i. Retention of Schedule 2 and Schedule 3
Since the Galbally Report in 2001, there has been a level of uncertainty about the retention of the two OTC medicine schedules – Schedule 2 (Pharmacy Medicines) and Schedule 3 (Pharmacist Only Medicines). During the 12 years since the Galbally Report, the Guild has invested considerable time and money collecting evidence to demonstrate the value in retaining the two OTC schedules.
Using data collected as part of the Quality Care Pharmacy Program (QCPP) Mystery Shopper Program, the Guild has presented evidence to the NCCTG to demonstrate the value in retaining the two OTC medicine schedules. Irrespective of all the evidence collected and analysed, in June 2006 and again in April 2010, the NCCTG advised the Guild that only 5-yearly interim retention periods for the OTC schedules have been endorsed by the Australian Health Ministers’ Conference. We are at a loss to understand the need for this to continue, particularly when the Guild has had to bear significant ongoing costs to collect and present the supporting evidence. While some evidence was collected through a research project funded under the Fourth Community Pharmacy Agreement (Fourth Agreement), the remainder has been determined from the data collected under the QCPP Mystery Shopper Program. The operations of the QCPP Mystery Shopper Program were revised specifically to respond to NCCTG requests with costs associated with extended data collection and analysis covered by the Guild.
This uncertainty has been a burden on the pharmacy sector, particularly as this has been in addition to changes to the Pharmaceutical Benefits Scheme impacting the viability of many community pharmacies.
With consideration of the financial burden and uncertainty this issue has had on the pharmacy sector, the Guild would welcome closure of this matter with a recommendation for the permanent continuation of the two OTC schedules.
Below is a summary of our justification:
The Guild considers the availability of OTC (Schedule 2 and Schedule 3) medicines via community pharmacy to be in the best public health interest of the Australian community. Medicines are not normal items of commerce. If used incorrectly or inappropriately, they have the potential to do significant harm. Given the generally low level of health-literacy of many Australians, access to pharmacist advice for OTC medicines provides protection for consumers. This is particularly so for the more vulnerable groups such as children, the elderly, those from poorer socio-economic backgrounds or those who do not speak or understand English well. The high prevalence of poly-pharmacy also warrants consideration by a pharmacist to ensure there are no interactions between any prescribed, complementary or OTC medicines.
The Scheduling Policy Framework outlines from a population based perspective, the risk/benefit balance for consumers according to different levels of access to medicines, categorised by the schedule. Schedule 2 medicines are essentially safe for self-diagnosis and self-treatment, with access to a pharmacist for information and advice if needed. Schedule 3 medicines are safe to treat health conditions identified by the consumer and verified by the pharmacist. When responding to requests for OTC medicines, pharmacy staff apply a professional supply protocol (e.g. Ask, Assess, Advise - External Link) to assess an individual’s needs and risks.
The tables provided in Attachment B cross-reference the population-based factors for Schedule 2 and Schedule 3 medicines defined in the Scheduling Policy Framework with the role of pharmacy staff in managing supply to identify and address individual risk factors. These tables differentiate the level of involvement of pharmacy staff in supplying Schedule 3 medicines versus Schedule 2 medicines. The level of involvement reflects the intent of obligatory involvement with the supply of higher risk Schedule 3 medicines, with optional involvement for lower-risk Schedule 2 medicines, available for self-selection in all jurisdictions except Western Australian and Queensland.
While consumers self-selecting Schedule 2 medicines have the option to seek advice, pharmacy staff are trained to promote and facilitate interaction with a pharmacist if the consumer has questions or if any potential risks are identified.
Attachment A provides examples of where pharmacy staff have responded to and managed an individual’s risk with OTC medicine supply.
The Fourth Agreement Research Project (The Guild 2007 - 08-02 - External Link) demonstrated that consumer access to OTC medicines was not an issue and that for the main part, consumers were satisfied with the level of pharmacy advice provided and wanted this advice to remain available.
The extent of pharmacy staff involvement in responding to requests for OTC medicines is promoted by the professional supply protocols and determined by the type of request from the consumer. The Mystery Shopper data demonstrates that almost all consumers receive some advice in pharmacy and the pharmacy role of supporting consumers with the purchase of OTC medicines is being largely fulfilled. By contrast, there is no information gathering or provision of professional advice available to consumers when purchasing medicines through non-pharmacy outlets.
Irrespective of schedule category, the Mystery Shopper Program has identified greater involvement of pharmacy staff associated with symptom based requests as compared to direct product based requests.
Since commencing in October 2002, under the QCPP, until February 2013 the Guild has conducted 31,645 mystery shopper assessments. Below is a summary of evidence gathered to date as part of the QCPP Mystery Shopper Program that demonstrates the value added by community pharmacy in the supply of Schedule 2 and Schedule 3 medicines. Should the panel require further information about the reports provided to the NCCTG, the Guild would be pleased to assist.
