Recycling HIV Drugs: Exporting Medicine, Experience, and Hope
This article is about a program started by HIV-positive people in New York to send surplus HIV medicines to people who need them in Latin America.
Despite the desperate need for HIV treatment in parts of the developing world with soaring rates of death due to AIDS, pharmaceutical companies have been reluctant to either reduce prices or to set up meaningful drug donation programs. The companies have claimed that drugs sent to regions without an infrastructure for monitoring and educating patients will be wasted and may even contribute to an epidemic of drug resistance that will sabotage treatment efforts down the line. But by focusing on the problems of providing HIV treatment on a mass scale, these arguments have shifted attention away from effective actions that can be taken immediately. Fortunately, networks of individuals have emerged in Europe and the United States willing to send HIV drugs to developing regions by recycling and redirecting the excess supply of rich countries.
AID for AIDS -- A Case Study
AID for AIDS (AfA) was begun in 1996 in a New York City East Village apartment. Gay men from Venezuela living in New York collected unused HIV medications and started sending them to their HIV-positive friends back home. During the first year they provided 20 people with drugs. Most of those first clients are still alive, many of them now staffing local offices of AfA in their home countries. Last year, AfA served 248 clients and shipped over $3 million worth of HIV drugs from New York to people in Latin America and around the world. AfA has done this with no significant help from pharmaceutical companies, relying instead on donations of drugs and money from individuals in the States and abroad.
AfA now has regional offices in Venezuela, Peru, Chile, and the Dominican Republic. AfA regional offices are part of the fabric of AIDS service organizations in the home country and AfA staffs are all members of the local AIDS communities. AfA also maintains liaisons with local government agencies and social security programs. Since each country served has different resources and needs, local representation helps ensure AfA's responsiveness. For example, in Venezuela, individuals who are employed are eligible for local Social Security, which will pay for HIV medicines. But the government AIDS drug program is not always reliable and sometimes AfA has to step in if supplies are interrupted. Although there is a Public Health Service available to unemployed Venezuelans, it has no money to buy AIDS drugs. It's not uncommon for Public Health social workers to send clients in need to AfA. Virtually no private insurance system in Latin America pays for HIV drugs.
AfA has served about 500 individuals since its operations began; 250 clients are actively enrolled in the program, and there are currently about 150 people who have qualified and are waiting for drugs. Only six children are currently receiving medicines, but AfA is developing a "Kids Project" to increase the amount of pediatric formulations of HIV drugs that are donated.
Besides providing drugs and assistance to people living with HIV in Latin America, AfA considers it an important part of its mission to improve the local professional capacity to prescribe and manage antiretroviral therapy. Doctors are informed about drugs, their side effects, and interactions. International treatment guidelines (from the U.S. and the local country, if any) are distributed and AfA's client qualification policies are explained. Doctors gain experience using the drugs and adjusting regimens with results of CD4 assays and, increasingly, HIV RNA and genotype testing. More importantly, physicians, patients, families and the community see evidence that AIDS does not need to be fatal and that treatment is effective.
Theorists of economic development refer to this process of distributing knowledge and experience as "capacity building." Hans Binswanger, an HIV-positive man and Director of the Environmental, Rural, and Social Development Department for Africa at the World Bank, is a proponent of immediately extending treatment to developing countries without waiting for organized improvements in infrastructure. Binswanger believes that drug recycling efforts are a positive move. He maintains that as drugs are imported and used, local infrastructure will spontaneously begin to develop. Medical labs will upgrade their equipment as the demand for CD4+ counts increase and viral load assays will soon follow. If and when large-scale donation programs begin to operate, there will already be in place a network of doctors experienced with using the drugs and managing patients. As the thin end of the wedge, the recycling programs may have an impact that extends far beyond the lives directly saved.
Some critics say recycling programs are futile since drug donations provide a mere "drop in the bucket" compared to what is needed in developing countries. But to any of the 250 people served by AfA last year, it's a life-giving drop. And because many of AfA's clients are involved in HIV advocacy and prevention, the lives saved stay engaged in the work of saving other lives. A cadre of committed activists serve as walking advertisements for the power of HIV treatment as they help organize community pressure on government and non-governmental agencies to expand treatment opportunities further.
AfA is committed to documenting the impact of their efforts so others can learn from their experience. AfA-sponsored research was presented in a poster session at the International AIDS Conference at Durban, South Africa, in 2000. AfA also has partnered with researchers at the University of Rio in Brazil to obtain free HIV genotype testing for their clients.
