governmentchemist


Watch List for pharmaceuticals established under WFD by Nick Boley

The European Commission has legally established a “Watch List” for three pharmaceutical substances in EU water bodies under the Water Framework Directive (WFD).

Commission Implementing Decision 2015/495 lists the three substances diclofenac, 17-beta-estradiol (E2) and 17-alpha-ethinylestradiol (EE2) for inclusion on this initial watch list, as well as Estrone (E1) a breakdown product of E2. This necessitates Member States making a series of measurements for these substances across a wide range of water bodies in order to ascertain if there is a potential problem. The proposed levels at which these should be monitored are exceptionally low – 10 ng/L for diclofenac, 0.4 ng/L for E2 and E1, and o.035 ng/L for EE2. The capability of many laboratories to measure at these levels is not proven, and the cost of these measurements will be significant.

The Commission has also proposed that some further substances now be added to this Watch List:

oxadiazon, methiocarb, 2,6-ditert-butyl-4-methylphenol, tri-allate, four neonicotinoid pesticides, the macrolide antibiotic erythromycin, and 2-ethylhexyl 4-methoxycinnamate. Monitoring for these substances, albeit at a higher level than the pharmaceuticals (between 9 and 6000 ng/L) must also be carried out, which will add a further cost burden to laboratories in Member States.



New Drug Drive legislation for March 2015 by Nick Boley

New legislation which covers the subject of drug driving come into force in the UK on 2 March 2015. This legislation, published by the Department of Transport, aim to improve road safety by setting limits for the levels of 8 illicit drugs and 8 prescriptions drugs in the bloodstream. These are set so that levels above are associated with impairment to drive. The levels for the illicit drugs are very low, but those for the prescription drugs (clonazepam, diazepam, flunitrazepam, lorazepam, oxazepam, temazepam, methadone and morphine) are much higher to reflect average to above-average prescription use so that those drivers keeping to any prescribed dose would be safely below the legal limits.

There is also a proposal to add amphetamine at a level of 250 µg/L to the new legislation – this level is sufficiently high not to catch legitimate users of amphetamine for medical purposes (e.g. those suffering with ADHD).

The Government Chemist responded to a consultation issued in 2014 by the Department of Transport and the response can be accessed here. One of our major concerns is that for legislation like this to be fully effective, measures need to be in place similar to those for drink-driving such as validated roadside tests and certified reference materials (CRMs) to underpin laboratory measurements for drugs in blood. The measurement uncertainties associated with many of these measurements are significantly higher than those associated with alcohol in blood measurements, and these can, in turn, lead to higher uncertainty in the interpretation of results. This is an issue which does, in our opinion, need to be properly resolved for the legislation to have the effect for which it was designed.



Update on Pharmaceuticals in water by Nick Boley

The Permanent Representatives Committee of the European Council have endorsed the informal
agreement reached with the European Parliament on the directive on priority substances in
the field of water policy.

12 new substances will be added to the existing list of 33 priority substances under the Water Framework Directive, but the 3 pharmaceuticals which had been proposed to be added to this list – Diclofenac, 17-beta-estradiol (E2) and 17-alpha-ethinylestradiol (EE2) – will be added to the EU’s “Watch List”  to be monitored in all member states (watch list) to support future reviews of the priority substances list.

 



Fake medicines – action taken by Nick Boley
March 18, 2013, 12:46
Filed under: pharmaceuticals | Tags: , ,

Interpol and pharmaceutical companies are taking action together to face down the problem of counterfeit medicines.

The problem of counterfeit medicines being so readily available is truly international in scale, and in some developing countries as much as 50% of all medicines purchased are counterfeit. Counterfeit products not only lack the active ingredients they need to be effective, some actually contain substances which are positively injurious to human health.

Testing of suspected counterfeit medicines is important in this fight; it can be relatively straightforward to determine the level of active ingredients in a pharmaceutical product, but to determine what else may be present in a fake medicine requires more extensive work.