Guide to Pain Management in Low-Resource Settings


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part of making the human right to pain relief a reality.
References
[1]  De Lima L, Krakauer EL, Lorenz K, Praill D, Macdonald N, Doyle D. 
Ensuring palliative medicine availability: the development of the IAH-
PC list of essential medicines for palliative care. J Pain Symptom Man-
age 2007;33:521–6.
[2]  Foley KM, Wagner JL, Joranson DE, Gelband H. Pain control for peo-
ple with cancer and AIDS. In: Jamison DT, Breman JG, Measham AR, 
Alleyne G, Claeson M, Evans DB, editors. Disease control priorities in 
developing countries, 2nd edition. New York: Oxford University Press; 
2006. p. 981–93. Available at: http://fi les.dcp2.org/pdf/DCP/DCP52.pdf.
[3]  Human Rights Watch. Please do not make us suff er anymore. March 3, 
2009. Available at: http://www.hrw.org.
[4]  International Narcotics Control Board. Report of the International Nar-
cotics Control Board for 1995. Availability of opiates for medical needs. 
New York: United Nations; 1996. Available at: www.incb.org/pdf/e/
ar/1995/suppl1en.pdf.
[5]  Joranson DE, Rajagopal MR, Gilson AM. Improving access to opi-
oid analgesics for palliative care in India. J Pain Symptom Man-
age 2002;24:152–9. Available at: http://www.painpolicy.wisc.edu/
publicat/02jpsm3/index.htm.
[6]  Joranson DE, Ryan KM. Ensuring opioid availability: methods and re-
sources. J Pain Symptom Manage 2007;33:527–32. Available at: www.
painpolicy.wisc.edu/publicat/07jpsm/07jpsm.pdf.
[7]  Joranson DE, Ryan KM, Maurer MA. Opioid policy, availability, and 
access in developing and nonindustrialized countries. In: Fishman SM, 
Ballantyne JC, Rathmell JP, editors. Bonica’s management of pain, 4th 
edition. Baltimore: Lippincott Williams & Wilkins; 2010. p. 194–208.
[8]  Pain and Policy Studies Group. Internet course: Increasing patient ac-
cess to pain medicines around the world: a framework to improve na-
tional policies that govern drug distribution. University of Wisconsin 
Paul P. Carbone Comprehensive Cancer Center. Available at: www.pain-
policy.wisc.edu/on-line_course/welcome.htm.
[9]  Rajagopal MR, Joranson DE, Gilson AM. Medical use, misuse, and di-
version of opioids in India. Lancet. 2001; 358(9276):139–143.
[10] World Health Organization. Essential medicines. Geneva: World 
Health Organization; 2005. Available at: www.who.int/topics/essential_
medicines/en.
[11]  World Health Organization. Cancer pain relief: with a guide to opioid 
availability, 2nd edition. Geneva: World Health Organization; 1996. 
Available at: http://whqlibdoc.who.int/publications/9241544821.pdf.
[12] World Health Organization. Achieving balance in national opi-
oids control policy: guidelines for assessment. Geneva: World 
Health Organization; 2000. Available at: www.painpolicy.wisc.edu/
publicat/00whoabi/00whoabi.htm.
[13]  World Health Organization. Access to controlled medications program. 
Geneva: World Health Organization; 2007. Available at: www.who.int/
medicines/areas/quality_safety/access_to_controlled_medications_
brnote_english.pdf.
Recommended websites
Pain & Policy Studies Group: www.painpolicy.wisc.edu/
World Health Organization: www.who.int/medicines/
International Narcotics Control Board: www.incb.org
International Association for Hospice and Palliative Care: www.hospicecare.
com/

329
Guide to Pain Management in Low-Resource Settings, edited by Andreas Kopf and Nilesh B. Patel. IASP, Seattle, © 2010. All rights reserved. Th
  is material may be used for educational 
and training purposes with proper citation of the source. Not for sale or commercial use. No responsibility is assumed by IASP for any injury and/or damage to persons or property 
as a matter of product liability, negligence, or from any use of any methods, products, instruction, or ideas contained in the material herein. Because of the rapid advances in the 
medical sciences, the publisher recommends that there should be independent verifi cation of diagnoses and drug dosages. Th
  e mention of specifi c pharmaceutical products and any 
medical procedure does not imply endorsement or recommendation by the editors, authors, or IASP in favor of other medical products or procedures that are not covered in the text.
