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• W1690595801 abstract "Administration of parenteral antibiotics outside the inpatient setting, either outpatient or home parenteral therapy (OHPAT), can produce considerable savings in hospital costs [1Grainger‐Rousseau TJ Segal R Economic, clinical and psychosocial outcomes of home infusion therapy: a review of published studies.Pharm Pract Manage Q. 1995; 15: 57-77Google Scholar, 2Thickson ND Economics of home intravenous services.Pharmacoeconomics. 1993; 54: 29-38Google Scholar, 3Williams DN Bosch D Boots J Schneider J Safety, efficacy, and cost savings in an out‐patient intravenous antibiotic program.Clin Ther. 1993; 15: 169-179PubMed Google Scholar], improve patients’ quality of life by enabling them to remain at home or return to work [4Milkovich G Benefits of outpatient parenteral antibiotic therapy: to the individual, the institution, third‐party payers and society.Int J Antimicrob Agents. 1995; 5: 27-31Abstract Full Text PDF PubMed Scopus (14) Google Scholar], and greatly reduce the chance of contracting a nosocomial infection [5Parker SE Davey P Pharmacoeconomics of intravenous drug administration.Pharmacoeconomics. 1992; 1: 103-115Crossref PubMed Scopus (63) Google Scholar]. OHPAT has become possible following the introduction of better catheters for vascular access and improved infusion devices [6Gilbert DN Dworkin RJ Raber SR Leggett JE Drug therapy: outpatient parenteral antimicrobial drug therapy.N Engl J Med. 1997; 337: 829-838Crossref PubMed Scopus (101) Google Scholar]. Additionally, the availability of antibiotics that can be administered by a simple bolus injection, require once-daily dosing and do not require serum monitoring makes it easier for patients or their carers to administer treatment at home [6Gilbert DN Dworkin RJ Raber SR Leggett JE Drug therapy: outpatient parenteral antimicrobial drug therapy.N Engl J Med. 1997; 337: 829-838Crossref PubMed Scopus (101) Google Scholar, 7Craig WA Selecting the antibiotic.Hosp Pract. 1993; 28: 16-20Google Scholar]. In the USA, OHPAT services, also known as community-based parenteral anti-infective therapy (CoPAT), have a well-developed infrastructure and deliver a high-quality service to a large number of patients [8Nathwani D Seaton W Davey P Key issues in the development of a non‐inpatient intravenous (NIPIV) antibiotic therapy programme—a European perspective.Rev Med Microbiol. 1997; 8: 137-147Crossref Scopus (6) Google Scholar]. Indeed, OHPAT services now account for more than a billion US dollars in healthcare expenses annually [10Balinsky W Mollin A Home drug infusion therapy. A literature update.Int J Technol Assess Health Care. 1998; 14: 535-543Crossref PubMed Scopus (3) Google Scholar]. OHPAT guidelines already exist from the USA [9Williams DN Rehm SJ Tice AD Bradley JS Kind AC Craig WA Practice guidelines for community‐based parenteral anti‐infective therapy.Clin Infect Dis. 1997; 25: 787-801Crossref PubMed Scopus (100) Google Scholar] and Canada [11Canadian Advisory Committee on Home IV Antibiotic Therapy. Canadian Home IV Guidelines. Highlights of a Consensus Conference, 11–12 November, Toronto, Canada 1994: 1–9.Google Scholar]. Elsewhere, there is evidence of evolving interest in OHPAT, with reports of successful programs in Australia, Argentina, Mexico, Israel and Venezuela [12Tice AD Outpatient and parenteral antibiotic therapy in different countries.Int J Infect Dis. 1996; 1: 102-106Abstract Full Text PDF Scopus (11) Google Scholar]. In contrast, in Europe the existing evidence for OHPAT services is rather sparse and ill-defined except in some areas of Italy, Austria, The Netherlands and the UK. Only in the UK do national OHPAT guidelines exist [13Nathwani D Conlon C on behalf of the OHPAT UK Workshop Outpatient and home parenteral antibiotic therapy (OHPAT) in the UK: a consensus statement by a working party.Clin Microbiol Infect. 1998; 4: 537-551Crossref Scopus (34) Google Scholar], but OHPAT services have yet to be initiated in the majority of healthcare regions of this country. Furthermore, a recent survey conducted in England revealed that, for patients receiving home infusions, antimicrobial therapy is primarily confined to cystic fibrosis and antivirals for HIV infection [14Loader J Sewell G Gammie S Survey of home infusion care in England.Am J Health Syst Pharm. 