Civil and Administrative Tribunal New South Wales Medium Neutral Citation: Health Care Complaints Commission v Bova [2016] NSWCATOD 43 Hearing dates: 13 November 2015, 1, 2 & 3 December 2015, 9 & 10 February 2016 Date of orders: 13 April 2016 Decision date: 13 April 2016 Jurisdiction: Occupational Division Before: O Shub, Principal Member J Zwart, Professional Member M Duguid, Professional Member P Hooker, General Member Decision: The Respondent is guilty of professional misconduct Catchwords: Pharmacy, compounding, substitution, commercially available Legislation Cited: Health Practitioner Regulation National Law (NSW) Cases Cited: Briginshaw v Briginshaw [1938] Gianoutsos v Glykis (2006) In re Dr. Suman Sood [2006] Health Care Complaints Commission of New South Wales v Jonathan Fryar [2013] Kirby P., in Pillai v Messiter [No. 2] (1989) Category: Principal judgment Parties: Health Care Complaints Commission (HCCC) (Applicant) Nicholas Patrick Bova (Respondent) Representation: Counsel: W Hunt (Applicant) R Lancaster SC and A Gerard (Respondent) Solicitors: Health Care Complaints Commission (Applicant in Person) Schofield King Lawyers (Respondent) File Number(s): 1520093 reasons for decision Preliminary Matters 1. A disclosure was made by the Tribunal that Ms J. Zwart had, in the period from approximately 1998 to approximately 2005 sat with the proposed expert Mr Gerard McInerney as a board member of the Pharmacy Board. The disclosure was made in order to ensure that there was no conflict or perceived conflict in respect of Ms Zwart being a professional member on the Tribunal. 2. After taking instructions, both parties indicated that they had no objection to the expert and the professional member. 3. The principal member of the Tribunal indicated to the parties that in light of the diametrically opposed views expressed by the two experts, Mr Gerard McInerney and Mr Daryll Knowles, that it would be beneficial for the hearing for these expert witnesses to hold a conclave and seek to agree on as many of the issues as possible and the principal member then proposed that the expert witnesses would be called to give their evidence concurrently. The parties indicated that they were prepared to accept that proposal. Background/History 1. The Applicant, the Health Care Complaints Commission, has brought an application for disciplinary findings against the Respondent, Mr Nicholas Bova. The Respondent is a pharmacist registered under the Health Practitioner Regulation National Law (NSW) ("the National Law"). The Applicant complains that the Respondent: 1. is guilty of unsatisfactory professional conduct within the meaning of section 139B of the National Law in that he has 1. engaged in conduct that demonstrates that the knowledge, skill or judgment possessed, or care exercised, by the practitioner in the practice of pharmacy is significantly below the standard reasonably expected of a practitioner of an equivalent level of training or experience; and/or 2. engaged in improper or unethical conduct relating to the practice or purported practice of pharmacy ("Complaint One") 1. is guilty of unsatisfactory professional conduct within the meaning of section 139B of the National Law in that the practitioner has: 1. engaged in conduct that demonstrates that the knowledge, skill or judgment possessed, or care exercised, by the practitioner in the practice of pharmacy is significantly below the standard reasonably expected of a practitioner of an equivalent level of training or experience; and/or 2. engaged in improper or unethical conduct relating to the practice or purported practice of pharmacy. ("Complaint Two") 1. is guilty of professional misconduct within the meaning of section 139E of the National Law in that the practitioner has: 1. engaged in unsatisfactory professional conduct of a sufficiently serious nature to justify suspension or cancellation of the practitioner's registration, or engaged in more than one instance of unsatisfactory professional conduct that, when the instances are considered together, amount to conduct of a sufficiently serious nature to justify the suspension or cancellation of the practitioner's registration. ("Complaint Three") Particulars Complaint One 1. Between 23 December 2011 and 8 January 2012, the practitioner incorrectly dispensed ten (10) dropper bottles of 4.8mL Dextran T(500) Sulphate 20% on two occasions ("the Dextran Sulphate Product") to Dr James McAlister for Patient A in circumstances where: 1. He received two prescriptions from Dr McAlister on or around 23 December 2011 for Patient A: 1. "G Riboflavin 0.1% (in sterile water) for peroperative use 5mL 10 repeats"; 2. G Riboflavin 0.1% [in 20% Dextran (T500]] for peroperative use 5mL 10 repeats"; 1. On or around 7 December 2011 he received an email from Dr McAlister which sought to clarify the composition of the product to be sought by prescription by attaching a "Certificate of Analysis" from a previous supplier which stated; "Product Name: Dextran solution from leuconostoc mesenteroides 20% (w/w) (Autoclaved)"; 2. He was aware that the drops were for use: 1. In the human eye preoperatively; 2. For a corneal collagen cross-linking ophthalmic procedure; 1. Dr McAlister had not authorised the substitution of Dextran T(500) with Dextran T(500) Sulphate. 1. Between approximately 30 November 2011 and 8 January 2012, the practitioner used or permitted BCC to use, a technical grade of Dextran T(500) Sulphate rather than a pharmaceutical grade of Dextran T(500) Sulphate when preparing the Dextran Sulphate Product. 2. Between approximately 30 November 2011 and 8 January 2012, the practitioner failed to take make appropriate enquiries to clarify with Dr McAlister whether Dextran T(500) Sulphate could be substituted for Dextran T(500). 3. Between approximately 30 November 2011 and 8 January 2012, the practitioner failed to take reasonable steps to clarify whether Dextran T(500) Sulphate was appropriate and safe for use in the human eye. 4. Between approximately 30 November 2011 and 8 January 2012, the practitioner failed to provide Dr McAlister with sufficient notification that the Dextran Sulphate Product contained Dextran T(500) Sulphate rather than Dextran T(500). 5. Between 23 December 2011 and 8 January 2012 the practitioner dispensed ten (10) bottles of the Dextran Sulphate Product to Dr McAlister for Patient A on two occasions which was inappropriate in that: 1. The supply of ten (10) bottles was an excessive quantity for a single patient; 2. He knew or ought to have known that the ten (10) bottles were to be used for patients other than Patient A. Complaint Two 1. Between approximately 2010 and 13 December 2012 the practitioner failed to ensure that prescriptions for special restricted substances were stored separately from other prescriptions as required by clause 42 of the Poisons and Therapeutic Goods Regulation 2008 (NSW) ("PTGR"). 2. Between 2010 and 13 December 2012, the practitioner failed to ensure that a drug register for drugs of addiction was maintained at BCC as required by clause 111 of the PTGR. 3. Between 15 April 2011 and 15 April 2013, the practitioner failed to ensure that supply of dexamphetamine was entered into a drug register on approximately 63 occasions as required by clause 112 of the PTGR. 4. The practitioner dispensed or permitted eight prescriptions for testosterone to be dispensed in circumstances where the prescriptions were dated more than six months before the date of supply, contrary to clause 40(1)(g) of the PTGR on: 1. 20 August 2012 for Patient B; 2. On 4 September 2012 for Patient C; 3. On 21 September 2012 for Patient D; 4. On 3 October 2012 for Patient E; 5. On 9 October 2012 for Patient F; 6. On 2 July 2012 for Patient E; 7. On 15 November 2012 for Patient G; 8. On 13 December 2012 for Patient B. 1. Between approximately 2010 and 13 December 2012 the practitioner failed to ensure that prescriptions for special restricted substances were stored separately from other prescriptions as required by clause 42 of the Poisons and Therapeutic Goods Regulation 2008 (NSW) ("PTGR"). 2. Between 2010 and 13 December 2012, the practitioner failed to ensure that a drug register for drugs of addiction was maintained at BCC as required by clause 111 of the PTGR. 3. Between 15 April 2011 and 15 April 2013, the practitioner failed to ensure that supply of dexamphetamine was entered into a drug register on approximately 63 occasions as required by clause 112 of the PTGR. 4. The practitioner dispensed or permitted eight prescriptions for testosterone to be dispensed in circumstances where the prescriptions were dated more than six months before the date of supply, contrary to clause 40(1)(g) of the PTGR on: 1. 20 August 2012 for Patient B; 2. On 4 September 2012 for Patient C; 3. On 21 September 2012 for Patient D; 4. On 3 October 2012 for Patient E; 5. On 9 October 2012 for Patient F; 6. On 2 July 2012 for Patient E; 7. On 15 November 2012 for Patient G; 8. On 13 December 2012 for Patient B. Complaint Three 1. Complaints One and Two and the particulars thereof are repeated and relied upon both individually and cumulatively. Expert Opinion Topic Areas Q1. The circumstances where it is, or may be, appropriate for a pharmacist to substitute an alternative ingredient for an ingredient described in a prescription. Q2. Whether Ribolink™ (riboflavin) a commercially registered product available in Australia in December 2011. Q3. What is Dextran, Dextran (T500) and Dextran Sulphate. Q4. Is sulphar (sic) inherently toxic to the human eye. Q5. Is a solution with a pH of 6.98 toxic to the human eye. Q6. The intended role of Dextran T500 in a corneal collagen cross-linking ophthalmic procedure. Q7. The utility of Material Safety Data Sheets as a basis to conclude that a product, at any particular concentration, is an irritant. Q8. In all the circumstances was it open to Mr Bova to look to substitute Dextran Sulphate for Dextran (T500). Q9. Mr Bova's conduct in substituting Dextran Sulphate for Dextran (T500) in relation to the prescription for Cameron Jones. Q10. Steps taken by Mr Bova to clarify whether Dextran Sulphate was appropriate and safe for use in the human eye. Q11. In the circumstances was Mr Bova's conduct in substituting Dextran Sulphate for Dextran (T500) appropriate and safe. Q12. Steps taken by Mr Bova to clarify with Dr McAlister which form of Dextran to use and whether Dextran Sulphate was appropriate and safe. Q13. The appropriateness of the amount of Dextran Sulphate supplied by Bova Compounding Chemist to Dr McAlister. Q14. Whether Mr Bova gave sufficient notification to Dr McAlister that the product supplied contained Dextran Sulphate rather than Dextran (T500). Q.15 The sterility of the Dextran Sulphate Solution supplied by Bova Compounding. 1. The Respondent filed a reply to the application for disciplinary findings in terms of which the Respondent made certain admissions in respect of the Applicant's complaints and denied various other particulars. 2. In respect of Complaint One, the Respondent denied that he incorrectly dispensed ten dropper bottles of 4.8mL Dextran T(500) Sulphate 20% on two occasions to opthalmologist Dr James McAlister for Patient A, admitted particular 1A, admitted subject to aspects of denial in respect of 1B, admitted particular 1C, denied particular 1D, admitted subject to comment particular 2, denied particulars 3 to 6. 3. In respect of Complaint Two, the Respondent denied Complaint Two and in respect of the particulars of Complaint Two, admitted particulars 1 to 4, admitted the supply referred to in particular 5 but denied the dates, admitted the supply in particular 6 but denied that there was no valid prescription, admitted paragraphs 7 to 17. 4. In respect of Complaint Three, the Respondent denied that he is guilty of professional misconduct under section 139E of the National Law. 5. The Tribunal was called upon to decide various issues: 1. Was the Respondent authorised to substitute Dextran T(500) Sulphate for Dextran T(500)?; 2. If the Respondent was not authorised to substitute Dextran T(500) Sulphate for Dextran T(500), did the supply of that product lead to complications when used by Dr McAlister on his patient or patients?; 3. If the Respondent was authorised to substitute Dextran T(500) Sulphate for Dextran T(500), was that product suitable for use by Dr McAlister in the eyes of his patients without it causing any damage?; and 4. Is the Respondent guilty of unsatisfactory professional conduct and/or professional misconduct in respect of Complaints Two and Three, which arise out of the investigation by the Pharmaceutical Services Unit ("PSU")? Evidence of Dr James McAlister 1. Dr James McAlister was sworn. He was asked by Mr Hunt during examination in chief to confirm his statement of the 17th of November 2015 and to confirm that he adopts that statement as his evidence for purposes of the hearing. Dr McAlister was asked whether he required to make any corrections to the affidavit, to which Dr McAlister stated that he needed to correct paragraph 5 of his statement as the statement indicates that he spoke to Catherine Gilbert of the Mater Hospital Brisbane following a conversation which he had with the Respondent on the 7th of December 2011. Dr McAlister indicated that he could not recall whether he had spoken to her. He does recall, he had left a message for her and had not had a return call. Dr McAlister indicated that what was wrong with paragraph 5 of his statement was that the conversation was not that day, but they had had several conversations. In his evidence in chief, Dr McAlister explained that the particular solution was being used as a device to improve the treatment being undertaken to the eye and that it was part of a research program. In seeking the product from the Respondent, Dr McAlister said that he was looking to emulate the Mater product but the other products referred to in his statement were not quite the same. 2. The witness was shown an email from Catherine Gilbert dated 26th of November 2011 and was asked whether it was true and correct that he asked Catherine Gilbert to send him the details of the formula that was used by the Mater Hospital. 3. Dr McAlister confirmed that he saw from that email that there were products which could be available under the Special Access Scheme. He was then referred to a later comment in the email where Catherine Gilbert refers to in vitro research of another reagent, Dr McAlister confirmed that he saw that that was a product that was not for use in humans. The email contained a certificate of analysis by Sigma-Aldrich and Dr McAlister was happy to accept that that Sigma document was sent to him on that date. 4. There was questioning as to whether Dr McAlister was aware of the source being used by the Mater to source the products to provide him with the eye drops necessary for his operative treatment, Dr McAlister replied that he did not know the source, but he did know that it was not the product that Sigma was providing. 