APPENDIX extracts from the expert report of Mr Jack Leigh
In my opinion, based on the dispensing history of Late Night Chemist Auburn, the supply of Fentanyl to Patient A does not accord with the recognised therapeutic standard of what is appropriate in the circumstances and I clarify this statement as follows:-
From the dispensing record of Patient A, Zydol (Tramadol) SR 200mg 1 daily, was first dispensed on 17/11/2013 with a subsequent prescription dispensed almost a year later on 24/10/14 at the same dosing schedule. Next dispensing for an analgesic at this pharmacy was for Durogesic (Fentanyl) 50 patches which occurred Two months later on 17/12/14.
Fentanyl is not considered first line treatment for opioid naive patients with chronic pain (Therapeutic Guidelines Analgesic Version 6 2012) and is not recommended for opioid naive patients with non-cancer pain due to cases of hypoventilation and death (Durogesic Product Information (PI) 15/01/14). Furthermore, in circumstances where it is considered appropriate for opioid naive patients to use Fentanyl, it is recommended that patients first be titrated with low doses of immediate release opioids to receive an equianalgesic dose of not more than Fentanyl 25mcg/hour before conversion to Fentanyl patches (Durogesic PI 2014).
While Tramadol is classified as an opioid analgesic, it has relatively weak affinity to the mu opioid receptors and the misuse potential appears to be low (AMH 2012 p. 58). Also, Tramadol does not appear on the Equianalgesic table potency conversion table within the Durogesic Product Information (PI) 2014.
From the above information a pharmacist, before dispensing the first Durogesic 50 script, should have known that this dose is reserved for opioid dependent patients and is considered a higher than normal initiating dose (Durogesic PI 2014) so a pharmacist should have considered whether the use of the medicine was appropriate and not excessive (Code of Conduct for Health Practitioners March 2014 Paragraph 5.2)
This would have consisted of clarifying with the prescribing doctor whether the patient had been initiated with Fentanyl outside of the pharmacy and, if so, confirmed that the dosing schedule was correct. If no prior initiation of opioids then a pharmacist should have discussed the above information with the prescribing doctor to provide good care for the patient through shared decision making (Code of Conduct 2012 p.1, Overview).
There was then a break in dispensing until 24th March 2015 when the next Durogesic 50 script was dispensed. Due to the three month time lag, the pharmacy should have treated the Patient A as a new patient and gone through the same procedure as above before dispensing the medication.
There was a further break in dispensing until 6th May and again until the 3rd June. A further break occurred between the 9th December and 13th January 2015. On each occasion the above procedure should have been carried out.
On 10th June 2015 and 15th September 2015 Sertraline 100mg, a SSRI, was dispensed. Fentanyl is a drug that may contribute to serotonin toxicity (AMH 2012 p.747) and the combination should be avoided or closely monitored (AMH 2012 p.750). The doctor should have been contacted for clarification.
On two occasions the directions for use were not provided except for as directed. (see above)
As a pharmacist and proprietor of the pharmacy since 2002, Dr. Abdalla should have been aware of the Guidelines on responsibilities of pharmacists when practicing as proprietors, 29th January 2013, which states that a proprietor pharmacist must maintain an awareness of the standards published by the profession. Therefore he should have maintained an active interest in the practice of pharmacy and known that he could not delegate his professional responsibility (Guidelines for proprietor pharmacists 2nd September 2015). However, as he stated in his interview with the PRU (28th April 2016 p.73 paragraph 40) he only did some administration such as payments and superannuation in terms of the day to day running.
Each of the above occasions required the pharmacist to consider the safeguards above before dispensing to ensure good patient care and a clinical intervention noted.
From the above, I consider that Dr Abdulla's lack of oversight caused his conduct as a pharmacist and proprietor of the pharmacy to fall significantly below the standard reasonably expected of a practitioner of an equivalent level of training and experience and invites my strong criticism.
…
Based on the dispensing history of Late Night Chemist Auburn, the supply of Fentanyl to Patient B does not accord with the recognised therapeutic standard of what is appropriate in the circumstances and I clarify this statement as follows:-
First dispensing at this pharmacy for Durogesic (Fentanyl) 100 patches occurred on 28th April 2014.
Fentanyl is not considered first line treatment for opioid naive patients with chronic pain (Therapeutic Guidelines Analgesic Version 6 2012) and is not recommended for opioid naive patients with non-cancer pain due to cases of hypoventilation and death (Durogesic Product Information (PI) 15/01/14). Furthermore, in circumstances where it is considered appropriate for opioid naive patients to use Fentanyl, it is recommended that patients first be titrated with low doses of immediate release opioids to receive an equianalgesic dose of not more than Fentanyl 25mch/hour before conversion to Fentanyl patches (Durogesic PI 2014).
From the above information a pharmacist, before dispensing the first Durogesic 100 script, should have known that this dose is reserved for opioid dependent patients and is considered a higher than normal initiating dose (Durogesic PI 2014) so a pharmacist should have considered whether the use of the medicine was appropriate and not excessive (Code of Conduct for Health Practitioners March 2014 Paragraph 5.2)
This would have consisted of clarifying with the prescribing doctor whether the patient had been initiated with Fentanyl outside of the pharmacy and, if so, confirming that the dosing schedule was correct. If no prior initiation of opioids then a pharmacist should have discussed the above information with the prescribing doctor to provide good care for the patient through shared decision making (Code of Conduct 2012 p.1, Overview).
The next dispensing of Fentanyl 100 patches occurred over one year later on the 15th May 2015 and due to the long interval between scripts a pharmacist should have treated this dispensing as if for a new patient and a clinical intervention inserted to confirm that the patient had been continuing opioid treatment away from the pharmacy and therefore the prescription was appropriate.
It is noted that between the 15th May 2015 and 24th November 2015, Fentanyl appears to have been prescribed by five different doctors and in three different strengths. The pharmacist should have considered that it is better for the patient to have only one doctor responsible for prescribing and monitoring a patient's opioid use (Oxycontin PI 2011 p.4) There is also one occasion when the interval of repeat was only 4 days (31st August and 5th September 2015) and two occasions with 10 and 11 day intervals. The pharmacist should have considered the possibility that the patient was struggling with pain control or possibly abusing the opioid because Fentanyl has the potential to be abused by ingestion or injection and has led to deaths as a result (Durogesic PI 2012 p.7). Furthermore it is also known to have been diverted for sale on the street at a price of over $100 per patch (The Age 19/10/2012).
On three occasions the directions for use were not provided except for apply as directed or simply as directed.
Durogesic 50 was last dispensed on 24th November 2015 and there is a gap until 9th April 2016 when the patient presented with a prescription for Oxycontin MR 10mg with a dosing schedule of one daily when required. Due to the long interval between scripts a pharmacist should have treated the dispensing for the Oxycontin as if for a new patient especially as the patient had been prescribed Durogesic several months previously.
The pharmacist would need to clarify with the prescribing doctor, who had previously supplied Patient B with Durogesic, whether the patient had been initiated with Oxycontin outside of the pharmacy because Oxycontin, as a controlled release tablet, is not recommended for initial stabilisation or acute pain (AMH 2012 p.56). The pharmacist should also have known that there is a significant difference in potency between the Two medications with Durogesic 50 being equivalent of 135-224mg of oral morphine per day as a recommended starting dose and with patients on stable and well tolerated opioid therapy this equivalence is still only reduced to 90-149mg of oral morphine per day. This compares with 10mg Oxycontin a day being equivalent to 15mg of daily oral morphine (Durogesic PI 15/01/2014 p.18).
