EDITORIAL

Implementing real-time prescription drug monitoring:Are we ready?

In recent years, there has been considerable interest inthe misuse of pharmaceutical drugs, resulting in partfrom the large increases in mortality from prescriptionopioids seen in the USA [1]. In Australia, there havebeen dramatic increases in opioid prescribing [2,3], andcoarse estimates of pharmaceutical opioid-dependentpeople have been in the order of 150 000 people, com-parable with the number of heroin users at the peak ofthe heroin market in the late 1990s [4].

In response to concerns around unsanctioned orinappropriate prescription drug use, many countrieshave introduced prescription drug monitoring pro-grams (PMP) [5]. Depending on how monitoring isimplemented, there is a range of potential benefits ofPMPs, including alerting prescribers and dispensers tomedication history and interaction potential, andmaking available information on medications recentlydispensed. Such information can assist health profes-sionals in determining if medication is prescribed bymultiple doctors and/or dispensed at greater frequencyor in larger amounts than may be medically necessary.

A plan for implementing an electronic PMP inAustralia was announced in 2012 [6], expanding anexisting system that was piloted in Tasmania. Issuesrelating to the implementation of this plan are currentlyunder consideration. When the system is eventuallyintroduced nationally, health professionals such as pre-scribers and pharmacists may be headed into unchartedterritory, with access to medication history informationnot previously available and a need to make decisionsbased on this information. The practical question ofhow regulators and practitioners could make best use ofthis information needs to be addressed, in addition tothe consideration of how this new ability to identifyprescription drug-related issues will impact on healthservices, including those services that provide drugtreatment.

Several key questions need to be considered inthe implementation process for prescription drugmonitoring:

Are we monitoring the right prescription drugs?

The proposed Australian PMP will monitor onlySchedule 8 controlled drugs, including stronger opioids

such as Oxycodone morphine and fentanyl, and thebenzodiazepines flunitrazepam and alprazolam. Thesystem will not monitor weaker opioids such astramadol, codeine–paracetamol combinations and themajority of benzodiazepines despite these also beingimportant contributors to morbidity and mortality[7–10]. The range of drugs covered is a crucial part ofany PMP, and the range proposed for Australia does notcover the full range of pharmaceutical drugs withknown significant non-medical use and harms.

At what threshold of medication dispensing willthe PMP trigger a response?

Any PMP implementation in Australia needs tosupport good clinical practice, in line with consensusguidelines for pain management. Simple triggers suchas the receipt of opioid prescriptions from more thanone prescriber or receipt of concurrent opioid andSchedule 8 benzodiazepine prescriptions from differentpractitioners may not be not sufficient as they couldresult in false positives, which can unnecessarily stig-matise patients who are using medications appropri-ately. There is the potential for ‘flags’ to be set thatspecify clinical requirements for regulatory approval,which could include prescribing medications beyond aparticular period, above a particular dose or if thepatient has particular characteristics (co-morbidpsychological disorder, history of substance depend-ence, etc). Expert input is required to reach an agree-ment on what these ‘flags’ might be in order tomaximise the usefulness of a PMP.

Who will respond and how?

While introducing a PMP represents an enormousopportunity for improving clinical care, it raises thequestions of (i) whether there is sufficient person powerin the regulatory body to be able to respond in a timelymanner to these requirements and (ii) of the ability toaccess review from specialists in a timely manner.Thesetwo issues were able to be managed in the Tasmanianpilot scheme. However, upscaling the Tasmaniansystem to NSW alone would result in 90 000

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Drug and Alcohol Review (September 2014), 33, 463–465DOI: 10.1111/dar.12195

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applications per year, an unmanageable number forboth the current regulatory and addiction medicineworkforces. Further, the Tasmanian experience showedemergent problems with consumer complaints, wherein some cases the decision was not clearly communi-cated to those affected the most (i.e. those prescribedthe medications being monitored) [11].

