Home » Global Health, Global Health Projects

Antibiotic Resistance: Conquering the Killer Within

January 11th, 2010

Section I: Summary

Antibiotic resistance has become a major hurdle in treating diseases. The rate of drug discovery is incomparable to the rate of drug resistant bacterial mutations. Although the treatment of many diseases has been impaired by this challenge, the treatment of tuberculosis, one of the top three infectious diseases, is by far the most impeded. Tuberculosis, which affects one third of the world’s population[1], is highly prevalent in the developing world. As a result, the treatment and prevention of this disease has been limited due to lack of funding, research, and established programs. The global emergence of multi drug resistant tuberculosis (MDR-TB) has quickly become a universal concern.  The lack of effective drugs to treat MDR-TB has drawn our attention to preventative measures to impede the possibility of global emergence.

Our strategy towards a preventive measure was inspired by successes seen in rebate programs applied in various contexts.  Rebates have infrequently been implemented in the health sector.  As premature termination of drugs is a major contributing factor to antibiotic resistance, instituting a rebate system in the health sector will motivate patients to comprehensively complete drug regimens because of the financial responsibility placed on them. The rebate system has great potential as it not only motivates patients, but also provides an incentive for pharmaceutical companies to provide the rebate. Patients are more likely to complete and thus receive greater amounts of the antibiotic if they have an incentive to finish their drug regimen. As a consequence, there will be greater demand for the antibiotic from the manufacturing pharmaceutical companies, causing increased revenue. If only a portion of this were to be redistributed in form of a rebate to the patients, this program would not only be self-sustainable, but also not require government funding. In conjunction with a national awareness campaign regarding the importance of drug completion and the potential for a financial rebate, the rebate system has great promise in areas without preexisting treatment programs.

In areas with existent treatment programs where drugs are provided to patients at no cost, rewards and contract programs can be used to entice patients to complete their drug regimen. Through this program, patients are reimbursed for transportation fees, and provided with food and hygiene products, after receiving treatments. Although this program is not self-sustainable, as it requires that a third party, such as the government, to provide funding for the rewards, case studies have indicated low costs associated with this program. Patients sign a binding contract stating that they will be financially responsible for the cost of treatment if they do not complete the drug regimen, further enticing them to comply with the regulations of the program. We believe that the implementation of these programs provide motivation for patients to complete prescribed drug regimens, diminishing the emergence of drug resistant tuberculosis due to selective pressure associated with early termination of drugs.

antibioitic_resistance_concept_map

Section III: Microbial Resistance

The development of antimicrobial agents to fight infectious diseases was a breakthrough in the scientific community. Antimicrobial agents have proven to be very effective in treating certain diseases; however, their effectiveness is only attainable when they are administered and used appropriately. Microbes can confer resistance as a result of natural mutations in their genetic code, though a more pressing concern is resistance attributed to human factors. Failure to adhere to drug regulations or drug regimens results in a microbe’s ability to survive in the presence of the particular drugs used. This microbial resistance is then passed on to the microbe’s progeny as it replicates and divides. The ease and rapidity at which microbes pass on genes conferring resistance pose a serious threat to our health and our ability to fight off infections, for which science and drugs simply cannot keep up. The avenue in which to best combat this issue lies in amending human factors, as they are a major cause of antimicrobial resistance[2].

Drugs rendered ineffective by antimicrobial resistance have serious implications for treating infectious diseases. If a microbe develops resistance to first-line drugs, second-line drugs are then issued which are typically more expensive. Treatment is usually much longer, less successful and tends to have more harmful side effects– all factors that increase the chance of resistance spreading. Seeing the potential for antimicrobial resistance to become an even larger concern, the World Health Organization (WHO) initiated the Global Strategy for Containment of Antimicrobial Resistance in 20011. As stated in the title of this project, antimicrobial resistance is a global issue; every country is susceptible to the phenomenon and thus every country must take action. All countries, developing or developed, need to collaborate in order to help stop the spread and emergence of antimicrobial resistance. Moreover, because of increased globalization and ease of transnational travel, the threat of resistance spreading across boarders is greatly increased.

Tuberculosis

One disease in particular that is subject to microbial resistance is tuberculosis (TB), which is a contagious airborne diseased caused by the bacterium Mycobaterium tuberculosis. TB is one of the top three deadliest infectious diseases, alongside HIV/AIDS and malaria[3]. One third of the world’s population is infected with M. tuberculosis, with 10% of them developing the active, transmissible form of TB, capable of infecting an average of 15 other individuals[4]. Clearly there is the potential for the spread of TB to grow if left unchecked. The number of global TB cases has increased from 6.6 million in 1990 to 9.27 million in 20074. Although TB is present in every country, the regions hit hardest with the disease are Asia and Africa, where 55% and 31% of the incident cases in 2007 were located, respectively[5]. As seen in Figure 1 (pg. 3), the number of TB cases has increased for both Asia and Africa, while the number of TB cases in other regions has remained roughly the same. This figure also shows that the rate of increase in Africa is greater than that of Asia, partly due to the higher rate of HIV in Africa2.

antibioitic_resistance_figure_1

Figure 1. The number of new TB cases per year for Asia, Africa, and other regions between 1990 and 200510

Several initiatives have been put in place to help stop the spread and emergence of TB, including the WHO-led DOTS (directly observed treatment, short-course), the Stop TB strategy, and the Green Light Committee. All three, in addition to other programs, have been successful in stopping TB’s prevalence in countries that strictly adopt their policies. In particular, DOTS has been able to produce cure rates of over 95% in countries that comprehensively adopt the program5. DOTS’ success stems from its insistence on directly observing patients take their medications. One of the biggest problems with TB treatment is that patients do not realize the importance of strictly adhering to their drug regimen. If throughout the course of treatment they begin to feel better, they may stop taking their medications because they believe they have been cured. Terminating treatment, however, has dire consequences, as it allows for those microbial strains to develop resistance to the drugs that were used. In the case of TB, developing resistance to both first-line drugs – isoniazid and rifampicin – results in multidrug-resistant TB (MDR-TB)[6].

