Worldwide UN Survey Shows Many Impediments to Morphine Availability

MADISON, Wis-In attempting to increase availability of opiatesfor pain, "we are really up against the war on drugs,"David E. Joranson, MSSW, said, "because it is the same lawsaimed at preventing illicit narcotic trafficking that also controlmedical availability of opioid analgesics, and some governmentsmay be reluctant to relinquish that control."

Mr. Joranson described himself as a "recovering regulator"who is now working to achieve a more balanced regulation of controlleddrugs through his association with the World Health Organization(WHO).

Mr. Joranson is director of the Pain and Policy Studies Groupat the University of Wisconsin, and the WHO Collaborating Centerfor Policy and Communications in Cancer Care, located on the Wisconsincampus.

Speaking at the WHO workshop on cancer pain at the Vancouver IASP(International Association for the Study of Pain) congress, Mr.Joranson said that health care professionals now have a new toolto help them in their negotiations with government regulators.

The tool is a report from the International Narcotics ControlBoard (INCB)--an organization that is part of the United Nationsand is headquartered in Vienna (see box)--on the availabilityof opiates for medical needs that has recently been sent to allnational governments.

"The INCB report will be useful in helping you persuade yourgovernments to work with you to improve the availability of opioidsor in reinforcing current efforts," he said.

The report is based on a survey conducted last year on opioidavailability and impediments in which 65 of 209 governments responded.This group, composed of developed and developing nations, represents50% of the world's population, he said.

The INCB had made recommendations to governments in 1989 aboutimproving opioid availability, and the 1995 survey asked eachnation if they had, in fact, implemented the recommendations.

Of the 36 nations (55%) that reported that they had examined theirlaws for impediments to opioid availability in the last 5 years,32 said that indeed they had found impediments; only 4 countriessaid they had not (Italy, Andorra, Cypress, Tunisia).

When asked to choose the most significant impediments from a listof 13 possible factors, the barrier that was ranked highest consistentlyby all governments was concerns about opiate addiction.

"Maybe it is a hopeful sign that governments themselves arerecognizing the fear of addiction as an impediment, but I'm notsure they understand that it is an unfounded fear," Mr. Joransonsaid.

Other important impediments in the laws of many countries are:

• Use of special government prescription forms for controlledsubstances, "one problem being that in some countries therequired forms are often unavailable," he said.
• Laws that include specific dosage unit limitations for morphineor restrict the amount of morphine or other opioids that can beprescribed at one time.
• Laws that specify a maximum duration of time that an opioidprescription can be filled.
• Laws that mandate strict penalties for violation of prescriptionregulations, causing physicians to fear prescribing opioids forlegitimate purposes.

On the bright side, 40% of governments said they have a law thatallows a family to return any opioids left over when a patientdies. "This is a useful provision, which the United Statesdoes not have," he said. "Such a provision allows thesedrugs to be returned to stock if unopened and provides an importantway for low-budget hospices and palliative care programs to savemoney."

One "shocking" result of the survey, Mr. Joranson said,was that only 48% of countries reported that morphine was stockedin all their hospitals with cancer programs.

More than half reported that they had had periodic shortages ofopioids during the last 5 years and had to increase their estimateof need (see box) because demand was increasing more rapidly thananticipated.

"If you have the same level of consumption every year, thenit is easy to look back and take an average to estimate next year'sneeds," he said, "but now that countries are increasingtheir consumption of analgesics, new and forward-looking methodsof determining the estimate are needed."

The INCB believes the worldwide demand for some opioids will continueto increase, including not only morphine but also other opioidssuch as hydromorphone and fentanyl, while demand for pethidine(meperidine) is gradually declining.

The New Recommendations

From the survey, the INCB concluded that their recommendationsfrom 1989 were far from being implemented and that the availabilityof opioids for medical purposes was far from being satisfied.As a result, the INCB made a series of further recommendationsto governments, to WHO, and to the IASP.

The major point of the recommendations to governments is thateach nation should establish a clear legal and administrativeauthority for managing its responsibility to ensure opioid availabilityto patients.

Governments should assess their current methods of estimatingtheir opioid requirements and add a margin to the estimate toaccount for unforeseeable increases, "so that minor changesdon't cause interruptions in the opioid supply to patients,"Mr. Joranson commented.

The INCB recommended to WHO that it continue to publicize itsanalgesic ladder and also the correct use of the term "drugdependence" (see article on page 5).

For health care professionals, the INCB recommends that they (1)communicate with regulators about unmet needs and impediments,(2) develop safe drug distribution systems that allow for littleif any diversion while also getting the drugs to patients, and(3) teach students and clinicians about the rational use of opioids,their control, and the correct use of terms related to dependence.

SIDEBAR

The Legal Framework of International Control of Narcotic Drugs

Control of narcotics by individual governments is based on aninternational treaty--the Single Convention on Narcotic Drugs--thathas as its purpose to reduce or prevent diversion of drugs andnarcotic abuse, and also to ensure that sufficient amounts ofopioids are available for all medical and scientific purposes.

The mechanism for accomplishing this purpose is the annual estimateeach government makes of its need for narcotics for the comingyear.

The United Nations International Narcotics Control Board (INCB)is responsible for monitoring the compliance of governments withthe international treaty and reviewing the estimates of need.

Once a country's estimate is confirmed by the INCB, the countryis free to import or manufacture the specified amount of opioids.If during the year, the demand exceeds the estimate, it can bechanged by contacting the INCB.

In his Vancouver presentation, David E. Joranson, MSSW, stressedthat "there is no sinister international government agencythat limits the availability of morphine." Rather, he said,morphine availability within each nation is determined by theaction of its government.