Journal of Pharmaceutical Care in Pain & Symptom

Control

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Governmental Barriers to Opioid Availability in

Developing Countries

Denise M. MacDonald (Faculty) & G. Allen Finley (Associate Professor and

Faculty)

To cite this article: Denise M. MacDonald (Faculty) & G. Allen Finley (Associate Professor and
Faculty) (2001) Governmental Barriers to Opioid Availability in Developing Countries, Journal of
Pharmaceutical Care in Pain & Symptom Control, 9:1, 5-23, DOI: 10.1300/J088v09n01_02

To link to this article: https://doi.org/10.1300/J088v09n01_02

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 ARTICLES

Governmental Barriers
to Opioid Availability
in Developing Countries
Denise M. MacDonald
G. Allen Finley

ABSTRACT. Although management of cancer pain is relatively easy

to accomplish in most cases, patients in many developing and devel-
oped countries are deprived access to appropriate analgesic medications
due to governmental, bureaucratic, and physician barriers, such as re-
strictions on quantity, type, and storage of drugs. Many of these govern-
mental and bureaucratic barriers are discussed as are steps being taken
to overcome them in the different countries. [Article copies available for a
fee from The Haworth Document Delivery Service: 1-800-342-9678. E-mail
address: <[email protected]> Website: <http://www.HaworthPress.
com> E 2001 by The Haworth Press, Inc. All rights reserved.]

KEYWORDS. Opioids, cancer, pain, palliative care, narcotic, control,

international, INCB, world, health, WHO, barriers, availability, Kenya,

Denise M. MacDonald, BSc, is a medical student and G. Allen Finley, MD,

FRCPC, is Associate Professor of Anesthesiology and Psychology, Faculty of Medi-
cine, Dalhousie University, Halifax, Nova Scotia.
Address correspondence to: Dr. G. Allen Finley, Pediatric Anesthesia, IWK Grace
Health Centre, 5850 University Avenue, Halifax, NS, B3J 3G9, Canada (E-mail: allen.
[email protected]).
Journal of Pharmaceutical Care in Pain & Symptom Control, Vol. 9(1) 2001
E 2001 by The Haworth Press, Inc. All rights reserved. 5
6 Journal of Pharmaceutical Care in Pain & Symptom Control

Bangladesh, India, Egypt, Thailand, Costa Rica, Chian, Papua New

Guinea, Colombia, Mexico, United States, United Kingdom, Domini-
can Republic

INTRODUCTION
The World Health Organization (WHO) recognizes ‘‘pain as an
important but neglected public health issue in both developed and
developing countries.’’1 The WHO supports the notion that patients
throughout the world should have adequate access to pain relief. The
achievement of pain relief can easily be accomplished by a few effec-
tive and relatively inexpensive drugs administered according to the
individual needs of each patient.1 The WHO has identified a number
of essential drugs, including opioids, that should be available in every
country to provide pain relief to the population. Although the WHO
recommendations are specifically focussed on cancer pain, the same
principles apply to other disease, surgical, trauma, and chronic pain, in
adults and children. Despite the ease of pain management with op-
ioids, a number of countries either do not permit opioids or severely
restrict their use. As a result, the people of those countries may suffer
needlessly for lack of adequate pain relief. Developing countries in
particular tend to have decreased access to opioids when compared to
more developed societies. A variety of governmental and physician
barriers exist that lead to decreased opioid availability. In this review,
we will discuss the governmental barriers that impede access.
There are numerous organizations addressing the problem of opioid
availability in developing countries. Two of the most important are the
World Health Organization and the International Narcotics Control
Board.

THE WORLD HEALTH ORGANIZATION

The World Health Organization (WHO) has been a principal advo-
cate for increasing the accessibility of opioids since its 1986 publica-
tion Cancer Pain Relief.1 The guidelines to managing cancer pain set
out in this report are based on the ‘‘three-step analgesic ladder’’ of
cancer pain treatment. Step one of the ladder uses non-opioid analge-
sic drugs to treat mild cancer pain. Step two involves mild opioid
analgesics (such as codeine) plus non-opioid analgesics to provide
 Denise M. MacDonald and G. Allen Finley 7

relief of mild-to-moderate pain. Step three incorporates strong opioid

analgesics plus non-opioid analgesic agents for progressive or moder-
ate-to-severe pain. Doses of strong opioids, such as morphine or hy-
dromorphone, may be escalated rapidly and administered by a variety
of routes.2 Adjuvant drugs, such as tricyclic antidepressants, anticon-
vulsants, and steroids, may be synergistic with opioids in pain relief,
and can be added at any level of the ladder.
Because of the reliance on opioids in treating cancer pain success-
fully, the WHO has encouraged countries to ensure that the necessary
opioids are readily available by establishing governmental policies on
pain, cancer pain, and terminal care. The WHO Model List of Essen-
tial Drugs defines as ‘‘essential’’ those drugs that satisfy the health
care needs of the majority of the population.3 The List includes opioids
in the subsection ‘‘Drugs used in palliative care.’’ The WHO has also
developed a Cancer Pain and Palliative Care Unit, which introduced a
regime for managing cancer pain following the WHO approach. This
has focused attention on the underuse of opioids.4

