Names have been removed to protect privacy. Identifying letters are assigned in alphabetical order and bear no relationship to the person’s actual name.
Introduction
- This report discusses the care provided to Ms A (aged in her mid-twenties at the time of the events) by a local pharmacy (the pharmacy) (owned and operated by […]). The complaint concerns a dispensing error in which Ms A was dispensed the wrong medication.
Background
- Ms A had been diagnosed with endometriosis.[1] Her general practitioner (GP) had prescribed three months of cyproterone[2] for June, July and August 2024. On 21 June 2024, Ms A picked up her medications from the pharmacy.[3]
- Ms A told HDC that the sertraline, taken in conjunction with Ms A’s other prescribed medication, escitalopram,[4] caused serotonin syndrome.[5] Ms A described experiencing fainting and being unconscious for 15 minutes, nausea, diarrhoea, uncontrollable sweating, tachycardia, hypertension, hypotension, and other symptoms. Ms A told HDC that she went to the hospital, after-hours clinic, and GP clinic multiple times. She said that she notified the pharmacy of the dispensing error once she became aware of it.
The pharmacy’s response
- The pharmacy told HDC that on 21 June 2024 its dispensing software identified that Ms A was due for her repeat prescriptions. A text message was generated and sent. Ms A responded confirming that she wanted the repeat prescriptions to be processed. The pharmacist, Mr B, processed the repeat prescription using the dispensary software, which printed the medication labels and a certified repeat prescription, which is used for the dispensing and checking process.
- The prescription was dispensed by pharmacy technician Ms C, who selected the medications from the shelf, applied labels, and placed the medications in a basket for checking by a pharmacist. The medication was checked by Mr B, bagged up and placed on a shelf for collection.
- The pharmacy said that the main cause of the dispensing error appears to have been the similarities between the brand name of the prescribed cyproterone (Siterone) and the name of the dispensed medication (sertraline, brand name Setrona). It appears that the pharmacy technician misread the label and selected sertraline 50mg instead of cyproterone 50mg. The error was not picked up by Mr B when he undertook the final check of the medication, likely for the same reason.
Relevant standards and SOP
Pharmacy Council of New Zealand
- The Pharmacy Council of New Zealand’s Competence Standards for the pharmacy profession (2015) provide that a pharmacist[6]‘maintains a logical, safe and disciplined dispensing procedure’ and ‘follows relevant policies, procedures and documentation requirements for the administration of medicines’.
SOP
- The pharmacy had a standard SOP[7] (excerpt attached as Appendix A). The SOP states that a final clinical and accuracy check of medication dispensed should occur. This involves the pharmacist ensuring that the medication dispensed is therapeutically appropriate and the correct medication for the indication and checking the accuracy, dose, and quantity of the medicine.
Notification
- On 28 February 2025, I notified Mr B of an HDC investigation of this matter. I proposed that HDC find Mr B in breach of Right 4(2)[8] of the Code of Health and Disability Services Consumers’ Rights (the Code) based on previous HDC precedents, failure to adhere to the pharmacy’s SOP, and the Pharmacy Council of New Zealand’s competency standards.
- On 18 March 2025 Mr B accepted my proposal and agreed to a breach of the Code.
Follow-up and changes since event
- Mr B and the pharmacy apologised to Ms A.
- Additional warning signs have been placed on the medicine shelf next to the two medications in question.
- Staff training related to the SOP and the dispensing process has been completed.
- An amendment has been made to the pharmacy’s SOP for the dispensing process to highlight that medications should be processed under the generic name, not the brand name.
Responses to provisional decision
- The pharmacy, Ms C, Mr B and Ms A were given the opportunity to respond to the provisional decision.
- The pharmacy and Ms A responded that they had no comments to make.
- Ms C responded with a suggestion regarding a recommendation, which has been incorporated accordingly in the final decision.
- Mr B responded that he accepts the HDC’s finding that his error breached the Code and made suggestions for a recommendation and for the anonymisation process, which have been incorporated accordingly in the final decision.
Decision
Introduction
- I consider this to be a significant incident in which the dispensing error appears to have caused harm to Ms A.
