Lima-Dellamora, Caetano R, Gustafsson LL, Godman BB, Patterson K, Osorio-de-Castro CG. An Analytical...

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Received Date: 22-Oct-2013

Accepted Date: 03-Feb-2014

Article Type: Original Article

An Analytical Framework for Assessing Drug and Therapeutics

Committee Structure and Work Processes in Tertiary Brazilian

Hospitals

Running Title:

DTC framework for Brazilian hospitals

Elisangela da Costa Lima-Dellamora1,2

Rosângela Caetano3

Lars L. Gustafsson4

Brian B. Godman4,5,6

Ken Patterson7

Claudia Garcia Serpa Osorio-de-Castro2

Author for correspondence: Elisangela da Costa Lima-Dellamora, Faculty of Pharmacy,

Federal University of Rio de Janeiro (UFRJ). Address: Avenida Carlos Chagas Filho,

373, Rio de Janeiro, Brazil. Zip Code: 21.941-902 – (E-mail:

[email protected]).

2Sergio Arouca National School of Public Health, Post-Graduate Program –Oswaldo

Cruz Foundation, Rio de Janeiro, Brazil

3Social Medicine Institute– State University of Rio de Janeiro, Rio de Janeiro, Brazil

4Division of Clinical Pharmacology, Department of Laboratory Medicine – Karolinska

Institutet, Karolinska University Hospital Huddinge, Stockholm, Sweden


5Center for Technology Development in Health – Oswaldo Cruz Foundation, Rio de

Janeiro, Brazil

6Strathclyde Institute of Pharmacy and Biomedical Sciences – University of Strathclyde,

Glasgow, Scotland, United Kingdom

7University of Glasgow, Glasgow, Scotland, United Kingdom

Abstract: University teaching hospitals usually provide tertiary care and are subject to

early adoption of new technologies, which may compromise healthcare systems when

uncritically adopted. Knowledge on the decision-making process – drug selection by

drug selection committees or DTCs - is crucial in order to improve the quality of care.

There are no models for studying the selection of drugs in Brazilian healthcare services.

This study aims to discuss DTC structure and the processes regarding adoption of

medicines in tertiary university hospitals in Brazil, and to propose an analytical

structure for providing direction for the future. State-of-the-art content regarding drug

selection processes and DTC procedures was reviewed in three databases. Information

on the medicine selection process in a Brazilian gold-standard teaching hospital was

collected through observations and a review of existing procedures. A structured

discussion on medicines selection and DTC procedures in tertiary hospitals ensued. This

discussion resulted in findings that were organized in three dimensions, composing an

analytical framework for application in tertiary Brazilian hospitals (i) motivations for

the adoption of drugs; (ii) necessary structural and organizational aspects for decision-

making; and (iii) criteria and methods employed by the decision-making process. We

believe the suggested framework is compatible to tertiary Brazilian hospitals, since a

gold standard in the country was able to conduct all its procedures in light of WHO and

international recommendations. We hope to contribute in producing knowledge which

may hopefully be adopted in tertiary hospitals across Brazil.


Keywords: Drug and Therapeutics Committees, Brazil, hospitals

Timely and evidence-based adoption of medical technologies and medicines is critical

for improving patient care [1-3]. Researchers, physicians and patient groups tend to

welcome new technologies [4] that may pose risks to patients and might compromise

the effectiveness of healthcare systems. Also, lack of evidence-based procedures and

clear policies for handling conflicts of interests may challenge the provision of equitable

services and therapy to all in need [1-5].

Possible advances of novel pharmaceuticals may be limited. A study in France

perceived that only 17 of 984 (1.7%) medicines launched were real advances in

pharmacotherapy studied during the period of 2001 to 2010 [6,7]. Unfortunately, the

intense marketing practices to health professionals and the public by manufacturers

generates undue expectations and induces demand for innovations if not critically

balanced in technique-oriented healthcare facilities [8-11]. This is not in the best interest

of physicians, patients or health authorities.

