Ensuring Access to Controlled Substances for Medical and Scientific Purposes

2.2 Ensuring access to controlled substances for medical and scientific purposes

azepam, ephedrine, ergometrine, hydromorphone, Key recommendations lorazepam, midazolam, methadone, morphine, ox- ycodone and phenobarbital.38 These represent the ‘minimum medicine needs for a basic healthcare • National drug control regulations should system’ and ‘the most efficacious, safe and cost-ef- be reviewed using WHO’s 2011 guidance35 fective medicines’.39 A number of countries also to ensure that they do not needlessly inter- apply similar national controls to other essential fere with the availability and accessibility medicines outside of those proscribed by interna- of controlled medicines, especially opioid tional law – such as ketamine40 (see Chapter 2.1 for analgesics more details). • The adequacy of annual estimates for med- Although ensuring the adequate availability of con- ical and scientific needs of controlled sub- trolled substances for medical and scientific purpos- stances should be reviewed in accordance es is one of the fundamental aims of the UN drug with the INCB and WHO’s Guide on estimat- conventions, the UN system and UN member states ing requirements for substances under in- have so far failed at fulfilling this objective. The WHO ternational control,36 and estimates should estimates that 5.5 billion people live in countries be adjusted as needed with low or non-existent access to controlled med- • Adequate training for current healthcare icines, and that tens of millions of people in these workers should be provided on the use of countries experience moderate to severe pain with- controlled medicines, and incorporated out access to treatment every year, including 5.5 into undergraduate and graduate curricula million people with terminal cancer and a million for all relevant healthcare workers people with late-stage HIV/AIDS.41 • National health strategies should be re- The international drug control regime also interferes viewed, including for cancer, non-commu- with scientific research into potential medical uses nicable diseases and HIV, to ensure that of controlled substances. An increasing body of ev- they adequately address the need for pal- idence suggests that substances such as cannabis liative care and cannabinoids, heroin, ketamine, ketobemidone, • More scientific research should be encour- LSD and MDMA, have medical uses in the treatment aged, conducted and funded on the medi- of a variety of conditions, including pain, multiple cal value of cannabis and psychedelics.37 sclerosis, drug dependence, glaucoma, depression, post-traumatic stress disorder, and Parkinson’s dis- ease.42 Yet, the fact that these substances are listed in schedules that recognise no medical or scientific use Introduction in the drug control treaties creates significant regulatory and financial obstacles to further research and Some substances controlled under the international the development of new medications.43 drug control treaties are routinely used in healthcare in diverse fields of medicine, such as anaes- thesia, drug dependence, maternal health, mental Legislative/policy issues health, neurology, pain management and palliative involved care. For example, the World Health Organisation (WHO) has included 12 medicines that contain in- The 1961 Single Convention on Narcotic Drugs and ternationally controlled substances in its Model List the 1971 UN Convention on Psychotropic Substanc- of Essential Medicines: buprenorphine, codeine, di- es articulate a dual obligation for states with respect

