Under the provisions of the National Health Service (Pharmaceutical Services) Regulations 2005 pharmacy contractors are required to have in place arrangements, for the handling and consideration of complaints about any matter connected with its provision of pharmaceutical services, which are essentially the same as those set out in Part II of the NHS (Complaints) Regulations 2004. Those regulations also impose a duty on PCTs to ensure that pharmacy contractors have those arrangements in place. This paper sets out PSNC s view of what is required of pharmacy contractors in order to comply with the regulations. The purpose of the complaints procedure is only to resolve complaints not to investigate disciplinary matters or to apportion blame. If this objective is to be achieved, the process must be transparent and open, but must also be fair to staff involved. The arrangements must be accessible and such as to ensure that complaints are dealt with speedily and efficiently, and that complainants are treated courteously and sympathetically and as far as possible involved in decisions about how their complaints are handled and considered. The arrangements must be in writing and a copy must be given, free of charge, to any person who makes a request for one. Pharmacy contractors may wish to set out the details of how complaints are dealt with in a document specifically for this purpose, and refer to its availability in the pharmacy practice leaflet. Each pharmacy contractor has responsibility for ensuring compliance with the arrangements made under the regulations and that action is taken in the light of the outcome of any investigation. The pharmacy contractor will be responsible for compliance with the regulations and must designate a complaints manager, to manage the procedures for handling and considering complaints. During the absence of the complaints manager, the pharmacy contractor can authorise another person as deputy to perform the complaints manager s functions. Complaints that are not required to be considered under the arrangements Not all complaints need be considered under the regulations the following are types of complaint that are not required to be considered by the pharmacy contractor (although there is no prohibition on consideration being given to such a complaint): a complaint made by an employee about any matter relating to his contract of employment; a complaint which is being or has been investigated by the Health Service Commissioner; a complaint about which the complainant has stated in writing that he intends to take legal proceedings; Page 1 of 7
a complaint arising out of the pharmacy contractor s alleged failure to comply with a data subject request under the Data Protection Act 1998 or a request for information under the Freedom of Information Act 2000 (both of which are covered by provisions within those Acts); and a complaint about which a pharmacy contractor is taking or is proposing to take disciplinary proceedings in relation to the substance of the complaint against a person who is the subject of the complaint. Persons who may make a complaint A complaint may be made by a patient or any person who is affected by or likely to be affected by the action, omission or decision of the pharmacy contractor. A representative can make the complaint where the above person has died; is a child; is unable by reason of physical or mental incapacity to make the complaint himself; or has requested the representative to act on his behalf. In the case of a patient or person affected who has died or who is incapable of making the complaint himself, the representative must be a relative or other person who, in the opinion of the complaints manager, had or has a sufficient interest in his welfare and is a suitable person to act as representative. If the complaints manager is of the opinion that a representative does or did not have a sufficient interest in the person's welfare or is unsuitable to act as a representative, he must notify that person in writing, stating his reasons. In the case of a child, the representative must be a parent, guardian or other adult person who has care of the child and where the child is in the care of a local authority or a voluntary organisation, the representative must be a person authorised by the local authority or the voluntary organisation. Because handling complaints necessarily involves discussing the services provided to a patient, pharmacy contractors must be satisfied that any representative is authorised to act in that capacity, otherwise a serious breach of confidence could occur. Support for people who wish to make a complaint Pharmacy contractors should be able to provide people with details of support they can access when making a complaint. Patients can talk to Patient Advice and Liaison Service (PALS) staff or the complaints manager at the primary care trust. They can also contact NHS Direct on 0845 4647. Page 2 of 7
An Independent Complaints Advocacy Service (ICAS) is available to provide advice and support to people who wish to complain about the NHS. A patient leaflet How to make a complaint about the NHS is available on the DH website: http://www.dh.gov.uk/assetroot/04/02/00/39/04020039.pdf Making the complaint A complaint can be made orally or in writing (including electronically) to the complaints manager or any other member of the staff of the pharmacy contractor. If the complaint is made orally, the complaints manager must make a written record of the complaint which includes: the name of the complainant; the subject matter of the complaint; and the date on which it was made. Where the complaint is made in writing, the complaints manager must make a written record of the date on which it was received (which is then deemed to be the date on which the complaint is made). Time limit for making a complaint A complaint need not be investigated if it is not made within six months of the date on which the matter which is the subject of the complaint occurred, or within six months of the date on which the matter which is the subject of the complaint came to the notice of the complainant. But, even if this date is missed, the complaints manager may investigate it if he is of the opinion that having regard to all the circumstances, the complainant had good reasons for not making the complaint within that period and notwithstanding the time that has elapsed it is still possible to investigate the complaint effectively and efficiently. Acknowledgement of a complaint The complaints manager must send to the complainant a written acknowledgement of the complaint within 2 working days of the date on which the complaint was made. Where a complaint was made orally, the acknowledgement must be accompanied by the written record mentioned above with an invitation to the complainant to sign and return it. This acknowledgment and indeed any other correspondence with the complainant should be made by first class post, or, in exceptional cases, by special delivery. The use of the second class post may lead to both delay in the complainant receiving the Page 3 of 7
