Australian pharmacy perspectives on increasing access to medicines through reclassification

Abstract

Objectives

Availability of medicines without prescription can increase consumers’ timely access to treatment and promote self-management of minor ailments and adherence to long-term medications. Globally, access to relevant medicines has improved through increased reclassification of medicines from prescription to non-prescription availability. However, Australian reclassification lags behind countries with comparable health systems, and the factors influencing this are poorly understood.

Methods

Semi-structured interviews were conducted during May 2015 to explore the perspectives of Australian pharmacists and support staff on future reclassification. Interview responses were transcribed verbatim, and the data were analysed thematically, primarily informed by the general inductive approach.

Results

Participants identified a broad range of medicines as candidates for future reclassification by applying risk versus benefit judgements, assessing any medicines with potential for misuse and hazardous medicines as unsuitable. Key drivers for change in classification were underpinned by participants’ desire to support consumers’ management of minor ailments and adherence for those on long-term therapy. Barriers to reclassification were identified by pharmacy staff as internal, negatively impacting pharmacists’ readiness for reclassification and external, negatively impacting the overall progress of change.

Conclusions

While the research provided valuable insights to inform the ongoing discussion on future reclassification, a larger, more representative sample is needed to confirm these findings.

Keywords

community pharmacists and pharmacy support staff medicines scheduling Australia

Introduction

Australia’s National Medicines Policy aims to optimize health and economic outcomes through a number of objectives, including ‘timely access to the medicines that Australians need, at a cost individuals and the community can afford’.¹ Self-medication with non-prescription medicines is an important aspect of health care, which recognizes consumer autonomy and encourages greater independence in health decisions.² In Australia and other countries with comparable health systems, consumer access to medicines is regulated through a structure of classification or scheduling.³ Outlined in the national Standard for the Uniform Scheduling of Medicines and Poisons, and implemented through relevant state and territory legislation, the classification of medicines is guided by multiple factors, including purpose for use, potential for abuse, safety, toxicity and the need for access.⁴ Medicines that are assessed to have low associated risk are unscheduled and available for general sale from retail outlets, while medicines that are assessed to have potential risks are classified into schedules, the progression through which signifies increasingly restrictive regulatory controls.⁵ In summary, Schedule 2 (S2) Pharmacy Medicines and Schedule 3 (S3) Pharmacist Only Medicines are only accessible from pharmacies, with the latter requiring professional advice for safe use, Schedule 4 (S4) Prescription Only Medicines and Schedule 8 (S8) Controlled Drugs require a prescription for supply.⁴

In recent years, a number of former Prescription Only Medicines, including emergency hormonal contraception and oral famciclovir, have been down-scheduled to enable timelier access to treatment.^2,6,7 Other benefits of improved access include potential reduction in duration of illness and prevention of disease progression,⁸ and empowerment of consumers to make decisions regarding their health.^2,9 A 2003 review of medicines scheduling in six countries recognized that those with pharmacy-only schedules for medicines supply, that is, Australia, New Zealand, Canada, France and United Kingdom (UK), were more likely to down-schedule prescription medicines for non-prescription availability than those with prescription availability or unrestricted general sale, such as the United States.⁶ However, New Zealand was more proactive than Australia in down-scheduling medicines between 2003 and 2013,⁷ despite the goal of regulatory harmonization between the two countries.^10,11 For example, New Zealand pharmacists may supply sildenafil for erectile dysfunction, triptans for migraine, trimethoprim for urinary tract infection and oseltamivir for influenza,^7,12–14 whereas these medicines remain Prescription Only in Australia. In a comparison of six nations, Australia was found to lag behind all others in medicine down-scheduling,⁷ which raised questions over whether Australians have unnecessary barriers to timely access to medicines.

Previous research into the attitudes of pharmacists and pharmacy staff regarding medicines classification highlights the variations between countries. One study exploring the views of pharmacy stakeholders from New Zealand and Australia in relation to medicines classification suggested that Australian barriers to down-scheduling included conservatism and advertising restrictions.⁷ Other New Zealand studies examining pharmacists’ views on trimethoprim and oseltamivir availability highlighted potential consumer benefits as motivators to enabling over-the-counter (OTC) supply.^15,16 Flexibility, proactivity and reclassification driven by groups other than medicine manufacturers were identified as New Zealand facilitators that contributed to the observed trans-Tasman variations.⁷ UK studies that explored pharmacists’ views on the down-scheduling of omeprazole, tamsulosin and simvastatin found support at policy and professional levels for medication down-scheduling and education.^17–19 An Australian study on the OTC supply of the emergency contraceptive pill found that over 75% of requests were denied by pharmacists, revealing more conservative attitudes of Australian pharmacists than their international colleagues.²⁰ While this research has provided some insights, Australian studies exploring the views of those at the coalface of medicines supply, that is, community pharmacists and pharmacy staff, are limited. Such views are important as pharmacy staff serve a key role in non-prescription medicines supply and may facilitate or hinder consumer access to medicines. The overarching aim of this research was to explore the perspectives of community pharmacy staff regarding opportunities, barriers and readiness for future down-scheduling of prescription medicines in Australia.