THE INTERNATIONAL NARCOTICS CONTROL BOARD

The International Narcotics Control Board (INCB), a division of the

United Nations International Drug Control Program, is also involved
in ensuring opioid availability for pain management.5 This is the body
responsible for administering the Single Convention on Narcotic
Drugs, an international treaty that governs opioid availability in the
world. Most governments are party to this treaty. According to a
summary on INCB:
The INCB regulates global production and distribution of op-
ioids. It confirms estimates of medical need for opioids from
national governments and produces an annual report analyzing
the drug situation worldwide. The INCB insures the availability
of opioids for medical purposes, and prevents their diversion and
abuse. The WHO Cancer and Palliative Care Unit has worked
closely with the INCB on the recognition of opioids as a neces-
sary part of cancer pain relief.6
In 1989, the INCB asked all governments to ‘‘determine if impedi-
ments to opioid availability were present and, if so, to develop plans of
8 Journal of Pharmaceutical Care in Pain & Symptom Control

action to redress them.’’5 The realization that opioids are underused in

the treatment of many types of pain, especially cancer, caused the
INCB to suggest governments re-evaluate their estimates of how
much opioids they require. In 1996, INCB released a special report,
Availability of Opiates for Medical Needs,7 for which they had sur-
veyed all governments in the world during 1995. This was a follow-up
to the initial 1989 INCB report.5 A second follow-up survey was
conducted during 1999, on 1998 data, and published early in 2000.8
This report emphasized the need to ensure adequate availability of
opioids for medical needs.

BARRIERS

Despite the effort put forth by the WHO and INCB, there is still
inadequate opioid availability in many countries. Developing nations
suffer more severely from this problem. Many developing countries
have drug laws that prohibit or severely restrict the availability and
medical use of opioids by controlling the quantity of opioids that can
be distributed, the type of opioid that can be administered under vari-
ous settings, the duration of the treatment, and/or how the available
opioids can be stored. Many governments cite diversion as the main
reason for these policies.8

QUANTITY

The WHO, through the INCB, monitors the consumption of mor-

phine for medical purposes globally as an important indicator of drug
availability. Morphine consumption has increased dramatically in past
years. From 1972 to 1991, the worldwide quantity of morphine con-
sumed grew by approximately 550%, from roughly 2000 kg to 11,074
kg consumed.3 Up to 1999, however, there have been relatively small-
er increases in global licit opioid consumption. The total volume
reached approximately 240,000 kg of morphine equivalents in 1999.8
These statistics imply that people in many countries are receiving
more morphine, or morphine equivalents, in response to their medical
needs. However, the statistics don’t give the entire picture.
Despite the tremendous increase in reported morphine consumption
between 1972 and 1991, over ninety percent of the increase occurred
 Denise M. MacDonald and G. Allen Finley 9

in only 26 countries out of the 183 WHO member states (of which 168
are signatories to the Single Convention on Narcotic Drugs). These 26
countries are mostly well-developed, with market economies.3 Fifty-
seven percent of all morphine consumed in 1991 was in 10 very well
developed countries: Australia, Canada, Denmark, Iceland, Ireland,
New Zealand, Norway, Sweden, the UK, and the USA.9 The 46 least
developed countries reported either consumption of morphine at 1 kg
or less, absolutely no consumption, or failed to make a report altogeth-
er. Ninety developing countries consumed about two percent of the
total amount of morphine.3 The developing countries showed a marked
decrease in morphine consumption, despite having the majority of the
world’s population. Some countries, such as Kenya and Bangladesh,
have actually reported a decrease in morphine consumption, down
to 0 kg.9
Low levels of morphine have been consumed in some countries
despite an overall surplus of morphine produced. Worldwide mor-
phine production has increased since 1986, with 1999 recording the
highest total production levels of 414.7 tons of morphine equivalent.8
However, consumption of morphine has remained relatively stable
during this same time period; in other words, a deficiency in morphine
production is not to blame for the low levels of consumption.
The national government of each country determines the amount of
opioid analgesics that the country can import or manufacture.9 Each
national drug regulatory authority must prepare and submit to INCB
an estimate of the quantity of opioids the country will need for medical
and scientific purposes during the next year. The INCB only confirms
the estimates that are supplied by each individual country. It plays no
role in deciding the actual amount of the estimate, and the INCB quota
does not restrict access. If the country realizes its estimate was too low
at some point during the year, they may submit an amended estimate
to the INCB, which can quickly confirm a revised amount.
On the other hand, in Thailand in 1990, the estimated annual re-
quirement for morphine was about 15 kg but the consumption for
medical purposes was only 5 kg.10 The utilization of morphine in
Thailand is often under quota. As well, hospitals have a maximum
amount of morphine they can access each year. The morphine quota in
Thailand increased in 1993 from 200 to 400 g in government hospi-
tals, and from 20 to 40 g in private hospitals. However, the hospital
quotas could still be increased even more.10
10 Journal of Pharmaceutical Care in Pain & Symptom Control