5. He confirmed that he was in possession of the documents in Annexure B to his statement but confirmed that they were not initially attached to the email to the Applicant but were sent subsequently. One of those attachments was a document from the Royal Victorian Eye and Ear Hospital pharmacy department and which contained the formula being utilised in respect of the particular eye drops. Dr McAlister was questioned on whether he provided that document to the Respondent, to which he replied that he offered the document to him but that the Respondent indicated that he did not need it, as it was a simple formula. 6. Dr McAlister was asked numerous questions about the fact that there was no reference to that discussion in the statement that he provided. In respect of that document Dr McAlister initially stated that he offered the document to the Respondent, but subsequently in cross-examination conceded that he offered the formulation which derives from the Royal Victorian document, not the document itself (the Respondent's evidence was to the effect that Dr McAlister asked him what he needed and whether he wanted the formula. He did not say that there was a document). 7. Dr McAlister maintained the position that what he was indicating was how and what he wanted to receive and he wanted to be sure that it would all be okay. Dr McAlister was asked why these important matters were not in his statement and that they are only arising in his evidence, to which he replied that in his assessment, those are issues separate to the evidence and he is here to say his piece (see T31.16). 8. The cross-examination then turned to the Sigma information and the fact that Dr McAlister indicated to the Respondent in November 2011 that he was looking for a stable source, as the Mater were no longer able to provide him with a stable supply of the Dextran T(500) product that they had been using. Dr McAlister was asked on what basis he referred to Sigma having withdrawn the product and whether he agrees that he was incorrect because he knew at that time that Sigma had not provided that product to the Mater. He replied that he felt that the statement is correct because he was not referring to the analysis. He had no idea what Dextran product the Mater were using and there were a variety of products. It was put to him that he had no idea of the source of the Mater Dextran, to which he replied that he did not need to, but when it was put to him that it wasn't Sigma supplying, he stated that he did not know. Being pressed on that issue and the fact that he knew that the Sigma product was only used in-vitro, he replied that what company it came from was not something that he was concerned about. 9. There was then questioning in regard to price. The Respondent was raising with Dr McAlister the fact that there was a non-sterile Dextran available, but if Dr McAlister required it to be sterile in order to make it so, the cost would be a lot more. In essence, the indication to the witness was a difference between $80 for the use of Dextran T(500) or approximately $9 for use of an alternative Dextran product, namely Dextran T(500) Sulphate. There was a dispute as to whether the possibility of using Dextran T(500) Sulphate was ever put to Dr McAlister and Dr McAlister indicated that he was more interested in knowing that the product would be right than the price and that what he wanted was confirmation that the product would be right and the price would come later. 10. Dr McAlister was asked whether his comment in an email at tab 4 of the Applicant's documents, where he said that if the Respondent could provide "a reliable sequence to keep costs down and maintain sterility and reduce handling that would be great". Dr McAlister indicated that he is not a pharmacist and does not need to tell the pharmacist how to do the manufacturing process (see T36.15). They had conversations where Dr McAlister indicated that he wanted exactly what he had before. Dr McAlister maintained that position throughout, but in cross-examination on a number of occasions indicated that he might not have said that, but it would have been obvious to the Respondent. He was asked specifically whether he regarded the comment in tab 4 as giving the Respondent some discretion. He responded yes, but he meant that the product needed to be okay for clinical use. 11. Dr McAlister was taken to an email to which was attached a Sigma analysis and which stated that that is the previous source of Dextran. When asked whether that was in fact not correct, Dr McAlister conceded that it wasn't correct, but he had had discussions on Dextran T(500) and Mr Bova spoke of various grades and how he was going to bring the product in. Dr McAlister stated that he told the Respondent that he wanted Dextran T(500) and no substitute, but conceded that the Sigma analysis would not have indicated to the Respondent anything about Dextran T(500). 12. There was considerable cross-examination in regard to the email from Catherine Gilbert of the 26th of August 2011 and particularly in regard to whether the Sigma document indicated anything about Dextran T(500). Dr McAlister ultimately said that the wording may have been unfortunate. It was put to Dr McAlister that it would have been easy for him in his email, if he wanted only Dextran T(500) and no substitution to have said that. Dr McAlister responded that in retrospect it would be. 13. Dr McAlister was then asked whether he agreed that an email of the 7th of December 2011 at tab 5 referred to iron Dextran or Dextran Sulphate. He indicated that he had not read that prior to his telephone conversation later that day with the Respondent. He was challenged on comment "the statement" at the top of page 2 of his statement and that he could not possibly have said that. Dr McAlister stated that he did, and that the Respondent's suggestion took his breath away. 14. There was debate about whether the Respondent used the term ferro Dextran or iron Dextran and he was asked whether the Respondent didn't discuss iron Dextran with him at all. He indicated that that was the only thing he discussed. 15. On numerous occasions he was asked whether Dr McAlister actually said to the Respondent that he wanted Dextran T(500) and nothing else and he conceded that he didn't say it, but it was what he was thinking. On numerous occasions he indicated that the Respondent could be under no illusion that he wanted nothing else. 16. The Respondent was asked whether he knew at the time that he was allegedly calling Catherine Gilbert that she was on leave, to which he initially stated that he was not aware but when asked whether he was aware that she was on leave overseas from the 5th to the 16th of December 2011, he stated that he vaguely recalled that she was away somewhere. 17. Dr McAlister maintained the position that he had not authorised any substitution. He was questioned about why he should have had his breath taken away when it was him who had indicated that he was happy for the Respondent to find some cheaper alternative. He stated that $80 would not work, they would need to see where they would go with Dextran T(500) Sulphate. Dr McAlister denied that he did say that, and denied that he was aware that the call was in fact to discuss Dextran T(500) Sulphate, at which point Dr McAlister indicated that he made it clear that he did not want Dextran Sulphate. Dr McAlister stated "[of] course, I wanted to keep costs down but I don't think that bears any relationship to using the wrong drug" (T50.34). 18. There was questioning in regard to the prescriptions provided by Dr McAlister on the 23rd of December 2011 found at tab 12 to Mr Corry 's statement, which did not refer to Dextran. Dr McAlister stated that that was correct, but that was the way to do it. There was an issue as to whether it was riboflavin phosphate or riboflavin and that also was not clear from the prescription. Dr McAlister replied that there was, however, no discussion about Dextran T(500). He thought that that was clear and never thought that it was Dextran T(500) Sulphate. Dr McAlister was referred to tab 17, where he had indicated that he was writing the prescriptions while he was on the telephone to the Respondent, and yet the discussion indicates clearly that he was not on the telephone at that time. There was some hesitation in his response, but he clearly remembers that he was on the phone when he was writing the script. He agreed, however, in questioning his recollection, that perhaps it was not correct and that maybe there were other calls. 19. Dr McAlister was referred to the email of the 8th of December 2011 behind tab 8 at 8.04pm, where he confirmed the order. Dr McAlister indicated that he recalled that email and it was put to him that he knew that the price was $9 and that he knew that it was Dextran T(500) Sulphate. Dr McAlister said that he could not see how he would get to that from the document and the matter was left at that point. 20. Dr McAlister was asked questions about receiving the product early in January 2012, which came with a label. He did recall that. He was asked whether he read the label, to which he replied that he did and he confirmed that it does refer to Dextran T(500) Sulphate but it did not register with him that it was Dextran T(500) Sulphate. He only thought of Dextran and did not see Sulphate. He did not realise that for a long time. It was put to him that he must have realised that it contained Dextran T(500) Sulphate, which he denied. He stated that he read it wrongly, he was duped and it was his mistake. Dr McAlister stated: "I read the label, I felt that through the course of our conversations, me writing consistently Dextran T(500), him never stating until this particular document I felt that the product I got was the product that I needed and that I used. I read the label, I just did not see that Sulphate and I did not appreciate that for a long time" (T56.20-23). 21. Questions were then put to him as to the fact that the Tribunal was not dealing with whether or not the Dextran Sulphate caused the side effects that some patients had that were treated by Dr McAlister. Dr McAlister stated that he was not aware of that but it was put to him that he was recreating matters because he did not want his patients to blame him for his part in the matter. Dr McAlister indicated that he wanted to come to give evidence and to give his version, and he promised his patients to do everything possible. It was put to him that he has an axe to grind because he is being sued in Queensland, to which he responded that he has no axe to grind but that his patients had to go through him to get to the Respondent. Dr McAlister indicated that as far as he was concerned, the Respondent led him down a path that the product was one that he could use and denied that he knew or agreed that Dextran T(500) Sulphate could be used and that that was what he was ordering on the 7th of December 2011. It was put to him that the reason that he did not go back to the Respondent when he saw Dextran T(500) Sulphate on the eye drops was because he knew that it was Sulphate and he was expecting that. He stated that he did not appreciate that when he read the label. 22. On re-examination, Dr McAlister was asked whether before he secured the eye drops with the label as to whether he had done any research into using a substitute. He responded that he had not done that because he had never had any intention of using it. 23. The evidence of Dr McAlister was concluded and Dr McAlister was excused. Expert Evidence 1. The experts were then asked their position on each of the issues listed and their responses were as follows: Issue One * If there is a commercial product listed on the Australian Register of Therapeutic Goods registered list the pharmacist should not compound that particular product. * If a commercial product is available then a compounder should not compound that product. A commercially available product is a product that is available and made under the Code of Good Manufacturing Practice (GMP) defining it from a product made in a pharmacy * The active ingredient ordered by the doctor should be supplied if it's available. If it's not available discussion should take place with the prescribing doctor as to a suitable alternative substituteHere, there are two substitutes. There was no commercially available product as listed in the prescriptions. Issue Two Ribolink is commercially available. There was discussion about the fact that Dr McAlister had access to Ribolink through the Special Access Scheme, however the website stated that their source was from a pharmacist that was a grade 2 manufacturing pharmacy. They were unsure as to whether it was made under the GMP. Issue Three The experts agreed that Dextran is a polysaccharide and Dextran (T500) a technical grade, although it has been used for many years in this particular procedure. Dextran Sulphate is formed by esterification of Dextran and is available as a sodium salt. However, the experts indicated that they do not know the extent of ionisation of the sulphate salt. Iron Dextran is normally used in the treatment of iron deficiency anaemia. Issue Four The experts indicated that they were not able to answer definitively that sulphur was not toxic to the eye. Particularly as the sulphur, as sulphate, was esterified with Dextran. Mr Knowles stated sulphur is not inherently toxic unless the patient has a sensitivity to it, which is reasonably common. Mr Knowles quoted sulphur being a component of sulphacetamide in eye drops in concentrations up to 20%. Issue Five It was agreed that a solution of pH 6.98 is not toxic to the human eye. Issue Six The experts agreed that the intended role of Dextran T(500) is as an inner lubricant in corneal collagen cross-linking ophthalmic procedures. Issue Seven The experts agreed that "hazardous" on a material safety data sheet (MSDS) may not necessarily indicate that a concentrated solution is hazardous or lacks safety. Mr Knowles pointed to studies where solid DDextran Sulphate bandages were applied to corneal ulcers in human beings with no side effects. It is still necessary, however, to test the final product because it may be safe on the MSDS and when the final product is complete it is toxic. Mr McInerney stated that Mr Knowles has more expertise in that than him, but he finds it untenable that a product that is registered as harmless could be put into sterile water and suddenly become toxic. The Tribunal asked whether something toxic could become safe by mixing. Mr McInerney said that it could be in a particular concentrarion. Issue Eight Issue 8 was not agreed by the experts. Mr McInerney believes it was not appropriate. He states that the report of Clinical Network Services toxicologist Dr Douglas Francis said that Dextran Sulphate is not defined as a substitute for Dextran. Mr McInerney found nothing in the literature after an extensive search where DDextran Sulphate had actually been substituted for Dextran. Mr Knowles believes it was open for the Respondent to consider substitution given the fact that Dextran T(500) was not available. He did, however, add to the discussion that taking a non-sterile product and making it sterile is both expensive and