D.F.P.S.

Summary
In the previous 18 months, South Australia has gone from having an excellent system of regulation of narcotic medications to an arrangement of Third World standards with numbers of patients searching for adequate pain relief.  The group Dignity for Pain Sufferers (DFPS) is aware of about 100 who are so traumatised that they had joined this organisation in order to lobby for support.  This group believes that there are possibly another 500 who are not even being offered pain relief because their doctors are fearful to prescribe adequate medication which may, in turn, incur the wrath of the regulators.
It is not clear why there has been such a systemic breakdown.  It is clear however that those who make people decisions about pain relief prescribing are drawing on out dated clinical evidence/research sources to guide their decision making.

What is absolutely clear is that there is no way to resolve the problem of inadequate narcotic management except at the parliamentary level.  There is no right of legal appeal currently against regulator’s adverse decisions.

How the system works
Chronic non-malignant pain is a rapidly growing component of our health-care system.  Should such a pain suffering patient come to consult a doctor, and it is found that narcotic medication is appropriate, this medication can only be prescribed for a period of two months before bureaucratic regulation.  Beyond two months the prescribing medical officer must apply to the Drugs of Dependence Unit, at Drug and Alcohol Services SA (DASSA) for a permit to continue to prescribe narcotics.  The reason for this is apparent.  These drugs are addictive and can be abused.  Regulation is necessary to ensure that appropriate techniques for pain relief are being applied, and that medication does not fall into the hands of inappropriate persons including those deemed drug addicts.

Until18 months ago the system worked well. At that time the regulating authority was located in the South Australian Health Commission and the section was run by Mr. Geoff Anderson.  His handling of the Act and its regulations was excellent in that he was able to reduce medication abuse while at the same time supporting the majority of patients, and those medical officers who found it necessary to prescribe this medication.

Pain is now a very common and increasing problem, so that prescribing must be undertaken by general practitioners who increasingly report feeling unsupported and fearful of the regulatory system which does not work with them in caring for patients.

It is not possible to provide adequate pain relief for all patients with narcotic medication and at the same time to totally eliminate drug abuse.  What is needed here is an effective balance.  There has to be a degree of flexibility but it is the role of regulators to minimise risk, while at the same time treating the pain, a function that Mr. Anderson and the Drugs of Dependence Unit (DDU) at the South Australian Health Commission was able to manage well. 

The approval process
In the previous system it was clear that a medical practitioner needed to apply for approval to continue prescribing was necessary to fill in the appropriate form, to send it to the Drugs of Dependence Unit and to expect a prompt reply usually within 24 to 48 hours.  If there was concern about the approval, DDU staff would offer support and offer alternative suggestions.
New regulations.

Approximately 18 months ago, a decision was made to transfer the regulating body to Drug and Alcohol SA (DASSA), under the Minister for Mental Health and Substance abuse, which is, for them, a clear-cut conflict of interest. This conflict relates to the fact that this organisation is the biggest user of narcotic medication, prescribed almost exclusively for the treatment of “drug addicts and drug abuse”. Thus the largest user of narcotic medications is regulating itself and all prescribers in South Australia in its own interest.  This is being done by regulators with no experience of pain management so the system is being run in a manner dedicated to curbing drug addiction but not for the management of patients with more difficult issues.

Medical officers seeking to obtain approval for their pain patients regularly spend hours of their time negotiating with DASSA and then wait weeks or more to gain approval.  Many doctors now choose not to deal with pain patients since they view DASSA’s performance as very much substandard. Many comment that their treatment is excessively regulated and primitive.
Qualifications of Bureaucrats.

The bureaucrats currently charged with regulating the drugs have minimal experience in managing drug addicted patients and absolutely none at all in managing chronic pain patients.  They are now controlling pain patients with mechanisms that are suitable for drug addicts, including sending non-addict patients to a drug addiction Centre (Waranilla) and thereby denying them their right to seek the doctor of their choice.

Clearly the current approval process, regulated by these bureaucrats is in breach of International Treaties on Human Rights.

It is of major concern that these bureaucrats make decisions without ever:

• Examining a patient.
• Taking a history.
• Or indeed ever seeing or talking to such a patient.
• Never speaking to the treating doctor and certainly never taking that opinion into account.
• Creating a class of people who, having been denied appropriate pain medication, are sometimes forced to obtain drugs in illicit ways. As a consequence, one should not be surprised that some patients then attract the label of “addict”.
  Appeal against decisions.

One of the more concerning aspects of this process is that there is absolutely no appeal against any of the decisions made by these bureaucrats. The Controlled Substances Act allows certain actions on the part of the regulators to force known drug addicts into a drug program but it was never intended that this mechanism should be used for pain patients. In operating in this manner, the act is being misapplied by bureaucrats.

Systemic Breakdown
The end result of this process is a clear systemic failure by the Department of Health and its branches.  This systemic breakdown has been recognised by the Minister in a meeting with the leaders of the organisation Dignity for Pain Sufferers (DFPS) and promises were made to remedy this situation. The situation has now worsened and promises have not been met. The Minister has now said that these decisions are in the hands of the bureaucrats.
Problem for prescribers.

Prescribers are now very reluctant to request the regulating authorities for approval to prescribe narcotic medication because of: -

• The time taken dealing with the regulating authorities.
• The delay in getting approval.
• The hostility directed by bureaucrats towards prescribers.
• The unprecedented un-unpleasantness of communications between the regulators and prescribers.

Problem for patients
As a consequence it has become very difficult for people in need of pain medication to obtain adequate treatment. Some bureaucrats have assigned a notional maximum dose allowed to be prescribed, even though the evidence does not support such a view.  The current research and clinical evidence demonstrates that the dose of pain medication to be prescribed is the one that relieves the pain.  Usually this dose is small, but not always.  The result of these restrictions means that there are a number of severely ill patients who are unable to obtain relief, and are given standard doses even though they previously experienced relief.   Many who once coped with life and work, are not now able to function as they wish.

We are aware of about 100 people who are quite unable to obtain essential medication.  The following consequences result: -

• Under medication leaves them in pain.
• Medication doses are being reduced without discussion with patients or doctors, and no account is taken of the pain status of such patients.
• Some are now unable to work who were doing so prior to the implementation of this regime.
• Some are now actively seeking illegal drugs because the medications currently prescribed do not give them pain relief.
• Many are angry that their lives have been transformed from one of ‘coping’ to’ non-coping’ because of poor bureaucratic practice.
  Reign of terror.

What is now in place has been described as a ‘reign of terror’ for both prescribing practitioners and patients in a system which is clearly letting down both groups.  The role of pain medication is to allow people to cope with this situation and to return to as near a normal function as is possible.  The current bureaucrats do not examine any patients, do not speak to treating doctors but merely send letters directing doctors to reduce medication.  As a consequence these bureaucrats are either not aware of the damage they do and if they are, they appear unconcerned by it.

Role of the Minister
Dr. Lomax Smith is a person of capacity, intelligence, sensitivity and integrity.  When visited by office bearers of the DFPS she was supportive and understanding at a joint meeting.  She gave clear directions to the bureaucrats to resolve the problem but since then the situation has deteriorated significantly.  It is the belief of the DFPS and the many involved in this problem that Dr. Lomax Smith is being misled by officers in her department to the detriment of good quality patient care.
Since there is no avenue of appeal possible under current law, for persons adversely affected by these bureaucratic decisions, we have no alternative but to seek help from parliamentarians.
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