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Pharmacies as providers of expanded health services for people who inject drugs: a review of laws, policies,… Hammett, Theodore M; Phan, Son; Gaggin, Julia; Case, Patricia; Zaller, Nicholas; Lutnick, Alexandra; Kral, Alex H; Fedorova, Ekaterina V; Heimer, Robert; Small, Will; Pollini, Robin; Beletsky, Leo; Latkin, Carl; Des Jarlais, Don C Jun 17, 2014

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CORRESPONDENCE Open AccessPharmacies as providers of expanded healthservices for people who inject drugs: a review oflaws, policies, and barriers in six countriesTheodore M Hammett1*, Son Phan2, Julia Gaggin3, Patricia Case3, Nicholas Zaller4, Alexandra Lutnick5, Alex H Kral5,Ekaterina V Fedorova6, Robert Heimer7, Will Small8,9, Robin Pollini10, Leo Beletsky11, Carl Latkin12and Don C Des Jarlais13AbstractBackground: People who inject drugs (PWID) are underserved by health providers but pharmacies may be theirmost accessible care settings.Methods: Studies in the U.S., Russia, Vietnam, China, Canada and Mexico employed a three-level (macro-, meso-,and micro-) model to assess feasibility of expanded pharmacy services for PWID. Studies employed qualitative andquantitative interviews, review of legal and policy documents, and information on the knowledge, attitudes, andpractices of key stakeholders.Results: Studies produced a mixed assessment of feasibility. Provision of information and referrals by pharmacies ispermissible in all study sites and sale and safe disposal of needles/syringes by pharmacies is legal in almost all sites,although needle/syringe sales face challenges related to attitudes and practices of pharmacists, police, and otheractors. Pharmacy provision of HIV testing, hepatitis vaccination, opioid substitution treatment, provision of naloxonefor drug overdose, and abscess treatment, face more serious legal and policy barriers.Discussion: Challenges to expanded services for drug users in pharmacies exist at all three levels, especially themacro-level characterized by legal barriers and persistent stigmatization of PWID. Where deficiencies in laws, policies,and community attitudes block implementation, stakeholders should advocate for needed legal and policy changesand work to address community stigma and resistance. Laws and policies are only as good as their implementation, soattention is also needed to meso- and micro- levels. Policies, attitudes, and practices of police departments andpharmacy chains as well as knowledge, attitudes, and practices of individual PWID, individual pharmacies, and policeofficers should support rather than undermine positive laws and expanded services. Despite the challenges, pharmaciesremain potentially important venues for delivering health services to PWID.BackgroundAlmost 150 countries on all continents had reportedinjection drug use by 2007 and 120 of these had reportedrelated HIV infections [1]. According to estimates for2010–2011, HIV prevalence among the 14–16 millionpeople who inject drugs (PWID) worldwide is 12% withwide variation across regions [2,3]. Injection drug use isdriving HIV epidemics in many countries in Asia, theMiddle East, and Eastern Europe and there are continuingepidemics of HIV and other parenterally transmitted vi-ruses such as hepatitis C among PWID in many locationsworldwide [4-6]. In many countries, controlling HIV/AIDS and hepatitis epidemics depends on reducing trans-mission among PWID and other people who use drugs.For various reasons including widespread stigma anddiscrimination, people who use drugs are generallyunderserved by and/or reluctant to visit traditionalhealth providers – physicians, health clinics, and hospi-tals [7]. In developed countries, many drug users rely onparamedic and/or emergency room care when they areseriously ill, suffer overdose, or experience other health* Correspondence: ted_hammett@abtassoc.com1Abt Associates Inc., Cambridge, MA 02138, USAFull list of author information is available at the end of the article© 2014 Hammett et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the CreativeCommons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, andreproduction in any medium, provided the original work is properly credited. The Creative Commons Public DomainDedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article,unless otherwise stated.Hammett et al. BMC Health Services Research 2014, 14:261http://www.biomedcentral.com/1472-6963/14/261problems. In both developed and developing countries,pharmacies are a type of health facility that is commonlyaccessed by drug users but their use is often limited tothe purchase of needles/syringes and other items relatedto drug injection [8-10]. Because drug users frequentlyvisit pharmacies there is the potential for pharmacies toprovide expanded health services for them [11].To assess the potential for pharmacies to become venuesfor expanded health services for PWID, including servicesrelated to HIV/AIDS, hepatitis, and substance use preven-tion and treatment, the National Institute on Drug Abuse,U.S. National Institutes of Health funded linked grantsfrom a consortium of investigators from six sites in fourcountries – the United States (Boston, Providence, andSan Francisco), Russia (St. Petersburg), Vietnam (Ha GiangCity), and China (Xichang, Sichuan Province) – to conductmixed-methods feasibility studies. These sites were se-lected