Guide to Pain Management in Low-Resource Settings
Uriah Guevara-Lopez and Alfredo Covarrubias-Gomez
Chapter 44
Setting up Guidelines for Local Requirements
Case report
A 65-year-old Mexican woman reported generalized ab-
dominal pain. She went to a rural medical practitioner 
in San Juan de Bautista, who prescribed 30 mg of ketoro-
lac t.i.d. After 2 days the pain had not stopped, and she 
returned for medical assistance; this time, the physician 
added to his prescription 90 mg of etoricoxib per day. Af-
ter two more days, the pain continued, and the woman 
went to a regional hospital located 10 miles from her 
home in Lloredo. In the hospital a uterine cancer with 
omental and liver metastasis was diagnosed, and ad-
equate pain management was provided.
Th
 e prescription from the rural practitioner 
drew the attention of local health authorities. Th
 ey 
asked the clinician about his prescription and about his 
knowledge about Mexican practice guidelines for cancer 
pain management. Th
  e physician responded that he had 
heard of them but he did not know about their content or 
recommendations, although he had received education 
on Mexican practice guidelines for pain management: he 
had attended a 1-month fellowship in the regional hospi-
tal, and was also encouraged to promote education to lo-
cal organizations about the guidelines and their benefi ts. 
A follow-up program for pain management evaluation 
in his community was established.
So what went wrong?
What are practice guidelines?
Th
  e original concept of practice guidelines (PGs) was 
described as “a recommendation for patient manage-
ment that identifi es one or more strategies for treat-
ment”. However, in 1990, the Institute of Medicine in the 
United States defi ned PGs as “systematically developed 
statements to assist practitioner and patient decisions 
about appropriate health care for specifi c clinical cir-
cumstances” (see Table 1). Th
 is defi nition had been gen-
erally accepted.
Guidelines are not rules or standards; they are 
helpful, fl exible syntheses of all the available, relevant, 
good-quality information applicable to a particular clin-
ical situation that the clinician and patient need to make 
a good decision. Since medical knowledge, techniques, 
and technology are in constant development; PG must 
be actualized and improved in certain time intervals.
Why do we need                       
practice guidelines?
Medical knowledge is under a continuous evolution. 
Assume, that a physician knows everything about a dis-
ease or its treatment on the basis of training and clini-
cal judgement, but continuing medical education was 
not available. Since there is a great chance, that medi-
cal concepts have changed meanwhile, the physician’s 

330
Uriah Guevara-Lopez and Alfredo Covarrubias-Gomez
diagnostic and therapeutic approaches are outdated 
meaning either impaired effi
  cacy or decreased safety.
Th
  e speed of medical evolution has complicated 
medical decision making; for that reason, PG may be 
used as an instrument to assist the clinician. Th
 is objec-
tive is possible because PG summarizes the collective ex-
perience and establishes grades to scientifi c knowledge.
Are there diff erent types                    
of practice guidelines?
Attempts to regulate PG had been made since the early 
1980s. Nowadays, diff erent types of practice guidelines 
can be identifi ed: (i) for the diagnosis and management 
of specifi c clinical circumstances, (ii) for risk manage-
ment, (iii) for the improvement of quality systems, (iv) 
for medical regulation, (v) for education, and (vi) for 
preventive care.
Why do we need practice guidelines 
for pain management?
Pain is considered a health problem in few countries, 
but the number of countries where pain management 
becomes a health care priority is increasing. Th
 e de-
velopment of PG in pain medicine is supported by 
the following issues: (i) the number of surgical inter-
ventions is increasing in many low-resource countries 
without any concept to control postoperative pain; (ii) 
the demographic change (increase of older population) 
worldwide will be associated with a growing preva-
lence of cancer pain; (iii) the frequency of chronic non 
cancer pain is recognized more today, for which it has 
been estimated, that the annual treatment costs equal 
or exceed exceeds those for coronary disease, cancer 
and AIDS.