Making it Work
AID for AIDS has established a set of procedures to ensure that scarce resources are used to the greatest effect. These procedures include standards for accepting clients, insuring the quality of the drugs, protecting the confidentiality of clients, and following up to see that drug regimens are effective. Just as important are procedures that provide education for professional development and a system for medical review of cases and outcomes.
Who is Eligible?
To qualify for AfA drugs, patients must document that they meet the medical criteria.
AID for AIDS has its headquarters in New York City and currently has regional offices in Santiago, Caracas, Lima, and Santo Domingo. Clients who enter the program through the regional AfA offices are counseled and screened by local AfA medical staff. The local offices collect the application documentation and fax it to New York, where it is evaluated and the client is qualified. Clients who live in remote areas of countries with AfA offices will apply to and receive their drugs through the local office. Clients from countries without a local office must apply to and receive drug shipments from the New York office directly.
When a new client is accepted into the program, the New York medical officer assigns a confidential client code number. Thereafter, all cases are processed and prescriptions filled by code number only. Names are linked only to client numbers when the sealed cartons of drugs are actually shipped.
In New York, inventories are maintained on a real-time basis and the local offices are updated weekly about what is in stock. If requested drugs are not available or if the AfA medical staff thinks the prescribing doctor has made a mistake or has prescribed an ineffective regimen, the doctor is contacted. If supplies are short, the client's doctor is informed of which drugs are available and given the option to change the prescription. If the doctor has constructed an inappropriate combination, educational materials are provided that explain current treatment guidelines. If the AfA medical officer is still not satisfied with the prescription, a case review is conducted.
Case presentations are made to a panel of five AfA-associated doctors who reside in the various countries served. The panel is presented with the patient's clinical history, a recent CD4+ cell count and a viral load result, if available. Case presentations are confidential. Reviewers give their individual opinions about the best drug combination for the patient, with a written explanation for their choice. These opinions are summarized and are sent to the client's doctor. The review process is intended to be a learning opportunity for all involved and is a critical part of the AfA mission to educate providers about HIV treatment and clinical management. If a client's doctor continues to prescribe inappropriate combinations, the client is counseled to select a doctor with experience in the accepted use of HIV medications.
If AfA learns that a client has stopped taking the supplied drugs or is selling them on the black market, the client is terminated from the program. So far, most clients have been highly motivated and adherent.
The Role of Local Offices
The regional offices, in addition to screening clients and distributing drugs, provide support groups, education, and adherence education. Local staff can refer people with HIV to other agencies and government assistance programs. Some offices also offer supportive services such as massage and advice about herbs and alternative therapies. Clients in countries with no local office receive long-distance telephone counseling and educational materials from New York.
Local offices also provide services to people on the waiting list and to people who do not yet qualify for treatment. Secondary prevention counseling is crucial to reduce transmission from healthy but virally unsuppressed individuals. Treatment and adherence education in advance helps prepare people for a successful outcome when they eventually qualify for therapy.
Regional offices also maintain on hand a small stock of locally donated drugs to cover emergencies or to temporarily supply patients until a government program takes over. If an individual's government-provided medications are interrupted due to bureaucracy or error, the local drug bank can offer an interim supply. The local drug banks also occasionally send emergency supplies to AfA sister offices when needed. However, no drugs are shipped to the New York office.
Dispensing the Drugs
All full-time clients of the program are served and dispensed from the New York office. Computer-generated fill-sheets detail the client code number and monthly medication count for that client. Orders are filled on an individual basis and sent in their original bottles. An individual's entire order is packaged together in a single bag coded with the client number.
Monthly supplies destined for clients in a country with a local office are packed together in a carton and shipped to that office. The local office receives the shipment and checks-in each order, matching the prescriptions to the drugs received. Individual supplies are then picked up by clients at the office or are mailed within the country to the client. Clients in countries without a local office receive individual packages directly from the New York office each month.
Shipping from New York is by FedEx, by courier (usually friends of AfA who are traveling to the country), or is otherwise sponsored by individuals who donate shipping fees. Drugs are shipped only out of the country. There have been no unsolvable customs or regulatory problems encountered to date. Newer formulations of drugs such as Norvir that can survive brief periods without refrigeration have made overnight shipping of all HIV drugs feasible.