to provide a range of geographic settings and per-ceived attitudes towards harm reduction and otherservices for drug injectors.The feasibility studies were carried out between 2009 and2012 with investigators conducting similar studies in Van-couver, Canada and Tijuana, Mexico joining the researchgroup in 2011, bringing the number of countries repre-sented to six and the number of sites to eight. Table 1 pre-sents basic statistics on the epidemics of injection drug useand HIV in these eight sites.The projects aimed to assess current pharmacy servicesand the potential for their expansion and to identify bar-riers to and facilitators of such expanded services. Thesefactors included pharmacists’ attitudes and possible inter-ference from law enforcement and policy makers. In thispaper, we assess further the feasibility of pharmacies toimplement expanded services for PWID based on the legaland policy frameworks of the six countries and other inhi-biting and facilitating factors.MethodsThe multi-site feasibility studies of expanded pharmacy ser-vices for drug users employed mixed methods: qualitativeand quantitative interviews with key stakeholders in health,police, and other sectors, including government officials,health care providers, pharmacists, and PWID, as well asreview of relevant legal and policy documents and literaturein the field.Table 1 Injection drug use, HIV, and research methods in study sitesSite Est. n PWID Predominantinjected drug(s)Est. HIV prevalenceamong PWIDEst. % of HIV infectionsattributable to drug useMethodsOriginal sites funded under linked NIDA grantsBoston 10,064a heroin 4.5%b-8.4%c 9%d Formative research, qualitativeinterviews, quantitative surveys,review of legal andpolicy documentsProvidence 2,137a opiates 5.3%b 6%eSan Francisco 17,000 heroin,methamphetamine12% 22%fHa Giang, Vietnam 1,000 heroin 18% >50%St. Petersburg, Russia 83,000g heroin 44%-59%h 76%Xichang, China 2,250 heroin 18% 60%Additional sitesTijuana, Mexico 6,400-10,000 heroin, heroin/methamphetamine4%i 12% Focus groups, quantitativesurvey, review of legal andpolicy documentsVancouver, Canada 10,000-15,000 Cocaine, heroin,methamphetamine17% (2006) 18% (since 2008) Ongoing ethnographic andqualitative research, reviewof legal and policy documentsaBased on methods in Brady JE, Friedman SR, Cooper HL, Flom PL, Tempalski B, Gostnell K. Estimating the prevalence of injection drug users in the U.S. andin large U.S. metropolitan areas from 1992 to 2002. J Urban Health 2008, 85: 323–351.bTempalski B, Lieb S, Cleland CM, Cooper H, Brady JE, Friedman SR. HIV prevalence rates among injection drug users in 96 large US metropolitan areas,1992–2002. J Urban Health 2009, 86: 132–154.cNational Health Behavior Survey, 2009.dCases reported in 2010, from Massachusetts Department of Public Health, 2012 Epidemiological Profile.eCases reported 2008–2010, from Rhode Island Department of Public Health, 2010 Epidemiological Profile.fNewly reported cases in 2010, includes PWID and MSM/PWID.gHeimer R, White E. Estimation of the number of injection drug users in St. Petersburg, Russia. Drug Alcohol Dependence 2010, 109: 79–83.hNiccolai LM, Shcherbakova IS, Toussova OV, Kozlov AP, Heimer R. The potential for bridging of HIV transmission in Russian Federation: sex risk behaviorsand HIV prevalence among drug users (DUs) and their non-DU sex partners. J Urban Health 2009, 86(Suppl 1): 131–143; Eritsyan K, Heimer R, Barbour R,Odinokova V, White E, Rusakova MM, Smolskaya TT, Levina OS. Individual-, network-, and city-level factors associated with HIV prevalence among peoplewho inject drugs in eight Russian cities. BMJ Open, In press.IStrathdee SA, Lozada R, Ojeda VD, Pollini RA, Brouwer KC, Vera A, Cornelius W, Nguyen L., Magis-Rodriguez C, Patterson TL, Proyecto El Cuete. Differentialeffects of migration and deportation on HIV infection among male and female injection drug users in Tijuana, Mexico. PLoS One 2008,3(7):e2690.doi:0.1371/journal.pone.0002690.Hammett et al. BMC Health Services Research 2014, 14:261 Page 2 of 11http://www.biomedcentral.com/1472-6963/14/261The original NIDA grants supported formative study,qualitative interviews, and quantitative surveys in the six ori-ginal sites. The formative study described the IDU and HIVepidemic situations. Qualitative interviews were then con-ducted with PWID and key informants from legal, publichealth, and pharmacy systems and quantitative face-to-facesurveys were conducted among PWID and pharmacists. Alldata collection investigated current HIV and substanceabuse services for PWID and the needs for additional ser-vices, explored perceptions of pharmacists regarding newservices for PWID, and identified barriers to pharmacy par-ticipation in health-related interventions for PWID, includ-ing possible interference from law enforcement and policymakers. To explore further the enabling environment forpotentially expanded pharmacy-based interventions, eachsite investigator reviewed relevant legal and policy docu-ments and corporate policies of pharmacy chains bearingon the implementation of the expanded services identifiedin the feasibility studies. The site investigators also providedinformation from their own knowledge on street-level prac-tices that conform to or contradict the laws and policies ofgovernments and pharmacy chains.Investigators in the additional sites employed slightlydifferent methods. In Tijuana, information was