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

Pharmacy

Pharmacist, Mr B

 

 

 

A Report by the Deputy Health and Disability Commissioner

 

 

Contents

Executive summary
Information gathered during investigation
Relevant standards
Opinion: Introduction
Opinion: Mr B — breach
Opinion: Pharmacy — no breach
Recommendations
Follow-up actions
Addendum 

 

Executive summary  

1. This report concerns the care provided to a woman by a pharmacist. The report highlights the importance of pharmacists checking dispensed medication and being truthful and honest following an adverse event or error.
2. In May 2019, the woman visited a pharmacy to pick up her repeat medication. One of her medications was rifaximin 550mg. Instead of being dispensed rifaximin, the woman was dispensed rivaroxaban 20mg, and the pharmacist failed to identify that incorrect medicine was dispensed. The woman consumed the incorrectly dispensed rivaroxaban for the next eight days.  She was then admitted to the Emergency Department at a public hospital and diagnosed with an upper gastrointestinal haemorrhage as a result of having taken the incorrectly dispensed rivaroxaban.
3. Although he was the pharmacist responsible for the dispensing, he initially alleged that another pharmacist made the error. The pharmacist produced a certified repeat copy (CRC) form that stated that the other pharmacist dispensed the incorrect medicine. The other pharmacist denied this. The Deputy Commissioner considered it more likely than not that the first pharmacist amended the CRC and forged the other pharmacist’s initials onto it when he entered the pharmacy by himself on the morning of 28 May 2019 (the date on which the CRC was found).
4. Since this incident, the pharmacist has sold his interest in the pharmacy and ceased to practise as a pharmacist. He said that he is remorseful, and apologised for his actions.

Findings summary

5. The Deputy Commissioner found the pharmacist in breach of Right 4(1) and Right 4(2) of the Code. The Deputy Commissioner was critical that the pharmacist failed to check the incorrectly dispensed rivaroxaban adequately, and was highly critical of the pharmacist’s management of the adverse event investigation and his dishonest and unprofessional conduct following the dispensing error.
6. The Deputy Commissioner considered that the failings identified in this report did not indicate broader systems or organisational issues at the pharmacy, and that the pharmacy did not breach the Code.

Recommendations

7. The Deputy Commissioner recommended that the pharmacist apologise to the woman, and that the Pharmacy Council consider whether a competency review is warranted should the pharmacist return to practice. The Deputy Commissioner referred the pharmacist to the Director of Proceedings.
8. The Deputy Commissioner recommended that the pharmacy conduct an audit on staff compliance with the standard operating procedures and any errors and near misses in relation to the dispensing of medicines. He also recommended that the pharmacy arrange refresher training for its staff on the dispensing of repeat medications.

Complaint and investigation

9. The Health and Disability Commissioner (HDC) received a complaint from Ms A about the services provided to her by Mr B and the pharmacy. The following issues were identified for investigation:

• Whether the pharmacy provided Ms A with services of an appropriate standard between and including May 2019 and July 2019.
• Whether Mr B provided Ms A with services of an appropriate standard between and including May 2019 and July 2019.

10. This report is the opinion of Deputy Commissioner Kevin Allan, and is made in accordance with the power delegated to him by the Commissioner.
11. The parties directly involved in the investigation were:

Ms A                                                          Consumer/complainant
Pharmacy                                                  Provider
Mr B                                                           Pharmacist

12. Also mentioned in this report:

Ms C                                                          Pharmacy technician
Ms D                                                          Pharmacist

13. Further information was received from:

The Pharmacy Council                              
A District Health Board   

 

Information gathered during investigation

Background 

14. This report concerns the dispensing of medicine to Ms A by Mr B,[1] and Mr B’s subsequent actions.
15. On 13 March 2019, Ms A presented to the pharmacy as a new customer with a prescription from her GP. One of the medicines prescribed was rifaximin[2] 550mg tablets, one tablet twice daily.
16. At the time of the incident, the pharmacy had three pharmacists and two pharmacy technicians working on a roster system. The pharmacy told HDC that on a typical day, it dispenses between 400–450 prescriptions.