Mr B — breach
- As a registered pharmacist, Mr B had a duty to provide adequate care and was responsible for ensuring that he provided services of an appropriate standard to Ms A, including complying with the professional standards set by the Pharmacy Council, the pharmacy’s SOP, and the Code.
- In a similar case that involved a medication dispensing error, this Office stated:[9]
‘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, and checking for any interactions.’
- In accordance with the pharmacy’s SOP, it is clear that a final clinical and accuracy check should have occurred. However, it appears that Mr B missed the dispensing error and therefore failed to correct it. A check of therapeutic appropriateness or that it was the correct medication for the indication would have identified the error, as would a check of whether the medication would interact negatively with Ms A’s other prescribed medication.
- I remind Mr B that although the onus was still on Ms C to dispense the medication for Ms A correctly in accordance with the pharmacy’s SOP, the ultimate responsibility for the final check rested with him.
- In not carrying out the final check adequately and thus allowing an incorrect medicine to be dispensed, Mr B failed to adhere to the standards set by the Pharmacy Council of New Zealand and to the pharmacy’s SOP. Accordingly, I find that Mr B breached Right 4(2) of the Code.
- I note that Mr B has accepted the breach of the Code.
- I acknowledge that Mr B took swift action when he became aware of the error, accepted full responsibility for the mistake, apologised to Ms A, and made changes to the SOP.
Ms C — adverse comment
- As a fully trained pharmacy technician, Ms C had a duty to provide adequate care and was responsible for ensuring that she provided services of an appropriate standard to Ms A, including complying with the pharmacy’s SOP.
- The pharmacy’s SOP states that when dispensing medication, the dispensing person should ‘ensure the correct: active ingredient, strength and brand (if not interchangeable)’. When the medication has been dispensed, the dispensing person should check against the original prescription to ensure the accuracy of the patient’s and doctor’s name, the medication, strengths, quantity, dosage form, brand, and directions on the label.
- I am critical that Ms C dispensed sertraline (brand name Setrona) without ensuring that this was the correct active ingredient (cyproterone, brand name Siterone) and strength of the medication prescribed. The error appears to have occurred because of similarities between the brand name of the prescribed medication and the name of the medication dispensed in error. I note that if Ms C had focused on the active ingredient in the prescribed medication, rather than the brand name, this dispensing error could have been avoided.
- The pharmacy has in place a final check by a pharmacist after the medication has been dispensed, to ensure that the dispensed medication matches the prescription accurately, as discussed above. However, in this case, the dispensing error was not identified and rectified, and I remind Ms C that the process should never be relied on to pick up dispensing errors.
- Nonetheless, as discussed above, the dispensing error could have been avoided if Mr B had conducted a thorough check of the dispensed medication, which did not occur. In my view, the main responsibility for this dispensing error rested with the pharmacist, who failed to identify the dispensing error in his final check.
- I remind Ms C that despite the insurance of a pharmacist checking the dispensed medication, the onus is still on her to ensure that the correct medication is dispensed.
The pharmacy — no breach
- The pharmacy had a duty to ensure that it provided services to Ms A with reasonable care and skill. This included ensuring that its practices were safeguarded by a robust SOP and applicable in-house training to ensure that staff provided safe, accurate, and efficient dispensing services.
- As outlined above, I have found that pharmacist Mr B breached Right 4(2) of the Code and that Ms C’s error warrants adverse comment. I consider that the pharmacy had in place a standard SOP and that ongoing relevant training had been provided to all staff. In my view, the medication dispensing error was the result of individuals’ actions and does not indicate organisational issues at the pharmacy. Furthermore, the pharmacy was entitled to rely on Mr B and Ms C, as an experienced pharmacist and pharmacy technician, to dispense medication accurately and adhere to the standards set by the Pharmacy Council of New Zealand and in accordance with the pharmacy’s SOP.
- The pharmacy submitted that ‘pursuant to section 72(5) of the Health and Disability Commissioner Act 1994, [it] took such steps as were reasonably practicable to prevent Mr B from the error that unfortunately occurred and should not therefore be considered vicariously liable for Mr B’s error’. I agree.
- Accordingly, I do not find the pharmacy in breach of the Code.
- I commend the pharmacy for having already provided an appropriate apology to Ms A and for having provided ongoing training to staff to ensure that this error is not repeated.