obtainedthrough focus group discussions and a quantitative survey,as well as review of legal and policy documents. InVancouver, review of relevant legal and policy documentsand ongoing ethnographic and qualitative research by thesite investigator were used.To inform further the analysis of these data, we adapteda conceptual framework based on elements proposed byRhodes [12,13] and Burris [14]. This framework consistsof three levels, defined as follows: Macro level: Laws and policies governing pharmacyoperations and procedures; overall legal frameworkon drugs and drug paraphernalia; attitudes of thegeneral community; Meso level: Attitudes, policies and practices ofpharmacy chains and police agencies; and Micro level: Behavior and attitudes of individualpharmacies/pharmacists, police officers, and peoplewho inject drugs.ResultsThe feasibility studies found that the following types ofservices were most desired by PWID and most likely tobe offered by pharmacies in the future: expanded nee-dle/syringe sales and distribution; safe disposal of usedneedles/syringes; HIV testing; hepatitis B and other vac-cinations; methadone maintenance and/or other opioidsubstitution treatment; provision of naloxone for over-dose prevention and rescue; skin abscess prevention andtreatment; brief counseling and informational materials;and referrals to HIV/AIDS, substance abuse treatment,and other services.Table 2 summarizes the government laws and policiesin the six countries that are most relevant to each of theproposed expanded services. Table 3 summarizes phar-macy chains’ policies in the sites where such chains existand information on their policies was available: Boston,Providence, San Francisco, Vancouver, and St. Petersburg.Needle/syringe sales without prescription are legal in allstudy sites, but several have experienced practical barriersto implementation including attitudes and behaviors ofindividual pharmacies, even if the law or their chainsauthorize sales. In Vietnam, a female injector said thatpharmacy sellers should be hospitable, because…IDUsare usually ashamed… If you’re not a hospitablepharmacy seller, then here come a bad IDU [and] he/she could shout at you …–49 year-old ethnic femalePWID, injecting for 11 yearsIn Tijuana, where pharmacy sales of needles/syringesare legal, focus group discussions with PWID revealed thatmany pharmacies refused to sell needles/syringes due tonegative attitudes towards drug users, fear that PWID be-havior would drive away other customers, and concernabout police response [15]. In a “buy study”, only 28% ofattempted purchases by “mystery shoppers” were success-ful [16]. Tijuana PWID noted the unpredictability andinconsistency of pharmacy sales and the commonly nega-tive attitudes of pharmacy workers:I mean it can’t be distinguished as one pharmacy oranother, the one that does sell to you and the one thatdoesn’t. You go into the pharmacy and there are timeswhen it does sell to you and others when it doesn’t. –Male focus group participant.[W]e’re “tecatos”,….we’re junkies and drug addicts,many pharmacies don’t want to sell it to you…. I’venoticed by how they look at us. –Female focus groupparticipant.In San Francisco, under a Disease Prevention Demonstra-tion Project (DPDP), participating pharmacies may sell upto 30 needles/syringes at a time but a “buy study”, carriedout as part of the feasibility study presented in this paper,revealed inconsistent compliance with program provisionsincluding outright refusals to sell and varying minimumnumbers of needles/syringes required for purchase [17].In St. Petersburg, Russia, a syringe “buy study”, alsoconducted as part of the pharmacy feasibility study in onecentral and one peripheral district of the city, found thathalf of the pharmacies that refused to sell syringes toresearch staff nonetheless reported in a telephone surveythat they stocked syringes [18].Hammett et al. BMC Health Services Research 2014, 14:261 Page 3 of 11http://www.biomedcentral.com/1472-6963/14/261Table 2 Government laws and policiesSites:Interventions:US (Boston) US(Providence)US (San Francisco) Canada(Vancouver)Mexico (Tijuana) Vietnam (HaGiang)China (Xichang,Sichuan)Russia (St. Petersburg)Needle &syringe sales/distributionMGL ch 94C,sec 27, 27A,32 L: authorizespharmacy saleswithoutprescription atdiscretion topeople 18 orolder with nolimits onquantityPharmaciesmay sell atdiscretion; nolimits onquantity.Non-prescriptionsales legal (up to 30)but requires localapproval andpharmacistenrollment indisease preventiondemonstrationproject (DPDP).Pharmacy saleslegal.Sale at pharmacieswithout aprescription is legal.Retail non-prescription sale islegal; redemption ofvouchers for freeneedles & syringesalso legal.Non-prescriptionsale is legal.Non-prescription sale is legal;but pharmacies not requiredto stock.Needle &syringedisposalMGL ch 111,sec 127A:prohibitsimproperdisposal. Thereare no legalbarriers topharmaciescollectingwaste forproper disposal.No legal barrierto pharmaciesmaintainingsharpscontainers.Sharps must bedisposed inapproved containerand transported tocollection center; nolegal barriers tosharps containers inpharmacies;information on safedisposal required tobe provided withneedle/syringe salesunder DPDP;participatingpharmacies mustprovide safedisposaloptions.No legal barriersto pharmaciescollecting usedneedles/syringes.Any facilities(includingpharmacies) thatgenerate at least25 kg of biologic/infectious