Hormoontherapie met geregistreerde of zelfbereide medicijnen?

In Nederland is onduidelijkheid ontstaan over het zelf bereiden door apothekers van levothyroxine. In de berichtgeving rond de nieuwe circulaire Handhavend optreden bij collegiaal doorleveren van eigen bereidingen door apothekers van de Inspectie voor de Gezondheidszorg (IGZ) is namelijk verwezen naar de problemen met de levering van Thyrax. Apothekers in Nederland mogen alleen medicatie bereiden indien er geen geregistreerde adequate alternatieven beschikbaar zijn. Voor Thyrax zijn deze geregistreerde alternatieven wel beschikbaar.

Compounded bioidentical hormones in endocrinology practice: an Endocrine Society Scientific Statement
N Santoro, GD Braunstein, CL Butts, KA Martin, M McDermott, JV Pinkerton

Choosing commercial or compounded medicines
RM Plotzker

In bijgaande artikelen kun je lezen dat de keus tussen het zelf bereiden door apothekers of het gebruik van geregistreerde commerciële medicijnen ook in de Verenigde Staten speelt. Artsen worden aangespoord geregistreerde medicijnen voor te schrijven. Maar ook dan kan het fout gaan. Als voorbeeld wordt Synthroid genoemd, te vergelijken met Thyrax.

Abstract

Custom-compounded bioidentical hormone therapy (HT) has become widely used in current endocrine practice, which has led to unnecessary risks with treatment. This scientific statement reviews the pharmacology and physiology of popular compounded hormones and the misconceptions associated with these therapies. The hormones reviewed include: estradiol and estrogens, progesterone and progestins, testosterone, dehydroepiandrosterone, levothyroxine and triiodothyronine.

Results

Overall, there is a general lack of standardization and quality control regarding how custom-compounded bioidentical hormones are produced and administered, leading to the possibility of overdosing, underdosing, or contamination. There is also recent evidence of patient harm and death associated with treatment, as seen with fungus-contaminated glucocorticoid preparations. With estrogen, progestin, and dehydroepiandrosterone treatments, the practice of baseline hormone measurements to replace “abnormal” hormone deficiencies has no basis in medical practice. Furthermore, there is no evidence that monitoring compounded HT with serial salivary or blood testing is effective, except in the case of thyroid hormone. Finally, no evidence supports the popularized notion that custom-compounded bioidentical hormones have fewer risks when compared with Food and Drug Administration (FDA)-approved hormone treatments.

Conclusion

The widespread availability of FDA-approved bioidentical hormones produced in monitored facilities demonstrates a high quality of safety and efficacy in trials; therefore, there is no rationale for the routine prescribing of unregulated, untested, and potentially harmful custom-compounded bioidentical HTs. Clinicians are encouraged to prescribe FDA-approved hormone products according to labeling indications and to avoid custom-compounded hormones.