The proposed PMP identifies medications at thepoint of dispensing, meaning that pharmacists will havea key role to play. Pharmacists have already identifiedthat responding to addiction, mental health and opioidsupply issues is an area in which they feel challengedand hesitant to intervene [12–14]. Evaluations of exist-ing PMPs have demonstrated that when provided withadverse dispensing records, prescribers are likely torefer patients on [15], and pharmacists often informconsumers that medication is ‘out-of-stock’, when con-fronted with problematic pharmaceutical use [14,16].The US experience suggests that pharmacists may beless likely to communicate information directly to con-sumers when they have information from electronicPMPs [15].These findings suggest action is required toprovide pharmacists with the skills to communicatewith patients who are ‘flagged’ in PMPs. Early engage-ment of professional pharmacy groups, in addition toother key stakeholders, may identify opportunities forbetter infrastructure and skills to support pharmacistsin talking to patients about the difficult subjects ofaddiction and mental health, which would have benefitsthat would be more far-reaching than the implementa-tion of a PMP [17].

Increasing the capacity in primary care to respondto alcohol- and drug-related problems is desirable andrecommended [18], independent of the introductionof a PMP. The implementation of a PMP may providean important formal mechanism to identify, andrespond to, prescription drug-related problems. A keyfactor in realising this opportunity will be providingthe support and training for primary care clinicians inthis regard.

What represents ‘best practice’ in responding tothe needs of those identified through PMP?

Current treatment pathways for those dependent onprescription medications people are not well defined,with few services currently sufficiently equipped tomanage the common presentation of concurrent addic-tion and pain. Chronic pain and addiction are bothcomplex clinical areas, with limited evidence availableto inform clinicians of the best approaches to treatingthese conditions concurrently [19]. There is no doubtthat (i) chronic pain is a considerable health issue, and(ii) increased use of opioids has been associated with

increased mortality and morbidity [20].The implemen-tation of PMP may bring much-needed attention tothese important issues.

Further, the referral pathways to specialist servicesneed to be established while ensuring primary, second-ary and tertiary services have the capacity for the poten-tially large number of patients that may be identified bya PMP. Many community and specialist drug treatmentservices already operate at capacity and/or have sub-stantial waiting lists.Well-known geographic challengesto treatment exist in regional and rural areas, locationsin which pharmaceutical use is known to be most prob-lematic [21]. The Tasmanian experience suggests thatone likely approach to manage patients may involveincreased use of community pharmacy programs todispense medications in smaller amounts, known as‘staged supply’, though the limited funding for theseprograms may need to be expanded to meet thedemand [22].

Finally, to prevent unintended harms, considerationneeds to be given to a range of issues such as

• Ensuring patients are not inadvertently directedtowards illicit opioids, including addressing the riskthat opioid- or benzodiazepine-dependent individ-uals are not instantly ‘cut off’ when it becomesapparent that they have been seeing multiple pre-scribers to maintain their dependence.

• Preventing stigma and discrimination when health-care prescribers become aware of a patient’s opioidsubstitution treatment status [23].

• Monitoring for inappropriate shifts to weakeropioids or other psychotropic medication. In theUSA, it was observed that greater scrutiny withprescribing stronger opioids led to increased pre-scribing of less restricted opioids despite a weakerevidence base for their efficacy [24], with unknowneffects on clinical outcome.

PMPs have long been recommended to reduceharms related to pharmaceuticals and, although furtherevaluation is required, may also produce real benefits inimproved quality and safety of clinical practice. Whilethere is still time for the practical aspects of implemen-tation to be considered, a formal mechanism for con-sultations with those with addiction and chronic painexpertise, alongside representatives from primaryhealth-care professional bodies, is required. This couldinclude a roundtable with representatives from keyorganisations, such as the AMA, pharmacy professionalgroups and treatment providers involved. Furthermore,in addition to the logistical and infrastructure costs ofimplementing the PMP, thought must be given to theresources needed for up-skilling the health care profes-sionals who will be responding where concerns are

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identified. Finally, establishing clear clinical treatmentmodels for those with concurrent pain and substanceuse disorder is essential. Even if the introduction of anational PMP is delayed, addressing these issues shouldremain priorities, in light of the increasing morbidityand mortality associated with prescription opioids.While both pharmacy and medical professional groupsappear to be supportive of the introduction of a PMP[25,26], the best outcome will be if a plan is made nowto address these important issues with significant inputfrom the professionals who will be most impacted byany PMP.