waste permonth are requiredto dispose ofsyringes and othersharps in apuncture-proof con-tainer. Unclear whatrules apply to phar-macies generatingless than 25 kg permonth.Not provided for inLaw on Pharmacy(2005); butOrdinance onPrivate Medical andPharmaceuticalPractice (Feb 25,2003) authorizesthose certified asprivate medicalpractitioners(including thosewith pharmacydegrees) to provideprimary health careand HIV preventionservices (Art. 18).Needleexchange anddisposal centercan be set up inlocal CDC,medicalinstitutes orother locations.No legal barriersfor pharmaciesto providesharpscontainers.Federal Law #128 (August 8, 2001)requires a license for collection,storage, or disposal of hazardouswaste (including used needles & syringes).HIV testing There iscurrently nostanding orderfor pharmaciststo conduct HIVtesting.Pharmaciesneed CLIAwaiver to offerfinger pricktesting.Persons withrequired training &certification mayperform rapid HIVtests; regulationswould need to bemodified to allowpharmacies to drawblood, but not iftesting was done byan outsideorganization.Provincialrequirements forpre-/post-testcounseling mayconstrainpharmacy-basedtesting.Cheek-swab testspossible but noblood may bedrawn or handled atpharmacies.Not provided for inLaw on Pharmacy(2005); may bepermitted byOrdinance onPrivate Medical andPharmaceuticalPractice (Art. 18), ifpharmacies can beconsidered medicalestablishments.Only local HIV/AIDS preventionagencies may dotesting;pharmacies notincluded.Decree #1081 (December 22, 2011)on licensing of pharmacies does notallow pharmacies to conduct HIVtesting; additional license for medicalpractice is required (FL #128 ofAugust 08, 2011; Decree #30 ofJanuary 22, 2007).Hammettetal.BMCHealthServicesResearch2014,14:261Page4of11http://www.biomedcentral.com/1472-6963/14/261Table 2 Government laws and policies (Continued)HBV/othervaccinationCritical adultvaccinationspermitted bypharmacistsfollowingappropriatetraining.No legalbarriers; othervaccinationsalreadyavailable inpharmacies.HBV vaccinationrequired forchildren; Personswith requiredtraining andcertification mayprovide vaccination.No legal barriersto pharmaciesproviding HBVor othervaccinations.However, itwould requirestaff who haveappropriatetraining, andadequatestaffing levels.The law does notpermit vaccinationsat pharmaciesunless the staff hasthe propercertification, such asa nursing degree.Not provided for inLaw on Pharmacy(2005); may bepermitted byOrdinance onPrivate Medical andPharmaceuticalPractice (Art. 18) ifpharmacies can beconsidered medicalestablishments.Vaccination isnot allowed inpharmacies.Vaccinationrequires licensedmedical doctor,medical assistant,or nurse andinfrastructure tostore vaccine.Decree #1081 (December 22, 2011)on licensing of pharmacies doesnot allow pharmacies to providevaccinations; additional license formedical practice is required (FL #128of August 08, 2011; Decree #30 ofJanuary 22, 2007).MMT/OST Federallyregulated;methadone fordrug treatmentcannot bedispensed inpharmacies.Federallyregulated;methadone fordrug treatmentcannot bedispensed inpharmacies.Office-basedphysicians canprescribemethadone andprescriptions aretreated like anyother but mostpharmacies are notequipped to dodaily dosing.Pharmacies candispensemethadone, butregulationsrestrictprescription.Methadone is a“Control 1” drugthat requires aprescription limitedto one-time admin-istration, which ef-fectively bars dailydosing, and “Control1” drugs can onlybe handled bymajor medicalinstitutions.Prohibited by Lawon Pharmacy (2005)Article 26.2 becausemethadone is listedas a habit-formingdrug, which phar-macies are prohib-ited fromdispensing.Methadone isstrictly controlledand can only bedispensed ingovernmentapproved drugtreatmentcenters. It cannotbe dispensed inpharmacies.Methadone is included in List Iof forbidden psychoactive agents(FL on narcotics and psychoactiveagents of December 10, 1997).Naloxone/overdoseprevention/rescuePharmaciesmay dispensethroughstandingorders; trainingis needed onnasal delivery.Pharmaciesmay dispensethroughcollaborativepracticeagreementsLimited liability forlicensed healthprovidersprescribing and/ordistributingnaloxone.Regulatorybarriers makenaloxoneunavailable toindividualsthroughprescription.Pharmacies stocknaloxone as a“Control 3” drugthat requires aprescription thatmay be filled 3times and expires in6 months.Not provided for inLaw on Pharmacy(2005); may bepermitted byOrdinance onPrivate Medical andPharmaceuticalPractice (Art. 18), ifpharmacies can beconsidered medicalestablishments.Naloxone canonly bedispensed inmedical facilities.Print materialson overdoseprevention canbe provided inpharmacies.Decree #2199-r (December 7, 2011):naloxone is on the list of vitallynecessary and most essentialmedications; but only medicalfacilities are allowed to dispenseand administer and to provideCPR if needed.AbscesstreatmentNot currentlyavailable butno legalbarriers toprovidinginformation.Pharmaciescannot providemedical orclinical caresuch as cuttingand draining.Not currentlyavailable butno legalbarriers toprovidinginformation.Pharmaciescannot providemedical orclinical caresuch as cuttingand draining.No legal restrictions. No legal barriers. No legal barriers,but only minorwounds may betreated at apharmacy.Perforation orcutting of any sortin order to treat anoriginal wound notpermitted.Not provided for inLaw on Pharmacy(2005); may bepermitted byOrdinance onPrivate Medical