2000; 57: 763-766PubMed Google Scholar]. The lack of clear information on European OHPAT activity was evident from the outcomes of an interactive question and answer session held during an OHPAT workshop at the 2nd European Congress of Chemotherapy (Hamburg, Germany, 12 May 1998). Fifty-five per cent of those attending the workshop did not have an OHPAT program in place, and, of those who did, only 26% treated more than 100 patients annually, with orthopedic and skin and soft tissue infections identified as key infections amenable to OHPAT. The majority (89%) of the audience felt that OHPAT activity would increase over the next 5 years but that the greatest barriers to progress were funding issues and the lack of systems or guidelines. This was the stimulus for the formation of a group (now called the AdHOC group) of key opinion leaders, primarily from Europe but including Argentina and Brazil, whose remit was as follows: 1.to ascertain country-specific denominator data and personal experiences of OHPAT activity2.to highlight the key strengths and opportunities for OHPAT3.to investigate, individually and as a group, the existing barriers to OHPAT, with emphasis on the fiscal barriers in the European Union (EU)4.to offer solutions on how these barriers may be overcome5.to provide a position document on behalf of the group, outlining the key issues. The relative lack of uniform activity in the UK was recently highlighted by the findings of the first national survey of OHPAT activity in the UK and the Republic of Ireland, as presented at the first AdHOC meeting by Nathwani and published in this issue of Clinical Microbiology and Infection [15Seaton A Nathwani D What do British and Irish infection specialists think about inpatient parenteral antibiotic therapy?.J Infect. 2000; 40: 1-35Abstract Full Text PDF Google Scholar]. A questionnaire was sent to 348 infection specialists. Of the responses received (n = 157), only 21% reported having an OHPAT service in place already, and the majority of specialists without such a service (81%) felt that OHPAT was required in their region. The most frequently reported factors preventing the development of an OHPAT service included funding issues (reported by 36% of 124 responders), lack of leadership (34%), and difficulties in coordinating hospital and community care (30%). Indeed, lack of guidelines was identified as a barrier by only 6% of individuals, presumably acknowledging the existence of the UK guidelines. Similar problems appear to be widespread throughout Europe, where OHPAT is largely driven by a few clinical enthusiasts working without official support for the funding, development and implementation of such programs [16Nathwani D Davey P Intravenous antimicrobial therapy in the community: underused, inadequately resourced, or irrelevant to healthcare in Britain.Br Med J. 1996; 313: 1541-1543Crossref PubMed Scopus (18) Google Scholar]. Those with existing services in the UK have claimed that OHPAT is only a reasonable option in small numbers of patients [17Wiselka MJ Nicholson KG Outpatient parenteral antimicrobial therapy: experience in a large teaching hospital.J Infect. 1997; 35: 73-76Abstract Full Text PDF PubMed Scopus (13) Google Scholar]. However, a feasibility study conducted in Scotland showed this is not the case, as 86% of inpatients receiving intravenous antibiotics were found to be suitable for OHPAT and the patients also considered this to be a suitable option for treatment [18Seaton RA Nathwani D Williams FL Boyter AC Feasibility of an outpatient and home parenteral antibiotic therapy (OHPAT) programme in Tayside.Scotland J Infect. 1999; 39: 129-133Abstract Full Text PDF PubMed Scopus (14) Google Scholar]. Despite receiving little or no official support, OHPAT programs outside of North America have been shown to be clinically effective, safe, cost-effective and associated with attendant improvements in quality of life [12Tice AD Outpatient and parenteral antibiotic therapy in different countries.Int J Infect Dis. 1996; 1: 102-106Abstract Full Text PDF Scopus (11) Google Scholar, 19Dagan R Einhorn M A program of outpatient parenteral antibiotic therapy for serious pediatric bacterial infections.Rev Infect Dis. 1991; 13: S152-S155Crossref PubMed Scopus (28) Google Scholar, 20Graninger W Presterl E Wenisch C Schwameis E Breyer S Vukovich T Management of serious staphylococcal infections in the outpatient setting.Drugs. 1997; 54: 21-28Crossref PubMed Scopus (36) Google Scholar, 21Grayson ML Silvers J Turnidge J Home intravenous antibiotic therapy: a safe and effective alternative to inpatient care.Med J Aust. 1995; 162: 249-253PubMed Google Scholar, 22Huminer D Bishara J Pitlik S Home intravenous antibiotic therapy for patients with infective endocarditis.Eur J Clin Microbiol Infect Dis. 1999; 18: 330-334Crossref PubMed Scopus (38) Google Scholar, 23Kayley J Berendt AR Snelling MJM et al.Safe intravenous therapy at home: experience of a UK based programme.J Antimicrob Chemother. 