hazardous. Issue Nine Mr Knowles points to the fact that the Respondent seems to have gone through a fairly lengthy process and he did convince himself that this was an appropriate substitution. Mr McInerney disagrees with that approach. He says that another form of Dextran was available which was the pharmaceutical grade which should have been used and was the appropriate choice. On the basis that the correct substance was available, it was inappropriate. Dextran Sulphate is not appropriate because it is not a substitute for Dextran. Issue Ten The experts agreed that there was insufficient documentation. They agreed that a responsible compounding pharmacist who had made sufficient inquiries into substituting Dextran Sulphate would have a list of clinical papers where it has been used detailing the results and the adverse reactions. Counsel for the Respondent indicated that in his view this was not subject of the complaint and that it goes to some of the objections that they take from Mr McInerney's report of 2014. Issue Eleven The experts partially agreed on this issue. Nobody has come up with a toxicity issue with the Dextran Sulphate itself. Mr McInerney stated that he is not sufficiently expert on that issue but contended that it was not appropriate because it went against the guidelines of the APF and the Pharmacy Board- the product in question was available in pharmaceutical grade. Mr Knowles stated that "[w]hen looking at the availability, which in Australia we don't manufacture anything basically, availability is a whole extra layer that's put onto procuring ingredients." Mr Knowles doesn't believe there is a commercially available product and that the Respondent was open to substitute. Mr McInerney could find no evidence for any research done into the safety of Dextran Sulphate in a 20% solution and thought "it was a risk too far to even contemplate". Mr Knowles indicated that he had found evidence that it was safe in the use of the eyes in those concentrations, and the fact that the availability of the commercial product has not been established leads to the conclusion that the Respondent was open to substitute. Issue Twelve Mr Knowles stated that he does this on a daily basis and every case is different. The standard reasonably expected is very dependent on the two parties involved. Some doctors will tell you what they want and it is evident they have done their research and if he is satisfied with their level of knowledge and the level of safety it may be one phone call. In the Respondents case there were emails going back and forward and holes in the documentation. Mr Knowles stated that it was out of his scope to comment on whether the Respondent received enough satisfaction or confidence from the conversations and the documents to form his opinion. Mr McInerney agreed that he is in the same position of knowledge. He states that he has seen documentation that shows the Respondent ask Dr McAlister if Dextran Sulphate was okay, but no written response from Dr McAlister. To protect himself Mr McInerney was of the opinion that he would have asked Dr McAlister for a reply in writing. Issue Thirteen Mr McInerney had an issue with the fact that the Dextran Sulphate eye drops provided all had one patient's name on the labels. He said the pharmacist should not have supplied that quantity all in the one name as the Pharmaceutical Society of Australia Standard says that if a doctor writes a prescription, the pharmacist should put the name of the patient for whom it is intended on it. Mr Knowles pointed out that the drops in this case had been provided as devices for the last two years and supplied by the Melbourne Hospital and the Mater Hospital to multiple patients which means they do not come under the guidelines. The experts were asked whether in other words the prescription is not a prescription, to which Mr Knowles replied that it was not a prescription because it did not have an Rx on it, used to indicate a prescription is for therapeutic use. Mr McInerney disagreed and stated that because the prescription was issued to a named patient it should have been treated as a prescription and not a device. He stated that there should have been ten prescriptions written for it in the names of each individual person. Mr McInerney says he would have rung the doctor and asked him for the multiple names. Mr Knowles agreed with the standards, but pointed out that there is no requirement for a prescription as this is an unscheduled product. He did say that if it was in fact a prescription, then it would need to be in ten names, but he remained committed to the view that it is a device and does not need to be issued in individual names. Mr Knowles also stated that when Dr McAlister ordered this from Mater Hospital in the past, he never ordered by patients but ordered a supply. Issue Fourteen On the information provided, Mr McInerney says the first indication Dr McAlister would have had would have been when he received the eye drops in the mail. He said that the label bearing the words "Dextran Sulphate" was not sufficient notification. Mr Knowles considered the conversations that occurred before Dr McAlister received the product and stated that a doctor receiving Dextran Sulphate after those discussions probably would have had sufficient notification if that doctor had enough pharmaceutical knowledge. The experts were asked if there had been an agreement to use Dextran Sulphate, what amendment would have been required to the prescriptions. Mr Knowles said that there would have been no amendment to the prescription because there wasn't a prescription necessary. However, he would have wanted to see documentation of this change. Mr McInerney agrees with Mr Knowles on this point and added that email documentation would have been adequate. If a doctor confirmed by telephone Mr McInerney would ask them to put it in writing for his protection. Issue Fifteen Mr Knowles believed that the Respondent obtained a sterile grade of Dextran Sulphate which is used in blood products. Mr McInerney noted that sterile powder was used and as such he accepts that the Dextran Sulphate solution supplied was sterile. 1. That concluded the conclave evidence of the experts and opened the way to the process of cross-examination of the experts. 2. Mr McInerney was cross-examined and an issue emerged immediately in that Mr McInerney indicated that he had not read aspects of the Respondent's evidence. This led to two applications. 3. The Tribunal had before it two applications, one to disregard all of the expert evidence of the expert witness Mr McInerney, and, in the alternative, to only consider the general opinion on the grounds that his evidence is fundamentally flawed to such an extent that it cannot be remedied. It was submitted that to allow the evidence to go forward for consideration would be highly prejudicial to the Respondent. 4. There was significant argument on the issues but on conclusion of the conclave Mr McInerney was cross-examined by counsel for the Respondent. He was asked whether he had read the evidence from Mr Bova and indicated that he may well not have read it, as he had read so much and could not recall what exactly he had read. He did remember seeing it but he does not think that he read it. He was challenged on how he could express views to the Tribunal without reading the Respondent's affidavit to which he responded that his report was prepared before he had the affidavit. Questioning on the issue of his failure to deal with the comments in Mr Bova's affidavit. The commission sought an adjournment to remedy the defect and enable Mr McInerney to read the document then return and the matter was accordingly adjourned to resume the following day. 5. A further application was made by the Applicant to tender a judgment in respect of a civil matter which involved the expert witness Mr Knowles. The Applicant indicated that they did not want to tender the judgment for purposes going to credit and accepts that the Tribunal is not bound by a decision on credit. There was considerable argument as to whether that application could be heard and determined by the principal member alone, or whether it was necessary for the application to be heard and determined by the Tribunal. It was argued as the matter was a question of law it should be determined by the principal member only. The matter was considered and in light of the powers of the Tribunal it was determined that the matter would be heard by the full Tribunal as it is obliged to do. The document was reviewed, and it was determined that the document was not relevant for the purposes for which the Applicant sought to introduce it and as such the document was denied acceptance. Cross-examination of Mr McInerney 1. The expert cross-examination then proceeded. The expert Mr McInerney confirmed that he had read the affidavits of the Respondent and the annexures overnight. He indicated that he is not a compounding pharmacist but had owned a pharmacy that employed two pharmacists who were registered compounding pharmacists. He conceded that Mr Knowles has more experience in compounding but not in regulation. Mr McInerney was questioned on the evidence of Mr Knowles where he indicated that there was no commercial product available. This was put to Mr McInerney and he agreed. However in cross-examination Mr McInerney indicated that there was a commercial product available and indicated that there must have been a misunderstanding as Ribolink was available. He was able to confirm that in December 2011 it was available. He indicated that he did not know if it was available from the supplier but that Mr McAlister had indicated that he used it when there wasn't a cheaper alternative. It was put to him that his criticism was therefore wrong, and he agreed. In further cross-examination he indicated that Ribolink was not available in Australia, but was available under the Special Access Scheme. He did not agree that the fact that a product was only available under the Special Access Scheme did not make it commercially available. When the Respondent stated that Dextran was available but was unsterile and the process of making it sterile and suitable for use in the human eye carried an expense, Mr McInerney pointed out that the Mater Hospital were preparing sterile eye drops from non-sterile Dextran and they weren't charging $80. However, on cross-examination he conceded that he had no idea what the Mater Hospital was doing, or whether they had special arrangements with their suppliers.. 2. There was further cross-examination on the availability of Ribolink followed by cross-examination on the question of the use of the term Dextran. It was indicated that Dextran was an abbreviation for Dextran sulphate as it was for Dextran T 500. Mr McInerney indicated that Dextran T 500 could be referred to as Dextran but Dextran suphate was a different entity. He indicated the use T in Dextran T sulphate was an irrelevant abbreviation and criticised its use of on the label because he thought that it was misleading for Dr McAlister. He was asked whether on receipt of the product from the Respondent, Dr McAlister should have read the label to which he responded that the doctor should have read the label. On being asked whether the doctor should have understood the label, he stated that he did not know and could not answer (T222.10). 3. Cross-examination turned to the safety data sheets referred to in evidence. He was cross-examined on the fact that in his report he did not say that he looked at other MSDS reports but in his evidence before the Tribunal he said that he looked at others. He responded that he didn't look at MSDS reports for the December 2011 period. He was tackled on whether on that basis he was able to criticise the Respondent for his actions in 2011. Mr McInerney indicated that his whole argument is that there is no toxicological information which demonstrates that it is safe to use Dextran Sulphate in the eye and conceded that he is unable to say that in December 2011 there were MSDS reports showing it as hazardous. There was considerable cross-examination on the question of the use of an eye bandage containing Dextran Sulphate but he made no investigation in that regard because the eye bandage contained a polymerised form of Dextran Sulphate. He was unable to say whether it made a difference one way or another because it was a polymer of carboxymethyl moiety combined with Dextran Sulphate, a different substance to Dextran Sulphate. He indicated that he was able to discount Mr Knowles example of the eye bandage showing Dextran Sulphate as safe because it was not comparing like with like. 4. Cross-examination turned to a Sigma Aldridge Hazard Statement Status Report which was introduced in 2015 but had a revision date of 18 September 2014. That report indicated that Dextran Sulphate was not a hazardous substance and Mr McInerney was questioned on why when he wrote his report of 22 October 2010 he did not include it in his report that Dextran Sulphate was not a hazardous substance. He indicated that he may not have looked at that report. Mr McInerney sought to explain that he found it strange that there were some reports that say hazardous and others that do not. 5. There was considerable discussion and examination of Mr McInerney on how he compiled his report and responded to matters relating to Mr Knowles report without going through all of the documentation provided by Mr Knowles, to which he responded that he was looking at Mr Knowles' answers and obviously didn't look at the scientific MSDS. At that point the matter was adjourned to the 9th of February 2016. 6. On resumption of the hearing on the 9th of February 2016, Mr McInerney was again sworn in. He requested an opportunity to make a point of clarification to the Tribunal and pointed out that in his earlier evidence and cross-examination he wasn't sure whether he had seen the 2014 Safety Data Sheet, when the hazardous nature of Dextran had been removed. 7. Prior to 2014 if there was a hazard warning sheet it would have been on every safety data sheet. The point he wanted to make is that the fact that if it was withdrawn he needs to withdraw his comments that there was any danger from its use. It was put to him that that means that his evidence that the use of Dextran Sulphate was not likely to cause damage to the eye if used. He stated that that was correct. 8. He was asked to agree whether the current position contradicts a lot of what he said in writing in his expert report. He agreed that once the hazard is removed then there is no reason not to use it in humans. 