Policy Tag: Drug

Adopted by the 62nd WMA General Assembly, Montevideo, Uruguay, October 2011
And amended by the 71st WMA General Assembly (online), Cordoba, Spain, October 2020

 

PREAMBLE

Around the world, tens of millions of people with cancer and other diseases and conditions experience moderate to severe pain without access to adequate treatment. These people face severe suffering, often for months on end, and many eventually die in pain. Those who may not be able to adequately express their pain – such as children, people with intellectual disabilities and those with altered consciousness– and individuals and populations that have historically been undertreated for pain and pain management due to bias, are especially at risk of receiving inadequate pain treatment.

Inadequate pain treatment contributes to individual suffering physically and emotionally, but also causes huge care burdens and negative economic impact on a national level.

However, most of the suffering is unnecessary and is almost always preventable and treatable.

In most cases, pain can be stopped or relieved with inexpensive and relatively simple treatment interventions, which can dramatically improve the quality of life for patients. Sometimes, especially in severe chronic pain, psycho-emotional factors are even more significant than physiologic factors.

Pain treatment in these cases may require a multi-faceted approach to care by multidisciplinary teams.

Over the years, the use of opioids has seen significant growth in some countries. In many other areas around the world, however, access to essential pain treatment remains limited for patients in pain. Even in countries with a high volume of use, it can be difficult for specific populations to receive adequate treatment for their pain. Incomplete pain assessment or improper use of pain medication can bring about adverse drug reactions. All of these are very important and urgent issues need to be addressed.

Governments should adopt effective measures, wherever possible, for adequate pain treatment. For this goal, governments shall ensure that healthcare professionals across fields are entitled to educational training on pain evaluation and management; that the right of all patients in pain to pain treatment is not compromised due to unnecessary regulations; and that policies on the management of controlled drugs help with effective monitoring of and prevention against risks associated with controlled drugs.

 

RECOMMENDATIONS

  1. Access to adequate pain treatment is a human right. Physicians, medical professionals and health care workers must offer pain assessment and pain treatment to patients with pain. Governments must provide sufficient resources and proper pain treatment regulations.
  2. Pain is a complex perception consisting of physical, psychological, social, cultural and spiritual sufferings. Physicians, medical professionals and health care workers must offer holistic pain assessment and appropriate pain treatment, such as pharmacological and/or non-pharmacological interventions to patients with pain. All healthcare professionals should seek to fulfill the goal of effectively evaluating the pain of all patients, including pain suffered by children, cognitively impaired patients and those unable to properly express themselves.  Healthcare professionals should also seek to effectively evaluate and treat pain in patients and populations who have historically been undertreated for pain due to implicit and explicit biases.
  3. Pain treatment and control education shall be provided to healthcare professionals including physicians, other medical professionals, and other health care workers.

Education should include pain assessment, evidence-based pain control, and the efficacy and risks of painkillers. Education should include pain medicine, including the action of opioids, preventing adverse reactions, and the adjustment and conversion of the dosage of opioids. Patient-centered care should be taught to fulfill the goal of adequately stopping pain and reducing the incidence of adverse reactions. The curriculum shall be highly competence-based in design enhancing the knowledge, the attitude, and the skills of healthcare professionals while treating pain.

Education should support the development of pain and palliative specialists, in order for them to effectively support first-line physicians and other medical professionals.

Pain treatment education for medical professionals shall include the non-medicinal treatment options. Education should equip medical professionals with proper interpersonal communication skills, cultural sensitivity, and the ability to evaluate the overall pain suffered by patients at the physiological, psychological, and spiritual levels and to empower them in inter-professional practice so that professionals can work together to alleviate the pain felt by patients with and without medication.

  1. Governments, regulators and healthcare administrators must acknowledge the consequences of pain in terms of health, productivity, and economic burden. Governments should provide ample resources and have suitable regulations governing controlled drugs.

For policies on the control of drugs, governments shall periodically review and adequately revise them to ensure the availability and accessibility of controlled drugs such as opioids. In addition, abuse and illicit use must be prevented.

