Names have been removed to protect privacy. Identifying letters are assigned in alphabetical order and bear no relationship to the person's actual name.
Pharmacist, Mr B
A Pharmacy Company
A Report by the Health and Disability Commissioner
Mr A Consumer
Mrs A Complainant
Mr B Provider/ Pharmacist
Dr C Orthopaedic Surgeon
Ms D Pharmacy Technician
A Pharmacy Company Employer
On 24 June 2004, the Commissioner received a complaint from Mrs A about a pharmacy. The complaint was made on behalf of her husband, Mr A, to the Pharmaceutical Society of New Zealand, which forwarded the matter to this Office. The issue arising that the Commissioner investigated was summarised as follows:
- Whether the pharmacy provided services of an appropriate standard on 19 June 2004 to Mr A. In particular, Hybloc 100mg was dispensed instead of tramadol 50mg.
The investigation commenced on 22 September 2004.
- Mrs A's letter of complaint to the Pharmaceutical Society of New Zealand, dated 22 June 2004.
- The pharmacy's Standard Operating Procedure for dispensing medication.
- Prescription written by Dr C.
- Information provided by:
- Mrs A
- Mr B
- Ms D
Information gathered during investigation
On Saturday 19 June 2004, Mrs A drove her husband, Mr A, home from a public hospital following a total hip replacement. Dr C, orthopaedic surgeon, had prescribed Mr A with tramadol for pain relief. The prescription, written by hand, was for 30 x 50mg tramadol. On the way home, Mrs A called into the pharmacy to have the medication dispensed.
The dispensing pharmacist on duty was Mr B. Mr B is listed as a director of the pharmacy company, which owns the pharmacy.
When Mrs A presented the prescription to Mr B, she recalled him remarking that the prescribed 50mg dose had not been available for a number of years. As an alternative, he suggested cutting in half 15 x 100mg of the same medication to correspond with Dr C's prescribed dose. Mrs A conveyed her surprise to Mr B that Dr C would prescribe medication in a dose that was no longer available. Nevertheless, she agreed with Mr B's suggestion, and purchased her husband's medication from him. Mrs A noted that the tablets Mr B dispensed differed in appearance from the tramadol capsules her husband had received in the public hospital, but thought that this was a different form of the same medication.
Mr B explained that he had misread Dr C's handwritten prescription, mistaking the word "tramadol" for "Trandate" (see Appendix 1). At the time Mrs A presented her husband's prescription, the pharmacy was especially busy as it was a Saturday. Mr B was the only pharmacist working in the dispensary, and there were other customers waiting for their medications to be dispensed. Mr B commented that he did not know why the medication had been prescribed, and observed that Dr C's writing was quite small. When he suggested contacting Dr C for clarification, Mrs A replied that it was likely he would have left the hospital for the day. Mr B stated:
"I did not inform [Mrs A] that Tramadol was unavailable as I read the prescription as Trandate and informed her that Trandate was unavailable and tried to locate some stock in order to fill the prescription".
Mr B said that he sent his assistant, who was not technically trained, to the neighbouring pharmacy with a note asking to borrow 30 x 50mg Trandate tablets. As none were available at that pharmacy, Mr B resorted to using his own supply of 100mg Trandate tablets. He cut each of the 15 Trandate tablets in half to enable him to dispense the mediation in the dose prescribed by Dr C. However, Mrs A differed in her recollection, and informed me that Mr B dispensed 32 half tablets to her husband. At no time did Mr B ask Mrs A the purpose of Dr C's prescription.
Mr B explained that when a patient receives new medication, the computer automatically prints an information sheet about the medication. The sheet is comprehensive, covering matters such as a description of the medication, how the medication works, what to do before taking the medication, how to use it, directions on what to do while taking the medication, precautions, side effects, dose and safety advice (see Appendix 2). Mr B included a copy of the information pamphlet with the medication he dispensed to Mr A.
Mrs A said that the fact sheet outlining the drug's benefits and side effects was enclosed with the medication. However, she did not read it because her husband, who was in extreme pain, and their six-month-old baby, were waiting for her in the car. Mrs A recalled that her husband consumed a half tablet that evening and another that night.
On Sunday morning 20 June 2004, Mr A complained of a severe headache, dizziness, and hallucinations, and remained in pain. It was then that Mrs A read the information sheet provided by Mr B and realised that the medication dispensed was taken for hypertension. As the pharmacy was closed on a Sunday, Mrs A rang another pharmacy, where the pharmacist confirmed that Trandate, the medication named on the label of the bottle, was different from tramadol, and that the medications were used for treating different medical conditions.