9. Mr McInerney was questioned on whether he knew the Respondent prior to being asked for a report into his behaviour. He indicated that he did know him professionally and had attended conferences in his area of compounding. He was questioned on whether he had made critical comments, about the Respondent at conferences or seminars. Although he did not recall having made comments when it was put to him that he made negative comments about the Respondent compounding, stated that he might have been talking about the Respondent compounding an antibiotic that was readily available and which followed a complaint that a pharmaceutical company was losing sales because of his compounding. Mr McInerney was asked how he could assure the Tribunal that in writing his report he was dealing with it in an independent manner. He replied that he had been in the field a long time and believed that he is completely objective. Mr McInerney did not however concede that his change in position on Dextran Sulphate constituted a substantial change in his expert evidence. He simply accepts that in 2014 there was not a hazard warning and therefore it could be used in the human eye. A question arose from the Tribunal as to whether Dextran Sulphate and Dextran Sulphate sodium salt, are the same thing or different as some of the MSDS reports used the term Dextran Sulphate and the report which indicated that it was not a hazardous substance refers to Dextran Sulphate sodium salt. Mr McInerney indicated that they are the same thing with Dextran Sulphate in fact being Dextran Sulphate sodium salt. That concluded the cross-examination of Mr McInerney and Mr McInerney was excused. Cross-examination of Mr Knowles 1. Mr Knowles was cross-examined by the Applicant. In essence, the main issues raised by the cross-examination related to whether or not the Respondent was entitled to substitute in the circumstances of this matter. Mr Knowles was asked whether if the Tribunal found that there was no need for substitution, would it have been okay for the Respondent to substitute what he did. He was asked whether if there was no agreement for substitution, would that be below the standard. Mr Knowles conceded that if there was no discussion with Dr McAlister to substitute then it would be below the standard expected of a pharmacist with the Respondent's level of experience. He was then asked whether if the Tribunal accepts that there was discussion but no approval for substitution whether that would be below the standard. Mr Knowles indicated that that would depend on a number of factors. In response to a question as to whether if the communication commenced with emails, whether it should continue right through by email to agreement, Mr Knowles indicated that that was not necessarily how it happens, it would be ideal but often these things took place out of hours and at all times, and at the time there was no requirement for the confirmation to be in writing. Mr Knowles was challenged on that issue as at page 85 of the transcript Mr Knowles indicated that he agreed with Mr McInerney that there would have needed to be confirmation in writing. Mr Knowles explained that that was correct but that sometimes one relies on file notes if out of hours etc. 2. That ended the cross-examination of Mr Knowles. There were questions put to Mr Knowles by the Tribunal and in particular questions relating to whether substituting Dextran Sulphate for Dextran in the corneal cross-linking procedure could have altered the action of Riboflavin in the procedure. Mr Knowles indicated he was unable to comment. Evidence of Mr Corry 1. Mr Corry was sworn to give evidence which in summary was to the effect that he is the senior pharmacist at the Respondent's company and described the processes which applied at the time. In summary it appears that the company was a small company consisting of a few pharmacists, that there were regular but informal conversations between the pharmacists as to matters that were being dealt with and he recalls discussion about Dextran and Dextran Sulphate by virtue of the compounding which was proposed to be done on behalf of Dr McAlister. He recalled that there was some confusion not about the product itself but about the availability of the products. He recalled that the bulk of the conversation centred around having to get a special form of Riboflavin and a substitute for Dextran. Mr Corry spoke about his own research into Dextran and Dextran Sulphate and indicated that some of the research had been done for his own interests prior to the incident with Dr McAlister and some of it after the problem arose. He asked why he would have done any of this research prior to the current issue. He advised the Tribunal that at that time he was locuming n pharmacy and over the weekend he had been researching Dextran for the purposes of his teaching as well as for his personal interests. 2. Mr Corry was referred to emails between the Respondent and Dr McAlister and use of the word Dextran loosely without the addition of the word Sulphate. Mr Corry indicated that in his view it is not uncommon for pharmacists to refer to a drug by its first part of a compound name without referring to the whole name. That would generally be understood by the doctor in light of conversations between the Respondent and the doctor. He was challenged on that, and asked whether he was coming to that type of conclusion because he knew the issues in the case and it was to suit his case. He stated that that was not so and that he was looking at it in the context of the conversations. He explained that by way of example Doxycycline is regularly used to indicate a drug which could be Doxycycline or a salt of Doxycycline. Mr Corry was then asked whether he would have expected the conversations and the references to Dextran Sulphate to be recorded in writing, and he indicated that it would depend on the particular circumstances but you could either make a note on the prescription or perhaps on a paper file. 3. Mr Corry was then cross-examined on matters relating to Complaint Two and indicated that prior to December 2012 the Respondent's company was generally not in the business of dealing in Schedule 8 drugs. It was not a situation that they hadn't turned their minds to having a drug register, it was more that Schedule 8 drugs were transferred to the pharmacy across the road. He indicated that when the businesses were split between the retail pharmacy and the compounding pharmacy there was not, to his knowledge, a discussion which took place to have a register because the situation was so infrequent that it would not have been considered at the time. He conceded however, that even if there was one instance of dispensing of a Schedule 8 drug it should have been recorded but explained that that would normally be taken to another pharmacy and therefore it was expected that they would keep the register. He indicated that there had been some discussion about keeping a register and that a decision was made that it was not necessary to do so. That concluded the evidence of Mr Corry and he was excused. Evidence of Mr Bova 1. The evidence of the Respondent was to the effect that he had worked in his parent's pharmacy from a very young age and had a sense of what working in a pharmacy was like. From 2001 – 2007 he worked as a pharmacy assistant and in 2008 after obtaining his registration his role changed to being a fulltime pharmacist. He then worked in the pharmacy with his wife who was a more experienced pharmacist, having been registered in 2001 and with his father who had been a pharmacist for a considerable period of time. In the circumstances he stated that he felt confident enough to purchase the pharmacy in 2008. 2. It was his decision to move into compounding and he set about putting the retail pharmacy into a saleable situation and concentrating on the compounding business. 3. In summary, Mr Bova's evidence was to the effect that he had learnt a great deal from his experience with Dr McAlister and certainly if he were now compounding any product on behalf a client, in seeking to use some form of substitution, he would ensure that that was fully documented and communicated to the doctor in writing. He did indicate that there were some substitutions which were very minor such as in respect of taste or flavour, but he certainly would not substitute any product that does not have a clear safety profile. In addition he indicated that he would not do any substitution without absolute clarity with the prescribing doctor. 4. He was asked questions about his not handling schedule 8 drugs and whether he made the decision not to do so after the events with Dr McAlister. He stated that he had made the decision beforehand because his pharmacists were dealing with a lot of issues, there were multiple areas for error and he wanted to limit those. Insofar as the conditions on his registration not to participate in any way in schedule 8 drugs, it was he who offered the conditions which are now on his registration. He repeated the evidence given by Mr Corry that at the time of this incident they were a very small compounding pharmacy, a small team and that all matters happening in the pharmacy were discussed informally between the team. 5. The Respondent conceded that in his evidence and his affidavit he was of necessity to some extent relying on his memory, but indicated that in areas where he made positive statements he had a clear recollection of those discussions. 6. His evidence was to the effect that he had discussions with Dr McAlister specifically on the issue of Dextran Sulphate and recalled specifically that Dr McAlister was very much concerned about the cost of the eye drops. He stated that Dr McAlister pointed out to him on several occasions in the conversations which he had that the cost was a significant issue. The Respondent's evidence was to the effect that he had made it clear to Dr McAlister that in the event that he was to use Dextran and needing to sterilise the product that the cost would be significantly higher than the cost that he was being charged by the Mater Hospital, and significantly higher than he would be able to produce it if he substituted Dextran Sulphate for Dextran. The Respondent was cross-examined on why he believed that he had an absolute discretion to substitute, relying on the discussions and the emails. He stated that he needed to put that into context. He stated that they had had a discussion on the phone the day before the email which referred to the use of a non-sterile product and the need for sterilising the product. He did not believe that that gave him the go ahead to produce a substituted product, but it gave him the go ahead to seek and come up with a solution which he would then need to discuss with Dr McAlister. 7. There was considerable questioning in regard to his reference in the email at tab 5 of his affidavit to Iron Dextran, and yet according to his evidence he did not use the words Iron Dextran in the telephone conversation thereafter. He stated that this was easily explainable in that he had checked and found various forms of Dextran and that the reference to Iron Dextran in his email was simply related to the fact that it existed. However on consideration he realised that Iron Dextran had no possible application to use in eye drops and therefore did not raise the question of Iron Dextran in the telephone conversation which followed that email. It was put to him that logically he must have indicated to Dr McAlister that he would not be considering Iron Dextran. He said that he had a clear recollection that he did not discuss Iron Dextran in the conversation and that he certainly would not have wanted to highlight the fact that he had suggested an inappropriate product, "it would not make me look good". He rejected any suggestion that he discussed Iron Dextran in the conversation with Dr McAlister. 8. There was considerable questioning on why he had not recorded in writing to Dr McAlister the substitution and the nature of the substitution. He stated that he wished that he had done so, but in light of the very conversation that took place the day before he believed that he and Dr McAlister were clear on what was to be compounded. He conceded that he should have used the word Sulphate in his following emails, but failed to do so as he believed that they understood each other and that his references to Dextran would be references to Dextran Sulphate. He agreed that as a pharmacist it would have been appropriate for him to record in writing the substitution with Sulphate. He wished he had done so but he had not. 9. It was pointed out to him that in his email he referred to Dextran T(500), the very term used by the doctor, and asked whether that would undercut his argument that it should have been understood. He conceded that that would be so. 10. That concluded the evidence in the matter. Submissions 1. The Tribunal received very detailed and helpful submissions from counsel in this matter concerning the credit of witnesses. Dr McAlister 1. The Applicant made the following submissions regarding Dr McAlister's credibility: 20. Dr. McAlister was the original complainant to the Health Care Complaints Commission. In giving his evidence, he principally relied on email correspondence between himself and the practitioner. He was frank in being mistaken about certain dealings with the pharmacist at the Mater Hospital and did not present as a witness who was seeking to mislead the Tribunal. He was unmoved in his evidence that he placed significant reliance on the practitioner and importantly that he was never aware of a proposal to substitute Dextran Sulphate for Dextran and was emphatic that he never agreed to that course. His account is largely supported by the extrinsic documentary evidence. 1. The Respondent claims that Dr McAlister's evidence should be rejected. In support of this assertion, the Respondent made the following detailed submissions: 2. The Tribunal had the benefit of observing Dr McAlister's oral evidence. There are powerful reasons to reject Dr McAlister's version of events in respect of discussions about Dextran Sulphate and "Ferro Dextran" in December 2011 and concomitantly to accept Mr Bova's evidence. In particular: 1. first, Dr McAlister prepared and signed his Statement, which was incorrect in a material respect so far as the events of 7 December 2011 are concerned. There was no good explanation for that inaccuracy, other than a serious failure of memory or the invention of facts; 2. second, he was not able from his own recollection of events, to correct elements of his statement regarding the events of 7 December 2011 that remained incorrect (the continued assertion he may have spoken to Dr Gilbert); 3. third, he engaged in unreliable guess work in preparing both his written evidence and giving his oral evidence under cross-examination; 4. fourth, he gave evidence that was internally inconsistent on the crucial issue of communications between he and Mr Bova about Dextran Sulphate; and 5. fifth, he gave unsatisfactory evidence about his receipt of labelled bottles that correctly identified on them the use of Dextran Sulphate. He says he read but did not comprehend the labels. The much more likely position is that he read the labels, understood them and raised no objection to the use of Dextran Sulphate because that had previously been agreed between him and Mr Bova. 1. Dr McAlister presented as an unreliable witness. That is emphasized and amplified by the fact that the Applicant, in cross-examination of Mr Bova, did not put to Mr Bova any suggestion that, in the 7 December 2011 phone conversation, Mr Bova and Dr McAlister never discussed the issue of using Dextran Sulphate (which was the substance of Dr McAlister's evidence). The Applicant also did not put to Mr Bova that Mr Bova's evidence, both in paragraph [78] of his main Affidavit and his oral evidence that in December 2011 he and Dr McAlister discussed Dextran Sulphate on occasions after the 7 December 2011 conversation, was untrue. 