Petition 2014/45 of Carolyn Hodson and 184 others Report of the Health Committee Contents Recommendation 2 Introduction 2 Submission from the petitioner 2 Response from the Ministry of Health 3 Conclusion 6 Appendix 7
Petition 2014/45 of Carolyn Hodson and 184 others Recommendation The Health Committee has considered Petition 2014/45 of Carolyn Hodson and 184 others, and recommends that the House take note of its report. Introduction Petition 2014/45 of Carolyn Hodson and 184 others was referred to the Health Committee on 19 February 2016 and requests: That the House of Representatives investigate fully the regulation, prescribing, and impact of psychoactive medications that can trigger and cause chronic mental disability and suicide and homicide. Submission from the petitioner Background Carolyn Hodson, the petitioner, is a friend of Gladys Dent. Both Mrs Hodson and Mrs Dent contributed to the substantial amount of evidence we received on the petition. In 2001, Mrs Dent s husband, Ross, suicided after an extended battle with mental illness. In 2006, an investigator from the Office of the Health and Disability Commissioner assessed the care that Mr Dent received. The investigator concluded that the care provided to Mr Dent through the period from early 2000 to August 2001 was of a satisfactory standard. However, the investigator also acknowledged that the approach to pharmacological management could have been different. The petitioner s concerns The petitioner is concerned about how psychoactive medications are regulated and prescribed in New Zealand. Her concerns were outlined in her written submission, which discussed some of the side-effects of inappropriate use of psychoactive medications. She understands that some medications can trigger and cause chronic mental disability, which can sometimes lead to suicide and homicide. She asked why no action has been taken to prevent medication-induced homicides and suicides in New Zealand. The petitioner believes the following statements are crucial to the treatment of mental illness: Suicide, homicide, and mental illness/disability are adverse effects and risks of psychoactive medications. 1 1 Carolyn Hodson and Gladys Dent submission, Page 2 2
Mental illness is not a biological/physical illness, a brain disorder, or chemical imbalance, but psychoactive drugs affect the biological functions of the brain and can cause chemical imbalances and brain injuries. 2 Both licit prescription drugs and illicit drugs act on the same neurochemistry in the brain, inducing similar adverse effects and behaviours. 3 The petitioner s suggestions The petitioner suggests several ways of ensuring the continued safe treatment of mental health patients and the safe use of medicines in New Zealand. These suggestions include: education for all professionals involved in supporting mental health services raising awareness of the potential harms of medication by providing product data sheets with each prescription regulating the way pharmaceutical companies interact with health professionals and PHARMAC improving reporting and recording of medication-induced deaths, including increased access to coroners inquests and the ability to appeal decisions preventing the use of psychoactive medication for treating children and adolescents. Response from the Ministry of Health The ministry told us that the events that led to the petitioner s concerns happened some years ago. It advised that the way that psychoactive medication is prescribed and regulated has changed significantly since those events. Effects of psychoactive medicines The ministry agrees that the petition raises legitimate concerns about the use of psychoactive medications. The risk of adverse drug events is widely acknowledged, and the safety of psychiatric medication is continuously under scrutiny for this reason. Regulation The ministry told us that many agencies now have a role in regulating and monitoring the use of psychoactive medicines. These agencies include: the Ministry of Health (Medsafe) the Centre for Adverse Reactions Monitoring (CARM) Standards New Zealand the Health Quality and Safety Commission (HQSC) the Health and Disability Commissioner (HDC). Medsafe is the medicines regulator for New Zealand. Pharmaceutical organisations must meet legislative standards set out in the Medicines Act 1981 and the Medicines Regulations 2 Carolyn Hodson and Gladys Dent Submission, Page 2 3 Carolyn Hodson and Gladys Dent Submission, Page 2 3
1984. They must convince Medsafe of the efficacy of a proposed psychoactive medicine for the medicine to be approved. Medsafe monitors approved medicines to ensure that the benefits continue to outweigh the risks of harm. Medsafe provides information to consumers and healthcare professionals, in the form of data sheets that are available online, to enable the safe use of medicines and medical devices. An example of consistent monitoring by Medsafe occurred in 2006 when it was provided with new advice and information about the use of Thioridazine. Thioridazine is no longer an approved medicine in New Zealand as a result of the update. CARM is contracted by Medsafe to collect voluntary reports of adverse reactions to various medicines. These reports help to identify local patterns and often result in safety alerts to prescribers. The information CARM collects is communicated to Medsafe quarterly to ensure continuous monitoring. Standards New Zealand is a business unit within the Ministry of Business, Innovation and Employment. It produces standards, in collaboration with sector experts, about best practice. The Health and Disability Services Standards Pharmacy Services Standard 2010 defines good practice and outlines the importance of continuous improvement in the quality of pharmacy services. Principles outlined in these standards include pharmacists promoting consumer self-determination and pharmacists acting to prevent harm to the consumer and the public. 