  • Patients in pain shall be given access to effective pain medication, including opioids. Depriving them of such right is a violation of their right to health and is medically unethical.
  • Governments must ensure that controlled drugs, including opioids, are made available and accessible to help relieve the suffering. Relief of suffering and prevention against abuse shall be balanced in the management of controlled drugs.

Government shall provide abundant resources and create a national pain management research institute to explore issues in pain treatment and to come up with solutions, in particular:

  • Explore issues that become barriers to pain treatment, such as financial condition, socioeconomic status, patient race and ethnicity, urban and rural differences, logistics, insufficient training, and culture (the misunderstanding that people have about opioids, for example)
  • Promote the use of validated pain assessment tools.
  • Conduct studies of emerging therapies or non-medicinal therapies.
  • Establish a system and a standard procedure to record and collect pain-related data for correct statistics and monitoring. Pain-related data includes the incidence and prevalence of pain, cause of pain, burden of pain, pain treatment status, reason for pain not properly treated, and number of people with drug abuse, etc.
  1. Governments shall prepare a national pain treatment plan to be followed in pain prevention, pain treatment, pain education, and policies on the management of controlled drugs.
  • The national pain treatment plan shall be evidence-based.
  • Governments must take into consideration opinions of policymakers, medical professionals, and the general public in order to prepare a national pain treatment plan that is extensive, practical, and forward-looking, contributing to enhanced nationwide pain treatment efficacy.

Adopted by the 34th World Medical Association General Assembly, Lisbon, Portugal, September/October 1981,
revised by the 39th World Medical Association General Assembly, Madrid, Spain, October 1987,
by the 45th World Medical Association General Assembly, Budapest, Hungary, October 1993,
by the 51st World Medical Association General Assembly, Tel Aviv, Israel, October 1999,
reaffirmed by the 185th WMA Council Session, Evian-les-Bains, France, May 2010,
and revised by the 72nd WMA General Assembly (online), London, United Kingdom, October 2021

 

PREAMBLE

Sports medicine physicians are physicians concerned with the prevention and treatment of injuries and disorders that are related to participation in sports. In some countries, sports medicine physicians are recognized as medical specialists. They are trained to address issues associated with nutrition, sports psychology and substance misuse, and may also counsel athletes on injury prevention.

Considering the involvement of physicians in sports medicine, the World Medical Association (WMA) recommends ethical guidelines for sports medicine physicians, recognizing the special circumstances in which their medical care and health guidance is given.

Anabolic Agents and Performance Enhancing Drugs and Methods

The use of anabolic agents, performance enhancing drugs, pain killers and performance enhancing methods by athletes is contrary to the rules and ethical principles of athletic competition as set forth by most sports governing bodies. Performance enhancing drugs and methods have been associated with adverse health effects.

The sports medicine physician should be aware that methods, drugs or interventions which artificially modify blood constituents, biochemistry, genome sequence, gene expression or hormone levels and do not benefit patients, violate the basic principles of the WMA’s Declaration of Geneva, which states: “the health and wellbeing of my patient will be my first consideration.”

The WMA believes that the use of anabolic agents and performance enhancing drugs and methods is a threat to the health of athletes and is in conflict with the principles of medical ethics. The physician must oppose and refuse to administer or condone any means or method which is not in accordance with medical ethics, or which might be harmful to the athlete using it. The physician must also inform athletes of potential health risks.

Examples of these drugs and methods include, but are not limited to:

  • The use of drugs or other substances whatever their nature and route of administration, including central-nervous-system stimulants or depressants and procedures which artificially modify reflexes, alter a sense of well-being and/or general mental outlook.
  • Procedures or therapeutics to mask pain or other protective symptoms if used to enable the athlete to take part in events or training activities when clinical signs make his or her participation inadvisable. This includes allowing participation in athletic activity when doing so would be dangerous to the athlete.
  • Procedures or therapeutics used to mask the presence of other performance enhancing drugs or to induce rapid water or weight loss.
  • Measures aimed at an unnatural improvement in or maintenance of endurance or oxygen carrying capacity during competition. This includes the manipulation of blood and/or blood components defined as the administration or reintroduction of blood or red blood cell products of any origin into the circulatory system, artificially enhancing the uptake, transport, or delivery of oxygen using chemicals such as erythropoietin, or other forms of intravascular manipulation to artificially increase red blood cell mass, unless medically indicated for the treatment of a documented disease or medical condition. Blood doping also exposes the athlete to unwarranted and potentially serious health risks.
  • Use of anabolic agents including “designer steroids”, which are substances that are undetectable through the use of standard testing methods.
  • Use of anabolic steroid precursors, including dietary supplements, that claim to provide “safe” steroid equivalents, but that metabolize in the body into anabolic steroids.
  • Use of non-approved substances which have no current approval by any governmental regulatory health authority for human therapeutic use, for example, drugs under pre-clinical or clinical development, discontinued drugs, designer drugs or substances approved only for veterinary use.
  • Use of peptide hormones, growth factors and related substances to increase red blood cell count, blood oxygenation or oxygen-carrying capacity.
  • Use of hormone and metabolic modulators, which are substances to modify hormone activity by blocking the action or increasing the activity of a hormone.

