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Healthcare professionals should maintain records of the patient care activities that they perform. Record keeping is essential for continuity and consistency of care, and it also provides a record of professional decision-making from a medicolegal perspective. Furthermore, recording care interventions facilitates audit and quality monitoring, which has become of increasing significance in today’s NHS, and provides data to justify service development.
Doctors, nurses and other health professionals have maintained patient records in paper form for many years and, during the past 30 years, computerised patient record systems have been developed for use in various clinical healthcare settings.
Although pharmacists have been maintaining patient medication records (PMRs) from prescriptions dispensed for over 20 years on PMR systems, the recording of patient care activities has not traditionally been part of community pharmacy practice. However, with community pharmacists increasingly developing new services to support patients with long-term conditions and local public health needs, there is now a pressing need for pharmacists to record details of the care they provide, to support the consultation process, to produce a medicolegal record, to justify service provision and monitor outcomes.
This article discusses issues that pharmacists should be aware of in the use of electronic health records (EHRs), and how they might be used to support pharmaceutical care.
Development of EHRs
The development of desktop computers, together with coding systems to enable large amounts of medical data to be stored in a machine-readable format (Read codes) led to the advent of electronic record systems for the GP consulting room. These systems helped the doctor to manage the consultation process, and gave support for prescribing, referrals and other standard medical activities, as well as providing a record of patient care and observations. Although GP systems were first introduced in the 1980s, their uptake was slow, and even by 1996 only one in four practices were using computers in the consultation process.1
The stimulus for the development and adoption of pharmacy systems (PMR systems) in community pharmacy was the legal requirement for printed medicine labels, introduced in hospitals in 1976 and rolled out into the community subsequently. Pharmacy systems were developed largely by pharmaceutical wholesalers as part of their service offering and have stock control as one of their core function, as well as dispensing and medication records. These systems are now being developed to support service-based pharmacy practice, such as medicines use reviews (MURs) and the new medicine service (NMS) in England.
In recent years, national healthcare IT initiatives have developed national summary records, based on data extracted from GP systems, which provide a standard dataset of medical information to health professionals in a range of settings. These standard records support unscheduled care (for example, out-of-hours medical services) and are useful where communication of medical information needs to be facilitated (for example, medicines reconciliation in hospital). These records include the England summary care record, the Scottish emergency care summary and the Welsh individual care record.
Key principles of patient record use
There are three important legal concepts — confidentiality, consent and liability — relating to medical records. These concepts apply equally to electronic patient records as to paper records.
Confidentiality
The privacy of patient-identifiable data is governed by common law, by the Human Rights Act 1998 and by the Data Protection Act 1998. Anyone who accesses patient identifiable data where there is a reasonable expectation that the information was collected in confidence and should be stored in confidence therefore has a common law duty of confidentiality. This applies to all health professionals, including pharmacists, and this principle is reflected in the General Pharmaceutical Council’s guidance on patient confidentiality.2 There is also a need for some records to be stored on a “sealed envelope” basis, where the record can be viewed by some, but not all, of the professionals caring for the patient.
Consent
The Data Protection Act 1998 requires healthcare professionals to obtain a patient’s consent to store information about them to support services provided, stating the purpose for which the information is being collected. Pharmacists should therefore seek explicit, informed consent from a patient to process information to support any pharmacy services where the keeping of records is not required by statute. The principles of seeking consent are as described in the GPhC’s guidance on consent.3
Liability
Records of patient care have traditionally played a major part in providing evidence of appropriate patient care in situations when allegations of negligence are made. This has not affected pharmacists directly in the past but, as pharmacists take on new roles and provide clinically focused professional services, they will need to make an appropriate record of their professional decision-making.
Some pharmacists may be reluctant to document professional activity in case it is challenged by a patient or relative at a later time. However, there is an equal liability associated with not comprehensively recording details of care provided.
The other major liability issue concerns the use of information from standard records. One concern is that, if the information is available in a standard record — for example, in the English summary care record —then the record must be accessed every time that a professional decision needs to be made, in order for the health professional to avoid liability. However, the current consensus is that health professionals have a number of record sources available to them, and that they should use their professional judgement concerning the best record to access in each instance.