Brazil is a middle-income country that in July 2013 had an estimated population size of

200.1 million inhabitants [12]. The Brazilian Public Health System (Sistema Único de

Saúde - SUS) was initiated in 1990 and adopts comprehensive universal care as a

principle. Over the years, a trend to establish parallel subsystems (reimbursed private

and direct public providers) in the scope of SUS was developed to meet demand for

specific needs. Parallel subsystems lead to difficulties in system management and

continuity of care [13]. Failures in resolving simpler clinical needs in primary and

secondary settings burden structure and processes pertaining to tertiary care [14].


In SUS, expensive and technically advanced health services and care are

predominantly delivered by private outpatient clinics and hospitals and by public

university hospitals [13], usually early adopters of new technologies [8,15]. The

Brazilian Association of University and Teaching Hospitals cites around 100 such

institutions in the country, of which 70% are public facilities [16]. Innovative drugs

account for a large percentage of formulary additions in Brazilian university hospitals.

Related expenditures with these medicines are high [17].

The financing of high-cost medicines is the responsibility of Brazilian federal

and state governments and expenditures have increased in the last decade. From 2003 to

2008, a 347% increase in total cost of these medicines for the system was observed. In

absolute values, from 2005 to 2008, federal public expenditures in medicines amounted

to nearly 1.15 billion USD per year, while in the entire four-year period, federal and

state public spending with high-cost medicines totaled approximately 13.4 billion USD

[18,19].

In light of this, it is especially important for tertiary Brazilian university hospitals to

acknowledge and build on the perspectives of health professionals and managers to

assure correct information as a basis for decisions on the adoption of new drugs. The

process of recommending drugs must be performed in a critical, evidence-based

manner, ideally by a drug and therapeutics committee (DTC) formed by respected

independent pharmacotherapeutic drug experts including clinical pharmacologists,

pharmacists and general practitioners [3,9,20-22]. This is the only way to assure the

inclusion of true pharmaceutical innovations in formularies since their actual

prescription and use are subject to the influence of a myriad of medical, economic and

social factors involving researchers, pharmaceutical companies, governments, mass

media, health professionals, individual patients and patient organizations [10,11,23].


Few studies shed light either on triggers for adoption, or on structure and organization

of complex health facilities and the selection process for new therapeutic alternatives by

DTCs [24-26].

Despite the importance of the selection process, few Brazilian hospitals

presently have a functioning DTC and little is known about how the adoption of

medicines takes place [27, 28]. This study aims to discuss DTC structure and the

processes regarding adoption of medicines in tertiary hospitals in Brazil, and to propose

an analytical structure for providing direction for the future.

Methods

State-of-the-art content regarding drug selection processes and DTC procedures were

reviewed in Medline, and in the most consulted databases in the Brazilian context:

LILACS and SCIELO. The core search included publications in Portuguese, English and

Spanish. No further limits were applied. The following search terms were used, in

English, Spanish and Portuguese, individually or combined: 'drug selection'; 'drug

committee'; 'pharmacy and therapeutics committee'; 'drug and therapeutics committee';

'priority settings'; 'hospitals'; 'new medicines'. The World Health Organization (WHO)

policy recommendations were also consulted [29].

Also, DTC procedures at a gold-standard tertiary Brazilian university hospital, the Porto

Alegre General Hospital (Hospital de Clínicas de Porto Alegre - HCPA) were

examined. This hospital is classified as a large general hospital, part of SUS, with

approximately 700 clinical and surgical beds including highly complex care as well as

services in neurology, neonatology, oncology and transplantation [30]. HCPA has been

continuously conducting a consolidated drug selection process since 1986 with

allocated staff and medical experts [31]. Activities of the drug committee (Comissão de


Medicamentos - Comedi) were studied. Sources of information included documents,

interviews and observation of committee meetings. During meetings, hospital

administrative support to the committee, member involvement and responsibilities,

evidence-based discussions and decisions, activities regarding development and

dissemination of DTC publications, policies and guidelines were observed. Information

collection was authorized by Comedi’s coordinator. A review of normative and

procedure documentation and the summary of Comedi’s observed procedures and

decision-making from 2006 onwards was subsequently undertaken.

