Proprietor responsibilities: your questions answered


Our recent webinar generated many interesting, thorny questions; here they are, complete with answers from PDL Professional Officers Georgina Woods and Gary West, and Meridian Lawyer Chandrika Darroch

Q: In my early practice I was taught that liability around scripting lay with the prescriber in a community setting, but that in a hospital type setting it was shared 50-50 with the dispenser. Was this correct? And is this still the case?

Patient expectations are important. If there is a problem with a prescription it is important that the pharmacist communicates this directly with the patient so that they can understand why there might be a delay in the supply. A respectful and polite explanation that you may need to seek further information before supplying gives the patient the opportunity to take their prescription elsewhere or perhaps leave it with you and then you can contact them when the issue has been resolved.

Q: Can you please comment on the relationship between pharmacists in charge and proprietors? For example, if a PIC dispenses a forged S8 prescription, what is the proprietor responsibility when the proprietor is not the dispensing pharmacist?

If a prescriber will not get back to you at all then you can sometimes discuss this with the patient so that it can be addressed during their appointments. Eg. If a prescriber is continually writing S8 prescriptions incorrectly. While this is not the fault of the patient, sometimes the fact that they are an inconvenience might allow the prescriber to understand why it is important to adhere to the legislation.

Q: What can you do when you have concerns or wish to clarify something with a prescriber and they won’t take your call or call you back, e.g. early or seemingly excessive supply of opioids or benzos, where the dose info on the prescription does not match what patient states they are taking with doctor’s approval?

PDL understands it can be very difficult to contact prescribers. Unfortunately, this must be done from time to time. If it is urgent and you have a patient waiting, we suggest that you politely explain this to the receptionist to see if there is any way that you can speak with the prescriber now or in a timely manner. I believe emails are also useful as if it is a complicated matter such as excessive supply then a detailed email outlining your concerns with evidence supporting this can be useful for both the prescriber and you, especially if the matter is further scrutinised. Patient expectations are important. If there is a problem with a prescription it is important that the pharmacist communicates this directly with the patient so that they can understand why there might be a delay in the supply. A respectful and polite explanation that you may need to seek further information before supplying gives the patient the opportunity to take their prescription elsewhere or perhaps leave it with you and then you can contact them when the issue has been resolved.

 If a prescriber will not get back to you at all then you can sometimes discuss this with the patient so that it can be addressed during their appointments, e.g. if a prescriber is continually writing S8 prescriptions incorrectly. Whilst this is not the fault of the patient, sometimes the fact that they are an inconvenience might allow the prescriber to understand why it is important to adhere to the legislation. Pharmacists have professional obligations to exercise their own independent clinical judgement when dispensing any medication, and particular scrutiny is required with any drugs of addiction.  If you are not comfortable dispensing the medication then you should not do so, even if the patient is frustrated and doesn’t want to wait, or if you cannot seek the information you require in order to safely dispensing the medication.

Q: How can you ensure adequate proprietary oversight with an interstate owned pharmacy with current border restrictions and lockdowns?

There are many ways in which an interstate proprietor can maintain an awareness of what is occurring in a pharmacy, without being physically present.  Proprietors who cannot physically attend their pharmacies need to have very good ways of remotely keeping an eye on what’s happening in the pharmacy and should look at ensuring that their programs and software allow them to do this daily.  Further suggestions:

  • Communicate regularly with pharmacy staff and with their business partners via telephone or Audio Visual Link technology (AVL)
  • Be able to conduct off-site audits (via remote access to computer systems) so that any deficiencies or issues can be identified
  • Arrange on-site inspections and audits by an independent auditor or a business partner who can visit the premises
  • Take appropriate action when any deficiencies or concerns are identified
  • Be able to obtain and review key data on a daily, weekly and monthly basis
  • Conduct staff meetings and partnership meetings via AVL
  • Have systems in place to record when such meetings, inspections and audits occur

Q: Why isn’t anyone checking whether pharmacists are following practice guidelines such as patient counselling and provision of a CMI?

