The P of the EL is to C and not to C

�Definition and Objectives

�Evidence and countries where it is being given

�Delivery Models

�Ideal Infections

�Key elements

�Antimicrobials Administered

�Risks and Safeguards

�Areas of Controversy

�Barriers for Implementation and Suggestions

�Summary and References

Outline of My Presentation

� a.k.a

>outpatient and home parenteral antimicrobial therapy (OHPAT),

> hospital in the home therapy (HITH)

> community-based parenteral anti-infective therapy (Co-PAT).

�OPAT is out patient administration of antimicrobial therapy (through intravenous route) to patients in an outpatient setting or in their own home.

�IDSA defines it as the provision of parenteral antimicrobial therapy in at least 2 doses on different days without intervening hospitalization

1• To reduce healthcare-acquired infections and length of stay (LOS) in hospitals.

2

• OPAT would offer patients a treatment programme that is equally effective and safe, compared with inpatient treatment, while reducing inpatient costs, and optimizing usage of resources, particularly in resource limited healthcare setting.

3• OPAT is offered to patients , depending on the severity of the disease, the patient’s own

willingness and the availability of a support system to implement the programme.

�First described in 1974 by Rucker and Harrison for the treatment of cystic fibrosis.

� OPAT has expanded substantially and is now a standard practice in many countries.

� Infusion centres -dominant model in the US

�Australia - “hospital in the home” visiting nurse model.

� Some individual OPAT services offer all three models,allowing treatment to be tailored to each patient’s circumstances.

� Means of reducing healthcare-acquired infection.1. The implementation of an OPAT programme in a Canadian

teaching hospital resulted in an estimated cost saving of C$1 730 520 over a

3 year period.

2. The well-established OPAT programme in Oxford, UK, saved over 6200 bed days in one calendar year.

Matthews PC, Conlon CP, Berendt AR et al. Outpatient parenteral antimicrobial therapy (OPAT): is it safe for selected patients to selfadminister at home? A retrospective analysis of a large cohort over 13 years. J Antimicrob Chemother 2007; 60: 356–62.

3. The mean cost of care per episode of infection for OPAT was £1749, compared with £11 400 for inpatient treatment in a retrospective analysis of 55 episodes of bone and joint infections in the UK.

Nathwani D, Barlow GD, Ajdukiewicz K et al. Cost-minimization analysis and audit of antibiotic management of bone and joint infections with ambulatory teicoplanin, in-patient care or outpatient oral linezolid therapy. J Antimicrob Chemother 2003; 51: 391–6.

4. In addition, a study in France reported that treatment of 39 osteomyelitispatients with OPAT resulted in a potential cost saving of US$1 873 885, compared with conventional therapy.

L. Bernard. Outpatient parenteral antimicrobial therapy (OPAT) for the treatment of osteomyelitis: Evaluation of efficacy, tolerance and cost. Journal of Clinical Pharmacy and Therapeutics 26(6):445-51 · January 2002.

� Other more subjective benefits of OPAT, such as patient satisfaction and quality of life, are difficult to quantify directly;� Patient at home in family environment� Continued attendance at work or school� Decreased risk of nosocomial infections� Reduced healthcare costs

� One retrospective study from a UK service compared the actual costs of OPAT over two years with the theoretical costs of inpatient care for the same patient cohort and found that OPAT cost 47% of equivalent inpatient national average costs.

Chapman ALN, Dixon S, Andrews D, Lillie PJ, Bazaz R, Patchett JD. Clinical efficacy and

cost effectiveness of outpatient parenteral antibiotic therapy (OPAT): a UK perspective.

J Antimicrob Chemother 2009;64:1316-24.

� OPAT frees inpatient capacity, which can then be used either to admit further patients or as part of a planned reduction in bed capacity.

� Better compliance especially for prolonged therapy� PATIENT SATISFACTION

Studies of pneumonia in patients with cystic fibrosis indicate at least comparable outcomes and higher patient satisfaction with OPAT than hospital care.