The pharmacist could also confirm that the strength and the unusual dosing schedule were correct as Oxycontin MR 10mg is usually used as a starting dose for opioid naive patients or patients presenting with severe pain uncontrolled by weaker opioids and the dosing schedule is twice daily, not on a once daily when needed basis (Oxycontin PI September 2014 p.12).
On two occasions the directions for use were not provided except for as directed (see above)
Each of the above occasions required the pharmacist to consider the safeguards above before dispensing to ensure good patient care and clinical interventions noted.
As a pharmacist and proprietor of the pharmacy since 2002, Dr. Abdalla should have been aware of the Guidelines on responsibilities of pharmacists when practicing as proprietors, 29th January 2013, which states that a proprietor pharmacist must maintain an awareness of the standards published by the profession. Therefore he should have maintained an active interest in the practice of pharmacy and known that he could not delegate his professional responsibility (Guidelines for proprietor pharmacists 2nd September 2015). However, as he stated in his interview with the PRU (28th April 2016 p.73 paragraph 40) he only did some administration such as payments and superannuation in terms of the day to day running.
From the above, I consider that Dr Abdulla's lack of oversight caused his conduct as a pharmacist and proprietor of the pharmacy to fall significantly below the standard reasonably expected of a practitioner of an equivalent level of training and experience and invites my strong criticism.
…
Based on the dispensing history of Late Night Chemist Auburn, the supply of Fentanyl, Buprenorphine and Oxycodone to Patient C does not accord with the recognized therapeutic standard of what is appropriate in the circumstances and I clarify this statement as follows:-
First dispensing at the pharmacy for 28 Oxycontin 80mg tablets occurred on 13th September 2011. As Oxycontin 80mg should only be given to opioid dependent patients to prevent fatal respiratory depression in opioid naïve patients (Oxycontin PI 2011 p.10), a pharmacist, before dispensing this script, should have contacted the prescribing doctor to clarify whether the patient had been initiated with Oxycontin MR 80mg outside of the pharmacy. Dosing schedule of 12 hourly is normal (Oxycontin PI 2011 p.10). On the same day the patient was also prescribed 20 Tramal SR 200mg with a dosing schedule of one tablet twice daily when required. This is considered the maximum daily dose of Tramal (AMH 2012 p.58) Tramal controlled release tablets are not recommended for acute pain management as slow onset and offset make rapid and safe titration impossible (AMH 2012 p.58) so the discussion with the doctor would have clarified the need for the Tramal as well as the "when needed" dosing. In fact a trial of Tramal SR 200mg twice daily is recommended before trying other opioids (AMH 2012 p.58).
If no prior initiation of opioids then a pharmacist should have discussed the above information with the prescribing doctor to provide good care for the patient through shared decision making (Code of Conduct 2012 p.1, Overview). This would also ensure that the service provided was appropriate for the assessed needs of the patient and not excessive (Code of Conduct for pharmacists March 2014 p.16 paragraph 5.2a)
Two days after the initial dispensing on the 13th September 2011 a second prescription was dispensed for 28 Oxycontin 80mg and 20 Tramal SR 200mg. As the Oxycontin supplied 2 days earlier was a 14 day supply and the Tramal SR 200mg a minimum of 10 days' supply, a pharmacist should have immediately questioned the need for a second dispensing, especially as Oxycontin can cause physical dependence and was known to be drug of abuse (Oxycontin PI 2011 p.5 and p. 10) with a high street value (The Age 19/10/2012)
Before dispensing either script a pharmacist should have contacted the prescribing doctor to clarify the reason for the second script and from the information obtained decide if the service provided by the doctor was appropriate. If not satisfied with the discussion then the pharmacy should refuse supply.
Significantly early dispensing of Oxycontin 80mg occurred on 3 further occasions, between 20th December 2011 and 5th March 2012, but, as above, no clinical interventions have been provided to explain these anomalies. Ditto for the script for 40 Tramal SR 200mg on 11th October 2011 for $45 which was for a quantity that constituted a private script and more than 3 times the price for 2 lots of 20 Tramal SR 200mg on the PBS. This should have alerted the pharmacy to appropriate dispensing by the doctor and the appropriateness of supply by the pharmacy.
On the 15th October 2012 the pharmacy dispensed a script for 28 Oxycontin 80mg as a private script, charging the patient $105.00 (this is about 20 times more than the patient would normally pay). Also the period of dispensing was 21 days after the previous dispensing for the normal 14 days' supply which doesn't match up to the patients usual dispensing timetable. As Oxycontin could cause physical dependence and was known to be drug of abuse (Oxycontin PI 2011 p.5 and p. 10) with a high street value (The Age 19/10/2012) the pharmacist should have contacted the prescribing doctor to clarify the long time frame between scripts and the reason for prescribing it as a private prescription. Again this should have alerted the pharmacy to appropriate dispensing by the doctor and the appropriateness of supply by the pharmacy
The first script for 5 Fentanyl 50 patches was dispensed on 23rd February 2012 which was over three months after the final Oxycontin 80mg script had been dispensed and One day after a short acting Oxycodone (Endone) had been dispensed.
Due to the long interval between the Oxycontin and Fentanyl scripts a pharmacist should have treated the dispensing on the 23rd February 2012 as if for a new patient and clarified with the prescribing doctor whether the patient had been continuing opioid treatment away from the pharmacy as a pharmacist should have known that this Fentanyl dose is reserved for opioid dependent patients and is considered a higher than normal initiating dose (Durogesic PI 2014).
Two days later a script was dispensed for 2 Norspan 20mcg patches, another opioid analgesic, and four days later 5 Fentanyl 100 patches were dispensed. A pharmacist should have immediately contacted the prescribing doctor to clarify the reasons for the short time span between prescriptions and the mixing of these two opioids. The combination can not only increase the risk of respiratory depression (AMH 2014 p.950) but Norspan can block the therapeutic effects of other opioids which may reduce analgesia or precipitate withdrawal symptoms in opioid dependent people. It is advised to avoid this combination (AMH 2014 p.950). Furthermore a pharmacist should have considered the large difference in the potency of the Two opioids as a 20mcg/hr Norspan patch is less potent than a Fentanyl 12mcg/hr patch (AMH 2012 p.48)
Furthermore the pharmacist should have checked with the doctor and the patient about the whereabouts of the remaining Durogesic 50 patches as two of these could have been used instead of one Durogesic 100 patch (Durogesic PI 2014 p.19).This is because Fentanyl patches have the potential to be abused by ingestion or injection and has lead to deaths as a result (Durogesic PI 2012 p.7). It is also known to have been diverted for sale on the street at a price of over $100 per patch based on the 2012 price (The Age 19/10/2012)
Between 23rd February 2012 and 11th November 2015, Five Fentanyl patches, equal to fifteen days supply, were dispensed many times but with many anomalies.