This should be part of everyday practice and a standard procedure in any pharmacy. If the pharmacy utilises documents such as the PDL Guide to Good Dispensing, then they should be aware and reminded that these actions are a component of professional practice. Continuous quality improvement activities including review of QCPP protocols should highlight these expectations and references.

Q: There is so much regulation and red tape, how can we keep up, it’s becoming so difficult and frustrating?

PDL understands there are many responsibilities on pharmacists irrespective of being an employee or owner – although these expectations are on all health professionals as there is a growing focus on patient safety and best practice. We need to remain engaged with the profession, the representative organisations for the profession and the industry media. We suggest you seek out means to remain updated by the regulators in your jurisdiction. This may mean reading newsletters from PBA or PCNSW, link with providers of CPD such as ACP, SHPA or PSA, subscribe to media such as the AJP Daily and take advantage of memberships such as PDL (including complimentary subscription to the AJP), Practice Alerts and other resources. It is expected that all health professionals remain up to date in their area of practice which would include those who are in management or ownership positions. 

Q: How would you suggest we should keep up when things are constantly changing e.g. vaccination guidelines?

Ensure you are engaged with representative organisations, PDL for alerts, media such as AJP Daily, and ensure your management or owners pass on information provided by their representative organisations such as the Pharmacy Guild.

Q: How do I get support if I were to report a business partner who appears to be self-medicating and stealing S4D?

In cases of illegal activities, you have an obligation to review and consider mandatory reporting requirements. A lack of action is not defendable and may see someone involved in regulatory action because of an absence of action. A health practitioner who is self-medicating has a health impairment and should be referred to their treating GP or specialist. Impairments occur for a range of reasons and regulators are mindful of how such situations need to be handled. A health professional practising with an impairment may be a risk to the public and therefore some action needs to be considered. If you are not the practitioner with the impairment, then an insurer is not able to engage a lawyer to provide you with legal advice under the insurance policy. If you feel you need legal advice you should seek out a privately funded legal opinion. 

Q: There have been instances where pharmacists with provisional registration (interns) have received notifications from a regulatory authority for example AHPRA. If they are working under supervision at this stage of their career, can they be held responsible by AHPRA in relation to a situation that led to a complaint, or should the notification have been directed to the supervising pharmacist?

Interns still must follow the legislation, guidelines and codes that apply to all pharmacists, but if they are working under supervision then you also have to ensure the person supervising them is doing just that. They should be giving the intern appropriate tasks based on their level of experience.  The Regulator will be looking to ensure that the intern has learned from the error or mistake and that there are not significant issues that need addressing.  It could be viewed as educational for the intern, but some action could also (and will likely) be taken in relation to the supervisor/ proprietor, where the intern was not being appropriately supervised, and where the pharmacist responsible for supervising their work did not identify that an error had occurred.

Q: I have customers who want to return S4 medications after leaving the pharmacy and it is always refused. However, they often threaten to make formal complaints – can they?

Every case is different, so this response is general in nature. However, anyone can complain about anything to a regulator. Sometimes regulators will note that the pharmacist’s actions are legal and supported by legislation and/or practice standards and they will not proceed with the complaint process. Other times the pharmacist is asked to respond. The PDL Professional Officers, and on occasion the policy underwriter and their lawyers, will assist with such a response; in a case like the one described it is likely to see the matter closed with no further action.

Q: Employee pharmacists have no liability for any disciplinary action even when the proprietor is completely overseeing their operations. How come the owner takes the full impact of their employed pharmacists’ actions?

This is not the understanding of the PDL Professional Officers. The regulators can, and do, take action against both employers and employee pharmacists. The actions may begin with owners as they have overall responsibility for the governance within the pharmacy; however, the employee pharmacists may also have to respond to the regulators in due course, especially regarding their individual practice. Our experience indicates that while there has been a focus on proprietors recently, the dispensing pharmacists are also being asked to respond to the regulators.