30 IDPC Drug Policy Guide Credit: Ed Kashi/VII / Human Rights Credit: / Human Rights Ed Kashi/VII Watch

Dr. Gloria Dominquez Castillejos, pain clinic director, speaks with a patient in Hospital Doctor Angel Leano in Guadalajara, Mexico to controlled substances and their medical use: • limitations on which healthcare workers can countries must ensure their availability for medical prescribe controlled substances and scientific use, and prevent their use and diver- • requirements for additional licenses for hospi- sion for other uses (i.e. recreational and non-medical tals, pharmacists and healthcare workers use).44 The Single Convention formulates four basic • additional record keeping or reporting require- requirements for national regulations of opioid ments analgesics, which are in the strictest schedule for • limitations on the daily doses that can be prescribed. substances with medical uses: Furthermore, the laws on controlled substances of • Individuals dispensing the medication must be some countries impose harsh criminal punishments licensed, either by virtue of their professional li- for healthcare workers, sometimes even for unin- cense or through a special licensing procedure tentional errors in handling them. • Only authorised institutions or people may handle and transfer these medications The WHO,47 the International Narcotics Control 48 • The medications can only be dispensed to a Board (INCB), the Commission on Narcotic Drugs 49 patient upon a medical prescription (CND), the United Nations Office on Drugs and Crime (UNODC),50 and the World Health Assembly • Records on the movement of these medica- (WHA)51 have repeatedly called on UN member tions are kept for no less than two years.45 states to review their regulations on controlled The 1971 Convention contains similar provisions for substances to ensure they do not needlessly inter- psychotropic substances. However, both the 1961 fere with medical use. The WHO has also published and the 1971 conventions explicitly open the door guidance for countries on reviewing their national for countries to adopt measures of control stricter or policies on controlled substances.52 more severe than those provided by the drug control treaties, including a special prescription form for controlled medications, if they deem it necessary.46 Implementation issues In contrast, specific operative paragraphs requiring involved states parties to ensure access to controlled medicines are conspicuously absent. Regulatory barriers are not the sole reason why the availability of controlled medicines, especially opi- Many countries have adopted regulations around oid analgesics, is so limited in much of the world. controlled substances that go far beyond the re- Few governments have put in place effective sup- quirements of the 1961 Convention or the 1971 ply and distribution systems for these medications; Convention. Often, these regulations directly in- they have no relevant health policies or guidelines terfere with medical practice and make controlled for practitioners; they do not ensure that healthcare medicines inaccessible for patients. Common barri- workers get instructions on the use of controlled ers in national legislation include: medicines as part of their training; and they do • requirements for special prescription forms not make sufficient efforts to ensure that they are • limitations on the number of days a prescrip- affordable.53 Myths about controlled medicines tion can cover among both healthcare workers and the public, as

IDPC Drug Policy Guide 31 Box 1 Mexico reviews its prescribing and dispensing system for opioid analgesics

On 15 June 2015, Mexico introduced a new government oversight of their use. Previously, system for prescribing and dispensing opioid pharmacies were unable to scan the bar-code analgesics in response to concerns that the old stickers on prescriptions for opioid analgesics to system was so cumbersome that it deprived authenticate them because they were not linked people with advanced illnesses of access to to a central system. Thus, the requirement for essential pain medicines. The new system al- bar codes, which was intended to allow close lows physicians to download special prescrip- monitoring of prescribing and dispensing opioid tions from a secure website with bar codes analgesics, did not actually help prevent their required for prescribing opioid pain relievers. misuse, but did create a major barrier to legiti- It also introduces electronic record keeping mate medical use. 54 for pharmacies. Under the new system, pharmacies will be able Before June 2015, physicians had to travel in per- to authenticate prescription forms using the bar son to state capitals to obtain the bar-code stick- code, and scripts will be automatically cancelled ers that Mexican law requires for prescriptions of once they have been scanned. The new system opioid analgesics. This highly time-consuming for prescribing opioid analgesics is one of a se- requirement discouraged many physicians from ries of measures by the Mexican government to prescribing these medicines. Moreover, phar- improve access to palliative and end-of-life care. macies had to record all transactions involving Pain treatment is an important component of these medicines in multiple log books, posing a this kind of healthcare. significant bureaucratic burden. A 2014 Human In December 2014, the Ministry of Health issued Rights Watch report found that Mexico’s regula- guidelines to its healthcare system to put into tions were so burdensome that the vast majority effect provisions on end-of-life care as outlined of doctors, especially those living outside state in Mexico’s 2009 health law and created a de- capitals, simply did not prescribe these medica- partment to advance palliative care. In January tions and that very few pharmacies kept them 55 2015, the government adopted an inter-agency in stock. agreement on palliative care, which made it Apart from simplifying the prescription of opioid mandatory and instructed medical schools to analgesics, the electronic system also improved include it in their curricula. Credit: Ed Kashi/VII / Human Rights Credit: / Human Rights Ed Kashi/VII Watch

