7 November 2018

Antibiotic Policy



Emergence of antibiotic resistance in pathogens is a global threat to human health and a matter of grave public health concern. Resistance of micro-organisms towards an antibiotic renders it ineffective in curing any disease caused by those organisms. Some micro-organisms develops resistance to a wide range of antibiotics including even to newer and more potent antibiotics such as Carbapenems, making treatment of patient difficult, costly and sometimes impossible.  Due to this antibiotic resistant micro-organisms leads to increased mortality, morbidity and healthcare costs.  
A major reason of emergence of antibiotic resistant strains of micro-organism is indiscriminate and irrational use of antibiotics. It is estimated 50% of antibiotic usage in Indian hospitals are inappropriate and irrational. Hence, there is an urgent need that hospitals formulate and implement appropriate Antibiotic Policy that ensures rational use of antibiotics and prevent any indiscriminate use.  This post describes how should be a hospital’s Antibiotic Policy and what should it contain.

Antibiotic Policy serves as a guideline for doctors to decide which antibiotic shall be used for treating a specific infectious condition. It also states practices that must be followed while using Antibiotics on patients. The antibiotic policy must ideally be developed collaboratively. Pharmacotherapeutic committee or the Infection control committee can take a lead role in formulation of this policy, with inputs from all clinical departments.

An antibiotic policy must include following sections


POLICY FOR PRESUMPTIVE VS. DEFINITIVE APPROACH IN ANTIBIOTIC THERAPY 

When an antibiotic therapy is used based on clinical diagnosis of an infection and on educated experience of probable pathogen that might be causing the infection, it is called as presumptive antibiotic therapy. Against this, using antibiotic therapy when infection is confirmed by micro-biological test and identifying the micro-organism causing the infection either by isolating it in the lab or by other direct evidence, is called as definitive antibiotic therapy.

The antibiotic policy must state definitive antibiotic therapy as a preferred approach for treating infections. The presumptive therapy can be started based on patient’s condition and urgency of the situation and should be replaced by appropriate antibiotic as soon as definitive results are available. For example, patients in septic shock or bacterial meningitis, presumptive therapy can be initiated immediately after or concurrently with collection of diagnosis specimen. In conditions where patient is stable, presumptive therapy should be deliberately delayed till the time appropriate sample has been collected and sent to microbiology.

Before starting of presumptive therapy, following things must be ensured
      ·         Standard investigations for all suspected infections have been sent for
      ·         Antibiotic shall be started only after appropriate samples has been sent for culture
      ·         Antibiotic Sensitivity profile of the organism isolated must be taken into consideration for  continuation or change of antibiotic being used for therapy
      ·         Antibiotic therapy must be reviewed daily and adjustments shall be made accordingly, especially after culture reports are available.

RECOMMENDED ANTIBIOTICS FOR PRESUMPTIVE THERAPY

A large and important section of the Antibiotic Policy constitutes of a table that recommends first line and second line antibiotics to be used for specific conditions on a presumptive basis. The table must have following columns. Few examples (Referred from ‘National Treatment Guidelines for Antimicrobial use’, Version 1, 2016), is stated for a better understanding. Hospitals should make their own policy based on specialities they offer and type of microbes in their local area.
Condition
Likely Causative Organism
Presumptive antibiotic – First line
Presumptive antibiotic – second line
Comments
Central Nervous System Infections
Acute bacterial meningitis
S. pneumoniae, H.influenzae, Neisseria meningititidis
Ceftriaxone 2 g IV 12 hourly/ Cefotaxime 2 g IV 4-6 hourly

10-14 days treatment
Chloramphenicol if patient is allergic to penicillin
Antibiotics should be started as soon as the possibility of bacterial meningitis becomes evident, ideally within 30 minutes. Do not wait for CT scan or LP results
Brain abscess, Subdural empyema
Streptococci, Bacteroides, Enterobacteria-ceae, S.aureus
Ceftriaxone 2 gm IV 12hourly or Cefotaxime 2 gm IV 4-6hourly
AND
Metronidazole 1 gm IV 12 hourly

Duration of treatment to be decided by clinical & radiological response, minimum two months required.
Meropenem 2gm IV 8hourly
Exclude TB, Nocardia, Aspergillus, Mucor
Cardio-Vascular System Infections
Infective Endocarditis
Viridans Streptococci, other Streptococci, Enterococci
Penicillin G 20MU IV divided doses, 4 hourly
or
Ampicillin 2 gm iv 4h AND Gentamicin 1mg/kg im or iv 8h

Duration: 4-6 weeks
Daptomycin 6 mg/kg IV once a day

Duration: 4-6 weeks
If patient is stable, ideally wait for blood cultures.