A study comparing morphine use in Canada to that in Argentina

found that Canadian centers gave 44 mg of morphine per day per
patient on average, while hospitals in Argentina gave 9 mg per day per
patient.11 Some countries have shown relatively recent improvements.
A regional pain clinic in India has increased the amount of oral mor-
phine it uses 250 times in just two years. In 1992-93, the clinic used
only 30 g of oral morphine but the quantity was up to 7735 g by
1994-95.12

TYPE
The INCB monitors consumption of morphine equivalents, but does
not differentiate between the various forms of morphine being con-
sumed by different routes of administration. There are no separate
statistics for orally administered morphine, which is given in higher
doses, and morphine that is administrated by injection or intravenous
routes. As morphine is not the only opioid analgesic that is used to
treat pain, some countries report their annual opioid consumption in
morphine equivalents. Therefore, although the measurement of mor-
phine consumption alone may not accurately reflect a country’s total
use of opioids, it is generally taken to be a good indicator.9
An essential drug list based on WHO recommendations was found
in three fourths of the governments responding to the INCB survey.7
However, not all narcotic drugs recommended by the WHO are on
such lists. Seventy-one percent of the governments had morphine on
their essential drug lists, but in varying forms. Injectable narcotic
drugs are more commonly available, including morphine in 79% of
countries, pethidine (meperidine) in 72%, and fentanyl in 69%. Oral
immediate-release preparations are less available, with the most com-
mon, codeine tablets, found in 65% of countries, morphine powder or
solution in 40%, and morphine tablets in only 29%. Also available in a
few countries were the slow-release formulations of morphine (45%)
and fentanyl (14%).
A few countries provide examples of how the type of morphine
available determines its administration. In Costa Rica, morphine is
usually only available in parenteral formulation.13 Morphine pills are
rarely available, necessitating admission to or return to hospital for
morphine to be administered. This prevents people from returning to
homes located some distance from the hospital or health care service.
 Denise M. MacDonald and G. Allen Finley 11

There is no oral liquid morphine, morphine rectal suppositories, or

long-acting morphine available. As well, there are no short-acting
opioid alternatives to morphine, such as oxycodone, hydromorphone,
or oxymorphone. Costa Rica’s yearly supply of methadone in 1992
was so small that it was only sufficient to help 2 or 3 patients.
In Egypt, the only available forms of oral morphine in the country
are slow-release morphine tablets that are imported under the name of
various approved hospitals.14 It was only in 1990 that these tablets
were officially registered and made available. China has restrictions
on the type of opioid that may be prescribed. In most cases, the
strongest opioid allowed is intramuscular or oral meperidine, with
morphine rarely being given.11A national symposium in Indonesia led
to the refinement of the country’s policy on types of morphine avail-
able15:
After careful consideration of the serious problems related to
drug distribution, drug storage, drug security, and supervision of
treatment, the decision was taken to permit the use of oral mor-
phine by patients at home, instead of limiting this treatment to
hospital outpatients.15
In Papua New Guinea, injectable morphine is available in an unlim-
ited amount, not only in city hospitals but also in countryside medical
facilities.16 However, strict regulations only allow five major hospitals
to stock morphine powder for oral preparations. The most common
form of morphine dispensed is an aqueous morphine solution, which is
not stable in the warm climate and can spill during transport. Mor-
phine tablets are not available in Papua New Guinea.
Short-acting oral opioids are scarce in many Latin American coun-
tries.17 Local pharmacies are unable to produce simple oral morphine
preparations because governments of many of the countries forbid the
importation of morphine powder. Less potent drugs are often substi-
tuted. In the Dominican Republic, patients may receive nonsteroidal
antiinflammatory agents, which may not be appropriate for their type
or degree of pain, instead of the opioid analgesics they need.17
Changes in regulations regarding the type of opioids available can
have a great effect on patients.
The introduction of oral opioids to a regional pain clinic in Kerala,
India, has made a great difference in the type of treatment provided.12
In 1986-87, only 25% of the clinic patients received any mild opioids,
12 Journal of Pharmaceutical Care in Pain & Symptom Control

while another 25% were able to receive parenteral opioids. With oral
morphine becoming available in 1990, the number of patients receiv-
ing potent analgesia increased significantly. By 1994-95, a full 72.3%
of patients were receiving oral morphine.

