Provision of pain- and symptom-relieving drugs for HIV/AIDS in sub-Saharan Africa

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Original Article Provision of Pain- and Symptom-Relieving Drugs for HIV/AIDS in Sub-Saharan Africa Richard Harding, BSc, MSc, DipSW, PhD, Richard A. Powell, BA, MA, MSc, Fatia Kiyange, BSc, MSc, Julia Downing, RN, PhD, and Faith Mwangi-Powell, MSc, PhD Department of Palliative Care, Policy and Rehabilitation (R.H.), King’s College London, London, United Kingdom; and African Palliative Care Association (R.A.P., F.K., J.D., F.M.-P.) Kampala, Uganda Abstract Context. Although pain and burdensome symptoms among HIV-infected persons can be effectively managed, the availability of opioids and other symptom- controlling drugs is a particular challenge in sub-Saharan Africa. Objectives. This study aimed to identify current drug availability and prescribing practices in 12 sub-Saharan African countries and to examine the barriers and potential facilitators for use of opioids and other key HIV/AIDS symptom-controlling drugs. Methods. This was a cross-sectional survey, integrating data from palliative care facilities and competent authorities within ministries of health in 12 African countries. Results. Of 62 responding facilities, problems were reported in accessing named nonopioids, with a small number of facilities unable to dispense them. Less than half the facilities were currently prescribing opioids of any strength. Further problems were identified in terms of the availability and supply continuity of named antiemetics and anxiolytics. The data identified a number of systemic problems, suggesting that opioid supply issues are similar to less controlled drugs, such as antiemetics. Among competent authorities, there was no agreement on whether further opioid expansion was possible. Integration of data from care facilities and competent authorities highlighted a disparity in the understanding of the availability of specific drugs, with competent authorities naming drugs that were not listed by any responding facility in their respective country. Conclusion. This study shows that opioid expansion needs to balance supply and skills: Currently there are insufficient trained clinical personnel to prescribe, and supply is unreliable. Efforts to expand supply should ensure that they do not This study was supported by a grant from the United States Agency for International Development (USAID) under a subagreement (number J0E- G-001), made under the authority provided to Pact under Cooperative Agreement with USAID, number GPH-A-00-01-0007-00, entitled ‘‘Rapid Re- sponse Mechanism for HIV/AIDS Activities.’’ The authors declare no conflicts of interest. Address correspondence to: Richard Harding, BSc, MSc, DipSW, PhD, Department of Palliative Care, Policy and Rehabilitation, King’s College London, Weston Education Centre, London SE5 9RJ, UK. E-mail: [email protected] Accepted for publication: January 19, 2010. Ó 2010 U.S. Cancer Pain Relief Committee Published by Elsevier Inc. All rights reserved. 0885-3924/$ - see front matter doi:10.1016/j.jpainsymman.2009.12.025 Vol. 40 No. 3 September 2010 Journal of Pain and Symptom Management 405

Transcript of Provision of pain- and symptom-relieving drugs for HIV/AIDS in sub-Saharan Africa

Vol. 40 No. 3 September 2010 Journal of Pain and Symptom Management 405

Original Article

Provision of Pain- and Symptom-RelievingDrugs for HIV/AIDS in Sub-Saharan AfricaRichard Harding, BSc, MSc, DipSW, PhD, Richard A. Powell, BA, MA, MSc,Fatia Kiyange, BSc, MSc, Julia Downing, RN, PhD,and Faith Mwangi-Powell, MSc, PhDDepartment of Palliative Care, Policy and Rehabilitation (R.H.), King’s College London, London,

United Kingdom; and African Palliative Care Association (R.A.P., F.K., J.D., F.M.-P.)

Kampala, Uganda

Abstract

Context. Although pain and burdensome symptoms among HIV-infected

persons can be effectively managed, the availability of opioids and other symptom-controlling drugs is a particular challenge in sub-Saharan Africa.

Objectives. This study aimed to identify current drug availability andprescribing practices in 12 sub-Saharan African countries and to examine thebarriers and potential facilitators for use of opioids and other key HIV/AIDSsymptom-controlling drugs.

Methods. This was a cross-sectional survey, integrating data from palliative carefacilities and competent authorities within ministries of health in 12 Africancountries.

