Access to controlled medicines for people who need them

Thursday, 6 February, 2014
EU-funded researchers are working to ensure that people with a medical need for controlled opioid medicines such as morphine can get them.

Medicines derived from opium, such as morphine, are strictly controlled under the law because of their potential for abuse. But in some cases the controls are so restrictive that patients are denied access for medical use, including those who need treatment for pain or opioid dependence.

The EU-funded project ATOME aims to deliver a clear set of recommendations to governments on making controlled medicines accessible for treating such patients. These are based on the principle of balance promoted by the World Health Organization (WHO) – ensuring that in parallel to a system of control in order to prevent misuse, controlled medicines will be sufficiently available for patient care.

The work includes comprehensive legislative and policy reviews, in close cooperation with government officials and public health and medical experts in different countries.

It is estimated that over 80% of the world's population, at one time or another, is denied treatment because the opioid medicines they need have been restricted as ‘controlled substances’.

In Europe, for example, about 1.7 million people die from cancer each year, many in severe pain, even though effective pain medications are available, says Professor Lukas Radbruch, Chair of Palliative Medicine of the University Hospital Bonn and coordinator of the ATOME project. In 15 EU countries, medical consumption of opioids and similar medications is close to non-existent, he adds.

To improve this situation, a balance in national drug control policies needs to be ensured, allowing access to controlled medicines for the relief of pain and suffering in all cases while preventing their diversion and misuse.

“We have made great progress in pain management in the last decade, and nobody ought to suffer from pain," he says. "But still patients are dying in terrible pain, without a chance to get morphine.”

Meanwhile, there are around 3.7 million injecting drug users in Europe, but only a minority have access to a methadone therapy that could help them re-integrate into society, prevent them from buying illegal drugs and reduce their risk of becoming infected with a disease such as HIV.

Therefore, a balanced strategy is needed to counter the problem, which not only focuses on law enforcement, but also includes a public health perspective.

“There is great deal of variability across Europe in terms of legal restrictions on morphine and other opioids,” Radbruch says. “This means that in some countries it is very difficult for doctors to prescribe pain management medicines. In other cases, physicians are simply not in the habit of prescribing this special class of medicines.”

The project is focusing in particular on 12 European countries where statistical evidence shows very low morphine per capita consumption. These are Estonia, Latvia, Lithuania, Poland, Slovakia, Hungary, Slovenia, Serbia, Bulgaria, Greece, Turkey, and Cyprus.

Specifically, the work entails:

  • analysis of national policies and circumstances that affect the availability of opioid medicines;
  • proposing amendments to current law to better balance the need to prevent drug abuse, while allowing patients access to such medicines;
  • understanding the socio-cultural context of drug use and abuse in each country, and evaluating the impact of the activities of the ATOME project.

Making sure people know

The ATOME project is also contributing to increasing awareness of the issues around opioid medicines. For example, the project has organised a series of workshops and conferences aimed at sensitising different stakeholder groups to the negative effects of too-tight restrictions on opioid medicines – for patients, their families, and also for healthcare professionals.

ATOME’s researchers say they are helping to build a critical mass of interested parties, bringing people together from different fields such as pain therapy and palliative care, and from national governments.

The concrete outcome will be 12 country reports, including firm recommendations for legislative changes. These reports will be presented to the relevant governments, national organisations and health-care professionals. In some countries, changes in legislation have already been prepared and even implemented, supported by the recommendations coming out of the ATOME analysis of the law.

Given the impact of the various workshops and conferences on participants’ attitudes regarding opioid availability, ATOME partners say they expect to make a real difference, helping to improve legal opioid availability for patients in the 12 target countries.

Access to opioid medication in Europe
Project Acronym: