Pharma product wrappers, vials & containers

In his excellent publication Hospital Waste, volume 14/3, Alan B Jones writes from the US perspective of the disposal of the various wrappers, vials & containers that had previously contained P list pharmaceuticals.

These P-list drugs comprise, among others, warfarin (>0.3%), nicotine, arsenic trioxide, epinephrine, physostigmine salicylate, physostigmine and phentermine. Only the pharmaceutical residue in these containers designates and should be counted as waste, but in practice the entire container must be managed as RCRA hazardous waste.

So far, so good. It is often not safe, or not practical, to separate drug waste from the primary containers in which it was packaged. But Jones goes on, to state:

Most containers, including IV bags, glass vials and syringes, constitute trash when they contain less drug than 3% of the container volume. But containers of P-listed pharmaceuticals still contain enough residue to require that they be managed as RCRA (federal) hazardous waste, even if they appear visually to be completely empty.

These materials harbor microgram quantities of residue when the tab or patch has been removed, causing the wrapper to designate unless it is “triple-rinsed with a suitable solvent.

But triple rinsing of pharmaceutical packaging including wrappers, vials and IV bags is not a practical or realistic pre-treatment. Rinse solutions would become contaminated with the pharma residues removed from the packaging waste thus creating yet more regulated P-list waste in a self-defeating process.

The rules, applicable in Washington but derived from federal law are described in an EPA memorandum “Containers That Once Held P-Listed Pharmaceuticals”, stipulate that it is important to distinguish between the P-listed pharmaceutical residue that designates as RCRA hazardous waste and the container, wrapper, vial or IV bag, which doesn’t designate.

But even though the container doesn’t designate and its weight shouldn’t count towards the facility’s Extremely Hazardous Waste volume, it must be managed as RCRA hazardous waste. For example, 100 glass vials might weigh 1,000 grams, but the residue from all those vials weighs just 1 milligram. Accordingly, 1 milligram counts towards the facility’s dangerous waste generator status, but 1,000 grams must be hauled away by the facility’s Treatment, Storage & Disposal vendor to be incinerated.

Work that on out, and you will realise that the system is quite ridiculous, seeking to tick boxes and satisfy a bureaucratic framework rather than manage wastes safely, effectively and efficiently. In the UK, we do seem to import a lot of ideas about clinical waste management from a selective trawl through US legislation and practice.

This is just the type of thing that may be picked up over here, but perhaps not quite as described by Jones. For is anyone suggested that containers, wrappers, vials or IV bags that had contained a POM or other non-prescription pharmaceutical alarm bells would ring long and loud.

There should, or course, be a happy mid-ground that deals properly with the disposal of drug waste, separated secondary packaging and deals effectively with primary wrappings where a need is demonstrated. That requires an independent and comprehensive assessment of the quantities and range of pharmaceuticals in the average load of clinical wastes, with additional assessment of the quantum and composition ranges that may be seen in different circumstances. Instead, we make do with a single small assessment, nonetheless costly, produced by each waste processor. Leaving aside the issue of these scientifically flawed assessments that are too limited in scope to provide solid answers to issues of environmental impact, there is much opportunity for a single “official” study, of size suitable to provide an accurate overview of UK clinical waste production, to reflect clinical practices in different hospitals and units, and to consider each of the various ATT processes.

That there are few available ATT processes makes a study of this type entirely logical; the data gained will be applicable universally. Instead, it is required that individual operators produce their own assessment, as if more to bow down to the authority of individuals within the EA. Scientific integrity is largely non-existent.

What a mess. The entire issue of pharmaceutical waste disposal is as yet unresolved. While those concerned with clinical wastes get hot under the collar about teh occasional tablet or vial in a bag of waste intended for ATT disposal, the context is that over 99& orf the dose has been given to the patient, excreted in urine and passed througha Victorian sewage disposal system that fails to remove many pharma residues except by dilution. Much more work is needed to assess the problem and define lower limits for regulation. That will be hugely costly – and should be funded centrally – and will time consuming if it is to be done properly but cannot be shirked, to be replaced only by a biggoted and idealistic approach to regulation that relies on or hides behind bad science.

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