Multi-drug Resistant Tuberculosis

A person can acquire MDR-TB either by catching it from another individual, or by developing resistance after failed attempts at treating drug-susceptible TB. Because MDR-TB is resistant to both first-line drugs, second-line drugs must be used, which tend to produce harmful side effects. These drugs are much more expensive as well, as they can be up to 1400 times more costly than first-line drugs7. Treatment is also much longer; drug-susceptible TB treatment lasts roughly six months, while MDR-TB treatment lasts up to two years. A 2007 study in Singapore found that the transmission rate of Beijing’s MDR-TB strains increased from 4.4% to 7.7%8. Additionally, the cure rate of MDR-TB decreased to 67% from a 95+% cure rate for drug-susceptible TB9. If MDR-TB is not properly treated, it can lead to extensively drug-resistant TB (XDR-TB), which has even more serious implications regarding treatment9. Seeing the complexity and difficulty of treating MDR-TB, our solution to this problem takes a preventative approach; it consists of implementing an initiative that targets drug-susceptible TB so that it does not develop into MDR-TB.

antibioitic_resistance_figure_2

Figure 2. The incidence rates of MDR-TB between 1994 and 2007 on a global scale66.

According to Figure 2, the areas in yellow correspond to countries with more than a 6% incident rate of MDR-TB among new TB cases. It is clear that the highest rates of MDR-TB are located in Eastern Europe, the Russian Federation and areas in Western Asia. It is estimated that the population-weighted mean of MDR-TB cases among all reported TB cases worldwide is 5.3%, with some areas reporting 0% and some areas reporting up to 35%6. Even though absolute numbers of TB cases are located largely in Asia and Africa, the occurrence of MDR-TB is greatest in India and China (who shoulder 50% of the cases), and the Russian Federation (who shoulders 7% of the cases)6.

The WHO report, Anti-tuberculosis drug resistance in the world, published in February 2008 recorded the highest rates of MDR-TB compared to all previous reports. It estimated that half a million new cases of MDR-TB emerge a year10. Even though it reported the highest rates worldwide, MDR-TB trends vary by region. In Peru, for example, MDR-TB is on the rise, while in the US, MDR-TB is declining6. Proportions of MDR-TB among all TB cases in Moldova, Ukraine, the Russian Federation, and Uzbekistan were all higher than the rates recorded in 2004. The country with the highest recorded rate was Eastern Europe’s Azerbaijan, where 22.3% of all TB cases were MDR-TB1010.

Targeting MDR-TB in Eastern Europe

Referring back to Figure 2, one of the regions with the highest percentage of MDR-TB among new TB cases is Eastern Europe, making it our region of interest in targeting MDR-TB. Table 1 shows the large disparity between Eastern Europe and the remaining regions regarding the percentage of MDR-TB. The proportion of MDR-TB in Eastern Europe is 22.6% for combined cases, 10.0% for new cases, and 33.7% for previously treated cases.

antibioitic_resistance_table_1

Table 1. Incidence rates for MDR-TB per region among new cases6.

This is dramatically higher than rates in Central and Western Europe, where proportions of new, previously treated, and combined cases are 9%, 7.7%, and 1.5%, respectively6. As seen in Figure 3, the proportion of MDR-TB among TB cases is greatest in Azerbaijan, Moldova, and the Ukraine.

antibioitic_resistance_figure_3

Figure 3. Rates of MDR-TB among new cases in various countries6.

The high rates of MDR-TB in Eastern Europe are largely attributed to the fall of the Union of Soviet Socialist Republics in 1991. The Soviet prisons were breeding grounds for MDR-TB because of poor sanitation environments; when these prisoners were released in 1991, MDR-TB was no longer contained in prisons, but spread amongst the population.  The economic crisis that ensued affected the health care system, resulting in poor treatment of infectious diseases, including TB. This ultimately led to increased prevalence of drug-resistant TB throughout the region. Some countries were less affected, such as Georgia, which recorded proportions of resistance among new cases to be 6.8%6. Such countries have attributed their lower rates to strict adherence to WHO-led initiatives. Needless to say, failure to strictly adopt these policies can result in higher rates of drug-resistant TB, which has been the case in many countries3. For example, Figure 4 (below) shows the difference in MDR-TB rates between Chile and Estonia11. Poor handling of TB, along with a lack of DOTS in Estonia led to increased rates.  On the other hand, the very low rate of MDR-TB in Chile over the years is credited to the presence of the DOTS program, indicating the effectiveness of the program.

antibioitic_resistance_figure_4

Figure 4. MDR-TB rates in Chile and Estonia from 1991 to 199811.

Conclusions Regarding this Pressing Issue

From discussions about the issues associated with antimicrobial resistance, TB, and particularly MDR-TB in Eastern Europe, it is clear that further actions must be taken in order to tackle this rising problem. Despite increased surveillance and improvements in treating TB patients, drug-resistant TB is still prevalent, especially in the Eastern European region. Our solution to this issue recognizes the lack of TB-drug education among patients and the medical community, and also recognizes the need for an incentive for patients to complete their drug regimens to prevent the spread of resistant strains.

Section IV: Solutions

Providing a solution to prevent the spontaneous occurrence of antibiotic resistance in tuberculosis patients revolves around preventing the selective conditions for mutated resistant bacteria to form. There are two means of approaching a preventive solution to prevent resistance: through the healthcare providers, or patients.  Although regulating the prescription of drugs to patients is an important and essential part of preventing drug resistance, we decided to focus on implementing strategies to prevent this global challenge through the patients for several reasons. Educating physicians about carefully prescribing medications to patients can ensure that patients are given the correct antibiotics, but it cannot guarantee that they will complete their dosages. Enticing patients to take drugs responsibly by educating them and providing them with an incentive is the best approach to preventing the occurrence of antibiotic resistance.

