Pharma waste disposal — are you in the know?

The pharmaceutical sector is required to dispose of waste medicines, and the disposal route must completely conform to compliance requirements

Guidance from the World Health Organisation (WHO) titled Safe Management of Wastes from Health-Care Activities (Second edition, 2014, p.129) states that for “large quantities of pharmaceutical waste, the options available include encapsulation and burial in a sanitary landfill or incineration in kilns equipped with pollution-control devices designed for industrial waste and that operate at high temperatures”. The document also states “several options exist for small quantities of pharmaceutical waste, including the return of expired pharmaceuticals to the donor or manufacturer or encapsulation and burial in a sanitary landfill.”

In developed nations with modern infrastructure, such as the UK and others in the EU, high-temperature incineration is considered to be the accepted standard of destruction required for pharmaceutical waste. In the UK, the landfill of pharmaceutical waste is specifically prohibited, being listed as a ‘banned waste’ on the waste acceptance criteria for landfill.

Landfilling pharmaceutical waste is also environmentally unsustainable, as there is a lack of landfill site capacity on a national scale.

Implications of the incorrect disposal of pharmaceutical waste also extend to counterfeiting should any of these products fall into the wrong hands. This very real issue saw Interpol and 29 of the world’s largest pharmaceutical companies create Interpol’s Pharmaceutical Crime Programme to further build on the work of its Medical Product Counterfeiting and Pharmaceutical Crime (MPCPC) unit.

The illegal manufacture, trade and distribution of fake, stolen or illicit medicines and medical devices also includes the counterfeiting and falsification of medical products, packaging and associated documentation.

A media release that announced this landmark agreement in March 2013  included the comment from Interpol’s Secretary General Ronald K. Noble: “With no country, no drug, no medical product immune from counterfeiting, a global effort is needed to combat this threat which puts the lives of millions of people at risk every single day.”

The secure destruction of pharmaceutical waste is the only fail-safe method of ensuring all products have been completely destroyed. Depending on the waste stream, secure destruction of waste can range from shredding (for items such as waste pharmaceutical packaging) to high-temperature incineration with energy recovery (for items such as unused medicines).

Surjit Bains at waste management company Avanti Environmental explained: “This secure destruction method sees the waste collected, logged and the customer receive a consignment note to show the waste has been collected and left their premises. This waste is then taken to one of our fully licenced, secure sites, with 24-hour CCTV coverage, ready for processing. Once the waste is destroyed, customers are issued with a certificate of destruction within 24 hours.”

Avanti Environmental’s Dr. Chris French added: “We see varying volumes that can range from a small one-off consignment to larger pallets and can process in excess of 50,000 tonnes per annum.”

This best practice of secure destruction has a clearly defined audit trail — vital when it comes to manufacturers seeking or maintaining ISO 9001 and OHSAS 18001 certifications. Where the incineration process incorporates energy recovery, this brings additional benefits to the manufactures’ operations that can be useful for demonstrating ISO 14001 environmental performance criteria.

“We’ve seen pharmaceutical manufacturers ask for more sustainable solutions over the last few years,” continued Bains. “They’re not only looking for a secure destruction service, but also one that demonstrates sustainability.

“As more sector members are adopting the waste hierarchy as a way of being sustainable, they’re looking for suppliers to meet similar sustainability standards. For the pharmaceutical waste that we collect and assign for incineration, the energy recovered is put to good use in the form of electricity for the grid or steam for heating and hot water.”

However, as outlined by Bains, the industry has differing approaches to waste disposal depending on whether the product is over the counter (OTC) or prescription only. “There seems to be more caution applied to prescription only products, whereas waste OTC products are not always treated with the same diligence,” he said. “In reality, all products containing active pharmaceutical compounds, both OTC and prescription, require secure destruction via high-temperature incineration.”

To conclude, an undeviating, secure destruction process that deals with all and not selective pharmaceutical waste is the only way to safeguard against the dangerous pitfalls of counterfeiting.