2. The McAlister Statement comprises ten numbered paragraphs. Paragraphs 3-7 of the McAlister Statement set out Dr McAlister's original version of the events of 7 December 2011. In paragraph 5 of the McAlister Statement, Dr McAlister said: "After out telephone conversation I contacted Catherine Gilbert, Acting Production Services Co-ordinator at the Mater Hospital and asked her to send me the exact details of the Dextran product that I had previously used. Later that day Catherine emailed me details of the type of Dextran in the form of the certificate of analysis." 1. The email asserted to exist in the second sentence of paragraph was not annexed to the McAlister Statement. Mr Bova requested the Commission supply a copy of that asserted email. No email was provided. No email existed. 2. Early in his examination in chief Dr McAlister apparently sought to correct the second sentence of paragraph 5 and confirm that the email he received from Dr Catherine Gilbert attaching the Sigma-Aldrich Certificate of Analysis (Sigma CA) was in fact sent by Dr Gilbert to Dr McAlister by email on 26 August 2011. 3. Whether Dr McAlister eventually corrected the flaw in Paragraph 5 or not, taken with numerous other instances of the doctor giving unreliable evidence, the correction required to Paragraph 5 is a powerful indicator of the doctor's overall unreliability as to the events of 7 December 2011 and December 2011 generally. 4. The McAlister Statement did not deal with the email Dr McAlister sent to Mr Bova on 30 November 2011, wherein Dr McAlister wrote to Mr Bova, "If you can come up with a reliable sequence to keep costs down and maintain sterility and reduce handling that would be great." Dr McAlister agreed in cross-examination that by those words he intended to give Mr Bova some discretion in coming up with a compounded product that met his requirements. 5. In relation to the Sigma CA, Dr McAlister agreed he knew from the time he received the Sigma CA on 26 August 2011 that it was not a Certificate of Analysis for a product the Mater was using in supplying the Dextran eye drops to Dr McAlister and was not, as advised to Mr Bova in the email, "the previous source we have used". Dr McAlister also accepted that he did not know where the Mater sourced its Dextran from for the purposes of preparing Dextran eye drops for him. 6. In cross-examination, Dr McAlister attempted to suggest that his intention in providing the Sigma CA to Mr Bova (post the 7 December 2011 telephone conversation) was to show Mr Bova that it was "Dextran T500" that Dr McAlister wanted. In response to the proposition that nothing on the Sigma CA identified the Dextran referred to as "Dextran T500", Dr McAlister asserted that upon receipt of the Sigma CA from Dr Gilbert he positively verified that the Sigma CA did refer to Dextran T500 by looking at the Sigma website: 7. Dr McAlister ultimately changed his evidence on this from a positive recollection of "verifying" that it was, to evidence to the effect that he "would like to think he did (verify): 8. The evidence given by Dr McAlister on this issue is but one further example of the unreliability of the doctor's evidence. The doctor's evidence was given not from a reliable independent recollection but on the basis of what the doctor would, now in November 2015, "like to think" he may have done. 9. Turning to the telephone call to Dr Gilbert on 7 December 2011, although Dr McAlister was able to (eventually when pressed) identify from his email records that he did not receive the Sigma CA in an email from Dr Gilbert on 7 December 2011, during cross-examination and in his recollection of the events of that day, the doctor nevertheless remained unsure as to whether he had spoken to Dr Gilbert on 7 December 2011. Nevertheless that is what the doctor asserted in the McAlister Statement. The following answer from Dr McAlister says a lot about the manner in which he put together the McAlister Statement, and the Respondent contends, his oral evidence generally: "Q. The thing is, Dr McAlister you put paragraphs 4, 5 , 6 and 7 together as a tight fitting internally consistent structure of what happened on 7 December, didn't you? A. Yes. Q. In your statement? A. Yes. Q. And now it turns out that you agree that that's not correct? A. Well I think that point 5 is incorrect but it's incorrect because - I mean every time I had a query regarding Dr Bova that I didn't feel comfortable with I contacted Catherine and I feel I would have at least tried to make contact with her on that day. I have gone through the emails. I found the email certificate of analysis and I have saved that to my external hard drive. That's given me the date so when I put this summary together that was my interpretation of what happened but it was incorrect but I can't say to what extent because I don't know if I did actually have a conversation with Catherine or not on that day and I'm unable to verify it and so that's why on Friday I sent the further email correcting paragraph 5." (our emphasis)" 1. As matters have transpired, the Tribunal has the benefit of evidence from Dr Gilbert, who was not cross-examined by the Commission. Dr Gilbert was on an overseas holiday between 5 December 2011 and 16 December 2011 and did not speak to Dr McAlister on the phone on 7 December 2011. Equally as instructive is the evidence from Dr McAlister as to his approach in preparing the McAlister Statement (and giving his oral evidence) is the evidence Dr McAlister gave in response to the suggestion that he did not speak to Dr Gilbert on 7 December 2011 because she was away overseas on holiday: "Q. Is it news to you that she was on leave and overseas on holidays between 5 December and 16 December 2011? A. She - I vaguely recall something about that now, yeah." 1. In paragraph 4 of the McAlister Statement, the doctor gave evidence of his version of the conversation between he and Mr Bova after Mr Bova sent the 7 December 2011 email to Dr McAlister at 11.58am. In paragraph 4 and throughout his oral evidence, Dr McAlister maintained his denial that he and Mr Bova discussed Dextran Sulphate in the 7 December 2011 conversation. Dr McAlister said the only topic discussed was "ferro Dextran". 2. That evidence is inherently implausible and could not be accepted. Not only is that so having regard to context, it is also self-serving and deeply unreliable having regard to the basis upon which Dr McAlister explains he has come to attribute the words "ferro Dextran" to Mr Bova and additionally how he attributes them as having been said by Mr Bova in a conversation on 7 December 2011. The following excerpt from the Dr McAlister's cross-examination is instructive: "A. He may well not have done but then I have to ask myself, well then where did I hear that and I can't think - and I remember as the different documents came in and it was all to refer to iron Dextran and I remember every time thinking the phrase I remember was ferro, ferro, do when it came to making the statement I tossed up do I put in iron Dextran because that's what everybody's been using or ferro Dextran because that's what I recall so I went with what I recalled." (our emphasis)" 1. It was suggested to Dr McAlister in cross-examination that when Mr Bova and he spoke on 7 December 2011 that Mr Bova said he can get raw material Dextran but that it isn't sterile and the price would end up being $80 a bottle. Dr McAlister agreed that Mr Bova may have said that but he does not recall, thinking it may have been in an email later. 2. Dr McAlister thus apparently recalls the substance of those words being the subject of a communication between he and Mr Bova. Importantly, it is to be observed that those words do not appear in any email. Those words are said by Mr Bova to have been spoken in the 7 December 2011 conversation. 3. Further, it was suggested to Dr McAlister that when Mr Bova and he spoke on 7 December 2011, Mr Bova said he could get Dextran Sulphate solution. Dr McAlister denied that. Dr McAlister attempted to deny ever having had a conversation with Mr Bova about Dextran Sulphate on 7 December 2011 and otherwise: 71. Apart from being implausible and self-serving, those denials were also internally inconsistent with Dr McAlister's own evidence. The substance of Mr Bova's evidence of the 7 December 2011 conversation regarding Dextran Sulphate and Mr Bova's ability to supply it at "roughly the same price that the Mater was supplying it" was put to Dr McAlister. The relevant passage is as follows: 1. "Q. On 7 December 2011, Mr Bova said to you something like because Dextran sulphate is already sterile I can supply it at roughly the same price that Mater was supplying it. He said something like that? A. So I do, I do recall - I honestly - I can't be sure whether he would have said that or not. It does ring a bell, but it's just not what I wanted." (our emphasis)" 1. Immediately following it was suggested to Dr McAlister that in the 7 December 2011 conversation he said words to the effect of "it's not going to work at $80, I can't pay that". Dr McAlister denied it. The following relevant question and answer then occurred: "Q. There's no doubt in your mind that Dextran sulphate was mentioned during the conversation? A. I have very little doubt, but that last line does ring a bell but I would not have been interested in Dextran sulphate. But I don't recall any conversation, but I do recall that line somewhere but I don't know where" (our emphasis)" 1. Apart from being implausible and entirely self-serving, Dr McAlister's denial of ever discussing Dextran Sulphate in the 7 December 2011 phone conversation or in any other communication with Mr Bova (apart from Mr Bova's 7 December 2011 email sent at 11.58am) coupled with his flimsy evidence regarding a discussion about "ferro Dextran" and how he attributes those words to Mr Bova are illogical and internally inconsistent with Dr McAlister's own evidence. Ultimately the doctor has plainly accepted that at some time in around December 2011: 1. Mr Bova may have communicated to Dr McAlister that he can get raw material Dextran but that it isn't sterile and the price would end up being $80 a bottle; and 2. "it rings a bell" and "I do recall" the line "because Dextran Sulphate is already sterile I can supply it at roughly the same price that Mater was supplying it". 1. Those two matters are the central substance of Mr Bova's evidence regarding the content of the 7 December 2011 conversation. The doctor did not accept that either of those two statements were made in a verbal communication and certainly not in the 7 December 2011 conversation. In that regard, the evidence demonstrates those words do not appear in any email. 2. Mr Bova's evidence about the 7 December 2011 conversation (and indeed other communications with Dr McAlister) is plainly the more logical, consistent and preferable evidence. 3. Again, it is instructive that despite calling Dr McAlister in its case and despite Dr McAlister's written and oral evidence, the Applicant never put to Mr Bova in cross-examination any suggestion that: (a) Mr Bova and Dr McAlister never discussed the issue of using Dextran Sulphate in the 7 December 2011 conversation; or (b) that Mr Bova's written and oral evidence that he and Dr McAlister talked about Dextran Sulphate on occasions after the 7 December 2011 conversation, was untrue. 4. The view of the Tribunal accords largely with the Respondent's submissions. It is of the view that Dr McAlister significantly reconstructed situations from his memory and the Tribunal found his evidence considerably self-serving. Mc McInerney 1. The submission of the Applicant is that significant reliance ought be placed on Mr McInerney's opinions and evidence. Mr. McInerney has qualifications and a range of highly relevant professional experiences that, of themselves, accord his evidence significant weight. His reports and his oral evidence demonstrated the dispassion and independence of mind consistent with a neutral expert witness intending to assist the Tribunal's deliberations. Further, Mr. McInerney presented in the best traditions of the expert witness by being prepared to ameliorate or change opinions previously expressed on the basis of further information. The Applicant's submission is that he presented as dispassionate and professional and did not advocate for the Applicant's position. The Tribunal would be comfortably satisfied that any prior dealings with, or comments about Mr. Bova, did not infect the independence of opinions expressed by Mr. McInerney. 2. The Respondent's submissions draw attention to a number of issues with Mr McInerney's evidence including erroneous factual assumptions, failure to consider material, flawed reasoning analysis and conclusions. 3. The Respondent submitted that the Applicant relies on the peer opinion evidence of Mr McInerney. Mr McInerney was first commissioned to provide the Applicant with a report on or around 23 September 2014 in relation to the compounding and dispensing of the eye drops by Mr Bova to Dr McAlister for Patient A. Mr McInerney was provided with the NSW Civil and Administrative Tribunal Procedural Direction 3: Expert Witnesses (Procedural Direction). The Procedural Direction contains a "Code of Conduct for Expert Witnesses" (Code of Conduct). 4. On or around 22 October 2014, Mr McInerney provided a report to the Applicant (First Report). In his First Report Mr McInerney agreed to abide by the Code of Conduct. Thereafter Mr McInerney was requested to review Mr Bova's submission made pursuant to s.40 of the Complaints Act. In turn, Mr McInerney provided an email report to the Applicant on or around 28 November 2014 (Second Report). 5. Following the institution of these proceedings by the Applicant, the Applicant re-served Mr McInerney's First Report on Mr Bova and served the Second Report. Mr McInerney's First Report traversed matters which were not particularised in Complaint One. Nevertheless, Mr McInerney was not asked to, and concomitantly nor did he, provide an updated report dealing only with matters expressly particularised in Complaint One. 6. In turn Mr Bova served a peer opinion report from Mr Knowles. On 6 November 2015, Mr McInerney was provided with the report of Mr Knowles, in conjunction with the entirety of the Respondent's evidence. Mr McInerney was asked to provide a supplementary report if his opinion was altered in any way or if he would like to respond to or comment on any of the material. Mr McInerney provided a further report dated 18 November 2015 (Third Report). 