Results. Of 62 responding facilities, problems were reported in accessingnamed nonopioids, with a small number of facilities unable to dispense them.Less than half the facilities were currently prescribing opioids of any strength.Further problems were identified in terms of the availability and supply continuityof named antiemetics and anxiolytics. The data identified a number of systemicproblems, suggesting that opioid supply issues are similar to less controlled drugs,such as antiemetics. Among competent authorities, there was no agreement onwhether further opioid expansion was possible. Integration of data from carefacilities and competent authorities highlighted a disparity in the understandingof the availability of specific drugs, with competent authorities naming drugs thatwere not listed by any responding facility in their respective country.

Conclusion. This study shows that opioid expansion needs to balance supplyand skills: Currently there are insufficient trained clinical personnel to prescribe,and supply is unreliable. Efforts to expand supply should ensure that they do not

This study was supported by a grant from the UnitedStates Agency for International Development(USAID) under a subagreement (number J0E-G-001), made under the authority provided toPact under Cooperative Agreement with USAID,number GPH-A-00-01-0007-00, entitled ‘‘Rapid Re-sponse Mechanism for HIV/AIDS Activities.’’ Theauthors declare no conflicts of interest.

Address correspondence to: Richard Harding, BSc, MSc,DipSW, PhD, Department of Palliative Care, Policyand Rehabilitation, King’s College London, WestonEducation Centre, London SE5 9RJ, UK. E-mail:[email protected]

Accepted for publication: January 19, 2010.

� 2010 U.S. Cancer Pain Relief CommitteePublished by Elsevier Inc. All rights reserved.

0885-3924/$ - see front matterdoi:10.1016/j.jpainsymman.2009.12.025

406 Vol. 40 No. 3 September 2010Harding et al.

weaken current systems. J Pain Symptom Manage 2010;40:405e415. � 2010 U.S.Cancer Pain Relief Committee. Published by Elsevier Inc. All rights reserved.

Key Words

HIV, pain, symptoms, Africa, drug availability

IntroductionPalliative care is concerned with the assess-

ment and relief of pain and symptoms amongpatients affected by progressive, life-limiting,incurable disease1 and is distinguished fromsupportive care by the clinical dimensions ofpain and symptom control.2 Given that painis experienced throughout the HIV disease tra-jectory,3 and that severe pain is experienced by80% of those with advanced HIV,4 the WorldHealth Organization (WHO) identified pallia-tive care as an essential component of compre-hensive HIV care.5 Additional burdensomesymptoms in advanced disease include nausea(43%e49%) and depression (10%e82%).4

The advent of antiretroviral therapy (ART)has not removed the need for effective painand symptom control, as problems persistand may be treatment-related,6,7 and otheremerging life-limiting comorbidities requirepalliative therapy as the chronic disease phaseincreases in duration.8,9

The Joint United Nations Program on HIV/AIDS (UNAIDS) estimates that there were22.4 million HIV-infected individuals in sub-Saharan Africa in 2008 and 1.4 million deaths.10

These data constitute a clear public health argu-ment for the availability of pain- and symptom-relieving drugs to enhance quality of life andensure freedom from unnecessary suffering.Most problems can be controlled with adequateclinical knowledge and drug availability, witha systematic review of outcomes under HIV pal-liative care identifying significant improve-ments in pain and symptom control andanxiety.11 However, the availability of pain- andsymptom-relieving drugs is a particular chal-lenge in sub-Saharan Africa,12,13 and theWHO/International Narcotics Control Board(INCB) has identified woefully inadequatelevels of opioid consumption.14

Furthermore, cancer is an underemphasizedissue in Africa, despite it being relatively com-mon, with the lifetime risk of dying from

cancer among females double that in devel-oped countries.15 The cancer burden in Africais predicted to greatly increase, with sub-Saharan Africa projected to account for morethan a million new cancer cases by 2020.16e18

Cancer symptom relief in sub-Saharan Africahas been relatively neglected in the literature,and research into drug availability and practicein HIV palliative care in the region providesdirect relevance for pain and symptom man-agement among patients with advanced malig-nant disease.

