Real-time prescription monitoring system in Victoria Angela Liu RUSSELL KENNEDY LAWYERS New legislation in Victoria to implement mandatory real-time prescription monitoring It is well accepted that the increasing harm and deaths from the misuse of prescription medicines is a major public health concern in Victoria. In 2016, there were 372 Victorian drug overdose deaths involving pharmaceutical medicines, higher than the number of overdose deaths involving illicit drugs (257) and the road toll (291). 1 There has been an increasing push by coroners in Australia for the implementation of a mandatory realtime prescription monitoring system (RTPM) that alerts doctors and pharmacists to people who are misusing prescription drugs. 2 In a response to the coroners recommendations, the Victorian Government introduced legislation for a RTPM system to be rolled out in 2018. The Drugs, Poisons and Controlled Substances Amendment (Real-time Prescription Monitoring) Act 2017 (Vic) (the Act) was passed on 19 October 2017 and is expected to commence on 1 August 2018. 3 The Act establishes the legislative framework that will underpin Victoria s RTPM system, which provides doctors, nurse practitioners and pharmacists with access to the system and allows them to review up-to-date information on the prescriptions histories of the patients in their care. 4 The RTPM system, to be known as SafeScript, will allow pharmacy dispensing records for certain medicines to be transmitted in real-time to a centralised database which allows doctors and pharmacists to access the up-to-the-minute medication prescription history of certain high risk medicines for their patient at the point of consultation. 5 SafeScript will monitor all Sch 8 medicines (as prescribed in the Drugs, Poisons and Controlled Substances Act 1981 (Vic) (DPCS Act)) such as morphine and oxycodone which carry the highest risk of misuse (monitored poisons), 6 and some Sch 4 medicines, including all benzodiazepines such as diazepam and quetiapine. 7 It will also streamline the existing Sch 8 permit requirements to reduce duplication and regulatory burden. 8 Objectives of the Act The purpose of the Act is the prevention of prescription drug overdoses and earlier detection of prescribed medicine misuse. 9 The main objectives of the Act are to amend the DPCS Act and to: empower the Secretary of the Department of Health and Human Services (Department) to establish a database containing records of the supply of all monitored poisons 10 provide the Secretary with the power to require a prescribed person, class of person or data source entity to provide information to the database in accordance with the regulations 11 enable access, use and disclosure of information on the monitored poisons database by: pharmacists, registered medical practitioner or nurse practitioners for purposes specified in the Act 12 prescribed entities or person authorised by the Secretary (or class of such entities or persons) for purposes prescribed in the regulations or the authorisation 13 Mandatory requirements under the Act Under the Act, registered medical practitioners, pharmacists, nurse practitioners and authorised suppliers will be required to review a patient s dispensing history on SafeScript before writing, dispensing or supplying a prescription (exceptions apply in circumstances where the risk of prescription shopping is low, such as in prisons, residential aged care or as hospital inpatients). 14 A penalty of more than $15,000 applies to practitioners who do not take reasonable steps to check the monitored poisons database before prescribing or supplying the monitored poisons (100 penalty units). 15 Reportable drug event The Act also requires a registered medical practitioner, pharmacist or nurse practitioner to notify the Secretary as soon as practicable of a reportable drug event. 16 2
A reportable drug event is defined as: for a pharmacist, when a request is received for the sale, supply or dispense of any drug of dependence from Sch 8, Sch 9 or Sch 4 that are either in greater quantities, or more frequently than reasonably necessary 17 for a registered medical practitioner, when there is a reason to believe that the patient is a drugdependent person in circumstances where: the patient requests or seeks Sch 9 drugs the medical practitioner intends to treat or is treating the patient with a Sch 9 drug 18 The Act responds to coroners calls for implementation of RTPM in Victoria A number of Victorian coroners had recommended the implementation of a RTPM in an attempt to reduce the number of lives that are lost as a result of overdosing on prescription medications. The next section explores some of the findings into deaths due to prescription medication overdose and considers whether the Act has addressed the concerns raised by the coroner in those decisions. Case of Ms B Ms B was a 44-year-old woman who had a psychiatric condition and was a heroin user. 19 At the time of her death in December 2011, police found several prescription medications at her home in a kitchen cupboard. No illicit drugs were found. 