Learning from Inquiries

The PSI shares learnings from inquiries and other situations, to help improve pharmacy practice and patient safety by highlighting potential errors and risks.

Where it has been decided that there is sufficient cause to warrant further action in relation to a complaint, the Preliminary Proceedings Committee (PPC) may refer the complaint to a committee of inquiry.

Here you will find learnings from these inquiries and other situations.  All registrants should consider how they can use these learnings to review and improve their own practice and the practice of other staff members in the pharmacy where they work. Superintendent and supervising pharmacists should use these observations and learnings to review the policies and procedures in their pharmacies and ensure all staff are trained on, and following them.  

The Professional Conduct Committee (PCC) heard an inquiry into a complaint which had been made in 2020. The complaint was that a parent had been supplied with the influenza vaccine (live attenuated) nasal spray suspension (the "Vaccine") for their 7-year-old child. 

  • The parent, who is not a registered pharmacist, presented at the pharmacy and enquired about getting the Vaccine for their child who was not with them on the day in question. The parent was a regular customer at the pharmacy and had attended with their child on previous occasions. 
  • The pharmacist supplied the parent with the Vaccine to take home and administer to the child themselves. 
  • The pharmacist gave evidence before the PCC that he explained to the parent how the vaccine should be stored, how to administer it, provided accompanying leaflets explaining possible side effects, and arranged for the parent to sign the consent form for the Vaccine before leaving the pharmacy. 
  • The pharmacist gave evidence that the parent indicated there were logistical challenges in relation to being able to return to the pharmacy with the child to get the Vaccine, and that the heightened anxiety and fear around the Covid pandemic had influenced the pharmacist's decision to supply the Vaccine to the parent to be administered at home instead of onsite at the pharmacy. 
  • Evidence was heard at the Inquiry that the parent subsequently took the Vaccine home and administered it to the child themselves without a pharmacist present.
  • Although the pharmacy had standard operating procedures (SOP’s) in place in respect of the supply and administration of the flu vaccine, the pharmacist gave evidence to the PCC that they had failed to comply with those SOPs.
  • The pharmacist acknowledged that supplying the Vaccine, to be administered by the child's parent, in their home was not in accordance with the legislative requirements.  Additionally, the pharmacist gave evidence that the supply was made without appropriate safeguards in place to ensure adequate post-vaccination observation and the pharmacist acknowledged that they had not considered the implications of a possible anaphylactic reaction based on the patient’s medical history. The pharmacist acknowledged that providing the vaccine to the child’s parent for administration at home was the wrong thing to do.   

Learnings

This complaint highlights the following important learning points: 

  • When supplying and administering the flu vaccine, pharmacists must be satisfied that they are doing so in compliance with: 
  • Pursuant to regulation 4B of the aforementioned 2003 Regulations, flu vaccines must only be administered to a patient by a pharmacist who has undertaken the approved training and who is authorised to administer the vaccine at a suitable and appropriate place, having regard to public convenience and the need to protect the health and safety of the public and safe administration of the product.
  • As set out in the PSI’s guidance documents referenced above, prior to administering a vaccination, a pharmacist must carry out a documented assessment of a patient’s suitability for vaccination with a record of the assessment maintained in the pharmacy. In accordance with best practice identified by the National Immunisation Office, the pharmacist must ensure that the patient and/or their carer/guardian has sufficient information and advice regarding potential side effects and how these should be managed.
  • Post vaccination, the patient should remain in the pharmacy, or designated area for an observational period in case they have an allergic reaction, and this requirement should be explained to the patient.  The pharmacist should be competent in responding quickly should an adverse event occur, particularly an event that requires the administration of adrenaline (epinephrine) or the provision of basic life support to a child. 
  • All vaccinations supplied and administered must be recorded and a copy of the particulars must be notified to the HSE and GP of the person to whom the product was administered.

The Council of the PSI recommended that a learning from this complaint be shared with the profession. The PSI also recommends that all pharmacy staff members and pharmacies should review SOPs where necessary to ensure that they mitigate the risk of a similar incident occurring.

Guidance Documents and Additional Information

The Professional Conduct Committee (PCC) heard a complaint in which a patient had been supplied with an incorrect quantity of a High Tech medicine, Xeloda® (Capecitabine) tablets, on two separate occasions and that the medicine supplied was labelled with an incorrect dose on two separate occasions.

  • A fax of a High Tech prescription was sent from a hospital to a community pharmacy and read: Xeloda® tablets ‘1800mg Po bid x 14/7 on, then 1 week off’. Written instructions on the prescription also stated: ‘Repeat every 21 day cycle x 8 cycles’, ‘Dispense one cycle at a time’ and ‘Dispense exact number of doses’.
  • To make up the prescribed dosage of the first cycle of treatment (1800mg twice daily for 14 days) the patient required:
  • Xeloda® 500mg x 84 tablets; Take three tablets twice daily for 2 weeks, then 1 week off
  • Xeloda® 150mg x 56 tablets; Take two tablets twice daily for 2 weeks, then 1 week off
  • On the date of the first review when the High Tech prescription was to be dispensed, the Xeloda® 150mg tablets were not in stock in the pharmacy, the patient was not waiting on the medication and the Pharmacist working in the pharmacy that day gave evidence at the Inquiry that he wanted to contact the prescribing Consultant to clarify the dose.
  • The Pharmacist gave evidence that he set the prescription aside and placed a “post-it” on it indicating that the prescription would be dealt with the following week.
  • A staff member working alongside the Pharmacist gave evidence at the Inquiry that on the date of the first review she generated a label for Xeloda® 500mg tablets from a previous supply recorded on the Patient Medication Record (PMR) in order to compare it to the new prescription as the dosage had changed. The previous dosage was Xeloda® 500mg tablets with instructions to ‘Take three tablets twice daily Monday-Friday only for 6 weeks in total’. This label was set aside with the faxed prescription.
  • The following working day, the Pharmacist concerned was not on duty, the post-it was not seen and Xeloda® 500mg tablets were dispensed using the label re-printed from the PMR.
  • Later that week a pharmacist at the hospital where the patient was receiving treatment contacted the pharmacy and informed the Pharmacist that the patient had been supplied with 90 x Xeloda® 500mg tablets labelled with an incorrect dose. The hospital pharmacist also informed the Pharmacist concerned that the Xeloda® 150mg tablets had not been supplied to the patient.
  • New labels for Xeloda® 500mg tablets and Xeloda® 150mg tablets were printed, and Xeloda® 150mg tablets were prepared and collected by the patient.
  • The next day the hospital pharmacist rang the pharmacy again and informed the Pharmaceutical Assistant on duty that the patient had collected 60 x Xeloda® 150mg tablets from the pharmacy when they should only have been supplied with 56 x Xeloda® 150mg tablets and that the label read ‘Take one tablet twice daily’ when the dose required for the Xeloda® 150mg was ‘Take two tablets twice daily’. The patient had contacted the hospital pharmacist as they were confused as to how many to take.