DURATION
Governments in developing nations often impose strict regulations
on physicians who prescribe opioids. This philosophy is not always
agreed with:
Decisions about the strength of drug used, the number of dosage
units, and duration of therapy are best made by medical profes-
sionals, based on the individual needs of patients. These deci-
sions should not be made by government regulation.9
All governments that participated in the INCB survey reported that
physicians could prescribe morphine to a patient in a hospital.7 How-
ever, twenty percent of governments imposed a maximum length of
time that a hospitalized patient could receive morphine. In some cases
this maximum was as low as 3 days.7
For patients who live at home, government requirements are more
onerous.7 Twenty-eight percent of governments determined a maxi-
mum duration of morphine treatment for a patient at home. This maxi-
mum was as low as 3-7 days in some cases, although it was occasion-
ally possible to renew the prescription.7 In South Africa, there is a 30
day limit to prescriptions, resulting in considerable hardship for rural
patients.18 In Colombia, the length of an opioid prescription is current-
ly limited to a maximum of 10 days, requiring patients to return to visit
their doctor or pharmacy much too frequently.17
In many countries in Latin America, physicians are required to
prescribe using triplicate prescription pads, and each prescription must
be for 5 days or less.19 This can cause undue hardship for people who
often have to travel many kilometers to visit a physician. To get
around this, physicians frequently fake the dates or the total amount of
medication the patients are receiving. Regulatory agencies tend to
look at the average prescription instead of the prescription adequate
for a given patient. Many physicians have been investigated by regula-
tory agencies because of what is perceived to be unusually high use of
opioid analgesics.
 Denise M. MacDonald and G. Allen Finley 13

In Costa Rica, physicians are required to use special prescription

forms issued by the Health Ministry when prescribing opioids.13 A
maximum of six morphine, meperidine or methadone ampules can be
prescribed with each prescription form. However, the number of pre-
scriptions per day is determined by the physicians. Most physicians
and pharmacists interpreted this provision as a legal mandate allowing
for only six ampules a day, thus considering any doses over this limit
as illegal. Whether or not this was the intended effect of the policy is
difficult to say; however, it was the end result.

STORAGE
The WHO has found that professionals involved in health care often
fear losing their license over their storage practices of opioids.20 To
help diminish this reluctance and eliminate this barrier to an adequate
supply of opioids, governments need to be educated as to the effects of
their legal constraints. Storage of opioids should not be so burdensome
as to prevent adequate supplies from reaching those in need.9 It has
been recommended and subsequently legislated that opioid distribu-
tion take place only between duly authorized individuals, that opioids
are stored in secure places, and that suitable inventory records of the
opioids are kept as ways to eliminate potential storage problems.
Storage of analgesics in many Latin American countries occurs in
pharmacopeias that stock only a limited amount of parenteral op-
ioids.19 It has been reported that the increase in morphine use in these
countries has been much slower than that seen in developed nations.19
However, the use of other opioids traditionally considered less desir-
able, such as meperidine and buprenorphine, has increased much more
than morphine. Pharmacopeias are more willing to stock these ‘‘mild-
er’’ forms of opioids. The pharmaceutical industry in Argentina, for
example, has no parenteral morphine formulations available, nor does
it provide low cost oral preparations.21 In the large urban center of São
Paulo, Brazil, encompassing 16 million people, there are reportedly
only 5 drugstores where morphine can be purchased.17
In theory, Egyptian pharmacopeias stock all forms of morphine
tablets and syrups.14 In practice, however, only morphine sulfate am-
pules manufactured in Egypt are available. The general attitude of
pharmaceutical companies and pharmacists is ‘‘not to deal with mor-
phine under any circumstances for fear of taking responsibility.’’14 In
14 Journal of Pharmaceutical Care in Pain & Symptom Control

Thailand, district hospitals are often very reluctant to possess op-

ioids.10 The strict drug legislation and fear of burglaries by drug
addicts usually prevent the hospitals from stocking opioids for medi-
cal purposes.
Mexican pharmacies often do not carry opioids because they have
no licensed pharmacist on site allowed to dispense drugs.17 Burglary
is also a concern in Mexico, as it is in Thailand. Many pharmacies do
not have a safe area and the risk of being robbed is great.17 Only one
institution in Mexico, the National Cancer Institute in Mexico City, is
allowed to stock morphine powder. This makes it extremely difficult
for hospital pharmacies in the other 31 states to access the powder
needed for oral morphine solutions.17 If regulations were changed,
more pharmacies could store morphine powder, which would improve
patient access to analgesic treatment.
Few places in India are able to stock opioids because of strict
government regulations. ‘‘A health facility wishing to dispense op-
ioids must obtain an opioid possession license, purchasing form, trans-
port permit, and import license from the State.’’12 These necessary
licenses are rarely given out. For example, the state of Kerala only has
3 facilities that are licensed to dispense oral morphine, an inadequate
number to service a population of 30 million people.12

