Names have been removed to protect privacy. Identifying letters are assigned in alphabetical order and bear no relationship to the person’s actual name.

 

A Decision by the Deputy Health and Disability Commissioner

 

 

Introduction

Background — initial complaint

Information gathered during investigation. 2

Opinion: Mr B — breach. 5

Opinion: Ms D — adverse comment. 7

Opinion: Pharmacy — adverse comment. 7

Changes made since events. 8

Recommendations. 10

Follow-up actions. 11

Appendix A: Standard Operating Procedures at the time of events. 12

Appendix B: Revised Dispensing 2 SOP. 23

 

 

Introduction

1.               This report is the opinion of Dr Vanessa Caldwell, Deputy Health and Disability Commissioner, and is made in accordance with the power delegated to her by the Commissioner.

2.               The report discusses the care provided to Mrs A by Mr B at a pharmacy on 27 May 2022 when Mrs A was dispensed incorrect medication.

3.               The following issues were identified for investigation:

·     Whether Mr B provided Mrs A with an appropriate standard of care on 27 May 2022.

·     Whether the pharmacy provided Mrs A with an appropriate standard of care on 27 May 2022.

4.               The parties directly involved in the investigation were:

Mrs A                                                                    Consumer/complainant

Mr B                                                                      Pharmacist

Pharmacy

5.               Further information was received from Mr C, the owner and director of the pharmacy and Ms D, a pharmacy technician at the pharmacy. Ms E (a pharmacist at the pharmacy, and the previous owner of the pharmacy) is also mentioned in the report.

Background — initial complaint

6.               On 27 May 2022 Mrs A visited the pharmacy to collect her prescription for Provera[1] and clomiphene[2] (as prescribed by a doctor at a fertility clinic). Clomiphene was prescribed to be taken starting on ‘day 3 of [Mrs A’s menstrual] cycle’.

7.               Mr B was the pharmacist on duty who processed Mrs A’s medication, with the help of Ms D, the pharmacy technician who dispensed the medication. Mrs A collected her medication from Mr B, but when she returned home that day, she noticed that she had received clomipramine[3] instead of clomiphene. Mrs A called the fertility clinic, who confirmed that Mrs A had received the wrong medication.

8.               Mrs A returned to the pharmacy the next day (28 May 2022) and raised the error with Ms E, who acknowledged and apologised for the error, directed Mrs A to a different pharmacy to receive the correct medication (as the pharmacy had insufficient clomiphene in stock), and processed a refund. Mrs A did not consume any of the prescribed clomipramine.

Information gathered during investigation

Standard dispensing process

9.               The standard process for dispensing medications at the pharmacy at the time of the events is set out in the pharmacy’s Standard Operating Procedures[4] (SOPs) (see Appendix A). Of particular note:

·     When the pharmacist enters prescription details into the computer, an accuracy and clinical check should be carried out before the medication label is prepared or dispensing occurs. This includes checking the dosages, quantities, and clinical appropriateness of any medication. Any changes or differences should be investigated and confirmed with the patient and/or prescriber.[5]

·     When dispensing medicines, the name, brand, strength, and formulation should be checked against the prescription, as opposed to the label. Labels should then be double checked against the original prescription before attaching to the container.[6]

·     At the final accuracy check stage, the pharmacist should check the label and dispensed medicine against the original prescription and the stock supply used to dispense the medicine, noting the prescriber, instructions for use, and formulation. Self-checking is not recommended, but if self-checking cannot be avoided, the ‘physical’ and ‘mental’ activities should be separated by another task.[7]

·     When handing the medication to the patient, pharmacists should use ‘check-back’ questions to ensure that the patient understands the purpose and reasons for use for each medicine, and any changes, such as altered formulation.[8]

·     In the case of a dispensing error detected and reported after the medication has left the pharmacy, the pharmacist should seek to correct the error immediately, replace the incorrect item, and apologise to the patient. An Incident Form should be filled in and the Pharmacy Defence Association should be contacted.[9]

Dispensing error (27 May 2022)

10.             Mr B and Ms D were the staff directly involved in dispensing Mrs A’s prescription on 27 May 2022. Mr B qualified as a registered pharmacist in 2021 and began working as a full-time registered pharmacist at the pharmacy. Ms D had several years’ experience as a pharmacy technician and qualified as a pharmacy accuracy check technician (PACT) in 2018. Ms D began working at the pharmacy in 2020 and was working in the role of pharmacy technician at the time Mrs A’s prescription was dispensed. Ms E was the other pharmacist present at the pharmacy on both 27 and 28 May 2022.