• On several occasions prescriptions were dispensed well before the due date, and example being on 28th November 2013 and 2nd December 2013, a gap of only 4 days and each occasion should have alerted the pharmacy to appropriateness of supply
• Between 8th October 2014 and 28th January 2015 there was a three month gap in the dispensing history of Fentanyl patches
• On four occasions Patient C was charged privately for Fentanyl scripts and each occasion should have alerted the pharmacy to appropriateness of supply
• On approximately twenty occasions Fentanyl scripts were dispensed without adequate directions for use (see above)
• On 14th May 2013 and 23rd August 2013 the pharmacy dispensed prescriptions for Antenex 5mg prescribed by another doctor. A pharmacist should have known that Fentanyl and Diazepam are not a recommended combination as Diazepam may also cause respiratory depression thereby exacerbating the effect from the Fentanyl. Antenex may also cause dependence (AMH 2012 p.778)
• Tramal SR 200mg tablets were regularly dispensed yet Tramal controlled release tablets are not recommended for acute pain management as slow onset and offset make rapid and safe titration impossible (AMH 2012 p.58).
• On three occasions the pharmacy dispensed prescriptions for Aurorix 300mg whilst the patient was taking Fentanyl patches. A pharmacist should have known that this combination is contraindicated due to the possibility of causing Serotonin toxicity (AMH 2012 p.909).
Each of the above occasions required the pharmacist to consider the safeguards above before dispensing to ensure good patient care and clinical interventions noted.
As a pharmacist and proprietor of the pharmacy since 2002, Dr. Abdalla should have been aware of the Guidelines on responsibilities of pharmacists when practicing as proprietors, 29th January 2013, which states that a proprietor pharmacist must maintain an awareness of the standards published by the profession. Therefore he should have maintained an active interest in the practice of pharmacy and known that he could not delegate his professional responsibility (Guidelines for proprietor pharmacists 2nd September 2015). However, as he stated in his interview with the PRU (28th April 2016 p.73 paragraph 40) he only did some administration such as payments and superannuation in terms of the day to day running.
From the above, I consider that Dr Abdulla's lack of oversight caused his conduct as a pharmacist and proprietor of the pharmacy to fall significantly below the standard reasonably expected of a practitioner of an equivalent level of training and experience and invites my strong criticism.
…
However, based on the dispensing history of Late Night Chemist Auburn, the supply of other medicines to Patient D does not accord with the recognized therapeutic standard of what is appropriate in the circumstances and I clarify this statement as follows:-
First dispensing of Diazepam occurred on the 20th June 2014 together with Mirtazapine. As both medications may cause sedation (AMH 2012 p.759 and p.779) a pharmacist should have contacted the prescribing doctor to clarify the prescriptions.
On the 10th September 2014 the pharmacy dispensed 50 Diazepam 5mg with a dose of 2 twice daily when needed and 25 Oxazepam 30mg with a dose of 1 daily which from subsequent information is a night time dose. As both of these medications are benzodiazepines a pharmacist should have assessed the need for two medicines from the same class to be dispensed together, especially as the patient had also been dispensed Mirtazapine on the 29th August. Each of these three medications causes drowsiness and the patient could be adversely affected through the additive effect. They should also have taken into consideration the fact that although Oxazepam is classified as short acting, with a half life of 6-12 hours and Diazepam is classified as long acting, with a half life of greater than 24 hours, Diazepam has a rapid onset of action which again raises the question of the need for the two to be dispensed together (AMH 20012 p.779). Furthermore Mirtazapine has a sedative action which may be useful in depression where insomnia is a feature (AMH 2012 p.760) again raising questions about the need for another hypnotic.
A pharmacist should have had strong reservations about dispensing these three medications at the same time so the prescribing doctor should have been contacted to clarify the prescriptions. If not satisfied with the outcome of the discussion with the doctor, a pharmacist should refuse supply.
Subsequent Diazepam and Oxazepam scripts were dispensed nine days later by the same doctor, four days after that from another doctor (not known if from the same practice) and again seven days after that by the first doctor. All of these should again have raised a warning flag with the pharmacy about the interval of supply as Patient D should still have ample supplies of the above medicines. The pharmacist should have been aware that benzodiazepines have the potential to be abused and can cause dependency if used for more than 2-4 weeks (AMH 2012 p. 779). Furthermore they should be reserved for short term use, 2-4 weeks, and should be part of a broader treatment plan (AMH 2012 p. 779). The pharmacist should have considered whether Patient D fitted into this category. On each occasion the doctors should have been contacted as above including notification of possible doctor shopping, refusal of supply considered and a clinical intervention recorded.
First dispensing at this pharmacy of Norspan 10mcg/hr patches occurred on 11th March 2015 a break of six months since the previous dispensing. A pharmacist should have considered the previous history of the patient with relation to benzodiazepine usage, the fact that Norspan is not considered a first line treatment for analgesia (AMH 2012 p.47) and that the commencing dose for Norspan in opioid naïve patients is 5mcg/hour patches. The prescribing doctor should have been contacted to clarify the prescription.
On 24th March 2015, thirteen days later, the pharmacy dispensed Oxazepam and Diazepam scripts. From the past history of the patient concerning the same Two benzodiazepines and the fact that they and Norspan are not a recommended combination due to possible significant respiratory depression (Norspan PI 2014 p.7) the pharmacist should have been highly alert to the ramifications of dispensing these medications. The pharmacist should therefore have contacted the doctor to clarify the prescriptions and if not satisfied with the outcome of the discussion supply should have been refused.
First dispensing of Durogesic (Fentanyl) 50 patches occurred on 3rd April 2015.
This represented a three week gap in the dispensing history since the patient had received two weeks supply of the Norspan 10mcg/hr. The pharmacist should have contacted the doctor to clarify the reason for the gap and at the same time discussed the continuing use of the two benzodiazepines as well as the fact that the Durogesic 50 Patches constituted a substantial increase in strength of opioid over the Norspan 10mcg/hr (AMH 2012 p.48) and was considered a higher than normal initiating dose (Durogesic PI 2014).
From 3rd April 2015 until 2nd September 2015 there was continued dispensing of the two benzodiazepines and the Fentanyl but with other anomalies as below:-
• Short intervals of supply for the Durogesic especially on April 14th, 21st April, 1st , 8th, 12th May 29th May 5th June, 12th June
• Short intervals of supply for the benzodiazepines especially on 3rd, 14th 21st April and 1st 8th May and 26th and 29th June
The pharmacist should have been aware that Fentanyl patches have the potential to be abused by ingestion or injection and has lead to deaths as a result (Durogesic PI 2012 p.7). It is also known to have been diverted for sale on the street at a price of over $100 per patch, based on the 2012 price (The Age 19/10/2012). Also that benzodiazepines may cause dependence and may be abused (AMH 2012 p.779)
On the 10th September 2015, five months on from receiving a regular supply of Durogesic 50 and 75 patches, the patient was dispensed 2 Norspan 10 patches only seven days after receiving 15 Durogesic 50 patches. This again should have raised questions with the pharmacist about the reason for the sudden change by the doctor especially because the Norspan was significantly weaker than the Durogesic and could precipitate opioid withdrawal symptoms (AMH 2012 p.48) Before dispensing the pharmacist should have contacted the doctor for clarification and if not satisfied with the discussion the pharmacist should have refused supply.
