Chapter 15 Record keeping
Introduction
Pharmacists are required to keep a number of different types of records within the pharmacy, the majority of them being legally required and some as good practice. With the evolving role of pharmacists, the need for and types of records to be kept are ever increasing. The aim of this chapter is to consolidate the different aspects and issues around record keeping in the pharmacy.
Why keep records?
There are many things that need to be recorded in the pharmacy. They can be categorized into three main groups; however, it should be noted that there can be considerable overlap between these groups:
Aside from the fact that many of these records are required legally or as part of the pharmacy’s contractual requirements with the NHS, there may be different reasons why each type of record is made. The traditional records of supply and clinical governance are mainly kept for the purpose of invoicing and to provide an audit trail for monitoring standards, improving quality and ensuring safety.
Pharmacists may well be the only healthcare profession in the UK that has not documented their contribution to the health of the nation over the years. Therefore, unless the pharmacist develops the skills for and embraces record keeping, their role and future roles may be called into question. The reasons for record keeping have now taken on a new importance. Documentation can be used as justification for a pharmacist’s decisions and judgment in difficult situations. Also pharmacists, like other professionals, have to justify their very role within the community. The records provide evidence and aid decision making. In addition, record keeping is an important form of communication between pharmacists and other healthcare professionals and can ensure continuity of care for a patient.
What to record?
In the majority of cases the information that should be recorded will be specified, or there may be a specific form to fill in. The traditional records of supplies and clinical governance are generally specified which makes this information relatively easy to record. The problem arises when there are no specified procedures to tell pharmacists what to record, e.g. consultation records. This is a relatively new area for the pharmacist. Before the changes to the pharmacy contract in 2005 they were not required to record interactions with the public and information was provided on a daily basis without it being logged.
Consultation records should be written so that others can use the information provided and realize the same outcome as the person that made the record. The level of information recorded will depend on the situation. All records need to be concise, organized, factual and legible, and abbreviations should be avoided if possible unless clear and established. Beware of recording personal views and opinions about patients and their behaviour, unless it is relevant to the record, as according to the Data Protection Act (DPA) 1998 patients have the right to request their records. The list in Box 15.1 indicates the type of information to record if not specified.
Barriers to record keeping
There are two main barriers to record keeping, namely time and knowledge. The traditional records of supply and, to some extent, clinical governance are generally well kept and the time taken to carry out the record is generally already built in to the procedures for the normal working day. Knowledge of the record, the procedure and location are also generally not an issue, as again the pharmacist is accustomed to the procedure. The problem arises with newer consultation records and some aspects of clinical governance that are not carried out regularly.
Knowing how to make the record can be a problem, especially for consultation records of which pharmacists in many cases will have no experience. Time can be a major issue for recording consultations, especially if the contact was opportunistic, which is often the case with the advice the pharmacist may provide. Is it feasible to record all of the information the pharmacist provides to patients on a day-to-day basis? The pharmacist cannot be expected to know the name of every person they give advice to concerning over the counter medicines, yet it may be necessary to record this interaction.
The sooner the record is made the better. Forgetting to record an opportunistic consultation is more likely if the pharmacist intends to ‘come back to it later’. It may be helpful to have a logbook where a note can be kept and recorded appropriately later. Other healthcare professionals, such as GPs and nurses, leave themselves time after a consultation to record it straight away. Pharmacists may need to look at how these other professionals have overcome the barriers to record keeping in these new areas.
The future of records
The drive to keep records electronically is becoming more and more apparent. The benefits of keeping electronic records surround the potential for shared information between healthcare professionals and external audit purposes. For example, the Royal Pharmaceutical Society of Great Britain (RPSGB) inspectors or police may monitor an online controlled drug (CD) register without needing to attend the premises.
The advancement of electronic transfer of prescriptions (ETP) has led to the debate over the best method of access for pharmacists to view full patient medication records. This will enable the pharmacist to be better placed to intervene when necessary and may avoid unnecessary interruptions to the doctor. Medicines use reviews (MURs) can potentially be carried out more effectively and may reduce the likelihood of making recommendations that have already been tried or are inappropriate. Pharmacist prescribing will definitely require better access to records. Pharmacists are often required to make decisions without the full patient history. Improved access to records will save time and provide more efficient and effective outcomes for patients. Likewise other healthcare professionals involved in patient care need to know what input the pharmacist has made.
