of sterile injection devices
and sharps boxes should be stated