Dispensing error

17. On 3 May 2018, Ms C, a pharmacy technician, processed future blister pack foils, dispensing labels, and certified repeat copy forms for Ms A. Some of the packs used Ms A’s old medicines, which she provided from home. However, there was an insufficient amount of rifaximin (brand name Xifaxan) and clonazepam,[3] so Ms C processed an order for these medications.
18. On 4 May 2019, the order for rifaximin and clonazepam arrived. A pharmacy technician received the order, unpacked it, and put the medicines on the medicine shelf.
19. On 6 May 2019, Mr B dispensed Ms A’s repeat prescription for paracetamol.
20. On 7 May 2019, Ms D, a pharmacist, gave Ms A’s partner the repeat of paracetamol.
21. On 9 May 2019, Ms C prepared Ms A’s medicines and dispensed the rifaximin incorrectly. Ms C dispensed rivaroxaban[4] 20mg (brand name Xarelto) instead of rifaximin.
22. A photograph of the incorrectly packed medicine was provided to HDC. It shows a dispensary sticker labelled “60 RIFAXIMIN TA[BLETS] 550 MG Take ONE TABLET TWICE daily” placed on top of a rivaroxaban box. The title “Xarelto 20mg” was still visible on the top of the medicine package, and “Xarelto 20 mg rivaroxaban” was still visible on the side of the medicine package.
23. Mr B told HDC that “at some point between Friday 10 May 2019 and Monday 13 May 2019, [he] checked the medication and failed to detect the dispensing error”.
24. On 16 May 2019, Ms A collected her medicines and received the incorrectly dispensed rivaroxaban, instead of rifaximin (subsequently referred to as “the dispensing error”).

Admission to hospital

25. On 24 May 2019, Ms A was admitted to the Emergency Department of a public hospital and diagnosed with an upper gastrointestinal haemorrhage[5] as a result of having taken the incorrectly dispensed rivaroxaban since 16 May 2019. The hospital’s admission summary stated: “[O]n inspection of her medications, she has a box with a rifaximin sticker on it that in fact contains RIVAROXABAN tablets!! …”
26. On 27 May 2019, a hospital pharmacist called the pharmacy and spoke to Mr B. Mr B was informed that Ms A had been admitted with multiple bruising, acute kidney injury, and hypovolaemia[6] as a result of having taken the incorrectly dispensed rivaroxaban. Mr B asked the hospital pharmacist for further information and waited to hear back from her. On 28 May 2019, the hospital pharmacist sent an email to the pharmacy regarding the dispensing error, and provided a photograph of the incorrectly dispensed medicine.

Management of dispensing error

27. On 27 May 2019, Mr B attempted to locate the certified repeat copies[7] (CRCs) generated by Toniq[8] for rifaximin and clonazepam (as both had been processed at the same time). However, Mr B told his staff that the CRCs could not be found on this date.
28. On 28 May 2019, in the morning, Mr B found the CRC for rifaximin 550mg. The rifaximin CRC had Ms C’s initials in the “packed by” field, and Ms D’s initials in the “checked by” field. Mr B informed Ms D and asked whether she could remember how the dispensing error may have occurred.
29. Later on the same day, staff found the CRC for the repeat clonazepam 0.5mg tablets, which showed Ms C’s initials in the “packed by” field, and Mr B’s signature in the “checked by” field.
30. The pharmacy’s notification form to the Pharmacy Defence Association noted:

“[T]he staff was surprised that it was only the CRC for the repeat of rifaximin 550 mg [and] not both rifaximin 550 mg tablets & clonazepam 0.5 mg as they were both processed through the Toniq dispensary system at exactly the same time.” 

31. Subsequently, the pharmacy requested information regarding the Toniq dispensary system, and told HDC:

“Toniq has confirmed that the two medicines … were processed in the same visit, along with the pack fee (as they have the same visit ID in the database). They have advised that to the extent they can be sure, the medicines, Clonazepam and Rifaximin, would have been printed on the same [CRC] … however they are unable to obtain an audit trail of access to the dispensary system to identify when reprinting occurred … as this is recorded on each particular desktop or computer and the logs are either overwritten or deleted monthly.”