Methods

Face-to-face semi-structured interviews were conducted with participants in May 2015. The interview guide was designed to encourage open dialogue and gauge participants’ opinions about the potential for future down-scheduling (Table 1). In addition, a questionnaire containing a list of current Prescription Only Medicines available overseas without prescription was completed with interviewees and discussed. For each medicine, participants were asked whether they supported non-prescription availability and whether they considered any qualifying requirements appropriate, for example, professional protocols guiding supply, additional training or medication-specific accreditation. Ethical approval was obtained from Griffith University Human Research Ethics Committee (PHM/04/15/HREC).

Table 1.

Guiding questions and discussion prompts for semi-structured interviews.

Question	Prompts
What are your thoughts on the current state of reclassification from Prescription Only to non-prescription medicine schedules in Australia?	In recent years, Australia has lagged behind New Zealand in switching (down-scheduling) medicines from prescription to non-prescription, what do you think of this? What barriers do you think there are to down-scheduling of medicines (e.g. safety)? It has been suggested that Australian pharmacists are risk averse and that this is a barrier to reclassification. What do you think of this?
What medicines have consumers requested to buy that are currently Prescription Only?	Has anyone ever asked to buy a prescription medicine from you? Have people asked for medicines that they have been able to purchase without prescription overseas? For example, antibiotics are sometimes available to buy without prescription.
What Prescription Only Medicines do YOU think should be made available without prescription?	Why? If these medicines were to become non-prescription, how do you think this should be managed? ○ Sub-prompt: Reclassification (i.e. schedule) ○ Sub-prompt: Pharmacy process (i.e. training, protocol)
Which classes of Prescription Only Medicines do you think should NEVER be considered for reclassification?	Why?

Potential participants (community pharmacy support staff and pharmacists working in the Gold Coast region of Australia) were approached by members of the research team either in person, via telephone or email, and invited to participate in the study. Pharmacies were targeted where the supervising pharmacist was identified by the researchers as demonstrating exemplary professional practice, as evidenced by involvement in continuing professional development, student and intern supervision and engagement with pharmacy professional bodies and academia. Two experienced researchers were present at each interview; one conducted the interview while the other took field notes. One researcher (AM) was present for all the interviews to ensure consistency. On average, interviews took approximately 20 min to complete, ranging from 11 to 34 min. Following each interview, a summary document of the discussion (checked by the researchers present) was sent to all members of the research team. Interviews were audio-recorded, transcribed verbatim and quality checked by a different researcher. Interviews were conducted until data saturation was reached.

Data management followed rigorous quality guidelines,^21,22 and checked transcripts were uploaded to QSR NVivo® software to facilitate analysis. Thematic analysis of the data was primarily informed by the general inductive approach.²³ AM read and re-read all 15 transcripts to become immersed in the data and to formulate open codes. Concurrently, the transcripts were divided between the remaining researchers to read and independently formulate open codes. The researchers then met to discuss the emerging themes. Common and diverging themes were discussed until consensus was reached on the overarching coding framework which captured the core themes (axial codes). AM coded the data according to the axial codes, and DH independently coded one randomly selected transcript to ensure reliability and trustworthiness of the analysis. A third team member (MK) reviewed a selection of codes alongside the corresponding text units. Iterations of the coding document were available to all team members, and the researchers maintained open dialogue throughout. Participants’ demographics and their responses to questions regarding the list of internationally available medicines were summarized.

All members of the research team are practising pharmacists with complementary roles in teaching and research. Data analysis was a reflexive process individually and collectively to limit bias and ensure transparency through ongoing open dialogue throughout.