11.             Mrs A’s prescription was sent by the fertility clinic and received by the pharmacy at 11.25am on 27 May 2022. The prescription requested 10 tablets of Provera 10mg, 1 tablet to be taken once daily, and 10 tablets of clomiphene 50mg, 1 tablet to be taken daily for 5 days, starting on day 3 of Mrs A’s menstrual cycle.

12.             Mr B told HDC that he processed the Provera tablets correctly, but misread clomiphene for clomipramine, and did not pick up on the error due to insufficient clinical and accuracy checking.[10] Mr B adjusted the dosage instructions and annotated a change in the quantity of the tablets to be dispensed from 10 clomiphene tablets to 20 clomipramine tablets (as clomipramine came in only 25mg tablets, and the prescription required a 50mg dose) without a thorough clinical check of the medication in context. Mr B acknowledged to HDC that it would be unlikely for the fertility clinic to prescribe clomipramine, and that on reflection, the short course of the prescription would be ‘unusual instructions’ for clomipramine.

13.             The error was ‘carried forward’ at the dispensing step by Ms D. Ms D told HDC that she noticed that the pharmacy label for clomipramine was different to the prescription, but incorrectly assumed that clomipramine was a new brand name for clomiphene, as she believed there had been a brand change some time previously. Ms D said that her error was in part because she read from the label, as opposed to the prescription, when selecting the medication from the shelf.

14.             A final accuracy check was carried out by Mr B at around 5.15pm on 27 May 2022 when Mrs A came to collect her medications. Mr B told HDC that he self-checked the medication as there were only two pharmacists present in the pharmacy at the time (Mr B and Ms E), and Ms E was ‘unavailable’.

15.             Mr B told HDC that although the ‘mental’ and ‘physical’ activities of the prescription were separated (by Ms D carrying out the dispensing of the medication), he accepts that there may have been an element of confirmation bias in his final check, as he had processed the prescription earlier that day, and he also felt pressured not to keep Mrs A waiting.

Subsequent events following dispensing error

16.             The pharmacy held a dispensary staff meeting on 30 May 2022 (at which both Mr B and Ms D were present) to discuss the events surrounding the dispensing error and implement preventative measures. These are set out below in the ‘Changes made’ section of this report.

17.             An Incident Notification Form was also completed and submitted to the Pharmacy Defence Association on 30 May 2022.

18.             The pharmacy provided HDC with a copy of an apology letter dated 17 June 2022 that Mr B told HDC he sent to Mrs A via post. However, Mrs A told HDC that she did not receive the letter, and she had ‘been at the same address for 3 nearly 4 years’.

19.             Mr B told HDC that he is ‘truly sorry’ for the error, and both Mr B and the pharmacy were surprised and sorry that Mrs A did not receive his apology letter.

Contributing/mitigating factors

20.             Of note, Mr B received his pharmacy qualification in 2021, which is when he first began working as a registered pharmacist at the pharmacy. The dispensing error occurred on 27 May 2022, five months into full-time work as a registered pharmacist.

21.             Mr B told HDC that on the day of the event there were three pharmacists rostered throughout the day, and pharmacy roles are rotated halfway through the day so that the ‘workload/mental load was spread, and that self-checking could be avoided’. He said that during the day, usually another pharmacist would be available to check prescriptions he had been involved with, but this could be difficult in the last half hour before closing if the pharmacy was busy.

Standard Operating Procedures (SOPs)

22.             The pharmacy provided HDC with the relevant Dispensing SOPs in place at the time of the dispensing error (see Appendix A). The pharmacy stated that there was no specific reference to ‘look-alike, sound-alike’ (LASA) medications in the Dispensing 2 SOP, as the final checking procedure is designed to identify dispensing errors regardless of whether or not the medication is a LASA medication. However, the Dispensing 2 SOP was revised in May 2022, for an ‘additional layer of protection’.[11] The pharmacy also began a complete revision of its SOPs in October 2023, aimed to be completed by February 2024.

Other relevant standards

23.             The Pharmacy Council of New Zealand’s Competence Standards for the Pharmacy Profession (2015) provides that a pharmacist ‘[m]aintains a logical, safe and disciplined dispensing procedure’, and ‘monitors the dispensing process for potential errors and acts promptly to mitigate them’.[12]

Responses to provisional opinion

Pharmacy

24.             The pharmacy was given the opportunity to respond to the relevant sections of the provisional opinion. The pharmacy told HDC that it wished to reiterate its apologies for what happened, and that ‘significant’ changes have occurred in light of this incident and resulting investigation.