Six days later on 16th September 2015 the pharmacy dispensed another script for Durogesic 50 which in light of the above would again have created doubts about the safety of the patient as above.
The Antenex, Durogesic and Mirtazapine continued to be dispensed to the patient at regular intervals until 13th January 2016.
On four occasions the directions for use were not provided except for apply as directed or simply as directed.
Each of the above occasions required the pharmacist to consider the safeguards above before dispensing to ensure good patient care and clinical interventions noted.
As a pharmacist and proprietor of the pharmacy since 2002, Dr Abdalla should have been aware of the Guidelines on responsibilities of pharmacists when practicing as proprietors, 29th January 2013 which states that a proprietor pharmacist must maintain an awareness of the standards published by the profession. Also Dr Abdalla should have maintained an active interest in the practice of pharmacy and known that he could not delegate his professional responsibility (Guidelines for proprietor pharmacists 2nd September 2015). However, as he stated in his interview with the PRU (28th April 2016 p.73 paragraph 40) he only did some administration such as payments and superannuation in terms of the day to day running.
In addition, Dr Abdalla as proprietor of the pharmacy should have had systems in place for raising concerns about risks to patients (Code of conduct for health practitioners July 2012 p.10 paragraph 6.2d)
From the above, I consider that Dr Abdulla's lack of oversight caused his conduct as a pharmacist and proprietor of the pharmacy to fall significantly below the standard reasonably expected of a practitioner of an equivalent level of training and experience and invites my strong criticism
…
Based on the dispensing history of Late Night Chemist Auburn, the supply of Fentanyl to Patient E does not accord with the recognized therapeutic standard of what is appropriate in the circumstances and I clarify this statement as follows:-
From the dispensing record of Patient E, first dispensing at this pharmacy of Durogesic (Fentanyl) 75 patches occurred on 25th July 2014.
Fentanyl is not considered first line treatment for opioid naive patients with chronic pain (Therapeutic Guidelines Analgesic Version 6 2012) and is not recommended for opioid naive patients with non-cancer pain due to cases of hypoventilation and death (Durogesic Product Information (PI) 15/01/14). Furthermore, in circumstances where it is considered appropriate for opioid naive patients to use Fentanyl, it is recommended that patients first be titrated with low doses of immediate release opioids to receive an equianalgesic dose of not more than Fentanyl 25mcg/hour before conversion to Fentanyl patches (Durogesic PI 2014).
From the above information a pharmacist should have known that this dose is reserved for opioid dependent patients and is considered a higher than normal initiating dose (Durogesic PI 2014) so a pharmacist should have considered whether the use of the medicine was appropriate and not excessive (Code of Conduct for Health Practitioners March 2014 Paragraph 5.2) and taken all reasonable steps to address the issue if reason to think that the safety of the patient could be compromised (Code of Conduct for Health Practitioners March 2014 Paragraph 6.2F).
As there was no previous dispensing history of analgesics to patient E a pharmacist, before dispensing the first Durogesic 75 script, should have clarified with the prescribing doctor whether the patient had been initiated with Fentanyl outside of the pharmacy and, if so, confirmed that the dosing schedule was correct. If no prior initiation of opioids then a pharmacist should have discussed the above information with the prescribing doctor to provide good care for the patient through shared decision making (Code of Conduct 2012 p.1, Overview). This would also ensure that the service provided was appropriate for the assessed needs of the patient and not excessive (Code of Conduct for pharmacists March 2014 p.16 paragraph 5.2a)
In the dispensing history of Patient E there is a time period of three weeks between 8th and 29th August 2014 when no Fentanyl 75 was dispensed. As the normal length of supply is 15 days the pharmacist should have contacted the doctor to confirm continuity of supply outside the pharmacy or current status of the patient. There is a long gap between 30th January and 8th May 2015 when no dispensing of Durogesic 75 occurred. The pharmacist should have treated the dispensing on the 8th May 2015 as if for a new patient and clarified the appropriateness of the prescription as above.
On one occasion the directions for use were not provided except for apply as directed or simply as directed.
Each of the above occasions required the pharmacist to consider the safeguards above before dispensing to ensure good patient care and clinical interventions noted.
As a pharmacist and proprietor of the pharmacy since 2002, Dr Abdalla should have been aware of the Guidelines on responsibilities of pharmacists when practicing as proprietors, 29th January 2013 which states that a proprietor pharmacist must maintain an awareness of the standards published by the profession. Also Dr Abdalla should have maintained an active interest in the practice of pharmacy and known that he could not delegate his professional responsibility (Guidelines for proprietor pharmacists 2nd September 2015). However, as he stated in his interview with the PRU (28th April 2016 p.73 paragraph 40) he only did some administration such as payments and superannuation in terms of the day to day running.
In addition, Dr Abdalla as proprietor of the pharmacy should have had systems in place for raising concerns about risks to patients (Code of conduct for health practitioners July 2012 p.10 paragraph 6.2d)
From the above, I consider that Dr Abdulla's lack of oversight caused his conduct as a pharmacist and proprietor of the pharmacy to fall significantly below the standard reasonably expected of a practitioner of an equivalent level of training and experience and invites my strong criticism
…
Based on the dispensing history of Late Night Chemist Auburn, the supply of Fentanyl to Patient F does not accord with the recognized therapeutic standard of what is appropriate in the circumstances and I clarify this statement as follows:-
First dispensing at this pharmacy was for Durogesic (Fentanyl) 75 patches which occurred on 28th March 2014.
Fentanyl is not considered first line treatment for opioid naive patients with chronic pain (Therapeutic Guidelines Analgesic Version 6 2012) and is not recommended for opioid naive patients with non-cancer pain due to cases of hypoventilation and death (Durogesic Product Information (PI) 15/01/14). Furthermore, in circumstances where it is considered appropriate for opioid naive patients to use Fentanyl, it is recommended that patients first be titrated with low doses of immediate release opioids to receive an equianalgesic dose of not more than Fentanyl 25mcg/hour before conversion to Fentanyl patches (Durogesic PI 2014).
From the above information a pharmacist, before dispensing the first Durogesic 75 script, should have known that this dose is reserved for opioid dependent patients and is considered a higher than normal initiating dose (Durogesic PI 2014) so a pharmacist should have considered whether the use of the medicine was appropriate and not excessive (Code of Conduct for Health Practitioners March 2014 Paragraph 5.2) and taken all reasonable steps to address the issue if reason to think that the safety of the patient could be compromised (Code of Conduct for Health Practitioners March 2014 Paragraph 6.2f).
As there was no previous dispensing history of analgesics to patient F a pharmacist would have clarified with the prescribing doctor whether the patient had been initiated with Fentanyl outside of the pharmacy and, if so, confirming that the dosing schedule was correct. If no prior initiation of opioids then a pharmacist should have discussed the above information with the prescribing doctor to provide good care for the patient through shared decision making (Code of Conduct 2012 p.1, Overview).
There are four elongated gaps in the patients dispensing history between 10th April 2014 and 27th August 2014 where the patient has not received a script within a period of 15 days which is the length of time a prescription would last. This should have been discussed with the prescribing doctor to check if the patient had been receiving scripts and was having them dispensed elsewhere to ensure that supply was still appropriate. This would also act as an alert in case the doctor had not been prescribing the medication to the fact that the patient may have been getting prescriptions from elsewhere.