DIVERSION AND DRUG ABUSE

Diversion is often cited by governments as a major reason for such

stringent rules regarding opioid availability.7 The barriers imposed by
government ‘‘usually include draconian regulations that do little to
hold back the illicit drug traffic but sharply limit the access of . . .
patients to adequate analgesia.’’4 The WHO has prepared the Guide to
Opioid Availability, which provides the requirements for opioid pro-
duction and distribution that countries should observe in making mor-
phine and other opioids available, while preventing drug diversion to
illicit markets.9
The INCB and the Single Convention on Narcotic Drugs have the
dual purpose of assuring the medical availability of opioids and pre-
venting their diversion and abuse.8,9 Some governments have re-
stricted the use of opioids so tightly that it is nearly impossible to
obtain them even under legitimate conditions. As a matter of interna-
 Denise M. MacDonald and G. Allen Finley 15

tional law, governments have an obligation to make opioid analgesics

available to meet medical needs.
The Single Convention on Narcotic Drugs recognizes that individu-
al governments do have the right to more restrictive regulations to
prevent the diversion of opioid analgesics to illicit use.9 However, the
INCB has found that:
Prevention of availability of opiates for medical use does not
necessarily guarantee prevention of the abuse of illicitly procured
opiates. Overly restrictive approaches may, in the end, merely
result in depriving a majority of the population access to opiate
medications.22
It must be acknowledged that drug abuse is a reality throughout the
world.9 Health care professionals and government regulators need to
work together to prevent diversion of drugs to illicit uses. Health
professionals must also be willing to comply with and promote rea-
sonable safeguards against diversion.9 The relationship between in-
creased medical consumption and increased illicit diversion was eval-
uated in the American state of Wisconsin. From 1986 to 1990, the
consumption of morphine in Wisconsin increased by 160%, from 421
to 1093 kg.9 At the same time, sources of diversion were eliminated by
a cooperative effort of professional organizations and government
agencies. Consequently, diversion trends evaluated through the State
Crime Laboratory were very low. During the study period, less than 10
laboratory analyses were conducted on morphine seized by the police
in any one year period. This is in contrast to several hundred lab
analyses per year for other controlled prescription drugs when diver-
sion was at its peak. These results suggested that the increase in
morphine consumption that occurred in Wisconsin did not lead to an
increase in diversion.
A recent study in the United States found that opioid analgesic
abuse increased by 6.6% from 1990 to 1996, but decreased as a per-
centage of total drug abuse, from 5.1% in 1990 to 3.8% in 1996.23 The
authors concluded that ‘‘the present trend of increasing medical use of
opioid analgesics to treat pain does not appear to be contributing to
increases in the health consequences of opioid analgesic abuse.’’23
Other nations besides the United States have demonstrated increases
in morphine consumption with concurrent decreases in diversion. Ja-
pan has shown a 25-fold increase in the medical use of morphine
16 Journal of Pharmaceutical Care in Pain & Symptom Control

preparations between 1979 and 1991 without an increase in diver-

sion.24 Even in heroin addict detoxification trials conducted in Swit-
zerland in 1992, diversion was not a difficulty.25 There were limited
reports of problems in the local neighborhood of the heroin clinic,
despite the daily attendance by many addicts.
Although developed countries have avoided increases in diversion
or abuse, it is not as clear how this translates to developing countries.
The Wisconsin model demonstrates that reasonable controls can pre-
vent increased abuse in spite of an increase in the medical use of
opioid analgesics.9 Health professionals and governments in develop-
ing countries need to work closely to ensure proper safety precautions
are in place without unnecessarily hampering the medical distribution
of opioids. Overall, the INCB believes the system of diversion con-
trols established worldwide is working well.
Diversion of narcotic drugs from the licit trade into illicit channels
remains relatively rare and the quantities involved are small in com-
parison with the large volume of transactions. That holds true for
drugs in the international trade as well as in domestic wholesale cir-
cuits.26
A recent report by the INCB supports this view.8 There have been
no increases in the number of cases of illicit diversion of opioids
during manufacturing or distribution, despite increased consumption.
Public concern about drug abuse plus governmental concern about
diversion leads to many restrictions on the prescribing and dispensing
of controlled substances.27 In the United States, state cancer pain
initiatives recommend that no additional regulations should be put in
place regarding diversion ‘‘unless there is clear evidence of the need
for such programs, their benefit in reducing prescription drug abuse
and diversion, and their impact on patient access to pain-relieving
drugs.’’27 Based on this, governments of many developing countries
should consider reducing their regulations, not adding new ones.
Countries with extensive illicit drug operations often have more
complex regulations pertaining to opioid availability. In Colombia, for
example, national health authorities will not commit to providing a
sufficient and permanent supply of opioids.28 The amount of opioids
distributed in regional areas is inadequate to cover the needs of the
population. The problem exists in part because the regional authorities
are unaware of the magnitude of the problem and because of fears
concerning diversion.28 This is compounded by the fact that Colombia
 Denise M. MacDonald and G. Allen Finley 17