It is impossible to control the range of painintensity without access to the WHO PainLadder19 (Fig. 1), for example, drugs from para-cetamol (acetaminophen, a nonopioid) to co-deine (a so-called ‘‘weak’’ opioid) to morphine(a so-called ‘‘strong’’ opioid) (with adjuvantdrugs). The WHO Pain Ladder was developedin 1986 and has been validated, and researchhas suggested that those with more severe paincan be safely and effectively started at Step 3.20

Between 70% and 90% of patients with cancerpain, treated according to the three-step ladder,achieves effective analgesia.21,22

The WHO Expert Drug Committee desig-nated morphine, codeine, and other opioidsas essential drugs, that is, those that satisfythe health care needs of most populationsand that should be available at all times in ad-equate amounts and appropriate dosages. Oralopioid analgesics, such as codeine, hydromor-phone, morphine, and oxycodone, are the cor-nerstone of effective pain management. Theessential drug list has been recently reviewedand updated for palliative care by the Interna-tional Association for Hospice and PalliativeCare at the request of the WHO.23

Minimal empirical data exist describingthe availability of essential pain and keysymptom-relieving drugs (anxiolytics and anti-emetics) for HIV management in sub-SaharanAfrica. This study aimed to identify the currentavailability and prescribing practices in 12 sub-Saharan African countries and examine the

Fig. 1. The WHO Pain Ladder.19

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barriers and potential facilitators for use ofopioids and other key symptom-controllingdrugs for HIV/AIDS. This study offersevidence-based mechanisms to deliver im-proved pain and symptom relief to patientsacross sub-Saharan Africa.

MethodsStudy Design

The study used a cross-sectional survey meth-odology, collecting data from palliative careprovider facilities and ‘‘competent authorities,’’that is, those responsible for carrying out re-quired functions (including making estimatesand reporting consumption statistics) withinministries of health for each government thatis party to the Single Convention on NarcoticDrugs (1961).24 Each government that is partyto the Single Convention on Narcotic Drugsmust designate an office, called the CompetentAuthority, whose staff is responsible for carryingout the functions required by the internationaldrug control treaties. This office is often locatedin a country’s pharmaceutical department

within the Ministry of Health or in the nationaldrug control agency. The Competent Authorityis the principal national authority for ensuringthat opioid analgesics are adequately availablefor medical and scientific purposes and for sub-mitting the required documents to the INCB.Although the INCB is responsible for monitor-ing the global supply of controlled medicines,it is the responsibility of national governmentsto procure and distribute essential controlledmedicines (such as morphine) within a country.

Data were compared and integrated at thecountry and continent levels. This study wasreviewed by, and received full ethical approvalfrom, the Ugandan National Council forScience and Technology (Study Ref. HS 535).

Recruitment and Data CollectionThe study population was defined as Presi-

dent’s Emergency Plan for AIDS Relief-funded sub-Saharan African focus countries,with recruitment of all sites identified as palli-ative care facilities currently providing HIVcare using multiprofessional staff trained inpalliative care. A comprehensive list of poten-tial palliative care facilities was compiled

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from advocate member lists, databases ofknown providers, government representativesand their partners, and palliative care traininggraduates. Data collection was completed in2007.

All facilities identified as meeting the studyinclusion criteria were contacted electronicallywith the survey tools. Telephone contact de-tails were identified for facilities without elec-tronic contact details. Hard copies of toolswere printed and posted to those without ac-cess to e-mail and delivered by hand wherepossible. The competent authorities withingovernment ministries were identified througheach country’s health department and a tele-phone survey was conducted.

Survey ItemsFor the facility survey, items addressed analge-

sia and symptom control availability, prescrib-ing and dispensing, the national legislativeframework for opioid use, and challenges toopioid provision. Competent authorities’ ques-tions investigated opioid availability, essentialdrug lists, legislative restrictions, and currentchallenges.

Data Processing and AnalysisData were entered into SPSS V.12� (SPSS

Inc., IBM, Chicago, IL) for checking, cleaning,and analysis. For quantitative items, descriptivestatistics were reported. Where open-endedquestions had been asked, post hoc codingframes were developed to present data themat-ically.25 The funder had no role in analysis.

ResultsPalliative Care FacilitiesSample Characteristics. Sixty-two facilities partic-ipated, a response rate of 61%, with responsesfrom the following countries: South Africa,n¼ 27 (43.5%); Uganda, n¼ 8 (12.9%);Zambia, n¼ 8 (12.9%); Kenya, n¼ 6 (9.7%);Tanzania, n¼ 4 (6.5%); Nigeria, n¼ 3 (4.8%);and one response from each of the followingcountries: Botswana, Cote d’Ivoire, Ethiopia, Mo-zambique, Namibia, and Rwanda (1.6% of thesample each). This was broadly representativeof sub-Saharan African palliative care activity atthe country level.

