Important information regarding the use of SafeScript in Victorian hospitals
SafeScript provides essential information of patients' dispensing history to both prescribers and pharmacists so that they can make safer decisions about whether to supply high risk medicines. Given that the harms suffered by Victorians from prescription medicines are still rising, with 422 Victorian lives lost in 2018 (compared to 414 in 2017), the need for clinicians to be better informed before supplying these medicines is greater than ever - and universally so, whether that be in primary care settings or acute care.
Throughout the implementation of SafeScript, the Victorian Government has focused on two key matters: making sure that patient data is appropriately secure while also ensuring that the user experience for clinicians accessing SafeScript is as straightforward as possible. SafeScript has strong security measures including two factor authentication. An assessment was recently commissioned to look at security and workflow issues within hospital environments in the context of how prescribers access SafeScript. The assessment has revealed that a seamless user experience for prescribers cannot be delivered in hospitals without waiving two factor authentication and the design of the system means that forgoing this important security measure cannot be adequately mitigated at this present time.
A decision has therefore been made that until a better balance can be struck between the data security requirements of SafeScript and the ease with which prescribers can access the system, that hospital prescribers should not be required by law to access SafeScript before prescribing. This means that while mandatory use of SafeScript will commence on 1 April 2020, prescribers in all hospital settings, including outpatients, will be exempt from the regulatory requirement to check the system before a monitored medicine. This arrangement will be reviewed when the digital landscape within hospitals is more amenable to SafeScript's security requirements.
It is important to reiterate that exemptions for prescribers in hospital environments are only being applied because the technology cannot at this time be optimised in hospitals and this does not negate the utility of information that SafeScript provides to prescribers. The Victorian Government continues to encourage all clinicians to use SafeScript when prescribing high-risk prescription medicines in order to keep patients as safe as possible. It has been encouraging to see that SafeScript is already being used by doctors in many hospital emergency departments.
The regulatory requirement for hospital pharmacists dispensing monitored medicines to hospital out-patients or patients being discharged from hospital will remain. We expect hospital dispensing software will be fully integrated with SafeScript by April 2020, providing the same seamless integration with SafeScript that doctors and pharmacists in primary care have. Many hospital pharmacy departments have also begun incorporating SafeScript into dispensing workflow.
Should you require further information, please contact the SafeScript implementation team by email at firstname.lastname@example.org.
While SafeScript is predominantly intended to support safe clinical practice in the primary care setting, hospital clinicians will be able, and will be encouraged, to access the system to obtain information that may assist in the treatment of patients.
Registration Training Setting up SafeScript
What is SafeScript?
SafeScript is computer software that allows prescribing and dispensing records for certain high-risk medicines to be transmitted in real-time to a centralised database which can then be accessed by doctors and pharmacists during a consultation.
SafeScript provides prescribers and pharmacists with a clinical tool to make safer decisions about the prescribing or dispensing of high-risk medicines, and facilitate the early identification, treatment and support for patients who are developing signs of dependence.
After a successful study area focussed on the Western Victoria Primary Health Network region, SafeScript was implemented across Victoria from 1 April 2019.
Why is SafeScript necessary?
The harms and increasing number of deaths from prescription medicines are a major public health concern.
| Deaths in Victoria
| Pharmaceutical medicines
| Illicit drugs
| Road toll
In 2018 there were 422 Victorian drug overdose deaths involving pharmaceutical medicines, higher than the number of overdose deaths involving illicit drugs (263), and higher than the road toll (213). In 2016-17, there were almost as many ambulance callouts relating to pharmaceutical medicines (10,517) as for illicit drugs (11,097).
What medicines are monitored through SafeScript?
Based on the latest international and local research and recommendations from an expert advisory group, the system monitors prescription medicines that are causing the greatest harm to the Victorian community.
Medicines that are monitored include:
- all Schedule 8 medicines
- benzodiazepines, such as diazepam
- 'Z-drugs' (zolpidem, zopiclone)
- codeine containing products
SafeScript monitors all prescriptions for these medicines regardless of whether they receive a PBS subsidy or are private, non-PBS prescriptions.
What information does SafeScript collect from hospitals?
SafeScript is intended to provide clinicians with information on what high-risk medicines have been supplied to patients in the primary care setting.
Work to collect out-patient and discharge prescription records from hospital pharmacy systems is underway.
SafeScript does not collect records of medicines administered in hospital in-patient settings.
Who has access to patient records in SafeScript?
Doctors, nurse practitioners and pharmacists have access to SafeScript to view records of all high-risk medicines that have been supplied to patients under their care. This enables health professionals to make safer and more informed clinical decisions and facilitates the co-ordination of treatment and communication by giving them visibility of all clinicians involved in the patient's care.