is a country where the illegal drug trade is already a large problem. In

accordance with treaty, the government has created ‘‘closed channels
of distribution,’’ making the acquisition of opioids a difficult process
full of legislative requirements for the institutions and physicians.28
Thailand is well known for the illegal opium cultivation in the north
and as a transit and refining center for Southeast Asia, and also has
restrictive quotas for the use of morphine in hospitals.10 The impact
national drug legislation has on the medical use of opioids cannot be
underestimated.
Many countries have imposed regulations which make it difficult to
prescribe or obtain potent opioids in the hopes of keeping these drugs
from falling into the wrong hands.11 The Indian government, for ex-
ample, imposes very strict regulations on opioids, partially out of fear
that their availability will lead to a drug abuse problem within their
country. ‘‘Developing countries generally view the illicit drug epidem-
ic in western nations with alarm and determination to prevent the
establishment of a drug subculture within their own borders.’’12 The
Indian government created a Central Narcotics Control Bureau to
oversee the distribution of opioids. In its task to prevent diversion, the
Bureau has actually made it more difficult to obtain opioids for legiti-
mate medical use.12
Some countries have a fear that even prescribed morphine will fall
into misuse. If a patient is prescribed oral morphine in Egypt, a rela-
tive is appointed to be responsible for the care of the tablets.14 The
relative is also responsible for returning the rest of the tablets if the
treatment is terminated for any reason. If a patient dies, the relative is
required to return the tablets and be able to balance the number of
tablets remaining with the date of death.14 Forty percent of govern-
ments responding to the INCB survey allowed or required that unused
opioid medication such as morphine be returned to the hospital or
pharmacy after the death of a patient.7 This provision may have been
put in place not only to maintain control over these drugs, but also to
reduce waste if the medication is returned unopened and unexpired.7
Palliative care volunteers in Latin America have developed a simi-
lar plan to save medications and help prevent diversion.29 In autho-
rized countries, family members of deceased cancer patients are allowed
to return unused analgesic medications to the medical institution.29
For example, Brazilian pharmacists get left over medications back from
families of patients who have died. These medications are then re-
18 Journal of Pharmaceutical Care in Pain & Symptom Control

introduced to the health care system, which can then make them avail-
able to other patients if appropriate.29 It has also been reported that
this arrangement works quite satisfactorily in the Dominican Republic:
Families of patients who have died are encouraged to bring the
left-over medications back to the clinic; if the family is poor,
which is true 90% of the time, the clinic buys the drugs back
from them, if the family is better off financially, they are asked to
donate the drugs back to the clinic.29
Only 37% of responding governments reported little or no concern
about diversion in the INCB survey.7 The remaining governments
showed varying levels of concern, with 19% being moderately con-
cerned, 26% very concerned and 11% extremely concerned. Govern-
ments that were least concerned about diversion were more likely not
to have shortages and to have morphine available in most community
pharmacies.7 The International Narcotic Control Board believes that
an efficient and effective national drug control regime needs to incor-
porate a program to prevent illicit trafficking and diversion into a
program that ensures the availability of opioid drugs for medical and
scientific purposes.7 As stated by the Board:
Controls over the professionals and medical facilities that distrib-
ute narcotic drugs should ensure accountability and prevent di-
version while making narcotic drugs available to the patients
who need them. Controls should not be such that for all practical
purposes they eliminate the availability of narcotic drugs for
medical purposes.7

OVERCOMING GOVERNMENTAL BARRIERS

The action of the WHO in a number of developing countries has led
to encouraging negotiations with government and health leaders to
allow the introduction and efficient distribution of analgesics.4 These
discussions are often accompanied by ‘‘training workshops where,
using the > train the trainer’ technique, WHO policies are discussed
with national leaders and plans are established for introducing the
WHO program.’’ In setting up this program, drug availability is a key
area discussed.4 Changes often need to be made in health care regula-
tions and legislation to improve drug availability, especially opioids.
 Denise M. MacDonald and G. Allen Finley 19

Improvements in the area of prescribing, distributing, dispensing, and

the overall administration of drugs also need to be addressed.
In deciding how much to estimate for the country’s yearly need of
opioid analgesics, government officials should consult more closely
with people directly involved in clinical care. Professionals can help
regulators understand the rationale behind increasing the national esti-
mate for opioids. It is then up to the governments to import or
manufacture a sufficient and reliable supply of opioid analgesics to
meet the country’s needs, and to modify regulations to allow the
rational use of opioids.9 Changing governments’ views on pain con-
trol to a high priority topic can be a major step in overcoming com-
binations of many barriers.30 If governments acknowledge that con-
trolling pain should be a priority, they are much more likely to change
regulations in ways that make opioid analgesics more accessible.
People in control of setting health standards, acquiring medical sup-
plies, and regulating the use of opioid analgesics should be encour-
aged to see pain control as a top priority. Invoking the authority of the
WHO can help make pain control and availability of opioids a part of
the stated health policy of the country.30
For example, in Papua New Guinea (PNG), the WHO, in conjunc-
tion with health service providers, recommended to the government
that the narcotics control measures be revised to make oral morphine
more widely available.16 The introduction of morphine tablets was
also encouraged. It was recommended that oral morphine be pre-
scribed in doses for 1 month or more at any one time to improve the
availability of the drug to patients staying at home. The WHO’s active
participation in the report to the PNG government helped bring about
much needed change.
In the Philippines, the Dangerous Drugs Board (DDB) issued new
regulations on the use of morphine. It was reported that these new
regulations: (a) simplify requirements for securing DDB prescription
forms; (b) decentralize the approval of applications for DDB forms;
(c) assign dispensing to hospital pharmacists; and (d) increased from
10 to 84 the number of tablets that can be purchased at one time.31 The
Bureau of Food and Drug also approved new formulations of immedi-
ate release morphine and the registration of sustained release oral
morphine.31 All these changes improve patients’ access to opioid
analgesics.
The INCB has issued a number of recommendations for consider-
20 Journal of Pharmaceutical Care in Pain & Symptom Control