The facilities categorized themselves as a ter-tiary specialist palliative facility (e.g., hospice)

n¼ 22 (35.5%); a nongovernmental organiza-tion offering a number of services includingpalliative care (i.e., integrated care) n¼ 35(56.4%); or as a governmental facility at eitherthe primary or the secondary level (e.g., hospi-tal or clinic) or as part of the state facilitynetwork n¼ 5 (8.1%).

Pain and Symptom Control Prescribing and Dispens-ing. Thirty-six (58.1%) facilities were cur-rently dispensing opioids, dispensed in thefollowing formulations: oral liquid n¼ 29(46.8% of all sites); tablets n¼ 20 (32.3%);and injectable n¼ 17 (27.4%). The drugs pre-scribed for each step of the WHO ladder andfor specific symptoms are described in Table 1;the number of times each drug was reported islisted after the drug name.

Of the Step 1 analgesics named, 156 of 180were dispensed on site. Forty-two facilities indi-cated that Step 1 analgesics were available100% of the time; the remaining seven rangedfrom only 10% to 95% (nine missing). Of theStep 2 analgesics named, 52 of 73 were dis-pensed on site. Twenty-one facilities indicatedthat Step 2 analgesics were available 100% ofthe time; the remaining seven ranged fromonly 10% to 75% (15 missing). Of the Step 3analgesics named, 45 of 69 were dispensedon site. Twenty-eight facilities indicated thata Step 3 analgesic was available 100% of thetime; the remaining seven ranged from only5% to 90% (eight missing). Therefore, al-though the majority had access on site toStep 1 analgesics, fewer had access to Step 2and 3 analgesics. However, those that listedStep 2 also were likely to have Step 3.

Of the antiemetics listed, 81 of 109 nameddrug responses indicated that they were dis-pensed on site. Seventy responses indicatedthat the drug was available to be dispensed100% of the time; the remaining 32 rangedfrom only 20% to 90% (seven missing). Ofthe agents listed for the management of neu-ropathic pain, 68 of 90 of the named drugswere dispensed on site. Sixty-three responsesindicated that neuropathic pain agents wereavailable to be dispensed 100% of the time;the remaining 20 ranged from only 5% to95% (seven missing). Of the anxiolyticsnamed, 51 of 71 were dispensed on site.Forty-one responses indicated that anxiolytics

Table 1Analgesics, Antiemetics, and Anxiolytics Prescribed

Step 1 (Nonopioid) Step 2 (Weak Opioid) Step 3 (Strong Opioid) Antiemetics Management of Neuropathic Pain Anxiolytics

Drug name prescribedNSAIDs (88) Codeine (33) Morphine (57) Metoclopramide (44) Amitriptyline (34) Benzodiazapine (48)Paracetamol (64) Dihydrocodeine (11) Pethidinea (6) Phenothiazines (19) Carbamazepine (19) Lorazepam (11)Aspirin (22) Tramadol (14) Fentanyl (7) Haloperidol (18) Phenytoin (9) Amitriptyline (5)Nimesulide (4) Dextropropoxyphene (6) Levallorphan (1) Cyclizine (10) Vit B (7) Haloperidol (4)Tricyclic (3) Antiepileptics (1) Pentazocine (1) Promethazine (9) Steroid (5) Chlorpromazine (2)Benzodiazipine (1) Co-dydramol (1) Valdecoxib (1) Meclizine (1) Gabapentin (4) Phenothiazine (1)Steroids (2) Antidepressant (1) Tilidine (1) Ondansetron (4) Tricyclic antidepressant (3)Cyclofenal (1) Coproxamol (1) Methadone (1) Trimethobenzamide (1) Phenothiazine (2)Hyoscine (1) Domperidone (1) Morphine (2)Cyproheptadine (1) Dexamethasone (1) NSAID (2)Menthol (1) Paracetamol (1)

Haloperidol (1)Benzodiazapine (1)

No response, n¼ 4 No response, n¼ 19 No response, n¼ 19 No response, n¼ 13 No response, n¼ 18 No response, n¼ 17

Total¼ 188 drug responses Total¼ 73 drug responses Total¼ 69 drug responses Total¼ 109 drug responses Total¼ 90 drug responses Total¼ 71 drug responses

This question had a multiple answer format, for each drug category.NSAIDs ¼ nonsteroidal anti-inflammatory drugs.aPethidine is identical to meperidine.