On 21 June, Mrs A went back to the pharmacy to report the error. As Mr B was out of town, she informed the attending staff member, Ms D, of the error. Ms D was working as a pharmacy technician in the dispensary when Mrs A returned with the incorrect medication. On learning of the mistake, Ms D retrieved the prescription from the dispensary. After viewing it, she commented that it was difficult to interpret the writing at first look. On further inspection, she realised that Mr B had dispensed Hybloc (Trandate). Ms D offered to dispense the correct medication, but Mrs A refused. Consequently, Ms D refunded the dispensing fee to Mrs A, who commented on the inconvenience she had experienced as a result of Mr B's error.
As Ms D was worried that Mr A may have taken a dose of Trandate, she immediately counted the number of half tablets in the bottle that Mrs A returned. She found 30 half tablets in the bottle and concluded that Mr A had not consumed any of the Trandate. Mrs A agreed that 30 half tablets were returned on 21 June 2004. However, she recalled that 32 half tablets had been dispensed on 19 June 2004, and that Mr A had consumed two half tablets that Saturday evening.
During the investigation, Mr B provided this Office with the bottle containing the Trandate tablets dispensed on 19 June 2004. There were 29 half tablets in the bottle, rather than the 30 recorded by Mr B in the following statement he provided to me:
"Upon my return to work I was informed of the error. I was mortified that I had misread the doctor's writing and given incorrect medication. I was thankful that I had given [Mr A] a Med Info sheet and that he was able to identify that the medication was not the pain relief Tramadol that he was expecting.
I wrote a letter of apology to [Mr A] and enclosed petrol vouchers for $30.00 to assist [Mrs A] with costs associated with her return to [the pharmacy] (enclosed). I did not contact [Mr A] by telephone as I did not have a contact number, although in hindsight I could have checked with telephone directory services.
[Mrs A] returned 30 x ½ tablets to the pharmacy on Monday 21 June, which suggests that [Mr A] in fact did not consume any of the medication and that the dispensing error may have been discovered when he went to take the first dose.
I am not denying that I made an error, just that there seems to be some conflicting information regarding the consumption of any medication and therefore the possible side effects that were alleged.
I did follow the standard Dispensing procedures of the pharmacy (a copy enclosed) and was the only pharmacist present at that time.
The dispensing error occurred due to the misreading of the doctor's handwriting. Reading the prescription as Trandate 50mg not Tramadol 50 mg, due to the small handwriting from a doctor I had not seen very often, if at all.
We have appropriate checking systems in place, the problem here was the doctor's writing and being unable to contact him.
I [Mr B] dispensed the prescription on the 21 of June 2004 and realised the consequences to [Mr A] and I am truly sorry for any undue pain caused to him.
To prevent errors with hard to read handwriting, the prescriptions are not to be dispensed until clarification can be sought from the prescriber.
If errors are made we try to contact the patient as soon as the error is known. Talk to the patient and assess the patient's needs, help them to resolve and minimise any danger to the patient. Advise them of their rights and record the details in an incident report."
Mr B has accepted full responsibility for dispensing the wrong medication. He acknowledged that in hindsight, irrespective of whether Dr C was available, he could have clarified Mr A's prescription with the nursing staff at the public hospital.
Standard operating procedure
The pharmacy's Standard Operating Procedure applicable at the time stated:
- To describe the procedure to follow to check a dispensed medication against the prescription.
- The Pharmacist
- Prescriptions are to be checked only by pharmacists.
- Check the dispensed medicine against the prescription for:
- Label accuracy.
- Medicine dose and form.
- Contain the date of birth for a child under 13.
- C&A labels.
- Contents accuracy
- Correct medicine
- Correct dose
- Correct form and quantity
- Dispenser and checker to be identified on all prescriptions - stamp each prescription with the 'dispenser/checker' stamp and sign in the appropriate box.
- Checks are to be made at each step in dispensing, to help eliminate errors - (refer to PP1.01.10.1, The New Zealand Hospital Pharmacist Guidelines for minimising dispensing errors).
Created by: Mr B Date : 04/04
Approved by: Mr B Date : 04/04
Review date : 04/05."
Code of Health and Disability Services Consumers' Rights
The following Rights in the Code of Health and Disability Services Consumers' Rights are applicable to this complaint:
Right to Services of an Appropriate Standard
2) Every consumer has the right to have services provided that comply with legal, professional, ethical, and other relevant standards.
Other relevant standards
The Pharmaceutical Society of New Zealand Pharmacy Practice Handbook 2003 states:
"Principle 2: Beneficence 2.6
The pharmacist who is responsible for dispensing of the prescription must verify its authenticity, interpret and evaluate the prescription, ensure that it is correct and complete, assess the suitability of the patient within the limitations of available information, and dispense it correctly."
Standard 6 Services: Principle 6.2
"A pharmacist maintains a disciplined dispensing procedure which ensures that the appropriate product is selected and dispensed correctly and efficiently."