7. In his oral evidence in chief Mr McInerney adopted each of his Reports as his evidence in the proceedings. In each of his reports, Mr McInerney purported to give opinion evidence as to Mr Bova's conduct (importantly, so far as the factual assumptions he made in expressing his opinion, on the basis of the facts as he understood them) in terms of whether it fell below the standard reasonably expected of a practitioner of an equivalent level of training or experience. 8. In relation to the evidence of Mr McInerney generally, close analysis of Mr McInerney's First, Second and Third Reports in conjunction with the oral evidence he gave during the hearing, and the circumstances under which he gave much of that evidence, reveals crucial errors made by him in the facts he chose to assume, his technical reasoning process and ultimately his processes of opinion formulation generally. Those errors have combined to result in a deeply flawed opinion being presented to the Tribunal. Section 79(1) of the Evidence Act provides that if a person has "specialised knowledge based on the person's training, study or experience," s.76 does not apply to opinion evidence of that person "that is wholly or substantially based on that [specialised] knowledge". 1. Albeit in the context of admissibility in HG v The Queen (1999) 197 CLR 414 Gleeson CJ emphasised the importance of the requirement that an expert's opinion must be shown to be wholly or substantially based on "specialised knowledge". In dealing with an expert whose opinion was not based on specialised knowledge but rather on a combination of "speculation, inference, personal and second-hand views" his Honour said: "[In this case, the opinion sought to be adduced] was not shown to have been based, either wholly or substantially, on [the expert's] specialised knowledge as a psychologist. On the contrary, a reading of his report, and his evidence at the committal, reveals that it was based on a combination of speculation, inference, personal and second-hand views as to the credibility of the complainant, and a process of reasoning which went well beyond the field of expertise of a psychologist… …it is important that the opinions of expert witnesses be confined, in accordance with s.79, to opinions which are wholly or substantially based on their specialised knowledge. Experts who venture "opinions" (sometimes merely their own inference on fact) outside their field of specialised knowledge may invest those opinions with a spurious appearance of authority, and legitimate processes of fact finding may be subverted."(our emphasis) 1. Whilst said in the context of admissibility, those comments raise considerations that are, in the context of admitted evidence, equally relevant to the issue of the weight to be afforded those opinions. Many of the opinions expressed or views reached by Mr McInerney, as identified below, were based on "speculation, inference, personal and second-hand views" and not any "specialised knowledge" of his own. 2. Third, but connected with and indeed a consequence of the above, Mr McInerney's evidence has been revealed to contain a litany of errors in respect of technical issues the subject of consideration, in concert with errors committed in the process of the formulation of his ultimate opinion as to Mr Bova's conduct. These include 1. Mr McInerney's understanding of the facts and the assumptions of fact he chose to make. Key examples are: 1. the unfounded assumption, based not on research or inquiry but on speculation and inference, that RibolinkTM was a commercial product that was available in December 2011/January 2012 and that it fit the description of the prescriptions written by Dr McAlister; 2. the unfounded assumption, based on speculation, that the raw material used in the Dextran Sulphate Solutions was non-sterile raw material and was not properly sterilised by Bova Compounding; 3. the erroneous understanding that MSDSs for raw material are consistent in their content, which understanding then formed a key foundation in the views expressed by Mr McInerney as to Mr Bova's conduct; 4. the erroneous view that Dextran Sulphate was "contraindicated" for application to the human eye or is dangerous to the human eye, and that should have been Mr Bova's starting position, which view was formed in reliance and supported by the single "Gold Biotechnology" MSDS for Dextran Sulphate identified in the First McInerney Report;: 1. Mr McInerney's own processes applied in forming his opinions generally. Key examples include: 1. the assumption made that factual inquiries, which Mr McInerney undertook in September and October 2014, had any application whatsoever to what the situation was in December 2011 and could be used for that purpose; 2. the unfounded inference Mr McInerney read into the 26 August 2011 email from Dr Gilbert to Dr McAlister regarding Dr Gilbert's intentions; 3. the preparedness to doubt (indeed not accept), although Mr McInerney is not a toxicologist, the opinion of Dr Francis. 1. Those specific errors are not quarantined to the specific topics in relation to which they were made. They reveal a wider deficiency in the manner in which Mr McInerney has formed and expressed his ultimate opinion in respect of Mr Bova's conduct. It is impossible to discount the proposition that the opinions expressed in respect of Mr Bova's conduct overall have been ultimately founded, informed and influenced, cumulatively, by those improper considerations and erroneous conclusions. 2. In regard to sterility, the opinions expressed by Mr McInerney in his First and Third Reports on the (non) issue of whether the Dextran Sulphate drops supplied to Dr McAlister were sterile solutions (Sterility Issue) are a primary example of the Tribunal being in receipt of an expert's opinion that is not "soundly based, complete and reliable". 3. In the First and Third McInerney Reports, Mr McInerney concluded, and consequently criticised Mr Bova, for not providing Dr McAlister with sterile solutions. Mr McInerney reached his conclusions on the sterility issue on the key factual premise that the starting Dextran Sulphate raw material used by Bova Compounding was itself not sterile and thereafter "aseptic technique" was not used. As the evidence demonstrated, there was never any basis for Mr McInerney to proceed upon that factual premise. The starting raw material used in the Dextran Sulphate Solution was sterile. This information was available to Mr McInerney. 4. Whilst it became apparent in the oral evidence that: 1. Mr McInerney did not read Mr Bova's main Affidavit (either prior to providing the Third McInerney Report or giving his oral evidence in chief and in the concurrent evidence phase); and 2. whilst Mr McInerney did, correctly, concede that if Mr Bova had used a sterile raw material Dextran Sulphate then he had no concerns on the Sterility Issue and the process followed by Mr Bova "was quite appropriate", it nevertheless remains the case that the general processes of reasoning and opinion formulation adopted by Mr McInerney, as revealed by this issue, are demonstrably flawed. 1. Accepting that Mr McInerney did not read Mr Bova's main Affidavit before preparing the Second Report and before providing his evidence both in chief and in the concurrent evidence phase, that fact alone identifies at least two primary problems with the entire approach adopted by Mr McInerney to the formulation of his opinions which have been presented to the Tribunal. 2. First, he has not complied with the Code of Conduct in a very relevant respect. Second, the reasoning offered as to why he chose to assume the starting raw material was not sterile and in consequence then level of criticism at Mr Bova is also revealing. In his oral evidence in the concurrent evidence, Mr McInerney said: The approach taken by Mr McInerney in respect of the issue of whether RibolinkTM was a commercially available product in December 2011/January 2012 reveals a similar flaw in the entire process of reasoning applied by Mr McInerney in his evidence (Ribolink Issue). 1. Albeit not pleaded as a particular of Complaint One by the Applicant, in both the First and Third McInerney Reports, Mr McInerney criticises Mr Bova for taking steps to and ultimately compounding any product for Dr McAlister in December 2011/January 2012 on the basis that RibolinkTM was a commercially available product in December 2011/January 2012, which met the prescriptions written by Dr McAlister. 2. In forming those opinions, Mr McInerney proceeded on the premise that RibolinkTM was commercially available in December 2011/January 2012. 3. The Applicant never asked Mr McInerney to assume a fact either way on the issue. Second, and most importantly, in proceeding on his assumption, Mr McInerney never made any research investigations to ascertain whether RibolinkTM was a commercial product available in December 2011/January 2012. Third, in proceeding on his assumption, Mr McInerney did not recognise that RibolinkTM does not correlate to the prescriptions written by Dr McAlister (a fact pointed out by Mr Knowles in conclave evidence with which Mr McInerney agreed). 4. The Respondent understands that the agreement reached between Mr Knowles and Mr McInerney on the Ribolink Issue is that each of Mr Knowles and Mr McInerney agreed that for a product to be a relevantly "commercially available product" that product either needed to be listed on the "ARTG registered list" or "made under GMP". Each agreed that RibolinkTM was not on the "ARTG registered list" in December 2011/January 2012 and they were not able to ascertain whether in December 2011/January 2012 it was made under GMP. Mr Knowles, and not Mr McInerney it is to be noted, was able to identify that RibolinkTM is currently (in November 2015) made by "GD Pharmaceuticals" being a company who only obtained its GMP licence in March. 5. Eventually but ultimately far too late in the context of the proceedings, in cross-examination of the RibolinkTM issue, Mr McInerney apparently withdrew any criticism of Mr Bova based on the RibolinkTM where he said "and so on the basis of that discussion between Mr Knowles and myself I would then be more than happy that Ribolink was taken out of the equation and that Mr Bova was entitled to make it up". 6. There are four MSDS's issued for Dextran Sulphate and Dextran in evidence. Those are: (a) the "Gold Biotechnology" MSDS for a Gold Bio Dextran Sulphate product (GoldBio MSDS); (b) Pharmacosmos A/S MSDS for Dextran; (c) Fisher Scientific MSDS for Dextran; (d) Sigma-Aldrich MSDS for Dextran sulphate, sodium salt. 7. Mr McInerney formed a view and cited an undated MSDS for a Dextran Sulphate product produced by "Gold Biotechnology" (GoldBio MSDS), which recorded Dextran Sulphate as a potential irritant to the eye. Mr McInerney accessed the GoldBio MSDS from the internet sometime in September/October 2014. 8. Mr McInerney did not assert that Mr Bova should have reviewed the GoldBio MSDS per se in December 2011/January 2012 (as it transpired he had no evidence that it even existed at that time) but did opine that perusal of "any" manufacturer's MSDS for Dextran Sulphate would have revealed the same information to Mr Bova as the GoldBio MSDS. In that regard, Mr McInerney opined: "Perusal of any manufacturer's …(MSDS) for Dextran sulphate … would have indicated the required hazard statement and Precautionary Statement and set alarm bells ringing. This is an elementary search." (our emphasis) 1. Concomitantly, the central thesis of Mr McInerney's First, Second and Third Reports (and a significant part of his oral evidence) is that perusal of any MSDS for Dextran Sulphate should have inextricably lead Mr Bova to the conclusion, or at least the starting premise, that Dextran Sulphate was to be considered or assumed to be unsafe for use in the human eye at any concentration. Mr McInerney opined, based solely on the content of the undated MSDS, that "the literature describes the danger of using Dextran sulphate in the eyes". 2. The First McInerney Report reveals Mr McInerney's original ratio in that regard. This ratio forms the foundation of later opinions Mr McInerney offered as to what type of research Mr Bova would have needed, in those circumstances, to justify the use of Dextran Sulphate. There are no less than ten direct references to that opinion in the First and Second McInerney Reports. There are no references in the First and Second McInerney Reports as to any other basis upon which Mr McInerney opined that Mr Bova should have considered Dextran Sulphate to be unsafe for use in the human eye at a particular concentration. 3. Another central thesis of Mr McInerney's First, Second and Third Reports (and a significant part of his oral evidence) is that perusal of any MSDS for Dextran (not Dextran Sulphate) would inextricably lead Mr Bova to the conclusion, or at least the starting premise, that Dextran, in contradistinction to Dextran Sulphate, was safe for use in the human eye and thus that only Dextran could be considered appropriate for Dr McAlister's purposes. 4. Undeniably, both the Applicant in its formulation and prosecuting Complaint One and Mr McInerney (until the fifth day of hearing and despite powerful evidence to the contrary being provided at least a year earlier) proceeded on the premise that Mr McInerney's views in respect of MSDSs and what they apparently revealed about Dextran Sulphate were correct. That foundation was incorrect. 5. In contradistinction to the approach of Mr McInerney and the Applicant, Mr Bova contends and indeed has always correctly contended that in the process of undertaking a risk assessment and forming a proper view as to the safety of a particular product at a particular concentration, an MSDS does not by itself provide any proper clinical or pharmaceutical foundation to determine the safety of the product at a particular concentration. 6. Rather, an MSDS provides information to handlers of a raw product in its full concentration. Well prior to the commencement of these proceedings, on 27 November 2014, Mr Bova responded pursuant to s.40 of the Complaints Act to the Applicant's investigation and particularly the contents of the First McInerney Report (Section 40 Response). The Section 40 Response contained the following: "In criticising the use of Dextran Sulphate, the Expert Report relies on statements as to Hazards in an MSDS for Dextran Sulphate (Attachment F), and contrasts an MSDS for Dextran (Attachment G). Such an MSDS cannot conclusively establish the appropriateness for the use of Dextran Sulphate, nor that it is contraindicated for use in ophthalmic preparations. There are examples including MSDS's for Dextran containing the same or similar warning 'may cause eye irritation'. Amongst other things, the toxicity referred to in the MSDS referred to by the Expert appears to contain pure Dextran Sulphate rather than the concentration present as a solution used in a particular compounded medication. It should be noted, the Dextran Sulphate compounded by Bova was not supplied by Gold Biotechnology." 