Of special concern is the use of anabolic agents and steroid precursors in adolescents. Young users are considered particularly susceptible to potentially serious health problems during this physically and emotionally vulnerable period when their own hormonal cycles are changing. In females, anabolic agents have been associated with a number of adverse effects, some of which appear to be permanent even when drug use is stopped. Physicians should strongly discourage using these products.

World Athletics Gender Rules for Classifying Female Athletes

World Athletics 2018 Eligibility Regulations for Female Classification[1] imposes an upper hormonal limit for athletes wishing to compete in the female category in certain disciplines of international athletics competitions.

The WMA opposes World Athletics’ rules[2] requiring female athletes with differences in sex development to take drugs to reduce and maintain their natural level of blood testosterone in order to compete. The mere existence of a condition caused by a difference in sex development, in a person who has not expressed a desire to change that condition, does not constitute a medical indication for treatment. Medical treatment solely to alter athletic performance is unethical.

 

RECOMMENDATIONS

  1. Sports medicine physicians have an obligation and duty to respect and comply with the ethical standards of the medical profession.
  2. The sports medicine physician who cares for athletes has an ethical responsibility to recognize the special physical and mental demands placed upon athletes by their participation in athletic activities. The physician’s duty is to preserve the athlete’s mental and physical health and not solely to increase athletic performance.
  3. When the sports participant is a professional athlete and derives livelihood from that activity, the physician should understand the occupational health aspects involved.
  4. The sports physician should give his or her objective opinion about the athlete’s state of fitness clearly and precisely, leaving no doubt as to his or her conclusions.
  5. In all sporting events, it is the physician’s duty to decide whether the athlete is medically fit to compete in an event. This decision cannot be delegated to other non-physician professionals.
  6. In order to carry out his or her ethical obligations, the sports medicine physician’s authority must be fully recognized and upheld, particularly when it concerns the health and safety of the athlete. Concern for the athlete’s health and safety must override the interests of any third party.
  7. The sports medicine physician is obligated to uphold the ethical principles of the medical profession. This includes the right to privacy and respect for the confidential nature of the patient-physician relationship. These principles and obligations should be supported by an agreement between the sports medicine physician and the athletic organization involved.
  8. The sports medicine physician must oppose and refuse to administer any substance or condone any means or treatment method which is not in accordance with medical ethics and/or which might be harmful to the athlete using it. The physician must also inform athletes of potential health risks.
  9. The sports medicine physician should be invited to participate in the design and modification of a sport’s rules and regulations in order to protect the health and safety of athletes.
  10. The sports medicine physician, with patient consent, should work cooperatively with the patient’s personal physician, and keep him or her fully informed of the patient’s current condition.
  11. All physicians should recognize that the desire to enhance performance, appearance, and/or well-being is not limited to elite athletes. Amateur and recreational athletes, as well as adolescents, are also at risk of and subject to sociocultural pressures to misuse anabolic agents and performance enhancing drugs and methods. A harm-reduction approach with discussions focused on risks, harm minimization, prevention strategies, and health promotion is recommended.

 

[1] Specifically, Rule 2.3 of Competition Rule 3.6, “Eligibility Regulations for the Female Classification.”

[2] Specifically, Rule 2.3 of Competition Rule 3.6, “Eligibility Regulations for the Female Classification.”