andPharmaceuticalPractice (Art. 18), ifpharmacies can beconsidered medicalestablishments.Pharmacies canprovide printmaterials only.Pharmacies can provide information andmedications.Hammettetal.BMCHealthServicesResearch2014,14:261Page5of11http://www.biomedcentral.com/1472-6963/14/261Table 2 Government laws and policies (Continued)Briefcounseling/materialsNo legalbarriers exceptto substanceabusetreatmentcounseling,which iscovered bystateregulationsNo legalbarriers.No legal barriers;DPDP participatingpharmacies requiredto provide healthinformation withneedle & syringesalesNo legal barriers. No legal barriers. Should bepermissible.Should bepermissible.Pharmacies can provide such information.Referrals No legalrestrictions.No legalrestrictions.No legal restrictions. No legalrestrictions.No legal restrictions. No legal restrictions. No legalrestrictions.No legal restrictions.Hammettetal.BMCHealthServicesResearch2014,14:261Page6of11http://www.biomedcentral.com/1472-6963/14/261Table 3 Corporate pharmacy policies (chain pharmacies)Sites/interventionsUS (Boston) US (Providence) US (SF) Canada (Vancouver) Russia (St P)Needle/syringesales/distributionCorporate policy eitherspecifically allows for or issilent on non-prescriptionsales of syringes. Mostpharmacies sell needles/syringes but the law providesthat sales of syringes is at thediscretion of the pharmacist.Sales may be at the discretion ofthe on-site pharmacy managerChains can enroll in Disease PreventionDemonstration Programs so individualstores can sell needles/syringes, butimplementation within chains has beeninconsistent.aMost chains sell needles/syringes but individualstores can set policies;many stores will not sellChains have noobjection to sellingneedles/syringes butwould probably opposefree distributionNeedle/syringedisposalPharmacies generally will notaccept used syringes for disposal.Pharmacies generally will notaccept used syringes for disposal.One chain allows; another prohibits Most chain pharmacieshave sharps containers andaccept full containers;individual store policiesmay differRequires additionallicense for collectingand storage ofepidemiologicallyhazardous wasteHIV testing HIV testing is not available in pharmacies. HIV testing is not available inpharmacies.Some pharmacies in one chain offeredfree HIV testing as part of National HIVtesting monthNot currently available Only at medically-licensed facilityHBV/othervaccinationA recent change in pharmacy policy (MDPH,Drug Control Program and ImmunizationProgram, Joint Policy 2012–2) permitsadministration of the hepatitis B vaccine inpharmacies to adults by a qualified pharmacist.Two major corporate chains have opened walkin clinics for adult vaccination including hepatitisB vaccines.Pharmacies may offer anyvaccine including hepatitis B,pneumonia, shingles, pertussis,tetanus, meningitis and humanpapillomavirus.Most chains offer vaccinations Could be offered if staffare properly trainedOnly at medically-licensed facilityMMT/OST Federal Law prohibits dispensing methadone atretail pharmacies.Federal Law prohibits dispensingmethadone at retail pharmacies.Prescriptions could be filled but DOTrequires corporate approvalRegularly dispensed byprescriptionMethadone is aprohibited psychoactiveagentNaloxone/overdoseprevention/rescuePrescriptions for naloxone may be filled. Also see collaborative practiceagreement comments above(Table 2).Prescriptions could be filled Individuals cannot obtainby prescription; pharmaciesfill orders for clinics andother authorizedorganizationsNot generally stockedby pharmaciesAbscesstreatmentCorporate policies support provisionof informationCorporate policies supportprovision of informationInformation about wound carecan be providedPharmacies refer customersto health clinicPharmacies could offerinformation; requiresdisplay spaceBriefcounseling/materialsCorporate policies support the provisionof information.Corporate policies support theprovision of information.Information about medicationsand health concerns can be providedSome pharmacies mayhave informationalmaterials, but most do notPharmacies could offerinformation; requiresdisplay spaceReferrals Corporate policies support the provisionof information.Corporate policies support theprovision of information.Referrals can be made Pharmacies make referrals Pharmacies could offeraLutnick A, Cooper E, Dodson C, Bluthenthal R, Kral AH. Pharmacy syringe purchase test of nonprescription syringe sales in San Francisco and Los Angeles in 2010. J UrbanHealth 2012.doi:10.1007/s11524-012-9713-7.Hammettetal.BMCHealthServicesResearch2014,14:261Page7of11http://www.biomedcentral.com/1472-6963/14/261There appear to be no legal barriers to needle/syringedisposal in pharmacies except in St. Petersburg where aspecial license for such disposal is required, and Ha Giang,Vietnam where disposal of used needles/syringes atpharmacies must comply with the Ministry of Health’sregulations on management of medical wastes (VietnamMinistry of Health. Decision No. 43/2007/QD-BYT,November 30, 2007). However, individual pharmaciesmight refuse to offer disposal services. Cost may also playa role in such decisions, as revealed in St. Petersburg:It [syringe disposal] costs a lot. Not every medicalfacility can afford waste disposal. –Department Head,drug treatment facilityIn San Francisco, some pharmacies’ reluctance to offerrequired disposal services may explain their refusal tojoin the DPDP, under