32. The Pharmacy Defence Association notification form noted that on 28 May 2019, Ms D “was very upset about this error” and she strongly believed that she had not checked this dispensing as she normally circles and ticks all the important information on a prescription against the dispensing medicine on the CRC.
33. On 28 May 2019, in the evening, Mr B emailed Ms A’s GP and advised that Ms A had been dispensed the incorrect medication. Mr B also notified the organisation overseeing the pharmacy [9] about the dispensing error, and the Advisory Pharmacist was asked to carry out an independent investigation into the incident.
34. On 29 May 2019, Ms D returned to work and maintained that she did not check the incorrectly dispensed medicine and believed that someone had forged her initials on the CRC. Ms D said that Mr B told her that she was responsible for the dispensing error as she had signed the CRC for the rifaximin. Ms D was then given extended stress leave from work.
35. At 9.38am on 29 May 2019, Mr B completed the first version of the notification form and sent it to the Pharmacy Defence Association. Mr B initially noted on the notification form that the incorrectly packed medicine had been dispensed by Ms C and checked by Ms D on 7 May 2019.

Subsequent events

36. On 30 May 2019, Mr B held a meeting with the staff at the pharmacy about the dispensing error, and an immediate action plan was discussed. Mr B asked staff to read the Standard Operating Procedures (SOPs) about dispensing medicines. The meeting minutes were provided to staff.
37. On 31 May 2019, Mr B sent a letter of apology to Ms A. The letter stated:

“On behalf of [the pharmacy] please accept my deepest apology for the error where I understand that Rivaroxaban 20 mg tablets were dispensed and checked on the 7 May 2019 (processed on the 3 May 2019) instead of the prescribed Rifaximin 550 mg tablets … we have taken this matter extremely seriously and would like to reassure you … and your family that a thorough investigation is being conducted.”

38. On or about 5 June 2019, Mr B called Ms A to check on her and expressed his apology. He said that on or about the same day, he also visited Ms A at her home and assured her that he would be conducting further investigations. They also exchanged text messages that day.
39. On 25 June 2019, the Advisory Pharmacist wrote another letter to Ms A apologising for the dispensing error and informing her of the outcome of the investigation. The letter stated that the dispensing error was due to an isolated incident of human error by two dispensary staff members. The letter listed the likely factors that contributed to the dispensing error, and the improvements that the pharmacy had implemented following the dispensing error.
40. On 26 June 2019, Ms A returned to the pharmacy and advised that the pharmacy could continue to dispense her medicines the following day.
41. On 4 July 2019, the notification form was updated following the investigation by the Advisory Pharmacist and the form was sent to the Pharmacy Defence Association. The updated notification form stated:

“There is currently a disagreement between [Mr B] Pharmacist/Owner [and] [Ms D] Pharmacist, as to which Pharmacist checked the incorrect dispensed Rivaroxaban 20 mg tablets … [and] on what day the incorrectly dispensed medicine was checked.”

Information from the Pharmacy Council 

42. On 18 July 2019, the Pharmacy Council informed HDC that on 31 May 2019 it had received a notification from Ms D about Mr B’s conduct, and that the Council had been aware of the dispensing error. The Pharmacy Council stated:

“The information raises wider and serious concerns about [Mr B’s] conduct and competence in the manner he has dealt with the complaint at his pharmacy … Following initial enquiries into this notification, [Mr B] has confirmed he is responsible for checking [Ms A’s] prescription and dispensing Rivaroxaban 20 mg tablets (labelled as Rifaximin) …”

43. A copy of Ms D’s and Mr B’s correspondence to the Pharmacy Council was provided to HDC.
44. Ms D’s letter to the Pharmacy Council dated 31 May 2019 noted her suspicion of Mr B’s actions, as the CRC form had not been found earlier. The CRC form was also found as two separate items, and not printed on one page, despite having been processed at the same time. Ms D stated that when she undertakes a check of dispensing, her normal practice is always to circle the strength and quantity on the CRC, but this had not been done on the CRC for rifaximin found by Mr B. Ms D noted that she did not complete the CRC for rifaximin, and provided examples of previous CRCs she had completed for other patients, to show her normal practice of circling or marking the strength and quantity of the medicines being dispensed.
45. Ms D also said that she checked the video footage outside the pharmacy on the day the CRC was found (28 May 2019), and it showed Mr B entering the back of the pharmacy at 6.59am and leaving just before 8am, and then returning to the front entrance of the pharmacy at 8.36am. She also informed the Pharmacy Council of other previous occasions on which she had been concerned about Mr B’s dispensing and checking processes.
46. In Mr B’s responding letter to the Pharmacy Council dated 4 July 2019, he admitted that he was the pharmacist who had dispensed the medicine incorrectly and had wrongly alleged that Ms D had been the responsible pharmacist. Mr B’s letter stated:

“What I want to make clear is that I take responsibility for my actions. I understand the error I made and the gravity of it. I am committed to doing whatever is necessary to address the Council’s concerns. My actions hurt [Ms D] and [Ms A]. I am deeply regretful and I apologise sincerely to both of them … I am profoundly remorseful. I cannot put into words how badly I feel for [Ms D] and [Ms A]. I hope that by putting my hand up at the earliest reasonable opportunity I have provided them some degree of comfort …”

Further information

Mr B

47. Mr B told HDC:

“[T]he notification I sent to the Pharmacy Defence Association states that the pharmacist responsible for checking [Ms A’s] medication was [Ms D]. That is incorrect.”