The Data Protection Act 1998
The Data Protection Act (DPA) was first introduced in 1984 as concern grew over the amount of personal information that was being held on computer. This act related only to data held electronically but in 1998 was updated to the current DPA which applied to data held in any format. Now in most cases the individual’s permission must be sought before personal information can be stored, processed or used for direct marketing. Personal information is defined as any information that can be used to identify a living individual, such as name, address, date of birth, etc. Interestingly, there is no lower age limit that applies to the DPA, so as long as a child can understand their rights, their consent must also be sought.
The DPA requires explicit consent before the processing of personal data can take place. This is not the case for sensitive personal data when the processing is necessary for medical purposes. For consent not to be required, a healthcare professional or their staff, including pharmacists and their dispensing staff, must undertake the processing. Sensitive personal data relates to any information including opinions relating to the physical or mental health or condition of the individual. Processing of information means the use of this information in virtually any way, including destroying the information. All systems used to store information will need to be registered with the Information Commissioners Office which enforces the DPA, and this now includes electronic and written information. In the pharmacy, the patient medical record (PMR) system, prescription only medicine (POM) register, controlled drug (CD) register and any other method of data collection will need to be registered.
There are eight principles within the DPA. We will look at each principle in turn and how it applies to pharmacy.
Confidentiality
Confidentiality is protected by scores of pieces of legislation such as the DPA, the Human Rights Act 1998 as well as by common law. The NHS also has its own code of practice, as do pharmacists, and pharmacists must have systems that conform to all of the above. Confidential information includes both personal and medical details of patients and also information about other NHS employees such as a doctor’s prescribing habits. In addition to the DPA, confidential information must be protected against improper disclosure during storage, removal, receipt or transfer. Also access control and data encryption are necessary. All confidential information must be disposed of so the information is irretrievable; in most pharmacies they will have a confidential waste bin.
Records of supply
The major examples of supply records made in the pharmacy and where they are kept are described below (this is not an exhaustive list).
POM register
The prescription only medicine (POM) register is possibly the most longstanding means of recording within the pharmacy. It is primarily used for recording the supply of POMs as a legal requirement of the Medicines Act 1968, but is also used traditionally by the pharmacist to record significant incidents occurring in the pharmacy for future reference. They are found in both the community and hospital pharmacy and must be kept on the premises for the specified time frame for the record made, generally 2 years from the date of last entry. They are used to record every sale or supply of a POM unless it is with relation to an NHS prescription or a prescription for a contraceptive. A record also is not necessary if the supply is by way of wholesale dealing where the invoice is retained or if a separate record has already been made in the CD register.
The supply of a POM may take many forms and each will require different information to be entered in the register and to be kept for a specified duration of time. This information may be found in the current edition of the Medicines, Ethics and Practice guide (MEP). The following list includes commonly made records of supply in the POM register:
CD register
This is probably the most important legal record in the pharmacy in relation to supply records. Not only the supply but also the receipt of all CD schedules one and two are recorded here as a legal requirement of the Misuse of Drugs Act 1971. Again, they are found in both the hospital and community pharmacy and must be kept on the premises for 2 years from the date of last entry. Discrepancies in the CD register can lead to serious consequences. If unresolved, there may be an investigation by the primary care organization (PCO) and the police. As a result of this, all written entries must be in indelible ink with no cancellations, alterations or obliterations. Any corrections must be made by a dated footnote to prevent unlawful supplies and create an audit trail. The legal requirements for the format of the register and information to be recorded can be found in the MEP.
Extemporaneously prepared medicines
Medicines are sometimes prepared and compounded by pharmacists in response to a prescription in the community or hospital pharmacy. This does not include the reconstitution of powders. The RPSGB has set out guidance in relation to this service which can be found in the MEP. This service is a type of manufacture which, in the case of pharmaceutical companies, is regulated by the Medicines and Healthcare products Regulatory Authority (MHRA). Pharmacists are not subject to these regulations as the manufacture is only small scale; however, the product must be prepared accurately and meet quality standards.