Theoretical information of DTC activities and structure and practical aspects

regarding structure and the selection process at the gold-standard Brazilian hospital

permitted the drafting of a structured discussion regarding the adoption of drugs by

tertiary hospitals, and the workings of DTCs. A resulting analytical framework for

assessing drug and therapeutics committee structure and processes in tertiary Brazilian

hospitals was subsequently proposed.

This research was approved by the Ethics in Research Committee of the Sergio

Arouca National School of Public Health. Oswaldo Cruz Foundation, in Rio de Janeiro,

Brazil (review number 142/10 CAAE 0148.0.031.000-10).

Results and Discussion

Motivation for adoption of new medicines

Characteristics of new technologies have shown to be directly related to demand and

adoption [11,23]. As a consequence, the nature of these technologies, and especially the

sources of information regarding them are important analytical categories to consider.


In addition to information on efficacy of innovative drugs disseminated in scientific

journals [32-34], other elements give rise to requests for formulary inclusion. They

involve the simple interest for what is new; this might be reinforced by rare clinical

situations for which there are no established pharmacological therapies.

As such, evaluation and selection of essential medicines should be based on priority

therapeutic needs of the population, according to the WHO [29]. Therefore, the

epidemiological profile of patients should guide decision-making, an explicit

recommendation by the WHO.

Other important elements are prescriber contact and involvement with new drugs in

controlled clinical trials conducted at university hospitals and the direct influence and

relationship of power brokers - professors and researchers - with the pharmaceutical

industry [10,11,35-37].

During the selection process, at institutional or at country level, comparative assessment

is a mandatory procedure when deciding on the adoption of any new technology

considered essential for the health facility or system. In countries such as Australia,

Scotland, Spain (Catalonia) and Sweden [9,21,38,39], drugs are evaluated to allow

market authorization and on the benefits for healthcare and patients, usually in two

separate processes. This will depend on where budgetary responsibilities lie, e.g. new

drugs may be reimbursed or recommended by national bodies (such as the Scottish

Medicines Consortium or the reimbursement agency in Sweden - TLV). However,

recommended drugs are significantly reduced in formularies and guidance such as the

Wise List in Stockholm Healthcare Region [9,21].


In Brazil, the drug registration process, although requiring that many relevant

aspects of the technology be evaluated (efficacy, safety and, for instance, cost-

effectiveness) does not in fact compare it with already available technologies [29].

In HCPA, the epidemiological profile is a first motivation for adoption of medicines. An

addition to the formulary is recommended if the drug to be evaluated: (a) offers

advantages that justify replacing the first choice for treatment; or when (b) is indicated

for any new therapeutic procedure in the institution. In both cases, a crucial, strict

criteria-based comparison of available options is made when a request for formulary

inclusion is received through proper committee channels and procedures.

It is worth noting that teaching hospitals in Brazil and elsewhere are traditional targets

for pharmaceutical companies, since those institutions gather professors (who wish to

pass on what is perceived as the best and most up-to-date knowledge to their students)

and students (who are eager for everything that is new and thus regarded as the best)

[15,40]. Gertner [41] studied the use of evidence to subsidize adoption of health

technologies in Brazil. He found that pharmaceutical companies create markets in the

public system, by exploring what he names as ‘uncertainty’ – the use of foreign data as

favourable approximations in the clinical setting, when no Brazilian data are available -

and the resulting vulnerability of decision-makers in making clinical choices. In Brazil,

uncritical adoption of medicines and treatments in university hospitals has been linked

to health litigation throughout the heath system [42].

Structure and organization for medicines selection

Structure and organization for medicines selection refers to the necessary resources for

the selection process to effectively take place. The DTC structure seems to be directly

related to the organization of the decision-making process. DTCs show diverse


organizational features and support from either pharmacy, pharmacology, clinical

pharmacology or clinical departments [3,20,32-34,43-46].

A list of essential medicines, or a medicine formulary, is considered helpful in

assisting prescribers with assessing the value of medicines based on critical evaluation

of the evidence and cost-effectiveness as compared to current alternatives [3,21].

Drafting a list of essential medicines involves interdisciplinary aspects and different

types of knowledge. The procedure must be decentralized and participatory but

conducted by a single entity; its institution must be ratified by an internal norm or

equivalent [29]. According to the WHO, some aspects are essential. These include

technical support, trained human resources and access to databases and bibliographies.

