Drug approval processes in Australian Paediatric Hospitals.

OBJECTIVE: To describe and evaluate the decision-making processes for drug approval in Australian paediatric hospitals. DESIGN: Multicentre descriptive study involving face-to-face interviews of drug and therapeutics committee chairs and secretaries, review of committee documents and drug submissions for all Australian paediatric hospital drug and therapeutics committees over a 1-year period. SETTING: All eight paediatric hospitals in Australia. PARTICIPANTS: Eight committee chairs and seven secretaries or delegates. MAIN OUTCOME MEASURES: Total drug expenditure, number of formulary submissions, individual-patient use approvals and approval rates for each hospital from 1 July 2006 to 30 June 2007, stratified by therapeutic class. Qualitative description of the approval processes. RESULTS: Total drug expenditure varied from $A1.7 million (US$1.5 million) to $A11.1 million (US$9.8 million) per hospital. The number of formulary submissions also varied, from 7 to 21, but approval rate was high (76%-100%) and not significantly different among hospitals (p=0.17). Several committees approved identical submissions for five drugs. The number of individual-patient use applications varied considerably, ranging from 10 to 456 per hospital. Where estimable, individual-patient use approval was 76%-100% and variable (p=0.03). Quality of evidence relating to safety and efficacy of drugs being considered was regarded as the most important factors influencing decision making, with the cost less important. Most committees had poor infrastructural support for approval processes. No committee formally included a pharmaco-economic evaluation. CONCLUSIONS: Most drug submissions in tertiary paediatric hospitals are approved; however, workload, drug expenditure and individual-patient use schemes vary considerably. Duplication of effort occurs, and few committees are resourced sufficiently given their terms of reference.

Effect of the introduction of a lumbar-puncture sticker and teaching manikin on junior staff documentation and performance of paediatric lumbar punctures.

BACKGROUND: Performing a lumbar puncture in an unwell child can cause anxiety in both the parent and the junior doctor. There is increasing evidence of post-lumbar-puncture complications in this age group. AIMS: To improve the documentation, consent for and technical performance of paediatric lumbar punctures to 100% of the required standard within 3 months. SETTING: The paediatric emergency department of a the Royal North Shore Hospital (University of Sydney, Sydney, Australia). PARTICIPANTS: Paediatric emergency staff, including residents, registrars and consultants. METHODS: Medical records of 40 consecutive children who had undergone a lumbar puncture in the 6 months before the introduction of the lumbar-puncture proforma were reviewed. After introduction of the proforma, the records of 25 consecutive patients were reviewed to assess changes in the outcome measures. Before introduction of the proforma, junior medical staff were instructed in the procedure using specialised lumbar puncture manikins (Baby Stap; Laerdel, USA). RESULTS: Before introduction of the proforma, the median number of documented indicators was 4, out of a maximum of 12. There was almost no documentation of parental consent, patient complications and analgesia. Introduction of the proforma resulted in a highly marked increase to a median of 12 documented indicators per patient (p<0.01, 95% confidence interval 6 to 8). CONCLUSIONS: The introduction of a lumbar-puncture proforma and formal teaching sessions using a paediatric manikin led to a marked improvement in the documentation of paediatric lumbar-punctures. Lumbar-punctures can be performed only by accredited medical officers who have achieved competency on the lumbar-puncture teaching manikin.

Retrospective review of the management of simple febrile convulsions at a tertiary paediatric institution.

OBJECTIVES: To review the medical records of children presenting to a tertiary paediatric emergency department (ED) with febrile convulsions over a 3-year period in order to assess quality of clinical practice. METHODS: The medical records of all children presenting to our ED with a discharge diagnosis of 'simple febrile convulsion' during the years 2001-03 were reviewed. Data was extracted based on the parameters of clinical presentation, diagnosis and management. RESULTS: A total of 288 patients were identified. The patients were separated into two groups - those that were discharged from the ED and those that were admitted to the hospital. Two hundred and sixty (84%) of the children were discharged from the ED. A further 28 (15%) patients were admitted to the ward. Of the children discharged from the ED, 78% had not been seen by a medical professional in the previous 24 h, 82% were diagnosed with a viral illness and clinical examination was normal in 88% of cases. A total of 36 out of 527 (6.8%) investigations performed on this group were abnormal. Most children (85%) had no clinical indication to necessitate investigation. Almost all (91%) were treated with antipyretics. The number of inappropriate investigations was directly linked to the inexperience of the treating medical officer. Of the 28 patients admitted to the hospital, 61% were diagnosed with a viral illness. A total of 15 out of 137 (10.9%) investigations were abnormal. Sixty-one per cent of patients were admitted for less than 24 h, a further third of children for 48 h. Twenty of the 28 children had no parental education documented. None were readmitted with a simple febrile convulsion during the same illness. CONCLUSIONS: Although many children who present to the hospital with simple febrile convulsions are managed appropriately, a large number are overinvestigated and overtreated, based on the clinical experience of the treating doctor. In these cases, medical record documentation can be improved. A clinical guideline based on our local fever guideline is suggested.

Long bone fractures in children under 3 years of age: is abuse being missed in Emergency Department presentations?