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were available 100% of the time; the remaining16 ranged from only 1% to 95% (14 missing).

Government, Country, and Policy Context forOpioids. Each responding facility identifiedthe main factors hampering opioid provisionwithin their country. The data demonstratethat, although some countries (e.g., Uganda)have made advances in opioid provision in com-parison to others,26 there is a remarkable simi-larity in the identified factors hamperingopioid provision. The responses were catego-rized as follows: 1) supply, that is, challengesin obtaining medications from import to dis-pensing (e.g., stores do not stock the drugs,overly tight control, unreliable stocks, and fewdispensers); 2) legislation, for example, regula-tions requiring seven-day only prescribing, lackof national policy on opioid use, and bureau-cratic processes; 3) education, for example, ex-isting clinicians do not know how to assess andtreat pain, fear of opioid addiction, poor patientcompliance, palliative care profession stressesspecialty to the point of exclusion, and doctorsare less interested in dying patients; and 4) prac-tical and logistical challenges, for example,costs to facilities, storage requirements, notenough prescribers, inadequate staff in home-based care (HBC), poor infrastructure to followpatients at home, and relatively short shelf lifeof morphine.

Opioid Training, Expanding Access, and CurrentChallenges. In terms of assisting more pro-viders in accessing opioids, the recommenda-tions were categorized as follows: 1) advocacyat government and public levels on the needfor opioids and on lifting restrictive legislation;2) collaboration with prescribing doctors,across all levels of care, and with hospital phar-macies; 3) training in pain assessment andmanagement, in all curricula, on palliativerather than supportive care, and a shorter

Table 2Comparison of Competent Authorities a

Morphine Pethidine Codeine Tramadol N

Kenya (n¼ 6) � U � X � U � XEthiopia (n¼ 1) � X � X � XTanzania (n¼ 4) � U U � U U

Uganda (n¼ 8) � U � U U

Namibia (n¼ 1) � X � X � X

� ¼ noted by Competent Authority as present in country; U¼mentioned by

course for prescribing; and 4) coverage to ru-ral and HBC services.

With respect to potential challenges to expan-sion, the identified difficulties were categorizedas follows: 1) political: achieving sufficient moti-vation; 2) educational: challenging myths,teaching that HIV requires Step 3 pain manage-ment, and achieving medico-cultural change;and 3) resources: time for doctors to prescribe,drug costs, storage facilities, number of pharma-cists, supply breaks, building up rural services,and the number of prescribers.

Current Challenges in Purchasing, Producing,Dispensing, and Prescribing Opioids. Finally, re-spondents described current challenges in thepurchasing, production, dispensing, and pre-scribing of opioids. The purchasing challengeswere summarized as overwhelming cost becauseof new government taxes, expense and scarcityof opioids, single source of supply, lack of fundswithin facilities, unreliable supply, distances,and too many restrictions. The production chal-lenges were summarized as no morphine pro-duced because of government embargo, hardto produce and source enough because of ex-panding patient base, and lack of pharmacists.The dispensing challenges were summarizedas restrictions to hospitals and hospices meanpatients do not get drug access, substantial de-lays between scripts and dispensing, and lackof pharmacists. The prescribing issues weresummarized as being the sole prescriber, heavyrestrictions, professionals do not know how toprescribe, lack of education, refusal to prescribefor children, lack of rural staff, and gross under-use because of fears and myths.

Competent Authority Representative DataDespite significant efforts over a period of

eight months, five interviews were achieved.This was, in large part, because of considerableconfusion within ministries as to whom the

nd Site Data: Opioid Availability

itrazepam Methadone Fentanyl Tilidine Etorphine

� U

� X� X

� X � X � X

at least one facility in country; X¼ not mentioned by any facility.

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appropriate person was and lack of contact de-tails for the identified individual. Interviewswere achieved with the Competent Authorityfor Ethiopia, Kenya, Namibia, Tanzania, andUganda.

Current Opioid Supply and Regulatory System. Allfive competent authorities stated that opioidswere currently on their respective country’s es-sential drugs list and available in country forpain relief. It is notable that most competentauthorities were satisfied with the functioningof the current regulatory system, contrary toprovider data. Competent authorities also felt(with the exception of Uganda) that therewere currently adequate numbers of opioidproviders. An important finding from thisdata is that competent authorities felt thatthey may not be able to offer adequate regula-tion and monitoring for increased numbers ofproviders, and the skills of those alreadyprescribing opioids were questioned.