Q: If all S8s moved to the e-script/token format, would that not eliminate most of the legislative/disciplinary issues surrounding S8s? Should we not be lobbying for such a change on behalf of the industry as a whole?

That is a good point as the data required for the script to be compliant should be automatically included in the electronic script. That would certainly limit the issues with omissions from the prescription, the issues with faxed or emailed scripts, as well as with owing scripts. Pharmacists should encourage doctors to utilise this option but patients need to be able to understand how the script is transmitted and stored; some patients may not have this ability.

Q: Pharmacists can feel very frustrated as it often falls to them to ensure legal obligations are met regarding prescribing requirements. Is there a way prescribers can be better educated and held responsible for acting within the legal requirements?

A positive and collegial approach is encouraged in the first instance. If the prescriber understands that deficiencies have impacts not only for pharmacists but also their patients, then they may be more understanding. If the prescriber is recalcitrant then as mentioned in the presentation, contact the health department and allow them to remind the prescriber of their legal obligations. Document all attempts to resolve this issue with the prescriber.

Q: We have come across some medical centres who do not post the S8 prescriptions (telehealth appointment and emailed/faxed a copy of the script) and request us to send paid envelopes to them. Is there a legislative requirement for the medical centre to arrange postage of the prescription to us?

The legislation requires that the original prescription be sent by the prescriber to the pharmacy supplying the medication.  For example, in NSW, Regulation 81 of the Poisons and Therapeutic Goods Regulation 2008 requires that: A person who so directs the supply of a drug of addiction: (a) must immediately make out a prescription, and (b) must send the prescription without delay (and in any case within 24 hours) to the person to whom the direction was given.  Under Regulation 96, if the prescriber fails to comply and the original prescription is not received within seven days, the pharmacy must report the prescriber to NSW Health. Prescribers should be reminded that pharmacists have an obligation to report the prescriber where they fail to comply with these regulations.

Q: What about GPs sending prescriptions directly to patient via email and not as an e-script?

That is not appropriate and the GP needs to be reminded of the legal obligation and also the risk. Once they understand scenarios such as patients presenting the same prescription at multiple pharmacies, they may be less likely to continue this practice. See https://www.health.gov.au/sites/default/files/documents/2020/09/covid-19-national-health-plan-prescriptions-via-telehealth-a-guide-for-prescribers.pdf

Q: What about doctors who refuse to correct S8 scripts that have details omitted (e.g. quantity in words and figures). What would you suggest is the best way to handle this situation?

A positive and collegial approach is encouraged in the first instance. If the prescriber understands that deficiencies have impacts not only for pharmacists but also their patient, then they may be more understanding. If the prescriber is recalcitrant then as mentioned in the presentation, contact the health department and allow them to remind the prescriber of their legal obligations. Document all attempts to resolve with prescriber. Do not supply the medication if the prescription does not comply with the requirements and is invalid.

Q: What action is required by the pharmacist if a patient mails you a prescription which goes missing in the post?

Pharmacists can only dispense from a valid prescription. If the prescription is lost in the mail then the patient needs to be advised to seek a new one. Alternatively use e-scripts to minimise risk of lost mail.

Q: Some jurisdictions may have a proprietor registered as a non-practicing pharmacist. What (if any) difference in responsibilities exist for registered compared to non-practising owners?

PDL cannot speak to regulatory obligations without checking with specific jurisdictions regulators. It might be assumed that all proprietors – including ‘non-practising’ pharmacists – have a responsibility to ensure they have appropriate oversight and knowledge of the professional and clinical activities occurring in their pharmacies. They should have ways to monitor compliance with the relevant legislation, guidelines and codes. They could be held to account in the event of regulatory action against them or their staff.

Q: What tools or checklists are available to help with proprietor oversight?

Missed the webinar? You can watch the recording below. 

 

 

 

 

 

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1 Comment

  1. (Mary) Kay Dunkley
    17/09/2021

    Great resource!

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