Financial rebates have been useful in various facets of society including recycling programs, product sales, and the automobile industry; however, they have been underutilized in global health programs. Rebates have proven to be a powerful tool to entice the public when there is general reluctance. Tuberculosis programs that have incorporated material and financial incentives have shown to have great success. We propose financial rebates as a means to increase patient responsibility when taking anti-tuberculosis antibiotics, and thus prevent the outbreak of antibiotic resistance. The true novelty of this program is its self-sustainability and it’s funding which rests in the hands of the private sector rather than government funding and organizations.

Rebate Program: Involving the Public and Private Sectors

Often, tuberculosis patients discontinue treatments when symptoms cease to exist. Unfortunately, rather than confirming that they are cured of the disease with a medical examination and tests, patients terminate their treatments on their own. Due to the latency of the diseases, bacteria usually continue to exist within the patient, after symptoms have terminated. When antibiotics are terminated prematurely, patients discontinue purchasing the drug from pharmacies. If there is a financial incentive for patients to continue purchasing and taking the treatment to the end of the course, they will undoubtedly purchase more of the antibiotics. In turn, this increased demand will provide increased profit for pharmaceutical companies. If only a margin of these increased profits was redistributed in form of rebates to patients, patients would continue to buy the entire course of the antibiotic, thus creating a self-sustainable cyclic rebate system. There will undoubtedly be patients who do not receive the rebate because they did not follow the guidelines; we suggest that the rebate be distributed to responsible healthcare providers to encourage diagnosis and proper record keeping and drug prescription. This rebate system is based on a similar strategy enacted by the Bangladesh Rural Advancement Committee, in which patients made a deposit when beginning treatment, which was partially returned to them when the treatment was completed. [7]

In addition to the rebate system, we propose the implementation of a government funded advertisement campaign to promote antibiotic resistance awareness. The purpose of this campaign should be to make residents aware of the symptoms that are characteristic of tuberculosis, and the importance of finishing and not sharing prescribed antibiotics. Without proper education on the risks to patients’ families and themselves, patients may discontinue treatment when symptoms subside.[8] As a part of this program, hospitals should implement a tutorial for patients diagnosed with tuberculosis and physicians detecting and treating tuberculosis. When patients are prescribed antibiotics, they should be made aware of the importance of completing their drug regimen as well as the opportunity to receive financial reimbursement for completing the treatment and frequently getting retested. In combination with a rebate, this two-tiered program will not only educate patients on the importance and severity of multi drug resistant –tuberculosis, but also provide them with an incentive to complete the entire treatment.

antibioitic_resistance_figure_5

Figure 5. The Self-Sustaining Cycle of the Rebate System.

Successful Cases Supporting this Program

Although the financial aspect of the rebate program is dependent on pharmaceutical companies, enforcement or regulations by the government is essential to the success of the program. In the oblast (district) of Orel in Russia, a combination of patient incentives, and monitoring and enforcement by the tuberculosis facilities and legal systems led to a very high success rate; only 3% of those diagnosed with tuberculosis neglected to complete their treatments, a much higher rate than surrounding areas.[9] The key to successful tuberculosis treatment program is the strict monitoring; if patients fail to attend treatments for three consecutive days, the doctor is sent to their home to speak with the patient. If in-facility treatment cannot be arranged, outpatient treatments are available at the patient’s home. If the patient refuses to comply, a representative from the nearest TB program visits the patient to inform them of the danger due to the patient’s negligence. This is followed by a visit from the police and lastly, a court notice. The endangerment of those around the patient refusing treatment is grounds for breaking the law. This strict enforcement has decreased incidence by 26.5%, mortality by 48.3%, and prevalence by 44.5%[10]. This district has become a model for tuberculosis treatment and containment success.

antibioitic_resistance_figure_6

Figure 6. Successful TB treatment monitoring system in the District of Orel.

The DOTS program has had massive success in TB prevalent areas, as treatments are overseen by medical personal, volunteers, or family members, preventing irresponsible or inconsistent antibiotic use.  However, the success of this program comes at a cost, which is unaffordable to some. The cost of traveling to healthcare facilities, frequent tests, and drugs becomes high, and, as a result, patients from impoverished backgrounds are often unable to comply with the DOTS standards. By providing a rebate to the patient for the cost of the drugs, and thus removing obstacles preventing treatment completion, impoverished patients, who have higher rates of TB,[11] are more frequently able to overcome the disease.

Rather than basing the rebate on the treatment outcome, the issuing of rebates is dependent on the actions of patients; attendance to treatments and examinations are requirements for this program to be successful. In addition to it’s self sustainability, the rebate program has potential and is an attractive option because it requires patients to assume the financial cost of the treatment, enticing patients to comply with the regulations of the program. Although other incentive programs have been used in regulating and promoting the treatment of tuberculosis, we suggest this novel program, as it helps sustain the pharmaceutical company providing the drugs, as well as make the patient financially liable for a part of the cost. While aforementioned deposit programs may seem more attractive, as patients receive most or the entire sum of the deposit back after completion after treatment, these programs are dependent on government funding to provide the drug at low or no cost. Fluctuations in national budgets and the priorities of varying political parties can have devastating effects and cause regression.

Establishing Incentives with Preexisting Treatment Programs

In cases where there are already preexisting programs, which cover the cost of DOTS treatment, our rebate program is not an option. The foundation for our rebate program relies on the rebate being provided from the pharmaceutical companies, which comes from increased profit margins. In these situations, we propose a program that incorporates a rewards program as well as government awareness campaigns and legal enforcement.

