Abstract
Anesthetics and psychoactive drugs could relieve diseases, if used properly. However, they can cause dependency, and their misuse or abuse could adversely affect people’s health and social stability. For a long time, the Chinese government has been reinforcing the regulation on anesthetics and psychoactive drugs to ensure their legal and proper usage, and to prevent abuse. The state council issued ‘the regulations on the administration of anesthetic drugs and psychotropic drugs’ in 2005, based on which a legal system was established for administration of anesthetics and psychoactive drugs with the objectives of ensuring their legitimate medical utilization, and preventing illegal abuse.
Keywords
China; CFDA; pain management; administration; opioid;
Anesthetics and psychoactive drugs could relieve diseases, if used properly. However, they can cause dependency, and their misuse or abuse could adversely affect people’s health and social stability. For a long time, the Chinese government has been reinforcing the regulation on anesthetics and psychoactive drugs to ensure their legal and proper usage, and to prevent abuse. The state council issued ‘the regulations on the administration of anesthetic drugs and psychotropic drugs’ in 2005, based on which a legal system was established for administration of anesthetics and psychoactive drugs with the objectives of ensuring their legitimate medical utilization, and preventing illegal abuse.
According to the drug management in China, drugs are classified into special drugs (including anesthetics and psychoactive drugs), prescription drugs, and over-the-counter drugs. The policy controlling anesthetics and psychoactive drugs was promulgated, and the controlled drugs were specifically formulated for China, using the international regulations issued by United Nations Narcotics Control Bureau as a reference.
Anesthetics are a type of drugs, natural medicinal plants, or chemical substances with the potential for psychological and physical dependencies, if they are used improperly or excessively. There are 121 medications marked as controlled anesthetic drugs in China, which were developed from 119 medications listed in the Single Convention on Narcotic Drugs, an international treaty signed in 1961 as an Act of the United Nations, and two more drugs were added based on China's national conditions.
Psychoactive drugs are a type of medication or chemical substance acting primarily upon the central nervous system, and resulting in excitation or depression. With improper use or abuse of these substances, psychological and physical dependencies may develop. The psychoactive drugs are classified into two categories based on the convention on psychotropic substances issued by the International Narcotics Control Bureau in 1971. The first category includes 45 substances listed under schedules I and II of the convention, and 23 additional medicines based on China's national conditions. The second category includes 66 out of 71 substances listed under schedules III and IV of the convention, and 15 additional medicines based on China's national conditions. The listed psychotropic drugs are mainly hallucinogens, stimulants (weight-reducing agents), phenobarbitals (largely used in the medical context), and some analgesics such as buprenorphine.
The catalogue of anesthetics and psychoactive drugs is regularly updated in China, and upgrading or downgrading of certain medications is made according to the risk of abuse. For instance, buprenorphine (injections and tablets) was initially classified in the second category (in accordance with the grade defined by the International Narcotics Control Bureau). However, it was frequently abused in combination with other type of medicines, and was therefore upgraded to the first category when the catalogue was updated. When buprenorphine transdermal patch was commercially approved, it was classified into the secondary category based on the low risk of abuse.
There are differences between the administration of anesthetic drugs or first category psychoactive drugs and second category psychoactive drugs, as shown in Table 1. The major difference is that the second category drugs are more accessible.
The prescription dose is also different for individual anesthetics and psychoactive drugs, according to the ministry of health in China.
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Anesthetic drug or first category psychoactive drugs: (moderate to severe pain at outpatient department or emergency department, or for cancer).
The prescription dose for injection is pro dosi (three-day dose for cancer-related pain).
The prescription dose for other types of formulations is no more than three-day dose (seven-day dose for cancer-related pain).
The prescription dose for sustained-release formulation is no more than seven-day dose (15-day dose for cancer-related pain).
The prescription dose for Ritalin (methylphenidate hydrochloride) is no more than 15-day dose.
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The prescription dose for second category psychoactive drugs is usually no more than seven-day dose (conditionally increased dose with justification by doctor).
The prescription dose for dihydroetorphine hydrochloride is pro dosi (restricted to be used in second grade hospitals).
The regulation of anesthetics and psychoactive drugs should be in accordance with the management principles, to prevent abuses and guarantee the legal demands, especially for pain management. Chronic pain is now understood to be a disease caused by long-term or persistent pain due to insufficient pain-relief. It could lead to depression or mental disorders. Thus, pain should be treated with timely, adequate and routine therapy. Opioids have demonstrated satisfactory effect for relieving chronic cancer and non-cancer pain.
Since 1980s, the WHO has advocated a three-step pain-relieving therapy worldwide, based on which 90% of the cancer pain has been controlled, and the quality of life of the patients has significantly improved according to extensive clinical evidence.
For opioids, especially the sustained-release formulations, stable blood concentration could be achieved by one or two daily doses. The favorable efficacy and stability of opioids was determined by their predictable pharmacokinetic characteristics (see Table 2).
The global consumption of anesthetic drugs in the medical context has altered greatly since 1980s. The production and consumption of morphine have significantly increased in China (Fig. 1).
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Pain management in China should be performed with persistent efforts according to the standard and principles mentioned below:
1.
Policy support, to guarantee the supply of opioids for medical use, increase the accessibility of opioids for pain management to meet the legitimate and reasonable needs of patients at utmost;
To develop new varieties and formulations of opioid drugs for medical use;
To improve the supply channels, establish convenient purchase and utilization channels for medical organizations; (signature card: from the limited system to planning system, and then to the archival filing administration; cancel the maximal limitation on morphine prescription for moderate to severe pain management; adjust the prescription dose and therapeutic duration);
2.
To establish standard guidelines for pain management;
3.
To establish a training system for doctors, nurses, and pharmacologists: doctors are critical for successful treatment, and the roles of nurses and pharmacologists are also important;
4.
Public education and publicity measures;
5.
To establish a monitoring and evaluation system for pain management in order to continuously improve the therapeutic effect.
Conflict of interest: Author does not have any conflict of interest.