Results

Fifteen community pharmacy staff (n = 9 pharmacists/pharmacy owners, n = 4 dispensary technicians and n = 2 pharmacy assistants) from nine pharmacies shared their perspectives on medicines scheduling. Eight participants were female. Participants’ experience of working in community pharmacy ranged from less than 5 years to over 51 years, the majority (n = 12) had worked in pharmacy for over 11 years. Findings from the interviews are presented below, relative to the key research questions that explored: (i) views on the current status of medicine scheduling, (ii) experiences with consumer requests for non-prescription supply of Prescription Only Medicines, (iii) motivating factors for down-scheduling, (iv) views about medicines that should be down-scheduled and those that should not and (v) perceptions about the readiness and barriers to down-scheduling in Australia. The themes presented are accompanied by quotations from the interviews, coded to indicate whether the participant was a pharmacist (P) or support staff (S), with a numerical code unique to each participant. Participant responses to the survey questionnaire are summarized in tabulated format.

Current state of medicines scheduling

Participants expressed mixed views about the current range of non-prescription medicines in Australia. The majority of pharmacists agreed that Australia lagged behind other countries, attributing this to limited involvement of the pharmacy profession in decision-making:

Australia is pretty heavily regulated and, again, through the TGA [Therapeutic Goods Administration] … I think there’s certainly a place for them to become more supportive of the industry and then back what the industry [pharmacy profession] should decide. (P002)

In contrast, support staff appeared satisfied with the current status, which in their views, reflected Australia’s emphasis on patient safety:

I guess it’s health and duty of care… we may have fallen behind, but I don’t think it’s a bad thing. (S009)

Requests for non-prescription supply of Prescription Only Medicines

All but one participant reported receiving consumer requests for non-prescription supply of Prescription Only Medicines, with antibiotics, lipid-lowering statins and antihypertensives identified as the most frequently requested. Some participants associated medicine requests with consumer demographics. For example, tourists who requested antibiotics might originate from countries where there is less restriction on their supply, and long-term medications (for example, antihypertensives) were mainly requested by regular customers who wanted to avoid going to their doctor. Participants noted that other consumers simply assumed that their prescription medicines were similarly accessible to other non-prescription medicines.

Motivating factors for down-scheduling

Pharmacists often considered the consequence of treatment disruption in their assessment of the patient’s needs:

I know that people say here in Australia you can go to a doctor whenever you want to [but] you can’t necessarily get in that day or the next day…. So they could easily be without their antidepressants for several days… (P001)

In contrast, support staff reiterated the need for consumers to adhere to Australia’s regulations regarding supply:

I think sometimes people aren’t so aware of the fact that they are scheduled obviously so that you can’t just buy them willy-nilly [randomly]. (S004)

Pharmacists’ desire to expand the non-prescription category appeared to be influenced by their knowledge of trends overseas and consumer requests for non-prescription supply of Prescription Only Medicines. One pharmacist highlighted the positive impact of recent scheduling changes:

[It is an] opportunity for pharmacists to care for their patients more effectively …examples that come to mind would be the proton-pump inhibitors, also products like famciclovir for treating cold sores. (P014)

Minimizing the financial and personal burden on individuals was frequently identified by both groups of participants as a motivator for down-scheduling, with many speculating that costs to individuals and the health system could be reduced. For similar reasons, some also wished for down-scheduling of additional antibiotic eye and ear drops to include some that are still prescription-only.

I know people that come in that don’t have a Medicare card and won’t pay the money to go and see a doctor, and like obviously need some Ibilex [cefalexin] or something like that. By the time you send them in, and it costs them $60 to $80, and they come back with their scripts and you think – huh? when you know they’re not going to get to a doctor. (P001)

Concerns regarding access to the prescriber also prompted some pharmacists to support down-scheduling of some long-term medications to ensure continuity of care and to minimize the risk of treatment interruption.

It would be all right if I could just give a single month’s supply and no more beyond that, just to say all right, you can’t get to the doctor this month I appreciate that. I mean it’s better than you going without your antihypertensive for the best part of a week until you can get around seeing a doctor. (P011)

Qualifiers for down-scheduling appeared contingent on both medication and patient factors. An established safety profile was important for many:

Those sorts of medications I suppose, that have a very good safety profile AND have virtually little or no contraindications. I think the safety’s got to be paramount if we can even consider whether it [should] be available. So, if it passes those sorts of benchmarks of safety being number one, I think there’s a lot of medication that may be reviewed. (P005)

Pharmacists also identified issues of chronicity and medical condition ‘complexity’ as important factors in determining which medicines should be down-scheduled:

Things like Levlen [combined oral contraceptive] or the pill, things like that and blood pressure medications. The very simple stuff. Cholesterol med[icine]s should be okay. But I think if you tend towards more chronic patient that has higher strength product you would probably want to steer clear of [supplying without prescription]. (P002)

Medicines that should be down-scheduled and those that should not

Pharmacists’ discussions of medicines suitable for down-scheduling focused on safety. Oral contraceptives, antihypertensives and cholesterol-lowering medicines were the medicines most often identified as appropriate for down-scheduling:

I think with statins, the evidence in view of their safety profile would be a widespread use now for decades. And the benefits that they provide for the population, there’s compelling argument to consider availability of that through a pharmacist-only scheduling. (P014)

Access to long-term medicines for chronic conditions was strongly advocated in order to promote adherence and reduce treatment disruption:

…if they’re regular patients and we’ve got a history that that’s what they’ve been on [medicine or medicine class], then I don’t think there’s any problem letting them have some until they can get to the doctor. (P001)

However, some did not support down-scheduling of medicines for long-term conditions, expressing concerns that pharmacists lacked the diagnostic skills to initiate therapy and that pharmacies lacked the infrastructure to provide ongoing care:

I don’t think we’ve got the tools to manage hypertension…I really believe that when they go back for a script, their hypertension and blood pressure should be monitored, checked because so many other concomitant factors could come into play that we’re just simply unaware of as pharmacists. (P005)

One pharmacist supported down-scheduling of antidepressants and antipsychotics to avoid the consequence of missed doses; the remaining participants did not align with this view.

Some participants spoke of potentially sparing their patients from embarrassment if they could provide medicines for erectile dysfunction without prescription. One participant highlighted that down-scheduling oral contraceptives could mitigate potential barriers to access such as time constraints, religious issues, prescriber access and costs:

If it was more readily available, then perhaps some of the younger population may be more inclined to use it whether there be family issues or religious issues that prevent them from doing that. (S010)

In general, pharmacists wanted to broaden treatment options and to manage non-complex conditions such as dermatitis, middle ear and eye infections. For example, some wanted to expand the range of Pharmacist Only dermatitis treatments to include more potent topical corticosteroids. Others referred to the ease with which diagnosis can be made at the pharmacy level and treatment initiated:

…skin infections, you could do those. They are quite easy to treat. You can at least start the treatment and then if it’s not gone the doctor can change it if they’re referred. (P007)

Several pharmacists wanted to facilitate better asthma management by down-scheduling inhaled corticosteroids and improve pain treatment through increased availability of tramadol (in limited quantities) and non-steroidal anti-inflammatory drugs.

Some pharmacists also recommended down-scheduling higher strengths of some Prescription Only Medicines which are currently available as Pharmacist Only Medicines at lower strengths or in limited quantities in order to offer consumers greater choice of safe and effective treatment.

Support for down-scheduling of some antibiotics was commonly discussed in the context of current restrictions on pharmacists’ ability to recommend appropriate treatment for what were perceived as minor ailments (for example, trimethoprim for urinary tract infections):

The frustrations that we have relating to potentially prescribing a medication that we could do fairly simply in the pharmacy after taking a relevant history. But having to go through the motion of referring to the doctor, it’s a bit frustrating for them and a bit frustrating for me. (P014)

In contrast to support for down-scheduling trimethoprim, the majority of pharmacists wanted other antibiotics to remain Prescription Only Medicines due to risk of misuse and subsequent antibiotic resistance:

People are always wanting amoxicillin and penicillin…Self-diagnosed. Got the flu [influenza]. They’re going to die and in fact, they’ve got a little head cold. You try to educate them. It’s not really going to help. So I’m certainly not for down-scheduling of antibiotics that’s for sure! (P005)

Participants were unanimous that S8 Controlled Drugs (which in Australia include the majority of opioid analgesics and psychostimulants), benzodiazepines, anxiolytics, medicines with a narrow therapeutic index and medicines which require ongoing specialist supervision (for example, chemotherapy medications) should never be considered for down-scheduling, citing concerns regarding the potential for misuse and harm.

Generally, support staff did not identify any Prescription Only Medicines for down-scheduling, apparently influenced by perceptions that Prescription Only Medicines posed greater risk to patient safety than current non-prescription medicines. They expressed concern that down-scheduling may increase consumer access to medicines with potential for misuse, leading to poor outcomes including addiction, deterioration of health, potential masking of serious underlying conditions or adverse effects, resulting in the genesis of new health issues.

When presented with examples of medicines available without prescription overseas, participants supported alignment for 11 of the 15 items on the list (Table 2), with more pharmacists than support staff expressing a desire for change. That is, the majority of pharmacists supported the down-scheduling of 12 of the listed medicines, while 4 medicines from the list received support by three or more (≥50%) of support staff participants. The influenza vaccine was identified by the majority (n = 13) as important to down-schedule, while only four participants wanted azithromycin and tamsulosin down-scheduled. When participants were supportive of down-scheduling, they commonly recommended protocols and training as associated requirements. While only a few pharmacists wanted accreditation, support staff voiced support for all three (that is, protocol, training and accreditation) as qualifiers for supply.