On six occasions the directions for use were not provided except for as directed (see above)
Each of the above occasions required the pharmacist to consider the safeguards above before dispensing to ensure good patient care and clinical interventions noted.
As a pharmacist and proprietor of the pharmacy since 2002, Dr Abdalla should have been aware of the Guidelines on responsibilities of pharmacists when practicing as proprietors, 29th January 2013 which states that a proprietor pharmacist must maintain an awareness of the standards published by the profession. Also Dr Abdalla should have maintained an active interest in the practice of pharmacy and known that he could not delegate his professional responsibility (Guidelines for proprietor pharmacists 2nd September 2015). However, as he stated in his interview with the PRU (28th April 2016 p.73 paragraph 40) he only did some administration such as payments and superannuation in terms of the day to day running.
In addition, Dr Abdalla as proprietor of the pharmacy should have had systems in place for raising concerns about risks to patients (Code of conduct for health practitioners July 2012 p.10 paragraph 6.2d)
From the above, I consider that Dr Abdulla's lack of oversight caused his conduct as a pharmacist and proprietor of the pharmacy to fall significantly below the standard reasonably expected of a practitioner of an equivalent level of training and experience and invites my strong criticism
…
In my opinion, based on the dispensing history of Late Night Chemist Auburn, the supply of [Oxycodone and Temazepam] to Patient G does not accord with the recognised therapeutic standard of what is appropriate in the circumstances and I clarify this statement as follows:-
First dispensing for Patient G occurred on 13th September 2011 for 28 Oxycontin CR 20mg with a dose of One twice daily when needed together with 50 Antenex 2mg one at night when needed.
The pharmacist should have contacted the doctor to clarify whether the patient had been initiated with Oxycontin outside of the pharmacy because Oxycontin, as a controlled release tablet, is not recommended for initial stabilisation or acute pain (AMH 2012 p.56). The pharmacist could also confirm that the strength and the unusual dosing schedule were correct as Oxycontin MR 10mg is usually used as a starting dose for opioid naive patients or patients presenting with severe pain uncontrolled by weaker opioids and the dosing schedule is twice daily and not on a when needed basis (Oxycontin PI September 2014 p.12).
At the same time the pharmacist should have discussed the fact that Oxycontin and diazepam are both CNS depressants and that concurrent use may result in increased respiratory depression, profound sedation and coma (Oxycontin PI September 2014 p.9). The above would ensure that the service provided was appropriate for the assessed needs of the patient
On the 13th and 22nd September 2011 fourteen days' supply of Oxycontin CR 20mg were also dispensed with only a nine day interval and subsequently with an eight day interval on the 22nd and 30th September 2011. These shortened intervals should have alerted the pharmacist to the possibility that the patient may not be coping with his pain management and was taking additional tablets, and/or showing signs of dependency and possible abuse (Oxycontin PI 17th September 2014 p.5). A discussion should have been held with the doctor to clarify the situation so that the pharmacist could ensure that the service provided was appropriate for the assessed needs of the patient. If the pharmacist was not satisfied with the outcome of the discussion then supply should have been refused.
On 22nd September 2011 and 18th October 2011 the pharmacy dispensed 20 Codapane forte with a dose of one or two tablets four times a day plus, on 16th October 2011, a script for Tramadol SR 150mg one twice daily when needed.
The pharmacist should have considered that the need for breakthrough medication greater than twice a day would indicate that that the patient should be reassessed and if appropriate the Oxycontin dose increased (Oxycontin PI 17th September 2014). The doctor should therefore have been contacted to clarify the prescriptions and based on their discussions the pharmacy could decide if the service provided was appropriate.
Between 18th October 2011 and 2nd July 2012 regular scripts were dispensed for Oxycontin CR 20mg together with Antenex 2mg and Tramadol SR 200mg together with an occasional prescription for 20 Codapane Forte and one script for 20 Endone 5mg with a dose of one three times daily when needed. All of these medications may have a sedative effect plus these scripts should have highlighted the need by the pharmacist to consider the pain management of the patient as per the recommendations of the Oxycontin PI 2014 plus the fact that Diazepam is only recommended as a short term treatment of two to four weeks (AMH 2012 p.779). Therefore the pharmacist should have been in regular contact with the doctor and constantly assessed if the service provided was appropriate for the assessed needs of the patient. If the pharmacist was not satisfied with the outcome of the discussion then supply should have been refused.
On 16th July 2012 and 17th August 2012 25 Temazepam 10mg was dispensed together with 28 Oxycontin CR 20mg. As a benzodiazepine, the CNS depressant effects as above should again have been considered and the doctor contacted to clarify the prescription.
On the 6th November 2012 28 Oxycontin 20mg were dispensed. The same medication was then dispensed again one day later plus the second script was charged as a private prescription at almost eight times the price of a PBS prescription. As the Oxycontin supplied the previous day was a 14 day supply, a pharmacist should have immediately questioned the need for a second dispensing and the reason for the private prescription status, especially as Oxycontin can cause physical dependence and was known to be drug of abuse (Oxycontin PI 2011 p.5 and p. 10) with a high street value (The Age 19/10/2012). Therefore, before dispensing this second script a pharmacist should have contacted the prescribing doctor to clarify the reason for the second script and from the information obtained decide if the service provided by the doctor and subsequently the pharmacist was appropriate for the assessed needs of the patient and not excessive. If not satisfied then the pharmacist should have refused supply.
Between 7th November 2012 and 8th February 2013 there was a three month break in the supply of Oxycontin Cr 20mg and the first prescription dispensed was charged as a private prescription. The fact that the last prescription dispensed in November 2012 was also charged as a private prescription, plus the long delay between prescriptions, should again have alerted the pharmacist to question the prescribing doctor about the circumstances surrounding these scripts and from this discussion decide if the service provided by the doctor and subsequently the pharmacist was appropriate for the assessed needs of the patient and not excessive. If not satisfied then the pharmacist should have refused supply.
Oxycontin 20mg and Diazepam 2mg and 5mg scripts then continued to be dispensed at regular intervals until 22nd October 2013 when a prescription for 28 Oxycontin CR 20mg was dispensed followed by a second prescription for 28 reduced strength Oxycontin CR 10mg three days later. The pharmacist should have taken into consideration the previous occurrence on 6th November 2012 and raised their concern with the prescribing doctor and refused supply if not satisfied with the outcome of the discussion.
On 18th November 2013, after a further prescription of 28 Oxycontin CR 10mg was dispensed on 8th November, possibly indicating that the patient had reduced needs for opioid medication, the pharmacy dispensed a prescription for 5 Durogesic 50 patches with a dose of as directed. The pharmacist should have known that there is a great difference in potency between the two medications, with Durogesic 50 being equivalent of 90-149mg of oral morphine per day (patients on stable and well tolerated opioid therapy) versus 20mg Oxycontin a day being equivalent to 30mg of daily oral morphine (Durogesic PI 15/01/2014 p.18) and contacted the doctor about a possible over treatment leading to a possible opioid overdose and discussed the option of increasing the dose of Oxycontin as there is no ceiling dose unless adverse drug reaction occur (Oxycontin PI February 2011 p. 10) At the same time the pharmacist could have told the doctor that the script had inadequate instructions for dosing and needed to be corrected or re-written.
