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Application to the Federal Opium Agency for cannabis flowers: what does "out of treatment" actually mean?

Franjo Grotenhermen

The most important part of the application for an exemption according to Section 3, Paragraph 2 of the Narcotics Act by the Federal Opium Agency for the use of cannabis flowers from the pharmacy is a medical report. In it, the attending physician(s) must justify why therapy with cannabis is necessary for the applicant. To this end, he/she explains why other therapies have so far been ineffective or have caused severe side effects. He/she presents the medical history, including previous therapy attempts. In the medical report, he/she may refer to medical records of the previously treating physicians or hospitals. He or she also states that any possible benefits of cannabis therapy outweigh the possible risks, and that the patient is likely to use the therapy responsibly.

The greatest uncertainty among many physicians and patients concerns the question of when a patient can be considered "out of treatment" with standard therapeutic procedures, so that an application for an exemption is likely to be successful. The amendment to the law planned by the German government also stipulates that cannabis-based medicines should only be reimbursed by health insurance funds if other therapeutic procedures are not sufficiently effective. Here, too, it would then have to be explained to the health insurance company why the disease in question cannot be treated with the usual, approved therapeutic procedures. Here are some examples of patients who have received an exemption.

Chronic pain

This is a 50-year-old man who suffered a fracture of the 12th thoracic vertebra with complete paraplegia following a motorcycle accident about 30 years ago, including severe chronic pain in his legs. In recent years, a variety of pain medications have been used, including novaminsulfone, pregabalin, duloxetine, morphine, and most recently L-polamidone. Novamine sulfone and pregabalin were ineffective. Morphine and polamidone were not tolerated. In addition, these medications also did not result in satisfactory pain relief.

Attention-deficit/hyperactivity disorder (ADHD)

The 40-year-old man was diagnosed with adult-onset ADHD last year. The focus is on hyperactivity with sleep disturbances, restlessness and nervousness, but beyond that also disturbances of attention. In addition to psychotherapy, he received methylphenidate. This medication led to pronounced side effects, including above all insomnia with wakefulness phases of up to 36 h, increased nervousness, hyperactivity, increased aggressiveness and loss of appetite. Medication with atomoxetine (Strattera) and dexamphetamine (Attentin) also caused pronounced side effects. He has found in self-experimentation that cannabis products provide good relief from ADHD symptoms.

HIV infection with joint pain and weight loss

The individual is 50 years old and suffers from weight loss and joint pain in the setting of HIV infection. He has received a number of medications since 1999 primarily for the pain (novaminsufone, ibuprofen, et cetera), but has had to discontinue them due to side effects including dizziness, headaches, sleep disturbances, and diarrhea. In addition, he has tried weak-acting opiates (tilidine, tramadol). These too were associated with side effects, mainly nausea and itching. He then found that cannabis products relieved his symptomatology without relevant side effects, and he was able to live again without pain and depression. Appetite-increasing medications, he said, were not available to him from his physician. The patient is able to work a mini-job despite symptomatic HIV infection with regular use of cannabis products.

Post-traumatic stress disorder

The patient, now 31, joined the U.S. Army at age 17. His health problems, characterized by depression, fear that something bad might happen, voices in his head that he won't make it, sleep disturbances, and nightmares, are based on experiences in the Iraq war. He is an American citizen and has been living in Germany for one year. He became addicted to alcohol in 2004. Between 2009 and 2012, he took a number of antidepressants and benzodiazepines, including citalopram, trazodone, diazepam, fluoxetine, bupropion, sertalin, et cetera. In addition, he had participated in group therapy for alcoholics and depressed patients, as well as individual psychotherapeutic sessions. After 3 years, he had to realize that none of the therapeutic measures had a relevant effect. When he takes cannabis, he feels much better. He can work during the day and concentrate on his studies in the evening.