Workshop 1 – Ethical and legal dilemmas: focus on the patient

Two examples of ethical and legal dilemmas concerning drug-therapy and ethical considerations of the pharmacist involved will be intensively discussed throughout the workshop.

Example 1: Use of Laetril in tumour patients

Within the last decades, the Amygdalin-related derivative Laetril (“Vitamin B17”) has been suggested to be an encouraging candidate for “alternative” cancer treatment.

Pros are primarily based on epidemiologic considerations (e.g. lower rate of cancer incidence in areas with higher amount of Amygdalin-containing food) as well as in vitro data clearly indicating an Amygdalin-related potency to block cancer cell growth. However, tablets as well as ampoules containing Laetril are extemporaneously prepared by some local pharmacies. As a consequence, hospital pharmacists may also be asked by their oncologists, whether they support an order and preparation of Laetril or not, e.g. for a paediatric patient when parents challenge its use based on Internet-related information. How shall we outweigh pros and cons?

Example 2: Cyp2C19-Genotyping to improve drug efficacy and tolerability

Several drugs, including Clopidogrel, Voriconazole, Thalidomide and Cyclophosphamide, undergo a clinically relevant Cyp2C19-mediated biotransformation pathway resulting in active or inactive metabolites. Concerning Voriconazole, carriers of the Cyp2C19*1/*1 genotype represent the expected spectrum of metabolism, whereas carriers of the Cyp2C19*2/*2 alleles or Cyp2C19*17/*17 alleles have been classified as poor (PM) and ultra-rapid metabolizers (URM), respectively, with supra- and sub-therapeutic drug levels as a consequence. In the case of Thalidomide, ongoing research indicates that Cyp2C19 genotype may play an important role for the extent of drug-related toxicity.

From an ethical point of view hospital pharmacists might be obligated to enforce genotyping of Cyp-Isozymes in oncology patients or even the whole population in order to select the right drug and dose more appropriately. On the other hand data indicate that carriers of Cyp2C19 PM genotype may expect a shorter life expectancy in general than extensive metabolizers. How shall we outweigh pros and cons?

 

 

• To develop a pathway to review alternative solutions if no authorised medicinal product is available for the specific need of patients.

 

 

 

After the workshop the participant should be able:

 

• to analyse the root cause of an unmet needs regarding a patients’ drug therapy;

• to review alternative solutions and to evaluate risk-benefit ratios of alternative solutions;

• to prepare a documentation of the added value and the quality issues of the pharmacy preparation.