You are the Responsible Pharmacist in charge of performing all clinical checks for prescriptions at your pharmacy. The pharmacy technician carries out accuracy checks on all dispensed items.
One day, a patient presents to the pharmacy and reports that they were accidentally dispensed 250mg Lamisil tablets (terbinafine; Novartis) instead of 25mg Lamictal tablets (lamotrigine; GlaxoSmithKline). The patient informs you that they have not taken any of the tablets.
What do you do? Where does responsibility lie in this scenario?
Source: Cathy Cooke
“There is joint responsibility between the two registered professionals”
The first important action is to examine the dispensed item to verify that there has been an error and then apologise to the patient on behalf of the team. I would then offer to re-dispense to correct the error and explain to the patient the steps we would be taking to ensure this doesn’t happen again, such as completing an incident report within the organisation’s reporting system, carrying out an investigation to determine the causes and consider learning points for the team.
Following that, I would bring the error to the attention of the pharmacy technician because it is important for anyone making an error that they have the opportunity to reflect and examine their practice. I would then carry out a root cause analysis to determine if any changes to operating procedures are necessary to reduce the risk of future errors.
Where does responsibility lie? As a registered professional, the pharmacy technician is responsible for their practice — in this case, carrying out the accuracy check. However, as the Responsible Pharmacist, there are legislative responsibilities which include “to secure the safe and effective running of the registered pharmacy when it is operational” and to “maintain and review pharmacy procedures designed to secure the safe and effective running of the pharmacy”. So there is joint responsibility between the two registered professionals — the pharmacy technician who carried out the accuracy check and the Responsible Pharmacist on duty. If the prescription was supplied at a time when there was another Responsible Pharmacist on duty, then it’s likely that they would also share responsibility for the supply of a medicine that did not meet the standard required.
a pharmacist with multisector practice experience within community pharmacy, social care, primary and secondary care, and secure environments
Source: Ade Williams
“Errors and near misses are a failure of processes and systems”
It is easy to let panic overwhelm you when a patient presents with a potential error, but it is crucial to try to keep these emotions in check. You should have a standard operating procedure (SOP) in your pharmacy to help guide you in this sort of situation.
Have an open and honest conversation with the patient to obtain as much information as possible and to identify any ongoing risks. Examine the returned medicines to determine if any are missing and, if so, why? Patients may want to keep the returned medication as proof that the incident occurred for fear it may be swept under the carpet. Explain what is involved during the investigation process, that the medicine should returned for safe disposal, and agree how and when you will keep them up to date. Once the patient understands and appreciates the investigative process the medicine is likely to come back.
When dispensing errors occur, it may be wise for you to seek legal advice.
Where possible, ask someone who is not part of the dispensing incident to facilitate the investigation to bring an objective point of view. Inform the prescriber of the incident and confirm the details of the initial prescription. They may also want to be kept informed of the investigation outcomes.
Your initial patient conversation will help inform a root-cause analysis, looking at:
- Whether the appropriate clinical checks were completed and endorsed;
- Who dispensed and completed the final accuracy check of the item;
- Who gave the prescription to the patient and what they recall discussing with the patient;
- If everyone involved was up to date with their training.
This will identify any contributing factors, such as workload. It will also ascertain whether appropriate procedures were in place, were up to date and followed.
That investigation will examine SOP compliance in the dispensing and handing out of prescriptions. In this case, the clinical and accuracy checks will be crucial factors.
Errors and near misses are a failure of processes and systems. These should be used as opportunities to learn and make changes where appropriate. The role of individuals in any failure, when identified, should be supported to address the causes.
Pharmacy owners are also expected to show how they have identified and managed emerging risks, and how underlying error trends in the dispensing process are identified and managed.
is superintendent pharmacist at Bedminster Pharmacy, Bristol
Source: Richard Hough
“Foster a culture of learning and risk prevention within your organisation”
The care of the patient is your first concern. Thankfully, they have confirmed that they have not taken any tablets. You should be open and honest with the patient — apologise and explain what went wrong. You should record the mistake and ensure that it is reported appropriately within the organisation. For example, notifying the superintendent pharmacist. You should direct the patient to your company’s complaints procedure in case they wish to make a formal complaint.
What can be learnt from the mistake? There are several factors that may have caused the problem to arise:
- Are the products’ packaging similar?
- Are the packets placed next to each other on the dispensary shelves?
- Were workload levels too high?
- Were there any avoidable distractions that led to inattentiveness?
Take appropriate preventative action to ensure that there is no recurrence of the mistake. For example, review staffing rotas or put stickers on the shelves to highlight the risk of a picking error, or separate the products on to different shelves.
Share details of the mistake with other staff members to foster a culture of learning and risk prevention within your organisation. Ensure that there is a system for regular review of errors so that any trends can be identified, such as whether they happen when staffing levels are particularly low or if it is the same person making the mistakes, which might identify a training need. As the Responsible Pharmacist, you are responsible for the safe and effective running of the pharmacy. The assembly process, including accuracy checking, takes place under your supervision. The degree of supervision that is required is what is regarded as good practice within the profession, having regard to the experience and qualifications of the person being supervised. Technicians are regulated by the General Pharmaceutical Council (GPhC) and it is acknowledged that highly experienced and qualified technicians should require lower degrees of supervision by the Responsible Pharmacist than less qualified or inexperienced ones.
Richard Hough is a former pharmacist, partner and head of healthcare at Brabners LLP
Source: Yogeeta Bhupal
“Take all reasonable steps to make things right”
As the Responsible Pharmacist, you are responsible for the safe and effective running of the pharmacy. Whether you are the person who made the error or if it was another member of the pharmacy team, once you become aware, you need to promptly take all reasonable steps to make things right.
The GPhC has provided guidance on responding to complaints and concerns and has outlined the steps you could take. For this scenario you could:
- Ask to inspect the medication — this may help to find out what went wrong;
- Offer an apology to the patient;
- Make a supply of the correct medicine;
- Establish the patient’s expectations — do they want to report a complaint? If so, provide the necessary details;
- Try to establish what went wrong;
- Follow company procedures/SOPs for reporting an error or complaint;
- Review records and learn from the mistake;
- Let colleagues involved in the error know — in this case the accuracy checking technician;
- Inform your professional indemnity provider.
Never try to minimise the seriousness of an error — strike a balance to reassure the patient if there has been harm but do not make the error sound insignificant.
It is important to review and learn from errors as this helps evaluate what went wrong and what can be done to prevent future mistakes. The Royal Pharmaceutical Society’s (RPS’s) guidance ‘Making things right when there’s a dispensing error’ looks at reviewing and learning from dispensing errors. ‘
Medicines ethics and practice’
has further information on getting the culture right — in particular, the importance of a just culture. If you have any concerns or would like confidential one-to-one support from a team of pharmacists and pharmacist advisers, contact the RPS professional support service.
Yogeeta Bhupal is a professional support pharmacist at RPS Support and a part-time clinical pharmacy lecturer