1996; 37: 1023-1029Crossref PubMed Scopus (51) Google Scholar, 24Nathwani D Moitra S Dunbar J Crosby G Peterkin G Davey P Skin and soft tissue infections: development of a collaborative management plan between community and hospital care.Int J Clin Pract. 1998; 52: 456-460PubMed Google Scholar, 25Nathwani D Morrison J Seaton RA France AJ Davey P Out‐patient and home‐parenteral antibiotic therapy (OHPAT): evaluation of the impact of one year's experience in Tayside.Health Bull. 1999; 57: 332-337Google Scholar, 26Stamboulian D Outpatient treatment of endocarditis in a clinic‐based program in Argentina.Eur J Clin Microbiol Infect Dis. 1995; 14: 648-654Crossref PubMed Scopus (30) Google Scholar, 27Van Den Broek PJ Haerkens HM Van Weert NJ Vermeij P Favorable results with intravenous antimicrobial therapy outside the hospital.Ned Tijdschr Geneeskd. 1997; 141: 2297-2301PubMed Google Scholar, 28Volkow P Sanchez‐Mejorada G De La Vega SL et al.Experience of an intravenous therapy team at the Instituto Nacional de Cancerologia (Mexico) with a long‐lasting, low‐cost Silastic, venous catheter.Clin Infect Dis. 1994; 18: 719-725Crossref PubMed Scopus (14) Google Scholar]. Programs involving teicoplanin, a drug not available in North America, have provided a significant component of OHPAT experience, as recently summarized by Nathwani [29Nathwani D Non‐inpatient use of teicoplanin.Int J Clin Pract. 1998; 52: 577-581PubMed Google Scholar] and Wilson and Gruneberg [30Wilson AP Gruneberg RN Use of teicoplanin in community medicine.Eur J Clin Microb Infect Dis. 1994; 13: 701-710Crossref PubMed Scopus (33) Google Scholar]. Experience from one of the larger centers clearly reveals a significant number of positive outcomes with OHPAT. In Tayside, UK, 101 patients were treated under the OHPAT scheme over a period of 1 year [25Nathwani D Morrison J Seaton RA France AJ Davey P Out‐patient and home‐parenteral antibiotic therapy (OHPAT): evaluation of the impact of one year's experience in Tayside.Health Bull. 1999; 57: 332-337Google Scholar]. The majority (51.5%) had complicated skin or soft tissue infection, 22.8% had osteomyelitis or septic arthritis, and 3.9% had bacterial endocarditis. The clinical outcome was ‘cure/improving’ in 94%, with ‘no change’ in a further 2%, and adverse drug reactions and unscheduled readmissions occurring in 6% and 7.5% of cases, respectively. In regard to economic outcome, it was estimated that 1461 hospital bed days had been saved, and the mean increase in drug acquisition cost per patient was less than £12/day. The antibiotics used, such as teicoplanin and ceftriaxone, were more expensive than those recommended in the hospital sepsis protocol but offered once-daily administration, and were of proven efficacy and safety in the OHPAT setting [24Nathwani D Moitra S Dunbar J Crosby G Peterkin G Davey P Skin and soft tissue infections: development of a collaborative management plan between community and hospital care.Int J Clin Pract. 1998; 52: 456-460PubMed Google Scholar]. Additionally, 93% of patients said the OHPAT service was preferable to inpatient treatment, 93% of patients’ families or carers were satisfied with the service, and 96% of patients said that the service improved their quality of life [25Nathwani D Morrison J Seaton RA France AJ Davey P Out‐patient and home‐parenteral antibiotic therapy (OHPAT): evaluation of the impact of one year's experience in Tayside.Health Bull. 1999; 57: 332-337Google Scholar]. The benefits of OHPAT programs to the patient are obvious. Recent work suggests, however, that it is important to evaluate closely patients’ perceptions of home and hospital as sites of treatment for acute illness [31Fried TR Van Doorn C O'leary JR Tinetti ME Drickamer MA Older persons' perceptions of home and hospital as sites of treatment for acute illness.Am J Med. 1999; 107: 317-323Abstract Full Text Full Text PDF PubMed Scopus (27) Google Scholar]. If necessary, these perceptions should be addressed through education, to adequately convey the experience of safety and efficacy to the patient population. Benefits to providers, such as hospitals and payers (e.g. social security or insurance companies), need to be carefully delineated against the background of the unique fiscal/accounting structure of each country within Europe and worldwide. One accepts that, although the demands and needs of many countries are similar, there is considerable disharmony related to healthcare and insurance systems. However, the benefits which can be gained from OHPAT suggest that a more organized strategy should be developed in Europe [8Nathwani D Seaton W Davey P Key issues in the development of a non‐inpatient intravenous (NIPIV) antibiotic therapy programme—a European perspective.Rev Med Microbiol. 