At the Inquiry before the PCC, the Pharmacist who was the subject of the complaint undertook not to repeat the conduct to which the complaint related and consented to being censured by the Council of the PSI. Following the submission by the PCC of its report to the Council of the PSI, the Council censured the Pharmacist.

Important Learnings

The sequence of events that caused the errors in this complaint involved a number of people over a number of days. Learnings from this complaint should be shared with all staff members and you should review your own practice to help ensure a similar incident doesn’t happen in your pharmacy.

The PSI has produced a practice notice on good dispensing practice for High Tech medicines.

This complaint highlights the following important learning points:

  • There should be an agreed procedure for ordering, storing and dispensing High Tech medicines, written down in the form of a Standard Operating Procedure (SOP). Following clear SOPs ensures consistent performance of a task to the required level and ensures that the system is as robust as possible. All new staff members should be trained to use and follow the SOPs, and they should be regularly reviewed to ensure that they are fit for purpose. SOPs should be unique to your pharmacy and tailored to your dispensary design and staff.
  • There should be a clear procedure for recording and communicating important information regarding patients’ prescriptions, for example, queries to be followed up with the prescriber, and the ordering of medicines. This should be in a format and place that is practical, cannot be misplaced or lost and can be used by the whole pharmacy team. This communication procedure should ensure that patient care is consistently maintained regardless of which pharmacist or staff member is on duty.
  • When dispensing a medicine which is owed from a previous day it must be checked against the original prescription. Dispensing a medicine from a dispensing label, PMR or an owing note, often compounds an error made on the first dispensing.
  • The patient must always be counselled on the correct use of their medicine, potential adverse effects, and precautions for use, and how to store the medicine. Patient understanding should be confirmed. This can also serve as a final check and help to pick up on an error that may otherwise have been missed.
  • Counselling with regards to a High Tech medicine is particularly important as these patients are often very sick and the medicines can be particularly harmful if used incorrectly. 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.
  • It should be noted that patients prescribed chemotherapy can tend to be over-compliant, as opposed to under-compliant, with regards to taking their medications, and therefore it is important that the exact amount needed by the patient for their treatment regimen is supplied.
  • If two members of staff are involved in the dispensing process there is a risk that both may rely on the other to be rigorous and hence neither give the task their full attention. There should be clear lines of accountability between staff members, the pharmacist being ultimately responsible for all medicines supplied from the pharmacy.
  •  An error log must be completed for all errors made in the pharmacy, and the staff members involved informed of the error. Recording errors should not be used as a way to blame individuals, but rather to encourage an environment of openness and learning, so that procedures can be reviewed and amended, and practices changed to guard against a similar error occurring again.

The Professional Conduct Committee (PCC) heard a complaint in which an infant had been supplied with a medicine labelled with the incorrect dose.

  • The infant’s parent presented a handwritten prescription to the pharmacy which read: ‘Zantac 75mgs/5mls, ∙3ml tid x 300mls'
  • The zero before the decimal point of the dose had been omitted. Instructions on the prescription also stated: ‘weight dependent’.
  • The prescription did not state an age or date of birth and the infant was not present in the pharmacy.
  • There was only an opened bottle of Zantac 75mg/5ml Syrup in the pharmacy. The pharmacist gave evidence that they checked the Patient Information Leaflet (Package Leaflet) to check the shelf life of the product when it is opened, as well as to read the other information on the leaflet. The pharmacist spoke to the infant’s parent to ascertain if they were happy to accept an opened bottle of 290mls, which they confirmed they were.
  • The pharmacist misread the prescription as 3ml (rather than 0.3).The pharmacist believed that the prescription related to a child because of the inclusion of the words ‘weight dependent’ on the prescription and presumed that the doctor had calculated the appropriate dose for the child’s weight. The pharmacist made no inquiry of the parent presenting the prescription as to the age or weight of the child.
  • The pharmacist dispensed the incorrect dose of Zantac and labelled the bottle accordingly, as: ‘GIVE THREE ML THREE TIMES A DAY AS DIRECTED’.
  • The dispensing error resulted in the infant receiving 45mg three times daily, rather than 4.5mg three times daily, as intended.
  • The error was identified by another healthcare worker six days later and the infant was taken to hospital and kept in overnight for observation.

Important Learnings

Learnings from this complaint should be shared with all staff members and you should review your own practice to help ensure a similar incident does not happen in your pharmacy.

This complaint highlights the following important learning points:

  • The pharmacist has a legal responsibility to review each prescription prior to dispensing and supply of the medicine to ensure that the medicine is safe and appropriate for the patient.
  • Ranitidine is often prescribed for infants ‘off label’ and therefore the relevant dosing information may not appear in the product’s Package Leaflet or Summary of Product Characteristics (SmPC). Therefore the dose should be checked using a reliable resource, for example, the BNF for Children. The infant’s weight will be needed to calculate the dose. In the absence of this information, a reliable average weight for age table (for example as given in the BNF for Children) can be used to calculate the dose. However, it is important to either see the infant or check with the parent or carer to ensure the value chosen is a good approximate. The infant’s actual weight should be obtained as soon as possible and the dose re-calculated to ensure it is appropriate.
  • Where at all possible get another colleague to check your workings. This does not necessarily need to be another pharmacist. Explaining your workings and logic to another member of staff can be enough to identify an error that may otherwise have been missed.
  • Do not rely on the doctor to calculate the correct dose; you must be satisfied with the clinical appropriateness of all medicines that you dispense.
  • If the dose on the prescription is not clear you should contact the prescriber to confirm. If the prescriber cannot be contacted, consider what other options are available to confirm the correct dose. 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.
  • Regulation 7 of the Medicinal Products (Prescription and Control of Supply) Regulations 2003, as amended, sets out the requirements for a legally valid prescription. It is a legal requirement for the prescription to specify the age of the patient if they are under 12 years old. If this information is omitted, the pharmacist can still dispense the prescription but they must exercise due diligence and care, and be satisfied that it is safe to do so.
  • The appropriate dose of ranitidine for an infant will often be a fraction of a millilitre. It is important to highlight this to the parent or carer and to supply an oral syringe that can accurately measure the correct volume.
  • The pharmacist must be mindful that the shelf life of Zantac liquid once it is open is 28 days and to highlight this to the parent or carer.
  • The pharmacist also has a legal responsibility to ensure that the infant’s parent, or their carer, has sufficient information and advice for the proper use and storage of the prescribed medicine. You should confirm understanding of this information; this can also serve as a final check and help to identify an error that may otherwise have been missed.
  • Consider what you would do if you discovered a dispensing error in your pharmacy; who would you contact? As well as the patient and/or their carer and the doctor, this may include for example the manufacturer of the product and the National Medicines Information Centre to ascertain further information on the product. Where would you refer the patient to? What information would be necessary to provide to the patient and/or their doctor?
  • An error log should be completed for all errors made in the pharmacy, and the staff members involved should be informed of the error. Recording errors should not be used as a way to blame individuals, but rather to encourage an environment of openness and learning, so that procedures can be reviewed and amended, and practices changed to guard against similar errors happening again.

The Professional Conduct Committee (PCC) heard a complaint in which Paralink® suppositories 500mg were supplied in error by a pharmacist for the treatment of a one year old child.

  • The child’s parent presented a prescription to the pharmacist for Tamiflu oral suspension and Motilium suppositories. The pharmacist dispensed the prescription and counselled the parent with regard to how to administer these two medicines to the child.
  • During this interaction the parent also requested to buy Paralink® (paracetamol) suppositories and Dioralyte® sachets for the child, as suggested by an out-of-hours doctor which they had attended during the night.
  • The pharmacist counselled the child’s parent on how to use these two products, but in error a box of Paralink® 500mg adult suppositories was supplied, rather than Paralink® 180mg suppositories which are the appropriate strength for a one year old child.
  • Over the next two days the child received a total of seven Paralink® 500mg suppositories at 6 hourly intervals, in addition to one Paralink® 180mg suppository which had been provided by the out-of-hours doctor just before they presented at the pharmacy.
  • The child’s symptoms persisted and hospital admission was required. The child was diagnosed with acute liver failure caused by accidental paracetamol overdose; and underwent an emergency liver transplant.

Important Learnings

Learnings from this complaint should be shared with all staff members. You should review your pharmacy’s procedures for supply of non-prescription medicines for infants and children, as well as your own practice, to help ensure a similar incident does not happen in your pharmacy.

This complaint highlights the following important learning points:

  • Children and infants are particularly vulnerable to drug overdose and side effects; this is true even with non-prescription medicines. It is essential that extra time and care is taken to ensure the correct product is supplied and the parent/carer has accurate and detailed information regarding dosing amount and frequency; in these cases supply only by the pharmacist should be considered.
  • It should be highlighted to the parent/carer that medicines containing paracetamol are extremely safe and highly beneficial when used correctly; however they can be toxic and indeed fatal when used inappropriately. Therefore it is imperative that the patient/carer are advised to always check the recommended dose for the age and weight of their child and not to give more than this.
  • It is recommended that you explain the directions for use to the parent/carer using the information given on the product’s outer packaging and/or the Package Leaflet, and confirm with them their understanding of this information. This can help to ensure that the correct product has been selected and identify an error that may otherwise be missed.
  • You should encourage the parent/carer to read the Package Leaflet themselves before administering the medicine to the infant or child and if they have any queries to contact the pharmacist or their doctor.
  • Non-prescription medicines for infants and children should be separated on the shelf from medicines for adults to help reduce the chance of them being mixed up during supply.
  • All members of staff should be appropriately trained on non-prescription medicines for infants and children and aware that the dose needed can be dependent on age and weight. It should be clear when it is necessary to refer to the pharmacist before making a supply.
  • In this particular case, a supply error had detrimental effects on the infant. You should consider ways in which a similar error may be prevented in your pharmacy, for example, by highlighting the information on the product’s box and patient leaflet during counselling to confirm who the product is for and what it is needed to treat. What other procedures or safe guards could you put in place?
  • An error log should be completed for all errors made in the pharmacy, and the staff members involved should be informed of the error. Recording errors should not be used as a way to blame individuals, but rather to encourage an environment of openness and learning, so that procedures can be reviewed and amended, and practices changed to guard against similar errors happening again.

The Professional Conduct Committee (PCC) heard a complaint in which the incorrect amount of Methadone was supplied to a patient for five consecutive days.

  • The patient presented two prescriptions for Methadone 1mg/ml oral solution.  The first prescription was for supervised consumption of 30mls per day, for three days, total quantity 90mls. The subsequent prescription was for supervised consumption of 40mls per day, for three days, total quantity 120mls.  This was the first time that the patient had been prescribed methadone and the first time that they had attended at the pharmacy.
  • The pharmacist gave evidence that she was not aware that the patient was just starting on methadone and that he was on an initial dose that would be increasing.  
  • The pharmacist misread the prescription and dispensed 90mls for the patient for supervised consumption.
  • The next day another member of staff printed the label for methadone for this patient from the Patient Medication Record on the computer.
  • The pharmacist gave evidence that on the pre-printed label she saw 90mls, looked at the prescription but didn't read it properly, so again supplied 90mls to the patient.
  • The pharmacist presumed that it was a seven day prescription and continued to dispense 90mls to the patient for the next three days (5 days in total).
  • As soon as the pharmacist realised the mistake she contacted the patient’s doctor to inform them.

Important Learnings

Learnings from this complaint should be shared with all staff members.  You should review your pharmacy’s policies and procedures which relate to the methadone treatment service, as well as your own practice, to help ensure a similar incident does not happen in your pharmacy.