correspondence, or the impression being given that the complaint does not merit anything other than a second class response. All correspondence relating to complaints should be marked Private and Confidential or Personal, since the contents may be highly sensitive. The complaints manager must send a copy of the complaint and his acknowledgement to any person identified in the complaint as the subject of the complaint. Although not a requirement of the regulations, it is recommended that any complaint which might give rise to a claim against the pharmacy contractor or a member of staff should be copied to the professional indemnity insurer. Insurance policies often require insured persons to notify the insurer as soon as there is any indication that an event has occurred which might give rise to a claim. Independent Complaints Advocacy Service (ICAS) The Independent Complaints Advocacy Service supports patients and their carers wishing to pursue a complaint about their NHS treatment or care. This statutory service was launched on 1 September 2003 and provides for the first time a national service delivered to agreed quality standards. ICAS empowers clients by providing information, support and guidance, helping them to articulate their concerns and navigate the complaints system. This may include assistance with constructing a complaints letter, drafting a complaint or attendance at meetings. ICAS supports the principle of local resolution and aims to help clients find a solution as close as possible to the point of the service that has caused dissatisfaction, maximising the chances of the complaint being resolved quickly and effectively. ICAS is provided on a regional basis by: Citizen s Advice Bureaux Carer s Federation POhWER South East Advocacy Projects (SEAP) The Department of Health manages these contracts. A map is available on the DH website which details the contact telephone numbers for local ICAS services. ICAS map: http://www.dh.gov.uk/assetroot/04/09/07/75/04090775.pdf An acknowledgement of a complaint sent as above, must inform the complainant of a right to assistance from the Independent Complaints Advocacy Service. Page 4 of 7
Investigation The complaints manager must investigate the complaint to the extent necessary and in the manner which appears to him most appropriate to resolve it speedily and efficiently. In appropriate cases, with the agreement of the complainant, the complaints manager may make arrangements for conciliation, mediation or other assistance for the purposes of resolving the complaint. It is also important that the complaints manager determines the expectations of the complainant for example, will the complainant be content with an investigation, explanation and apology, or is it likely that the complainant is seeking information in anticipation of making a claim for damages. The complaints manager must take reasonable steps to keep the complainant informed about the progress of the investigation. The regulations do not specify whether this should be in writing or by telephone, but we would recommend that a record is made of any telephone call or copy of correspondence is retained, to show that the pharmacy has complied with this requirement and where an investigation is protracted, we recommend that contact should be made regularly with the complainant, no less frequently than every two weeks. Action following investigation After carrying out the investigation, the complaints manager must prepare a written response to the complainant which summarises the nature and substance of the complaint; describes the investigation; and summarises its conclusions. This written response should be signed by or on behalf of the pharmacy contractor. The regulations require responses of other NHS bodies to be signed by the chief executive, and whilst this term may not accurately reflect the situation in many pharmacy businesses, it appears that the intention is that the response should be signed by a person who is sufficiently senior as to be authorised to act on behalf of the pharmacy contractor. The response must be sent to the complainant within 20 working days beginning on the date on which the complaint was made or, where that is not possible, as soon as reasonably practicable. Investigations therefore must be pursued promptly and diligently. The response should also notify the complainant of his right to refer the complaint to the Healthcare Commission (which is the body responsible for investigating all unresolved complaints within the NHS). The response should also highlight the fact the patient can gain further support from the Independent Complaints Advocacy Service (ICAS). The response should be copied to anyone who was sent a copy of the original complaint. Because of the possibility that the complainant made the complaint in order to gain information so as to pursue a civil claim against the pharmacy contractor or staff, it may be helpful to ask the professional Page 5 of 7
indemnity insurer for advice on the proposed response, before it is despatched. The remedial action needed, if any is identified during the investigation, should be implemented without delay with monitoring of on-going adherence. A complaint following an error, for example, which is properly investigated with positive steps identified to reduce the likelihood of further errors, should be the last occasion that the complainant has to make a complaint. If an error is repeated the credibility of the pharmacy will be seriously undermined and repeated errors, especially where the business has promised improvements, are more likely to result in escalation of the complaint. Further action by complainants who remain dissatisfied A complainant that remains dissatisfied with the investigation or outcome of a complaint can make a complaint to the Healthcare Commission: Healthcare Commission FREEPOST NAT 18958 Complaints Investigation Team Manchester, M1 9XZ Tel: 0845 601 3012 e-mail: complaints@healthcarecommission.org.uk website: www.healthcarecommission.org.uk A complainant could also make a complaint to the Primary Care Trust or to the Royal Pharmaceutical Society, both of which could launch investigations. It is also known that some complaints are passed to the media, particularly where there may be local or national interest. Further guidance Pharmacy contractors are generally inexperienced in handling formal complaints, as fortunately, complaints about pharmacy are comparatively rare. When a complaint is received, it is vital that it is investigated carefully, and that if there are any lessons to be learned from the investigation, that appropriate changes to practices are adopted, in order to avoid a repetition. However, do not be tempted to introduce knee-jerk changes to practices think through what is needed, and monitor any changes made to ensure they achieve what is needed without introducing additional risks. Page 6 of 7
Many pharmacists faced with a complaint may find the pressure caused undermines the pharmacist s ability to conduct either an investigation or indeed, his normal professional practice. A pharmacist must endeavour to ensure that he does not place himself in a position where these pressures lead to increased risk of errors. Discussing complaints with other pharmacists (without disclosing the patient s personal information) may provide the means of reducing pressure and gaining an objective overview, so as to put the complaint into context. The Department of Health has issued guidance to support implementation of the complaints regulations; although these precede the implementation of the new procedures for pharmacies so must be read as if that guidance applies to pharmacy http://www.dh.gov.uk/assetroot/04/08/81/57/04088157.pdf The Royal Pharmaceutical Society fact sheet 11 deals with dispensing errors. This also provides a useful resource for pharmacists who are faced with a complaint, if an error is the cause. http://www.rpsgb.org.uk/pdfs/factsheet11.pdf Contractors should remember that if a complaint is made as the result of an error or other patient safety incident, they should make a record of the incident (and in due course should report the incident to the National Patient Safety Agency, when an internet connection is available in the pharmacy). Page 7 of 7