A product should only be prepared extemporaneously if there are no appropriate licensed products available. Records of the manufacture must be made, usually in a bound book used solely for that purpose. The record is made as an audit trail to be kept for a minimum of 2 years, but if possible 5 years, and should include the following:
Supply of unlicensed medicinal products (‘specials’)
Some products may need to be compounded by a specials manufacturer, as there is a safety risk associated with the manufacture or if it is not possible to prepare the product accurately in the pharmacy. These products are referred to as ‘specials’. The request for a special can only be made on the order of an appropriate prescriber, and they should be made aware that the product is unlicensed. The Medicines Control Agency (MCA) issued guidance in 2000 about the records the pharmacist should make with respect to the supply of specials. This is as follows:
These details should be kept for a period of 5 years and be available for inspection; however, the format or place of the record is not specified.
Poisons book
Pharmacists are able to supply non-medicinal poisons within the pharmacy. In law a poison is defined as a substance listed in the Poisons Act. It is not very common to supply poisons, but would be more likely in a rural pharmacy. The different poisons can only be supplied for specified purposes and the purchaser may need a certificate or form of authority and a signed order for the purchase of the poison. The pharmacist must keep a record of the supply in the poisons book and the signature of the purchaser is needed either in the register or on a signed order. The register must be kept for 2 years from the date of last entry, as must any certificates. The particulars to be recorded can be found in the MEP.
Clinical governance records
Clinical governance is the process by which professionals are accountable for continually improving the quality of their services and maintaining high standards. It relies on learning from experiences and therefore being open and honest is essential. It is a combination of a number of processes including accountability, audit, clinical effectiveness, patient and public involvement, remedying underperformance, risk management, staff management and continuing professional development (CPD). This process binds all professionals within the heathcare environment. Clinical governance is covered in more detail in Chapter 8; the focus here is on record keeping associated with clinical governance. Some examples are described below.
Audit
Audit is the process of systematic evaluation of work against set standards. In the pharmacy many processes will need to be audited and the results may be used internally or externally, e.g. by the PCO. The results of the audit need to be documented and may result in change in policies or standard operating procedures (SOPs).
PMRs
PMRs can be considered as records of supply as well as clinical governance records. Within clinical governance, PMRs enable pharmacists to be clinically effective. In order for PMRs to be useful to pharmacists they need to be up to date, accurate and contain as much detail as possible about the patient’s medication history. The system used must have access control mechanisms, be able to identify drug interactions and highlight those that are more serious. There are minimum specifications for the contents of PMRs set out in the MEP with respect to identification of the patient, patient’s GP and prescription details. However, the pharmacy contract requires more information about patients to be recorded with regards to advice and counselling given by pharmacists.
Risk management
Risk management can encompass many aspects of the service delivery and will apply to both hospital and community pharmacy. Examples of risk management procedures include:
Standard operating procedures (SOPs)
These documents should relate to all the work processes within the pharmacy and how they should be carried out to ensure the least risk and greatest effectiveness. The process should be portrayed in a stepwise manner and written so that even people with no experience can carry it out by following the SOP. All SOPs need to be signed by the accountable pharmacist and all staff working in the dispensary need to be trained regularly on the SOPs and a record of the training should be made in a training matrix.
Complaints procedure
There is an NHS complaints procedure and this applies to both hospital and community pharmacy. Complaints can be made orally or in writing. In the case of an oral complaint, a record of the complaint must be made including the name of the person making the complaint, subject of the complaint and the date on which it was made. If written, a record of the date on which the complaint was received must be made. A written response must be made within 2 days of the date of the complaint. The complaint should then be investigated and resolved appropriately. A record of all correspondence or phone calls to the complainant should be kept.
Error reporting and near misses
A near miss is defined as an error in the dispensing process which is identified before the medicine reaches the patient. All near misses should be logged and audited in line with company and RPSGB policy. The outcome of the audit should be implemented and a record should be made, and if it results in a change in procedure the SOPs must be updated. Any incident that results in patient involvement needs to be logged, and as of April 2005, reported to the National Reporting and Learning System (NRLS). The information should be logged on a reporting form that has the minimum information required by the NRLS. Serious incidents will be reported anonymously to the National Patient Safety Agency (NPSA) via the NRLS. Pharmacists need to demonstrate evidence of recording, reporting, monitoring, analysing and learning from patient safety incidents. The incident may be reported to the NRLS via the organization’s risk management office (pharmacy superintendent office in large multiples), via the NPSA website or via the PCO.