Recommendations
- Given that the pharmacy and Mr B have already provided an appropriate apology to Ms A, I consider that no further apologies by them are necessary.
- I recommend that Ms C provide a formal written apology to Ms A for the dispensing error. The apology is to be sent to HDC, for forwarding to Miss A, within three weeks of the date of this report.
- I recommend that Mr B and Ms C complete the Improving Accuracy in Your Dispensary course, provided by the Pharmaceutical Society of New Zealand. Evidence of this and an outline of any further changes or improvements made to their practice as a result of the training should be provided to HDC within three months of the date of this report.
- I recommend that […], trading as the pharmacy […], undertake a random audit of the medication dispensing and checking of medication for 20 prescriptions within a one-month period to assess staff compliance with the dispensing and checking SOP, and report back to HDC with the outcome of the audit and any action plan to address the findings, within three months of the date of this report.
Follow-up actions
- A copy of the final decision 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.
- A copy of the final decision with details identifying the parties removed will be sent to Medicines Control at Manatū Hauora | Ministry of Health, and it will be advised of the name of […], trading as the pharmacy […].
- A copy of the final decision with details identifying the parties removed will be published on the HDC website (www.hdc.org.nz) for educational purposes.
Dr Vanessa Caldwell
Deputy Health and Disability Commissioner
Appendix A: Excerpt from [the pharmacy]’s standard operating procedure (SOP)
Dispensing medication [P2.7]
- Select the medication from the appropriate location in the dispensary, or compounding area using the original prescription.
Ensure the correct:
- Active ingredient
- Strength
- Dosage form
- Brand (if not interchangeable)
…
- Check the dispensed medication against the original prescription.
- Patient
- Doctor
- Medication
- Strength
- Quantity
- Dosage form
- Brand
- Directions on label
- CALs.
…
- Place the medicine, prescription/CRC/Owing, receipt, healthcare cards in the prescription basket and place in the designated prescription checking area located on the dispensary bench
Clinical and accuracy check of the dispensed medication
- Pharmacist will ensure that the medication dispensed is therapeutically appropriate.
- Correct dose
- Correct dosage form and route of administration
- Correct medication for the indication
…
- Pharmacist will open each skillet or bottle to compare the dispensed contents against stock supply and prescription. Dispensed liquid will be checked against the stock/original bottle supply
- Check label accuracy for name, date, medicine strength and form, instructions, CALs, expiry date if applicable and contents accuracy — correct medicine, dose, form and quantity
- Any error in dispensing will be corrected prior to handing out the medication to the patient. Pharmacist will teach and encourage the staff that has made an error to record their near miss electronically. See SOP P5.3 — Recording, Reviewing Near Misses.
- When the pharmacist is satisfied that the dispensed medication is correct, they will initial either on the third part label or “Ch[e]ck By” box on the pharmacy stamp.
- They will then collate the medication, healthcare cards, and any other relevant paperwork (such as CMI’s and receipts) and place in prescription basket.
Appendix B: Pharmacy Council of New Zealand: Competence Standards for the Pharmacy Profession (2015)
COMPETENCY O3.2 DISPENSE MEDICINES
Behaviours 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
[1] A condition in which tissues similar to the inner lining of the uterus grow outside the uterus, often affecting the ovaries, fallopian tubes, and the tissue lining the pelvis. It can cause severe pelvic pain, especially during menstruation, and may lead to complications such as infertility.
[2] (50mg to be taken once daily) to treat the pain related to endometriosis.
[3] Ms A proceeded to take the medications as prescribed for about a month, when she noticed that she had been dispensed sertraline, which was the wrong medication.
[4] Medication used to treat depression and anxiety.
[5] A toxic state caused mainly by excess serotonin in the central nervous system.
[6] Pharmacy Council Competence Standards for the Pharmacy Profession — Paragraph 6.2.5.
[7] SOP created 10 July 2023 and reviewed 15 September 2024 with the addition of Processing subscriptions —‘Enter medication details — as generic name rather than brand name as appropriate.’
[8] Right 4(2) states that every consumer has the right to have services provided that comply with legal, professional, ethical, and other relevant standards.
[9] Case 20HDC00383.