This article describes schemes that are operating in France and Italy for the disposal of unwanted medicines
Though obviously less satisfying all round than medicines supply, the task of taking back unwanted or unusable products is also an important one. Schemes with pharmacy involvement, like the DUMP campaigns, have shown worthwhile returns. These do, however, depend on strong local commitment and the availability of sufficient funds, and because of this can only take place for a few weeks every few years.
Case-by-case negotiation between the pharmacist or wholesaler and the manufacturer's representative may result in some financial recompense or exchange for short-dated or other unwanted, unopened products. However, it is more usual to try to prevent the problem occurring in the first place with prudent buying and good stock control.
This article describes two different well-established schemes for the disposal of unwanted medicines in routine use today in Italy and France. They are believed to be the only examples of their kind in Western Europe. As well as having practical value in terms of drug safety, the environment and economics, these schemes are commended for the sense of partnership they bring to members of the medicines supply chain.
Associazione Indennizzo Resi (Ass Inde) was established in Italy at the end of 1980 as an independent company to run an inter-sector agreement to refund the distribution chain, in full or in part, on behalf of pharmaceutical manufacturers, for the cost of expired, damaged or recalled medicines. Claims for exchange products or credit notes had previously been processed on a case-by-case basis, which led to very high costs and sometimes disputes.
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Table 2: pack prices and refund values (Italian lire) |
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| Year | Weighted mean price | Weighted mean refund |
| 1994 | 13,963 | 11,312 |
| 1995 | 13,476 | 11,767 |
| 1996 | 14,230 | 10,792 |
| 1997 | 15,807 | 10,196 |
| 1998 | 16,898 | Not available |
France, too, operates a structured, industry-funded system for recalling pharmaceutical waste. The system is run in a collaborative manner between manufacturers (265), wholesalers (6) and community pharmacies (22,590), but without any refunds. The scheme, run by an association known as Cyclamed, has both an environmental and a humanitarian aim. The trigger for action was a 1992 decree (implemented from January, 1993), named after the environmental minister at the time (Lalonde), which required companies to help eliminate the packaging of the household goods they sold. This extended a previous decree, forbidding the landfilling of wastes other than treated waste by 2002.
Most French firms across all sectors decided to join the "green dot" scheme, managed by the Eco-Emballages company. They paid a fee for each pack sold, but did not need to take any subsequent active part. Eco-Emballages in turn provided funds to the municipalities to invest in a recovery or recycling system for their inhabitants. Pharmaceutical companies, too, initially went along with the scheme, but not without expressing some concerns. Eco-Emballages was a private company, in the hands of the food industry, that was seeking to gain a public monopoly, even although minister Lalonde had intended there to be competition. Another problem was that the prices charged were biased against the type of small packages used for medicines. The result was that the pharmaceutical sector decided to find its own solution.
A well-functioning distribution chain was already in existence, so it seemed obvious to use it, but in reverse. Household drug-related waste amounted to about 70,000 tonnes annually (approximately 1kg per person per year), less than 0.4 per cent of the total, but it was considered that the special nature of the products required pharmacists' skill at all levels. Some products were unused and in-date and might be considered for charitable purposes. Industry also had to counter claims of pressure groups that its waste finished products were toxic, like mercury batteries or solvents. Packaging materials in fact made up more than 90 per cent of the weight (glass, 40 per cent; paper and cardboard, 35 per cent, plastics, 20 per cent; other waste 5 per cent). Furthermore, the remaining medicinal products only contained 1 to 2 per cent of active ingredients, of which only a few were hazardous.
Most general household wastes in France were either landfilled (45 per cent) or incinerated (42 per cent), with the remainder recycled (6 per cent) or composted (7 per cent). Energy recovery was only achieved with half the amount incinerated. Cyclamed instead chose to select products that could be reused for humanitarian purposes and to incinerate, with energy recovery, the rest.
Negotiations sponsored by the Conseil National de l'Ordre des Pharmaciens, the professional body for pharmacy, helped the national trade associations representing drug manufacturers, wholesalers and pharmacists, reach agreement about the plan. The government gave its consent and passed the relevant enabling decree in September, 1993. (It was renewed in August, 1997.) After a successful pilot in two regions, three ministers confirmed the Cyclamed agreement by signing a protocol in April, 1994. By the end of that year, the scheme was up and running throughout all of mainland France.