which needles/syringes are soldwithout prescription [17]. In Massachusetts, there is nobarrier to pharmacies accepting syringes for disposal,but very few do, citing the high cost and safety concernswith handling medical waste. The Massachusetts Depart-ment of Public Health provides disposal “kiosks” butnone of these are placed in pharmacies. Biohazardouswaste containers and prepaid envelopes to mail usedsyringes to a biohazardous waste company may bepurchased in some pharmacies.In most sites, HIV testing in pharmacies is not legallybarred but cannot be provided without additional stafftraining or certification. In Tijuana, only saliva-basedtesting may be done in pharmacies because blood drawingis prohibited. Similarly, St. Petersburg has an explicit pro-hibition on blood/serum-based HIV testing in pharmaciessince this practice is restricted to licensed medical facil-ities. Oral testing could be conducted at pharmacies in St.Petersburg but individuals testing positive would requireconfirmatory testing by the Municipal AIDS Center toqualify for care and treatment. In Vancouver, strictrequirements for provision of pre/post-test counselinglimit the potential for offering HIV testing in pharmacies,although access to testing has recently been expandedthrough health clinics and community health centers.In Boston, a recent change in pharmacy regulationspermits walk-in clinics to offer adult immunization,including for hepatitis B. With the walk-in clinic infra-structure in place, adding HIV testing may be feasible,but is not currently permitted. Some pharmacy chainsoperating in San Francisco allow vaccinations but othersdo not. Several sites, including Boston, San Francisco,Tijuana and Vancouver, require special training or certi-fication for staff to administer vaccinations, while in St.Petersburg pharmacies are prohibited from administer-ing any vaccinations since this requires a medical licenseand separate space in the facility:[Vaccination against hepatitis) is impossible [inpharmacies] due to technical reasons. There arenumerous regulations that must be met according tothe “Sanitary Rules and Norms.” For instance, theremust be a separate room with specific technicaldevices –Deputy Director, drug treatment facility.Provision of methadone or other OST in pharmaciesfaces serious legal and practical barriers. A pharmacyworker in Ha Giang, Vietnam noted thatVietnam Ministry of Health should enact legaldocuments so we are allowed to sell… it will betroublesome if selling is not permitted. Some specificdrugs only university-leveled pharmacists are permittedto sell”. –pharmacy worker in Minh Khai wardA number of the sites prohibit provision of OST inpharmacies, while in several others special legal dispensa-tion is needed for prescribing methadone or similar medi-cations. In Russia, standard OST is prohibited by law inall facilities. In Vancouver, OST in pharmacies is legallypermissible but a substantial proportion of methadone pa-tients attend “private methadone clinics” [19]. In addition,Vancouver physicians must receive an exemption underthe Controlled Drugs and Substances Act to prescribemethadone or other medications used in OST.The provision by pharmacies of naloxone for overdoseprevention and rescue also confronts diverse legal andpractical challenges. The difficulty or impossibility ofPWID getting to pharmacies to receive naloxone whilesuffering from overdose has prompted the creation ofcommunity-based overdose education and naloxoneaccess efforts in some places, designed to increase thelikelihood of timely emergency response [20]. Across allsites, naloxone remains a prescription drug, used primarilyin clinical settings and by emergency medical staff and po-lice, as recently proposed by New York’s Attorney General[21]. Naloxone is seldom stocked in pharmacies. This in-hibits efforts to utilize pharmacies as access points forPWID and their caregivers [22].In Boston, naloxone could be provided to PWID bypharmacists under the existing “standing order”. Thisorder, issued in 2007 by the medical director of the over-dose prevention program, provides that community mem-bers and agency workers may be trained to provide nasalnaloxone to drug users for overdose prevention. In Provi-dence, naloxone may be provided by pharmacies undercollaborative practice agreements with prescribers as partof wider overdose prevention and naloxone access schemes[23]. A collaborative practice agreement is a signed agree-ment, entered into voluntarily, between a pharmacist withadvanced training and experience relevant to the scope ofcollaborative practice and one or more physicians thatHammett et al. BMC Health Services Research 2014, 14:261 Page 8 of 11http://www.biomedcentral.com/1472-6963/14/261defines the collaborative pharmacy practice in which thepharmacist and physician(s) propose to engage.Many San Francisco pharmacists said that they wouldroutinely fill prescriptions for naloxone. Under Californialaw (SB 767 [2007]), licensed health providers who pre-scribe and/or distribute naloxone for emergency treatmentof drug overdose bear only limited liability. In 2010, thislimitation on liability was extended to lay providers of na-loxone who have received appropriate training through aprogram registered by a local health department [http://legiscan.com/CA/text/AB2145/id/60864].In St. Petersburg, naloxone may be dispensed and ad-ministered only in licensed health care