1. As it has transpired, Mr Bova's assessment, from day one, of the utility of MSDS in providing any proper clinical or pharmaceutical foundation to determine the safety of the product at a particular concentration coupled with his assessment that not all MSDS for the same raw material contain the same content is correct. It is also to be observed that both Mr Knowles and Dr Francis, retained during these proceedings to provide expert opinions on MSDSs, came to the same conclusion as Mr Bova. 2. Mr McInerney did not refer to or include the Sigma Dextran Sulphate MSDS. It was available to him at the time of the First Report. The Sigma Dextran Sulphate MSDS is Exhibit R7. At Section 2.1 titled GHS Classification it records "Not a hazardous substance or mixture". 3. Mr McInerney was cross-examined at length in respect of the MSDS. It is clear that Mr McInerney did not appreciate either that there are MSDSs for pure Dextran that contained different hazard warnings or that there are MSDSs for Dextran Sulphate that contain different hazard warnings. On the morning of the fifth day of the hearing and whilst still under cross-examination, Mr McInerney sought and was granted the opportunity to make what he described as a "clarifying statement" in respect of his opinions. He withdrew his comments in relation to hazard warnings on Dextran Sulphate as there would not be a danger in the operation because of Dextran Sulphate's use. Mr McInerney agreed that what he said in that clarifying statement contradicted much of what he said in his written reports and earlier oral evidence. 4. The errors in analysis and understanding on the part of Mr McInerney in respect of MSDSs and their utility are manifold. The incorrect understanding that Mr McInerney had as to the consistency and utility of MSDS was the central thesis and starting foundation of Mr McInerney's ultimate opinion as to the safety of Dextran Sulphate for use in the eyes and his opinions as to Mr Bova's conduct in compounding the Dextran Sulphate Solutions and assessing the safety and appropriateness of Dextran Sulphate for use. 5. Those errors in analysis, reasoning and understanding not only irremediably infect with error Mr McInerney's opinion as to those specific topics but also Mr McInerney's ultimate opinions as to Mr Bova's standard of conduct. It is impossible for the Tribunal to accept Mr McInerney's opinions as to Mr Bova's overall standard of conduct in circumstances where the central thesis and starting foundation of that opinion is so flawed in such a fundamental way. 6. Following the receipt of Mr Knowles report and Dr Francis' report which correctly doubted Mr McInerney's blunt, and incorrect, thesis regarding MSDSs, Mr McInerney (in the Third Report and later oral evidence) offered the opinion that Mr Bova would have required research going to Dextran Sulphate's use in the eye in a 20% concentration. There are a number of observations about that late expanded opinion: i. first, it is to be observed that nowhere in the First Report did Mr McInerney express or allude to holding such an opinion; ii. second, that peer opinion is not held by Mr Knowles; iii. third, the Applicant did not put to Mr Knowles in cross-examination that this research was the only basis upon which Mr Bova could have appropriately proceeded to conclude Dextran Sulphate was appropriate for use in the human eye ; iv. fourth, the Commission did not put to Mr Knowles that any particular published or unpublished standard of appropriate pharmaceutical practice required, in terms, the standard identified in Mr McInerney's assessment; v. fifth, the Commission did not put to Mr Bova the proposition that the only research Mr Bova could have based his assessment as to appropriateness on was that which Mr McInerney identified; vi. sixth, the asserted requirement for research identifying Dextran Sulphate's use in the eye in a 20% concentration is not stated in terms in any published or unpublished standard as a requirement. 1. Finally, and most tellingly, the central premise of that late expanded opinion as to the type of research Mr McInerney eventually contended Mr Bova required was that in Mr McInerney's view, Mr Bova's starting premise should have been that Dextran Sulphate was contraindicated for use in the human eye because of what was recorded on an MSDS. That is, Mr McInerney opinion remained wholly underpinned by the opinions he had formed (and not at that time retreated from) in respect of what conclusions must first be drawn from MSDSs. 2. Both Mr McInerney and Mr Knowles have provided their peer opinion as to Mr Bova's conduct in the absence of hearing the oral evidence of either Dr McAlister, Mr Corry or Mr Bova. Conventionally, each of Mr Knowles and Mr McInerney provided their peer opinion in respect of Mr Bova's conduct on the basis of facts they assumed or were asked to assume. 3. Mr Knowles provided his opinion accepting the facts he was asked to assume in the letter qualifying him. Those facts were consistent with the affidavit and oral evidence of Mr Bova and Mr Corry. Those facts were consistent with the facts Mr Bova says the Tribunal should find. 4. In contrast, Mr McInerney provided his opinion as to Mr Bova's conduct against the facts he assumed and identified at "Section 4 Assumed Facts" and in other areas of his First Report. Mr McInerney provided his opinion on Mr Bova's conduct: i. on an incorrect understanding of key chronological events around the period 7 December 2011 (that is so whether Mr Bova or Dr McAlister is accepted in respect of those dates); ii. by unquestioningly accepting Dr McAlister's version of events on the key issue of communications between Dr McAlister and Mr Bova about the use of Dextran Sulphate; and iii. by assuming facts outside his area of expertise, including facts as to Dr McAlister's and Mr Bova's intentions. In doing so it is notable in more than just a passing way that Mr McInerney assumed facts about Mr Bova's intentions negatively to Mr Bova. 1. This affects the assessment of the peer opinions offered in relation to each of the particularised conduct in Complaint One. The assessment of Mr McInerney's peer opinion must involve an assessment as to whether any of the ultimate opinions Mr McInerney reaches in respect of Mr Bova's conduct can stand having regard to the multitude of erroneous assumptions or inferences made in any event in conjunction with the demonstrated technical errors and errors in the process of opinion formulation. 2. Further, Mr McInerney's criticism in respect of Mr Bova's conduct in using a "technical" grade of Dextran Sulphate instead of a pharmaceutical grade of Dextran Sulphate centred on a further assumption of fact made by Mr McInerney for which he had no proper basis to make. That assumption of fact was that pharmaceutical grade Dextran Sulphate was available for acquisition in December 2011/January 2012. 3. So far as when it may generally be permissible to use a technical grade raw material, Mr McInerney opined that if a pharmacist ascertains the unavailability of the pharmaceutical grade of the material then depending on circumstances such as the urgency of its procurement and [the results of] a risk/benefit decision making process a substitution of technical grade material may be permissible. 4. First, Mr Bova did not use a "technical" grade of Dextran Sulphate but rather a biotechnology grade of Dextran Sulphate. Mr Bova and Mr Corry gave evidence that biotechnology grade is not pharmaceutical grade but it is a grade of raw material that is of a higher purity and grade to technical grade. Second, and relevant to Mr McInerney's central assumption that pharmaceutical grade Dextran Sulphate was available in December 2011/January 2012, Mr Bova gave uncontested evidence that Bova Compounding's inquiries did not identify that any pharmaceutical grade Dextran Sulphate at the correct molecular weight was available for purchase in December 2011/January 2012. Mr Bova's evidence is supported by the opinion of Mr Knowles. 5. Mr McInerney's opinion in respect of Particular 6 of Complaint One is identified on page 14 of the First and Third Reports is accurately characterised by the following passages: First McInerney Report "In my opinion the amount of Dextran T(500) Sulphate supplied by Bova Compounding Chemist to Dr McAlister on the script for Cameron Jones was inappropriate and excessive for the purpose to which it was to be used. As the prescription was Cameron Jones one should assume the prescription was for him alone…As the drops are to be used only perioperatively it would not seem necessary for Mr Jones to have eleven bottles." Second McInerney Report "To me it was obvious that the order for all repeats to be dispensed at once indicated that they were for multiple patients and not just for Mr Jones." 1. It is to be observed that the opinion is expressed without any reference, consideration or attempt to analyse how much of the supplied product is to be used pre-surgery, post anaesthesia, during surgery and post-surgery, a period which can last 3 to 4 days. This is surprising in the context of sterile preservative free eye drops provided in dropper bottles which have a limited safe life span once a bottle is opened. The analysis undertaken by Mr McInerney in the First and Third McInerney Reports presents as little more than "bare ipse dixit" reasoning. 2. In the circumstances of the above, the Tribunal would treat extremely cautiously, and in fact ultimately reject, any suggestion that once Mr McInerney had considered all relevant material or once he had retreated from specific areas of his reports where he was in error or had the facts he assumed been different that his ultimate opinions as to Mr Bova's overall conduct would nevertheless be properly unchanged: United Rural Enterprises Pty Ltd v Lopmand Pty Ltd and Ors [2003] NSWSC 870 at [15], by analogy. 3. The Tribunal should agree that Mr McInerney failed to consider material. In instances where the Tribunal believe there was reason for Mr McInerney to retract he refused to do so. Mr Knowles 1. The Applicant made submissions concerning Mr Knowles: 2. Mr. Knowles had conceded expertise as a compounding pharmacist, although it is submitted that his expertise to determine the appropriate standard or the relevant regulation is not as developed as that of Mr. McInerney given their differing curriculum vitae. 3. Mr. Knowles made it clear during cross examination on 9 February 2016 (and by implication in his report) that his opinions were based on an acceptance of the Facts (numbered 1-34) set out in his letter of instruction (Report p1). Accordingly, if the Tribunal finds facts inconsistent with the practitioner's account, Mr. Knowles' opinion will be without a proper basis. 4. Further, Mr. Knowles based his assessment of the practitioner's conduct on him being at the relevant time "a registered pharmacist with only 4 years of experience but had undertaken sufficient extra post graduate training in sterile compounding to satisfy the professional standards" (Report p.8 and evidence in cross examination on 9 February 2016). In reality, the practitioner had significantly more professional experience, given his evidence of having worked as a dispensary technician part time from 2001 until registered in 2008. 5. Although it was not demonstrated to necessarily have affected the integrity of his opinions, it would have been desirable for Mr. Knowles to disclose that he had past commercial relations with the practitioner when providing his report. The Respondent asserts that the Tribunal should place greater weight on the peer opinion of Mr Knowles than that of Mr McInerney. The Respondent submitted that Mr Knowles provided a peer opinion expert report in relation to Mr Bova's professional conduct relevant to Complaint One and in relation to the peer opinion reports of Mr McInerney. Mr Knowles is one of the most experienced compounding pharmacists in Australia and is an educator in the field of Advanced Pharmaceutics and Compounding Techniques. 1. In contradistinction to the flawed approach and assessment provided by Mr McInerney, Mr Knowles' evidence in respect of Mr Bova's professional conduct was considered, balanced, objective, logical, well-reasoned and inherently more reliable than that of Mr McInerney. Mr Knowles' peer opinion of Mr Bova's conduct, unlike Mr McInerney's, was founded on an accurate set of assumed facts. Demonstrating the balanced and well-reasoned peer opinion given by Mr Knowles, Mr Knowles is not in every respect wholly uncritical of Mr Bova. However, importantly, Mr Knowles does not consider that Mr Bova fell significantly below the standard of conduct expected of a pharmacist of an equivalent level of training and experience in any particular area having regard to all the facts and particularly not so in respect of areas actually the subject of the particulars in Complaint One. 2. The Respondent contends that it is clear that in the assessment of Mr Bova's professional conduct against the facts as found, the Tribunal should place greater weight on the peer opinion of Mr Knowles than that of Mr McInerney. 3. The Tribunal should accept that Mr Knowles has a greater knowledge and understanding of compounding than Mr McInerney. In relation to the submission that he does not have the level of regulatory experience the Tribunal should find Mr Knowles knowledge of regulatory issues adequate. Mr Corry 1. The Applicant made submissions regarding Mr Corry's evidence. 2. Mr. Corry gave relatively straightforward evidence, which was not the subject of significant challenge. Although he clearly supported his employer's past actions and had been an agent for change after the PBS audit that led to Complaint 2, if the Tribunal accepts his evidence in preference to that of the practitioner, Mr. Corry's evidence supports a view that: 1. his research into the safety or otherwise of using Dextran Sulphate was not undertaken directly to assist the practitioner in terms of his work for Dr. McAlister, and 2. a determination was made by staff, after discussion, that there was no need for BCC to have a dangerous drugs safe or register (relevant to certain particulars to Complaint 2) 1. The Respondent made submissions concerning Mr Corry's evidence. 2. Mr Corry swore one affidavit in the proceedings. Mr Corry also gave oral evidence. Mr Corry gave evidence, consistent with Mr Bova's evidence, in relation to: Bova Compounding staff consultations occurring in December 2011 regarding the availability and procurement of an appropriate grade of Dextran, Dextran Sulphate and Riboflavin-5-Phosphate for the compounds for Dr McAlister; conversations Mr Corry had with Mr Bova about Dextran Sulphate and Riboflavin-5-Phosphate; the research undertaken by Mr Corry in relation to Dextran Sulphate before dispensing; and Mr Corry's presence at Bova Compounding on 5 January 2011 at the time of dispensing. No aspect of Mr Corry's evidence was seriously challenged by the Commission in cross-examination. 3. The Tribunal found Mr Corry's evidence to be largely unchallenged and had no reason to not accept his evidence. Mr Bova 1. The Applicant made the submission in relation to the practitioner's evidence that it ought to be treated with some circumspection, unless it constitutes an admission against his interest or is corroborated by documentation or other credible evidence. Some of the practitioner's self-serving accounts ought be rejected. As to the agreements made with Dr. McAlister they ought be rejected as improbable or against the weight of other evidence and available inferences, which can be safely drawn to the contrary. 