Doña Remedios and her daughter, Orlanda Hernandez Ramirez, 44, take a very early morning journey to receive palliative care at the National Cancer Institute in Mexico City, 2014

32 IDPC Drug Policy Guide and prescription regulations, as well as the threat Box 2 Kenya’s improved of harsh punishment mentioned above, discour- age pharmacies and hospitals from stocking these access to opioid analgesics medicines, and healthcare workers from prescribing them, again resulting in low demand. This, in turn, Kenya has made significant progress in im- reinforces the low priority given to pain manage- proving access to opioid analgesics in the last ment and palliative care. This low prioritisation is five years, with morphine consumption jump- not a function of low prevalence of pain, but of the ing more than three-fold over that period. In invisibility of its sufferers. 2010, access to opioid analgesics was very lim- To break out of this vicious cycle, governments and ited and available in just a few Kenyan hospi- the international community should: tals. According to a 2010 Human Rights Watch • take a multipronged approach that focuses on report, Kenya recognised oral morphine as an eliminating regulatory barriers and criminal essential medicine but its central pharmaceu- sanctions for legitimate medical uses of con- tical supplier – the Kenya Medical Supplies trolled medicines Agency, which procures essential medicines • develop health policies, such as national strat- for public hospitals – did not purchase or egies on cancer or on non-communicable stock oral morphine. Hospitals therefore had diseases, that identify palliative care as an to negotiate individually with pharmaceutical objective, and integrate such services into the companies to obtain the medication. More- healthcare system over, the government levied an import tax on morphine powder pushing up the price.56 • overcome gaps in training on the use of con- As Kenya’s drug law prescribed heavy prison trolled medicines for healthcare workers sentences for illicit possession of morphine • take action to ensure an adequate supply and and provided no detailed guidelines on law- distribution system. ful possession for healthcare workers and patients, many healthcare providers viewed morphine as a dangerous substance rather Key resources than as an essential medicine for pain. • Duthey, B. & Scholten, W. (2014), ‘Adequacy of opi- Since 2010, Kenya has taken significant steps oid analgesic consumption at country, global and toward improving access to opioid analgesics. regional level in 2010, its relation to development It has integrated palliative care into the public level and changes compared to 2006’, Journal of health system, developed clinical guidelines, Pain and Symptom Management, 47(2): 283-97, and introduced multiple training curricula doi:10.1016/j.jpainsymman.2013.03.015 that include the use of opioid analgesics. In • Global Commission on Drug Policy (October 2013, the Kenya Medical Supplies Agency be- 2015), The negative impact of drug control on pub- gan to procure morphine centrally for public lic health: The global crisis of avoidable pain, http:// hospitals, and the government removed the www.globalcommissionondrugs.org/reports/ tax on morphine powder. As a result, 43 public • Hallam, C. (December 2014), The international hospitals offered palliative care by late 2014, drug control regime and access to controlled med- and all had a steady supply of morphine.57 icines (International Drug Policy Consortium & Transnational Institute), http://idpc.net/publica- well as often unfounded fears of diversion for illicit tions/2015/01/the-international-drug-control-re- purposes, are key factors blocking improved access gime-and-access-to-controlled-medicines to controlled medicines. • International Narcotics Control Board & World In the case of pain management and palliative care, Health Organisation (2012), Estimating require- these factors combine to create a vicious cycle of ments for substances under international control, under-treatment in many countries. Because pain https://www.incb.org/documents/Narcot- treatment and palliative care are not policy priori- ic-Drugs/Guidelines/estimating_requirements/ ties, healthcare workers do not receive the neces- NAR_Guide_on_Estimating_EN_Ebook.pdf sary training to assess the medicines necessary to • World Health Organisation (2011), Ensur- treat moderate to severe pain. This leads to wide- ing balance in national policies on controlled spread under-treatment and to low demand for opi- substances, http://apps.who.int/iris/bitstre oid analgesics. Similarly, the complex procurement am/10665/44519/1/9789241564175_eng.pdf

IDPC Drug Policy Guide 33