Through their local pharmacy, households are invited to acquire "the reflex" of returning all unused medicines and packaging, even empty packs. Bags and leaflets handed out at the time of dispensing and window stickers and posters reinforce this message. Television advertising - paid for, but at a special rate - has been used since 1996.
Partially used, expired, damaged or other clearly non-reusable stock is placed by the pharmacist in a "destroy" box. Products that could possibly find use by medical charities, in France or overseas, are stored in a second box. When full, the "destroy" boxes are picked up by a wholesaler on his normal rounds and put into an isolated, closed container at the warehouse. Unlike in Italy, where only certified waste disposal contractors can be used for transport, French wholesalers can be involved as it is labelled non-hazardous "special waste". Wholesalers also supply the communication materials and arrange for a waste contractor to collect containers when full for incineration.
Charities bound by the Cyclamed convention collect the supplies initially considered reusable from pharmacies direct or via a wholesaler, if previously agreed. A secondary selection is made and waste returned to the system. A minimum of 12 months of remaining shelf life is required for the medicines to be used in Asia or Africa and six months for central and eastern Europe. Any in-date stock can at least be considered for France's homeless people.
Through a levy on sales through pharmacies recorded the previous year, manufacturers finance all external costs. In 1999, the levy was set at 0.035 per cent of sales. Television advertising (FFr4.5m), incineration (FFr4.4m), waste transport (FFr3.2m), waste containers (FFr2.9m), and other forms of communication (FFr2.2m) account for the majority of expenses. The scheme is non profit-making, with any surplus reinvested.
The first full year with the system in place was 1995. From 6,900 tonnes then to almost 10,300 tonnes in 1998, the amounts collected have shown a steady increase (Table 3). Given that it has only been running for four years, an overall 15 per cent recovery of drug related waste is considered more than satisfactory. Awards are given to stimulate competition between the regions: in 1998, Limousin (which collected 227g per inhabitant) received "gold", followed closely by Auvergne and then Haute-Normandie.
Table 3: Output of the Cyclamed system (metric tonnes) |
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| Output | Year | ||||
| 1995 | 1996 | 1997 | 1998 | Change 1998/1995 | |
| Humanitarian distribution | 1,515 | 1,508 | 1,031 | 963 | –36% |
| Energy recovery | 5,379 | 7,714 | 8,635 | 9,330 | +73% |
| Total recovery | 6,894 | 9,222 | 9,666 | 10,293 | +49% |
Over time, the split between redistribution to charities and incineration has altered in favour of the latter. This is attributed both to improved patient compliance and to a stricter selection of what the charities really need. Thirty electricity-generating incinerators across the country are used for destruction, all offering fume treatment. Nevertheless, the 963 tonnes recycled to poor people in France and abroad equates to about 15 million packs. Ten charities benefited overall, with three accounting for 84 per cent of the total by weight, namely, Order of Malta (395 tonnes), Pharmaciens sans Frontières (308 tonnes), and Terre d'Amitié (106 tonnes).
Adoption of the Cyclamed system has produced a number of benefits. It ensures the safe disposal of unwanted medicines while at the same time generating energy from packaging wastes. It fosters good relationships towards a common goal between all members of the medicines supply chain. It has high awareness and acceptance among the general population, with the professional image of the pharmacist in particular benefiting. It has also proven to be less expensive for manufacturers than the Eco-Emballages system. The cost advantage will likely widen over the next few years as the latter has already announced a doubling of fees, while Cyclamed says it will only need a small increase. Interest in the concept has come from elsewhere, too - from Belgium, Germany, Spain and Sweden, for example - though Cyclamed acknowledges that, like the United Kingdom, most northern European countries look with caution on charitable donations of previously dispensed medicines.
ACKNOWLEDGMENT The author acknowledges the generous help provided in preparing this article from Dr Rodolfo Giannotti (Astra Zeneca Spa), president of Ass Inde, and Jacques Aumonier (Novartis France SA), secretary-general of Cyclamed.
Donald Macarthur is a pharmaceutical business analyst from Saffron Walden, Essex