1997; 8: 137-147Crossref Scopus (6) Google Scholar]. During a workshop held in Paris on 21 and 22 January 2000, the barriers which limit usage of OHPAT in countries outside of North America were examined. The aims were as previously outlined. To understand the composition of the group, their experience, the dynamics of OHPAT in each country/region and the key factors (e.g. economic, educational, logistic) controlling OHPAT, a questionnaire was sent to all participants (Table 1). An analysis of the responses was presented to the group and formed the basis of three key areas/questions: 1.Describe the ideal OHPAT for your country.2.What issues/barriers must be addressed to attain the best position for OHPAT?3.How are you going to handle/resolve these barriers, i.e. provide solutions?Table 1Questionnaire completed by AdHOC membersQuestionnaire1.In your own experience, what is OHPAT?2.What is your interest in OHPAT?3.Which medical specialities in your country use OHPAT?4.What is the level of OHPAT activity in your country?5.What is your information source for the answer to the previous question?6.Who controls OHPAT activity in your country?7.What trends do you expect to see in OHPAT in your country during the next 5 years?8.What are some of the issues that have slowed acceptance/development of OHPAT in your country?9.What are some of the issues in your country that will cause an increase (or decrease) in OHPAT use during the next 5 years?10.How should OHPAT be promoted in the future?11.Any other comments relevant to OHPAT in your country? Open table in a new tab To arrive at a consensus, the technique of meta-planning was used, as described previously [32Anonymous Non‐inpatient use of parenteral antibiotics. Discussions of a national working party meeting February. The Medicine Group (Education) Limited, Oxford1995Google Scholar]. In brief, a meta-plan session involves interactive discussion, facilitated by a moderator, structured to encourage the flow of ideas and information from the group without undue peer pressure, in order to arrive at a consensus. The complete generation, grouping and prioritization process pertinent to the above key questions is outlined in the following sections. The members of the workshop included infectious disease and internal medicine specialists, and experts in the fields of clinical epidemiology, health economics and oncology/hematology (see Appendix). The participants represented 11 European countries and two South American countries. Although most of the discussions centered on OHPAT, the majority of issues raised were considered to be applicable to other forms of non-inpatient parenteral therapies, e.g. cancer chemotherapy, blood transfusions, and palliative care. Indeed, early in the discussions, the group recognized the need to learn from the experiences gained from other home and outpatient treatments [33Kinsey SE Experience with teicoplanin in non‐inpatient therapy in children with central line infections.Eur J Haematol Suppl. 1998; 62: 11-14PubMed Google Scholar]. The assigned name of the workgroup took this into account: the Advisory group on Home-based and Outpatient Care (AdHOC). The outcomes from the first workshop are presented in detail here. We hope that this will lead the debate on OHPAT in Europe and worldwide and provide a basis for its broader implementation and evaluation. The experiences of OHPAT reported by the AdHOC members provided an indication of its current position within the European and South American countries represented. Seven of the 15 physicians already ran an OHPAT service, and a further four expressed interest in running such a program. Most participants agreed that OHPAT should begin in hospital and continue in the community with responsible surveillance. However, with the development of a more sophisticated community service, this process can probably be wholly performed in the community, with specialist assessment and back-up. In Germany, however, treatment continues on an outpatient basis, as nurses are usually not permitted to administer intravenous injections. The level of OHPAT activity in each country varied from ‘very little’ (Argentina, Belgium, Brazil, Greece, The Netherlands) to ‘widespread’ (Turkey, Italy) (Table 2), the latter reflecting the widespread use of parenteral (mainly intramuscular) antibiotics in Turkey and Italian general practice. This knowledge was based mostly on personal experience or ad hoc data, formal survey information being available in The Netherlands (R. Quak, personal communication), Italy, and the UK only [14Loader J Sewell G Gammie S Survey of home infusion care in England.Am J Health Syst Pharm. 