Comparison of Facility and CompetentAuthority Data

The data from competent authorities andthe data from care facilities were integratedand compared to appraise the congruity oftheir perspectives on opioid availability(Table 2). It is noteworthy that although theEthiopian Competent Authority reported thatopioids were available in the country, thecare facility reported that while opioids wereon the essential drugs list, they were not avail-able anywhere. In every country without excep-tion, the Competent Authority cited specificopioids that they believed to be available inthe country and that were never cited by anyfacility within that country.

DiscussionOur data offer important recommendations

for opioid expansion for the improved medicalmanagement of people living with HIV/AIDSin sub-Saharan Africa. Palliative care is deliv-ered in an increasingly diverse range of set-tings, with the potential for generalistpalliative care to be rolled out for greater cov-erage than the specialist care, which offers ex-pert management of complex cases. Opioidexpansion is important because it is not

possible for specialist hospice services to carefor all patients requiring palliative care, andall integrated services should be able to offeradvanced disease care (e.g., HIV and cancer,including opioids) for those who need it,with referral for complex cases to specific care.

With respect to Step 1 analgesics, it is con-cerning that a significant number of respon-dents reported problems in accessing Step 1analgesics. These are the least complex interms of prescribing, legislative bureaucracyand control, and so challenges suggest an in-ability to even begin to use the WHO ladder.Also, a small number of sites were unable todispense Step 1 analgesics. The prevalence ofpain and lack of policy restraints suggest thatany site should be able to provide Step 1 anal-gesia. Regarding Steps 2 and 3 analgesics, bothwere dispensed by fewer sites and supply wasan increasing challenge. Less than half the fa-cilities were currently prescribing opioids ofany strength. It is noteworthy that a quarterof sites stocked injectable morphine, which isa less feasible approach to sustained manage-ment of severe pain when most palliative careis home based.

The sample represents diverse countries interms of progress toward opioid availabilityfor a true public health approach to palliativecare provision, from the well-recognized Ugan-dan experience, the governmental/hospicelinks across South Africa, to the challenges ofEthiopian prescribing legislation. However, de-spite these significant differences, the data of-fer common themes to guide a strategicapproach to opioid scale-up. To aid identifica-tion of feasible and appropriate strategies foropioid expansion, the data have been inte-grated to demonstrate the commonalitiesacross themes and countries (Fig. 2).

Neuropathic pain is a common, distressing,and challenging presentation among peoplewith HIV disease and can be a result of the un-derlying disease or a side effect of ART. Effectivedrugs, such as gabapentin, are expensive, andthis is reflected in the low number of servicesthat cited its use. Antiemetics and anxiolyticsare also essential drugs in the management ofpatients with HIV disease in the era of ART,and further problems were identified in termsof availability and supply continuity. Althoughopioids often have an anxiolytic effect, anxio-lytics and antiemetics should always be available

Fig. 2. Challenges and responses: data integration.

412 Vol. 40 No. 3 September 2010Harding et al.

for patients with advanced disease. The dataidentify a number of systemic problems, sug-gesting that opioid supply issues are similar toless controlled drugs such as antiemetics.Therefore, although lobbying for opioid avail-ability is essential, the issues speak to drug sup-plies across the formulary. It was illuminatingto compare the data from the provider sample

with the competent authorities. Although thiscould only be conducted for five countries,the contrast in the data suggests conflicting un-derstanding of the current provision of opioids.

First, despite the need to lobby governmentsand achieve policy, legislative and bureaucraticchange, it was extremely difficult to identifyand then make contact with appropriate

Vol. 40 No. 3 September 2010 413Pain- and Symptom-Relieving Drugs in Sub-Saharan Africa

competent authorities in most countries.Second, competent authorities felt that cur-rent bureaucratic process works well, andthat there were adequate numbers of pro-viders. Third, it is important to recognizethat any expansion in opioid availability carriesimplications for the regulatory bodies (i.e., theMinistry), and these resource restrictions werenoted by the respondents. There was no agree-ment on whether further opioid expansionwas possible. The regulatory and legislativeframeworks were described by competent au-thorities as ‘‘enabling,’’ with some reportingconcerns about the competence of existingprescribing staff.