Rucker RW, Harrison GM. Outpatient intravenous medications in the management of cystic fibrosis. Pediatrics 1974; 54:358–60.

� USA

94% of infectious disease consultants in the USA reported that patients were frequently discharged on OPAT.

CharyA, Tice AD, Martinelli LP, et al. Experience of infectious diseases consultants with outpatient parenteral antimicrobial therapy: results of an emerging infections network survey

Clin Infect Dis, 2006, vol. 43(pg. 1290-5)

� Australia

Howden BP, Grayson ML. 5: Hospital-in-the-home treatment of infectious diseases. Med J Aust 2002; 176: 440–5

� Asia

Fisher DA, Kurup A, Lye D et al. Outpatient parenteral antibiotic therapy in Singapore. Int J Antimicrob Agents 2006; 28: 545–50.

� Europe

During 2005, OPAT accounted for >1% of total outpatient antibiotic use in only six out of 20 European countries,12 with some countries (e.g. the UK and Italy) having more-established OPAT programmes than others.

� Coenen S, Muller A, Adriaenssens N et al. European Surveillance of Antimicrobial Consumption (ESAC): outpatient parenteral antibiotic treatment in Europe. Clin Microbiol Infect 2008, 14 Suppl 7: S86–7.

� Cellulitis

Around 30% of patients presenting to hospital with cellulitis, have moderately severe infection that requires intravenous antibiotics, but do not have severe systemic sepsis necessitating inpatient care.

One randomised controlled trial of intravenous cefazolin, administered twice daily by a nurse at home compared with standard inpatient care, showed no significant difference in the duration of intravenous or subsequent oral antibiotic therapy, patient functional outcomes, or complications but reported improved patient satisfaction with home treatment.

Corwin P et al, Randomised controlled trial of intravenous antibiotic treatment for cellulitis at home compared to hospital.

BMJ 2005;330:129-32.

� Bone and Joint infections,

One UK study reported outcomes for 198 patients with a range of bone and joint infections treated by OPAT. Seventy three percent of patients were disease free at median follow-up of 60 weeks;

Mackintosh CL, White HA, Seaton RA. Outpatient parenteral antibiotic therapy (OPAT)for bone and joint infections: experience from a UK teaching hospital-based service.

JAntimicrob Chemother 2011;66:408-15

� Endocarditis,

Initially recommended only for uncomplicated native valve infections with low risk organisms, US, European, and UK guidelines now recommend OPAT as a part of routine clinical care for patients with infective endocarditis. (chapman)

Ann L N Chapman. Outpatient parenteral antimicrobial therapy. BMJ 2013;346:

�Andrews and von Reyn suggest that patients with uncomplicated endocarditis due to viridans group streptococci could be discharged to receive OPAT after 1 week of hospitalization.

Andrews MM, von Reyn CF. Patient selection criteria and management guidelines for outpatient parenteral antibiotic therapy for native valve infective endocarditis. Clin Infect Dis 2001; 33:203–9.

� UTI’S

� SSTIs

� Bacteraemia

�Prosthetic or orthopaedic device infections,

� Line and endovascular infections

� Intra-abdominal infections.

*Patients with a sepsis syndrome or infections such as meningitis,endocarditis, septic arthritis, or severe pneumonia should usually be hospitalized for initiation of parenteral antimicrobial therapy.

Once their condition has stabilized, however, many of these patients may be appropriately discharged to receive OPAT.

1. >25, Cephalosporins

2. >15, Penicillins

3. >10,Quinolones

4. Tetracyclines

5. Macrolides

6. Ketolides

7. Aminoglycosides

8. Carbapenems

9. Dihydrofolate reductase inhibitors

10. Streptogramins

11. Nitrofurans

12. Fusidane

13. Phosphonic

Antimicrobial classes

14. Glycopeptides

15. Glycylcyclines

16. Oxazolidinones

17. Everninomicins

18. Clindamycin

19. Lincosamides

20. Nitroimmidazoles

21. Rifamycins

22. Phenicols

23. Sulphonamides

24. Polymixins B and E

25. Glycolipopeptides

� Ceftriaxone

� Vancomycin

� Ceftriaxone

� Penicillins

� Meropenem

�Antivirals

� Cefazolin

� Cefepime

� Ceftazidime

� Clindamycin

�Tigecycline

� Teicoplanin or Daptomycin(MRSA infection)