2000; 57: 763-766PubMed Google Scholar, 34OECD Health Data 99 A comparative analysis of 29 countries. CREDES, Paris1999www.oecd.org/els/health/software99.htmGoogle Scholar, 35Esposito S Parenteral cephalosporin therapy in ambulatory care. Advantages and disadvantages.Drugs. 2000; 59: 19-28Crossref PubMed Scopus (17) Google Scholar, 36Esposito S Outpatient parenteral treatment of bacterial infections: the Italian model as an international trend?.J Antimicrob Chemother. 2000; 45: 724-727Crossref PubMed Scopus (15) Google Scholar]. The expected trend in OHPAT activity over the next 5 years ranged from a small increase’ (Austria, Belgium, Greece, Italy, Sweden, The Netherlands, Turkey, the UK) to a small decrease’ (Italy), with the remainder (Argentina, Brazil, Germany, Spain, Sweden, Switzerland) expecting a large increase. The small decrease foreseen in Italy is due to the current limitations on parenteral antibiotic prescription by general practitioners (GP), imposed recently by the Italian government.Table 2The level of OHPAT activity in various European and South American countries (AdHOC members' personal experiences)CountryVery littleWell accepted but limited to few specialitiesUsed in certain regions onlyWidespreadArgentinaXAustriaXBelgiumXBrazilXXGermanyXGreeceXItalyXXThe NetherlandsXSpainXXSwedenXSwitzerlandXTurkeyXUKXX Open table in a new tab Austria, Germany and The Netherlands were the only countries where reimbursement agencies or insurance companies were involved with OHPAT programs. In most of the remaining countries, OHPAT was controlled by individuals or individual hospitals or hospital departments. The major issues considered by the group as slowing the acceptance or development of OHPAT are listed in Table 3. The group felt that any increase in OHPAT use over the next 5 years would be in response to increased hospital costs and the evolution of healthcare towards the community setting, coupled with recognition of OHPAT as a useful, cost-effective and safe alternative to hospital treatment, as demonstrated by existing studies and experience.Table 3The issues that have slowed the acceptance or development of OHPAT (AdHOC members' personal experiences)The issuesFinancial concerns Increased cost of hospitalization Restricted hospital economic policy/lack of financial support Unfavorable reimbursement systems Mandatory use of oral antibiotics (Italy)Increase in cancer and elderly populationLack of experience/knowledgeLack of organizational support/government commitmentLegal limitation for nursesConfused accountabilityUnfavorable drug regimens, e.g. too many doses per day Open table in a new tab It was generally felt that randomized controlled trials comparing non-inpatient therapy with traditional hospital treatment were no longer feasible or ethical. Indeed, when considering the efficacy of antibiotic therapy, there was a general opinion that demonstrations of efficacy in the inpatient setting should be considered applicable to the OHPAT setting also. It was felt that all one needs to prove is the safety, feasibility and cost-effectiveness of OHPAT, for which there is now increasing evidence. The over-riding comment from the majority of respondents was that ‘if patients demand OHPAT because it gives them better quality of life, then funding (from insurance, reimbursement or public bodies) should not be denied’. In fact, it is likely that patient power plus increasing empowerment of the public due to the growth and increased accessibility of information will increase the demand for OHPAT. The details of this analysis were recently presented at the 10th European Congress of Clinical Microbiology and Infectious Diseases, 28–31 May 2000, Stockholm, Sweden [37Nathwani D Zambrowski J‐J Harding I AdHOC: Advisory Group on Home‐based and Outpatient Care. Results of a survey of OHPAT practice in the EU and beyond [abstract MoP231]. Program and Abstracts of the 10th European Congress of Clinical Microbiology and Infectious Diseases, Stockholm, Sweden.Clin Microbiol Infect. 