Table 2.

Positive responses to potential non-prescription supply of medicines and qualifiers for supply.

Medicine/medicine class	‘Yes’ to supply		Qualifiers for supply
	‘Yes’ to supply		Pharmacist			Support staff
	Pharmacist (n = 9)	Support staff (n = 6)	Protocol	Training	Accreditation	Protocol	Training	Accreditation
Azithromycin, for chlamydia	4	–	4	4	1	–	–	–
Calcipotriol, dermal, for psoriasis	7	4	6	7	2	3	4	2
Mebeverine, for GI spasm/IBS	8	1	7	5	2	1	1	1
Oseltamivir, for influenza	7	2	6	5	2	1	2	–
Oxybutynin, transdermal for urinary incontinence	4	1	4	2	–	1	1	1
Statins, for cholesterol	7	1	6	4	1	1	1	–
Tamsulosin, for BPH	4	–	3	2	1	–	–	–
Tranexamic acid, for heavy menstrual bleeding	5	1	3	3	1	–	1	1
Triptans, for migraine	9	3	8	7	4	2	3	–
Trimethoprim, for UTI	8	4	7	4	1	3	4	2
Vaccines								b
Influenza	9	4	7	8	6	3	3	4
Herpes zoster	7	2	5	6	4	2	2	2
Meningococcal	6	2	4	5	4	2	2	2
Tetanus–diphtheria–pertussis	8	3	6	7	5	2	3	3
Cholera and traveller’s diarrhoea	8	4	6	7	5	3	4	3

GI: gastrointestinal; IBS: irritable bowel syndrome; BPH: benign prostatic hyperplasia; UTI: urinary tract infection.

Readiness for further down-scheduling and barriers to change

Discussions about readiness to accommodate change focused on personal readiness, other pharmacy staff, the pharmacy industry and consumers. Participants reflected on potential barriers such as attitudes, workforce knowledge and skills, alongside possible implications for the industry. The majority of pharmacists perceived the Australian pharmacy profession to be well-equipped to handle future down-scheduling. They welcomed the opportunities and challenges that this would present and emphasized that they were well-prepared by their training to broaden their scope of practice, particularly those who had worked overseas with greater responsibilities:

Eminently our training qualifies us for such a vast knowledge of drugs, therapy, physiology and pharmacology, that we really understand what we’re doing when it comes to supplying medications. (P014)

Those who had completed training to administer the influenza vaccine in Australia felt confident and ready for non-prescription availability of the vaccine within associated guidelines, as part of expanding practice roles:

You’ve got appropriate guidelines to practice within and govern within. With my approval, I can do your MMRs [medication management reviews], your booster, DTPa [diphtheria, tetanus, pertussis vaccine] and your flu [influenza] vaccine. (P011)

However, some pharmacists were less optimistic about the readiness of other members of the profession. One participant reflecting upon a recent negative experience questioned whether professional and ethical standards would be upheld and expressed concerns about increased commercial influences:

I’d be a little bit angry and upset if we get the triptans on page one of the catalogues promoting it on price… I think pharmacists have got the training and have got the skills. The pharmacies they work in sometimes are a bother and it’s scary. (P003)

Concerns were also raised about the ability of small pharmacies, as a business, to accommodate the workload and financial pressures that would accompany change. One participant used the down-scheduling of vaccines as an example to foreshadow possible negative impacts:

…the majority of the smaller community-based [pharmacies] they’re going to be at a huge disadvantage because they can’t implement these schemes and because of that, will fall by the wayside. In the long term, I don’t think that’s good because then a lot of communities will miss out on that service because they can’t survive. (P005)

Some pharmacists were concerned that down-scheduling may result in removal of government medicine subsidies which would create financial burdens:

I’m mindful that suddenly the government has come out in the budget…saying that anything that’s over the counter, they will now no longer be on the PBS [Pharmaceutical Benefits Scheme]…and making it a private [prescription] so pensioners and those who can least afford it, and least afford families, don’t have access to the oral contraceptive. (P003)

