World Cancer Congress Montreal 27-30 August 2012 Joan Marston Chief Executive www.icpcn.org.uk
Acknowledgements WHO Dr Willem Scholten: Team Leader Access to Controlled Medications Programme of the Department of Essential Medicines and Pharmaceutical Policies In collaboration with the Departments of : Chronic Diseases and Health Promotion ! Mental Health and Substance Abuse ! HIV ! Essential Health Technologies ! Child and Adolescent Health and Development ! Guidelines Review Committee !
! WHO Steering Group on Pain Treatment Guidelines ! WHO Expanded Review Panel ! WHO Expert Advisory Panel on Drug Evaluation ! WHO Guidelines Peer Review Contributors ! WHO consultants ! Expanded Review Panel
Guidelines Development Group ! Pain specialists ! Paediatric palliative care specialists ! Pharmacists ! Researchers ! Methodologist ! Health systems professionals ! Oncology, neurology; anaesthesiology; haematology; psychiatry; drug dependence
Huda Abu-Saad Huijer ! Henry U. Lu Gouhar Afshan ! Joan Marston Hendrina Albertyn ! Rajat Ray Rae Bell ! Carla Ripamonti Mariela Bertolini ! Andrew gray John Collins ! Nicola Magrini Henry Ddungu ! Barbara Milani G. Allen Finley ! Lulu Muhe Cleotilde H How ! Willem Scholten
Donors ! Open Society Institute (Zug) Switzerland For printing of the Guidelines ! International Association for the Study of Pain ! The Diana Princess of Wales ! Mayday Fund Memorial Fund ! Ministry of Health, Welfare and Sport (Netherlands) ! International Children’s ! Rockefeller Foundation Palliative Care Network ! The True Colours Trust ! US Cancer Pain Relief Committee
First of three Guidelines 1. Pharmacological Treatment of Persisting Pain in Children 2. Pharmacological Treatment of Acute Pain 3. Pharmacological Treatment of Persisting Pain in Adults
! Overall Objectives of the Guidelines ! Methodology ! Content of the Guidelines Package ! Rationale for a 2- Step approach in children ! Taking the Guidelines forward
Overall Objectives ! To provide evidence-based recommendations on pain treatment including opioid analgesics, non-opioid analgesics, and adjuvents ! To improve pain management in children – neonates, infants and children 0-10 years experiencing persisting pain related to medical diseases
Principle regarding Pain Management Optimal pain management may require a comprehensive approach comprising a combination of non-opioid, opioid analgesics, adjuvents and non-pharmacological strategies. A comprehensive approach is possible even in resource-limited settings
“ Pain is a more terrible lord of all mankind than death itself” Albert Schweitzer
Pharmacological Guidelines Include Exclude ! Nociceptive pain ! Acute trauma ! Neuropathic pain ! Peri-operative pain ! Conditions considered but ! Procedural pain not restricted to ! Chronic, complex pain not ! Cancer related to tissue disruption eg fibromyalgia, headache ! Major infection (eg HIV/AIDS) ! Sickle-cell disease ! Non-pharmacological ! Burns interventions ! Persisting neuropathic pain ! Disease –specific therapies related to amputation
Exclude the role of Play Resources Early Childhood Development in Children’s Palliative Care www.hpca.co.za Textbook of Palliative Care for Children in Africa www.icpcn.org.uk
Targeted audience is Health Care Providers in the broadest sense ! Medical practitioners ! Clinical Officers ! Nurses ! Pharmacists ! Care givers of children ! Policy-makers and Regulatory authorities ! Public Health and Programme Managers
Profiles Recommendations for Pharmacological profiles of Health –systems issues recommended medicines based on published and and unpublished Opioid analgesics for experience in the safe opioid switching management of pain in health systems and the WHO Model Formulary guidelines group for Children expert opinion
Content of the Guidelines Classification of Pain 1. Evaluation of Persisting Pain in the Paediatric Population 2. Pharmacological Treatment Strategies 3. Improving Access to Pain Relief in Health Systems 4.
Also included are ! Recommended Research Agenda ! Opioid Analgesics and International conventions ! Recommendations on the importance of education
Methodology 1. Scoping document for review 24 PICOT questions – 21 on medications, 3 on Health Systems Evidence retrieval and review 2. Systematic reviews of Randomised Control Trials 2. Observational studies 3. 3. Values – high value placed on management of pain in children 4. Recommendations 5. Research implications
Definition of Quality of Evidence according to GRADE HIGH – further research is unlikely to change confidence in the estimate of the effect MODERATE – further research is likely to have an important impact on confidence in the estimate of the effect and may change the estimate LOW- further research is likely to have an important impact on confidence in the estimate of the effect and is likely to change the estimate VERY LOW- any estimate of effect is very uncertain
Interpretation of Strong and Weak Recommendations Related to " Patients and families ! Clinicians ! Policy makers
" Quality of evidence " Risks/benefits " Values and acceptability " Cost " Feasibility " Policy and Research agenda
Expert Opinion
STRONG RECOMMENDATIONS BUT LOW QUALITY EVIDENCE
Recommendations ! Indications ! Contra-indications ! Precautions ! Skilled Tasks ! Dosage ! Starting dose ! Continuation ! Breakthrough pain ! Discontinuation
! Adverse effects ! Common ! Less common ! Uncommon ! Rare ! Interactions with other medicines ! Notes ! Equianalgesic doses ! References
Principles for the pharmacological management of pain in children Correct use of analgesic medicines will relieve pain in most children Relies on the following concepts # Two-Step approach # Dosing at regular intervals # Using the appropriate route of administration # Adapting treatment to the individual child
2 Step Approach 1 st Step – Ibuprofen; Paracetamol “ The risks associated with strong opioids as the second step are acceptable when 2 nd Step – Strong Opioid compared with the (Morphine recommended) uncertainty associated with responses to codeine and tramadol in children”
Recommendations on Opioid-usage “Start Low and Go Slow” Pain should always be treated when the cause of pain is not addressed, supported by medical evaluation and adequate monitoring
Recommendations Dosages recommended around 50% of those normally considered Titration based on regular assessment Up-to-date pain education including risk management Opioid analgesics are intended to be used within functioning Health Systems
Questions around Diversion and Addiction Addendum to address this in process of finalisation Group believes that treating pain effectively is first priority Diversion is a separate issue and very rare in this age group
We have the guidelines And now ?
Present status of the Guidelines ! Published on the WHO website http://www.who.int/medicines/areas/ quality_safetyaccess_contr_Med/en/index.html ! For printing in English ! Assessment of evidence on diversion and over- consumption for an Addendum to the Guidelines ! Research Agenda – ICPCN appointed to co-ordinate the research
Guideline Package Guidelines 1. Brochures for 2. Physicians and Nurses Pharmacists Policy makers and Regulatory Authorities, Hospital managers and Health Insurers 3. Pain Scales for Assessment 4. Wall Chart
Research Agenda – 4 groups of priorities First Priorities ! Assessment of two-step treatment strategy ! Alternative opioids to morphine ! Intermediate potency opioid analgesics (eg Tramadol) ! Long-term safety data concerning 1 st step medicines (ibuprofen, paracetamol)
E-Learning module –www.icpcn.org.uk
Includes Clinical Placement Guidelines
Human Rights Approach and Submissions ! “to leave a person in avoidable pain and suffering should be regarded as a serious breach of fundamental human rights” Somerville 1995 ! “the relief of severe, unrelenting pain would come at the top of a list of basic human rights.” Cousins 1999
Dissemination , Translation and Advocacy
www.icpcn.org.uk
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