Marjolein G. Klous

Heroin-assisted treatment in the Netherlands: History, findings, and international context

This monograph describes the history, findings and international context of heroin-assisted treatment (HAT) in the Netherlands. The monograph consists of (1) a short introduction and seven paragraphs describing the following aspects of HAT in the Netherlands: (2) history of HAT studies and implementation of routine HAT in the Netherlands; (3) main findings on efficacy, safety and cost-effectiveness from the two randomized controlled HAT trials in the Netherlands; (4) new findings from a large cohort study on the effectiveness of HAT in routine clinical practice in the Netherlands; (5) unique data on the patients perspective of HAT; (6) data on the pharmacological and pharmaceutical basis for HAT in the Netherlands; (7) description of the registration process; and (8) account of the international context of HAT. Together, these data show that HAT can now be considered a safe and proven-effective intervention for the treatment of chronic, treatment-resistant heroin dependent patients.

Development and Manufacture of Diacetylmorphine/Caffeine Sachets for Inhalation Via ‘Chasing the Dragon’ by Heroin Addicts

In 1998, two clinical trials were started in the Netherlands to evaluate the effect of coprescription of heroin and methadone on the mental and physical health and social functioning of chronic, treatment‐resistant, heroin dependent patients. Since 75–85% of the heroin addicts in the Netherlands use their heroin by “chasing the dragon,” one of the two study arms concerned the coprescription of inhalable heroin. A pharmaceutical dosage form for inhalable heroin was developed for this trial, consisting of a 3:1 powder mixture of diacetylmorphine base and caffeine anhydrate. We describe the manufacturing process that was developed for filling sachets with this mixture in four dosages using a microdose auger filler. In order to control product quality, in‐process controls were developed to monitor the filling process and quality control tests were performed on the finished product. In‐process control results have shown the filling process to be accurate and precise. The diacetylmorphine/caffeine sachets were shown to comply with the specifications for content and uniformity of mass. The finished product was found to be stable for two years when stored at 25°C, 60% relative humidity and for 6 months when stored at 40°C, 75% relative humidity.