Other concerns included risk of ‘turf wars’ with the medical profession, a perception that there are already sufficient non-prescription options to meet patients’ needs at the pharmacy level and insufficient consumer demand. Furthermore, pharmacists expressed clear support for down-scheduling from Prescription Only Medicines to Pharmacist Only Medicines, but not for down-scheduling to Pharmacy Medicines, indicating a desire to retain a high degree of control over supply. Their comments reflected both doubts over consumers’ competency to self-select appropriate treatment and a lack confidence in the knowledge and skills of support staff. They were also concerned that down-scheduling beyond Pharmacist Only Medicines might result in loss of revenue for their business, as a consequence of unrestricted sales. One participant referred to a past example when non-steroidal anti-inflammatories (NSAIDs) were down-scheduled:

… classic cases like with your ibuprofen and stuff like that you know, it’s gone to [supermarkets] and your service stations. I can remember reading some journal articles probably about 12 months after down regulation happened and there was a spike in stomach ulcers and misadventure with regards to NSAIDs. (P011)

Support staff appeared less ready for change and self-reported a lack of medication knowledge and confidence to provide information and advice to consumers:

It used to be a script item only then there is a lot of stress handing it out if the [pharmacy assistants] don’t have the right training or aren’t even confident about saying information about it. You can get the qualification to have the certificate but it doesn’t mean that you know all about it. (S004)

Some support staff expressed concerns that further down-scheduling from Pharmacist Only Medicines to Pharmacy Medicines might involve additional responsibilities that they were reluctant to accept:

I’m comfortable telling people what we have scheduled [S2] [Pharmacy Only Medicine] and their access to those sorts of things. Obviously if they’re S3 [Pharmacist Only Medicine] then I don’t have to – I guess the buck doesn’t stop with me. (S015)

In addition, support staff appeared concerned about the increased workload for pharmacists and the impact on the pharmacy as a whole. They were unanimous in highlighting the need for a whole-of-pharmacy approach if, and when, medicines are down-scheduled.

I think it’s important though that there’s the knowledge and the training and that the staff all work together and are on the same page. I think that’s the most important thing, that the communication is right, that they flow well…(S006)

One participant was concerned that larger pharmacies may place greater focus on revenue gathering rather than promoting quality use of medicines:

I guess if there’s more medication that goes down from prescription to S2 or S3, there’s more of an opportunity that in a small community-based pharmacy that the pharmacist has more interaction with the customers in relation to their medication. Not that I’m saying in big pharmacies the pharmacists don’t care or they’re not interested, but I have noticed a difference. (S006)

The majority of participants felt that the public would welcome increased availability of non-prescription medicines, highlighting current acceptance of pharmacists as vaccinators and instances where the public already value pharmacists’ advice:

A lot of people now come in and say I thought I’d come and ask you because this is what the doctor said but I wanted to make sure that’s what you think. (P001)

Above all, the medical profession and its governing bodies were identified as the greatest barrier to change. Pharmacists perceived this opposition as protection of professional boundaries and livelihoods:

I think maybe the doctors to a fair extent see us encroaching on what they’re doing. It’s funny because some doctors complain that they’re just too busy…But then, you try and take some of their patients that might be going in for a script and all of a sudden there’s a bit of animosity there. (P001)

Discussion

This research provides the valuable information about the opinions and perspectives of Australian pharmacists and pharmacy staff regarding the current state of medicines reclassification. It also captures their views on potential medicines for future down-scheduling and their insights into perceived barriers to change. Such perspectives may help to inform the ongoing conversation regarding discrepancies between Australian medicines scheduling and that of other countries with similar health systems.

At present, Australian medication scheduling appears to be out of step with that of comparable nations. While alignment of medicine scheduling in Australia and New Zealand has been explicitly expressed as a goal in the Trans-Tasman Treaty,¹⁰ there is a significant and growing divergence between the two countries in the availability of medicines without prescription. Indeed, there are fewer non-prescription medicines in Australia than in other countries with similar health systems.⁶ While few Australian studies have explored medication scheduling, international studies have identified factors that may promote reclassification to non-prescription availability including consumer demand, the benefits of enhanced patient autonomy, the need to reduce the burden on general practitioners and the health system and the existence of medications with a well-recognized, positive safety profile.^24–26 In contrast, barriers can include fears about the likelihood of misuse, the medical profession’s protection of their domain, doubts regarding patients’ competence in self-care and pharmacists’ concerns regarding increased responsibilities.^24,27,28 Previous research identified risk averseness among pharmacists and a perceived lack of regulatory body trust in Australian pharmacists and the pharmacy industry as significant barriers to medicines reclassification.⁷

In this study, the perspectives of community pharmacy staff were explored to illuminate the current situation, better understand the elements that interplay within the Australian context and identify drivers and barriers to change. These findings suggest that pharmacists are dissatisfied with many components of the health system that influence the practice landscape.