The Medicines Act 1981, section 18 states:
"(2) No person may sell by retail any prescription medicine otherwise than under a prescription given by a practitioner, registered midwife, veterinarian, or designated prescriber."
Opinion: Breach - Mr B
Under Right 4(2) of the Code of Health and Disability Services Consumers' Rights (the Code), Mr A had the right to pharmacy services of an appropriate standard and that met professional and ethical standards. The standards that apply in this case are determined by the Pharmaceutical Society of New Zealand (the Society). Standard 6 of the Society's practice guidelines places a duty on the pharmacist to maintain a disciplined dispensing procedure, and Principle 2.2.6 holds the dispensing pharmacist responsible for ensuring that the appropriate product is selected and dispensed correctly. These requirements have been incorporated into the pharmacy's dispensing procedures.
On 19 June 2004, Mr B was the dispensing pharmacist who dispensed Mr A's medication. The prescription read 50mg tramadol. Mr B acknowledged that he had misread the handwriting on the prescription as 50mg Trandate. I accept that the pharmacy was busier than usual as it was a Saturday, and that Mr B had several customers to attend to, being the only pharmacist on duty.
Mr B's suspicions about the medication were aroused when he noted that the prescription was for Trandate 50mg, as Trandate 50mg tablets had not been available for a number of years. As the neighbouring pharmacy did not have any Trandate 50mg, Mr B used his own supply of 100mg Trandate, which he cut in half to correspond with the dose prescribed. He told Mrs A that he would check with Dr C before dispensing the medication, but did not do so when she stated that it was likely that Dr C had left the hospital for the day. Mr B has accepted full responsibility for the error, and acknowledged that irrespective of Dr C's availability, he could have clarified Mr A's prescription with the nursing staff at the hospital.
Mr B initialled the prescription after checking the medication name and Mr A's details, in accordance with the pharmacy's standard of practice. However, because Mr B was under the mistaken impression that the prescription was for Trandate, he incorrectly dispensed medication for treating hypertension. In my view, because there was doubt about the identity of the medication, as indicated by its unusual dosage, Mr B should have taken steps to clarify the purpose of the medication with either Mrs A, Dr C, or nursing staff at the public hospital.
Mr B's dispensing error constituted a breach of section 18(2) of the Medicines Act 1981, in that he supplied medicine otherwise than that pursuant to a prescription given by a medical practitioner.
It is clear that Mr B did not correctly dispense tramadol as prescribed, in accordance with professional and ethical standards set by the Pharmaceutical Society of New Zealand. In these circumstances, Mr B breached Right 4(2) of the Code.
Opinion: No breach - The Pharmacy Company
In addition to any direct liability for a breach of the Code, employers may be vicariously liable under section 72(2) of the Health and Disability Commissioner Act 1994 for any breach of the Code by an employee. Under section 72(5), it is a defence for an employing authority to prove that it took such steps as were reasonably practicable to prevent the employee from doing, or omitting to do, that which breached the Code.
Mr B is a director of the pharmacy, which is owned by the pharmacy company. On learning of his error, Mr B reviewed the procedures to determine whether the incident could have been avoided. Mr B simply misread the handwritten prescription, and has acknowledged that he should have enquired with the prescriber before dispensing the medication to Mr A.
I have reviewed the standards of practice operating at the pharmacy company at the time, and am satisfied that the pharmacy's standards comply with those set by the Pharmaceutical Society of New Zealand. I accept that the dispensing error in this case resulted from a human error by Mr B and was not due to a systems failure. Accordingly, in my opinion the pharmacy is not vicariously liable for Mr B's breach of Right 4(2) of the Code.
Non-referral to Director of Proceedings
After learning about the dispensing error, Mr B apologised to Mr A in writing, expressing regret and remorse for his actions. I commend Mr B on his prompt and unreserved admission of responsibility.
Mr B has reviewed his practice and the pharmacy's dispensing policies following his dispensing error.
In light of these circumstances, and taking into account Mrs A's express advice that she simply wanted the circumstances of the dispensing error to be investigated to prevent future recurrences, and that she did not want Mr B to be subjected to punitive measures, I have decided not to refer the matter to the Director of Proceedings for consideration of disciplinary proceedings.
- A copy of my final report will be sent to the Pharmacy Council of New Zealand.
- A copy of my final report, with details identifying the parties removed, will sent to the Pharmaceutical Society of New Zealand Incorporated, and placed on the Health and Disability Commissioner website, www.hdc.org.nz, for educational purposes.
Appendix 1 [see pdf for scanned image]
Appendix 2 [see pdf for scanned image]
See Re PR (Decision of the Disciplinary Committee of the Pharmaceutical Society of New Zealand, 8 May 2002).