The rewards program specifically targets the impoverished population, which shows the highest rates of TB prevalence. Through this program, in return for receiving treatments, patients are provided with transportation fees, food, and hygiene products – basic living necessities. The program providing the free antibiotics regulates and oversees patient treatments and visits. In addition, TB facilities and physicians oversee the program. Unlike the rebates program; however, this program is not self-sustainable, as it requires that government or a third party fund the rewards for this program.

antibioitic_resistance_figure_7

Figure 7. Noncyclical Rewards System in areas with Preexisting Treatment Programs.

Alternatively, a contract program would entice patients to attend and receive treatment regularly in a similar way that the rebate program does, but is applicable in areas where patients receive free treatments. In this program, patients would sign a contract agreeing to complete their treatments or pay for the medications they received, prior to the treatments. Rather than paying a deposit fee, patients sign a contract making them legally responsible for the payment of the treatments if they fail to take antibiotics. Because the cost for breaking the contract is rather high for low-income patients, this program provides a financial incentive for patients to comply and receive treatments. Although this may seem unethical or unattractive to push treatments on patients by holding them financially responsible, it seems more unethical for patients to not receive free treatments and put those around them at serious risk. The Perkumpulan Pemeberantasan Tuberkulosis Indonesia- Jakarta program has used a similar contract method. [12]

Conclusions Regarding Solutions

When it comes to solving the problem of antibiotic resistance in tuberculosis, there is no silver bullet. Ideally, the rebate program would provide the best solution as it is self-sustainable and holds patients financially responsible for receiving treatments. However, in areas where free treatments are already available, this program is not useful. Rather, the rewards and contract programs are useful because both can be applied to incentivize patients to attend treatments. In conjunction with awareness campaigns organized by the regional or national governments, we believe that these programs will be successful based on effective models of similar TB programs.

Section V: Strengths and Weaknesses of Our Solution

The intrinsic nature of each program type allows for certain strengths and weakness. An understanding of the factors that lead to these differences is critical to understanding the distinguishing characteristics of each program. In this section, the rebate and rewards-based programs will be compared with the intention of emphasizing their perspective strengths and weaknesses that, in turn, determine their appropriateness for a specific region.

The Need for Third-Party Participation

As has previously been described, the Rebate Program and Rewards Program differ in their degree of self-sustainability. The Rebate Program’s simple two-party system requires participation from only those sectors that stand to immediately benefit, those patients who are – or at least believed to be – infected with M. tuberculosis and the associated private pharmaceutical corporations (PMCs). The patients will be incentivized to complete the appropriate drug regimen because of the financial rebate. Similarly, the PMCs will be incentivized to provide the financial rebate because patients who might otherwise prematurely terminate treatment will buy more drugs. Thus, both patients and PMCs have a financial incentive to participate in the Rebate Program.

The Rewards Program, on the other hand, requires participation by a third party that does not stand to immediately benefit or make a financial profit. To sustain the Rewards Program, local and/or federal government assistance in the form of funding is absolutely necessary because the funds will be used to provide the actual rewards. Though the rewards may change depending on the region and socioeconomic class targeted by the program, the rewards themselves are the principle component of the Rewards Program. Without them, patients will not be incentivized to seek treatment and the program may not be as successful.

The operational maintenance of the rebate and rewards-based programs is the major difference between them. The Rebate Program is self-sustaining because it does not require funding by a third party. Rather, both the patients and PMCs are financially motivated to participate. However, the Rewards Program is forced to compete with numerous other programs and organizations for scarce government or agency funding. Ultimately, the Rebate Program is self-sustaining while the Rewards Program is not self-sustaining.

The Superiority of the Rebate Program in Terms of Self-Sustainability

The financial self-sustaining nature of the Rebate Program is its major strength. In fact, a recent publication in the British Medical Journal argues that the development and implementation of sustainable measures to improve adherence to TB control programs is of critical importance1. Though multiple reports have been made on the types of intervention used by TB control programs such as DOTS2, a publication in Tropical Medicine and International Health states that “most of these interventions, however, depend heavily on additional inputs, including external funding, and their sustainability is highly questionable” 3.

The self-sustainability of the Rebate Program makes it a potential long-term strategy for TB control in Eastern Europe. While the continued operation of the Rewards Program is contingent upon a dependable stream of funding, the Rebate Program is not. Many unanticipated factors can end government – or even agency – funding. For example, the short-term horizon of governments and funding agencies in addition to short budget cycles during times of internal political pressures can have negative impacts on the necessary funding4.  This unpredictable source of funding compromises the sustainability of the Rewards Program. Clearly, termination of the Rewards Program in a specific region due to lack of funding is counterproductive if TB still occurs in the area. Because the Rebate Program does not face the possibility of termination due to lack of third-party funding, it is superior to the Rewards Program in terms of self-sustainability.

The dependency of the Rewards Program on external inputs, however, should not be misinterpreted as a crippling feature. Tuberculosis control programs such as DOTS that also require funding have proven to be “remarkably inexpensive and cost-effective”5. A study conducted in Thailand, for example, found that for every $1.00 invested by the government in tuberculosis control, the local community gained $50 over a 20-year period6. In some low-income countries such as India, in fact, the per capita costs of implementing DOTS are as low as $0.057. This is significant because it shows that despite the need of the Rewards Program for funding, it can still prove to be highly economically efficient.

The Potential for Black Markets

Preexisting market conditions in the target region dictate which program is appropriate. In a market system where the patient community must pay for drugs, the Rebate Program should be used. In a market system where the drugs are freely available, the Rewards Program must be used. The possible development of black markets to satisfy the demand for antibiotics must be considered for each program type.

Black Markets as a Possible Weakness in the Rebate Program

The Rebate Program will require PMCs to charge slightly higher than normal prices for antibiotics. Appropriate TB treatment will thus represent a greater financial burden for patients under the Rebate Program. It is important to note, however, that this will only be the case during the actual course of treatment when the drugs are being bought. Ultimately, upon completion of the drug regimen, the patients will benefit when they receive the financial rebate. Nevertheless, the temporary price inflation may drive some patients to seek the drugs in black markets.