Eight days later and again ten days after that, two further scripts for 5 Durogesic 50, 15 days supply each, were dispensed with one again having inadequate dosing instructions. In light of previous short intervals of supply the doctor should have been contacted before the pharmacist dispensed these prescriptions and refusal of supply considered if no acceptable reason supplied by the doctor.
Six days later on 12th December 2013 the pharmacy dispensed 28 Oxycontin 20mg. The reduction in opioid dosage could lead to possible withdrawal symptoms and the fact that the patient would still have supply of Durogesic 50 patches in his possession would be grounds to contact the doctor before dispensing this script.
Between 28th January 2014 and 10th April 2014 28 Oxycontin 20mg was dispensed eight times, enough for 112 days. However the period of dispensing is only 75 days. Again this should have raised issues with the pharmacist about the frequency of dispensing and possible overuse, abuse or diversion of this medication.
There was then a gap of one month in opioid dispensing until 9th May which a pharmacist should have checked with the doctor closely followed by two 14 day scripts dispensed within a nine day period which again should have been checked by the pharmacist.
This was followed in September 2014 with two Oxycontin scripts being dispensed within 3 days of each other which should have again alerted the pharmacist to over treatment and possible abuse and or diversion by the patient.
During this whole period Diazepam 2mg or 5mg tablets were being dispensed which again should have been discussed with the doctor regarding prolonged usage and the possibly of additional CNS depression through the mixture of a benzodiazepine and an opioid.
There was another gap in the dispensing history between 26th September 2014 and 18th November 2014 which would necessitate the pharmacist contacting the doctor to confirm whether opioid dosing had continued outside of the pharmacy.
Oxycontin CR 20mg was regularly dispensed until 1st April 2016 with certain anomalies. These included short intervals between dispensing of both Oxycontin CR 20mg and Diazepam, a three month gap in Oxycontin dispensing between 7th December 2015 and 1st February 2016, a one month gap between 1st February 2016 and 7th March 2016 and ditto until 1st April 2016. All of which should have been checked by the pharmacy.
On every occasion outlined above, the pharmacist should have contacted the prescribing doctor and to clarify the situation so that the pharmacist could ensure that the service provided was appropriate for the assessed needs of the patient. If the pharmacist was not satisfied with the outcome of the discussion then supply should have been refused.
As a pharmacist and proprietor of the pharmacy since 2002, Dr Abdalla should have been aware of the Guidelines on responsibilities of pharmacists when practicing as proprietors, 29th January 2013 which states that a proprietor pharmacist must maintain an awareness of the standards published by the profession. Also Dr Abdalla should have maintained an active interest in the practice of pharmacy and known that he could not delegate his professional responsibility (Guidelines for proprietor pharmacists 2nd September 2015). However, as he stated in his interview with the PRU (28th April 2016 p.73 paragraph 40) he only did some administration such as payments and superannuation in terms of the day to day running.
In addition, Dr Abdalla as proprietor of the pharmacy should have had systems in place for raising concerns about risks to patients (Code of conduct for health practitioners July 2012 p.10 paragraph 6.2d)
From the above, I consider that Dr Abdulla's lack of oversight caused his conduct as a pharmacist and proprietor of the pharmacy to fall significantly below the standard reasonably expected of a practitioner of an equivalent level of training and experience and invites my strong criticism
…
In my opinion, based on the dispensing history of Late Night Chemist Auburn, the supply of [Fentanyl and Oxycodone] to Patient H does not accord with the recognized therapeutic standard of what is appropriate in the circumstances and I clarify this statement as follows:-
The first dispensing for 28 Oxycontin 40mg occurred on 13th January 2012 after Two prescriptions for analgesics in December 2011.
The pharmacy should have contacted the doctor to clarify whether the patient had been initiated with Oxycontin outside of the pharmacy because Oxycontin, as a controlled release tablet, is not recommended for initial stabilisation or acute pain (AMH 2012 p.56). The pharmacy could also confirm that the strength was correct as Oxycontin 10mg twelve hourly is the usual starting dose for opioid naive patients or patients presenting with severe pain uncontrolled by weaker opioids (Oxycontin PI February 2011 p.10).
The dispensing of the Oxycontin 20mg ten days later on 23rd January 2012 could signify that the patient had reduced needs for opioid medication or that the 40mg dose was causing adverse reactions yet one day later by a script for 5 Durogesic 75mcg patches with a dose of apply three HOURLY as directed was dispensed
The pharmacist should have known that there is a significant difference in potency between the two medications with Durogesic 75 being equivalent of 225-314 mg of oral morphine per day as a recommended starting dose. With patients on stable and well tolerated opioid therapy this equivalence is still only reduced to 150-209mg of oral morphine per day. This compares with 20mg Oxycontin a day being equivalent to 30mg of daily oral morphine (Durogesic PI 15/01/2014 p.18).
The pharmacy should have contacted the doctor about a possible over treatment and at the same time this should have reminded the pharmacist that the correct dosing interval for Durogesic was one patch every three days not every three hours.
In either case this could have prevented the incorrect labeling and possible overdosing which could have led to adverse effects for the patient.
Finally, in this instance, the pharmacy should have clarified that the patient understood not to combine the Oxycontin and Fentanyl as this could lead to increased respiratory depression, hypotension, profound sedation and coma (Oxycontin PI 2011 p.7) and a clinical intervention noted.
On 6th February 2012 the pharmacy dispensed a script for 5 Durogesic 100 patches followed ten days later by a script for only 14 Oxycontin 10mg and two days after that another script for Durogesic 100 with inadequate directions for use. Both of these dispensing should have been questioned by the pharmacy as the Oxycontin 10mg script is a substantial reduction in opioid strength (as above) followed by the much stronger opioid. The pharmacy should have known that If two opioids are used concurrently then additive CNS depression, respiratory depression and hypotension may occur (Oxycontin PI 2011 p. 8) adversely affecting the patient. Further, a pharmacist should have known that it is recommended to use small increments to titrate the correct dose (AMH 2012 p. 47)
Nine days later, on 27th February 2012 the patient was dispensed 50 Coumadin 1mg. The pharmacy should have been aware that opioids may potentiate the anticoagulant activity of warfarin (Oxycontin PI 2011 p.7) and the doctor contacted to confirm that he was aware of this possibility.
Between 6th February 2012 and 29th March 2012, a period of approximately 56 days Durogesic 100 was dispensed 6 times, equivalent to 90 days supply. This should have alerted the pharmacy to over prescribing by the doctor and the fact that the patient still required breakthrough analgesics on the 6th and 8th March should further have alerted the pharmacy to the fact that the patient was either struggling with pain control or possibly abusing the opioid because Fentanyl has the potential to be abused by ingestion or injection and has led to deaths as a result (Durogesic PI 2012 p.7). Furthermore it is also known to have been diverted for sale on the street at a price of over $100 per patch (The Age 19/10/2012).
On four of the six occasions there was inadequate dosing instructions for the Durogesic and the same procedure as above should have occurred.
The next dispensing of Durogesic 100 took place 6 months later on 28th September 2012. The pharmacy should have contacted the doctor to clarify the current opioid status of the patient and tell the doctor that there was inadequate dosing instructions.