facilities. However,naloxone is included in the “List of vitally necessary andthe most essential medicinal agents for 2012” (Decree ofthe Government of RF#2199-r dated of December 7, 2011)which ensures “physical and economical availability” ofcertain medicinal products. Thus, pharmacies could becompelled to make naloxone available should the appropri-ate government agencies wish to promote its availability.However, according to one drug treatment professional:Although it should be legalized, as far as I know,narcologist cannot prescribe naloxone to a drugaddict. …There is no indication in the labeling fornaloxone that would allow it to be used for overdoseprevention outside the clinical setting. It says that[the] medication is to be used in medical facilities bya physician. –Department Head, drug treatmentfacilityAccording to laws or regulations in most sites, pharma-cists cannot clean or dress abscesses because this wouldconstitute a practice of medicine prohibited to them. Insome countries, as well, providing such care could alsoraise medical malpractice issues. However, in most sitespharmacists could dispense antibiotics or ointments fortreatment of abscesses, with or without a prescriptiondepending on the country. In San Francisco, abscess treat-ment in pharmacies may not be authorized by relevantgovernment agencies because such services are alreadyavailable at clinics and hospitals.There are few if any legal or policy barriers to pharma-cies providing information, materials, brief counseling andreferrals on any health issues, including HIV/AIDS, hepa-titis, abscess treatment, overdose prevention and rescue,and substance abuse treatment. The challenges that existarise largely from the practices and attitudes of individualpharmacies and their staffs. In San Francisco, the needle/syringe “buy study” found that many pharmacies partici-pating in the DPDP were not providing written or oralinformation on substance abuse treatment, HIV/HCVtesting, and safe disposal of used needles/syringes that isrequired to accompany each needle/syringe sale [17].DiscussionThis review of laws, policies, and practices presents amixed picture of the possibilities for implementingpharmacy-based service enhancements for drug users.Provision of informational materials and referrals in phar-macies is legally permissible in all study sites and sale andsafe disposal of needles/syringes by pharmacies is legal inalmost all sites. Pharmacy provision of other services iden-tified as most promising in the study, such as HIV testing,hepatitis and other vaccinations, opioid substitution treat-ment, provision of naloxone for treatment of opioid over-dose, and abscess treatment face more serious andpervasive legal and policy barriers.We identified challenges to achieving a truly enablingenvironment for the implementation of expanded phar-macy services at all three levels of our conceptual model.The most commonly identified challenges occur at themacro-level where legal and policy provisions blockprovision of some services and medications in pharmaciesand persistent stigma and its internalization by PWID re-duce uptake of services that do exist. Lack of relationshipsbetween pharmacies and HIV prevention and addiction-related resources in the community and consequent lackof consensus as to who should provide specific HIV-related services also represent barriers to expansion of ser-vices in pharmacies. In places dominated by private chainpharmacies, skepticism that providing additional servicesfor PWID would translate into increased pharmacy profitshave also hindered offering such services.At the meso-level, our study uncovered variations inpolicy and practice related to services for PWID acrosspolice agencies and pharmacy chains. For example, somepharmacy chains narrowly define pharmacists’ roles andresponsibilities and limit interventions. Lack of sufficienttime and appropriate space may also limit possibilitiesfor expansion of services in pharmacies.At the micro-level, differences in knowledge (such aslack of understanding of addiction and harm reduction),attitudes (such as stigmatizing PWID customers), andbehaviors (such as refusal to sell needles/syringes tosuspected PWID) of individuals pharmacists, pharmacyworkers, shift managers in large pharmacies, police offi-cers, and other actors pose barriers to the expansion ofpharmacy-based services for PWID. In Russia, forexample, all aspects of life are highly bureaucratized andofficials and pharmacists feel that they must comply withall regulations or risk punishment and damage to theircareers. They may also use the existence of prohibitoryrules and regulations to rationalize the denial of servicesthat they know or suspect would advance public health.At the macro- level, where deficiencies and barriers ingovernmental laws and policies may block implementa-tion, stakeholders should advocate with relevant govern-ment bodies for the needed legal and policy changes. ForHammett et al. BMC Health Services Research 2014, 14:261 Page 9 of 11http://www.biomedcentral.com/1472-6963/14/261example, in Russia, PWID access to sterile injection equip-ment could be increased by inclusion of syringes in the fed-eral list of mandatory medical products sold by pharmacies[18]. Arguments from public health and safety are likely tobe the most persuasive and evidence should be marshaledfrom places that have successfully and effectively