48. Mr B also stated:

“I take responsibility for my actions, understand the gravity of the situation and am profoundly remorseful. I know my behaviour was inadequate. The only realistic option was to remove myself from my chosen field that I loved. I accept that I checked the prescription in question, not [Ms D]. On 28 May 2019, I arrived at the pharmacy and left again before the opening hour … I did myself absolutely no credit as a health care professionals and I will have the rest of my life to reflect upon that.”

Pharmacy

49. Initially, the pharmacy told HDC:

“It cannot be identified if the repeat of rifaximin 550 mg tablets (in which rivaroxaban 20 mg tablets was incorrectly dispensed) was dispensed and checked on the 7 May 2019, or the 9 May 2019, or the 13 May 2019 and what time this occurred on the specific day. Unfortunately, all video footage for these dates had been overwritten once this error was identified.”

50. The pharmacy provided HDC with a copy of the video footage from outside both the back and the front entrances to the pharmacy on the morning of 28 May 2019. The video footage confirmed Ms D’s statement that Mr B was seen at 6.58am coming from the back and leaving just before 8am, and then coming back from the front entrance at 8.36am.
51. The pharmacy said that until being told by HDC in August 2019, it had not been aware that Mr B had confirmed that he was responsible for checking Ms A’s prescription. The pharmacy stated that Mr B had been involved with its investigation until 3 July 2019, after which he did not respond to emails, telephone calls, or communication from the other director.
52. The pharmacy’s updated notification form noted the following contributing factors to the dispensing error:

• Rifaximin and rivaroxaban have similar names and both brand names begin with an X, and the medications were stored near each other on the medication shelf for brand names starting with “X”.
• The rifaximin 550mg tablets are not commonly used in the pharmacy, so staff were not familiar with the medicine.
• The technician missed vital steps in the pharmacy’s SOP for the dispensing of a medicine, and the pharmacist involved missed vital steps in the SOP for the checking of a prescription.

The pharmacy’s SOPs

53. At the time of events, the pharmacy had current SOPs in place. Document number C06 of the SOPs, “Dispensing and Checking a prescription”, approved in May 2018, states:

“When dispensing a medicine, the Pharmacist or technician shall:

• Select each medicine from the dispensary shelf at one time using the original prescription, making sure the correct medicine, strength and brand has been chosen. Never use the generated dispensary label to select the medicine …
• Double check the generated dispensing label(s) against the original prescription before attaching to the container, making sure that the dispensary label contains what is written on the prescription, e.g. correct medicine, dose, quantity, instructions, customer’s name, and prescriber ...

When checking the prescription, the Pharmacist shall:

• Check the prescription details are correct, including the customer’s details, statutory details and the suitability of the prescribed medicine(s) in terms of the quantities prescribed, funding and the prescriber’s scope of practice ...
• Check the appropriateness of each prescribed medicine with respect to its therapeutic use, appropriateness for the customer’s parameters …
• Check that each medicine dispensed is correct against the medicine prescribed on the prescription. This includes checking the generated dispensary label and dispensed medicine(s) against the original prescription for the:
  • Correct customer’s name;
  • Correct instructions for use;
  • Correct formulation, strength and quantity of medicine; …”

54. Document number C32 of the SOPs, “Dispensing error”, approved in February 2019, states:

“Purpose: To ensure correct procedures are followed if a dispensing error is identified to ensure it is dealt with quickly, safely and responsibly; …

• With all suspected and confirmed dispensing errors it is essential that the situation is dealt with in a professional and timely manner. At all times customer safety has to be the key focus.”

