PHARMACOLOGY

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Name:

AHMAD MURTAZA

Roll no:

70115960

Semester:
6B

Subject:
PHARMACOLOGY
Assignment:

HOW TO TACKLE ANTI BIOTIC RESISTANCE


Submitted to:
DR.AYESHA MUBASHAR
Antibiotic resistance
Antibiotics are medicines used to kill bacteria. Over time, certain groups of these
germs may adapt to these medicines. They may change in such a way that
antibiotics can′t kill them. The term for this is antibiotic resistance.
Bacteria are very small organisms. They can enter your body. Some of them are
harmless and may be helpful. But some of these germs can be harmful. When
these multiply inside your body, they can cause disease.
Before antibiotics, people often got very sick from bacterial infections. With these
medicines, it is now easy to treat many of these infections.
Antibiotic resistance is a serious concern throughout the world. It can lead to
illnesses that are very hard to treat. Standard antibiotics for treating a disease may
no longer work in these cases. Other medicines may also not help. As a result,
resistance to antibiotics is becoming more common.

Causes of antibiotic resistance:


Antibiotic resistance can happen when bacteria are treated with an antibiotic. The
medicine kills most of these germs. But a small group may survive. This might
happen in a number of ways. The germs may:
 Develop an ability to stop the medicine’s effect
 Develop an ability to pump the medicine out of the cell
 Change (mutate) so that the medicine no longer works
When bacteria become resistant, the original antibiotic can no longer kill them.
These germs can grow and spread. They can cause infections that are hard to treat.
Sometimes they can even spread the resistance to other bacteria that they meet.
When you use an antibiotic, there is a risk that some of the bacteria will turn
resistant. Using these medicines when they aren't needed is a major reason why
that is becoming more common. So you should use these medicines only when
needed.
Antibiotic resistance is often linked to a specific germ and antibiotic. For example,
Staphylococcus aureus (or “staph”) is a type of bacteria that can cause illness.
Methicillin-resistant S. aureus (MRSA) is a specific strain of staph bacteria. MRSA
no longer responds to the antibiotic methicillin (and closely related medicines). As
a result, it can cause many infections that are hard to treat.

Risk for antibiotic resistance:


The more people use antibiotics, the more likely that resistance will happen.
Sometimes people use antibiotics when they don’t really need them. For example,
antibiotics don’t work against viruses. Like bacteria, viruses are tiny organisms that
can invade your body and cause infection. A cold or the flu is a type of virus. Taking
an antibiotic in these cases does not treat the disease. It can actually raise the risk
for antibiotic resistance.
Not taking all of an antibiotic also raises the risk. If you stop taking it too early, you
might not kill all the bacteria. The remaining germs may become resistant.
How antibiotic-resistant infections spread
Resistant bacteria spread in the same ways as nonresistant bacteria. Someone
infected with the bacteria (or just carrying it on the skin) might touch an object.
When you touch the same object, the germs can enter your body. Often this is
through a cut on your skin. Some infections can spread in the air when a person
sneezes or coughs. Others can spread through sharing food with an infected
person. Sexual contact is one more way these infections spread.
You can help prevent the spread of all bacterial infections by:
 Always washing hands thoroughly with soap and water
 Not sharing food or beverages with others
 Practicing safe sex
 Using tissues to cover your mouth when coughing or sneezing
 Not touching other people's wounds
 Not sharing personal items such as razors, towels, or brushes
Plain soap is best for washing hands and shared surfaces. Soaps with antibacterial
ingredients don't help stop the spread of infection in a home setting. They may
also contribute to resistance.

Symptoms of an antibiotic-resistant infection:


Infections from these bacteria can affect almost every system of the body. They
can cause many symptoms. But symptoms alone can’t tell you if an infection is
from germs that are resistant to antibiotics.
How are antibiotic-resistant infections diagnosed?
Your healthcare provider may take a sample of your infected tissue and send it to a
lab. There, the type of infection can be figured out. Tests can also show which
antibiotics will kill the germs. You may have an antibiotic-resistant infection if you
don’t get better after treatment with standard antibiotics.