2. The Respondent asserted that Mr Bova was an impressive witness and made the following submissions: 3. Mr Bova swore two affidavits in these proceedings. Mr Bova gave detailed written and oral evidence of the facts and circumstances in and around November 2011 to January 2012 leading to dispensing and re-dispensing of the Dextran Sulphate drops including: Mr Bova's dealings and communications with Dr McAlister in relation to the use of Dextran Sulphate; the steps taken by Mr Bova and staff at Bova Compounding to source suitable available raw material to make the eye drops; the research, consultation, consideration and risk assessment undertaken by Mr Bova and staff at Bova Compounding in assessing the safety and appropriateness of the use of Dextran Sulphate; and the process and circumstances of the dispensing of the eye drops to Dr McAlister. 4. Mr Bova was an impressive witness. The only person who gave evidence disputing any aspect of Mr Bova's version of the key events was Dr McAlister. For the reasons identified in detail relating to Dr McAlister, the Tribunal should reject Dr McAlister's evidence to the extent it departs from Mr Bova's evidence and prefer the evidence of Mr Bova. 37. Concomitantly, the Respondent contends that the Tribunal should make findings of fact in accordance with Mr Bova's evidence. 1. The Tribunal should accept that whilst there are some elements of reconstruction, where there is a conflict between Mr Bova and Dr McAlister, the evidence of Mr Bova is to be preferred. The Standard of Proof 1. The standard of proof required to establish Complaints One, Two and Three in the present proceedings is the civil standard of proof, that is, on the balance of probabilities. However, given the seriousness of the allegations and the gravity of the consequences, the Tribunal must be "reasonably satisfied" that the particulars of the Complaint have been established. 2. In Briginshaw v Briginshaw [1938] HCA 34; (1938) 60 CLR 336, Dixon J at 362 to 363 held: "The seriousness of an allegation made, the inherent unlikelihood of an occurrence of a given description, or the gravity of the consequences flowing from a particular finding are considerations which must affect the answer to the question whether the issue has been proved to the reasonable satisfaction of the Tribunal. In such matters "reasonable satisfaction" should not be produced by inexact proofs, indefinite testimony, or indirect inferences ... this does not mean that some standard of persuasion is fixed intermediate between the satisfaction beyond reasonable doubt required upon a criminal inquest and the reasonable satisfaction which in a civil issue may, not must, be based on a preponderance of probability. It means that the nature of the issue necessarily affects the process by which reasonable satisfaction is attained." 1. The Tribunal is mindful of the decision in Briginshaw which is precedent for the fact that the Tribunal does not have to follow the criminal test of beyond reasonable doubt but while following the civil test of a balance of probabilities, has to be comfortably satisfied that the case against the Respondent has been made out. 2. The use of "comfortably satisfied" does not imply that proof to a higher standard than the balance of probabilities is required: Gianoutsos v Glykis (2006) 65 NSWLR 539 at 547-9, applied by the Medical Tribunal in In re Dr. Suman Sood [2006] NSWMT 1 at 10. National Law Framework- Unsatisfactory Professional Conduct and Professional Misconduct 1. 1. Part 8 of the National Law provides the framework for dealing with complaints concerning health practitioners, including pharmacists. 2. Section 139B of the National Law defines "unsatisfactory professional conduct". For present purposes, the relevant provisions are: (1) "Unsatisfactory professional conduct" of a registered health practitioner includes each of the following— (a) Conduct significantly below reasonable standard Conduct that demonstrates the knowledge, skill or judgment possessed, or care exercised, by the practitioner in the practice of the practitioner's profession is significantly below the standard reasonably expected of a practitioner of an equivalent level of training or experience. ... (l) Other improper or unethical conduct Any other improper or unethical conduct relating to the practice or purported practice of the practitioner's profession. 1. And, by s 139E of the National Law, "professional misconduct" is defined as follows: For the purposes of this Law, "professional misconduct" of a registered health practitioner means— (a) unsatisfactory professional conduct of a sufficiently serious nature to justify suspension or cancellation of the practitioner's registration; or (b) more than one instance of unsatisfactory professional conduct that, when the instances are considered together, amount to conduct of a sufficiently serious nature to justify suspension or cancellation of the practitioner's registration. 1. S 138 of the National Law defines "conduct" to mean "any act or omission". 2. In the case of Health Care Complaints Commission of New South Wales v Jonathan Fryar [2013] NSWPHT 2 the pharmacist was subject to two notices of complaint, the first concerning the supply of restricted substances including anabolic/androgenic steroids and the second relating to the supply of Minoxidil without prescription. The Tribunal found the Respondent guilty of Unsatisfactory Professional Conduct and Professional Misconduct in respect of both complaints. 3. In considering whether the Respondent's proven unsatisfactory professional conduct amounted to professional misconduct, the Tribunal drew attention to the words of Kirby P., in Pillai v Messiter [No. 2] (1989) 16 NSWLR 197, at 200, which although concerning a medical practitioner, are applicable to a pharmacist: "Departures from elementary and generally accepted standards of which a medical practitioner could scarcely be heard to say that he or she was ignorant could amount to professional misconduct. But the statutory test is not met by mere professional incompetence or by deficiencies in the practice of the profession. Something more is required. It includes a deliberate departure from accepted standards or such serious negligence as although not deliberate, to portray indifference and an abuse of the privileges which accompany registration as a medical practitioner." (Emphasis added) Reasons for Decision 1. The National Law provides (Section 3A) that in the exercise of functions under a NSW provision "...the health and safety of the public must be the paramount consideration." 2. In reaching its decision the Tribunal believes it necessary to consider each complaint and the individual particulars of each complaint. Complaint One Particular One 1. Between 23 December 2011 and 8 January 2012, the practitioner incorrectly dispensed ten (10) dropper bottles of 4.8mL Dextran T(500) Sulphate 20% on two occasions ("the Dextran Sulphate Product") to Dr James McAlister for Patient A in circumstances where: 1. He received two prescriptions from Dr McAlister on or around 23 December 2011 for Patient A: 1. "G Riboflavin 0.1% (in sterile water) for peroperative use 5mL 10 repeats"; 2. G Riboflavin 0.1% [in 20% Dextran (T500]] for peroperative use 5mL 10 repeats"; 1. On or around 7 December 2011 he received an email from Dr McAlister which sought to clarify the composition of the product to be sought by prescription by attaching a "Certificate of Analysis" from a previous supplier which stated:"Product Name: Dextran solution from leuconostoc mesenteroides 20% (w/w) (Autoclaved)"; 2. He was aware that the drops were for use: 1. In the human eye preoperatively; 2. For a corneal collagen cross-linking ophthalmic procedure; 1. Dr McAlister had not authorised the substitution of Dextran T(500) with Dextran T(500) Sulphate. The Tribunal found paragraph 1(a) and (b) to be a fact, save that in (b) the certificate was not from a previous supplier and did not clarify the position. Paragraph (c) was admitted and needed no comment. In respect of (d), the Tribunal was not comfortably satisfied that the Respondent was not authorised to substitute. Some change was accepted and authorised. Whilst for good practice the change should have been in writing that was not one of the particulars of the complaint. 1. Between approximately 30 November 2011 and 8 January 2012, the practitioner used or permitted BCC to use, a technical grade of Dextran T(500) Sulphate rather than a pharmaceutical grade of Dextran T(500) Sulphate when preparing the Dextran Sulphate Product. The Tribunal found this this particular not proven. The evidence showed that the Respondent used bio-technical grade product, which is a purer grade than technical grade Dextran and this was not challenged. 1. Between approximately 30 November 2011 and 8 January 2012, the practitioner failed to take make appropriate enquiries to clarify with Dr McAlister whether Dextran T(500) Sulphate could be substituted for Dextran T(500). The Tribunal found this not proven. Whilst good practice would have been to call for an amended prescription, this was not alleged in the complaint. 1. Between approximately 30 November 2011 and 8 January 2012, the practitioner failed to take reasonable steps to clarify whether Dextran T(500) Sulphate was appropriate and safe for use in the human eye. The Tribunal was comfortably satisfied that the Complainant had proved the allegation made in particular 4. The basis for this conclusion was that the evidence led indicated that he researched the issue of using Dextran Sulphate and found nothing to say that it was unsafe but for use in the eye the Tribunal was comfortably satisfied that before making the substitution he should have found evidence to say that it was safe before using it for the eye. 1. Between approximately 30 November 2011 and 8 January 2012, the practitioner failed to provide Dr McAlister with sufficient notification that the Dextran Sulphate Product contained Dextran T(500) Sulphate rather than Dextran T(500). The Tribunal found this allegation not proven. The Tribunal relied on the various discussions alleged by the Respondent which were accepted by the Tribunal. It also relied on the evidence of Dr McAlister that Dextran Sulphate had never been discussed and yet he received and read a label indicating Dextran Sulphate and ignored it. The Tribunal was concerned about the email behind tab 7 of the Bova documents which referred to Dextran (T500) but came to the conclusion that this could not outweigh the accepted discussion and the clear label on the product supplied which Dr McAlister admitted reading. 1. Between 23 December 2011 and 8 January 2012 the practitioner dispensed ten (10) bottles of the Dextran Sulphate Product to Dr McAlister for Patient A on two occasions which was inappropriate in that: 1. The supply of ten (10) bottles was an excessive quantity for a single patient; 2. He knew or ought to have known that the ten (10) bottles were to be used for patients other than Patient A. The Tribunal was comfortably satisfied that the practitioner should have been aware that the supply of 10 bottles was an excessive quantity for a single patient and that he ought to have known that the 10 bottles were to be used for patients other than Patient A. The Tribunal based this view on the email at tab 10 of the Bova bundle which has a clear reference to writing a prescription for one or multiple patients. In addition, the Tribunal was comfortably satisfied that the quantity contained in each bottle should have made it clear to the practitioner that the 10 bottles were for multiple patients. Complaint Two Particulars of Complaint Two 1. The Respondent admitted particulars 1, 2, 3, 4, 5, 7, 10, 11, 12, 13, 14, 15 and 17 without qualification and having regard to the nature of the allegations and the admissions made, the Tribunal was comfortably satisfied that it was not necessary for it to look behind the admissions made. 2. In respect of particular 4, by inference the Respondent admitted that by dispensing or permitting 8 prescriptions of testosterone to be dispensed, the particular was proven and accepted by him that it was ultimately his responsibility. 3. In respect of particular 6, the Respondent admitted that he had dispensed or permitted oxytocin to be dispensed without a valid prescription, but explained that the script was promised to be in the mail but never arrived because Dr Wilcox was no longer in practice. He should not have done repeats. 4. Particular 8 and 9, the Respondent effectively admitted the allowing of Dexamphetamine and codeine to be added to the drug register retrospectively but he explained that he was not intending to deceive but was seeking to correct a prior failure. 5. Particular 16, the Respondent admitted by implication that he failed to use or ensure a separate page of the drug register was used for each form or strength of a drug of addiction in that he admitted the non-existence of a drug register. 6. In the circumstances the Tribunal was comfortably satisfied that the Respondent is guilty of unsatisfactory professional conduct. Complaint Three 1. The Complainant sought to have the Respondent found guilty of professional misconduct under section 139E of the National Law in that the practitioner: 1. engaged in unsatisfactory professional conduct of a sufficiently serious nature to justify suspension or cancellation of the practitioner's registration; or 2. engaged in more than one instance of unsatisfactory professional conduct, that when the instances are considered together amount to conduct of a sufficiently serious nature to justify the suspension or cancellation of the practitioners registration. 1. The Tribunal considered the timeframe involved and the steps that had been taken by the Respondent during the period following the various breaches of his professional responsibilities and while the Respondent has put himself in a position where he would be unlikely to repeat any of the breaches, the subject of these complaints, the Tribunal is comfortably satisfied that at the time of the breaches and the multiplicity of them, the Respondent is guilty of professional misconduct. I hereby certify that this is a true and accurate record of the reasons for decision of the Civil and Administrative Tribunal of New South Wales. Registrar DISCLAIMER - Every effort has been made to comply with suppression orders or statutory provisions prohibiting publication that may apply to this judgment or decision. The onus remains on any person using material in the judgment or decision to ensure that the intended use of that material does not breach any such order or provision. Further enquiries may be directed to the Registry of the Court or Tribunal in which it was generated. Decision last updated: 13 April 2016