Additionally, pain has a signifi cant impact on 
physical function and activity, return-to-work-quota, 
social and family relations as well as the general psy-
choaff ective state of the aff ected patient. Th
  is may prove 
to be a burden for the family of the patient, but also to 
the society as a whole, since insuffi
  cient  pain  manage-
ment is a major cause for increased use of health care 
resources. Th
  erefore, health care policies need the im-
plementation of rationalized instruments that can op-
timize and improve the quality of medical attention for 
the most relevant diseases including pain syndromes.
How are practice guidelines 
developed?
Th
  ere is a general agreement, that PG must be submit-
ted to public scrutiny, revised regularly in response to 
medical advances, and derived from high quality scien-
tifi c evidence. PG must be easy to comprehend, inclu-
sive, and manageable. Th
  e method for evidence selec-
tion must be explained and the criteria used to grade 
each recommendation must be explained.
Protocols for developing guidelines have many 
common features: (i) Reviews of existing research fi nd-
ings are conducted, often with the aid of the National 
Library of Medicine. (ii) Studies are selected according 
to predetermined criteria and fi ndings are summarized 
using techniques such as meta-analysis or systematic 
reviews. (iii) Panels of experts are convened and guide-
lines are revised according to feedback received. (iv) 
Consensus is achieved in some areas; and where dis-
agreement or uncertainty remains and more research is 
needed, the developers describe this defi ciency.
Strategies for developing PG have been pro-
posed by diverse groups worldwide, a summary of those 
is described in Table 2.
Table 1
Defi nition of practice guidelines and other terms that are confused with practice guidelines
Concept
Defi nition
Practice guidelines
A systematically developed statement to assist practitioner and patient decisions about appropriate 
health care for specifi c clinical circumstances. “Protocol” is often used interchangeably with “guideline,” 
although some view “practice protocols” as a more specifi c (procedure- or specialty-specifi c) form of 
practice guidelines.
Clinical pathways
An optimal sequencing and timing of interventions for a particular diagnosis or procedure. A “care 
map” or multidisciplinary action plan extends the concept of a clinical pathway by including an outcome 
index, which allows for the evaluation of the interventions.
Clinical algorithms
A more complex set of instructions containing conditional logic, usually expressed in branching trees.
Information extracted from: Henning [4]. 

Setting up Guidelines for Local Requirements
331
How does the scientifi c evidence 
grade the recommendations            
of practice guidelines?
In 1979, the Canadian Task Force on Periodic Health 
Examination made the fi rst  eff orts to characterize the 
level of evidence underlying health care recommenda-
tions and their strength. Since then, a wide variety of 
methods have been developed for “grading” the strength 
of the evidence on which recommendations are made.
Grading methods take into account the study 
design, benefi ts and harms, and outcome (Canadi-
an Task Force, U.S. Preventive Services Task Force, 
GRADE working group, SIGN method, SORT taxon-
omy, etc.). A description of a strategy for grading the 
evidence according to the methodology of the study is 
described here:
•  Level 1: Evidence is extracted from systematic re-
views of relevant controlled clinical trials (with 
meta-analysis when possible)
Table 2
Strategies used for developing practice guidelines
Strategy
Description
Identifi cation of a 
regional medical 
problem
A regional health problem is identifi ed. Th
  e impact of this problem on the population and the usefulness of 
practice guidelines is analyzed. If needed, a consensus group for the development of guidelines (for manage-
ment, care, diagnosis, etc.) is formed.
Selection of a group 
of experts
Formed by specialists from areas related to the guideline topic. Selection criteria include experience (more 
than 5 years) in this particular fi eld, in clinical research, in grading the evidence for recommendations, and/
or an academic profi le. Clinical practitioners recommended from the national medical associations related to 
this specifi c area are also included. Experts must not have any confl ict of interest.
