INTRODUCTION

Informal drug shops are often the first line of health care for the poor in many developing countries. Not to be confused with pharmacies, drug shops do not ordinarily employ pharmacists and are legally allowed to sell only nonprescription, prepackaged medicines. A varied literature harshly critiques the quality of services that drug shops provide,^1–3 but also praises their accessibility and low cost,^3–5 noting in particular the gap they fill in underserved rural areas. One study, in which interactions between drug shop operators and their customers were observed, concluded that clients viewed drug shop operators not only as commercial outlets for medicines, but also as health care providers who dispensed advice and guidance.⁶

In Uganda, drug shops are distinct from pharmacies in several ways. Legally, drug shops can sell only nonprescription drugs, and must be registered with the Uganda National Drug Authority (NDA) and be owned by medically qualified persons with at least nursing or midwife training; nonowner operators must have received training at least at the level of nursing aide. Prior to registration, drug shops must first be inspected for suitability of the premises, and after being registered, they are supposed to be regularly monitored by district drug inspectors who act on behalf of the NDA.⁷ In 2008, there were 4,742 registered drug shops in Uganda, more than 10 times the number of pharmacies.⁸

In practice, drug shops in Uganda often sell a variety of prescription drugs—including those requiring injection—and also provide care and treatment,⁹ even though 30% of drug shop attendants lack any medical qualifications, according to one study.¹⁰ Drug shops are found not only in cities and towns, but also in small trading centers and rural areas. Many are not registered with the NDA as drug shops, but rather operate in the shadows of legitimacy, using the same trading license as simple shopkeepers, or sometimes no license at all. Even unlicensed drug shops, however, operate openly, implying lax inspection and enforcement standards. Typical drug shops in rural Uganda are storefronts with product displays and a counter; however, nearly all have a curtained back room where clients can be seen—and often treated—in private.

Most drug shops legally sell over-the-counter family planning methods such as oral contraceptives and condoms, usually social marketing brands. Many also sell and administer the three-month injectable contraceptive Depo Provera (depot medroxyprogesterone acetate, or DMPA), even though both the sale and the administration of any injectable drug by drug shops are illegal.⁷ In light of Uganda's low modern contraceptive prevalence rate (18%) and its ongoing health worker shortage, a strong case can be made for building the capacity of drug shop operators to safely provide the injectable contraceptive—the most popular method in the country.¹¹ Uganda's Ministry of Health has already sanctioned provision of the injectable by community health workers, a group generally far less qualified than typical drug shop operators. To better understand current practices by drug shop operators and their potential to provide the injectable to hard-to-reach populations, we visited shops in three districts and surveyed their operators.

METHODS

Study Design and Sample

Between November 2007 and January 2008, we used local informants and "snowball sampling" techniques to attempt to contact all drug shops and small private clinics* in three rural districts north of Kampala (Nakasongola, Luwero and Nakaseke) where one of the study partners, Save the Children–USA, was active. Drug shop operators who reported selling DMPA were eligible to participate in the study. Of the 157 operators identified in the three districts, 124 (79%) met the inclusion criterion, and all 124 agreed to participate. The study design was approved by the Protection of Human Subjects Committee of Family Health International (FHI).

Data Collection and Analysis

Health extension workers and community reproductive health workers affiliated with Save the Children–USA in Uganda interviewed the drug shop operators using an eight-page survey instrument that assessed details of sales and injection practices, knowledge of screening and counseling for hormonal methods, technical knowledge of safe injection skills and attitudes toward family planning. Typically, interviews were conducted in the shops between client visits, in the local language—Luganda—and took less than 30 minutes. Data were entered by clerks at Save the Children–USA in Luwero. Data cleaning took place in Uganda and at Family Health International (FHI) headquarters in North Carolina, USA, and data were analyzed by FHI staff in North Carolina. Because of the observational nature of the research and the absence of hypothesis testing, all analyses were descriptive. We summarized data using frequencies and percentages, or means and ranges where appropriate.

RESULTS

Seven in 10 respondents were female. Sixty-nine percent operated facilities in rural areas, and 27% did so in small towns, villages or trading centers (Table 1). Three-quarters (77%) identified their facilities as drug shops, whereas the rest identified them as private clinics, combined drug shop–private clinics or other types of facilities; none were pharmacies. Fewer than half of the facilities were actually licensed as drug shops (35%) or private clinics (9%); the majority reported having either a simple trading license (50%) or no license (6%). Only about half (48%) of the respondents reported owning the facility in which they worked.

In regard to their provider qualifications, 33% of operators reported being nursing aides, 26% nurses, 7% midwives and 4% auxiliary nurses; the remaining 30% reported a variety of other nursing and medical backgrounds. Most respondents said they had had formal training in family planning (77%), injection safety (62%), or infection prevention and control (59%). Respondents reported a mean of five years of experience in providing family planning (not shown).

Services Provided

Operators reported selling a mean of 3.5 doses of DMPA per week (Table 2); 83% reported selling the social marketing Injectaplan brand, and 17% sold loose vials. The vast majority (96%) of operators administered the injectable themselves in the shop; 89% sold or used the autodisable SoloShot syringe included in the Injectaplan package.^† Those who did not administer injections usually referred clients to qualified providers in the public or private sector for injections (not shown). Prices for DMPA were modest, usually the labeled social-marketing price plus a small amount (about US$ 0.65).

Safe DMPA Provision

Ninety-four percent of operators reported taking clients' medical history before providing DMPA (Table 3). Of those, 78% asked about pregnancy or menstruation status; 47% about heart condition, stroke or clots; and 41% about unusual bleeding. Forty percent of operators reported keeping a register of their DMPA clients—86% of whom said they included the due date for the next injection (not shown).