Key findings identified from the Quality Improvement in Pharmacy – NCCTG 2012 Report (reporting on data collected in 2011), included:
- There is greater pharmacy intervention for symptom based requests (SBR) compared to blended product requests (BPR) or direct product requests (DPR)
- With respect to information gathered, data indicated the following rank order: SBR > DPR (Schedule 3) > BPR > DPR (Schedule 2)
- There is greater information gathering when the pharmacist is referred to by the pharmacy assistant
- The quality of advice given is higher when both pharmacy assistant and pharmacist are involved in the supply
- Improvement in the quality of advice given is related to:
- improvements in the scope or amount of information gathered (in particular, information associated with risk and inappropriate use of medicines)
- increasing awareness of the implications of key information factors and their sequelae and the need for pharmacy assistants to refer to and involve the pharmacist
- improving the decision making skill of the pharmacy staff member through the availability of training, professional protocols and tools and support from the pharmacist
While the 2012 Report was the final report the Guild provided to the NCCTG, the Guild still conducts mystery shopper assessments as part of a quality improvement element to QCPP. An analysis of Mystery Shopper results from data collected in 2012 has demonstrated:
- scenarios involving an element of risk continue to score more highly than those with less risk
- there has been greater access to the pharmacist, either directly or via referrals from pharmacy assistants
- referral by pharmacy assistants to the pharmacist continues to result in improved scores for the supply of Schedule 2 medicines
- the significantly higher scores achieved with referral to the pharmacist indicates this is an important quality improvement process
- there is a greater number of mystery shopper scenarios with an element of risk in which the mystery shopper is being referred to the pharmacist by the pharmacy assistant
- pharmacy assistants are an effective triage point for requests involving OTC medicines with an element of risk
- there is little jurisdictional difference in scores for the supply of Schedule 2 medicines indicating minimal effects of restricting access for product selection within the pharmacy
- there is generally a greater incidence of questions asked and advice given associated with the supply of Schedule 3 medicines
It should be noted that since the Galbally Report, there have been a number of significant changes to how community pharmacy manages the supply of OTC medicines:
- Under QCPP, there is a mandatory requirement for pharmacy assistants to complete the training module – ‘Support the sale of Pharmacy and Pharmacist Only Medicines’
- Since April 2010, OTC medicine refresher training of pharmacy staff has also been mandated for QCPP re-accreditation
- Community pharmacy has introduced and trained against OTC medicine protocols such as ‘Ask, Assess, Advise’
- Over 92% of community pharmacies are accredited under QCPP
Based on this evidence, the Guild believes two separate OTC schedules remains appropriate. We also consider that access to OTC medicines via a pharmacy, as opposed to the grocery sector, to be fundamental to the government’s health reform agenda. Health reform efforts to make better use of the health dollar include the drive for consumers to be central to and take personal responsibility for their health. There is strong international evidence, such as in the United Kingdom, that self-care substantially improves the efficiency of the health system, leading to better individual and public health outcomes. Self-care embraces both curative and preventive health. It does not imply that individuals are left to treat themselves in isolation, but rather, are empowered to take personal responsibility for their health through the support of a multidisciplinary team of healthcare professionals, including pharmacists. Access to both Schedule 2 and Schedule 3 medicines via the pharmacy sector is a fundamental underpinning of the self-care concept.
ii. Modified Schedule 3
The Guild considers that the current Scheduling Policy Framework for OTC medicines could be further strengthened by modifying the Schedule 3 medicine category to include a ‘notifiable’ sub-schedule. Given the availability of Schedule 3 medicines that are at risk of misuse or abuse, a S3-Notifiable system would provide a decision support tool for pharmacists and a real-time management resource for regulatory bodies. Such a system is exemplified by Project Stop being used to manage the supply of pseudoephedrine products.
An S3-Notifiable system applied more broadly would provide the following opportunities to the health system:
A broader scope of health care intervention by pharmacists, including the monitoring and management of more serious and chronic health conditions in collaboration with other members of the health care team.
Facilitated collection and analysis of critical health care and supply data through an IT-enabled system to monitor the management of chronic health conditions.
Enabling the recording and review of Schedule 3 medicines used for chronic health conditions as part of the eHealth medicines repository.