Suitable Antibiotics Long Half Life , once daily, Minimal side effects Bioavailability assured with oral administration

�Definition and Objectives

�Evidence and countries where it is being given

�Delivery Models

�Ideal Infections

�Antimicrobials Administered

�Key elements

�Risks and Safeguards

�Areas of Controversy

�Barriers for Implementation and Suggestions

�Summary and References

Outline of My Presentation

1. Health care team/ OPAT TEAM2 Communications3. Outline of guidelines for follow-up of patients with laboratory testing

and intervention as needed4. Written policies and procedures

A. Consent of the patientB. Outline of responsibilities of team members C. Patient intake information D. Patient selection criteria E. Patient education materials

5. Outcomes monitoring A. Patient response B. Complications of disease, treatment, or program

C. Patient satisfaction

A. An infectious diseases specialist or physician knowledgeable about infectious diseases and the use of antimicrobials in OPAT.

B. Primary care or referring physicians available to participate in care.

C. Nurse expert in intravenous therapy, access devices, and OPAT.

D. Pharmacist knowledgeable about OPAT.

E. Case manager and billing staff knowledgeable about therapeutic issues and third party reimbursements .

F. Other health care professionals, including a physical therapist, a dietitian, an occupational therapist, and a social worker.

A. Physician, nurse, and pharmacist available 24 h per day.

B. System in place for rapid communication between patient and team members

C. Patient education information for common problems, side effects, precautions, and contact lists.

PATIENT SELECTION

Patient medically stable, in hospital only for i.v antibiotic therapy

Patient mentally sound

Not a drug abuser

INFECTIOUS DISEASE CONSULT FOR OPAT

REFERRAL INITIATION

Recommendation of Antibiotic drugs to be given

Lab monitoring for drug reactions and toxicity

PHARMACY ASSESSMENT

Appropriate antimicrobial dose, frequency, duration and drug stability for 7 days

Information on adverse effects and procurement of refills

OPAT CLINIC

Weekly visit for i.v line care.

Weekly reviewed lab results.

Monitoring of clinical progress by ID physician.

Adjustment of medical regimen if reqd.

CASE MANAGEMENT

ASSESSMENT

NURSING ASSESSMENT

Established Diagnosis...

QUALITY IMPROVEMENT•Measure ER utilization & 30 day readmission rates.•Survey patients for satisfaction with care delivery.•Audit antimicrobial utilization to improve stewardship efforts.•Design & implement programme improvements

1. Is parenteral antimicrobial therapy needed?

2. Do the patient’s medical care needs exceed resources available at the proposed site of care?

3. Is the home or outpatient environment safe and adequate to support care?

4. Are the patient and/or caregiver willing to participate and able to safely, effectively, and reliably deliver parenteral antimicrobial therapy?

5. Are mechanisms for rapid and reliable communications about problems and for monitoring of therapy in place between members of the OPAT team?

6. Do the patient and caregiver understand the benefits, risks, and economic considerations involved in OPAT?

7. Does informed consent need to be documented?

26

� Nothing is an offence if done to benefit the person –

I Physical

ii Physiological and

iii Functional

No other benefit not even social

� Done in good faith with due Competence, Care and Caution

Due competence : demonstrated knowledge and skill

Due care : Anything done outside general norm

I Case Specific

ii Context Specific

iii Situation Specific

� Done with consent – a better assesment

� Patients who are clinically stable: normal vital signs

� Patients at low risk of their infection progressing ,

or developing serious complications.

Eg, patients with a diagnosis of cellulitis, need to be assessed by a competent healthcare practitioner to exclude other more serious conditions that could be confused with cellulitis, such as septic arthritis or necrotising fasciitis. This would help in making such a patient a suitable candidate for OPAT.

