Learning from Complaints

The PPC noted that where locum staff are working in pharmacies on a temporary basis, it is vital for the pharmacy to have well drafted and tailored Standard Operating Procedures in place regarding the safe operation of the pharmacy, to assist the locum pharmacist in providing seamless and consistent care to patients.

Key Learning Points for Pharmacists

1.The superintendent pharmacist and supervising pharmacist should ensure that relevant information on the operation of the pharmacy is available for locum pharmacists in the pharmacy, and also communicated to the locum in advance where possible.
2. It is recommended that a manual which provides concise and relevant information is provided for locums. This should include an outline of services provided by the pharmacy, for example methadone treatment service, where the controlled drugs key and register is kept, the requirements for locking up the pharmacy and any other procedures that the locum pharmacist is expected to perform on a daily basis.
3. Any pharmacist providing locum services must also ensure they familiarise themselves with the procedure of the pharmacy they are working in.

The PPC noted issues arising for pharmacists due to handwritten prescriptions and highlighted this issue for both pharmacists and other medical professionals.The PPC stated that in circumstances where there is any doubt, pharmacists should carry out additional checks, for example ringing the prescribing doctor to clarify any uncertainty contained in the prescription. Similar issues were noted in the PPC Annual Report 2014 with regard to confusion arising from the wording of a prescription for a controlled drug.

Key Learning Points for Pharmacists

1. If the prescription is not clear, you should always contact the prescriber to confirm your understanding prior to dispensing the product to a patient.
2. The PSI is currently working with the Medical Council to examine patient safety matters of mutual concern, particularly focusing on safe prescribing and dispensing. The aim is to produce a resource that will be relevant to both pharmacists and doctors and will help to improve patient safety.

The PPC noted that a number of complaints received from patients included references to patient information leaflets not being furnished with their medications. Additional patient information leaflets can be printed from the Health Products Regulatory Authority’s (HPRA’s) website.

Key Learning Points for Pharmacists

1. Patient information leaflets, also called Package Leaflets, should be provided with all dispensed medicines.This provides important information for the patient on how to take their medicine and complements counselling provided by the pharmacist, especially when the patient themselves are not present in the pharmacy.
2. If a product’s pack is split for dispensing, you should photocopy the Package Leaflet for additional supplies or print extra leaflets from the HPRA’s website.
3. In addition to the Summary of Product Characteristics and Package Leaflet for each product, the HPRA’s website also has a section on ‘Educational Materials for Medicines’ to aid in optimising the safe and effective use of certain medicines. The information focuses on one or more specific safety concern and provides clear information on these specific risks and what actions are required to prevent and minimise such risks. This information should be used where appropriate to improve patient care.
4. If a patient information leaflet is not available for a particular medicine, pharmacists should take extra time to ensure that they have provided all relevant information to the patient to enable the safe use of the product and answer any questions that they may have.

The PPC noted that pharmacists should continue to be vigilant when they are supplying generic medicines as variability in the packaging, and tablet size and colour of generic medicines can be confusing for patients. The ongoing need for appropriate counselling, to ensure the patient understands that a generic medicine contains the same active ingredient as the branded version, was also highlighted in the PPC Annual Report 2014.

Key Learning Points for Pharmacists

1. Pharmacists should ensure that appropriate patient counselling is provided when a generic medicine is dispensed, so that the patient is clear what their medicine is for and how to take or use it.
2. All staff members should be trained on what a generic medicine is so that they can help to inform patients, and address any questions that they may have.
3. The HPRA has produced a leaflet on Generic medicines which may be of assistance when counselling patients.
4. In July 2013 the PSI issued a newsletter particularly on the requirements of the Health (Pricing and Supply of Medical Goods) Act 2013 which contains useful information on ‘Patient Consultation and Communication’, and ‘Mitigating the Risk of Dispensing Errors’. In August 2013 a further update on this topic was also issued in the newsletter.