Identifying medical 
tendencies
A questionnaire to evaluate the medical tendencies (for diagnosis, management, care, etc.) is developed by the 
group of experts. Items on the questionnaire are based on the statements made by other consensus groups, 
clinical guidelines, clinical pathways, or clinical algorithms. Results from questionnaires are sent to the se-
lected experts.
Review of the 
literature
From the selected guideline topic, a focused review of the literature is made. Th
  is process is achieved using 
diverse electronic medical databases (PubMed, EMBASE, LILACS, and others). Cross-reference of selected 
documents is made. Resources to obtain references are provided by the national institutes of health, national 
medical associations, and nonprofi t organizations.
Sending evidence to 
the selected experts
Results from the review of the literature are send to the group of selected experts. Th
  e objective is that every 
participant have the opportunity to analyze the literature before the consensus meeting.
Elaborating recom-
mendations
A consensus meeting is held to analyze the results obtained from the questionnaire and to develop specifi c 
recommendations (for management, diagnosis, education, care, etc.). Every recommendation is considered for 
further review based on the group’s expertise and the results from the review of the literature.
Preliminary results
From the consensus meeting a preliminary report is obtained. Each of the recommendations is submitted to 
a focused review of the scientifi c evidence. Meta-analysis, systematic reviews, randomized controlled trials, 
randomized uncontrolled trials, and case reports for each specifi c recommendation are analyzed. If there are 
no studies, the recommendation is “based on consensus group expertise.” Results from this search are sent to 
the group of experts.
Grading recom-
mendations
Feedback from the group of experts about the evidence to endorse a recommendation is analyzed. Th
 e 
method for grading for every recommendation is described in Table 3.
Preliminary practice 
guidelines
A preliminary document is sent to the consensus group. Final notes from the participants are considered, and 
a fi nal document is elaborated.
Review of the fi nal 
document
Th
 e fi nal document is sent to the participants for approval (as many times as needed). After this process is 
completed, the document is sent for publication in a peer-reviewed journal.
Implementation of 
guidelines
Extensive education among clinicians, health care administrators, policy makers, benefi t managers, and 
patients and their families is performed in every fi liation center from each consensus participant. Conferences 
at regional congresses or medical meetings are provided. Local eff orts to implement guidelines require the 
commitment of the participants.
Follow-up and 
evaluation of the 
guidelines
A questionnaire designed to evaluate clinicians’ knowledge of the guidelines or their outcome is performed. 
Evaluation is obtained by the method developed by the AGREE Collaboration Group.
Information extracted from: Frances [ref. 2], Guevara-López et al. [ref. 3]. AGREE Collaboration Group: www.agreecollaboration.org; 
National Institute for Health and Clinical Excellence (UK): www.nice.org.uk.

332
Uriah Guevara-Lopez and Alfredo Covarrubias-Gomez
•  Level 2: Evidence is extracted from one or more 
well-designed randomized controlled clinical trials
•  Level 3: Evidence is extracted from well-designed 
nonrandomized clinical trials or well-designed 
cohort studies or analytic case reports (if possible 
multicenter or performed at diff erent times)
•  Level 4: Evidence is extracted from expert opin-
ions and/or opinion leaders (supported if possible 
by the reports from other consensus statements)
Th
  e evidence can be converted into recommen-
dations (type A, B, or C) and the “strength of evidence 
and maximum benefi t” (Class A to Class E), depending 
on how advisable the use of a specifi c treatment or in-
tervention is (Class A = highly advisable and Class E = 
insuffi
  cient evidence).
How are practice guidelines 
evaluated?
Th
  e quality of clinical practice guidelines must be evalu-
ated and diverse methods to achieve this propose have 
been reported. Th
  ere are three basic stages of evalua-
tion: (i) evaluation during the development of guidelines 
and before their full dissemination and implementa-
tion (inception evaluation); (ii) evaluation of health care 
programs within which guidelines play a central role 
(guidelines-program evaluation); and (iii) evaluation of 
the eff ects of guidelines within defi ned health care envi-
ronments (scientifi c evaluation).