25.             Mr C told HDC that it is his belief that the SOPs were kept up to date by the managing director at the time, but he accepts that the dates on the versions provided to HDC do not indicate this. The owner of the pharmacy also told HDC that in 2023 the pharmacy noticed that its SOP reviews and updates may not have been saved as expected on the online platform used to store its SOPs. The pharmacy confirmed that the fault was identified, the platform was disestablished, and a new SOP storage system is in place. The pharmacy confirmed that a new system is in place, and that all the pharmacy’s SOPs have been revised.

26.             The pharmacy confirmed that Ms D had the opportunity to respond to the relevant sections of the provisional opinion and had no comment to make.

Mr B

27.             Mr B was given the opportunity to respond to the relevant sections of the provisional opinion. He confirmed that he had no further comments to make in response.

Mrs A

28.             Mrs A was provided with the opportunity to comment on the ‘information gathered’ section of the provisional opinion and had no comments to make.

Opinion: Mr B — breach

29.             As a registered pharmacist, Mr B is responsible for ensuring that he provides services of an appropriate standard, including compliance with the professional standards set by the Pharmacy Council of New Zealand (PCNZ) and with the pharmacy’s SOPs.

30.             In a previous dispensing error case, HDC noted:[13]

‘It is a fundamental patient safety and quality assurance step in the dispensing process to adequately check the medication being dispensed against the prescription for accuracy. This involves checking that the correct medicine, dose, form, strength, and quantity is being dispensed …’

31.             At several points throughout the processing and dispensing process Mr B did not utilise the safeguards set by the pharmacy’s SOPs:

a)        Mr B did not carry out a complete clinical check on the prescription in accordance with the Dispensing 2 SOP. He told HDC that he did not consider the prescription in the context of the prescriber (the fertility clinic) and the dosage instructions (which were ‘unusual’ instructions for clomipramine).

b)        Mr B’s final accuracy check as required by the Dispensing 4 SOP was carried out with an element of confirmation bias and pressure from not wanting to keep Mrs A waiting, which affected the purpose of the final accuracy check.

c)         Mr B appears not to have discussed Mrs A’s medication with her in accordance with the Dispensing 5 SOP. If the purpose and reasons for use of the medication had been discussed, either Mr B and/or Mrs A may have realised that the wrong medication had been dispensed, as the purpose and reason for use of clomipramine and clomiphene are distinctly different.

32.             The pharmacy’s SOPs outline processes to minimise the risk of processing and dispensing errors occurring, and to identify and correct errors before the patient leaves the pharmacy with the medication. By not following the SOPs in his dispensing process, Mr B missed numerous opportunities to identify the error at an earlier stage, and to prevent the error in the final checking stage.

Conclusion

33.             Mr B’s lack of thorough checking meant that he did not identify the dispensing error at several stages of the dispensing process, despite the various checkpoints set out in the SOPs. Ultimately this led to the wrong medication being dispensed to Mrs A.

34.             I acknowledge that Mr B had been practising as a full-time pharmacist for less than a year when this error occurred. However, having completed all the requirements to be a registered pharmacist, Mr B had an obligation to meet and to be measured against the required standards of all other registered pharmacists. The assessment and checking steps are basic competencies required of a registered pharmacist, as set out by the Pharmacy Council.[14] I find that by not providing services that complied with professional standards, Mr B breached Right 4(2) of the Code of Health and Disability Services Consumers’ Rights (the Code).[15]

35.             I commend Mr B for taking full responsibility for his mistake, and for taking proactive steps to learn from this event and make appropriate changes to his practice (as set out in the ‘Changes made’ section below).

Opinion: Ms D — adverse comment

36.             Ms D was the pharmacy technician who dispensed Mrs A’s medication. Ms D told HDC that she did not follow Dispensing 3 of the SOPs, as she selected the medication from the shelf against the label, not against the prescription itself. She also accepts that she did not check her (incorrect) assumption regarding clomipramine being a new brand name for clomiphene with a pharmacist.

37.             Although ultimately under the supervision and care of the supervising pharmacist, Ms D played a key role and had a key responsibility in the dispensing of medication to Mrs A. All dispensary staff are responsible for adhering to the pharmacy’s SOPs, so it is equally Ms D’s responsibility to reduce error in areas that have already been identified by these SOPs (such as reading from the original prescription, not the pharmacy-generated label).

38.             Considering that Ms D is an experienced pharmacy technician with several years’ experience and holds an additional PACT qualification (although not working in this capacity at the time), I am critical that she did not complete a more thorough check, and that despite being aware of the importance of reading from the prescription (not the label), this did not occur in practice.

Opinion: Pharmacy — adverse comment

39.             First, I commend the pharmacy for taking prompt corrective action in line with PDA requirements and the SOPs as soon as it was alerted to the error.