Conflict of interest

SN is supported by a National Health and MedicalResearch Council Research Fellowship (#1013803).The National Drug and Alcohol Research Centre at theUniversity of New SouthWales is supported by fundingfrom the Australian Government under the SubstanceMisuse Prevention and Service Improvements GrantFund. SN and RB are investigators on untied educa-tional grants from Reckitt-Benckiser. RB is aninvestigators on an untied educational grant fromMundipharma.

Suzanne Nielsen1,2 & Raimondo Bruno3

1National Drug and Alcohol Centre, University of NewSouthWales, Sydney, Australia,

2Drug and Alcohol Services, South Eastern Sydney LocalHealth District, Sydney, Australia, and

3School of Psychology, University of Tasmania,Hobart, Australia

E-mail: suzanne.nielsen@unsw.edu.au

References

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[2] Leong M, Murnion B, Haber PS. Examination of opioidprescribing in Australia from 1992 to 2007. Intern Med J2009;39:676–81.

[3] Roxburgh A, Bruno R, Larance B, Burns L. Prescription ofopioid analgesics and related harms in Australia. Med J Aust2011;195:280–4.

[4] Lintzeris N Prescribed medications: the new wave of opioiddependence. Of substance 2009;7:10–11.

[5] Australian Government. National Pharmaceutical DrugMisuse Framework for Action 2012–2015. 2012.

[6] Minister for Health AG. Media Release: New System toCrackdown on Prescription Painkiller Abuse. 2012.

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[8] Caplehorn JR, Drummer OH. Fatal methadone toxicity:signs and circumstances, and the role of benzodiazepines.Aust N ZJ Public Health 2002;26:358–62.

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[11] Tasmania Ombudsman. Investigation into the administra-tion of s59E of the Poisons Act 1971 by the PharmaceuticalServices Branch of the Department of Health and HumanServices. Tasmania 2013.

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[13] Cooper RJ. Over-the-counter medicine abuse—a review ofthe literature. J Subst Use 2013;18:82–107.

[14] Nielsen S, Cameron J, Pahoki S. Opportunities and chal-lenges: over the counter codeine supply from the codeineconsumer perspective. Int J Pharm Pract 2013;21:161–8.

[15] Green TC, Mann MR, Bowman SE, et al. How does use ofa prescription monitoring program change pharmacy prac-tice? J Am Pharm Assoc 2013;53:273–81.

[16] Pates R, McBride A, Li S, Ramadan R. Misuse of over-the-counter medicines: a survey of community pharmaciesin a South Wales health authority. Pharm J 2002;268:179–82.

[17] Sproule BA. Decreasing the harms of prescription opioids:a case for pharmacists. Drug Alcohol Rev 2011;30:327–9.

[18] Strobbe S. Prevention and screening, brief intervention, andreferral to treatment for substance use in primary care. PrimCare 2014;41:185–213.

[19] Morasco BJ, Gritzner S, Lewis L, Oldham R, Turk DC,Dobscha SK. Systematic review of prevalence, correlates,and treatment outcomes for chronic non-cancer pain inpatients with comorbid substance use disorder. Pain2011;152:488–97.

[20] Fischer B, Jones W, Urbanoski K, Skinner R, Rehm J.Correlations between prescription opioid analgesic dispens-ing levels and related mortality and morbidity in Ontario,Canada, 2005–2011. Drug Alcohol Rev 2013;33:19–26.

[21] Day C, Conroy E, Lowe J, Page J, Dolan K. Patterns of druguse and associated harms among rural injecting drug users:comparisons with metropolitan injecting drug users. Aust JRural Health 2006;14:120–5.

[22] Australian Government and the Pharmacy Guild. The fifthcommunity pharmacy agreement. 2010.

[23] Earnshaw V, Smith L, Copenhaver M. Drug addictionstigma in the context of methadone maintenance therapy:an investigation into understudied sources of stigma. Int JMent Health Addiction 2013;11:110–22.

[24] Simoni-Wastila L, Qian J. Influence of prescription moni-toring programs on analgesic utilization by an insuredretiree population. Pharmacoepidemiol Drug Saf 2012;21:1261–8.

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[26] Kaye B AMA repeats call for DORA national roll-out.Medical Observer; 2013.

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