Information governance/data sharing
All patient-identifiable data used by pharmacists, whether accessed from NHS services such as the summary care record or stored in local or networked systems, are subject to NHS information governance requirements. These cover many aspects of good practice in information management and security, including prevention of accidental disclosure, security of hardware and software, staff training, management of critical incidents and various other requirements.4
When local EHR systems are implemented, there is a need to consider the issues associated with sharing patient records with other healthcare professionals, in terms of shared record content, how records are updated and which professional would have clinical responsibility for the content. These issues have been addressed in the Royal College of General Practitioners shared record professional guidance report in 2010.5
Benefits of EHR use in healthcare
EHRs provide a number of potential benefits to healthcare professionals in their professional practice and in delivery of healthcare services. These include:
- Enabling security — depending on the design of the system, EHRs are likely to be more secure that paper records
- Structured content — the record may be structured in such a way as to support each professional activity in the healthcare workflow
- Provision of decision support tools — the availability of the patient record in an electronic format means that electronic decision support tools can be made available in an interruptive or non-interruptive manner at the point where information is entered onto the record
- Usefulness — patient record information is legible and machine-readable so may be used to support other IT applications
- Improved access — EHRs may improve access to patient information for authorised professionals
Because of these features, in theory EHRs have the potential to improve patient safety and quality of care. However, in reality, the findings of studies on the clinical benefits of EHRs are mixed.
In a transfer of care study, Boockvar et al6 concluded that there was no difference between patients with an EHR and those without one in terms of the number of medication-related discrepancies in the records, and that specialist tools would be required as part of the record system to facilitate medicines review. Indeed, Hurdle et al7 noted how a large number of adverse events relating to medication remained undetected within a Veterans’ Administration EHR system in the US, despite a prospective chart review study.
In any case, even if decision support tools within an EHR are effective, there may not be an obvious link between appropriate decision support alerts and positive patient outcomes. This was observed by Smith et al,8 in a study on the Kaiser Permanente North-Western system, where alerts were found to reduce the prescribing of potentially contraindicated agents (eg, tricyclic antidepressants) in the elderly, but the effect of the alerts on patient outcomes and morbidity was not clear. In another US study, Orrico et al9 noted discrepancies between the EHR system record and actual medicine use. It was common for medicines to be recorded on the EHR, but no longer taken by the patient. They indicated that medicine stop/review dates would be helpful to prevent this situation, and that a system of medicines reconciliation and review would be beneficial.
However, the use of structured data within an EHR system has the potential to identify cohorts of patients systematically where intervention may have positive health benefits. In a study looking at the identification of adverse events relating to amlodipine in UK general practice, Mohamed10 concluded that primary care prescribing databases could easily be used to identify ADRs by looking at cohorts of patients where a medicine has been discontinued. In a data study of 61,251 patients in two US outpatient settings, Buck et al11 demonstrated that EHRs could be used to identify inappropriate prescribing; they found that female sex, polypharmacy (six or more medicines) and multiple clinic visits were key determinants in identifying patients with inappropriate prescribing, and that the EHR system automated the search process by which patients can be identified. The use of EHRs for screening patients for medicationrelated problems was also demonstrated by Roten et al11 in a Swiss clinical pharmacy study with 501 patients. They found that the EHR efficiently identified drug related problems in 64.7 per cent of the 501 patients.
Towards a pharmaceutical care record
Consequently, although EHRs provide many benefits in managing patient information, there is little evidence at present that the use of an EHR guarantees a positive impact on patient safety and quality of care, compared with a paper record. However, there is evidence that EHRs can be used successfully to identify inappropriate prescribing and adverse events and to target cohorts of patients with specific health needs.
Furthermore, the value of the EHR in the care process will depend on the information stored in it. Record systems designed for use by other healthcare professionals may not adequately support pharmacy practice, or provide information specifically relevant to pharmaceutical care (eg, formulation types and compliance). So there is a need for EHRs where data used by a range of professionals is in a standard form, but there are specific data items that support pharmacy services.
