Monitoring the effect of herbal co-medications

Herbal products may have therapeutic value, but they can also have adverse effects on medical treatments. The WHO Herbal Dictionary will help pharmas to understand how herbal products may influence the action of their product and allow them to take necessary action.

The growing popularity of drugs of herbal remedies is a challenge that can no longer be ignored by everyone involved in drug safety, including the pharmaceutical industry. The herbal remedies might cause adverse events by themselves, but they are also affecting other medical treatments. In order to understand the effect of a medicinal product in the general population the industry must understand the co-medications used by its patients.

Although the therapeutic value of many herbals may be well recognised, herbal medicinal products, with few exceptions, are not part of the same regulatory framework as conventional medicinal products, and have not gone through the same rigorous scientific testing for efficacy and safety. As there is a growing awareness that herbal products may also cause harm, there is also a need for effective risk management strategies to cover herbal products.

Since most herbal remedies are not part of the regulatory framework it is especially important that the pharmaceutical industry and the regulatory authorities monitor the effect these products have on regulated medicinal products.

To enable herbal drug utilisation research and safety monitoring, the existing systems for capture, storage and analysis of data need to be adapted to accommodate relevant information on herbal products. In addition, the safety issues associated with the use of herbal products, and their public health impact, have to be evaluated and communicated.

In order to address this issue UMC Products & Services produced a new unique classification system: the Herbal Anatomical Therapeutic Chemical (HATC) classification and the WHO Herbal Dictionary with information about herbal products.

The WHO Herbal Dictionary is the first international dictionary of herbal products. The dictionary is used for identifying the names of herbal products, their active ingredients and therapeutic use, in the course of their drug safety surveillance. It translates a drug name into useful information, which is used for coding and analysis of drug safety data – both pre- and post- marketing.

The WHO Herbal Dictionary will help to:

• Find the trade names of herbal products and code them in clinical data.
• Translate the trade name into active ingredients – plants, parts of plants and extraction types.
• Analyse the coded data by using the new unique Herbal ATC classification.

This will help pharmaceutical companies to identify patterns, increase their understanding of how herbal products may influence the action of their product and allow them to take necessary action.

The combined offer of the WHO Drug Dictionary Enhanced and WHO Herbal Dictionary will improve the quality of the coding of co-medication in clinical trials and drug safety and make it more efficient. In turn, the improved quality of coded data will lead to more knowledge and better decisions.

An example: the co-medical effects of St John’s Wort

• A number of pregnancies were reported for women taking oral contraceptives and products containing St John’s Wort.
• St John’s Wort has been shown to reduce the serum concentration of the anti-HIV drug Inidavir (Crixivan). The sub-optimal concentration may reduce the effect of the drug, and even increase the risk of the development of resistance of the HIV virus to Inidavir.
• A few cases indicate that the use of St John’s Wort has reduced the effect of Cyclosporin, which has caused rejection of transplanted hearts.
• The herb has also been shown to reduce the serum concentrations of warfarin and some statins (simvastatin and atorvastatin).

The St John’s Wort incident illustrates the importance of knowing as much as possible about the co-medications taken when adverse events are detected.

For more information

UMC Products & Services
Email: sales@umc-products.com
Website: www.who-umc.org