The PCC considered a number of complaints that related to dispensing errors and highlighted:

• that pharmacists should be extra vigilant in making sure that the dosage instructions on the dispensing label reflect the information on the prescription and when dealing with medicines which have a narrow therapeutic index;
• the importance of pharmacists having a robust checking procedure in place for the supply of all prescription medicines;
• the importance of good stock management and suitable storage arrangements in minimising the risk of dispensing errors, especially where medicines have different strengths, similar packaging or similar sounding names;
• that where a dispensing error does occur, it is important to put in place suitable remedial actions to minimise the risk of a similar error occurring again.

Key Learning Points for Pharmacists

1. The superintendent and supervising pharmacist should take time to consider the inherent risks in their pharmacy and put in place procedures and staff training to help minimise the risk of dispensing errors occurring.
2. A robust dispensing and checking procedure should be in place in your pharmacy which is consistently followed.  Where at all possible, this should involve at least two people to help to minimise the risk of human error, and the pharmacist must always carry out a final check between the label, the medicinal product and the prescription.  
3. Careful consideration should be given to where medicines are kept in the dispensary being mindful of the potential for picking errors, for example medicines that can be easily confused due to their name or packaging should be separated where possible. Alerts on the shelf edge or computer can also help remind pharmacists and staff members about high risk medicines or those with a narrow therapeutic index.
4. Errors and near misses should always be reported and recorded, and the staff members involved informed of the error. All errors and near misses should be regularly reviewed and used to identify staff training and/or amend practice, policies and procedures, to minimise the risk of a similar incident happening again.

The PPC noted that a number of complaints concerned price differences between pharmacies. It was also suggested that providing a generic medication, pharmacists should ensure to counsel patients that the medication contains the same active ingredient as the branded version.

Key Learning Points for Pharmacists

1. Pricing for prescription-only medicines should be transparent and patients should be made aware that prices can vary between pharmacies; it is the patient's choice as to which pharmacy they attend to have their medicines dispensed.
2. Pharmacists have a very important role in providing information and education to patients on medicines. That role is particularly important when substituting a medicine on the HPRA list of interchangeable medicines.
3. Patients can often be confused by different packaging and names of 'branded generics', especially if the branded generic changes from month to month. This may impact on the patient's adherence to their medication regime and ultimately, on their health. Therefore, when a medicine is substituted, patients must be counselled and given the opportunity to ask questions.
4. Further guidance on the Transparency in the pricing of prescription medicines was provided in the March 2014 issue of the PSI newsletter.

The PPC highlighted that dispensing high-tech medicines is a 'high-alert' matter and pharmacists need to explain the treatment, dose and duration of treatment to the patient.

Key Learning Points for Pharmacists

1. Counselling with regard to a high tech medicine is particularly important as these patients may be very unwell and the medicines can be particularly harmful if used incorrectly.
2. Even if only one patient in the pharmacy is on a particular high tech medicine it is imperative that the pharmacist knows what it is being used for, so that they can counsel the patient appropriately.
3. A full therapeutic review using the original prescription must be carried out on each and every occasion to ensure that the medicine is correctly dispensed and patients receive any information and counselling required.

It was noted by the PPC that a significant number of complaints related to a communication breakdown between the pharmacist/pharmacy staff and the complainant.

Key Learning Points for Pharmacists

1. The issue of poor communication between pharmacists and patients was also highlighted in the PPC’s Annual Report 2013. The key learning points from this report should be reviewed.
2. As noted, many issues presented to PPC could have been addressed with better communication between patients and the pharmacist or pharmacy staff.
3. Pharmacists should remember the principles of the Code of Conduct in their interactions with patients and members of the public. The Code states that they must ensure the patient is treated with courtesy, dignity, integrity and honesty, and respond honestly, openly and courteously to complaints and criticisms.
4. The PSI has raised this with the Irish Institute of Pharmacy (IIOP) as a potential requirement for future training for pharmacists, and it is understood that a module in this regard will be available shortly.

The PPC noted that on a number of occasions, problems arose for pharmacists, partly as a result of confusion from the wording of a prescription for a controlled drug written by a prescribing doctor.