Patients who believe that the extended TB drug regimen is unnecessary to treat the disease will be unwilling to pay the inflated prices. This is of particular concern in Eastern Europe where a direct correlation has been found between TB incidence and wealth inequality8. Because individuals of lower socioeconomic status may not be able to afford the complete treatment, they may seek temporary treatment by buying drugs in black markets. This will compromise the efficiency of the Rebate System to control the evolution of drug-resistant strains of TB.

The fall of the communist regime in Eastern Europe took with it many of the control systems for a healthy market economy. The absence of these control systems have allowed for the flourishing of black markets9. The development of black markets under the Rebate Program may signal a failure on part of the tutorial system. The tutorial must succeed in convincing patients that the full regimen has to be completed in order to clear their bodies of the mycobacterium.

The establishment of black markets in a specific region can be prevented in two ways: either the tutorial system can be improved and/or the underground demand for TB drugs can be monitored. Expansions or improvements to the tutorial system will come in the form of greater educational efforts. The monitoring of underground demand will require constant policing networks. The employment of personnel and organization of resources necessary to improve the tutorial system and/or police underground networks will be a financial burden on the Rebate Program – potentially compromising its self-sustainability.

The Non-Existence of Black Markets is a Strength of the Rewards Program

The emergence of black markets is unforeseen under the Rewards Program. The rewards-based program requires a market system in which drugs are free. There will be no underground demand because the drugs are freely available. This is a strength of the Rewards Program.

The Potential for Negative Reactions

In areas where treatment is free, contractual agreements will be made with all patients seeking antibiotics. The contracts will be signed by patients before receiving any drugs and will dictate a set of conditions by which, should the patient prematurely terminate the drug regimen, he or she will have to pay the full cost of all the drugs taken up until the point of default. This will further incentivize patients to complete the treatment.

Note that contracts demanding payment cannot be used under the Rebate Program because patients will already be paying for their own drugs.

Contracts in the Rewards Program

Implementation of the contract system represents a change in the established means of acquiring drugs. By requiring patients to pay for the drugs themselves if they do indeed default, the contract may induce a negative public perception and/or reaction towards the Rewards Program. This is of unique concern in Eastern Europe where incomplete treatment often leads to the development of bacterial resistance10. Patients may refuse to participate in the Rewards Program if they believe – for whatever reason – that they will have to default. The fear of having to pay for treatment may cause them to shun the program and continue with the current inappropriate forms of treatment.

Concluding Remarks on Strengths and Weaknesses

This section has described the strengths and weakness of the rebate and rewards-based programs. The Rebate Program is highly self-sustaining under ideal conditions because both patients and PMCs have economic incentives to participate. Also, the Rebate Program does not require participation from a third party. The Rewards Program, on the other hand, is not self-sustaining because it requires funding from the organizations or governments in order to provide the actual rewards that are necessary to its continued operation. The need for funding, though, does not seriously compromise the effectiveness of the Rewards Program.

Each program has unique difficulties that must be considered. The Rebate Program is threatened by potential black markets while the Rewards Program is threatened by the patient’s negative reaction to having to sign a contract. Nevertheless, both programs are novel approaches to incentivizing TB patients in Eastern Europe to complete the appropriate drug regimen and, thus, control the spread and development of resistance amongst TB strains.

Section VI: Role of USAID and Policy Proposal

The rebate program links the private sector directly to TB positive patients, negating political volatility from tempering with the effectiveness of our solution.  In order to see lasting results in our efforts to contain—and diminish—the prevalence of MDR-TB, the action plan must be long-term.  By taking politics out of the equation, the rebate program comes through as impartial, credible and independent.  These qualities are particularly important because it inherently guarantees that patients will be rebated at the end, should their tests yield smear-negative results.  Because the rebate program does not have to factor in the nature of governance structures, it can be applied to any and all countries and be equally effective in improving the TB situation in respective countries.

From the experts we have consulted, we have discovered USAID to be especially involved in health issues around the world.  Not only does USAID have regional experts who specialize in understanding the social, political and cultural aspects of each region, but they also assign TB experts to the areas that demand extra attention on the disease.  Carolyn Mohan, one of the experts we interviewed, is USAID’s TB specialist in Eastern Europe.  Because of her unique position, she plays an integral role in incorporating health problems in Eastern Europe with the other USAID strategies in the area.  In addition, USAID seeks to build partnerships with local organizations as well with international agencies.  Because of how USAID is orchestrated, we think it is the optimal organization to champion the rebate program in different regions.  These experts would be adept at sticking to the backbone of the rebate’s objectives while modifying it to cater to each region’s distinct characteristics.

Furthermore, it is important to highlight that the rebate program relies on the cooperation of the private sector.  Specifically, it is the pharmaceutical industry.  Since the main pharmaceutical corporations that produce TB drugs are from the United States, having a US-based organization would be best in securing their participation.  USAID realizes the importance of maintaining relationships with private enterprises, and “has working relationships with more than 3,500 American companies.”[13] The rebate program is contingent on the pharmaceutical industry’s cooperation; pharmaceuticals need to know that a reliable “middle man” will be in charge of this following through with details of the rebate program.  Rather than having an international organization head the rebate program, USAID is in an unrivaled position because of its special track record with the US pharmaceutical companies.

As mentioned before, the solution we think will be most effective in addressing MDR-TB is a preventative one, with a mandatory tutorial prior to treatment and a rebate program at the end for successful patients.  At the same time, however, we realize that the current TB strategies operating across regions are different and must be factored in.  Since TB drugs are presently free for patients in Eastern Europe, the rebate program would not take off simply because it is highly unlikely for patients to agree to pay for drugs (even if they are rebated) if drug availability is currently unconditional.  Therefore, our proposal for Eastern Europe—as well as all other regions where TB drugs are free—to implement and enforce the rewards program.  In regions where these drugs are not free, our proposal calls for the adoption of the rebate program because it is distinctively self-sustaining and not subject to political caprice.  The latter is detailed in USAID proposal format below.