Antibiotic-resistant infections treated:


Treatment for these infections can vary. Your healthcare provider may have
another antibiotic that can fight the infection. But it might have certain drawbacks.
It may have more side effects or a risk of promoting more resistance. In a few
cases, your provider might not have another option. In this case, you will get
supportive care.
What can I do to prevent antibiotic resistance?
The best way to prevent antibiotic resistance is to use antibiotics correctly. Take
them only when needed. Here are some of the ways you can help:
 Don’t take an antibiotic for a virus.
 Don’t save an antibiotic for the next time you get sick.
 Take antibiotics exactly as prescribed. Don’t skip doses. Complete your full
course of treatment even if you are feeling better.
 Never take an antibiotic prescribed for someone else.
Healthcare providers can also help by:
 Only prescribing antibiotics that are needed
 Targeting the medicine as soon as possible to the specific bacteria involved
 Prescribing medicines for only as long as needed
Other public health measures can also help lower resistance. That includes cutting
the use of antibiotics in livestock.
Healthcare providers also need to take steps to stop the spread of these infections.
These bacteria are very common in healthcare settings. They should always
maintain good hygiene. They should also always use methods that control infection

WAYS TO DEAL ANTI BIOTIC RESISTANCE:

1. Reduce clinical trial risk and uncertainty.

The U.S. Food and Drug Administration (FDA) can significantly reduce the risk and
uncertainty that discourages drug developers from pursuing new antibiotics by
applying their unique access to data. A large hurdle in the approval of new
antibiotics is the determination of just how great the clinical effect must be. The
availability of robust and uniform historical controls to measure treatment effects
against would greatly increase the feasibility of completing trial enrollment and
remove some of the uncertainty that drug developers face in establishing
endpoints. The FDA has accumulated numerous and varied data sets on clinical
outcomes of infections under different treatment scenarios, including those with
pharmacometric data. These data are available to drug developers only in
fragmented, often proprietary records. The FDA should make these data useful to
current drug development efforts by conducting and publishing a meta-analysis
deriving historical control outcomes of different infections and under different
conditions.

The FDA should continue to build on the progress it has made in the last few years
toward using this analysis to establish clear, feasible, and uniform expectations of
clinical effectiveness across the field of antibiotic indications. While likely to be
imperfect, definition provided by a wide-reaching base of historical control data
would have three important benefits. It would significantly reduce the uncertainty
antibiotic developers face in trying to establish primary outcome expectations in
clinical trials to meet regulatory acceptance. It will also increase the feasibility of
completing trial enrollment. Acceptable historical controls will allow direction of all
enrollable patients to investigational therapy. In the many cases of studies reliant
on a limited enrollable population, this could make the difference between a study
being feasible or not.

2. Boost market value for not feeding animals antibiotics.

The U.S. Department of Agriculture (USDA) can catalyze market forces that will
reduce the prolific agricultural use of antibiotics. The USDA has instituted
certification of consumer products to set standards specific to industry practices
and enable these to be recognized by consumers. Certifications such as “USDA
Prime” for beef products (4) and “Organic” and “Biobased” on a wide range of
commodities (5, 6) have as a side effect created labels with market value. The
USDA should exercise this certification authority and create a “No Feed-
Antibiotics” label to provide consumers with the same ability to discriminate food
products that have been produced without growth-promoting antibiotics.
Antibiotic use in agriculture is recognized as a contributor to increasing antibiotic
resistance (7). Public awareness of this problem is sufficient to strengthen market
incentives against the still prolific use of antibiotics in agriculture when combined
with a widely recognized certification. This, and the next proposed action, will have
incremental effects in reducing antibiotic use for animal growth promotion—the
next best alternative to a ban such as Europe's, which has been unachievable in
the U.S.

3. Strengthen regulation of farm feeding of antibiotics.

The U.S. Environmental Protection Agency (EPA) can require manufacturers of


antibiotics for agricultural use to generate data on the public health and
environmental consequences of this use and can set limits on antibiotic use based
on these data. The EPA has a long history of exercising its authority under the
Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) (8) to regulate residues
from antimicrobial fungicides that accumulate in agricultural products and are
released into the environment from farming. FIFRA requires pesticide
manufacturers to register their products with the EPA before they can be
marketed for agricultural use. The EPA should explore requiring FIFRA registration
of antibiotics used in food animal production. The data requirements for
registration will help to focus and support the restricted use that is important for
deterring selection of antibiotic resistance in the food supply, as well as in the
environment due to farm antibiotic effluents. Registration under FIFRA requires
the generation of data on concerns such as “environmental fate” and dietary and
nondietary hazards to humans. Furthermore, registrations granted under FIFRA
stipulate the limitations and conditions under which registered chemicals can
legally be used.