This complaint highlights the following important learning points:

  • There should be written policies and procedures in the pharmacy for all aspects of the methadone treatment service.  Following clear procedures ensures consistent performance of a task to the required level and ensures that the system is as robust as possible.
  • A procedure should be in place for patient’s that are initiating treatment with methadone and/or receiving methadone from your pharmacy for the first time.  This should include details of what documentation to check to ensure that the correct patient has presented at the correct pharmacy, information for the patient with regard to how the service works, relevant contact details, and counselling on the proper use and storage of methadone, as well as any other relevant information specific to your pharmacy, for example the opening times of the pharmacy, any days that the pharmacy is closed etc.
  • It is important that all relevant staff members, and any locum pharmacists that will be providing this service, are trained on and following the pharmacy’s procedures so that patients are provided with a safe and consistent service.  If you are new to a pharmacy or work as a locum pharmacist you have a responsibility to ask for, and familiarise yourself with, the procedures of the pharmacy.
  • All patients receiving methadone for opioid dependence must be registered on the Central Treatment List and assigned to a specific pharmacy. Where a new patient has been assigned to your pharmacy, all relevant staff members should be made aware of when the patient is expected to start treatment.  
  • When you are not familiar with a patient you must always confirm the patient’s identity before dispensing methadone to them by requesting photographic ID and/or referring to their treatment card which should be easily accessible in the pharmacy.
  • Daily dosing is a potential area for complacency, when dispensing an instalment from a methadone prescription you must always check the dose against the original prescription. Dispensing methadone from a dispensing label or the Patient Medication Record (PMR) often compounds an error made on the first dispensing. At any time a patient’s dose may change, therefore you must confirm the dose at each dispensing and not assume that you know their dose.  
  • Methadone is a very high risk medicine and has well known toxicities that are dose dependent, and can be fatal. You have a responsibility to ensure that this medicine is dispensed and supplied safely, therefore extra vigilance is needed when dispensing this medicine. Where at all possible this should include an accuracy check by a second member of staff to confirm that the dispensing label and quantity dispensed matches the quantity prescribed.
  • The pharmacist should also verbally confirm the methadone dose with the patient before supplying it to them, this provides a final check of the dose and helps the patient to be informed about their treatment.  
  • An error log should be completed for all errors made in the pharmacy, and the staff members involved should be informed of the error. Recording errors should not be used as a way to blame individuals, but rather to encourage an environment of openness and learning, so that procedures can be reviewed and amended, and practices changed to guard against similar errors happening again.
  • The PSI has produced Guidance for Pharmacists on the Safe Supply of Methadone and Inspectors' Advice on Balance Checks and Reconciliation in relation to Methadone Products which may also help you to review your practice.

The Professional Conduct Committee (PCC) heard a complaint in which a patient had been supplied with the High Tech medicine Enbrel® (etanercept) 50mg solution for injection, without a valid prescription on multiple occasions over a 14 month period. This contributed to a situation where the patient did not attend clinical review with their Consultant Rheumatologist for over 2 years. This was brought to the attention of the PSI by a HSE primary care pharmacist and the patient’s Consultant Rheumatologist. As a result, the PSI initiated an investigation into the pharmacy, to review the documentation relating to the supply of Enbrel® to this patient, and the general systems that were in place in relation to the dispensing of Enbrel® generally.

  • The Authorised Officer's investigation led to a review of the relevant prescriptions at the pharmacy, which identified that two pharmacists had supplied the patient with Enbrel® 50mg injection after the expiry date of the last prescription issued by the Consultant Rheumatologist.  This resulted in the supply of this medicine on 11 separate occasions over a 14 month period, without a valid prescription or any clinical review.    
  • The Authorised Officer noted that the last valid prescription authorising the supply of Enbrel® 50mg injection for the patient was not endorsed, as required by the legislation.  If this requirement had been followed it would have assisted the pharmacists in identifying that the prescription was not in date and that the patient required a clinical review.
  • During the investigation the Authorised Officer requested to review the prescriptions used to authorise eight supplies of Enbrel® to other patients.  Seven of the eight prescriptions retrieved and presented for review were not endorsed to show the date and quantity of supply to the patient, as required by the legislation.

Important Learnings

The PSI is very concerned about the number of complaints raised involving the incorrect supply of High Tech medicines, and in particular the supply of Enbrel®, leading to potential harm to patients.  This issue has been highlighted to pharmacists on numerous occasions along with PSI guidance on Good Dispensing Practice for the High Tech Scheme.

If you are a superintendent or supervising pharmacist, we urge you to review this area of practice in your pharmacy regarding the safe supply of medicines to patients, under the High Tech scheme.  You should review your pharmacy procedures for dispensing and supply of High Tech medicines and ensure everyone in the pharmacy is in compliance of such procedures.  All pharmacists should ensure that they are clear on the requirements of the High Tech scheme, the contents of the PSI guidance and ensure that these medicines are handled and dispensed with due care and safety to their patients.  

We would like to highlight the following important learnings from this inquiry:

  • When dispensing a medicine from a repeat prescription it must be checked against the original prescription at each dispensing to ensure the prescription is legally valid and remains therapeutically appropriate for the patient. Carrying out this check will also ensure any errors made on the initial dispensing are identified and not repeated.
  • During the inquiry, it was highlighted that a note specifying the date of review for the last valid High Tech prescription was included in the comments box on the Patient Medication Record, however this was not picked up on at the point of dispensing.  Information recorded in the Patient Medication Record can provide useful notes and reminders about a patient’s care, however this can easily be missed and should not solely be relied upon for continued supply. You are personally responsible for ensuring each supply of medicine you make has been authorised by an appropriate prescriber and is therapeutically appropriate for the patient.
  • A prescription issued for a High Tech medicine is subject to the same legal controls as any other prescription. The maximum validity period for any prescription issued (excluding schedule 2 and 3 controlled drugs) is six months from the date of issue. This ensures that the patient receives ongoing clinical review at appropriate intervals and is central to ensuring the safe use of these medicines.  Some High Tech prescriptions may specify an earlier date of patient review and care must be taken to ensure the prescriber’s instructions are correctly interpreted and followed. A prescription dispensed outside its expiry date can result in the patient not receiving the necessary clinical review, which could potentially result in harm to the patient.
  • Where a patient requests a High Tech medicine without a valid prescription or past the validity period of a prescription, the pharmacist should first contact the consultant responsible for the patient's care to check if the patient needs to be reviewed and continuation of treatment is intended. If this is not possible, the patient’s GP should be contacted.  All relevant interactions should be documented in full.
  • The need to have a valid prescription for each supply should be highlighted to the patient, to ensure their understanding of the legal controls that are in place and the need for their condition and medication to be reviewed by either their consultant or GP on a regular basis.
  • It was noted that a Standard Operating Procedure (SOP) on ‘dispensing’ was in place in the pharmacy at the time the supplies were made. It provided that all prescriptions must be assessed for any legal and clinical issues prior to dispensing to ensure that the medication is clinically appropriate for the patient and legally valid. It is apparent that this procedure was not followed at the time of dispensing Enbrel® to this patient or it would have been identified that the prescription was expired. SOPs should be followed at all times to ensure that a process is carried out to a consistently high standard by all staff members involved, in line with legislation and good practice, and to minimise the risk of errors.
  • Dispensing procedures in place in your pharmacy should specifically address the particular requirements for supply of High Tech medicines.  The superintendent and supervising pharmacist are responsible for ensuring that staff involved in the supply of medicines under the High Tech scheme are trained on the relevant procedures. Training records should be maintained to document this.
  • Regulation 7 of the Medicinal Products (Prescription and Control of Supply) Regulations 2003 (as amended) requires that where a prescription is dispensed in part, the person who dispenses it shall record on the prescription the quantity of each product supplied, the date of supply and the name and address of the pharmacy where the prescription was supplied. Regulation 7 also requires that where the dispensing of a prescription has been completed in full, the person who dispensed it shall write or print prominently the word “dispensed” on the prescription.  As well as being a requirement of legislation, this provides a hard copy audit trail for the supply of the medicine for you and your colleagues.  This also provides an opportunity to confirm the prescriber’s directions and the validity of the prescription as well as identify an error made on a previous dispensing. This is an important part of the overall structure and control of the supply of prescription-only medicines and should not be ignored.  
  • An error log must be completed for all errors made in the pharmacy, the staff members involved informed of the error, and appropriate follow-up regarding the patients care provided. Recording errors should not be used as a way to blame individuals, but rather to encourage an environment of openness and learning, so that procedures can be reviewed and amended, and practices changed to guard against a similar error occurring again.

Further reading to help you review your practice:

The Professional Conduct Committee (PCC) recently heard a case in which a minor was supplied with twice the prescribed dose of their medicine Enbrel® (etanercept) solution for injection, over the course of approximately one year. It was clear from the detail of the case that the pharmacist had dispensed the medicine in error from the original prescription. This error was repeated in the subsequent supplies as the patient medication record (PMR) was referred to rather than checking or endorsing the original prescription. When a second prescription was received, the wrong dose was still supplied to the patient for a further 6 months. The error was only realised when a third prescription was presented at the pharmacy in respect of the same patient. The pharmacist then informed the patient’s parent of the error. The inquiry heard that the pharmacist did not inform the superintendent for the pharmacy of the dispensing error, or the patient’s GP or treating consultant that the patient had received an overdose of their medicine for 11 months.

The superintendent pharmacist learned of the dispensing error through queries subsequently raised by the patient’s parents approximately 2 months after the error was discovered. However, the superintendent pharmacist also did not inform the patient’s GP or treating consultant of the dispensing error and the consequential overdose the patient had received.

Important Learnings

The case highlights learnings for all pharmacists in ensuring safe supply of medicines:

  • The original hard copy prescription must be clinically reviewed by the pharmacist before each dispensing. It is a core professional role of the pharmacist to perform a pharmaceutical and therapeutic review of all prescriptions dispensed to ensure the medicine is safe and appropriate for the patient to take. This is a requirement for each supply of a medicine and should be given due time and concentration for every patient, and at each dispensing.
  • A thorough and robust checking mechanism must be in place when dispensing medicines. To minimise the risk of human error a double check system must be in place where at all possible, this should involve two members of staff in the dispensing process. If the pharmacist is working on their own, they should ensure that they have a mental break between the assembly and labeling of the medicine and doing the final check, to reduce the risk of errors. Particular attention should be paid to sound-alike, look-alike drugs and different strengths of the same drug.
  • When dispensing a medicine from a repeat prescription it must be checked against the original hard copy prescription. Dispensing a medicine from the PMR on the computer risks compounding or perpetuating an initial dispensing error.
  • A repeat prescription should be endorsed with each supply recorded. This is a legal requirement that allows the supplies to be recorded on the prescription and provides an opportunity to check the original prescription, confirm the prescriber’s directions and the validity of the prescription, as well as identify an error made on a previous dispensing. It also provides a hard copy audit trail for the supply of the medicine for the patient, you and your colleagues
  • The way a pharmacist handles a medication error has a direct effect on the patient, and also affects the likelihood of another medication error occurring at the pharmacy. When you discover an error, whether it is an error made by you or by someone else, it is vital that you take immediate action to minimise harm to the patient. Whilst the actions you take will depend on the incident, ensuring the health and wellbeing of the patient must be your first priority. This must include contacting the patient (or their parent or carer as appropriate) to inform them of the error and any necessary actions they need to take to minimise the potential harm, for example seeking immediate medical review. You must be satisfied that the patient understands what has happened, the potential effects and what they need to do next. You should also contact the relevant healthcare professionals involved in the patient’s care to inform them that the patient has received treatment different to that prescribed, and discuss any potential harm to the patient, any consequences for the patient outcomes and any monitoring or other actions needed.
  • It is important that a pharmacy has an error management procedure for recording and reporting errors and near misses which sets out how and where they should be recorded and who should be contacted in the event of an error happening. This allows the pharmacy to ensure that errors and near misses are recorded and reviewed regularly and any procedures are revised and updated so that other patients can be protected from harm from similar incidents. PSI have issued advice on medication error management which should be consulted for further details.

Further reading to help you review your practice:

 

The Professional Conduct Committee (PCC) heard a complaint in which a patient had been supplied with the high tech medicine Revlimid® without a valid prescription and not in compliance with mandatory procedures required by the marketing authorisation.