Administrative aspects, such as office space, weekly workload for members, keeping of

official decision records, policies and guidelines and the monitoring of activities by the

board of directors, are also essential [29]. A very relevant aspect must be highlighted –

the training of health professionals for their roles in the DTC. This specifically means

enabling health professionals, such as pharmacists and clinicians, to work

collaboratively with clinical pharmacologists to foster pharmacotherapeutic exchange

and debate in healthcare settings [3,20,47].

The member structure of DTCs varies according to the characteristics of those in

charge of decision-making. Overall, pharmacists, nurses and the main medical

specialties are represented in DTCs [32-34, 48,49]. Members’ insufficient knowledge to

evaluate drugs [50-52] and activity overload [49] are pointed out as problems

preventing smooth committee operations.

Defining DTC functions and activities and members’ roles are part of the

structuring process. The main DTC-reported roles are perceived as drug evaluation and


the maintenance of an institutional formulary [33,34,48,52]. The WHO [29] adopts an

additional number of functions: drug information provided to staff, drafting of

institutional policies and therapeutic guidelines, and monitoring use.

Members’ impressions and feelings with respect to their own participation in

decision-making and the relevance of interpersonal relationships in DTC performance

are highlighted by Bagozzi and colleagues [45]. The authors analysed the behaviour of

members of 222 DTCs in teaching hospitals with over 300 beds in the USA. Their

conclusion was that negative and positive feelings such as frustration, envy,

embarrassment, persuasion ability, cooperation and open-mindedness varied among

physicians, nurses and pharmacists involved in the process, but mainly in respect to the

roles they played inside the committee. Overall, personal interaction was positive but

not prominent. In hierarchical settings (such as a DTC), personal relationship effects are

less apparent and the official standing of the healthcare professional seems to prevail

and leads to collaboration. This speaks for the importance in keeping DTCs on the

formal side.

Adopting transparency and avoiding conflicts of interest are important

conditions for DTC decisions to be respected in clinical practice. This is especially

important in hospitals that deal with innovation and tertiary care. Members should

preferably not be connected with the pharmaceutical industry. In case some kind of

relationship exists, this connection must be clearly stated in Conflict of Interest

statements [29].

Dutch and Australian studies have reported situations in which the adoption

process did not seem to be entirely regulated in the scope of the DTC. In the

Netherlands, responsibilities of some hospital DTCs were transferred to the pharmacy

department. Routine prescription of non-formulary drugs, as well as the use of samples


donated by manufacturers, are both examples of circumstances that resulted in uncritical

adoption, since they bypassed the formal evaluation process that preceded adoption in

some hospitals in those countries [34,52].

In the United States, DTCs are reported as working in a formal manner, with an

agenda, meeting minutes and outcomes, e.g. the publication of institutional policies,

formularies and therapeutic protocols. If compared to that level of organization, in other

countries DTC operations often appear less formal and effective [32]. Inadequate DTC

structures and organizations were considered barriers to their implementation in Dutch

and Australian hospitals [34,52] and affected the formularies [51]. These problems were

due mainly to a lack of clinical pharmacologists and medical specialists as committee

members or to a lack of resources for comprehensive drug evaluation.

Physicians and DTC members are prone to involvement with the pharmaceutical

industry. Funding for educational meetings and training courses, and funding for

clinical research received from manufacturers are some of the frequent opportunities the

pharmaceutical industry is using to influence members [23]. The Wise List process

shows a comprehensive policy on conflict of interest. Members share values and

manifest conflict when existent [3]. The WHO [29] goes a step further and suggests that

members with potential conflicts should abstain from such relationships or not be part

of the medicines selection process.

Studies describing DTC experiences in countries did not always mention conflict

of interest precautions with the exception of Scotland and Sweden [3,9]. Farmer and

Nelson [53] reported that most (76%) individuals interviewed from 38 DTCs in

American university hospitals were not formally instructed on potential conflicts of

interest.