Finding the Drugs
When donated drugs arrive in the New York AfA office, any previous patient's name labels are removed. If a bottle has been opened, each individual pill is visually checked for damage. Drugs will be distributed up to six months past their date of expiration. The drugs are inventoried and placed in an air-conditioned drug storage room. Medicines that require cold storage are placed in refrigerators. Inventories are updated daily and low supplies trigger a search for new donations of that drug.
Drugs donations come from a variety of sources. Most donors are people with HIV in the U.S. who have accumulated an excess supply after a change of regimen or have collected unused drugs from friends. Social workers and clinics have been reliable sources for recycled drugs. AfA currently is supplied by about thirty different organizations that routinely collect excess drugs.
What Does it Take to be Effective?
Jesus Aguais, the director of AID for AIDS, is outspoken about the need for new drug recycling programs to take on this work and for existing ones to increase their activity. However, he is adamant that recycling programs should be prepared to implement operating procedures as stringent as AfA's if they expect to be effective.
Starting a drug-recycling program might seem like an attractive way to provide direct aid to those who need help. But it takes more than a good heart to establish and run a program, says Aguais. The consequences of an interrupted supply in terms of resistance or for the possibility of misdirected resale of drugs demands a carefully structured system of client validation and follow-up. At the very least, having close ties with local AIDS service organizations and PWA groups are crucial. Aguais stresses that programs need to be "fact-based," with a direct connection to clients and their needs. Building upon an established network of support for PWA's is a good start.
An easier initiative for concerned individuals and groups in the U.S. to set up is a collection-point operation. On the supply side, well-established connections with clinics and social workers are important to ensure a steady flow of donations. AfA has developed a "Starter Kit" for individuals and groups who would like to collect excess medicines for recycling programs. The essence of this effort is to make local contacts with AIDS agencies, social workers, and doctors to solicit drug donations and to collect funds that will support shipping costs. AfA provides guidelines and a sample flyer in the Starter Kit.
Ultimately, a committed medical and support staff that is willing to work long hours for next-to-nothing is at the heart of the program's success. Says Aguais: "If we run out of money it's not a disaster, as long as we have the drugs to send. We have some angels we call on to pay the FedEx bill."
Money is a constant struggle, but so far AfA has survived and grown on individual contributions. A fundraiser sponsored by POZ magazine has been the latest lifeline. Aguais says the next step is to start seeking grant money to help them expand their service. Pharmaceutical company contributions have been minimal. Regional offices are funded primarily by individuals in these countries. There are four full-time workers in Venezuela, three in Peru, one in Chile, and one in the Dominican Republic. Six full-time workers, including a physician, staff the New York office along with the help of volunteers and unpaid staff. Promises of funding for new offices in Colombia, Honduras, and Brazil have been received.
AID for AIDS Immigrant Program
As an offshoot of their drug-recycling work, AfA uncovered an unmet need among immigrants to the New York region that they decided to address. HIV-positive immigrants to the United States, regardless of legal status, have few support services to help them obtain HIV medications. AfA supports one case manager to serve 240 immigrant clients with education, counseling, and referral for care. AfA helps this underserved population to enroll into Medicaid and state ADAP programs that pay for HIV drugs.
Immigrants may lack a stable address or privacy at home, and they may face stigma if HIV drugs are mailed to them directly. As a service, AfA offers its address to receive medications mailed from pharmacies and drug assistance programs, then holds the packages for pickup by the client. This program does not involve recycled drugs and is only for individuals who have a source of prescription drug assistance.
Most Common Drugs
Currently there is a shortage of nelfinavir (Viracept) and efavirenz (Sustiva, Stocrin). AfA has a surplus of amprenavir (Agenerase), ritonavir (Norvir), saquinavir (Invirase) and delavirdine (Rescriptor).
A wide range of antifungal and other anti-infective drugs to treat and prevent HIV opportunistic infections are also routinely shipped, with TMP/SMX (Bactrim) the most requested drug. No narcotics are accepted.
How You Can Help
Individuals in New York who wish to donate can call the AfA office and arrange to have someone pick up the drugs. Those outside of New York can mail their donations to the office. AfA will provide FedEx shipping for large donations.
AID for AIDS
Other Drug Recycling ProgramsHIV Medicines for Guatemala
Dr. Matt Anderson
African AIDS Network
Also, see the December 2000 issue of POZ Magazine's POZ Partner for more about AID for AIDS and other HIV drug recycling programs.
This article was provided by Gay Men's Health Crisis. It is a part of the publication GMHC Treatment Issues. Visit GMHC's website to find out more about their activities, publications and services.