  • The PSI received a complaint from a consultant haematologist stating that the correct procedure to dispense Revlimid® (lenalidomide) had not been followed by the community pharmacy. These procedures are a requirement of the product’s marketing authorisation to reduce the serious risks associated with this drug. The consultant expressed her concern about patient safety because she was aware of a separate recent incident in which a community pharmacy had dispensed Revlimid® to one of her patients, without any of the appropriate documentation being completed.
  • This came to the consultant’s attention when the patient failed to collect the high tech prescription and the prescription authorisation form from the hospital. A prescription authorisation form is required alongside a valid prescription to order Revlimid® from the wholesaler, as per the requirements set out in the ‘Healthcare Professional’s Information Pack produced by the Marketing Authorisation Holder, Celgene.
  • Two pharmacists were the subject of this inquiry. The supervising pharmacist at the time the incidents took place accepted that he supplied Revlimid® on five occasions without a valid prescription. The second pharmacist involved in this complaint accepted that she supplied Revlimid® on one occasion without a valid prescription. 
  • Both pharmacists accepted that over the period of one year they failed to comply with Celgene’s requirements set out in the ‘Healthcare Professional’s Information Pack for Ireland’, including failing to keep the prescription authorisation forms. 
  • The supervising pharmacist stated in his evidence that he was not aware of Celgene’s requirements regarding supply of this product. 
  • He gave evidence that the patient, who was a man in his 60s, had been prescribed this medicine previously and would have been familiar with the medicine, the dosage cycles and the strength he was on. 
  • The second pharmacist had previously acted as the supervising pharmacist for the pharmacy and as such she had completed the training and documentation required by Celgene. In her evidence she stated that on the occasions when the patient presented without a prescription and/or the prescription authorisation form she dispensed the medication as she did not want the patient to break the cycle of chemotherapy, and took the patient at his word that his treatment and course of therapy had not changed.

Important Learnings

Learnings from this complaint should be shared with all staff members. You should review your pharmacy’s policies and procedures which relate to the high tech scheme, and in particular Revlimid® if you have a patient receiving this medicine. You should also review your own knowledge and practice, to help ensure a similar incident does not happen in your pharmacy.

We would like to highlight the following important learnings from this inquiry:

  • Revlimid® is authorised by the European Medicines Authority for the treatment of patients with multiple myeloma. It is structurally related to thalidomide, a known human teratogenic substance that causes severe and life-threatening birth defects. If Revlimid® is taken during pregnancy, a teratogenic effect of Revlimid® in humans is expected.
  • Given the potential serious risks associated with Revlimid®, its marketing authorisation requires additional safety controls to be in place for its supply, including a pregnancy prevention programme. The requirements of this programme must be followed in addition to the normal legal requirements for supply of a high tech medicine.
  • These controls include a requirement that:
  1. all pharmacies must register with Celgene in order to obtain a supply of Revlimid®,
  2. pharmacists must ensure that they have read and understood the ‘Healthcare Professional’s Information Pack for Ireland’ before dispensing Revlimid® to any patient, 
  3. every prescription for Revlimid® must be accompanied by a prescription authorisation form, which has been completed by the prescriber to confirm that the patient has been counselled about the teratogenic risk of treatment with Revlimid®,
  4. the pharmacist should not order or dispense Revlimid® until he/she has received both the prescription authorisation form and a valid prescription for Revlimid®
  5. the pharmacist signs the prescription authorisation form to show that he/she is satisfied that the authorisation form has been completed in full by the prescriber, dispensing is taking place within 7 days of the date of the prescription and that he/she has read and understood the contents of the ‘Healthcare Professional’s Information Pack’, and 
  6. every prescription authorisation form is kept in the pharmacy for a minimum of two years.
     
  • Both women and men must be counselled before initiation of therapy and throughout, to ensure that the appropriate precautions are taken to prevent pregnancy.
  • As gatekeepers to medicines it is of vital importance that all pharmacists follow the legislation and procedures in place, to ensure the safe supply of this medicine and reduce the risk of harm.
  • The need to provide the pharmacy with a valid prescription and the prescription authorisation form, before Revlimid® can be ordered, should be emphasised to the patient to ensure their understanding of the controls in place and that they receive their medicine in time to start their next cycle. 
  • If the prescribing doctor has not completed the prescription authorisation form the medicine should not be ordered by or supplied from the pharmacy.
  • It is important to reinforce the potential toxicities of this medicine to the patient at each dispensing, and that care must be taken in safeguarding this medication when it is in their own possession. 
  • As a pharmacist it is your responsibility to ensure that you are knowledgeable on the medicines that you are supplying to patients, and this is particularly important for high tech medicines. The marketing authorisation holder will often provide training materials for healthcare professionals or you can review the product’s Summary of Product Characteristics (SmPC), available on the Health Products Regulatory Authority’s (HPRA) or European Medicine Agency’s website. This is necessary to carry out your legal and professional responsibilities to therapeutically review the prescription and provide counselling to the patient. You should not assume that a colleague or another healthcare professional has provided adequate counselling to the patient and you should always confirm the patients understanding of what you have told them. 
  • Patients on Revlimid® are generally reviewed on a monthly basis to assess clinical response and side effects or toxicities, which can lead to changes to the medicines dosage. Therefore, you must review the current, in date prescription to confirm the correct strength and dosage instructions for the period of supply. 
  • When these incidents occurred there was a standard operating procedure (SOP) in place within the pharmacy specific to the ordering, storage and dispensing of drugs under the high tech scheme. This SOP highlighted that pharmacists must ensure that the prescription authorising supply is valid for each and every dispensing and each prescription must be stamped at the time of dispensing and endorsed by the pharmacist who performed the final check. However, from the actions of the pharmacists it is clear that this was not being followed, as if it had been this poor practice would not have occurred. SOPs should be followed at all times to ensure that a process is carried out to a consistently high standard by all staff members involved, in line with legislation and good practice and to minimise the risk of errors.
  • If you have a patient who has been prescribed Revlimid® there should be a SOP in place in your pharmacy that specifically addresses the requirements for supply of this medicine. All relevant staff members should be trained on this SOP to ensure that they are following it and understand the patient safety reasons for the controls that are in place. Training records should be maintained to document this. 
  • An error log must be completed for all errors made in the pharmacy, the staff members involved informed of the error, and appropriate follow-up regarding the patients care provided. Recording errors should not be used as a way to blame individuals, but rather to encourage an environment of openness and learning, so that procedures can be reviewed and amended, and practices changed to guard against a similar error occurring again.

