Thank you for giving the National Pharmacy Association (NPA) the opportunity to comment on the consultation on Better Waste Regulation in Scotland. We would like to make the following comments on the possible implications of the proposal for a Directive of the European Parliament and the Council on waste including a revision of the Waste Framework Directive (WFD) and the repeal and integration of the Hazardous Waste Directive into the revised WFD and how this may affect community pharmacies in Scotland.
The NPA represents the interests of community pharmacies. We have, in voluntary membership, over 12,000 community pharmacies (including over 1,000 in Scotland), which comprises virtually all the community pharmacies in the UK. The NPA provides a representative voice for its members as well as a range of services to help them with both commercial and professional aspects of running their businesses.
Article 4 - list of wastes
There is currently no official UK list of hazardous medicines. We support the proposal for a definitive list of hazardous waste to be published as part of the EU directive however we believe that careful consideration should be given to the concentration levels as well as the origin and composition of the waste. The only list of hazardous medicines currently available includes medicines such as oestrogens and progesterones which means, for example, that commonly prescribed medicines such as oral contraceptives and hormone replacement products would be classed as hazardous waste under current regulations. Such medicines are frequently included in returned medicines presented to the pharmacy and are in such low concentrations that they are unlikely to be harmful and are also usually enclosed in blister packaging. We believe that the low concentrations of hazardous waste in returned medicines encountered in a community pharmacy should be excluded from the hazardous waste legislative requirements.
Articles 12 - 15 - hazardous waste
The proposal that the Hazardous Waste Directive should be repealed and incorporated into the revised WFD provides an opportunity for several anomalies affecting community pharmacy to be addressed.
As stated above we believe that the small amounts of hazardous waste present in unwanted medicines returned to community pharmacy should be exempt from the requirements of the hazardous waste legislation.
The current requirement to separate hazardous waste from non hazardous waste causes practical problems in community pharmacies. Members of the public cannot be expected to sort their unwanted medicines in order to separate out the hazardous medicines for separate disposal. It is also completely impractical and against health and safety guidelines to sort medicines in the pharmacy at the time of return by the patient to ensure that no hazardous medicines are included.
The repeal of the Hazardous Waste Directive and its integration into the revised WFD provides an opportunity for the practical problems associated with hazardous waste currently affecting community pharmacies to be resolved.
Article 21 - EU-wide minimum standards
The proposed adoption of EU-wide minimum standards for waste disposal and recovery operations should be carefully considered with the needs of small businesses such as community pharmacies in mind. Any required standards should not be unnecessarily onerous for pharmacies who only handle small quantities of waste and provide a valuable service by safely and appropriately disposing of unwanted medicines.
Articles 22 -24 Permit Exemptions
It is essential that the existing exemptions for community pharmacies are retained. The WFD must also ensure that the exemption for community pharmacies also includes any returned medicines that may be classed as hazardous waste.
The current exemption for community pharmacies under the Waste Management Licensing Exemptions allows pharmacies to accept returned medicines for disposal under certain conditions. However under current EU legislation this excludes hazardous waste as the exemption only applies to waste that can be recovered and hazardous waste must be destroyed. This must be corrected under the WFD as this means, in effect, that community pharmacies are unable to accept any returned medicines without purchasing a waste management licence. If pharmacies are unable to accept hazardous medicines for disposal from the public, or in fact any returned medicines at all, without purchasing a waste management licence, there is a risk that these medicines will not be correctly disposed of in a safe manner.
We are also concerned that the change to Article 23 may constrain the flexibility of member states to provide permit exemptions for low risk recovery/recycling operations as we believe that this discretion must be maintained.
Article 25 - waste transport
Article 25 of the revised WFD requires anyone who collects or transports waste on a professional basis to be registered with the competent authority. Community pharmacists frequently transport small quantities of unwanted medicines. This may be as part of a delivery round, for example to a residential home, but sometimes this may be as a result of a home visit or delivery to a patient where the patient asks the pharmacist to take their unwanted medicines back to the pharmacy so that they may be safely disposed of. We believe that it would be preferable for there to be an exemption for the need for a waste carriers licence when small quantities of unwanted medicines are transported by pharmacy staff.
We are also concerned about the proposal that collectors of waste must comply with "certain minimum standards" as this may place excessive obligations on community pharmacists and their staff when transporting small quantities of unwanted medicines.
Article 32 - inspection and records
We are concerned about the proposal to require competent authorities to inspect the collection and transport of all waste as we believe that this is unnecessary for community pharmacies. Pharmacies are already subject to inspection by the Royal Pharmaceutical Society of Great Britain (RPSGB) and additional inspection is unnecessary in our view.
Other general comments
Community pharmacies are ideally placed to offer a safe and convenient method for the disposal of medicines returned by the public and other healthcare professionals. However if the opportunity is not taken to resolve issues that may arise in Scotland following implementation of the WFD then we believe that there is a real danger that eventually it will not be possible for pharmacies to continue to offer such services. This may lead to inappropriate disposal of medicines and sharps by the public with associated risks to health and the environment.
We hope you take our concerns on board.
Yours sincerely,
Billy Templeton
NPA NHS Service Development Manager (Scotland)
Working for Community Pharmacy in Scotland
