The patient was admitted to the dentist’s detox treatment centre in November 2017 for Ibogaine treatment due to an addiction to Xanax, a benzodiazepine, used to treat anxiety in patients. He died two days later from cardiac arrest while still under the treatment and care of the dentist.

The patient was allowed to continue taking Xanax prior to Ibogaine treatment being administered despite the dentist being aware that Ibogaine and Xanax, when administered together, pose a high risk of death in patients. Ibogaine treatment was administered without checking the patient’s vital signs prior to and during the course of treatment.

Treatment was administered by a nurse who was the only person on duty at the time. The patient was unmonitored, no intravenous line had been inserted and no drugs were available to counteract the effect of Ibogaine when the patient went into cardiac arrest.

The dentist imported Tabernanthe iboga, a shrub native to Central Africa, in terms of a permit issued to him under the Agricultural Pests Act, 1983. The shrub was used to manufacture Ibogaine which the dentist sold, dispensed and exported illegally.

Insufficient research has been conducted to prove or disprove Ibogaine’s use for treatment of any form of addiction, and it is not approved by the Food and Drug Administration Federal Agency or by South African Health Products Regulatory Authority (SAHPRA).

The dentist was found guilty of culpable homicide on the basis that he had no intention to murder the patient either directly or indirectly. However, in applying the “reasonable person” test and having heard expert evidence, the court concluded that the dentist was guilty of culpable homicide.

The reasonable person test is an objective test aimed at determining fault. A person is negligent if they deviated from the conduct of the reasonably prudent person acting under similar circumstances. The questions asked in establishing fault are:

• What steps would a reasonably prudent person have taken in the circumstances?
• What steps the person took?
• How that person’s actions or omissions deviated from the steps the reasonable person would have taken and caused the deceased’s death.

The test is adaptable in the sense that the standard of care is elevated to the degree of skill and care required.

In considering the five statutory charges which the dentist was found guilty of, it is imperative to note that SAHPRA is responsible for the regulation of registered and unregistered medicines, and scheduled substances for human and animal use in terms of the Medicines and Related Substances Act,1965, and its Regulations.

Application must be made by a manufacturer to SAHPRA in terms of its Guidelines and the Act for a license to manufacture, import and export medicines.

Before dispensing medication, a medical practitioner is required to complete a dispensing course and obtain a license to compound or dispense medication in terms of the Act.

The establishment of a treatment centre entails application for a license, an assessment being performed, certification being obtained and registration of the treatment centre under the relevant category which is dependent upon the level of service being provided. Additionally, treatment centres are required to comply with and meet the requirements of the National Health Act, 2003, The Prevention of and Treatment for Substance Abuse Act, 1970, the Regulations, the Guidelines issued by SAHPRA and the National Department of Health.

The process of “detoxification” which is aimed at clearing toxins from the body of a person who is dependent on substances of abuse is defined in The Prevention of and Treatment for Substance Abuse Act as “a medically supervised process by which physical withdrawal from a substance is managed through administration of individually prescribed medicines by a medical practitioner in a health establishment, including a treatment centre authorised to provide such a service under the National Health Act”.

A medical practitioner administering the treatment must be registered in terms of the Health Professions Act, 1974 with the Health Professions Council of South Africa under the relevant Professional Board to practice in a particular field of speciality.

Additionally, a person may only be regarded as an expert if they are highly skilled in the area of expertise which they claim to be an expert on. The person must be directly involved in peer reviewed studies relating to the area of expertise.

This case serves as a stark reminder to both, treatment facilities and medical practitioners, to ensure compliance with healthcare legislation, SAHPRA Guidelines, the HPCSA Guidelines and the National Department of Health’s Guidelines in establishing treatment centres and treating patients in general.