The availability of potentially dangerous drugs and chemicals needs to be restricted to enable their safe and effective use. Scheduling is the legal process used to achieve this. Schedules increase from 2-9 in increasing order of restriction. Scheduling in Australia is legally a State matter, but all States now adhere closely, or entirely, to the Standard for the Uniform Scheduling of Drugs and Poisons. Changes to schedules are made by the National Drugs and Poisons Schedule Committee. Current pressures to make drugs more available to the public must ensure that they continue to be used as safely and effectively as possible.
Medicinal products are unique in all developed countries in that there are no other essential commodities to which the public is legally denied access except through professionals. The process of prescribing and dispensing medicines is an integral part of our health system, yet few health professionals bother to think carefully about the principles upon which such restricted access is based, and the basis upon which changes in access (i.e. changes in scheduling) should occur.
Whilst few people would disagree with the overall principles of scheduling, in practice there are two major issues which are not easy to resolve:
- how should the initial decision be made with respect to the scheduling of each individual medicine?
- in these days of rapidly changing public knowledge and access to information sources, how, and by whom, should changes in scheduling be decided?
Toxicity is the keystone of scheduling. Medicines are inherently toxic which will cause harm in some circumstances. Drugs should only be used when the likely benefits to be gained outweigh the possible toxic effects.
This premise would not of itself require a system of scheduling, except for the corollary that members of the public often do not know enough about diseases to judge whether or not to take a particular drug. They are also not sufficiently aware of the different patterns of toxicity exhibited by different medicines to make this judgement.
The premise does not necessarily require the exact schedules used in Australia, which are a little different from those in many other countries. In particular, Australia has separate schedules for drugs and poisons:
- only available from a pharmacy, but which can be sold from open shelves and advertised (Schedule 2, or Pharmacy Only)
- only sold by the pharmacists themselves and cannot be advertised except as a generic drug group (Schedule 3, or Pharmacist Only)
- only sold on prescription (Schedule 4, or Prescription Only)
Most countries, however, have the equivalent of the Australian Schedule 8, which is for drugs that have legitimate therapeutic uses, but also have addictive or abuse potential and hence require special controls. Schedule 9 is for drugs that have no therapeutic use, but are subject to abuse. Schedule 9 drugs are only available for research purposes.
Schedules 5, 6 and 7 include non-therapeutic chemicals in increasing order of toxicity, and thus in increasing order of restricted availability.
Scheduling aims to permit the availability of drugs and poisons in a manner that should best lead to their safe and effective use. However, many different people and organisations have vested interests in the scheduling process. Health professionals, particularly doctors and pharmacists, have a major interest in maintaining the unique power given to them by the scheduling system. The public want access to medicines as freely as possible, yet also want to be protected as much as possible from potential toxic effects. The pharmaceutical industry is concerned with the sales of its products and justifiably resists unreasonable restrictions.
Initial scheduling decisions
Legally, scheduling in Australia has always been a State matter. There are no convincing arguments why the scheduling of a drug should differ between the States, and a national system would easily cope with any exceptions. Yet, the States have been reluctant to hand over their powers in this area to the Commonwealth.
This reluctance, set against the desire to make scheduling as uniform as possible throughout Australia, has resulted in complex Commonwealth/State arrangements. A Standard for the Uniform Scheduling of Drugs and Poisons in Australia (the SUSDP) has been published for many years by the National Drugs and Poisons Schedule Committee (DPSC).
This Committee was a Subcommittee of the Public Health Committee of the National Health and Medical Research Council (NHMRC), but more recently has become a Standing Committee of the Australian Health Ministers Advisory Council (AHMAC). The States then use the SUSDP as the basis for their own scheduling, and most States now adopt the SUSDP directly into their own legislation by reference. This is intended to happen in all States in the near future and welcome progress continues. An example of the very few remaining differences between States is the larger pack size of codeine-containing combination analgesics allowed in Schedule 2 in N.S.W. compared to the other States.
The DPSC is chaired by a medical officer from the Commonwealth Department of Health and Family Services, and is advised by senior toxicologists from within the Department. The Committee includes representatives of consumers, industry and the Pharmaceutical Society of Australia, and independent experts in toxicology, clinical pharmacology and occupational toxicology. Each State and Territory is also represented, so the State representatives strongly influence the Committee. No medical organisation is directly represented.
The need for reform
Probably because of the complexity of the scheduling process, calls are consistently made for change. For example, the Industry Commission inquiry into the pharmaceutical industry initially proposed an institutional reform of scheduling, but then contented itself by recommending research into the role of counselling by pharmacists.
The fact that scheduling is determined by a committee separate from the registration process means that a company applying for registration of a new product will not know what the schedule will be until after it is recommended for registration. However, virtually all new compounds are in Schedule 4, so this is rarely, if ever, a significant issue.
The DPSC has developed a policy that it will not, in general, consider changing the schedule for a new drug to make it more widely available until at least two years after it has been marketed. The argument for this policy is that local experience is required before a sensible decision can be made on its safety in the Australian health care system. However, the pharmaceutical industry is at times not happy with this policy, considering it to be too restrictive, particularly if a product has long been sold in other countries with less restrictions. Such experience may not be strictly relevant, of course, because of different patterns of health care utilisation in different countries. Some countries, in particular the U.S.A., do not have an equivalent of the Australian Schedule 2 or Schedule 3. Thus, experience in those countries will differ from the Australian experience. In addition, the 'two year' policy does not prevent companies from applying for exceptions which the DPSC judges on their merits.
Applications for change can be made to the DPSC, or the Committee can make changes itself if a significant public health issue arises. Concern has been expressed at times by various groups, particularly consumer groups and groups representing the pharmaceutical industry, about the seeming inconsistency in decision making on scheduling changes. However, major inconsistencies are rare, and the issues are frequently complex and involve value judgements on many issues. These include the:
- frequency and severity of adverse effects in a wide variety of different circumstances
- need for consumer access to the drug
- efficacy of the drug in relation to other available drugs
- potential for abuse if the drug is easily available
- possibility of use of the drug masking an undiagnosed medical condition
- financial implications to industry and to consumers and health professionals
- need for and level of professional intervention required to ensure the optimum risk benefit ratio in the use of the drug
Recent examples of possible changes to schedules which involved judgements on the need for consumer access, safety issues and possible masking of serious conditions were rescheduling the H2 antagonists from Schedule 4 to Schedule 3, the failure (despite strong representations to the contrary) to reschedule the new antihistamines from Schedule 3 to Schedule 2, and the failure (again despite strong representations to the contrary) to reschedule the inhaled beta2 agonists from Schedule 3 to Schedule 4.
The fact that these decisions are complex does not mean that the process should not be rationalised as far as possible, and the DPSC has been actively developing guidelines to ensure its decisions are as rigorous as possible.
Strong forces are now at work in Australia to reduce restrictions imposed by the scheduling system on consumer access to medicines. The forces include ideological arguments regarding individual autonomy and responsibility for health, governments attempting to shift payments from the public purse to individuals, and hopes by the pharmaceutical industry that lower schedules and, in particular, the access to direct advertising to the public which lower schedules allow, will increase sales (and profits). These forces should not be allowed to lead to an increase in morbidity. Health professionals and those involved in drug scheduling are responsible for getting the balance right.