40.             The pharmacy has an overall duty to ensure that its staff and processes support the provision of services to customers with a reasonable level of care and skill, and to an appropriate standard. This includes ensuring that pharmacy staff work in an environment conducive to safe, effective dispensing practice, and that the pharmacy’s policies facilitate safe dispensing and checking of medication.

41.             Although there were clear shortfalls by Mr B and Ms D, I consider that there may be areas for improvement in the pharmacy’s processes and policies.

42.             I question whether the pharmacy could improve its staffing arrangements to reduce instances in which self-checking occurs, and/or create more robust processes that reduce the element of confirmation bias that exists as a result of self-checking. Noting that the pharmacist in charge is responsible for Dispensing 4 of the SOPs, I am critical that a junior pharmacist such as Mr B was placed in an environment where self-checking had to occur, and question whether there can be improvements to the management of staffing and more support for, and oversight of, junior staff.

43.             The pharmacy told HDC that specific reference to LASA medication was not required in the SOP in May 2022, as the final checking procedure is designed to identify dispensing errors regardless of the nature of the error. However, considering that LASA medication is a well-recognised cause of medication errors,[16] I believe that specific guidance around look-alike sound-alike medication is prudent to have included. I am pleased that the pharmacy has since amended its SOPs and added warning labels to medications so that this potential source of error can be identified more readily.

44.             Guidelines set out by the PCNZ state that SOPs should be kept ‘up to date’ and reviewed at least once every two years.[17] I am critical that the pharmacy’s first review of its SOPs appears to have occurred five years after the date of issue, and in the case of Dispensing 5, seven years after the date of issue. The pharmacy told HDC that the SOPs were being updated at the time, but that the online platform used at the time may not have saved and stored updates and reviews to SOPs as expected. Without further evidence of such SOP reviews at the time, I consider it is difficult to make a finding on whether SOPs were reviewed within PCNZ timeframes. However, I consider that checking that updated SOPs are correctly loaded onto a system should form a part of the pharmacy’s review process. I remind the pharmacy of the importance of reviewing its SOPs regularly and ensuring that reviews are documented clearly. I am pleased that the pharmacy has a new SOP storage system and has revised its SOPs.

Changes made since events

Mr B

45.             Mr B told HDC that he has since reviewed his checking procedures and identified areas for improvement in the following ways:

a)        He has reviewed the importance of accuracy checks and clinical checks in his process, which includes checking the medication, strength, and instructions in the context of the prescription.

b)        He has adjusted his work practice by taking mental breaks, not carrying information from the processing stage into the checking stage, and slowing his checking procedure when under pressure.

c)         He has taken suggestions from pharmacist peers for a more robust checking procedure, such as underlining the medication name in syllables, reading the medication name out loud, and blocking off noise and creating an environment in which to focus.

d)        He has completed the Clinical Checking Workbook provided by the Pharmaceutical Society of New Zealand (PSNZ), applying the learnings of the Five Rights (right patient, right medication, right dose, right route of administration, right time to administer) to his practice.

e)        Currently he is working through another PSNZ course (Improving Accuracy in Your Dispensary) and has learned about including a four-way checking procedure: productàprescriptionàlabelà product.

Ms D

46.             Ms D told HDC that she has reviewed and identified the following areas of improvement in her practice:

a)        To check both the generic and brand names on the Toniq system[18] when in doubt about unfamiliar medicine names.

b)        To raise any changes, uncertainties, and assumptions with a pharmacist.

c)         To work from the prescription (not the label) in all future cases.

Pharmacy

47.             The following changes were identified at the dispensary staff meeting on 30 May 2022:

‘Clomiphene and Clomipramine tablets were previously stored next to each other … We have since separated both medicines and Clomiphene tablets are now stored in a designated shelf alongside with fertility/hormonal replacement therapy/contraceptive treatment.

Warning labels are affixed to the dispensary shelf … to prompt the dispensary staff to take extra care …

A warning note is now attached to both clomipramine and clomiphene in our computer, where a reminder note will appear … to double check the medication is correct against the prescription.

All dispensary staff have been reminded to take extra care when processing and dispensing medicines with similar sounding name.

If uncertain about brand changes, all pharmacy technicians are to discuss this with the pharmacist at the time of dispensing.

The Dispensing SOP has been further reviewed and amended to identify potential similar sounding medicines to be identified and tagged in the computer as an ongoing process.[19]’

48.             The pharmacy has also installed two robotic dispensary systems (Alpaca[20] and EV-54[21]) with the intention of improving accuracy and reducing error in medicine selection, and it has housed the top 54 dispensing prescription items to create more space on stock shelves, reducing the risk of picking closely stocked medications.