Research from other countries has demonstrated that health systems that support pharmacist autonomy have been more progressive with down-scheduling than Australia.^6,7,29–31 Respondents wished to support the continuity of care for those taking long-term medications and limit the negative health consequences through greater down-scheduling. While pharmacists generally agreed that they lacked the diagnostic skills to initiate therapy, there was strong support for policy change to enable pharmacists to better meet the needs of these patient groups. However, it is interesting to note that they did not wish to fully align with the selection of medications available in New Zealand. This finding may reflect the cautious attitude of Australian pharmacists identified in the previous research.²⁰ Paradoxically, one pharmacist expressed a wish for tramadol to be down-scheduled when many nations, including Australia, have been debating the scheduling of codeine due to the potential for misuse. All opioid analgesics in Australia require a prescription, including tramadol. Further studies would be required to determine whether this view is held by other Australian pharmacists. There was strong support for policy change to enable pharmacists to assist consumers in the management of minor ailments and non-complex chronic conditions, both of which pharmacists felt qualified and confident to provide.

This research identified discrepancies between the views of pharmacists and support staff with regard to the current situation and desire for future change. Pharmacists wanted an increased range of medicines that could be supplied without prescription. The main drivers underpinning this desire were to improve availability of effective therapeutic options for the management of minor ailments and to support adherence among those living with chronic conditions. Pharmacists noted that medications which would enable these outcomes were already available for non-prescription supply in other countries.^6,7 Opposition from support staff to potential change appeared seated in a lack of medication knowledge, generating fears regarding the potential for medicines to be misused and accompanying negative consequences. Support staff were concerned that down-scheduling might increase their workload, including additional requirements relating to counselling and advice.

Pharmacists identified a need to address knowledge gaps and implement proper administrative and structural processes in order to support their practice needs and ensure patient safety. In countries that have been compared with Australia, guiding protocols have been adopted, and staff have undertaken formal training and/or accreditation that direct provision for supply that appears to address gaps at both the individual and the systemic levels.^7,14,30 There is a desire among pharmacists for alignment with other countries and a readiness among staff to address gaps at both the individual and the infrastructure levels to promote progress.

Study limitations and future directions for research

This study is the first to specifically explore the perspectives of Australian community pharmacy staff on the potential down-scheduling of medicines that are available for non-prescription supply in other countries. While participant numbers could be considered limited, instruments were developed that enabled the gathering of both rich qualitative data and quantitative data. This mixed methods approach enabled the researchers to triangulate the findings and capture insights not possible with singular data collection methods. However, the views expressed by the study participants may differ from pharmacists and support staff in other regions of Queensland, or other states in Australia (which are governed by different legislation), or from staff who may be less inclined to participate in exploratory research. A larger sample size that is more representative of the workforce and includes participants from diverse practice contexts is needed to confirm study findings. This study also revealed a lack of agreement among pharmacists regarding the parameters that defined ‘minor’ and ‘non-complex’ conditions as well as confusion about medication down-scheduling to allow for non-prescription supply versus provision of continued medicines supply. Future research should seek to determine pharmacists’ understanding of both. Additional studies should seek to determine the model of supply and any additional measures that should be adopted (for example, protocols, training and accreditation) to balance medicines access and public safety.

Conclusions

This study among community pharmacy staff revealed that the key drivers for reclassification were the desire for increased options in the management of minor ailments and to ensure continuity of treatment in the management of chronic conditions. The barriers identified included the inability of some pharmacies to meet the associated costs of change, concerns regarding loss of control over supply, loss of revenue and the negative impact on patient safety should down-scheduling progress beyond Pharmacist Only and opposition from the medical profession. A larger study is needed to improve the generalizability of the research findings.

Footnotes

Acknowledgements

The authors wish to acknowledge and thank the participants for their time and opinions.

Declaration of conflicting interests

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding

The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This study was funded by the School of Pharmacy and Pharmacology Project Grant Scheme, Griffith University, where all of the authors were employed at the time of the study.

References

Australian Government Department of Health. National medicines policy, www.health.gov.au/internet/main/publishing.nsf/Content/B2FFBF72029EEAC8CA257BF0001BAF3F/$File/NMP2000.pdf (2000, accessed 23 August 2018).

Hughes

McElnay

Fleming

GF.

Benefits and risks of self medication. Drug Saf 2001; 24: 1027–1037.

NPS Medicinewise. Medicine schedule and availability, www.nps.org.au/topics/how-to-be-medicinewise/regulation-clinical-trials/medicine-schedules-availability (2012, accessed 23 August 2018).