Guidance from Infectious disease specialist or clinical microbiologist is recommended
Skin and Soft Tissue Infections
Cellulitis
Streptococcus pyogenes (common), S.aureus
Amoxicillin Clavulanate 1.2 gm IV TDS/625 mg oral TDS
or
Ceftriaxone 2 gm IV OD
Clindamycin 600-900 mg IV TD
Treat for 5-7 days.
Furunculosis
S.aureus
Amoxicillin Clavulanate 1.2 gm IV/Oral 625 TDS or
Ceftriaxone 2 gm IV OD

 Duration – 5-7 days
Clindamycin 600-900mg IV TDS
Get pus cultures before starting antibiotics


ANTIBIOTIC PRESCRIBING:

The antibiotic policy should also recommend good practices of prescribing antibiotics. These include
      1.       Before prescribing antibiotics appropriate investigations for all suspected infections shall be ordered for
      2.       All efforts shall be made to send micro-biological samples before initiating anti-biotic therapy.       The choice of antibiotic for presumptive therapy should be based on the recommended antibiotics in this policy or based on rapid tests , such as Gram stain
      3.       Differentiation shall be made between contamination, colonization and infection in a patient to prevent inappropriate use of antibiotic.
      4.       Antibiotic should not be prescribed as a habit or for just in case infection is present. It should always be based on reasonable clinical evidence of infection.
      5.       Choice of antibiotic: Antibiotic should be selected based upon antibiotic susceptibility of causative organism. Antibiotic susceptibility is a report provided by microbiology which states percentage of microorganism that can be killed by a specific antibiotic. Higher the susceptibility, better will be the antibiotic in treating the infection. Other points that should be considered while choosing an antibiotic are
      6.       Review of antibiotic therapy – A daily review of to assess the need of antibiotic therapy being given must be done. For most infections 5-7 days of antibiotic therapy should be sufficient. Simple UTI can be treated in 3 days of antibiotics
      7.       Presumptive therapy should start with a broad spectrum antibiotic. Once culture reports are available, the doctor should step it down to narrowest spectrum, most efficacious and most cost effective option.

RESERVE ANTIBIOTICS:

Selected few newer and more potent antibiotics shall be kept as reserve antibiotics and the antibiotic policy shall put restrictions on using them. The reserve antibiotics shall be made available after recommendation from Microbiology department as per the culture report. The antibiotics are kept reserve to maintain their efficacy in treating difficult infections. Pharmacy shall be instructed to ascertain indications before issuing reserve antibiotic to ward, and if indications are not met prescriber should be requested to consult the Infection Control In-charge or the Microbiology In-charge.
For example, Carbapenem and Linezolid, if kept as researve antibiotic shall be used only if following criteria are fulfilled
      1.       Severe sepsis as defined by more than one organ failure of new onset
      2.       Clinical failure of other classes of antibiotics over 48 hours
      3.       Underlying severe immuno-suppression – Neutropeniea, immuno-suppressive therapy, Diabetic Ketoacidosis (DKA) etc
      4.       The organism is susceptible to only Carbapenems / Linezolid, as per culture report

 
DRUG HYPERSENSITIVITY

The antibiotic policy must state measures to prevent adverse drug reactions. History of drug allergy should be taken from the patient before initiating any antibiotic therapy. Responsibility should be clearly assigned on who should ensure to get information of drug allergy.
If patients are unable to give an allergy history, the doctor caring in the patient should take reasonable steps to contact someone who can provide a reliable allergy history.

ALERT ANTIBIOTICS

Certain antibiotics are prone to be prescribed irrationally or as a routine by doctors. They generally include ciprofloxacin, ceftazidime, cefotaxime, ceftriaxone, vancomycin (or teicoplanin), imipenem, levofloxacin, meropenem and moxifloxacin. Collectively, these are among the drugs most frequently prescribed irrationally which is largely responsible for the current escalation of antibiotic costs. They also account for a significant proportion of serious antibiotic toxicity including Clostridium difficile diarrhoea and CNS toxicity/seizures as well as the emergence of major antimicrobial resistance. Safer, cheaper and equally effective alternatives are often available which allow such agents to be kept in reserve for occasions when there are clear cut microbiological indications.

Antibiotic Policy must therefore list out such antibiotics as ‘Alert antibiotics’ and ensure that they are prescribed only on the recommendation of senior medical doctor or after discussion with the Clinical Microbiologist or Infection Control In-charge.