49.             As mentioned, the pharmacy also commenced a further revision of its SOPs in October 2023, with the aim of completing this by February 2024.

Recommendations

50.             I acknowledge that both Mr B and the pharmacy have already taken proactive steps to improve their processes and practice, such as reviewing and updating the SOPs, reflecting on and updating processes, and undergoing further education and training.

51.             I recommend that Mr B:

a)        Provide a formal written apology to Mrs A for the failures identified in this report. The apology is to be provided to HDC, for forwarding to Mrs A, within one month of the date of this report.

b)        Complete the PSNZ ‘Improving Accuracy in Your Dispensary’ course and provide evidence of completion (or an update) to HDC within three months of the date of this report.

52.             I recommend that Ms D:

a)        Reflect on the learnings from this report and report back to HDC on the changes made, within three months of the date of this report.

b)        Provide evidence of recent self-review of the SOPs, in particular the SOPs relating to dispensing processes, and provide HDC with evidence of that review within three months of the date of this report.

53.             I recommend that the pharmacy:

a)        Consider whether the SOPs should include guidance on how new/junior staff will be supported, and report back to HDC on this matter within three months of the date of this report.

b)        Provide HDC with a copy of the revised SOPs within three months of the date of this report, including information about the process for SOP implementation and how compliance and effectiveness of the SOP will be monitored.

c)         Conduct a random audit of dispensing and checking of medication of 20 prescriptions over a one-month period to assess compliance with the revised SOPs and provide HDC with a report on the findings within three months of the date of this report.

Follow-up actions

54.             A copy of this report with details identifying the parties removed will be sent to the Pharmacy Council of New Zealand, and it will be advised of Mr B’s name.

55.             A copy of this report with details identifying the parties removed will be sent to the Pharmacy Defence Association and placed on the Health and Disability Commissioner website, www.hdc.org.nz, for educational purposes.

 

 

Appendix A: Standard Operating Procedures at the time of events

 

STANDARD OPERATING PROCEDURE
Pharmacy Name
Subject	Dispensing 1 — Receive prioritise and validate prescription
Page	Document N°         C 34		Issue Date	27/09/15

Purpose: To ensure all required details on new prescriptions are checked and confirmed Responsible Person(s): Pharmacist—in-Charge

Procedure:

At the prescription receipt counter (dispensary staff and shop assistants) :

·         Any staff member receiving prescriptions should check that all required patient, prescriber and funding eligibility details are included eg

·     Patient name and street address (not PO Box number)

·     age or date of birth - highlight the date of birth for children under 5 years, to prompt dose review by a pharmacist during the clinical check

·     NHI number

·     Community services, high user, or pharmaceutical subsidy card.

·     Prescriber full name, street address, and telephone number

·     Prescriber signature

·         Dispensing should be completed in order of receipt. Prioritise dispensings by asking the patient/caregiver if they will wait or return later.

·         Inform patient of approximate wait time eg standard prescriptions generally 5 to 10 minutes, or 15 to 30 minutes for a compounded prescription.

·         If returning later, record time on prescription and make sure it is dispensed by this time.

In the dispensary (pharmacy technicians, interns or pharmacists):

·         Where queried, check patient eligibility for funded prescriptions on the Ministry of Health website (2011 Guide to Eligibility) : http://www.moh.govt.nz/moh.nsf/indexmh/2011-eligibility-guide

·         If required, explain non-eligibility and medicine(s) costs to patient or family / carer; if not prepared to pay, refer back to the prescriber.

·         Where anomalies need noting eg expired antibiotic prescription, medicine missing from usual regime, early, late or infrequent dispensing, or duplicated therapy, ensure a note is attached to draw the dispensing and checking pharmacists' attention to relevant points.

·         If dispensing pharmacist and checking pharmacist is the same person, attach a note as above.

·         Check that it is within the prescribers SCOPE OF PRACTICE

o 

Regulation 39 was changed with effect 1/12/12 so that the only restriction on what may be prescribed by medical practitioners, dentists and midwives is that the medicine is within the prescribers scope of practice.

 

o  Note that Designated Prescribers (optometrists, nurse practitioners and diabetes nurses) can only prescribe those prescription medicines listed in their relevant prescriber regulations. See: http://wvvw.legislation.govt.nz/regulation/public/2005/0256/latest/DLM348602.html  http://www.legislation.govt.nz/reoulation/public/2005/0266/latest/DLM350325.html

http://www.legislation.govt.nz/regulation/public/2011/0054/latest/DLM3589235.html

 

 

 

 

 

 

 

 

 

 

Appendix B: Revised Dispensing 2 SOP