An important aspect of DTC success, and resulting quality of formularies, lies in

the recruitment of physicians knowledgeable in clinical pharmacology with research and

teaching experience, as well as in the adherence to clear criteria and procedures [3,9,20,

21,54]. Similarly, formularies encompassing primary and secondary care are well

accepted in Scotland with clear principles of drug selection enhanced by including

professionals knowledgeable in the disease areas and in clinical pharmacology [9].

University hospitals in Brazil present heterogeneity. Size, type of management,

legal nature, facilities, staff requirements and training are very different. Adjustments

are somewhat accomplished within the level of care. An additional cause of lack of

uniformity, is the fact that university hospitals are regulated by the Ministry of

Education and not by the Ministry of Health [25], which drafts clinical guidelines and

enforces sanitary regulations and policies.

Although recommended in teaching hospitals by the Ministry of Education,

DTCs are by law not mandatory in Brazil [27]. A study conducted with a sample of 250

hospitals in Brazil in 2003 found that only 29 had a DTC, and of these, only nine were

active [28]. Most of the hospitals that presented a DTC were complex university

facilities. However, data also showed that the adoption of new high-cost medicines was

frequently conducted outside the DTC and suggests that adoption of new medicines in

these settings may occur uncritically and informally by management. Hospital

procurement lists were frequently and inadequately accepted as a therapeutic formulary

in major university hospitals. Inclusion in this procurement list is not subject to

evidence-based selection, but the result of managerial choices or pressures from

prescribers and industry [16,17].


However, processes, organization and documentation of HCPA’s Comedi were

similar to the model recommended by the WHO [29]. The committee possessed an

independent structure with adequate facilities. It was administratively linked to the Unit

of Clinical Pharmacology. Since 1991, there have been eight published versions of the

hospital formulary (the last version was published in 2008 and a new one is in

development). DTC regulations are constantly updated and available to hospital staff.

Newsletters and bulletins on medicines and drug utilization are published periodically.

Executive members monitored drug prescribing on a daily basis. Observation of

Comedi’s structure and functions and of formulary management at HCPA indicated the

feasibility of application of international recommendations in Brazil.

In HCPA, consultative members include two full professors from the

Pharmacology Department with experience in clinical pharmacology, as well as one full

professor from the School of Nursing and the Head of the Pharmacy Service. Four other

members had executive functions: three physicians (general practitioners) and a

pharmacist officially designated by the hospital director. Clinical specialists contributed

as ad hoc consultants. The committee convenes weekly.

Aspects regarding conflict of interest are especially important in Brazilian

university hospitals. Close involvement of the pharmaceutical industry with students

and staff at these hospitals is common. Marketing is intense and invasive. Manufacturer

representatives are usually seen inside facilities, promoting innovations and providing

simple novelties to re-enforce the message and drug name as well as distributing

samples [56]. However, many physicians that recognize their involvement with the

pharmaceutical industry hesitate in admitting its influence on their daily practice. Over

98% of university hospital physicians admit receiving pharmaceutical company


representatives; 86% receive gifts and 14% actually admit prescribing medicines in

return for prizes and other amenities [56, 57]. Moreover, the influence on medical

students may also be pervasive, because it favours the habit of accepting not only

compensations but biased information which may pose a risk to their future patients

[56].

At the HCPA, according to WHO recommendations, all Comedi members must declare

in writing any connections with the pharmaceutical industry. Members involved in any

drug promotion or marketing activities are not allowed on the committee. No extra

monetary compensation for Committee members is allowed. Comedi’s experience

shows that there is a way to guarantee availability and involvement of key health

professionals in Brazilian settings, keeping a safe distance from potential conflict.

Criteria and methods for medicines selection: review on how Brazilian experience accords

to international reports

Efficacy, safety and cost-effectiveness are identified by the WHO as essential criteria

for selecting new drugs [29].

Search for quality evidence must be centered on systematic reviews of the literature and

meta-analysis and on treatment guidelines published by governments or medical

societies [33,34,44,50]. This must be highlighted as a best practice for DTCs. Lower

ranking information (in the hierarchy of evidence) includes oral communications given

by specialists at meetings and conferences, or published in case reports or made

available by the pharmaceutical industry [33,34,44].