However, despite these concerns, it shouldbe noted that there were important areas ofcongruence between care sites and competentauthorities. These included recognition thatlegislation has caused a reluctance to prescribeopioids, the need to review medical trainingcurricula, and a need for an increase in medi-cal school intake.

The limited availability of drugs was a con-stant theme throughout the data. However,the integration of data from care facilitiesand competent authorities highlights a dispar-ity in the understanding of the availability ofspecific drugs. In every country, the competentauthority named a drug that was not listed byany responding facility in that country. It maybe that the low number of respondents insome countries led to an underreporting ofsome drugs at sites, but these sites were identi-fied as the most prominent and accessible pal-liative care providers, suggesting undersupply.

There are several limitations to our findings.First, the lists of potential contacts may haveexcluded a number of providers but was com-posed of every service known to the funders,sub-Saharan African palliative care researchgroups, and the African Palliative Care Associ-ation (APCA), and we believe that it was aninclusive and exhaustive recruitment proce-dure. Second, significant difficulties were ex-perienced in the data collection phases,mainly logistical challenges (including failingpower, telecommunications, and unobtainablecontacts) that may have reduced the responserate. Moreover, the significant challenges ofundertaking primary research in Africa, whichare well recognized,27,28 were compounded byour aim of collecting data in 12 countries. The

low number of palliative care providers andpatchy coverage13 disallow the potential togeneralize from a randomly selected sample,and, therefore, we attempted to contact allknown services. Third, a high proportion of re-spondents were from South Africa (43.5%),where palliative care provision is relativelywell developed in some parts. However, therewere an insufficient number of operationalfacilities in other countries to conduct an analy-sis by country. Fourth, we recognize that all datawere self-reported and, therefore, may describea best-case scenario. The large-scale study didnot allow data verification by researchers. Lastly,we acknowledge that in South Africa, opioidsare ‘‘essential drugs’’ and, as such, are expectedto be available in public health care facilities.The scope of this exercise did not allow all pub-lic care facilities to be included and focuses in-stead on the perspective of palliative care sites.

ConclusionA key finding is that, although there are

common issues raised by sites and competentauthorities, it is clear that these key stake-holders have concerns regarding the potentialroll out of opioids. A number of practical rec-ommendations have been offered to enhancepain and symptom relief, as strategies that tar-get change in the domains of education, re-sources, bureaucracy, legislation, and clinicalpractice cannot achieve their goal in isolation.

We also can offer a concrete example ofadvocacy activity to enhance opioid availability.The APCA has held a number of workshops indifferent African regions. The aims of themeetings are threefold: 1) improve partici-pants’ knowledge of the policies, tools, andinfrastructure necessary to make opioids avail-able; 2) support participants in evaluatingtheir country-specific drug policies and lawson opioid availability; and 3) support partici-pants in developing tangible advocacy actionplans that can facilitate the accessibility to,and availability of, opioids. Work developmentplans were generated by participants, and invi-tees’ professional designations were carefullyconsidered to maximize potential to catalyzechange: senior/chief pharmacists; a drug regu-latory authority and/or Competent NationalAuthority representative; a National Registrar

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of Drugs; a Pharmacy Board/Council repre-sentative; Ministry of Health clinical servicespersonnel; actively engaged palliative care pro-viders; heads of national palliative care associa-tions; senior physicians and/or senior nursesfrom teaching institutions such as universityteaching hospitals; representatives from thedrug enforcement agencies; and heads of re-spective oncology and/or HIV/AIDS treat-ment units. This approach builds on previouswork reviewing evidence and outcomes forpalliative care in sub-Saharan Africa that hasidentified the need to balance quality and cov-erage.13 This study shows that opioid expan-sion needs to balance supply and skills: thereis currently insufficient staff to prescribe, sup-ply is unreliable, and any efforts to expandsupply should ensure that it does not weakencurrent systems.

AcknowledgmentsThe authors are grateful to the United States

Agency for International Development forfunding; the Palliative Care Technical WorkingGroup of the Office of the U.S. Global AIDSCoordinator; Liz Gwyther, Chief ExecutiveOfficer, Hospice Palliative Care Association ofSouth Africa; and Julie Chitty, former palliativecare advisor, Regional HIV/AIDS Program,South Africa, who gave useful input and com-ments on protocol drafts; all the sites and com-petent authorities that participated; and LucyBradley for manuscript management.

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