On the 19th October 2012 the next opioid dispensing was for 28 Oxycontin 80mg. The pharmacy should have been aware of the potency differential between Fentanyl and Oxycontin and that a conservative oxycodone dose of approximately 10mg every twelve hours should be initially substituted for each 25mcg Fentanyl patch (Oxycontin PI February 2011 p. 11). Because of this there is a potential overdose and the doctor contacted for clarification. A further cause to alert the pharmacy to reflect on whether this supply accorded with recognised therapeutic standards pursuant to Clause 109 of the Poisons and Therapeutic Goods Regulation 2008, especially in light of the past dispensing history of the patient, was the fact that the dispensing was done as a private prescription which was very unusual. The doctor should have been contacted to clarify the situation and if no satisfactory explanation received the pharmacy has the duty to refuse supply.
There was then a further break in opioid dispensing until 8th March 2013 when the pharmacy dispensed a script for 28 Oxycontin 40mg with a dose schedule of one daily by an unknown doctor. Due to the previous dispensing history the doctor should have been contacted to confirm the opioid status of the patient and to discuss the dosing schedule as the total daily oral Oxycontin dose should be divided into two twelve hourly doses (Oxycontin Pi Feb 2011 p.11)
On 24th March 2013 the pharmacy dispensed a script for 28 Oxycontin 80mg with the same dosing of one daily written by the same unknown doctor. Again the doctor should have been contacted to confirm change of strength and dosing schedule.
Nine days later on 2nd April 2013 the pharmacy dispensed a script for Durogesic 100 by a third doctor. Again the pharmacy should have contacted the doctor to discuss the change of medication from the previous doctor due to the potency differential where even in patients on stable and well tolerated opioid therapy; Durogesic 100 is equivalent to 210¬269 mg/day of oral morphine against Oxycontin 80mg equivalency of 80mg/day of oral morphine (Durogesic PI 2014 p.18). Based on this evidence there is a possibility of an opioid overdose.
There is a further break in the dispensing history until 28th May 2013 when a script for Durogesic 100 was dispensed from the original doctor. Between 28th May 2013 and the final dispensing shown on 14th December 2015, Durogesic 100 followed by Durogesic 75 from 28th January 2015 onwards was dispensed on many occasions with breaks occurring between June and July 2013, October and December 2013 and April and August 2014. At each resumption of dispensing the same procedure of checking with the doctor should have been carried out and a clinical intervention noted.
During the above period there were thirteen occasions when inadequate dosing instructions were added to the dispensing label.
On every occasion outlined above, the pharmacist should have contacted the prescribing doctor and to clarify the situation so that the pharmacist could ensure that the service provided was appropriate for the assessed needs of the patient.
As a pharmacist and proprietor of the pharmacy since 2002, Dr. Abdalla should have been aware of the Guidelines on responsibilities of pharmacists when practicing as proprietors, 29th January 2013, which states that a proprietor pharmacist must maintain an awareness of the standards published by the profession. Therefore he should have maintained an active interest in the practice of pharmacy and known that he could not delegate his professional responsibility (Guidelines for proprietor pharmacists 2nd September 2015). However, as he stated in his interview with the PRU (28th April 2016 p.73 paragraph 40) he only did some administration such as payments and superannuation in terms of the day to day running.
In addition, Dr Abdalla as proprietor of the pharmacy should have had systems in place for raising concerns about risks to patients (Code of conduct for health practitioners July 2012 p.10 paragraph 6.2d)
From the above, I consider that Dr Abdulla's lack of oversight caused his conduct as a pharmacist and proprietor of the pharmacy to fall significantly below the standard reasonably expected of a practitioner of an equivalent level of training and experience and invites my strong criticism.
…
In my opinion, based on the dispensing history of Late Night Chemist Auburn, the supply of Fentanyl to Patient I does not accord with the recognised therapeutic standard of what is appropriate in the circumstances and I clarify this statement as follows:-
The first dispensing at this pharmacy for Patient I was for Durogesic (Fentanyl) 100 patches which occurred on 17th December 2013
Fentanyl is not considered first line treatment for opioid naive patients with chronic pain (Therapeutic Guidelines Analgesic Version 6 2012) and is not recommended for opioid naive patients with non-cancer pain due to cases of hypoventilation and death (Durogesic Product Information (PI) 15/01/14). Furthermore, in circumstances where it is considered appropriate for opioid naive patients to use Fentanyl, it is recommended that patients first be titrated with low doses of immediate release opioids to receive an equianalgesic dose of not more than Fentanyl 25mcg/hour before conversion to Fentanyl patches (Durogesic PI 2014).
From the above product information a pharmacist, before dispensing the first Durogesic 100 script, should have known that this dose is reserved for opioid dependent patients and is considered a higher than normal initiating dose (Durogesic PI 2014). There the pharmacy should have clarified with the prescribing doctor whether the patient had been initiated with Fentanyl outside of the pharmacy and, if so, confirming that the dosing was correct. If no prior initiation of opioids then a pharmacist should have discussed the above information with the prescribing doctor to provide good care for the patient through shared decision making (Code of Conduct 2012 p.1, Overview). This would also ensure that the service provided was appropriate for the assessed needs of the patient and not excessive (Code of Conduct for pharmacists March 2014 p.16 paragraph 5.2a)
As there was a gap in the patients dispensing history between 16th January 2014 and 26th May 2015, a period of over one year, the pharmacist should have treated the dispensing on the 26th May 2015 as if for a new patient and clarified the appropriateness of the prescription as above.
It is further noted that on the 17th June and 6th July 2015 the pharmacy received prescriptions from Dr Abdalla for 10 patches of Durogesic 100 which equates to 30 days supply for each script. This is outside the concessional PBS limits and therefore converted the prescriptions into private scripts. Also the 6th July script was dispensed after 20 days when the patient should still have had 10 days' supply left.
The fact that the patient was prescribed a larger than usual amount, was prepared to pay over ten times more for each script plus the requested early supply for the 6th July script should have immediately aroused the suspicion of the pharmacist because Fentanyl has the potential to be abused by ingestion or injection and has lead to deaths as a result (Durogesic PI 2012 p.7). It is also known to have been diverted for sale on the street at a price of over $100 per patch based on the 2012 price (The Age 19/10/2012)
A pharmacist taking this information into consideration should have contacted the prescribing doctor to ascertain the reason for the large quantity of supply and again contacted the doctor about the reason for the need to supply the second prescription before the due time. If the pharmacist was not satisfied that the discussion with the doctor had provided a satisfactory explanation, he should have refused to dispense either or both the prescriptions.
Each of the above occasions required the pharmacist to consider the safeguards above before dispensing to ensure good patient care and clinical interventions noted.
As a pharmacist and proprietor of the pharmacy since 2002, Dr Abdalla should have been aware of the Guidelines on responsibilities of pharmacists when practicing as proprietors, 29th January 2013 which states that a proprietor pharmacist must maintain an awareness of the standards published by the profession. Also Dr Abdalla should have maintained an active interest in the practice of pharmacy and known that he could not delegate his professional responsibility (Guidelines for proprietor pharmacists 2nd September 2015). However, as he stated in his interview with the PRU (28th April 2016 p.73 paragraph 40) he only did some administration such as payments and superannuation in terms of the day to day running.