� Admitted patients , with no barrier for discharge

Eg

diabetic foot infections may be suitable for OPAT, many patients will require adjustment of diabetic control, vascular assessment, and surgical intervention.

�Establish presence or absence of funding source?

�Will the Patient/Designated family member be able to learn self administration technique & care for the i.v line at home?

�Does the patient have a home with working refrigerator & telephone?

� Can the patient travel weekly for clinic appointments?

�Education on self administered infusion technique at home.

�Education on i.v line care at home.

�Ensuring patient has appropriate supplies at time of discharge.

� Instructions for emergencies, risks, problems.

�Delivery of appointment card for first appointment in OPAT clinic following discharge.

• The patient attends a healthcare facility daily, or as required, with antibiotics administered by a healthcare practitioner.

• Community nurses, outreach nurses from the acute hospital, or nurses provided through a private healthcare company

• Advantages of engaging patients in their care, allowing more

• flexibility of dose frequency and timing, and reducing staffing costs)

AMBULATORY CARE CENTRE/PHYSICIAN DIRECTED

NURSE ATTENDING THE PATIENT’S HOME / HOME INFUSION MODEL

SELF ADMINISTRATION/ PATIENT, FAMILY MEMBER OR OTHER RESPONSIBLE

PERSON

�Model of OPAT �largely determines the type of intravenous access.

�Options:

1. Temporary “Butterfly” needles - inserted and removed for each dose

2. Short term peripheral cannulas, (<2 weeks for

adults and <1 week for children)

3. Peripherally inserted Central cannulas /

Tunnelled Central lines -for longer antibiotic courses

4. Bolus injections / Infusions may be used, depending on the choice of antimicrobial agent(s)

Novel delivery devices - allow patients greater freedom to continue normal daily activities.

For example, portable elastomeric infusion devices - carried in the patient’s pocket or a carrying pouch and deliver continuous infusions over 24 hours.

1. Clinical status (as reported by the responsible physician)

A. Improved

B. Clinical failure

C. No change

2. Bacterial infection status (if a pathogen was identified and repeat culture was done)

A. Culture negative for pathogen

B. Persistent pathogen

C. New pathogen

3. Program outcome (i.e., end of therapy)

A. Therapy completed as planned

B. Therapy not completed because of patient’s death, noncompliance with therapy, complication, patient’s preference, hospitalization (give reason), or other

4. Antibiotic use (i.e., end of treatment course) A. Course completed as planned B. Course not completed because of adverse drug reaction (note type), resistant

organism, persistent organism, patient’s preference, clinical failure

5. Vascular access complications, such as phlebitis, infection, thrombosis, infiltration, or becoming dislodged

6. Additional outcome measurementsA. Patient returned to work or school during OPAT (if applicable) B. Did outcome meet physician expectations? C. Survival status (patient alive, died of infection, died of other causes, lost to follow-up,

or status unknown)

� Include daily nurse review.

�Once or twice weekly physician review.

� Continuous clinical and lab monitoring.

� Establishment of an escalation pathway for medical staff familiar with the case to be informed of potential problems.

� Increasing evidence of treatment in formal OPAT centre is safe in more complex patients after an initial period of inpatient care, and a case by case assessment of potential risks.

1. Non-adherence with therapy

2. Misuse of iv access

3. Decreased supervision

At least 25% of patients having OPAT experience an adverse reaction of some type, ranging from mild antibiotic associated diarrhoea to severe line infections.

Chapman ALN, Seaton RA, Cooper MA, Hedderwick S, Goodall V, Reed C, et al. Good practice recommendations for outpatient parenteral antimicrobial therapy (OPAT) in adultsin the UK: a consensus statement. J Antimicrobial Chemother 2012;67:1053-62.