USAID Proposal:  Tutorial and Rebate Program for Drug-Susceptible Tuberculosis Patients

  1. A. Program Goal

To implement a preventative action plan that will address the growing MDR-TB population, mainly in Eastern Europe and Asia.  This action plan hopes to contain—and diminish—the number of MDR-TB patients by proactively motivating drug-susceptible TB patients to fully complete their drug regime.

  1. B. Critical Assumptions
    1. Drugs that meet international standards will be readily available for patients in all regions.  These drugs can be purchased through the Global Drug Facility.
    2. Pharmacies are readily prepared with TB drugs and are at least located in all the main cities and towns
    3. Physicians and health care provider have the proper training and facilities to correctly diagnose patients displaying TB symptoms.  They are also well read in the drug regimen and treatment process
    4. Governments are supportive of the DOTS program and all efforts to decrease the TB population
    5. Drugs will remain free in Eastern Europe
  2. C. Objectives and Expected Results: focus on the health sector
    1. Objective 1: to increase citizen understanding of drug resistance TB through the mandatory tutorial prior to drug regimen.

i.  Expected Results: a population more aware of the effects of premature termination of drug regimen.

  1. Objective 2: to keep physicians aware of the accuracy of their diagnosis by providing them with data to show proportion of patients with smear-positive TB results at beginning of drug regime and upon completion.

i.  Expected Results: higher percentage of proper diagnosis than prior to rebate program.

  1. Objective 3: to motivate patients to complete the entire drug regime with the conditional rebate at end of drug treatment period.

i.  Expected Results: a larger number of Tb patients who thoroughly complete drug regimen than previous to rebate program.

  1. Objective 4: coordinate a timely rebate provided from pharmaceutical company to patient.

i.  Expected Results: pharmaceuticals will standardize a system of providing rebates to successful TB patients.

  1. Objective 5: to decrease the number of MDR-TB cases through containing the number of existing MDR-TB patients.  These patients will continue to undergo second-line drug treatment headed by the Green Light Committee.

i.  Expected Results: percentage increase of MDR-TB patients will reduce per year until there are no more new MDR-TB cases.

  1. Indicators and Performance Baseline Data
  2. D. Indicators and Performance Baseline Data: “Indicator” number correlates to “Objective” number in [C]
    1. Indicator 1: Number of patients coming in for diagnosis per month.  If the national population is becoming more aware of the symptoms of TB/MDR-TB, they should be more apt to come in for smear tests.
    2. Indicator 2: Number of TB diagnosed patients compared to the number of rebates granted upon end-of-regimen testing.
    3. Indicator 3: Percentage of Tb diagnosed patients who come back at the end of regimen for a test, and get approved for rebate upon smear negative results.
    4. Indicator 4: Average time for a) a rebate request to reach pharmaceutical companies and b) average time for a rebate to be received by patient.  Another indicator would be the number of complaints filed to pharmaceuticals regarding untimely receipt of rebate.
    5. Indicator 5: WHO’s periodic report on new TB/MDR-TB cases worldwide.
    6. Performance Baseline Data: number of patients coming in for diagnosis per month, estimated number of TB patients per region, estimates of new TB cases next year, and estimated of new MDR-TB cases will serve as baseline data.
  3. E. Implementation
    1. Since USAID’s role is to coordinate the linkage between patients and pharmaceuticals—and thus plays an indirect role in this humanitarian effort– stating a targeted number of beneficiaries is not applicable.  It is important to note, however, at the targeted demographic of this program would be all TB positive patients in respective regions.
    2. USAID will negotiate a standardized rebate amount that pharmaceuticals must adhere to.  There could be some variation that is dependent on the differences in drug costs in different countries.
    3. USAID will, through partnerships with indigenous organizations and health care providers, create a paperwork process that is both credible and easy to understand for patients to request rebates from pharmaceuticals.
    4. In the beginning stages, USAID will be evaluating the efficiency of the rebate program, as well as if there are any loopholes in execution.  Revisions will be made if necessary.

Monitoring Plan

  1. Number of patients coming in for diagnosis per month:  provided by governments and health care institutions.
  2. Number of TB diagnosed patients compared to the number of rebates granted upon end-of-regimen testing:  provided by health care institutions. Data from the DOTS program will be used to cross-check the information provided by these health care institutions.
  3. Percentage of TB diagnosed patients who come back at the end of regimen for a test, and get approved for rebate upon smear negative results: provided by health care institutions. This number will be cross-checked with the number of rebates sent to pharmaceutical companies for accuracy.
  4. Average time for a) a rebate request to reach pharmaceutical companies and b) average time for a rebate to be received by patient.  (A) is provided by pharmaceuticals.  (B) will be evaluated based on the number of patient complaints.

*The rebate program will be evaluated bi-monthly for the year, and then every three months as maintenance.

*USAID’s TB specialists will be in charge of gathering the data mentioned above from regional governments, health care institutions, indigenous organizations, pharmaceuticals and international health organizations every two months (for the first year) and three months (for the following years).  If the rebate system seems to be operating effectively, thorough evaluations can be reduced to a bi-annual basis.

Evaluations

  • Evaluation forms (each question answered with a 1-5 “not satisfied” to “very satisfied”) will be distributed to physicians and pharmacists on a bi-monthly basis (frequency will be reduced when rebate system becomes ingrained).
  • A rewards incentive (either in a free meal or coupons) will be given to patients who volunteer to fill out the evaluation form post-rebate.  Same evaluating format as above applies here.
  • Periodic debriefing with pharmaceuticals on rebate system.  Since these persons would be easier to contact, evaluations will be in the form of interview.
  1. F. Transition or Exit Strategy
    1. When rebate system appears to be seamlessly incorporated into each countries’ health structure, USAID will execute a phase out strategy.  This will mainly be done through reduced participation in the monitoring process.