Key Learning Points for Pharmacists

1. If the directions on a prescription are not clear, or do not meet the requirements for a legally valid prescription, you should contact the prescriber to confirm your understanding prior to dispensing the product.
2. If the prescriber cannot be contacted, consider what other options are available to confirm the correct dose and/or obtain a legally valid prescription. For example, contact the pharmacy department in the hospital where it was first prescribed or another doctor in the practice if it was initiated by a GP.
3. The PSI will be liaising with the Medical Council in the coming year regarding supports to be developed for both doctors and pharmacists to promote safe prescribing and dispensing of medicines.

The PPC suggested that pharmacists should be made aware of the other requirements for dispensing of veterinary medicines.

Key Learning Points for Pharmacists

1. The main requirements are primarily set out in the European Communities (Animal Remedies) (No.2) Regulations 2007 (S.I. No.786 of 2007) (as amended), which can be viewed on the legislation section of this website, or on www.irishstatutebook.ie.
2. To improve compliance with this legislation, the PSI Inspectors have issued Advice on Animal Remedies (Veterinary Medicines).

The committee considered a number of complaints involving dispensing errors, where:

• medication was dispensed from the Patient Medication Record on the computer, as opposed to the original prescription;
• the appropriate label was prepared, but the wrong medication selected;the incorrect strength and/or incorrect dosage instructions were supplied in circumstances where the directions on the prescription were unclear.

Key Learning Points for Pharmacists

1. Pharmacists must always check the original prescription and the does prescribed at each dispensing; dispensing from the PMR can often compound an error made on the first dispensing.
2. Pharmacists are reminded that two people should be involved in the dispensing process where at all possible and the pharmacist must always carry out a final check between the label, the medicinal product and the prescription.
3. The overall work flow in the pharmacy should also be reviewed; a well thought out, logical workflow can increase efficiency and decrease the potential for errors.
4. Bench space used for assembling and checking prescriptions should be kept clear and free of clutter.

Patient-returned medicines should always be clearly segregated from normal stock as soon as they are received and processed into specialised waste bins.

• The expiry date of a medicine, or medical device, should always be checked as a routine part of the dispensing process before it is supplied to the patient.
• To decrease the risk of a date-expired medication being supplied to a patient, staff should be trained to check the expiry date of stock when it comes in from the wholesaler, to ensure stock is rotated on the shelf and to date check all stock on a regular basis.

The PPC reiterated the need for pharmacists to be extra vigilant when dispensing medicines which could be considered high risk including medicines for children and when dispensing methotrexate. These are regarded as higher risk dispensing practices as an error is more likely to result in significant adverse effects and serious harm to the patient. Pharmacists should review their dispensing procedure for these medicines and the extra steps that may be needed to minimise the risk of making an error. For example keeping paediatric medicines separate from adult formulations, ensuring a second member of staff double checks the dosage and any calculations performed, and that the patient/carer is thoroughly counselled on the safe and appropriate use and storage of the product.

Please re-read the PSI advice on Paediatric Dispensing Errors issued in the November/December 2012 newsletter and advice issued on Paediatric Paracetamol overdose: Risk Management in the March 2013 newsletter.

The PSI Guidance for Pharmacists on Safe Supply of Oral Methotrexate should also be reviewed and relevant procedures amended if necessary.

The PPC highlighted that poor communication may have contributed to matters escalating to formal complaints and that some complaints may have been resolved at local level if an appropriate complaints handling procedure had been in place. The Report notes that situations that gave rise to complaints involved the manner in which information was communicated to a patient, conversations being conducted in the public area of the pharmacy and concerns over confidential health matters being overheard by others. Patients also complained about the inability of the pharmacy to provide information when requested, telephone calls not being returned, inconsistent pricing of medicines supplied against private prescriptions, and generic medicines dispensed against a prescription for a branded product without consulting the patient.

Key learning points for pharmacists:

1. A complaints procedure should be in place in every pharmacy and all pharmacists and members of staff should be trained on how to handle a situation whereby a patient raises a concern or wishes to complain.
2. Pharmacists and other members of staff should be mindful of how they interact with patients especially about sensitive or personal issues. Where at all possible the patient should be given the option of using the consultation area to discuss health matters or concerns in private.
3. Many issues presented to PPC could have been addressed with better communication between patients and the pharmacist or pharmacy staff.