Th
  e evaluation of PGs also includes the identi-
fi cation of potential biases of guideline development, 
and the assurance that recommendations are valid and 
feasible for practice. Th
  is evaluation process takes into 
account the benefi ts, harms, and costs of the recom-
mendations, as well as the practical issues attached to 
them. Th
  erefore, the assessment of PGs includes judg-
ments about the methods used for its development, the 
content of the fi nal recommendations, and the factors 
linked to their uptake.
How can practice guidelines be 
implemented?
Th
  e fact that most PGs have been published and then 
forgotten has to do with the lack of eff orts for their 
implementation. Th
  e acceptance of PGs requires ex-
tensive education among clinicians, health care ad-
ministrators, policy makers, benefi t managers, and 
patients and their families. Th
  erefore, PGs must in-
troduce a comprehensive and integrative strategy for 
their implementation.
An implementation strategy relies on informing 
and educating physicians about the content of guide-
lines. Impersonal approaches that use the dissemina-
tion of written material alone or presentations to large 
audiences have not been very successful. Education of 
a specifi c PG must be personalized, involve respected 
physician leaders and incorporate a high degree of in-
teraction between the target audience and those pre-
senting the information.
Comparison of actual performance with the per-
formance that would be expected if the guidelines were 
followed may be used as a feedback strategy to achieve 
PG implementation. Feedback can occur either as the 
service is being provided (concurrent feedback) or after 
that service has been provided (retrospective feedback).
A physician’s knowledge of PGs to obtain 
board recertifi cation has been described as an useful 
strategy for guideline implementation. For that reason, 
medical associations or medical boards should be part 
of PG implementation strategies. Th
  eir role could be 
to generate distance learning programs and continu-
ing medical education (CME) certifi cation on the PG 
contents. To add (and receive) the support from health 
care administrators and policy makers, it is advisable 
to stress the economical impact of PGs (which usually 
attracts their attention!).
Finally, education of patients and their families 
as well as the public about the potential benefi ts  ob-
tained by PG must be part of the implementation pro-
cess. Th
  ese educational eff orts may be extended to non-
governmental organizations.
How do clinicians respond               
to practice guidelines?
Th
  e impact of guidelines on the behavior of physicians 
has been poorly documented, although some reports 
documented a considerable disappointment with PGs. 
Other studies show that physicians are generally posi-
tive about guidelines but that they do not integrate 
them into their practices to a large extent. Th
 e reason 
for this ambivalent behavior lies in problems associ-
ated with their production, dissemination, and use. 
However, little is known about physicians’ (and pa-
tients’) attitudes and suspicions toward PGs, as well as 

Setting up Guidelines for Local Requirements
333
regarding the motives for encouraging their use or as 
to their credibility. Th
  is has been recognized as a defi -
cit, since certain motives could cause practitioners and 
their patients to resist PGs.
Some studies indicate that the physician’s ad-
herence to guidelines may be hindered by a variety of 
barriers. Identifi ed were: (i) awareness, (ii) familiarity, 
(iii) agreement, (iv) self-effi
  cacy, (v) outcome expec-
tancy, (vi) ability to overcome the inertia of previous 
practice, and (vii) absence of external barriers to per-
form recommendations.
Another factor that may slow down adherence 
by physicians to PGs may be the dogmatic educational 
background. For example, Canadian family physicians 
show little resistance to guidelines and appear to need 
less threat of external control to incorporate them into 
their practice. On the other hand, American internists 
are less supportive of PGs. It is possible that informa-
tion acquired from medical training may play a role in 
PG support from practitioners. Th
  erefore, the develop-
ment of PGs must include lecturers and opinion lead-
ers at medical schools and respected organizations to 
foster dissemination.
Th
  e clarity and readability and the clinical ap-
plicability of a guideline are other elements that con-
tribute to the acceptance of guidelines by clinicians. 
In conclusion, PGs must be written in a user-friendly 
way, adapted to the practical needs of the clinician’s 
daily practice, and advocated thoroughly by medical 
boards, opinion leaders, and medical societies. If the 
implementation of a PG is successful, the results for 
patient safety are encouraging.
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