4. Patient may need readmission, with higher rates for patients with more complex infections.

5. May require further unplanned input during therapy.

6. An established system for 24 hour access to clinical support and a formal (re)admission pathway to secondary care- ESSENTIAL

7. Potential for suboptimal duration of OPAT: unnecessarily prolonged therapy due to less medical incentive to stop treatment, or insufficient duration due to failure to recognize deterioration or failure to improve

8. Non-adherence to medical advice e.g. bed rest, leg elevation

1. Complications of vascular access

2. Adequate Monitoring of patient's condition, response to treatment and ancillary care .

3. Unnecessary use of broader spectrum therapy might increase the likelihood of Clostridium difficile infections and resistance. However, global experience to date, suggests that removing patients from a healthcare environment serves to reduce the risk of acquiring these infections .

4. Ensure that the basic models of outpatient care can be provided- to ensure safety; payment or reimbursement incentives for clinicians, hospitals and patients (or their carers);

5. Lack of sufficiently trained healthcare personnel, particularly nurses; willingness of clinical infection specialists to embrace this alternative form of care.

1. Concerns for patient safety, including the risks of OPAT.

2. Perception of limited evidence for clinical and cost-effectiveness.

3. Possibility of adverse microbiological consequences (such as promotion of resistance).

4. Negative cultural attitude towards the need to use parenteral antibiotic therapy, particularly in the non-inpatient setting.

5. The cost of OPAT can vary considerably, depending on various factors:- such as the choice of antimicrobial agent, location of administration (i.e. an outpatient clinic, an infusion centre or the patient's home) and the clinical condition of the patient.

1. A national tariff for OPAT would allow consistency and equity and support wider use.

2. OPAT should operate within the context of an Antibiotic Stewardship programme, and it is essential that a microbiologist or infectious diseases physician is involved in both the initial design of antibiotic protocols, and ongoing patient care.

3. The core OPAT team should comprise, as a minimum,

i. an OPAT specialist nurse,

ii. A physician

iii. An Infection Diseases specialist (an Infectious Diseases physician / a Microbiologist)

iv. A pharmacist.

�A doctor with suitable training and experience (who may also be the infection specialist, when he or she delivers hands-on clinical care) should take responsibility for management decisions for each patient,incollaboration with the team.

�Patients on prolonged courses of antimicrobials should be reviewed daily to allow switching from intravenous to oral therapy, as soon as clinically appropriate.

1. The literature supports the effectiveness of OPAT for a wide variety of infections

2. A thorough assessment of the patient’s general medical condition, the infectious process, and the home situation is necessary before starting therapy.

3. Prescribing physicians should be aware of a number of aspects of OPAT which distinguish it from other forms of therapy.: the required teamwork, communication, monitoring, and outcome measurements

4. The physician has a unique role on the OPAT team, which may also include nursing, pharmacy, and social services: establishing a diagnosis, prescribing treatment, determining the appropriate site of care, monitoring during therapy, and assuring the overall quality of care.

5. Antimicrobial selection for OPAT is different from that for therapy in the hospital. Once-daily drug administration has many advantages. Potential for adverse effects and the stability of an antimicrobial once it is mixed must be considered.

6. The importance of administering the first dose of an antibiotic in a supervised setting is emphasized.

7. Regular clinical and laboratory monitoring of patients receiving OPAT is essential and varies with the antimicrobial chosen.

8. Outcomes measures should be an integral part of any OPAT program, to assure the effectiveness and quality of care.

9. Children receiving OPAT must be considered differently because of their special needs.

1. Developments in outpatient parenteral antimicrobial therapy (OPAT) for Gram-positive infections in Europe, and the potential impact of daptomycin

Dilip Nathwani . Journal of Antimicrobial Chemotherapy, Volume 64, Issue 3, 1 September 2009, Pages 447–

453,

2. Outpatient parenteral antimicrobial therapyAnn L N Chapman .BMJ 2013;346:f1585 doi: 10.1136/bmj.f1585 (Published 26 March 2013) Page 1 of 4

3. IDSA Practice Guidelines for Outpatient Parenteral Antimicrobial Therapy. Alan D. Tice.

Prepared by Dr.Parmeet Kaur & Dr.Dilip Mathai