Further reading to help you review your practice:

The Professional Conduct Committee (PCC) heard an inquiry into a complaint which had been made in 2018 in which a parent had been supplied with a controlled substance, Diazepam 2mg/5ml oral solution, for their child.

While the medicine supplied was labelled with the correct dosage the duration of treatment had not been clearly specified on the dispensing label. This resulted in the child receiving Diazepam over a period of five weeks, instead of for three days as intended by the prescriber.

  • The parent presented a prescription for the child to the pharmacy which read: ‘Diazepam 2.5mg BD PRN. PO,3/7’. Instructions on the prescription stated that it was to be taken twice daily for three days.
  • The pharmacist dispensed a 100ml bottle of Diazepam 2mg/5ml oral solution and labelled the bottle “6.25MLS TO BE TAKEN TWICE DAILY AS REQUIRED”, with no limit of three days clearly specified on the label.
  • The pharmacist gave evidence before the PCC of having verbally advised the child’s parent that the Diazepam should only be administered for three days.
  • The child’s parent stated that they had no recollection of being informed by the pharmacist that the medication should be administered for a period of three days.
  • The pharmacist gave evidence that they did not want to decant 37.5 ml from the 100ml bottle for fear of compromising the integrity of the product. The pharmacist stated that they had instead carried out a calculation to determine how much of the oral solution of Diazepam required to be administered in order for the dose of 2.5mg to be administered, they also checked the British National Formulary for Children (BNF for Children) to ensure appropriate dosage. The pharmacist however had failed to include the duration of treatment on the dispensing label.
  • The error was identified when the child was admitted to hospital for one day with behavioural issues which were thought likely to be secondary to withdrawal from medication taken on and off over a period of five weeks.

Important Learnings

Learnings from this complaint should be shared with all staff members and standard operating procedures (SOPs) should be reviewed to mitigate the risk of a similar incident in your pharmacy.

This complaint highlights the following important learning points:

  • Prior to the dispensing of each prescription, pharmacists have a legal obligation to review the pharmaceutical and therapeutic appropriateness of the medicine therapy for the patient. The pharmacist must also ensure that the patient and/or their carer/guardian have sufficient information and advice for the proper use and storage of the medicine.
  • Following the pharmaceutical and therapeutic review, if the pharmacist has concerns with regard to the content of the prescription, they should discuss these with the prescriber. If the prescriber cannot be contacted, consider what other options are available to clarify any queries on the 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.
  • Children and infants are particularly vulnerable to drug overdose and side effects. It is essential that extra time and care is taken to ensure not only that the correct medicine is supplied and the parent/carer has accurate and detailed information regarding dosing amount, but that the frequency and duration of treatment is also clearly labelled on the medicine and easily understood by the patient and/or their carer/guardian. Pharmacists should not rely solely on oral advice when labelling significantly reduces the risk of misunderstanding.
  • A thorough and robust checking mechanism must be in place when dispensing medicines. To minimise the risk of human error a double check system must be in place where at all possible, this should involve two members of staff in the dispensing process. If the pharmacist is working on their own, they should ensure that they have a mental break between the assembly and labelling of the medicine and doing the final check, to reduce the risk of errors.
  • SOPs should always be followed to ensure that a process is carried out consistently, accurately and completely by all staff members involved, in line with legislation and good practice and to minimise the risk of errors.

Further reading to help you review your practice:

On 27 and 29 September 2021 the Professional Conduct Committee (PCC) completed an Inquiry into a complaint made by the Registrar of the PSI which arose from a social media post made by a pharmacist in May 2018. The post was made in response to an online thread related to the referendum on the 36th amendment of the Constitution (“the abortion referendum”) which took place in May 2018.

In the course of the post, the pharmacist expressed their views regarding termination of pregnancy services and commented on the role of pharmacists including that in relation to supplying medication for the termination of pregnancy services. Furthermore, the pharmacist expressly identified themselves as being a pharmacist in stating their views.

The complaint of the Registrar had centered not on the substance of the pharmacist's views, but rather the manner in which those views had been expressed. The Committee found that the pharmacist, in posting a social media comment in which they identified themselves as a pharmacist, had used language to express their views on the issue of the termination of pregnancy services/abortion and/or the role of a pharmacist in the termination of pregnancy services, including in relation to the supply of medicines for the termination of pregnancy, which was inflammatory and/or inappropriate. The Committee found that as a result, the pharmacist was guilty of professional misconduct in that they had acted in a manner that was infamous and/or disgraceful in a professional respect and that they had breached Principle 4 of the Code of Conduct for Pharmacists (2009 version)*.

The Committee drew particular inference from the pharmacist identifying themselves as such and felt that expressing those views as a pharmacist was inappropriate and also in conflict with the PSI Guidance for Pharmacists on the use of Digital and Social Media and the PSI Code of Conduct for Pharmacists.

The Committee accepted in full the evidence of the expert witness called by the Registrar and found the following opinion to be particularly persuasive:

“The actions of pharmacists online are held to a higher standard of accountability by the public. [The pharmacist] identifies [themselves] as a pharmacist and as a result [their] online comments must be considered through the prism of the PSI Guidance for Pharmacists. In particular, it must be considered if [their] comments damage the good name of the pharmacy profession”

and

“Professionals have ethical standards that demand ‘more than conventional morality and law’. The guidance that currently applies governing the use of social media by pharmacists is in place to ensure that their online activity is consistent with their professional role. However, pharmacists must be cognisant of the fact that comments made in the heat of the moment on social media can have serious and unexpected repercussions. This is why it is important to separate online professional and private profiles and interactions.”

The Committee noted that professional misconduct can arise through the use of social media and that it is potentially damaging to society if it undermines pharmacists, who are at the forefront of healthcare provision. The Committee noted that such damage can be inadvertent and there was no evidence that the pharmacist in this case had set out to undermine the profession. The Committee felt however that the manner in which the pharmacist’s views were expressed introduced the potential to damage the good name of the profession in the eyes of the public.