OBJECTIVE: Distinguishing injuries due to accidents from those due to child abuse in young children is important to prevent further abuse. We aimed to study the presenting features, mechanism of injury, type of fracture and indicators of possible abuse in children under 3 years of age, presenting to the Emergency Department (ED) of a tertiary referral Children's Hospital, to see whether those injuries that were more likely abusive were distinguished from those that were more likely accidental. METHODS: We analysed the medical records from the Emergency Department Information System of all children below 3 years of age, who were treated for a long bone fracture at the Sydney Children's Hospital, Randwick, NSW, over a 1-year period. Demographic details, presenting complaint, mechanism of injury, type of fracture, other historical and examination data and action taken were noted. Nine indicators that raise suspicion of abuse were developed from the literature. Using these indicators, patients' ED notes were reviewed to establish whether long bone fractures suspicious for abuse had been referred for further evaluation. RESULTS: One hundred patients with a total of 103 fractures presented during the study period. No child had multiple fractures at a single visit. The fractures included 36 radius/ulna, 27 tibia/fibula, 20 humeral, 17 clavicular and three femoral. The mean age of patients was 21.6 months (range 13 days - 35 months). Fourteen patients were younger than 12 months. Review of the notes revealed 31 children with indicators suspicious for abuse, of whom 17 children had one indicator, 11 children had two indicators, and three children had three indicators. Only one child was referred for further evaluation to child protection. CONCLUSION: Abuse cannot usually be determined by fracture type alone. Doctors in the ED miss indicators for abuse because they do not look for these indicators in the history and examination. Knowledge of indicators that raise suspicion of abuse is needed for a further forensic assessment to occur. The development of specific referral guidelines, ongoing education and a comprehensive injury form may improve referral of children from the ED to child protection.

Euthanasia, the right to die and the law in South Africa.

In this article euthanasia is defined and classified. Each of the classification is examined in relation to the relevant South African law as are the possible defences to criminal charges flowing from a euthanasia situation. Further, the validity of the so-called 'living will' is examined. While most declarations or bills of human rights seek to protect an individual's right to life, this article shows that an individual enjoys no right (from a human right point of view) enabling him to choose the time and condition of his death, irrespective of whether he is terminally ill. The reason for this negative attitude to euthanasia by society is considered. In conclusion it is observed that due to the plurality of society in South Africa, it will be no easy task for the legislature to pass acceptable laws regarding euthanasia, however limited. Finally, positive suggestions are made for the implementation of a valid 'living will'.

The breaching of medical confidentiality by reason of an order of court.

The ethical rule of medical confidentiality is not sacrosanct, for a doctor may be ordered by a court of law to make disclosures against his patients wishes. While this may assist in justice being done, it also raises the question of whether sufficient regard is paid to a patient's right to privacy.

The rule of medical confidentiality v. the moral duty to warn an endangered third party.

The legal situations of a medical practitioner who breaches the rule of medical confidentiality in warning an endangered third party on the one hand, and on the other a doctor who fails to warn an endangered third party (who subsequently suffers illness or other damages as a result) are addressed. There is no direct South African law applicable to either circumstance; accordingly these issues are examined in the light of general legal principles. Further, since there have been a series of important judicial decisions in the USA on this subject, American law is also considered. In the final analysis, it would appear that in South African law by breaching medical confidentiality in warning an endangered third party (subject to the doctor acting bona fide) a medical practitioner incurs no legal liability. It would also appear that failure to warn an endangered third party incurs no legal liability under South African law.

The legal determination of the sexual identity of a post-operative transsexual seen as a human rights issue.

Following a definition of transsexualism, the acknowledged medical treatment and the groups of persons who may require sex changes are considered. The medical and surgical procedures involved in a sex change and the dangers inherent in such procedures are then briefly discussed. The legal implications of a sex change in various countries are touched upon with reference to several cases. The discussion is then extended to human rights aspects, with a report of a case considered by the European Commission of Human Rights and the European Court of Human Rights. The paper closes with a summary of some of the problems facing a transsexual after surgery.

Effect of the legislative definition of the terms 'stillborn' and 'viable'. A medicolegal impasse.

Like so many other medicolegal issues, the legal procedure and legal consequences when a child is stillborn may seem simple and straightforward. However, in practice this is anything but the case. The legislative definitions of the terms 'stillborn' and 'viable' cause inordinate problems. Various legal, medical and social difficulties will only be obviated by amendment of the legal definitions of these terms--a task which should be initiated by the medical and nursing professions.

Judicial determination of the sexual identity of post-operative transsexuals: a new form of sex discrimination.

Transsexualism is a condition in which an individual's psychological gender is the opposite of his or her anatomical sex. A "sex-change" operation can bring anatomical sex into line with gender, but it cannot create a new biological sex capable of procreation. The operation is expensive, dangerous and lengthy, yet in 1983 there were an estimated 6,000 post-operative transsexuals in the United States. Certain European countries have legislation recognizing the post-operative transsexual's new sex. Case law in the United Kingdom and the United States, however, prevent post-operative transsexuals from gaining legal recognition. The author does see some hope, however, for a change in the trend against recognition of transsexuals' post-operative sex. This Article discusses the reasons behind this trend and concludes that the greater danger would be a consensus of medical opinion holding that sex-change surgery is unnecessary, questioning the very existence of post-operative transsexuals. Finally, the author calls for legislative action to remove judicially-imposed obstacles and to give legal recognition to the post-operative transsexual's new sex and identity.