20 The cause of Ms B s death was intoxication by the combined effects of tramadol, methadone, diazepam, codeine, alprazolam, risperidone, doxepin and metoclopramide. 21 The toxicology report also noted that the concurrent use of depressant drugs such as benzodiazepines and other opioids might have contributed to the toxicity of methadone. 22 Ms B had a complex mental history, including schizophrenia, depression and anxiety and was dependent on prescriptions for pain management. 23 In 2011, Ms B was repeatedly prescribed the same analgesic, anti-anxiety and antidepressant medications from seven different general practitioners and had received treatment for opiate dependence in the form of takeaway methadone doses. 24 Coroner s recommendations The State Coroner commented that if the RTPM system was in place at the time of Ms B s death, it would have enabled all of the clinicians involved in her care to make better-informed decisions about her. His Honour further stated that whilst it cannot be determined with certainty that the successful operation of the RTPM system would have saved her life, the potential for a different outcome remains. 25 His Honour made the following recommendations: that the Victorian Department of Heath progress the implementation of a Victorian-based [RTPM] system as a matter of urgency to prevent ongoing harms and deaths prescribing and dispensing of pharmaceutical drugs. 26 that while the Victorian Department of Health continues with its efforts to implement a [RTPM system] for Schedule 8 drug dispensing, it [should also identify] the legislative and regulatory barriers that might prevent drugs listed in other schedules (particularly Schedule 4) from being monitored within the scope of the program[,] [so as to] enhance clinicians ability to make appropriate clinical decisions about patients. 27 that the Victorian Department of Heath consider meeting with private health information technology developers and vendors to discuss and, if appropriate, address the legislative and regulatory barriers that might prevent private companies providing [RTPM] capacity through their products and services. 28 Case of Mr A Mr A died on 23 September 2010 when he was 34 years old. At the time of death, police located drug paraphernalia as well as numerous prescription medications and scripts in his bedroom. 29 The cause of Mr A s death was mixed drug overdose (heroin, methadone, codeine, diazepam, nitrazepam, oxazepam and doxepin). 30 Mr A had a longstanding history of illicit drug use and prescription drug abuse dating back to early adolescence. 31 Coroner Olle identified Mr A s drug seeking behaviour as attending numerous doctors with the aim of obtaining benzodiazepines, including nitrazepam, oxazepam and diazepam and the opiate pain reliever tramadol. 32 For a significant period of time leading up to his death, Mr A was engaged in prescription shopping by attending multiple doctors to obtain pharmaceutical drugs of dependence in excess of his therapeutic need. 33 Coroner Olle commented that Victorian coroners have advocated the need for a functioning RTPM system in Victoria to assist medical practitioners in coordinating their care for patients and to reduce the harm and deaths associated with pharmaceutical drugs. 34 His Honour further commented that such a system can be of significant benefit for medical practitioners involved in the case of patients such as Mr A, as it can alert them to each other s existence and to the fact that the patient has been prescribed and dispensed prescription medications well above the therapeutic need. 35 In line with the recommendations published by State Coroner in the finding into the death of Ms B, Coroner Olle reiterated the urgent need for the implementation of the RTPM system for Sch 8 drugs and 3