Authorised Department of Health and Human Services staff will also access SafeScript as part of their regulatory role in ensuring the safe supply of medicines in the community.
When am I permitted to access a patient record in SafeScript?
Patient records in SafeScript may only be lawfully accessed when you are involved in that patient’s medical care and in the context of the medicines which are monitored.
If you do access a patient's record in SafeScript, you will need to make sure you can substantiate this access in your capacity as their registered health practitioner.
The following is a non-exhaustive list of circumstances where accessing patient records in SafeScript would be permitted in law:
- when prescribing or supplying a medicine to the patient,
- when reviewing the patient's medication history as part of a patient consultation (e.g. when a doctor takes a patient history or a pharmacist conducts a medication review), or
- when discussing the patient's medication history with other registered health practitioners who are involved in that patient's care.
You must not use the information in SafeScript for any other purpose. Any other purpose may include (but is not limited to) marketing or commercial purposes.
Do I need to seek patient consent to access SafeScript?
Doctors, nurse practitioners and pharmacists who are involved in the care of a patient are authorised under law to access that patient’s record in SafeScript, without express permission from the patient, for the purposes of ensuring the patient’s safety from prescription medicine related harm.
This authorisation is made under the Drugs, Poisons and Controlled Substances Act 1981.
How can prescribers and pharmacists in hospitals access SafeScript?
All clinicians can access the SafeScript portal on their computer or via a tablet or mobile device.
Hospital pharmacy software vendors are working to provide an integrated workflow for pharmacists. Like many community pharmacy software systems, Merlin and iPharmacy will feature pop-up notifications to alert pharmacists when high-risk circumstances have been identified in SafeScript which requires their review.
Work is also progressing to provide a more integrated user experience for hospital prescribers. However, health services are all at different stages of implementing fully electronic medication systems. This is a complex transition and will be subject to the IT roadmaps for individual health services.
What are the clinical alerts that display in SafeScript?
The clinical alerts in SafeScript are based on the prescribing/dispensing history of a patient. These are:
- Multiple provider episodes: When prescriptions from 4 or more prescribers or 4 or more pharmacies have been recorded in SafeScript within the last 90 days.
- High-risk drug combinations: When prescriptions for certain drug combinations have been recorded in SafeScript within the last 90 days.
- Methadone + a benzodiazepine
- Methadone + a long-acting opioid
- Fentanyl + a benzodiazepine
- Fentanyl + a long-acting opioid
- Opioid dose threshold: When the daily morphine equivalent dose (calculated based on an average over the last 90 days) exceeds 100 mg MED daily (i.e. a high-risk dose).
Does an alert in SafeScript mean I am not allowed to prescribe or dispense a medicine?
An alert does not mean that you are not allowed to prescribe or dispense a medicine, but it indicates that some clinical risk has been identified which you need to review and manage appropriately.
SafeScript does not instruct you on what to do or decide whether a medicine should or should not be prescribed to your patient. This remains your clinical decision to determine whether the medicines prescribed continue to be the safest and best option for your patient’s medical needs.
Should you decide that a medicine is no longer the safest treatment, you are reminded that good clinical practice involves ensuring that appropriate continuity of care is provided for your patient. Abruptly discharging the patient from your care or abruptly stopping treatment in patients who have been taking high-risk medicines over a long period of time may be contrary to patient safety. There may be implications to discontinuing some medicines too quickly. For example, sudden withdrawal of benzodiazepines may result in rebound insomnia or anxiety, or at worst, seizures.
Medical practitioners and pharmacists are also reminded of their responsibilities as part of their professional registration, contained within their code of conduct. It is important that all patients receive the same standard of care, remembering that anyone can develop a dependency on prescription medicines.
Clinicians are strongly encouraged to complete the comprehensive training provided as part of SafeScript implementation, which has a focus on enhancing clinical and counselling skills. When you identify a high-risk circumstance in SafeScript, this training will give you the confidence and skills to enable you to continue to provide safe and appropriate ongoing care to your patient. More information about the training available can be found at the SafeScript Training Hub.
What support is provided to patients and health professionals for the implementation of SafeScript?
SafeScript is accompanied by a range of initiatives to support and prepare patients and health professionals for its implementation. These include:
- A public awareness campaign aimed at improving understanding of the risks associated with some prescription medicines. Brochures about SafeScript for patients have been supplied to pharmacies and medical clinics. To order brochures, please email email@example.com.
- SafeScript GP Clinical Advisory Service is a peer-to-peer service helping GPs to support patients with prescription medicine concerns and complex needs (1800 812 804). More information can be found at the GP Clinical Advisory Service website.
- Accredited SafeScript training available online, covers planning for consultations, alternative management options and having challenging conversations. Online training can be accessed at the SafeScript Training Hub.