Competence in the critical assessment of drugs is essential to DTC membership, when

considering the pressures to adopt new medicines especially in a tertiary care

environment. Consequently, training in clinical pharmacology is a crucial aspect for


successful DTCs [3,20]. Joint involvement of primary care physicians and hospital

specialists in DTCs is also a key aspect as these complement each other and give scope

to formulary decisions and balance narrow super-specialist aspects on the role a new

drug option [3,9,29,33,34,47,58].

Dissemination of information on products by DTC members also appears to be a key

aspect that makes all the difference in the implementation of drug recommendations

from DTCs in hospitals and ambulatory care. Adequate communication, exchange and

follow-up with all physicians and other health professionals will help with

implementation of formulary guidance [3,9,59].

The context in which this paper specifically intends to examine DTCs is the

teaching hospital. In spite of the fact that DTCs should have the same central role

wherever they exist, i.e. selection of essential medicines in healthcare facilities and

systems, extra care must be taken to ensure compliance to best practice in tertiary care

facilities. This does not always happen since the pressures for adoption of new

medicines are much higher and comparative evaluation not always forthcoming. These

medicines have typically had only a short market history and basically more, if any,

data on efficacy than on safety.

In addition, there are concerns that the patient population in clinical trials may

be different to that seen in clinical practice with greater co-morbidities [1]. Typically

Phase III clinical trials are conducted under ideal and highly controlled conditions to

seek high internal validity to enhance the potential of demonstrating clinical benefit [1].

However, this may lead to substantial differences from their subsequent use in clinical

practice with generally Phase III clinical trials not including treatment preferences

and/or multimodal treatment programmes [1]. These points are particularly important in


teaching hospital environments with complex co-morbid patients. Without such

guidance, new drugs may be withdrawn due to unacceptable risk:benefit ratios in

routine clinical practice [1].

In Dutch and Australian hospitals, information pertaining to risks of use was

considered decisive for selection [34,46] while pharmacological data on drug efficacy

was a crucial domain in the USA, Sweden and the United Kingdom [36,44,60]. In a

number of countries, it was considered that the medicines selection process is

potentially influenced by political, social and ethical issues, such as drug financing,

pressures from patient groups, specialists’ opinions (peers, university professors and

members of medical societies) and marketing. These issues should be balanced by the

independent expert opinion in the DTC [33-35,40,48,54].

Surprisingly, ranking the level of evidence and stringency as to the use of the

best evidence available [21] were issues not typically mentioned or discussed in country

experiences, although this procedure is part of the selection criteria for the Wise List in

Stockholm County [3].

The Wise List experience in Stockholm shows that personal contact (visits) with

ambulatory care physicians by physicians and pharmacists employed by the County

Council to disseminate materials and exchange information enhances prescriber

adherence to the list [3,9], being founded on evidence-based academic detailing [60]

and comprehensive communication strategies adapted to the needs of various prescriber

and patient groups [3]. Similarly, adherence to formularies in Scotland is enhanced by

joint development of formularies involving different professionals and

pharmacotherapeutic experts as well as Health Board monitoring of physician behaviour

[7,59].


Brazil started organizing health technology assessment processes beginning in

2003. The federal government began fostering research and binding use of best

evidence and rational use to clinical, managerial and political decisions in the health

system. For this purpose, one initiative under implementation is the Health Technology

Assessment Centers (Núcleo de Avaliação de Tecnologias - NATS). Since 2009, 29

NATSs have been set up in university hospitals throughout the country [16].

In spite of this effort, in Brazilian hospitals, the importance given to specialists

commonly subverts organizational procedures. The power and authority conferred to

specialized physicians mark them as independent agents which govern independent

departments. In certain cases, the fragmentation brought by senior professors’

behaviours leads to multiple ‘institutes’ within departments. It also results in a certain

detachment and lack of institutional commitment, making uniform procedures and

adoption of protocols impossible to establish, hospital-wise [62]. Facing and changing

this situation is essential to improve rational adoption and use of new technologies and

legitimize the decision-making process.

At the HCPA, efficacy and safety were understood as the first essential

conditions in the process of adopting a new drug. When confronting two equally safe

and efficacious options, the focus shifts to comparative cost-effectiveness [31]. The use

of high-ranking evidence is also common practice at HCPA.