Record templates for pharmaceutical care have been used in the US for some time.6 Also, in the UK, some hospital pharmacists have developed pharmaceutical care record templates to support their fields of practice. However, while a number of centres around the UK have developed record templates, there has been no national initiative and there is a need for a national pharmaceutical care standard. This could be enabled by, and also support, current EHR systems.
The development of a standard pharmaceutical care record could provide the following benefits:
- An agreed standard for format and content of pharmaceutical care records, which is patient-centred and therefore independent of care setting and area of pharmacy practice
- A unified approach to pharmaceutical care and intervention recording across the pharmacy profession which will improve communications across the profession and with other professions
- A standard for future development of IT systems in medicines management
- A foundation against which key outcome measures may be determined
At the time of writing, the Royal Pharmaceutical Society is working with other stakeholders to develop a standard for pharmaceutical care records.
Conclusion
As pharmacy practice becomes more serviceoriented and clinically focused, pharmacists should keep records of the care they provide, as well as of medicines dispensed. Pharmacists may use EHRs of different types, but should be aware of the legal and professional framework for using any electronic record. EHRs that are appropriately structured for pharmacy practice can facilitate high quality medicines management and pharmaceutical care.
References
- Gillies A. Information and IT for Primary Care. 2000 Radcliffe Medical Press, Abingdon; p3.
- General Pharmaceutical Council. Guidance on Patient Confidentiality. 2012. Available at: www.pharmacyregulation.org/sites/default/files/Guidance%20on%2 0Confidentialiy_April%202012.pdf
- General Pharmaceutical Council. Guidance on Consent. VAilable at” www.pharmacyregulation.org/sites/default/files/GPHC%20Guidance %20on%20consent.pdf
- NHS Information Governance: Pharmacy Contractor Workbook. Pharmaceutical Services Negotiating Committee, Royal Pharmaceutical Society, NHS Employers. 2010. Available at: www.psnc.org.uk/data/files/IG/psnc_ig_workbook_2010web.pdf
- Royal College of General Practitioners Shared Record Professional Guidance. Available at: www.rcgp.org.uk/health_informatics_group/srpg.aspx (accessed September 2012).
- Boockvar KS, Livote EE. et al Electronic health records and adverse drug events after patient transfer. Quality and Safety in Health Care 2010;19:e16.
- Hurdle JF, Weir CR et al. Critical gaps in the world’s largest electronic medical record: ad hoc nursing narratives and invisible adverse drug events. AMIA Annual Symposium Procedding 2003, pp309–12.
- Smith DH, Perrin N et al. The impact of prescribing safety alerts for elderly persons in an electronic medical record: an interrupted time series evaluation. Archives of Internal Medicine 2006;166:1098–104.
- Orrico K.B Sources and types of discrepancies between electronic medical records and actual outpatient medication use. Journal of Managed Care Pharmacy 2008;14:626–31.
- Mohamed IN, Helms PJ et al. Using primary care prescribing databases for pharmacovigilance. British Journal of Clinical Pharmacology 2011;71:244–9.
- Buck MD, Atreja A et al. Potentially inappropriate medication prescribing in outpatient practices: prevalence and patient characteristics based on electronic health records. American Journal of Geriatric Pharmacotherapy 2009;7:84–92.
- Roten I, Marty S et al. Electronic screening of medical records to detect inpatients at risk of drug-related problems. Pharmacy World and Science 2010;32:103–7.
- Hepler CD, Strand LM. Opportunities and responsibilities in pharmaceutical care. American Journal of Hospital Pharmacists 1990;47:533–43.
- Smith L, McGowan L, Moss-Barclay C et al. An investigation of hospital-generated pharmaceutical care when patients are discharged home from hospital. British Journal of Clinical Pharmacology 1997;44:163–5.
- Blagburn J, Acomb C. Implementing and evaluating evidence based clinical pharmacy for older people admitted to a secondary care trust. Presented at UKCPA 2008