Therapeutic Goods Administration. Poisons standard (Standard for uniform scheduling of medicines and poisons), www.comlaw.gov.au/Details/F2013L01607 (2013, accessed 23 August 2018).

Australian Government. Poisons standard, www.legislation.gov.au/Details/F2017L00605 (2017, accessed 23 August 2018).

Gilbert

Rao

Quintrell

A review of pharmaceutical scheduling processes in six countries and the effect on consumer access to medicines. Int J Pharm Pract 2006; 14: 95–104.

Gauld

Kelly

Emmerton

et al . Widening consumer access to medicines: a comparison of prescription to non-prescription medicine switch in Australia and New Zealand. PLoS One 2015; 10: e0119011.

Mann

Safety concerns with over the counter drugs: mind the evidence gap?

SelfCare 2015; 6: 10–14.

Sukkar

Drug Switching Q&A: OTC medicines give power to the patient. Pharm J 2014; 293: online URI: 20067092.

10.

Australia New Zealand Therapeutic Products Agency. The treaty: agreement between the government of Australia and the government of New Zealand for the establishment of a joint scheme for the regulation of therapeutic products, www.health.gov.au/internet/main/publishing.nsf/Content/mr-yr11-dept-dept200611.htm (2003, accessed 23 August 2018).

11.

Australia New Zealand Therapeutic Products Agency. Transition to the Australia New Zealand Therapeutic Products Agency (ANZTPA), http://www.medsafe.govt.nz/hot/anztpa.asp (2012, accessed 31 August 2018).

12.

Gauld

Kelly

Emmerton

et al . Innovations from ‘down-under’: a focus on prescription to non-prescription medicine reclassification in New Zealand and Australia. SelfCare 2012; 3: 88–107.

13.

Gauld

NJ.

Improving access to urinary tract infection treatment: the reclassification of trimethoprim. SelfCare 2012; 3: 115–120.

14.

Medsafe New Zealand Medicines and Medical Devices Safety Authority. Database of medicine classifications, www.medsafe.govt.nz/index.asp (2012, accessed 23 August 2018).

15.

Gauld

Kelly

Shaw

Is non-prescription oseltamivir availability under strict criteria workable? A qualitative study in New Zealand. J Antimicrob Chemother 2011; 66: 201–204.

16.

Braund

Henderson

McNab

et al . Pharmacist-only trimethoprim: pharmacist satisfaction on their training and the impact on their practice. Int J Clin Pharm 2016; 38: 1357–1361.

17.

Stewart

John

Cunningham

et al . A comparison of community pharmacists’ views of over‐the‐counter omeprazole and simvastatin. Pharmacoepidemiol Drug Safe 2007; 16: 1290–1297.

18.

McCaig

Hansford

John

et al . Reclassification of omeprazole: a survey of community pharmacists’ early experiences and views. Int J Pharm Pract 2008; 16: 23–28.

19.

Ahmed

Rutter

UK community pharmacists experiences on over-the-counter tamsulosin. SelfCare 2011; 2: 152–159.

20.

Hussainy

Stewart

Chapman

et al . Provision of the emergency contraceptive pill without prescription: attitudes and practices of pharmacists in Australia. Contraception 2011; 83: 159–166.

21.

Pope

Ziebland

Mays

Analysing qualitative data. BMJ 2000; 320: 114–116.

22.

Meyrick

What is good qualitative research?

J Health Psychol 2006; 11: 799–808.

23.

Thomas

DR.

A general inductive approach for analyzing qualitative evaluation data. Am J Eval 2006; 27: 237–246.

24.

Blenkinsopp

Bradley

Over the counter drugs: patients, society, and the increase in self medication. BMJ 1996; 31: 629–632.

25.

Thomas

DHV

Noyce

PR.

Over the counter drugs: the interface between self medication and the NHS. BMJ 1996; 312: 688–691.

26.

Ferner

Beard

Over the counter medicines: proceed with caution. BMJ 2008; 336: 694–696.

27.

Kennedy

JG.

Over the counter drugs. BMJ 1996; 312: 593–594.

28.

Bradley

Blenkinsopp

Over the counter drugs: the future for self medication. BMJ 1996; 312: 835–837.

29.

Richardson

Pollock

AM.

Community pharmacy: moving from dispensing to diagnosis and treatment. BMJ 2010; 340: c2298.

30.

Emmerton

Marriott

Bessell

et al . Pharmacists and prescribing rights: review of international developments. J Pharm Pharm Sci 2005; 8: 217–225.

31.

Kartha

Pai

Bhat

et al . Switching drugs from Rx to OTC status – a regulatory perspective. J Young Pharm 2017; 9: 3–7.