expandedpharmacy services such as needle/syringe sales.Community-level stigma, discrimination, and resistance toharm reduction interventions also inhibit PWID’s access toall kinds of health services. Efforts are needed to convincecommunity members that those suffering from drug addic-tion, a medical and psychosocial problem, would benefit fromservices delivered in a respectful and non-discriminatorymanner and that such services contribute importantly to dis-ease prevention without encouraging drug use.In areas for potential expansion of pharmacy services inwhich there has been little success to date, such as vaccin-ation, MMT/OST, and naloxone provision, stakeholdersshould assess the local situation and determine theimportance of pharmacies providing these services beforeundertaking the difficult work needed to achieve thechanges in the legal and policy framework that would berequired. Laws limiting the liability of pharmacists whoprescribe naloxone to treat opioid overdose were adoptedin Massachusetts and Rhode Island since the completionof our study. There are also efforts underway to makenaloxone available over the counter in the United States,but this would require approval of the Food and DrugAdministration [http://drugtopics.modernmedicine.com/news/otc-naloxone-its-possible].Advocates should consider multiple stakeholder view-points when designing policy reform efforts, includingpossible incentive mechanisms to engage pharmacies andother healthcare providers in services for drug users. Nolegal or policy changes appear to be necessary to allowexpanded provision of counseling, informational materials,and referrals but structural changes such as provision ofinsurance coverage to compensate pharmacists for coun-seling or brief interventions may be needed to assureacceptability and sustainability of interventions [24,25].Attention is also needed at the meso- and micro- levels.Laws and policies are only as good as their implementation.Serious gaps in the implementation of needle/syringe pro-grams are well-documented and especially problematic insettings with weak rule of law [26-29]. Police departmentand pharmacy chain policies, and the knowledge, attitudes,and practices of individual PWID, individual pharmacies/pharmacists, and police officers should support rather thanundermine extant laws and policies. Pharmacists’ attitudesand practices have been shown to influence provision ofneedles/syringes, opioid substitution treatment, counseling,and dissemination of HIV prevention and other health pro-motion materials to PWID in Scotland [30], Australia[31,32], and Estonia [9].Training for pharmacists and police officers could be con-ducted to promote more supportive attitudes towards pro-posed programs [28,30,33]. Systematic monitoring of policeabuse of drug users around pharmacies and other servicepoints may also help address structural barriers to serviceaccess [34]. Programs are also needed to increase the self-efficacy of PWID to improve their relationships with phar-macists and thereby facilitate access to expanded services.Overall, a considerable amount of advocacy will beneeded if pharmacies are to reach their potential as venuesfor delivering services to drug users. This advocacy shouldemploy a public health perspective, demonstrate cost-effectiveness of harm reduction interventions, and pro-mote a human rights approach to the health problems ofmarginalized populations.Competing interestsThe authors declare that they have no competing interests.Authors’ contributionsTH conceived the idea for the paper; SP, JG, PC, NZ, AL, AHK, EVF, RH, WS,RP, LB, CL, and DDJ contributed data and writing; all authors read andapproved the final manuscript.AcknowledgementsThis work was supported by five linked R21 grants from the NationalInstitute on Drug Abuse, U.S. National Institutes of Health.Author details1Abt Associates Inc., Cambridge, MA 02138, USA. 2Abt Associates Inc.,Bethesda, MD 20814, USA. 3The Fenway Institute, Fenway Health, Boston, MA02215, USA. 4The Miriam Hospital, Center for AIDS Research, Providence, RI02906, USA. 5RTI International, San Francisco, CA 94103, USA. 6TheBiomedical Center, St. Petersburg 194044, Russia. 7Yale University School ofPublic Health, New Haven, CT 06520, USA. 8British Columbia Centre forExcellence in HIV/AIDS, Vancouver, BC V6Z 1Y6, Canada. 9Faculty of HealthSciences, Simon Fraser University, Burnaby, BC, Canada. 10Pacific Institute forResearch and Evaluation, Calverton, MD 20705, USA. 11NortheasternUniversity School of Law & Bouvé College of Health Sciences, Boston, MA02144, USA. 12Johns Hopkins Bloomberg School of Public Health, Baltimore,MD 21205, USA. 13Beth Israel Medical Center, New York, NY 10038, USA.Received: 4 October 2013 Accepted: 6 June 2014Published: 17 June 2014References1. 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BMC Health Services Research 2014 14:261.Submit your next manuscript to BioMed Centraland take full advantage of: • Convenient online submission• Thorough peer review• No space constraints or color figure charges• Immediate publication on acceptance• Inclusion in PubMed, CAS, Scopus and Google Scholar• Research which is freely available for redistributionSubmit your manuscript at www.biomedcentral.com/submitHammett et al. BMC Health Services Research 2014, 14:261 Page 11 of 11http://www.biomedcentral.com/1472-6963/14/261


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