Changes made since incident

55. Mr B told HDC that following this incident, he sold his interest in the pharmacy business and resigned as the director in 2019. He also surrendered his pharmacist practising certificate. The Pharmacy Council confirmed that Mr B volunteered to suspend his practising certificate effective from mid 2019.
56. The pharmacy told HDC that Mr B resigned as the Managing Director and the majority pharmacist shareholder. The pharmacy was sold to Mr E, who is the owner of another pharmacy in the area, and he became the new Managing Director and now operates the day-to-day business of the pharmacy.
57. The pharmacy told HDC that as a result of this incident and following the new management by Mr E, the following changes were made:
58. a) A new dispensary manager and a new pharmacy technician were employed in addition to the existing staff.
59. b) Mr E reviewed the compliance packaging procedures and is amending the processes to align them with systems in his other pharmacy, which will create a complete audit trail of who has been involved in each stage of the process; these changes include initiation of a new medication chart and a new correspondence work sheet that contains the initials of each person involved in the compliance pack process.
60. c) New checking stamps were ordered to include check boxes for each staff member to initial the step at which they are involved from start to finish, in both the compliance packaging and general dispensing processes.
61. d) Mr E reviewed most of the dispensary processes at the pharmacy to optimise the workload better and reduce the risk of errors, and now has an organised team structure with dedicated roles and a timetable of work duties.
62. The pharmacy stated:

“[Mr E] is pleased to report that a reduction in waiting times, improved communication and leadership and additional staff has greatly reduced the workload and stress for the team and that he is satisfied that he has created a better working environment based on structure and communication.” 

Responses to provisional opinion

Ms A

59. Ms A was provided with an opportunity to comment on the “Information gathered” section of the provisional opinion. She told HDC that Mr B told her that another pharmacist was responsible for the dispensing error. She noted Mr B’s dishonesty to her and she expressed her sympathy for Ms D about this event.

Mr B

60. Mr B was provided with an opportunity to comment on the provisional opinion. He told HDC:

“There are no matters I wish to clarify or dispute in relation to the information gathered, the preliminary conclusions or the proposed recommendations and follow-up actions.

… A day does not go by when I do not think about [Ms A], [Ms D] and my actions in May and June 2019.

I was and remain profoundly sorry for the pain I caused.”

Pharmacy

61. The pharmacy was provided with an opportunity to comment on the provisional opinion. The pharmacy stated: “We are all happy with the findings and have no further comments.”

 

Relevant standards

62. The Pharmacy Council of New Zealand Competence Standards for the Pharmacy Profession (2015) (the Pharmacy Competency Standards) state:

“O3: Supply and administration of medicines

… Pharmacists have an independent duty of care to use their professional judgement and apply their expertise to protect and promote the safety, health and well-being of patients and the public …

Competency O3.2 Dispense Medicines

O3.2.1 Maintains a logical, safe and disciplined dispensing procedure

O3.2.2 Monitors the dispensing process for potential errors and acts promptly to mitigate them …”

63. The Pharmacy Council of New Zealand Code of Ethics (2018) (the Pharmacy Code of Ethics) states:

“Principle 4: A pharmacist acts with honesty and integrity and maintains public trust and confidence in the profession …

A pharmacist: …

1. Provides accurate, truthful, relevant and independent information in an appropriate form that is not misleading to patients, the public and/or other healthcare professionals.
2. Will not abuse their professional position or exploit the vulnerability or lack of knowledge of others.
3. Responds honestly, openly, courteously and promptly to complaints and criticism

…

Principle 5: A pharmacist only practises under conditions which uphold the professional independence, judgement and integrity of themselves and others …

A pharmacist: …

1. Behaves in a manner that clearly demonstrates responsibility and accountability for all decisions made and actions taken in their professional practice.”

 

Opinion: Introduction

64. This opinion concerns the standard of care provided by Mr B and the pharmacy to Ms A in relation to the incorrect dispensing of rivaroxaban instead of rifaximin, and also the management of the adverse event by Mr B.