Drug shop operators reported giving a mean of 10 injections a week, about three of which were DMPA (Table 3). Of those who administered the injectable, fewer than half (43%) disposed of syringes in a sharps container immediately after use. This was corroborated by interviewer reports of visible, loose used syringes in 41% of the facilities and sharps in open containers in 58% of facilities (not shown). Only 27% reported having access to free sharps containers, such as those widely supplied to clinics by UNICEF and USAID. Regardless of what container was used for initial disposal, nearly all operators reported ultimately disposing of their used syringes either in pit latrines (51%) or by burning (54%). (Deep pit latrines may be suitable for disposal of low-volume medical waste, but these drug shops demonstrated a need for better waste disposal, such as by high temperature incineration.) Twenty-four percent of operators who administered DMPA had had at least one needle-stick injury in the past year, and 17% had had at least one patient suffer an injection-related abscess in the past year—typically caused by unsterile needles or poor injection technique, although not necessarily from a DMPA injection. Finally, 11% reported ever reusing a disposable syringe because of lack of supplies.

Safe Injection Knowledge

Of operators who injected DMPA, nearly all (95%) knew that disposable syringes cannot be sterilized and reused safely (Table 4). When asked the steps they follow in providing DMPA, only 45% spontaneously reported washing their hands, and 42% reported checking the expiration date on the injection bottle. Forty percent mentioned following the correct practice of gently shaking the bottle or turning it upside down several times before use, whereas 54% reported the incorrect practice of shaking the vial vigorously. Seventy-nine percent of the operators knew to remove the needle and try a different spot if blood is aspirated during injection. Finally, four-fifths of respondents knew at least one disease transmissible through unsafe injections or needle-sticks, though knowledge was mostly limited to HIV, with fewer than 10% mentioning hepatitis B or C.

Contraceptive Knowledge

When asked which contraceptive methods they knew about (besides the injectable), nearly all respondents mentioned oral contraceptives (97%), and smaller proportions spontaneously mentioned condoms (90%), the IUD (61%), the implant (63%), male and female sterilization (38% and 44%, respectively), fertility awareness methods (15%) and lactational amenorrhea/breast-feeding (12%).

To assess specific knowledge about DMPA, respondents were asked open-ended, multiple-response questions about the method's contraindications, advantages and disadvantages, and side effects. Only 16% of respondents could name more than one contraindication; 47% recalled one, and 37% could not correctly name any. Unexplained vaginal bleeding and severe high blood pressure were the most commonly mentioned contraindications (36% and 30%, respectively; Table 5). Few respondents could name any noncontraceptive benefits of DMPA, but nearly all knew one or more common side effects (not shown): For example, 75% reported headache as a side effect, 69% heavy bleeding, 59% irregular bleeding, 44% weight gain and 44% spotting. Only 39% spontaneously reported amenorrhea as a side effect, although it is eventually experienced by nearly all users. Most respondents knew only one or two of the four serious but rare side effects that require medical attention, such as "very heavy bleeding" (87%).

All respondents knew that DMPA provides reliable contraceptive protection for three months (Table 5). When asked how late a client could be for her injection without the contraceptive losing its effectiveness, only 21% of respondents said two weeks, the "grace period" recommendation at the time in Uganda,^‡ whereas 46% thought the grace period was less than two weeks (not shown).

Family Planning Attitudes

Operators were asked a series of questions about family planning knowledge and attitudes. Broadly speaking, operators held traditional views, such as that "a woman needs her husband's permission before using a contraceptive like Depo Provera" (75% agreed) and that "contraception encourages promiscuity among adolescents" (51% agreed). Some of the agree-disagree questions also provided a measure of respondents' technical knowledge of family planning. Most respondents (75%) correctly disagreed with false statements about DMPA causing permanent sterility. On the other hand, only 44% correctly disagreed with the statement "Depo Provera can only be given to a woman on a day when she is menstruating."

DISCUSSION

This survey revealed characteristics of a group of women and men who actively sell and inject DMPA in drug shops in rural Uganda. Although illegal, this practice almost certainly provides a much needed service, given the context of high maternal mortality and morbidity, poorly stocked clinics and high unmet need for family planning.

Many drug shop operators are fully qualified nurses and midwives who, we believe, should be encouraged to continue providing family planning services to poor, rural women. Other operators are less qualified, but in the current regulatory environment, will likely continue to sell and administer the injectable. All providers—no matter their qualifications—would benefit from training or retraining in safe injection skills and family planning counseling, as well as from better access to safe waste disposal and, ideally, medical supervision. This is not a radical idea: In Uganda and elsewhere, community health workers with limited training safely and legally provide the injectable.^12–15 Given the higher training and experience of drug shop operators—nearly all of those in our sample reported some clinical background—training them as community-based distribution agents makes good sense and could be done without the highly complicated process of changing Uganda's regulatory and policy environment. If properly undertaken, and with the institution of some element of ongoing supervision, such training could also have the important benefit of decreasing the number of unsafe and unnecessary injections of other drugs. (DMPA shots are probably the safest injection provided in Uganda's thousands of drug shops, because the social marketing version bundles a autodisable syringe with every vial.)

In the long run, of course, accreditation of trained providers and stronger enforcement of licensing and safety regulations are desirable and could make drug shops a stronger partner in Uganda's efforts to improve public health and achieve its Millennium Development Goals. For their part, drug shop owners need to take more seriously the responsibility of licensing their shops and employing qualified operators. In the meantime, however, our survey points to the immediate need for training and supervision, as well as universal access to puncture-proof sharps containers and the marketing and informational materials available to legal purveyors of social marketing injectables. In fact, this process may have started: Subsequent to our research, Uganda's principal family planning social marketing group trained 150 drug shop operators in four districts to safely provide injectable contraceptives. The training intervention, however, remains limited, and official policies have not changed.