Creating a greater level of accountability for pharmacists to ensure that a risk-based approach is employed with the supply of Schedule 3 medicines.
iii. Changes to cough and cold medicines
We would also like to draw the panel’s attention to the outcome of the review into the use of cough and cold medicines in children. The end result was a significant amount of confusion and angst for consumers and community pharmacy. After recommendations from both the NDPSC and ACMS to amend the scheduling of cough and cold medicines, a decision was made that the issue could be adequately managed through packaging and labelling. What resulted was a situation in which products with the old packaging and labelling remained available for resale while pharmacy was requested to comply with the new recommendations in not providing these products for use in children under six years of age. Interestingly, the grocery sector was not impacted at all. Products remained on sale for age groups according to the old labelling information from the grocery sector without any requirement for additional action. This demonstrated the double standards in managing identified safety risks. Acknowledging the responsibility of pharmacy as guardian of OTC medicines to manage such risks, these changes have demonstrated its capacity and ability to respond professionally and responsibly. The public should expect the non-pharmacy sector to also meet its responsibilities if it wants to sell medicines that are exempt from scheduling. Overseas, similar changes to the use of cough and cold medicines required over-labelling of the products in both the grocery and pharmacy sectors.
Pharmacists were also confused by the messages about the supply of cough and cold medicines for children under six years of age, particularly with regards to managing prescriptions for this age group. On one hand, the TGA was advising that they should not be used because of the risks requiring medical intervention, and on the other they were advising that there was no change to the scheduling and that prescriptions were not needed for supply. The advisory was subsequently updated to advise health care professionals that prescribing or supply of cough and cold medicines for children under six years of age constituted 'off-label’ supply.
This situation should not have happened. A decision should have been made to accept the scheduling recommendation of the two expert advisory groups, coupled with amendments to the labelling and packaging in which over-labelling should have been mandated for the ongoing sale of products with the old labelling. Timelines for introducing the changes should also have been determined in consultation with the affected sectors, particularly community pharmacy as the main retail supply sector.
iv. Packaging exemptions
Packaging exemptions for products that have schedule changes has presented challenges for community pharmacy which could be addressed by more co-ordinated communication. It would be particularly useful for pharmacists to have access to the information from a central location such as the TGA website.
As an example, when the schedule changed in May 2010 for combination analgesics containing codeine, there were exemptions in place for products on the market allowing them to be sold with the old Schedule 2 packaging. At the same time, pharmacists were required to treat the products as Schedule 3 with regards to storage, assessing therapeutic need and the quantity that could be supplied in one pack. While the packaging and labelling exemptions are coordinated through the states and territories, it would be useful for pharmacists to have accurate information in a timely manner to be able to readily identify which products have exemptions and for what period of time and whether there are any additional requirements or restrictions (e.g. re-labelling or re-packing).
Likewise, when chloramphenicol was down-scheduled to Schedule 3 for use in conjunctivitis, companies supplying chloramphenicol eye products had packaging and labelling exemptions to allow OTC supply of the product with Schedule 4 labelling. It would have been useful for pharmacists to be able to access information explaining the exemption and how supply should be managed. Professional bodies such as the Guild would be useful allies in conveying this information.
v. Standardised legislation
The application of the Poisons Standard has standardised how medicines are scheduled throughout Australia. As a legislative instrument referenced by States and Territories, it has also simplified how changes are simultaneously implemented in all jurisdictions throughout Australia. With this in mind, the Guild proposes the development of a standardised legislative instrument for reference by States and Territories that regulates the supply and use of medicines and poisons. There are a number of inconsistencies between jurisdictions which impacts consumer access to medicines (e.g. which professional groups can prescribe, how Schedule 3 medicines are handled). Developing and maintaining a national legislative instrument similar to the Poisons Standard would effectively and easily address such issues. It would also facilitate the national implementation of initiatives such as (Please see standarts and guidelines - External Link) :
- The Continued Dispensing of PBS Medicines in Defined Circumstances
- Supply and PBS Claiming from a Medication Chart in Residential Aged Care Facilities
- Electronic Reporting and Recording of Controlled Drugs
vi. OTC supply of Prescription Medicines
Finally, we also note an anomaly that causes significant confusion for pharmacists. A medicine may be listed in an OTC schedule but is marketed only as a Schedule 4 medicine. Many pharmacists are confused as to whether the Schedule 4 medicine can be re-labelled and supplied OTC. The Guild’s understanding is that the Schedule 4 medicine is registered, labelled and packaged as a Schedule 4 medicine and therefore cannot be supplied OTC, even if a pharmacist attaches a dispensing label with directions. As national legislation regulates labelling and packaging as part of the registration process but jurisdictional legislation regulates supply arrangements to consumers, clarification is sought from all parties on this issue, including the TGA and jurisdictional medicines and poisons units.
An example is mometasone which is listed in Schedule 2 for nasal preparations for hayfever in adults and children over 12 years of age. The only mometasone nasal product available is Nasonex™, which is a registered Schedule 4 product. The Guild is often contacted by pharmacists seeking information on whether they can supply Nasonex as an OTC medicine. While our advice is to seek clarification from the relevant jurisdictional pharmacy services unit, we believe the information should be publicly available for reference by pharmacists or consumers. We would welcome working with relevant bodies to ensure any information to clarify this situation was circulated to community pharmacists.