Control of Substances Hazardous to Health (COSHH) Regulations 2002
All work places must conduct risk assessments and produce safety precautions with relation to dangerous substances. A hazardous substance includes anything that can cause risks to health and safety. There is no one list of substances. Common substances can be found in Health and Safety Executive (HSE) guidance documents and Chemicals Hazard Information and Packaging (CHIP) for Supply Regulations. Even dust can be classed as a dangerous substance if the concentration in the air exceeds certain limits.
In the pharmacy there will be a number of drugs or chemicals that are classed as dangerous substances, such as hydrogen peroxide and potassium permanganate. They can usually be identified by the warning labels on the packaging as directed by CHIP regulations. Some dangerous substances have their own regulations such as asbestos, lead and flammable chemicals and therefore COSHH does not apply. There are eight steps to carry out to comply with COSHH regulations which are listed in Box 15.2.
COSHH assessments can be recorded on paper or electronically. They should include why the risks identified are significant or not, the control measures and plans that apply to the substance. The COSHH assessment is a working document and should be updated every time there is a significant change, although most pharmacies will update the COSHH assessment once a year. External bodies such as health and safety officers may request records of COSHH assessment.
CPD
This is a large part of clinical governance for which the pharmacist must take his or her own responsibility. Records tend to be kept at home and not in the pharmacy. The records may be kept on paper or electronically. Not only will a CPD cycle need to be completed, a portfolio of evidence supporting the cycle will also be required. More information about CPD can be found in Chapter 10.
Consultation records
Consultation records are a new concept for pharmacists and have come about as a result of the expanding role of pharmacists. The more services pharmacists provide, the more records they will need to keep. What to record may be specified and there may be a form to fill in but some of the time the pharmacist will need to decide what is relevant to record and where to record it. This section addresses the records kept for patient group directions (PGDs), services and the requirements of the pharmacy contract.
PGDs and services
Most PGDs and services that pharmacists can provide require some kind of training and accreditation by the PCO and involve the supply of a drug, usually a POM, to the patient under NHS payment agreements. All the terms of the service will need to be kept on the premises and this will specify the types of records required to provide the service. Each service will have its own requirements but they will encompass requirements of current legislation, namely the Medicines Act 1968. They may also require notes on the consultation in question, which may look more like a case history, much like doctors’ notes.
The Pharmacy Contract 2005 in England
There are three tiers of services provided within this contract which are essential, advanced and enhanced services. The essential services include day-to-day dispensing, counselling and the provision of advice. These are services that pharmacists have already been providing. Now pharmacists need to provide evidence of this advice and counselling. MURs are currently the only advanced service to be introduced. An example of enhanced services is the provision of free emergency hormonal contraception via a PGD, and records of this need to be kept, as discussed above.
Any interventions made or advice and counselling given to patients known to the pharmacist that can be classed as clinically significant need to be recorded by the pharmacist in the PMR. Clinically significant could be described as when the action taken has a direct impact on patient care, which encompasses most counselling, advising and interventions made by pharmacists. The information recorded needs to be sufficient for another person to understand why, when, who and how this consultation took place. The following need to be recorded in PMRs for essential services:
Some of these will also need recording on a specific form and be filed accordingly, such as the referral and intervention form, repeat dispensing cardex and owing dockets.
MURs and prescription interventions
More information about how to carry out a MUR or a prescription intervention can be found in Chapter 47. Here we will discuss the record keeping issues around MURs and prescription interventions. There is a standard form to be filled in when carrying out a MUR. Care must be taken so that all information is neat, legible and understandable, not only for the healthcare professional but for the patient as well, since they should also be given a copy for their own reference. Abbreviations and jargon should be avoided where possible and statements that may alarm patients or damage relationships with doctors ought to be worded sensitively. Patient, doctor and pharmacist details should be written in capitals to avoid misinterpretation.
One copy of the form will need to be kept in the pharmacy for a minimum of 2 years and filled in an appropriate manner, and a summary should be entered in the patient’s PMR. One copy will need to be sent to the GP, usually the top copy, so that they may be scanned onto the GP’s patient records. The third copy should be given to the patient as a reminder of the issues discussed or to be taken to the GP as a discussion aid. Anonymized MURs and interventions may be requested by the PCO in order to check their quality and that they met the service specifications.