ation by all governments, which are summarized in Table 1.7 The

WHO has also identified six steps that physicians and other health
professionals can take to ensure opioids are available for medical
purposes, which are shown in Table 2.6 Information is also available at
the website of the University of Wisconsin WHO Collaborating Center
for Policy and Communications in Cancer Care (http://www.medsch.
wisc.edu/painpolicy/).
A demonstration project or the organization of a national or interna-
tional conference is often a good method of drawing attention to the
problem of opioid availability. For example, meetings similar to the
one organized in March 1996 by the WHO Cancer Pain and Palliative
Care Program for Latin America in Santo Domingo offer health pro-
fessionals the chance to identify obstacles in their own countries.17
‘‘Identification of barriers is the first step in the process of determining
the proper strategy to overcome them.’’17 The guidelines presented
here work well in countries where fairly open dialogue exists between
physicians and governments.
Some developing countries, however, do not allow this type of
exchange of information. The government may be oppressive and
clinicians may be reluctant to present their views on governmental

TABLE 1. Suggested Government Initiatives to Improve Opioid Availability

1. Determine if regulations unduly impede the availability of narcotic drugs and

adjust these laws accordingly.
2. Reassess the methods of estimating the medical needs for narcotic drugs
and change if necessary.
3. Consult with health care providers and others as needed to assist in obtaining
information about changing medical needs.
4. Add an increase of ten percent at minimum to their annual estimates of
narcotic drugs to allow for increases in consumption.
5. Avoid delays or interruptions in supply of narcotic drugs.
6. Be aware of the international consensus that the medical use of narcotic
drugs is indispensable for the relief of pain and suffering.
7. Inform health professionals about the WHO analgesic ladder method for pain
relief.
8. Communicate with health professionals about the legal requirements for pre-
scribing and dispensing narcotic drugs and provide an opportunity to discuss
mutual concerns.
 Denise M. MacDonald and G. Allen Finley 21

TABLE 2. Physician Actions to Reduce Governmental Barriers to Opioid Avail-

ability

1. Determine the amount of opioids reported to have been consumed for the
past several years in the country.
2. Become familiar with the drug regulators in the country.
3. Provide information to drug regulators to aid them in preparing an accurate
estimate of the country’s opioid needs. Information regarding how rare addic-
tion is, the necessary opioid dosages, and forms of dosage needed can be
very beneficial.
4. Cooperate with drug regulations. This willingness to comply with regulations
will demonstrate concern for diversion and a desire to prevent its occurrence.
At the same time, indicate any concerns about restrictive regulations that may
be an impediment to opioid availability.
5. Understand the opioid distribution system. A thorough knowledge of this
system can help in identifying barriers along the way.
6. Develop a plan of action. One individual or group of knowledgeable and
committed professionals can take responsibility to develop an action plan.

regulations. Fear of reprisal by the government may prevent clinicians

from advocating for change regarding opioid availability. In situations
such as these, health professionals may try to educate the public about
the lack of opioid availability. Gaining the public’s support may help
their cause when pressing for changes by the government.
If professionals are unable to speak out and the public is not aware
of the problem, international agencies can try to advocate on their
behalf. Support from outside the country may lend credibility to the
cause and help convince a government of the validity of the profes-
sionals’ claims. In developing countries, change may be slow in com-
ing and there may be no easy solutions to the lack of opioid availabil-
ity. Of course, the countries mentioned above, and others, may have
made substantial improvements in access to opioids in recent years
that have not yet been reported or of which we are unaware.

CONCLUSION

The necessity of having opioids available to manage pain is well

established. Despite this fact, many countries in the developing world
do not allow their people adequate access to opioids. Governmental
22 Journal of Pharmaceutical Care in Pain & Symptom Control

barriers to opioid availability, such as quantity, type, duration, storage,

and diversion, have been discussed. Other barriers to opioid availabil-
ity include factors such as inadequate funding of health services, lack
of health care delivery infrastructure, and inadequate facilities for the
distribution of medicines.6 Clearly, there is no single factor affecting
opioid availability. All of the factors discussed, plus others, contribute
to the problem of inaccessibility.
The factors are heavily intertwined, with one difficulty often poten-
tiating the others. Because of the complexity of the factors, no simple
solution can be raised. Addressing each contributing factor individual-
ly may not be enough; a thorough, comprehensive plan needs to be
developed which incorporates all factors augmenting the problem.
Even with the development of such a plan, implementing it in many
developing nations may be a daunting task. Only through the coopera-
tion, commitment and hard work of many governments, physicians,
and other health professionals will the problem of opioid availability
be addressed.

