The "Pasimafi" investigation did not translate into a revision of the law that Dr. Fanelli helped to draft in Italy. For many, the investigation should not halt a law that protects and guarantees access to palliative care and pain therapy for the first time in Italy, as it especially benefits patients with incurable or chronic painful diseases.
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The Italian consumption of prescription opioids has gone from 1.1 daily doses per thousand people in 2005 to 4.5 in 2017, but the country does not seem to have entered a crisis of addiction at the moment.
A Grunenthal spokesperson reported that the company is analyzing if patterns of the American epidemic are emerging elsewhere and will soon release the results of the research. According to Mundipharma, no other country is experiencing the problem of dependence on the scale seen in the US.
Keith Humphreys, a professor at Stanford University, published an article in 2017 asking for a global focus to the problem, especially as prescription rates are increasing in developing countries that do not have strong regulations for opioids. The danger, in his view, is that countries like India may be on the brink of an opioid epidemic.
In an interview given to Corriere Della Sera earlier this year, Dr. Roberta Pacifici, director of the Italian National Center for Addiction and Doping at the Istituto Superiore di Sanità, said that in Italy there is currently no opioid epidemic. According to Dr. Pacifici there is not even the risk of an epidemic in Italy, because the Law 38/2010 (Law of March 15th, 2010 N° 38, titled: "Provisions to ensure access to palliative care and pain therapy,") has increased the use of opioids according to safe limits, and because the control mechanisms in Italy allow to avoid misuse and diversion. In this context, misuse is defined as the inappropriate use of a drug outside of the prescription; while diversion is the intentional transfer of the drug to other people who do not have a pain diagnosis).
The law contributed to the establishment of a maximum alert level for health authorities to determine situations of epidemic risk and allows for continuous improvement of control strategies to avoid the risk of abuse while ensuring the care of patients with pain. Among these strategies, there is the Rapid Alert System on new psychoactive substances (there is one for each country of the European Union, which report to a central coordination) whose management is entrusted to the Higher Institute of Health. This institute can track the information on which molecules are circulating according to medical reports in a timely manner. The maximum alert level is activated in the event of a confirmed death by overdose. In the interview, Dr. Pacifici states that Law 38/2010 establishes the right to “not suffer” for patients with chronic pain, and Italian doctors, following the appropriate guidelines, should have a clear understanding on false myths and prejudices surrounding certain medications, and the required treatment to certain patients, who may be perceived at risk of developing drug addiction.
Dr. Antonio Boschini, who works at the San Patrignano drug rehabilitation community center, believes that Italy has not been hit by the opioid epidemic partly because, unlike the Americans, there is a social tendency to not believe that all ailments can be cured only with one pill. He fears, however, that the experience of the United States has not been thoroughly assessed in Italy. He reports that many of his patients who went to the emergency room for ankle sprains or back pain have often returned with prescriptions of opioid analgesics. This fuels his fear that some doctors are unfortunately underestimating the risks of those drugs and the lax way opioids may be increasingly prescribed. "There is a feeling that this danger does not exist. It is a problem that happened in the US, but it would never happen in Italy", said Dr. Boschini. But his concern is palpable: "Why wouldn't it happen here?"
1. Galofaro C, D'Emilio F. Purdue foreign arm caught up in opioid probe in Europe. AP News. May 29, 2019
2. Corcella R. "Opioid epidemic? Maximum alert, but in our country, the long wave of the United States has not arrived". Corriere Della Sera. 6 March 2019