 

Opinion: Mr B — breach

Dispensing error

65. On 16 May 2019, Ms A received rivaroxaban 20mg instead of rifaximin 550mg. Ms C was the pharmacy technician who incorrectly selected and packed rivaroxaban and placed the rifaximin label on the rivaroxaban packaging.
66. Initially, it was unclear which pharmacist completed the final check of the medication. Ultimately, Mr B, then the manager of the pharmacy, accepted that he checked the medication and that he did not detect that rivaroxaban had been dispensed incorrectly. Mr B said that he undertook the final check at some point between 10 May 2019 and 13 May 2019, but he did not provide exact detail as to when he completed the final check.
67. The Pharmacy Competency Standards state that pharmacists must maintain a logical, safe, and disciplined dispensing procedure, and monitor the dispensing process for potential errors.
68. The pharmacy’s SOPs also provide a guideline on the checking process, and state that the prescription details should be checked against the medicine prescribed on the prescription, and that the check is to include the name of the customer, the instructions, and the formulation, strength, and quantity of the medicine. The incident form filed by the pharmacy noted that the pharmacist involved did not follow the SOPs.
69. In my opinion, the adequacy of the dispensing service provided to Ms A fell short of the standard of care expected. Had the SOPs been followed, the dispensing error is unlikely to have occurred, and accordingly I find that Mr B did not follow the required checking steps as stated in the SOPs.
70. I am critical that Mr B failed to follow the SOPs and failed to detect the incorrectly dispensed rivaroxaban. As a result of Mr B’s omission, Ms A consumed incorrectly dispensed rivaroxaban and suffered significant adverse health complications that required admission to hospital.

Management of adverse event

71. Following the incident, on 28 May 2019 Mr B found the CRC of the incorrectly dispensed rifaximin and indicated that it had been initialled by Ms D. Despite the rifaximin and clonazepam having been processed at the same time, different CRC sheets were found. The pharmacy and the provider of the Toniq dispensary system said that the rifaximin and clonazepam should have been on the same CRC, as they were processed at the same time.
72. The pharmacy said that video footage inside the pharmacy cannot be accessed. However, video footage outside the pharmacy shows that on the day the CRC was found (28 May 2019), Mr B entered the pharmacy via the back door at 6.58am, exited just before 8am, and then re-entered the pharmacy via the front door at 8.36am.
73. Initially, Mr B alleged that Ms D was the pharmacist who incorrectly dispensed rivaroxaban, as her initial was on the rifaximin CRC. On 29 May 2019, Mr B filed a notification form to the Pharmacy Defence Association on which he noted that Ms D was the pharmacist responsible for the dispensing error.
74. Ms D strongly denied this allegation and said that her normal practice is to circle the dose and strength on the CRC, and that this had not been done on the rifaximin CRC found.
75. Ms D notified the Pharmacy Council of her concerns about Mr B’s conduct and management of the investigation. In response to the inquiry by the Pharmacy Council, Mr B admitted that he was the pharmacist who checked the incorrectly dispensed rivaroxaban. He also accepted that he entered the pharmacy early in the morning of 28 May 2019. He wrote in his response that he deeply regretted his actions and apologised to both Ms D and Ms A. Following the complaint to HDC, Mr B told HDC that he was the pharmacist responsible for the dispensing error.
76. From the evidence available, I find it more likely than not that Mr B amended the CRC for rifaximin and forged Ms D’s initials on it when he entered the pharmacy by himself on the morning of 28 May 2019 (the date on which the CRC was found). It is apparent that at the time of the incident, Mr B intentionally accused Ms D of his own error and amended the pharmacy records to support his version of events.
77. Principle 4 of the Pharmacy Code of Ethics states:

“[A pharmacist must] provide accurate, truthful, relevant and independent information in an appropriate form that is not misleading to patients, the public and/ or other healthcare professionals … not abuse their professional position or exploit the vulnerability or lack of knowledge of others.”

78. Principle 5 of the Pharmacy Code of Ethics states that a pharmacist must “behave in a manner that clearly demonstrates responsibility and accountability for all decisions made and actions taken in their professional practice”.
79. Mr B failed to comply with his ethical and professional obligations as stated in principles 4 and 5 of the Pharmacy Code of Ethics. He abused his position as a senior pharmacist and manager to manipulate the adverse event investigation. By accusing Ms D of being responsible for the error, he exploited her vulnerability as a colleague and employee. Mr B was not honest with his staff, colleagues, or Ms A.
80. Mr B caused unnecessary stress for Ms D by accusing her of an error she did not make. Mr B also knowingly reported incorrect information to the Pharmacy Defence Association. I am very critical of Mr B’s actions, which were dishonest, unacceptable, and a clear breach of ethical and professional obligations.
81. I acknowledge that following the inquiry by the Pharmacy Council, Mr B accepted his wrongdoing and apologised to both Ms D and Ms A. He also sold his interest in the pharmacy and surrendered his practising certificate as a pharmacist.