- Secondary consultation services are also available to medical practitioners through Reconnexion, specialising in anxiety disorders, depression and benzodiazepine dependency. Reconnexion also offers counselling services for patients and can be reached on 1300 273 266 or at www.reconnexion.org.au.
- The SafeScript Pharmaceutical Helpline is ready to respond to patients with concerns about their use of high-risk medicines. This line is staffed by nurses and trained counsellors and is available 24 hours a day. Patients can reach the Helpline by calling 1800 737 233.
Will the use of SafeScript be mandatory in hospitals?
Hospital prescribers will be exempt from the mandatory requirement to check SafeScript when prescribing a monitored medicine.
Hospital pharmacists will be exempt from the mandatory requirement to check SafeScript when the monitored medicine supplied is intended for administration or use within the hospital.
Hospital pharmacists will be required to check SafeScript when the monitored medicine supplied is intended to be taken by the patient outside of the hospital, that is, when treating a hospital out-patient and discharging patient (either from a ward or an emergency department).
While there will be some exceptions from mandatory use, prescribers and pharmacists may still access SafeScript to review a patient’s medication history when they are involved in that patient’s medical care and consider it clinically necessary to do so.
How is patient privacy protected under law?
There are offences and strict penalties under the Drugs, Poisons and Controlled Substances Act 1981 for improper or unauthorised use of SafeScript.
A log is created each time a record is viewed in SafeScript and this is monitored by the Department of Health and Human Services. If inappropriate use is detected, health professionals may face penalties under Victorian law and the matter may be referred to the Australian Health Practitioner Regulation Agency for further investigation.
Health professionals must always adhere to privacy requirements set out in the Health Records Act 2001 and Privacy Act 1988 when handling patients’ health information. The Health Privacy Principles and Australian Privacy Principles specify the circumstances where health professionals can access, collect, use or disclose health information about an individual.
A Privacy Impact Assessment has been undertaken to ensure the implementation of SafeScript is compliant with privacy laws.
How does SafeScript keep records secure?
SafeScript has been built to the Victorian Protective Data Security Standards, which provide a set of criteria for the consistent application of risk managed security practices across Victorian Government Information. The Victorian Protective Data Security Standards are consistent with Commonwealth Government security measures, including the Australian Signals Directorate’s Information Security Manual.
SafeScript has been independently security audited as well as security tested to this standard.
Data encrypted in transit and at rest
Data transmitted between medical practice systems, pharmacy systems and the SafeScript database is encrypted at all times and occurs through a secure, encrypted internet connection. Data stored in the SafeScript database is also encrypted at all times.
SafeScript also utilises contemporary security measures to safeguard data against unauthorised access. Health professionals will be required to use multi-factor authentication (a username/password + PIN) in order to access the system.
The security of the system is routinely tested and reviewed to ensure data stored in SafeScript remains protected.
What are the changes to the Schedule 8 permit and notification requirements for hospitals?
As part of the legislation to establish SafeScript, a number of amendments were included to reduce the regulatory burden for hospital prescribers when treating patients with Schedule 8 medicines.
Legislative changes that take effect from 1 July 2018 relevant to hospital prescribers include:
- Permits no longer required to treat a patient in a day procedure centre
- Permit no longer required to treat a patient in an emergency department
- Permit no longer required when prescribing up to 7 days's supply on discharge
- Notification of drug dependent person no longer required (for Schedule 8 medicines and Schedule 4 drugs of dependence).
These changes were in addition to the existing Schedule 8 permit exemption when treating a hospital in-patient.
Will data be used for research purposes?
De-identified data in SafeScript may be used by the Victorian Government to inform service planning and policy decisions to improve healthcare for the Victorian community.
The harms from prescription medicines is a growing public health issue. Data in SafeScript may also be published at an aggregate population level to respond to the increasing research interest in understanding the level and trends of prescription medicine usage.
All data used for research and evaluation purposes will be in accordance with the requirements in the Health Records Act 2001 and the appropriate Human Research and Ethics Committee standards.
Why can't the My Health Record be used for real-time prescription monitoring?
The My Health Record is a patient-controlled summary of a patient’s health record, in which patients can choose what is included and who can view their medication history. SafeScript is different because it allows doctors and pharmacists involved in a patient’s care access to a complete record of high-risk medicines that have been supplied.
Patients are not be able to opt-out or restrict what medication history can be viewed in SafeScript. This is necessary to ensure a comprehensive medication history can be captured to allow health professionals to make safer clinical decisions and reduce the harms caused by high-risk medicines.
Where can I get further information?
Further information is available on the SafeScript website.
The SafeScript General Enquiries team can be contacted on 9096 5633 or via email.