REFERENCES
1. Jadad AR, Browman GP. The WHO analgesic ladder for cancer pain manage-
ment. JAMA 1995; 274 (23): 1870-1873.
2. McCaffery M. Pain control: Barriers to the use of available information. Can-
cer Supplement 1992: 70 (5): 1438-1449.
3. Stjernsward J, Teoh N. Current status of the global cancer control program of
the World Health Organization. J Pain Symptom Manage 1993; 8 (6): 340-347.
4. MacDonald N. Educational programs in pain and palliative care. J Pain Symp-
tom Manage 1993; 8 (6): 348-352.
5. Colleau SM, Joranson DE. Medical needs for opioids far from being met.
Cancer Pain Release 1996; 9: 1-2 (suppl.).
6. Colleau SM. The International Narcotics Control Board. Cancer Pain Release
1994; 7 (2-3): 3.
7. International Narcotics Control Board. Cancer Pain Relief and Availability of
Opiates for Medical Needs. New York: United Nations, 1996.
8. Report of the International Narcotics Control Board for 1999. New York:
United Nations, 1999. <http://www.incb.org/e/ar/1999/index.htm>
9. Joranson DE. Availability of opioids for cancer pain: Recent trends, assess-
ment of system barriers, new World Health Organization guidelines, and the risk of
diversion. J Pain Symptom Manage 1993; 8 (6): 353-360.
10. Chaudakshetrin P. Thailand: Status of cancer pain and palliative care. J Pain
Symptom Manage 1993; 8 (6); 434-436.
11. Rhymes JA. Barriers to effective palliative care of terminal patients. Clin Ger-
iatr Med 1996; 12(2): 407-416.
 Denise M. MacDonald and G. Allen Finley 23

12. Koshy RC, Rhodes D, Devi S, and Grossman SA. Cancer pain management in
developing countries: a mosaic of complex issues resulting in inadequate analgesia.
Support Care Cancer 1998; 6: 430-437.
13. Quesada L. Costa Rica: Status of cancer pain and palliative care. J Pain Symp-
tom Manage 1993; 8 (6): 407-408.
14. Tawfik MO. Egypt: Status of cancer pain and palliative care. J Pain Symptom
Manage 1993; 8 (6): 409-411.
15. Lickiss JN. Indonesia: Status of cancer pain and palliative care. J Pain Symp-
tom Manage 1993; 8 (6): 423-424.
16. Takeda F. Papua New Guinea: Status of cancer pain and palliative care. J Pain
Symptom Manage 1993; 8 (6): 427-428.
17. Colleau SM. Barriers to cancer pain control in Latin America and their impact
on patient care. Cancer Pain Release 1996; 9 (1): 2-3.
18. Beck SL. A systematic evaluation of opioid availability and use in the Repub-
lic of South Africa. J Pharm Care Pain Symptom Manage 1995); 6(40):5-22.
19. Bruera E. Palliative care in Latin America. J Pain Symptom Manage 1993; 8
(6): 365-368.
20. World Health Organization (WHO). Cancer Pain Relief and Palliative Care:
Report of a WHO expert committee. Geneva: WHO, 1990.
21. Wenk R. Argentina: Status of cancer pain and palliative care. J Pain Symptom
Manage 1993; 8 (6): 385-387.
22. International Narcotics Control Board. Demand for and supply of opiates for
medical and scientific needs. New York: UN, 1989.
23. Joranson DE, Ryan KM, Gilson AM, Dahl JL. Trends in medical use and
abuse of opioid analgesics. JAMA 2000; 283 (13): 1710-1714.
24. Takeda F. Japan: Status of cancer pain and palliative care. J Pain Symptom
Manage 1993; 8 (6): 425-426.
25. Farrell M, Hall W. The Swiss heroin trials: testing alternative approaches.
BMJ 1998; 316: 639.
26. United Nations. National Authorities Empowered to Issue Certificates and
Authorizations for the Import and Export of Narcotic Drugs and Psychotropic Sub-
stances. New York: UN, 1990.
27. Dahl JL. State cancer pain initiatives. J Pain Symptom Manage 1993; 8 (6):
372-375.
28. De Lima L. Colombia: Status of cancer pain and palliative care. J Pain Symp-
tom Manage 1993; 8 (6): 404-406.
29. Colleau SM. Volunteers save medications, help prevent diversion. Cancer
Pain Release 1996; 9 (1): 7.
30. Cleeland CS. Strategies for improving cancer pain management. J Pain Symp-
tom Manage 1993; 8 (6): 361-364.
31. Laudico AV. The Philippines: Status of cancer pain and palliative care. J Pain
Symptom Manage 1993; 8 (6): 429-430.