some Sch 4 drugs. The Coroner further recommended that the Australian Government Department of Human Services should review how Medicare Australia responds to medical practitioners Prescription Shopping Information Service 36 queries, to ensure that medical practitioners can appropriately identify a prescription shopper and to assist medical practitioners with making appropriate notifications as required under the DPCS Act. 37 Case of Mr W Mr W was a 30-year-old male who had a psychiatric condition and was regularly prescribed a combination of antipsychotic medication, narcotic analgesic and codeine. 38 Mr W died on 25 February 2011, and at the time of his death, several packets of prescription medications were found in his house, including: 39 benzodiazepines (Temaze, Alodorm, Alepam, Antenex) opioid analgesics (Codapane and Panadeine Forte) antipsychotics (Seroquel and Risperdal) antidepressants antiemetics antihypertensives antibiotics The cause of Mr W s death was mixed drug toxicity involving codeine, tramadol, oxazepam and diazepam. 40 Mr W had a complex medical history including: 41 bipolar affective disorder schizophrenia anxiety depression back pain secondary to spinal injuries sustained in traffic accidents previous opiate and benzodiazepine dependence excessive alcohol use absent right kidney previous heroin encephalopathy Mr W engaged in prescription shopping for multiple pharmaceutical drugs involving multiple prescribing doctors, medical practices and pharmacies. For example, in the 6 months prior to his death, Mr W attended at least 21 doctors practising from seven different medical clinics to obtain scripts for prescription-only drugs 42. Coroner s recommendations Relevantly, Coroner Spanos observed that numerous coronial investigations conducted over the last decade attest to the fact that curtailing prescription shopping requires a comprehensive, systematic and real-time solution to the information deficit that impedes coordination of medical care. 43 Her Honour further commented that for more than a decade in Victoria, coroners had recommended the development and implementation of the RTPM system to prevent ongoing harm and deaths prescribing and dispensing of pharmaceutical drugs. Her Honour stated that Mr W s death again highlighted the benefits such a scheme could have in saving lives. 44 In line with the recommendations published by the State Coroner in the finding into the death of Ms B, Coroner Spanos urged the Victorian Department of Health to progress the implementation of the RTPM system. 45 Her Honour also recommended that the Royal Australian College of General Practitioners should consider including and enhancing a section in its Standards for General Practices 46 to inform and advise general practitioners about their legal obligations when prescribing medications under the DPCS Act and to provide opportunities for professional development relating to the safe prescription of drugs of dependence to both drug-dependent and non-drug-dependent patients. 47 Does the Act address the issues identified by the coroners? These coronial decisions highlight the common issue amongst deceased persons: that they engaged in prescription shopping for multiple pharmaceutical drugs involving multiple prescribing doctors, medical practices and pharmacies, and that there were no systems in place at the time to alert the health professionals to this fact. One of the prominent observations of the coroners in each of the coronial findings was the need for the implementation of a Victorian-based RTPM system as a matter of urgency to prevent ongoing harm and deaths prescribing and dispensing of pharmaceutical drugs. The introduction of the Act addresses the issues raised by the coroners by implementing the RTPM system and allowing medical practitioners, nurse practitioners and pharmacists to access the up-to-the-minute medication prescription history of the monitored poisons. This will help improve communication and coordination of care between health professionals and assist with their clinical decision-making process and it may also provide opportunities for counselling and intervention where necessary. The Act also addresses the concerns relating to the monitoring of drugs other than Sch 8 poisons, such as Sch 4 drugs and other drugs of dependence. The scheme allows the Secretary of the Department to prescribe that 4
certain drugs are to be monitored by the system, which in turn will mean that SafeScript can be constantly evolving to reflect changes in prescription shopping behaviour. The majority of the other recommendations rely mainly on increased training and professional development for health professionals who deal with at-risk patients. The Victorian Government has announced it will deliver training to health professionals as part of the implementation program for the Act. 48 Conclusion Health practitioners face challenges everyday with the task of balancing effective management of their patients medical conditions while at the same time preventing the serious risks of dependence and misuse of prescription drugs. The implementation of the RTPM system will help address the issues raised by the coroners and assist health professionals to manage prescription shoppers more effectively, thereby reducing the ongoing harm and deaths associated with pharmaceutical drug misuse and inappropriate prescribing and dispensing of pharmaceutical drugs. However, it is important to note that the issue of identifying patients with the risk of prescription drug misuse and addiction is a complex one and requires a broad solution. As observed by Coroner Spanos in a number of coronial investigations, the issue of prescription shopping requires a comprehensive, systematic and real-time solution. 