HCPA maintains all information on requests, assessments and decisions

regarding the adoption of new drugs on the institutional webpage, which warrants

transparency of the selection process. This may, however, if not directly guaranteeing

involvement of hospital staff, promote sharing and dissemination of drug information

and adherence to drug formulary [29].


In countries such as Brazil, where oftentimes research data produced in loco is

not available [41], DTC work in evaluating evidence is essential to guide better clinical

decisions.

A theoretical model for assessing the selection process by DTCs in tertiary

Brazilian hospitals

According to the WHO, a crucial condition to achieve efficient management of new

technologies - such as drugs - in healthcare services is the institution of a forum that

gathers physicians, clinical pharmacologists, pharmacists and managers, to achieve a

balance between meeting the needs of quality health care and resource constraints [24].

The responsibility of DTCs is thus clearly defined: electing the best therapeutic options

through a systematic, multidisciplinary and transparent process, based on independent

information and objective evaluation with the contribution of the best available experts

[29].

Overall, the state of the art on drug selection in hospitals presented elements related to

the structure, activity and roles of multidisciplinary committees, i.e., DTCs. Selection

criteria and use of evidence, as well as factors that influenced decision-making were

highlighted. Aspects pertaining to the demand for adoption of new technologies by

healthcare services, such as the lack of available treatments for a wide range of health

problems, marketing strategies for the promotion of new pharmaceuticals and the

relationship between prescribers and the pharmaceutical industry were widely discussed

in the literature.


The USA and Canada [32,34,43-45,48,50,61,64], as well as European countries

[3,23,33-35, 38,39,51,66-69], Australia and Asian countries describe the evaluation of

new drugs by DTCs and experiences gathered with the implementation of

multidisciplinary forums in hospitals [39,46,47,49,52,55,58,70]. One Brazilian study

[27] that discussed the selection of drugs by a DTC was found. No publications from

other Latin American countries on DTCs were forthcoming.

Results that emerged from this discussion led to three main dimensions: (i) what

motivates the adoption of new drugs on the essential medicines list; (ii) what structural

and organizational aspects are necessary for decision-making; and (iii) what criteria and

methods the decision-making process employs. This may be organized in a simple

framework (table 1).

Perspectives for application of this framework are under way, in four major university

hospitals in Rio de Janeiro as a recommended tool for assessing adoption of new drugs

in these healthcare settings. We will report on their utility and acceptance in future

publications.

Final Comments

We believe this discussion gives insight into the role of DTCs in the drug selection

process and opens perspectives for their implementation in tertiary Brazilian hospitals.

We found very few publications in Brazil regarding DTCs as well as the criteria and

methodology for including new medicines in formularies. However, the country has a

large public health system which is committed to comprehensive universal care, thus

bringing forth the need to strengthen effective and safe selection of new drugs for the

system as a public health priority. University hospitals are environments that foster the


adoption of new technologies, and considered as a gateway to the entire system for

these technologies.

WHO recommendations, the experiences of other countries, as well as of the

Brazilian HCPA gold-standard, and especially descriptions of the Brazilian context,

provide information as to whether WHO and other recommendations can be adopted by

committees in diverse scenarios.

The discussion brought forth information with respect to structure, membership,

functions and DTC criteria as well as providing a great number of examples, especially

regarding difficulties experienced by DTCs. Important differences in how those

multidisciplinary forums were organized and in how they achieved their goals were

observed. In this respect, descriptions of North American and Australian committees

stand out, because of the number and quality of published experiences.

This study has limitations. We acknowledge the state-of-the-art was limited to three

large-scale databases. We did not aim to produce a systematic review. However,

because we intended to bring the discussion to Brazilian hospitals and to the Brazilian

healthcare setting, these databases represent the most consulted ones with respect to

collective and public health in Brazil. We also highlight that most of the aspects that

were discussed found corroboration in the WHO DTC guidelines and were addressed by

guidelines of the Brazilian gold-standard.

