Opioids and Palliative Care on the WHO EML(c) | Geneva – 8 April 20131

Willem Scholten  PharmD   MPAConsultant – Medicines and Controlled Substances

Opioids and Palliative Care on the WHO EML(c)

19th Expert Committee on the Selection and Use of Essential Medicines

Willem Scholten,  PharmD, M.P.A.Consultant – Medicines and Controlled Substances

Nyon, Switzerland

Opioids and Palliative Care on the WHO EML(c) | Geneva – 8 April 20132

Willem Scholten  PharmD   MPAConsultant – Medicines and Controlled Substances

About myself

• Pharmacist; Master in Public Administration• Former Team Leader, Access to ControlledMedicines in the WHO Dept. of Essential Medicines and Pharmaceutical Policies (2005‐2012)

• Developed WHO Pediatric Pain Guidelines and Policy Guidelines on controlled medicines

• Many publications on access issues

Opioids and Palliative Care on the WHO EML(c) | Geneva – 8 April 20133

Willem Scholten  PharmD   MPAConsultant – Medicines and Controlled Substances

ADDITION OF OPIOID PREPARATIONSand

POSITIONING OF PALLIATIVE CAREMorphineOxycodoneHydrocodone

Palliative Care Medicines at Highest Level Section 

Opioids and Palliative Care on the WHO EML(c) | Geneva – 8 April 20134

Willem Scholten  PharmD   MPAConsultant – Medicines and Controlled Substances

From: Duthey B and Scholten W ; unpublished data.

Opioids and Palliative Care on the WHO EML(c) | Geneva – 8 April 20135

Willem Scholten  PharmD   MPAConsultant – Medicines and Controlled Substances

15 Com

posite level Courtesy  Lynch T, Connor S and Clark D

Opioids and Palliative Care on the WHO EML(c) | Geneva – 8 April 20136

Willem Scholten  PharmD   MPAConsultant – Medicines and Controlled Substances

WHO Policy GuidelinesEnsuring Balance in National Policies on Controlled Substances, Guidance 

for accessibility and availability of controlled medicines (Geneva 2011)

http://www.who.int/medicines/areas/quality_safety/guide_nocp_sanend/en/index.html

Opioids and Palliative Care on the WHO EML(c) | Geneva – 8 April 20137

Willem Scholten  PharmD   MPAConsultant – Medicines and Controlled Substances

Guideline 7 (Recommendation text)

Governments should include the availability and accessibility of controlled medicines for allrelevant medical uses in their national pharmaceutical policy plans. […]

(bold‐underlined by WS)

Opioids and Palliative Care on the WHO EML(c) | Geneva – 8 April 20138

Willem Scholten  PharmD   MPAConsultant – Medicines and Controlled Substances

Guideline 7 (From explanation)

• Planning for availability through the formulation of policy plans is essential for defining and realizing the health policy objectives of a country. 

• Only after establishing this general [pharmaceutical –WS] policy should specific policy plans be developed for individual diseases. 

Opioids and Palliative Care on the WHO EML(c) | Geneva – 8 April 20139

Willem Scholten  PharmD   MPAConsultant – Medicines and Controlled Substances

WHO Persisting Pain in ChildrenPackage

http://www.who.int/medicines/areas/quality_safety/guide_on_pain/en/index.html 

Opioids and Palliative Care on the WHO EML(c) | Geneva – 8 April 201310

Willem Scholten  PharmD   MPAConsultant – Medicines and Controlled Substances

Pead. Treatment Guidelines

• Morphine recommended as 1st choice opioid• Two alternative opioids to be available

• Children’s pain should always be addressed• This will usually require opioids in case of moderate and severe pain All pain – NOT cancer pain only

Opioids and Palliative Care on the WHO EML(c) | Geneva – 8 April 201311

Willem Scholten  PharmD   MPAConsultant – Medicines and Controlled Substances

Pain in adults

Need for morphine and alternative opioids:• Equally true• No formal WHO pain treatment GLs ready(scoping document approved by GRC)

• Evidence from WHO Cervical cancer guidelines (in preparation)

Opioids and Palliative Care on the WHO EML(c) | Geneva – 8 April 201312

Willem Scholten  PharmD   MPAConsultant – Medicines and Controlled Substances

Conclusion (I)

Important messages to be given by WHO (I)

• Availability of morphine and two alternative opioids is an essential requirement for adequate treatment of pain in children

– To consider: to extend this to adults

Opioids and Palliative Care on the WHO EML(c) | Geneva – 8 April 201313

Willem Scholten  PharmD   MPAConsultant – Medicines and Controlled Substances

Conclusion (II)

Important message to be given by WHO (II)

• Palliative Care is for a wide area of diseases– Not: cancer only!– Application to move PC section to the highestlevel in EMLc and to extend this to the EML