49 It is essential that RTPM system does not prevent effective treatment when needed and that there are appropriately-funded drug addiction and counselling services to refer patients. It will also be very important that health professionals are provided with ongoing training regarding the new legal framework and on the use of SafeScript to ensure that they understand and comply with their obligations under the Act. Angela Liu Law Graduate Russell Kennedy Lawyers www.rk.com.au Footnotes 1. Department of Health and Human Services, SafeScript, 2017, www2.health.vic.gov.au/public-health/drugs-and-poisons/ safescript. 2. See for example E Turner Coronial inquests call for urgent implementation of real-time prescription monitoring to prevent ongoing harms and deaths from the combined effects of benzodiazepines and methadone replacement therapy (2015) 23(3) HLB 50. 3. Minister for Health, Victoria Life-saving real-time prescription monitoring laws pass parliament media release (19 October 2017) www.premier.vic.gov.au/wp-content/uploads/ 2017/10/171019-Life-Saving-Real-Time-Prescription-Monitoring- Laws-Pass-Parliament.pdf; Explanatory Memorandum, Drugs, Poisons and Controlled Substances Amendment (Real-time Prescription Monitoring) Bill 2017 (Vic) http://classic.austlii.edu.au/ cgi-bin/download.cgi/cgi-bin/download.cgi/download/au/legis/ vic/bill_em/dpacsapmb2017861.pdf. 4. Above. 5. Above n 1. 6. Drugs, Poisons and Controlled Substances Amendment (Realtime Prescription Monitoring) Act 2017, s 4. 7. Victoria, Parliamentary Debates, Legislative Council, 9 August 2017, 2178-2189, (Jill Hennessy); Life-saving realtime prescription monitoring laws pass parliament, above n 3. 8. Above. 9. Victoria, Parliamentary Debates, Legislative Council, 17 October 2017, 5077-5095 (Jeffrey Wooldridge). 10. Drugs, Poisons and Controlled Substances Amendment (Realtime Prescription Monitoring) Act 2017, ss 1 and 5 DPCS Act, s 30A(1). 11. Above, ss 1 and 5 DPCS Act, s 30B(2). 12. Above n 10, ss 1 and 5 DPCS Act, s 30C(1) (2). 13. Above n 10, s 5 DPCS Act, s 30C(3) (5). 14. Above n 10, s 5 DPCS Act, s 30E 30H, s 9 DPCS Act, s 34D, s 10 DPCS Act, s 34F(c) and s 11 DPCS Act, s 35A. 15. Above n 10, s 5 DPCS Act, s 30E 30H. 16. Above n 10, s 7 DPCS Act, s 32A. 17. Above n 10, s 7 DPCS Act, s 32A(2)(a). 18. Above n 10, s 7 DPCS Act, s 32A(2)(b). 19. Coroners Court (Vic) Inquest into the death of Anne Christine Brain (30 October 2014) paras 1 and 4 (Inquest) www.coronerscourt.vic.gov.au/resources/d0606efb-0dae-4320-9ba3-ec789446ccec/annechristinebrain_479711.pdf; above n 2. 20. Inquest, above, para 2. 21. Inquest, above n 19, para 13. 22. Inquest, above n 19, para 15. 23. Inquest, above n 19, para 4. 24. Inquest, above n 19, paras 5 7. 25. Inquest, above n 19, comment 1. 26. Inquest, above n 19, recommendation 1. 27. Inquest, above n 19, recommendation 2. 28. Inquest, above n 19, recommendation 3. 29. Coroners Court (Vic) Finding into death without inquest: Jamie Laurence Apap (24 Jul 2015) para 14 www.coronerscourt.vic.gov.au/resources/3ded5fc9-726f-4971-91dc-f6f07d4111d3/ jamielaurenceapap_367810.pdf. 30. Above, para 50. 31. Above n 29, para 3. 32. Above n 29, para 16. 33. Above n 29, para 23. 34. Above n 29, para 34. 5
35. Above n 29, para 34. 36. Available at www.humanservices.gov.au/organisations/healthprofessionals/services/medicare/prescription-shoppingprogramme. 37. Above n 29, recommendation 4. 38. Coroners Court (Vic) Finding into the death without inquest: Dean Wayne Wright (18 January 2016) para 2 www.coronerscourt.vic.gov.au/resources/5ced901b-0a87-4081-9283-55031d7e96a8/ deanwaynewright_072711.pdf. 39. Above, paras 5 6. 40. Above n 38, para 55. 41. Above n 38, para 1. 42. Above n 38, para 12. 43. Above n 38, para 60. 44. Above n 38, comment 1. 45. Above n 38, recommendations 1 3. 46. Royal Australian College of General Practitioners, Standards for General Practices, 4th edn, Royal Australian College of General Practitioners College House, Victoria, 2015. 47. Above n 38, recommendations 4 7. 48. Above n 3. 49. Above n 38, para 60. 6