There were also limitations with regard to language – consulted experiences were

limited to publications in English, Spanish and Portuguese. Again, we believe this is

acceptable since most sites concentrate on English language publications which are

retrieved by the health professions in Brazil. A single gold-standard was also chosen for

examination of drug selection in a tertiary hospital. We also believe this is acceptable

since the experience of the HCPA is unique in the country.


In Brazil, the assessment of drugs by multidisciplinary committees in healthcare

services has not been frequently described or discussed. We believe this is an important

finding and adds weight to the rationale behind this paper. However, despite the

potential for application in scenarios were selection of medicines is under way, this

analytical framework should be researched and challenged in other facilities to

investigate whether the processes need refining in wider and more diverse settings. In

regard to the level of care, different interests and players involved in formulary

decision-making, we estimate that the framework, developed according to the state of

the art and grounded in real and current experience in Brazil, may contribute to

knowledge on drug selection in tertiary hospitals and perhaps other health facilities that

present a drug selection process. Consequently, we hope other hospitals will review the

suggested approach and adopt it to their settings.

We emphasize that the scope of this discussion may be addressed by all tertiary

hospitals reviewing selection processes. A national gold-standard DTC, compliant to all

WHO recommendations, subject to the same influences and shortcomings that are

encountered elsewhere in Brazil was able to surmount difficulties and adhere to best

practices. This paper aims to show that reproducing this experience may be possible,

given necessary attention to each aspect discussed, ultimately leading to the

improvement of the quality and efficiency of prescribing, given increasing resource

pressures.

Competing interests

The authors declare that they have no competing interests.


Acknowledgements

We thank the Comedi at PAGH of the Federal University of Rio Grande do Sul

(UFRGS), and especially Dr. Leila Beltrami Moreira (Coordinator of Comedi) for

generously collaborating with our research.

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Table 1: Analytical framework for assessing drug and therapeutics committee structure and

processes in Brazilian hospitals

MOTIVATION FOR ADOPTION OF NEW DRUGS

Defining needs Epidemiological profile and priority needs of the hospital population or groups of

patients

Defining nature and

source of initial

information about

the new drug

Publication of new data about the drug in scientific journals

Medical staff contact with the drug through involvement in clinical research

Drug promotion at academic events, such as seminars and meetings or visits from

pharmaceutical sales representatives, donations and free samples

STRUCTURE AND ORGANIZATION FOR SELECTION

Defining structure Characterization of the decision-making process (mandate)

Technical-administrative support for committee (office space, human resources,

access to databases)

Documenting decisions, policies and guidelines as permanent hospital records.

Support and monitoring of activities by hospital board or clinical director

Proposals and alternatives to distance committee members from potential

conflicts of interest

Defining committee

membership and

participation criteria

Multidisciplinary membership; physicians (representing major specialties,

including surgery, obstetrics and gynaecology, internal medicine, paediatrics,

infectious diseases), clinical pharmacologists, pharmacists, nurses and managers

(representing the hospital’s board of directors)

Criteria for member participation and detailing member role

Formal designation of membership, workload and term

Presence of ad hoc consultants

Defining committee Evaluation of new drugs


roles and

responsibilities

Drafting list as final product of selection (formulary)

Developing drug use policies (non-selected drugs, research with new drugs, free

samples, limited use for certain patients, etc.)

Developing and monitoring therapeutic guidelines

Advice on drugs to the hospital’s entire board of directors

CRITERIA AND METHODS FOR SELECTION

Defining selection

criteria

Main criteria: drug registration with the relevant agency; need; efficacy and

effectiveness; safety and cost

Secondary criteria: epidemiological importance of health condition or its

complications; dosage form, manner and ease of administration; availability;

drug storage; existence of economic evaluation

Influence of other aspects: experimental use (clinical research); affordability and

funding; reimbursement; pressure from patient groups (organized into

associations or not), from physicians and/or industry

Defining methods

used throughout the

drug evaluation and

selection process

Modus operandi: Organization and forwarding of requests for evaluation;

frequency of committee meetings; existence and type of information included in

request for a new drug; policies for prescription of non-selected drugs

Comparative analysis of best evidence available, considering the study design

and quality and study outcomes

Drafting of evidence-based expert reviews

Other alternative methodologies used in drug adoption

Process transparency and dissemination

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