Learning Outcomes

This case highlights the risks which can arise when expressing views over social media. Pharmacists are reminded that if expressing personal views in a public context, particularly in important or socially sensitive subjects, they should do so in a manner that is consistent with PSI Guidance on the Use of Digital and Social Media and the Code of Conduct for Pharmacists. They should also ensure that any commentary is not damaging to the reputation of, and confidence in, the profession, and does not create a risk to public health & safety. Pharmacists should take care also in respect of the manner in which they express their personal views or opinions in a public domain such as social media, particularly where they identify themselves as a pharmacist.

The PSI Guidance for Pharmacists on the use of Digital and Social Media aims to ensure that pharmacists are cognisant of their responsibilities to ensure that their online activity is consistent with their professional role.

Key points, as set out on page 2 are as follows:

  • Interactions through digital and social media are subject to the same professional standards and ethical considerations as other personal or public interactions.
  • Consider how best to separate your online professional and private profiles and interactions.
  • Preserve patient confidentiality and privacy.
  • Ensure that all information posted online is appropriate for the audience that can access it and the location in which it is posted.
  • Evaluate health information for quality and accuracy before posting online.
  • Develop policies for the professional management of digital and social media.

In conclusion, pharmacists should remember:

  • The important distinction between the personal and professional views of the pharmacist.
  • How the pharmacist as a professional is perceived when using social media, even from a personal account.

Guidance Documents

The guidance documents referenced above are accessible at the following links:

*Principle 4 of the Code of Conduct for Pharmacists, 2009 stated as follows: ‘A pharmacist must conduct himself/herself in a manner which enhances the service which their profession as a whole provides to society and should not act in a way which might damage the good name of their profession”

In March 2022 the Professional Conduct Committee (PCC) completed an Inquiry into a complaint about the supply of an antibiotic, (clarithromycin 500MG) (‘Klacid® Forte’) to a 77- year-old female patient in circumstances where the patient was also taking warfarin.

The potential for interaction between clarithromycin and warfarin was not discussed between the pharmacist and the family members of the patient who collected the medication on behalf of the patient, and therefore, alternative therapies were not considered, nor was increased monitoring of the patient’s international normalised ratio (INR) put in place.

Following the supply and use of the antibiotic, the patient’s INR increased significantly, and she was admitted to hospital a week later. The patient had been experiencing a range of other serious health conditions, including chronic kidney disease, congestive heart failure, and she subsequently died in hospital.

There was no evidence at the Inquiry that the supply of medication and consumption thereof was the cause of death, or that the conduct of the pharmacist was responsible for the patient's death. Nonetheless, the Inquiry gave cause to identify a range of issues, mostly related to the need for extra care and counselling in relation to the supply of these medicines. In this case, whilst standard operating procedures within the pharmacy had highlighted the need for patient counselling “whenever possible”, on this occasion the prescription, although prepared by the pharmacist, was handed out by an assistant without any counselling being provided to the patient’s husband by the pharmacist.

The following issues were highlighted in particular:

i. the importance of offering counselling to patients or their representatives on the potential for drug-drug interactions between clarithromycin and warfarin;

ii. the necessity for the patient to be advised, if taking these medicines, to have increased frequency in monitoring of the INR when taking both clarithromycin and warfarin;

iii. the importance of consulting with the patient’s prescribing doctor prior to the dispensing of clarithromycin about:

a. the potential for drug-drug interactions between clarithromycin and warfarin

b. whether any better alternative antibiotic is appropriate

c. any action which should be taken if an interaction were to occur

d. the necessity for the patient to have the INR checked more frequently while taking both clarithromycin and warfarin

Important learnings

  • This complaint highlights the importance of effective counselling of patients by pharmacists in relation to the supply of medicines, particularly high-risk medicines with a high potential for interaction.
  • It also highlights the importance of proactive communication with prescribers to ensure that, if appropriate, an alternative medicine is prescribed, relative to the patient’s medical history and current health circumstances.
  • It further acts as a reminder of the importance of ensuring that all staff are aware of the importance of counselling patients and of knowing when to refer to the pharmacist as required. Relevant standard operating procedures (SOPs) should be reviewed to ensure there is sufficient clarity on the importance of counselling being offered to reduce the risk of a similar incident occurring in the future. Further guidance is available in the PSI Guidelines on the Counselling and Medicine Therapy Review in the Supply of Prescribed Medicinal Products from a Retail Pharmacy Business.
  • All Pharmacists should be reminded that they must counsel patients on their medicines, including the potential for a new drug to interact with existing medication, particularly for medicines which have a high risk of interaction, like warfarin. In accordance with the PSI Guidelines on the Counselling and Medicine Therapy Review in the Supply of Prescribed Medicinal Products from a Retail Pharmacy Business, the pharmacist should hand out all prescriptions where possible.
  • As stated in the PSI Guidelines on the Equipment Requirements of a Retail Pharmacy Business, all pharmacies:

“…must have a Drug Interaction Alert functionality as part of its computer dispensing system as well as an up to date hard copy and/or access to an online edition of an appropriate Interactions publication such as Stockley’s Drug Interactions (Ed. Stockley) (Pharmaceutical Press), Medscape Drug Interaction Checker (Online www. medscape.com). The interactions alert functionality should not be disabled during dispensing and the superintendent and supervising pharmacist must ensure the appropriate alert setting is activated.”

  • If the pharmacist has any reservations about potential interactions with the patient’s other medication, they should always contact the prescriber to discuss their concerns and discuss options for suitable, safer alternatives.
  • SOPs should highlight how the risk of therapeutic interactions with the patient’s existing medications are identified and managed in the appropriate manner as part of the dispensing process.
  • Warfarin is a ‘red flag’ medication with a significant potential for interaction with a range of other medicines. All staff within the pharmacy involved in the dispensing and supply of medicines should be aware that extra care is needed when warfarin is dispensed. Any time a new medication is prescribed alongside warfarin, there should be a check for any potential interactions. Pharmacists should check that a patient who is prescribed an additional medication when they are already taking warfarin has appropriate monitoring of their INR in place. They must also be counselled to be vigilant for signs of harmful side- effects that indicate their INR is not within the appropriate/targeted range.
  • Clarithromycin is a frequently prescribed antibiotic, that interacts with many commonly used medicines with a significant potential to cause patient harm. As it is also a high-risk medicine, extra vigilance and a thorough clinical review of the prescription as well as patient's medical history are needed when dispensing clarithromycin. The HSE PCRS have issued tips on safer use of clarithromycin.

Further reading to help you review your practice