Conclusion

82. I am critical that Mr B failed to check the incorrectly dispensed rivaroxaban adequately, and that as a result of the error, Ms A consumed the incorrectly dispensed medicine and required hospitalisation. I am also very critical of Mr B’s management of the adverse event investigation and his dishonest and unprofessional conduct during the investigation process by the pharmacy, until he admitted his wrongdoings to the Pharmacy Council. Mr B’s actions were in breach of the Pharmacy Code of Ethics. Accordingly, I find that Mr B breached Right 4(1)[10] and Right 4(2)[11] of the Code of Health and Disability Services Consumers’ Rights (the Code).

 

Opinion: Pharmacy — no breach

83. As a healthcare provider, the pharmacy is responsible for providing services in accordance with the Code. The pharmacy has an obligation to ensure that it has adequate policies in place to facilitate safe and disciplined dispensing. It also has a responsibility to ensure that all pharmacists working in the pharmacy are appropriately trained and experienced, and aware of the pharmacy’s expectations, including the SOPs.
84. I note that the pharmacy has SOPs in place to safeguard any dispensing error. At the time of events, Mr B — a senior pharmacist with more than 15 years of experience — was the manager of the pharmacy. I consider that the failings identified in this report were matters of individual clinical judgement, ethics, and practice, and that the errors that occurred did not indicate broader systems or organisational issues at the pharmacy. I note that following the incident, the pharmacy received advice from the Advisory Pharmacist. I also acknowledge that following the incident the pharmacy was sold, and is under new management, and that several changes have been implemented by the new owner, including the appointment of a new dispensary manager and a new pharmacy technician in addition to the existing staff, a review of the compliance packaging procedures, the implementation of a new checking stamp, and a review of most of the dispensary processes.

 

Recommendations

85. I recommend that Mr B provide a written apology to Ms A. The apology should be sent to HDC, for forwarding to Ms A, within seven weeks of the date of this report.
86. I recommend that the Pharmacy Council consider whether a competency review is warranted should Mr B return to practice.
87. I recommend that the pharmacy:
88. a) Conduct an audit, for the one-month period prior to the date of this report, on the following matters:
89. All errors and near misses in relation to dispensing of medicines, and common themes or patterns found; and
90. Staff compliance with its SOPs.

       The results of the audit, and any actions taken by the pharmacy following the audit, are to be reported to HDC within six months of the date of this report.

1. b) Arrange refresher training for its staff in relation to the dispensing of repeat medications, and provide HDC with evidence of the training and any learning, within six months of the date of this report.

 

Follow-up actions

88. Mr B will be referred to the Director of Proceedings in accordance with section 45(2)(f) of the Health and Disability Commissioner Act 1994 for the purpose of deciding whether any proceedings should be taken.
89. An anonymised 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.
90. An anonymised copy of this report with details identifying the parties removed will be sent to the New Zealand Pharmacovigilance Centre and the Pharmacy Defence Association and placed on the Health and Disability Commissioner website, www.hdc.org.nz, for educational purposes.

Addendum

91. The Director of Proceedings decided to issue disciplinary proceedings.

[1] At the time of the incident, Mr B was the Managing Director of the pharmacy. He had been practising for many years, but from 2017, a condition was imposed on his practice that he work in association with another pharmacist at all times when dispensing medicines, and he was under the supervision of a Pharmacy Council-approved pharmacist, Ms D, and another pharmacist. 

[2] An antibiotic used to treat diarrhoea, irritable bowel syndrome, and hepatic encephalopathy. Rifaximin is also sold under the brand name “Xifaxan”.

[3] A medication used to prevent and treat seizures, panic disorder, and movement disorder.

[4] An anticoagulant medication used to treat and prevent blood clots. Also sold under the brand name “Xarelto”.

[5] Bleeding arising from the esophagus, stomach, or duodenum.

[6] An abnormal decrease in the volume of circulating blood plasma.

[7] A form created when a repeat medicine is processed for dispensing.

[8] Software used by the pharmacy to dispense medications.

[9] A provider of primary healthcare services to communities in New Zealand.

[10] Right 4(1) states: “Every consumer has the right to have services provided with reasonable care and skill.”

[11] Right 4(2) states: “Every consumer has the right to have services provided that comply with legal, professional, ethical, and other relevant standards.”