In addition, Dr Abdalla as proprietor of the pharmacy should have had systems in place for raising concerns about risks to patients (Code of conduct for health practitioners July 2012 p.10 paragraph 6.2d)
From the above, I consider that Dr Abdulla's lack of oversight caused his conduct as a pharmacist and proprietor of the pharmacy to fall significantly below the standard reasonably expected of a practitioner of an equivalent level of training and experience and invites my strong criticism.
…
The three forged prescriptions [for Fentanyl to patient AE] were dispensed in December 2014. The pharmacy had been dispensing regular quantities of opioid medication since at least 2011 from the records provided and therefore would have had lots of experience in dispensing these drugs of addiction.
Furthermore they should have been aware that Fentanyl had the potential to be abused by ingestion or injection and had led to deaths as a result (Durogesic PI 2012 p.7) and was also known to have been diverted for sale on the street at a price of over $100 per patch (The Age 19/10/2012). Therefore all Fentanyl scripts should have been treated with extreme care.
However, through the lack of Dr Abdalla's oversight of the pharmacy, drugs of addiction were dispensed on forged prescriptions. There did not appear to be a system in place to ensure that Clause 87 which states that a drug of addiction must not be supplied by a pharmacist unless they are familiar with the handwriting of the doctor, or knows the person for whom the drug is prescribed or has verified that the person who is purported to have issued the prescription had actually done so, had been followed. Further, it does not appear that that a system existed to consider when drugs of addiction were dispensed within short time intervals as the three prescriptions were, the last being dispensed only one day after the previous script. As stated in clause 109 of the Poisons and Therapeutic Goods Regulations 2008 an authorized practitioner or pharmacist must not supply any of these substances in a quantity, or for a purpose, that does not accord with the recognized therapeutic standard of what is appropriate in the circumstances.
All of the above should have alerted the pharmacy to contact the prescribing doctor to verify the scripts so that the pharmacist could ensure that the service provided was appropriate for the assessed needs of the patient (Code of Conduct for pharmacists March 2014 p.16 paragraph 5.2a). If the pharmacy had a system in place to ensure that regulations were observed, none of these scripts would have been dispensed.
Dr Abdalla should have been aware of the Guidelines on responsibilities of pharmacists when practicing as proprietors, 29th January 2013 which states that a proprietor pharmacist must maintain an awareness of the standards published by the profession. Also Dr Abdalla should have maintained an active interest in the practice of pharmacy and known that he could not delegate his professional responsibility (Guidelines for proprietor pharmacists 2nd September 2015).
Dr Abdalla should also have considered the code of conduct for registered health practitioners 27th July 2012 which states under Risk management p.10 6.2d that if a practitioner has management responsibilities then they need to make sure that systems are in place for raising concerns about risks to patients. Risk management also entails working within systems to reduce error and improve the safety of patients and supporting colleagues who raise concerns about the safety of patients Section 6.2e. This would have included a system to document each intervention (The Standard and guidelines for pharmacists performing clinical interventions March 2011, paragraph 4.1) in which methods of documentation are recommended (paragraph 4.2)
Had Dr Abdalla overseen the running of the pharmacy he would have ensured that such systems were in place.
From the above, I consider that Dr Abdulla's lack of oversight caused his conduct as a pharmacist and proprietor of the pharmacy to fall significantly below the standard reasonably expected of a practitioner of an equivalent level of training and experience and invites my strong criticism.
…
The majority of [115] non-compliant prescriptions [of S8 drugs] were dispensed in 2015 when the pharmacy had been dispensing regular quantities of drugs of addiction since at least 2011 from the records provided.
Dr Abdalla should have been aware that a proprietor pharmacist must maintain an awareness of the standards published by the profession (The Guidelines on responsibilities of pharmacists when practicing as proprietors, 29th January 2013). He should therefore have maintained an active interest in the practice of pharmacy and known that he could not delegate his professional responsibility (Guidelines for proprietor pharmacists 2nd September 2015).
The quantity of non-compliant scripts shows a lack of knowledge in the pharmacy concerning Clause 80 of the Poisons and Therapeutic Goods Regulation 2008 which states the necessary information that must be on a prescription for a drug of addiction before it can be even considered for dispensing.
He should have set in place risk management systems at the pharmacy which entailed working within systems to reduce errors (The code of conduct for registered health practitioners 27th July 2012 Section 6.2e) and maintained and developed his knowledge and skills as these are core aspects of good practice (The code of conduct for registered health practitioners 27th July 2012 Section 7.1). Through the lack of Dr Abdalla's oversight of the pharmacy no systems appeared to be in place to ensure that correct procedures were followed.
This would have included a system to document each intervention (The Standard and guidelines for pharmacists performing clinical interventions March 2011, paragraph 4.1) in which methods of documentation are recommended (paragraph 4.2)
Had Dr Abdalla had followed the above, non-compliant scripts would not have been dispensed.
From the above, I consider that Dr Abdulla's lack of oversight caused his conduct as a pharmacist and proprietor of the pharmacy to fall significantly below the standard reasonably expected of a practitioner of an equivalent level of training and experience and invites my strong criticism.
…
[Re whether the Pharmacy's practice in the supply of S8 and S4D drugs was conducted in accordance with applicable laws, standards and guidelines].
Dr Abdalla should have been aware that a proprietor pharmacist must maintain an awareness of the standards published by the profession (The Guidelines on responsibilities of pharmacists when practicing as proprietors, 29th January 2013 (and should therefore have maintained an active interest in the practice of pharmacy and known that he could not delegate his professional responsibility (Guidelines for proprietor pharmacists 2nd September 2015).
Had he maintained an active interest, he would have been able to ensure that the pharmacy's practice for the supply of the above drugs would have been carried out in accordance with the various laws standards and guidelines as stated previously. Further that as a practitioner with management responsibilities he needed to ensure that systems were in place for raising concerns about risks to patients (The code of conduct for registered health practitioners 27th July 2012 states under Risk management p.10 6.2d) which are outlined in the above case histories.
He would have set in place risk management strategies at the pharmacy which entailed working within systems to reduce errors (The code of conduct for registered health practitioners 27th July 2012 Section 6.2e) and maintained and developed his (and his staffs) knowledge and skills as these are core aspects of good practice (The code of conduct for registered health practitioners 27th July 2012 Section 7.1)
As maintaining clear and accurate health records is essential for the continuing good care of patients Dr Abdalla should have ensured that the pharmacy kept up to date and legible records that reported details of clinical history, clinical findings, investigations and information given to patients (The code of conduct for registered health practitioners 27th July 2012 Section 8.4). This would have included a system to document each intervention (The Standard and guidelines for pharmacists performing clinical interventions March 2011, paragraph 4.1) in which methods of documentation are recommended (paragraph 4.2).
Through the lack of Dr Abdalla's oversight of the pharmacy no systems appeared to be in place to ensure that correct procedures were followed. Had he done so many if not all the incidents raised in the patient case histories above would not have occurred.
From the above, I consider that Dr Abdulla did not take adequate steps to ensure that the pharmacy's practice in the supply of S4D and S8 drugs was conducted in accordance with applicable laws, standards and guidelines and this caused his conduct as a pharmacist and proprietor of the pharmacy to fall significantly below the standard reasonably expected of a practitioner of an equivalent level of training and experience and invites my strong criticism.