The prevailing opinion in the scientific community is that antibiotic use in


agriculture contributes to the appearance of resistance in clinical settings and that
antibiotic use for animal growth promotion is an unacceptable squandering of the
finite lifespan of antibiotic efficacy. A large body of citations gathered by the Pew
Campaign on Human Health and Industrial Farming (9) forms a hefty indictment of
this kind of antibiotic use, although many of the references are either case reports
or reviews/committee reports. Recent research reveals associations between
resistance in agricultural, environmental, and community settings (10) and even
indicates movement of antibiotic resistance through the food supply into the
community (11, 12). At the same time, there are new data on Salmonella indicating
that distinct populations of antibiotic-resistant bacteria can exist largely
segregated in human and farm animal populations (13).

In December 2013, the FDA released Guidance for Industry number 213, which
seems unlikely to reduce the impact of using antibiotics as growth promoters in
farm animal production on the development of resistance. Although almost all of
the producers of antibiotics affected by the guidance signaled their intent to
request withdrawal of their approvals for feed use (14), many withdrawal requests
are stated to be because the, “products are no longer manufactured or marketed”
(15). The guidance focuses on eliminating the growth-promoting use of just
“medically important” antibiotics (16). This does not appear to be removing
antibiotics from use that are currently marketed and used for animal growth
promotion. Further, it will not close the gate on collateral selection for resistance
against medically important antibiotics, when genetically linked resistance
elements to other antibiotics remain under selection.

4. Unify U.S. government efforts.


The president of the United States can require coordination of efforts by the
various federal agencies that have a role in combatting antibiotic resistance. An
ongoing U.S. government working group, the Interagency Taskforce for
Antimicrobial Resistance (ITFAR), has been working to communicate federal efforts
related to combatting antibiotic resistance (18). The ITFAR has to date succeeded
in sharing information among various agencies from the U.S. Department of Health
and Human Services (CDC, FDA, National Institutes of Health [NIH], the Centers for
Medicare and Medicaid Services, the Biomedical Advanced Research and
Development Authority, and others), the U.S. Departments of Agriculture, Defense,
and Veterans Affairs, and the EPA. The ITFAR should be given more authority so
that it not only provides participating agencies and the public visibility into what
different agencies are doing to combat antibiotic resistance but also can require
agencies to make commitments as to future actions and prioritization of activities
to combat antibiotic resistance. As is clear from the work of this and many other
multi-agency task forces, the individual agencies will not move from contributing
to a discussion to complying with direction until there is an executive order. The
President of the United States should empower ITFAR to harmonize and focus U.S.
federal agencies' efforts at combatting antibiotic resistance.
5. Incentivize early sharing of data.
Publishers of peer-reviewed scientific journals can remove disincentives to sharing
information prior to publication when there are public health threats such as
emerging antibiotic resistance. Typically, researchers closely guard data about new
discoveries until they amass enough data and analysis for publication. In the case
of the infamous NDM-1 antibiotic resistance gene, almost a year intervened
between its discovery and the knowledge of its existence being made public (19).
In the intervening time, the tools for detecting and controlling its spread remained
undeveloped while it crept across various continents. Journal editors need to
exercise their authority over the publication process and incentivize the early
release of data that are critical to public health efforts like understanding and
containing antibiotic resistance. Part of the delay in the release of information
results from the publication process itself—in the case of NDM-1, the original
article was submitted in June 2009 and only published in December 2009. Rapid
publication and open online access are existing mechanisms for accelerating the
dissemination of information, but these may be insufficient to overcome long
review times and the insistence of journal editors that information in manuscripts
that have not completed peer review be left uncommunicated ahead of
publication. While other interests such as intellectual property also compete with
rapid sharing of data, protecting the currency of publication for authors who share
early should have a positive impact.
Journals could improve the situation by establishing policies providing for
expedited review of appropriate submissions or allowing prereview publication
based on a preliminary review by appropriate editors. After publication of a
prereview article, priority could then be given to bringing forward a more polished
version as a final publication. The disclosure of the data for the benefit of public
health prior to it appearing in a polished manuscript would no longer be penalized
with diminished chances of publication or risk of others racing ahead with a
preemptive publication analyzing the disclosed data.

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