Others Works Cited:

Berry, M., Kon, O.M. “Multidrug- and extensively drug-resistant tuberculosis: an

emerging threat.” Eur Respir Rev 2009; 18: 114-197.

<http://err.ersjournals.com/cgi/reprint/18/114/195

CDC. “Multidrug-Resistant Tuberculosis (MDR TB) and Extensively-Drug

Resistant (XDR) TB.” Centers for Disease Control and Prevention, last       reviewed June, 2009.<http://www.cdc.gov/tb/publications/ webcourseswebinars/mdrandxdrtb/SlideText.htm>

Downey, Maria. “Energy rebate program proves a success in Alaska.” Alaska’s            News Source. KTUU. http://www.ktuu.com/Global/story.asp?S=11146416,

Anchorage, Alaska, 16 Sept. 2009. Web.

Mabs-zeno, Carl. “Sciene and Society: Antibiotic Resistance.” Personal interview.        12 Oct. 2009.

Mohan, Caroline. “Science and Society: Antibiotic Resistance II.” Personal        interview. 23 Nov. 2009.

Nunn, P. “Addressing the threat of drug resistant TB: a realistic assessment.”

Institute  of Medicine – Stop TB Department, Nov 5,

2008.

<http://www.iom.edu/~/media/Files/Activity%20Files/Research/DrugForum/Nunn.ashx>

“Tuberculosis cases.” Map. WorldMapper. N.p., n.d. Web. 6 Dec. 2009.

<http://www.worldmapper.org/display.php?selected=228>.

“USAID: Infectious Diseases, Russia.” U.S. Agency for International

Development. USAID, May 2009. Web. 6 Dec. 2009. <http://

www.usaid.gov/our_work/global_health/id/tuberculosis/ countries/eande/russia_profile.html>.

WHO Global Strategy for containment of Antimicrobial Resistance.

Antimicrobial Resistance. The World Health Organization,

n.d. Web. 3 Dec. 2009. <http://www.who.int/medicines/  areas/rational_use/   WHO_Global_Strategy.htm/en/     index.html>.

WHO. “WHO report 2009 – Global tuberculosis control –    Epidemiology, strategy, financing.” 2009.< http:// www.who.int/tb/publications/global_report/2009/key_points/ en/index.html>

WHO. “10 facts about tuberculosis.” 23 March 2009.< http://

www.who.int/features/factfiles/tuberculosis/en/index.html>

Wright, A., Zignol, M. “Anti-Tuberculosis Drug Resistance in the             World.” WHO/IUATLD Global Project on Anti-Tuberculosis     Drug Resistance Surveillance, 2008

Zolotova, Elena. “Russian oblast is model in fight against TB.”    Bulletin of the World Health Organization. NIH, May 2007.        Web. 1 Dec. 2009. <http://www.ncbi.nlm.nih.gov/pmc/         articles/PMC2636654/>.


[1] WHO. “10 facts about tuberculosis.” 23 March 2009.

< http://www.who.int/features/factfiles/tuberculosis/en/index.html>

[2] “WHO | Antimicrobial resistance.” Jan. 2002. Web. 10 Dec. 2009. <http://www.who.int/mediacentre/factsheets/fs194/en/>.

[3] Dye, C., Harries, A.D., Maher, D., Hosseini, S.M., Nkhoma, W., Salaniponi, F.M. “Tuberculosis — Disease and Mortality in Sub-Saharan Africa — NCBI Bookshelf.” National Center for Biotechnology Information. 2006. Web. 10 Dec. 2009.

[4] WHO. “10 facts about tuberculosis.” 23 March 2009.

< http://www.who.int/features/factfiles/tuberculosis/en/index.html>

[5] WHO. “WHO report 2009 – Global tuberculosis control – Epidemiology, strategy, financing.” 2009.

< http://www.who.int/tb/publications/global_report/2009/key_points/en/index.html>.

5 “DOTS – The most effective way to stop TB.” WHO. SEARO, Stop TB. < http://www.searo.who.int/

LinkFiles/Tuberculosis_right2.pdf>

6 Wright, A., Zignol, M. Anti-Tuberculosis Drug Resistance in the World: Fourth Global Report. The World Health Organization/International Union Against Tuberculosis and Lung Disease Global Project on Anti-Tuberculosis Drug Resistance Surveillance, 2008. <http://whqlibdoc.who.int/hq/2008/WHO_

HTM_TB_2008.394_eng.pdf>

7 “Drug-Resistant TB.” TB Alliance. 2009. Web. 10 Dec. 2009. <http://www.tballiance.org/why/mdr-tb.php>.

8 “Mutlidrug-Resistant Tuberculosis (MDR TB) and Extensively-Drug Resistant (XDR) TB.” Centers for Disease Control and Prevention, last reviewed June, 2009.

< http://www.cdc.gov/tb/publications/webcourseswebinars/mdrandxdrtb/SlideText.htm>.

9 Nunn, P. “Addressing the threat of drug resistant TB: a realistic assessment.” Institute of Medicine – Stop TB Department, Nov 5, 2008. <http://www.iom.edu/~/media/Files/Activity%20Files/Research/DrugForum

/Nunn.ashx>.

10 “WHO | Antimicrobial resistance.” Jan. 2002. Web. 10 Dec. 2009. <http://www.who.int/mediacentre/factsheets/fs194/en/>.

10 “WHO | New survey finds highest rates of drug-resistant TB to date.” WHO. 26 Feb. 2008. Web. 10 Dec. 2009. <http://www.who.int/mediacentre/news/releases/2008/pr05/en/index.html>.

11 “Overcoming Antimicrobial Resistance.” WHO. Web. 10 Dec. 2009. <http://www.who.int/infectious-disease-report/2000/ch4.htm>.