4 The main priority of HQSC is to reduce patient harm. Medication safety is one of its programme areas, and it regularly monitors and reports on quality and safety. HDC was established to independently uphold consumer rights. Members of the public are able to make complaints to the commissioner if they feel any of their rights were breached during treatment. These rights are outlined in the Code of Health and Disability Services Consumers Rights, which was created in 1996. The code sets out 10 rights, including the rights to be treated with respect, to be treated with dignity, and to receive services of an appropriate standard. The code applies to all providers of health and disability services, including mental health services. Prescription and practices guidelines The ministry told us that appropriate prescribing practice is now well established and that patients must be supported to provide informed consent. Several stakeholders now produce guidelines to help service providers with issues referred to in the petition. These stakeholders include: the Medical Council of New Zealand (MCNZ) the Royal Australian and New Zealand College of Psychiatry (RANZCP). 4 Standards New Zealand (2010), Health and Disability Services Pharmacy Services Standard, retrieved from https://shop.standards.govt.nz/catalog/8134.7:2010(nzs)/scope. 4
The MCNZ provides general guidance on good prescribing practice. The guidance is used by the Health Practitioners Disciplinary Tribunal, the MCNZ, and the HDC as a standard to measure conduct against. It states that appropriate prescribing practice requires that a doctor s customary prescribing conforms within reason to patterns established by the doctor s peers in similar practice. The guidance says that medication should be prescribed only once the condition of the patient has been adequately assessed and that the provider must be satisfied that the treatment is in the patient s best interests. 5 The RANZCP produces clinical resources to help its members and other mental health professionals provide good quality services. Relevant resources include guidelines for managing depression and schizophrenia, and practice guidelines for mood disorders. These resources address all aspects of the care of people with mental health problems, including correct diagnosis, and offer a range of treatment options. The mood disorder guidelines also highlight that the possibility of antidepressant overdose should be a consideration when selecting an appropriate medication for depressed patients who are likely to be at risk of self-harm or suicide. Medication regime changes We asked the ministry about how the patient s experience with medication is managed when more than one type of medication is used. The ministry told us that, over time, new evidence emerges about the diagnosis and about the effectiveness of different medication to treat it. This often leads to patients and service providers seeking an alternative medication. The best practice would be to ensure that there is no cross-over of medication. When medication regimes change, the service provider would wait until the old medication is no longer in the patient s body before prescribing the new medication. Providers are aware that some medicines cannot mix and there is worry about the potential unknown consequences of drugs interacting. The ministry emphasised that it is essential that the patient and service provider continue to communicate during this process. Continuous improvement The ministry noted that the potential harm of certain psychoactive drugs has been well documented. New Zealand and international clinical guidelines acknowledge the safety issues associated with psychiatric medication and the need for ongoing assessment that balances risks against potential benefits for patients. The ministry told us that New Zealand s regulatory and medical practice environment has a good record of continuous improvement of its medical care and addressing concerns about particular medicines. However, the ministry is aware that it needs to remain vigilant about medication side-effects, opportunities for quality improvement in processes, and the need to update and implement clinical guidelines. 5 Medical Council of New Zealand (2016), Good prescribing practice, retrieved from: https://www.mcnz.org.nz/assets/news-and-publications/statements/good-prescribing-practice.pdf. 5
Conclusion We extend our sympathy to Mrs Dent for her loss. We commend the work that Mrs Hodson and Mrs Dent have done in providing us with extensive evidence in support of the petition. We are pleased to hear that there have been significant developments in the regulation and guidelines of practice for treating people with mental health issues. We consider that many of these developments have addressed the petitioner s concerns. We encourage the Ministry of Health and other sector service providers to continue improving the way in which psychoactive medication is used to treat people with mental health issues. 6
Appendix Committee procedure Petition 2014/45 of Carolyn Hodson was referred to the committee on 19 February 2016. We received written and oral evidence from the petitioner and the Ministry of Health. Read the evidence that the committee received on this petition (this link will take you to the relevant page on the Parliament website). Committee members Simon O Connor (Chairperson) Dr David Clark Sarah Dowie Julie Anne Genter Barbara Kuriger Melissa Lee Dr Shane Reti Barbara Stewart Poto Williams 7