2000; 6: 192Abstract Full Text Full Text PDF Scopus (24) Google Scholar]. The following sections condense the key components of the meta-plan discussion session and provide a keen critique of how the AdHOC group felt about OHPAT implementation. The features of the ideal OHPAT service identified by the AdHOC group, which are listed below, also provide a checklist of the key barriers to its implementation: 1.Administration by a hospital-based, multidisciplinary home-care team, led by an OHPAT expert. Although the prescribing physician will be ultimately responsible for the delivery of patient care, it may be preferable that responsibility for the day-to-day running of the service is taken by a nurse experienced in non-inpatient parenteral treatment.2.Service run from more than one or two centers per country to give wide availability, with consistency between centers.3.Effective lines of communication established between hospitals and the community.4.Availability of clear guidelines, including agreed indications. OHPAT given clear definitions, as logistic and training issues will differ with the type of parenteral administration (intravenous/intramuscular/subcutaneous injections).5.Regular or continuous audit of service by using predefined, simple, measurable and coherent performance/quality indicators. This should evolve into an international outcome registry for benchmarking purposes.6.Rather than being used primarily as a means of reducing the number of hospital beds, savings should be re-invested, possibly within other hospital departments.7.The healthcare system managers, reimbursement agencies and patients are on board and convinced of the benefits of OHPAT, as shown by efficacy and cost-effectiveness trial data (evidence-based OHPAT’). Changes in healthcare systems have been made to remove any financial constraints, or the process of financial accountability is clearly defined and easy to administer.8.Legal responsibilities are clear for the OHPAT team and patient, and the service is supported by the regulatory authorities enabling, for example, nurses to administer intravenous injections in all countries. In this section, the issues concerning or barriers to attaining the best position for OHPAT, identified by the AdHOC group, are clustered into four major categories, and are the focus of the remainder of this report: 1.Political and funding issues—creating the political will to make legislative changes. Obtaining the appropriate financial support for the creation and maintenance of OHPAT teams, reimbursement for patient care, payment for equipment supplies and antimicrobial drugs.2.Lack of international guidelines—these must be based on demonstrations of clinical effectiveness (efficacy, safety, and enhanced quality of life) and cost-effectiveness (illustrated by the results of pharmacoeconomic studies). Guidelines for assembling an OHPAT team for patient selection, community liaison, training of the healthcare team and patients, and monitoring service performance, are also required.3.Medico-legal issues—clarifying the legal responsibility for drug prescribing (allowing community nurses to give intravenous injections), patient outcome, etc., with regulatory back-up from EU healthcare authorities.4.Lack of local awareness of OHPAT—generating awareness among health professionals, health administrators and patients, marketing the benefits of OHPAT, and providing the motivation for local health authorities to change systems. Virtually all countries other than the USA have a nationwide healthcare system. However, the ability to provide inpatient parenteral treatment varies according to each individual country's wealth. In poorer countries without the finances to build hospitals, the primary form of therapy is often through outpatient clinics when medication is available. Moreover, in areas of high population density, outpatient treatment is attractive to hospital administrations unable to supply extra hospital beds. Most countries, however, have a system of public and private hospitals and provide intravenous treatment in both facilities. Where health insurance is available, there may be incentives for outpatient care, though usually only if the cost of hospitalization is high. Self-administration may be possible in countries with greater resources to devote to healthcare, although, despite saving staff and overhead costs, this requires investment in vascular access and infusion devices, as well as well-trained medical personnel to evaluate and monitor patients’ progress." @default.
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• W1690595801 title "Advisory group on Home-based and Outpatient Care (AdHOC): an international consensus statement on non-inpatient parenteral therapy" @default.
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