[7]Beith, Alexandra, Rena Eichler, and Diana Weil. “Worldwide: Incentives for Tuberculosis Diagnosis and Treatment.” Center for Global Development. N.p., n.d. Web. 1 Dec. 2009.

<http://www.cgdev.org/doc/books/PBI/12_CGD_Eichler_Levine-Ch12.pdf>.

[8] Beith, Alexandra, Rena Eichler, and Diana Weil. “Worldwide: Incentives for Tuberculosis Diagnosis and Treatment.” Center for Global Development. N.p., n.d. Web. 1 Dec. 2009.

<http://www.cgdev.org/doc/books/PBI/12_CGD_Eichler_Levine-Ch12.pdf>.

[9] Zolotova, Elena. “Russian oblast is model in fight against TB.” World Health Organization. May 2007. Web. 14 Dec. 2009. <http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2636654/>.

[10] Zolotova, Elena. “Russian oblast is model in fight against TB.” World Health Organization. May 2007. Web. 14 Dec. 2009. <http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2636654/>.

[11] Beith, Alexandra, Rena Eichler, and Diana Weil. “Worldwide: Incentives for Tuberculosis Diagnosis and Treatment.” Center for Global Development.Web. 1 Dec. 2009.

<http://www.cgdev.org/doc/books/PBI/12_CGD_Eichler_Levine-Ch12.pdf>.

[12] Beith, Alexandra, Rena Eichler, and Diana Weil. “Worldwide: Incentives for Tuberculosis Diagnosis and Treatment.” Center for Global Development. N.p., n.d. Web. 1 Dec. 2009.

<http://www.cgdev.org/doc/books/PBI/12_CGD_Eichler_Levine-Ch12.pdf>.

1 Garner, Paul, and Jimmy Volmink. “Directly observed treatment for tuberculosis.” BMJ: helping doctors make better decisions. BMJ. Web. 10 Dec. 2009. <http://www.bmj.com/cgi/content/full/327/7419/823?etoc>.

2 Volmink, Jimmy, Patrice Matchaba, and Paul Garner. “Directly observed therapy and treatment adherence.” Lancet 355.9212 (2000): 1345-350. Http://sciencedirect.com. Science Direct. Web. 10 Dec. 2009. <http://www.sciencedirect.com/science?_ob=ArticleURL&_udi=B6T1B-4049VK9S&_user=655954&_rdoc=1&_fmt=&_orig=search&_sort=d&_docanchor=&view=c&_acct=C000035538&_version=1&_urlVersion=0&_userid=655954&md5=739eb5ba47cf174c410ff35717eee8e7>.

3 Liendhart, Christian, and Jessica A. Ogden. “Tuberculosis control in resource-poor countries: have we reached the limits of the universal paradigm?” Tropical Medicine and International Health 9.7 (2004): 833-41. Wiley InterScience. Web. 10 Dec. 2009. <http://www3.interscience.wiley.com/cgi-bin/fulltext/118806551/HTMLSTART>.

4 Shedica-Rizkallah, Mona C., and Lee R. Bone. “Planning for the sustainability of community-based health programs: conceptual frameworks and future directios for research, practice, and policy.” Health Education Research 13 (1998): 87-108.

5 Frieden, Thomas R., and Cynthia R. Driver. “Tuberculosis control: past 10 years and future progress.” ELSEVIER 83 (2003): 82-85.

6 Sowart, Holgart, Sukhontha Kongsin, Vallop Payanandan, Pasakorn Akarasewi, Paul P. Nunn, and Mario C. Raviglione. “Costs and benefits of improving tuberculosis control: The case of Thailand.” Social Science & Medicine 44.12 (1997): 1805-816. ScienceDirect. Web. 10 Dec. 2009. <http://www.sciencedirect.com/science?_ob=ArticleURL&_udi=B6VBF-3SWXX70-4&_user=655954&_rdoc=1&_fmt=&_orig=search&_sort=d&_docanchor=&view=c&_searchStrId=1131350979&_rerunOrigin=google&_acct=C000035538&_version=1&_urlVersion=0&_userid=655954&md5=19052ac9fd16154ff96e2a7dcf372044>.

7 WHO. Joint program review: India. New Delhi: World Health Organization, 2000: WHO/SEA/TB/2000.224

8 Suk, Jonathan E., Davide Manissero, Guido Buscher, and Jan C. Semenza. “Wealth Inequality and Tuberculosis Elimination in Europe.” Center for Disease Control. Nov. 2009. Web. 10 Dec. 2009. <http://www.cdc.gov/eid/content/15/11/1812.htm>.

9 Paldam, Martin, and Gert T. Svendsen. “Missing social capital and the transition in Eastern Europe.” IDEAS: Economics and Finance Research. Web. 10 Dec. 2009. <http://ideas.repec.org/p/hhs/aareco/2000_005.html#abstract>.

10 Goossens, Herman, Matus Ferech, Robert V. Stichele, Monique Elseviers, and ESAC Project Group. “Outpatient antibiotic use in Europe and association with resistance: a cross-national database study.” The Lancet 365 (2005): 579-87. Science Direct. 11 Feb. 2005. Web. 10 Dec. 2009. <http://www.sciencedirect.com/science?_ob=ArticleURL&_udi=B6T1B-4FFX4C2-15&_user=655954&_rdoc=1&_fmt=&_orig=search&_sort=d&_docanchor=&view=c&_searchStrId=1131376351&_rerunOrigin=scholar.google&_acct=C000035538&_version=1&_urlVersion=0&_userid=655954&md5=658d03ba7de8997a12183c3c1f31887a>.

[13] USAID. “This is USAID.” USAID. N.p., 29 Apr. 2009. Web. 10 Dec. 2009. <http://www.usaid.gov/about_usaid/>.

Global Health, Global Health Projects


Leave a Reply