Tuesday, November 25, 2014
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Should U.S. apply GAO report on foreign program to health care at home?

Three of the six Government Accountability Office reports issued Monday dealt with pharmaceuticals, but the evaluation of the most distant program might have lessons for Americans as the country wrestles with how to provide better health care for more citizens for less money.

Should U.S. apply GAO report on foreign program to health care at home?

Three of the six Government Accountability Office reports issued Monday dealt with pharmaceuticals, but the evaluation of the most distant program might have lessons for Americans as the country wrestles with how to provide better health care for more citizens for less money.

The GAO is supposed to be "an independent, nonpartisan agency that works for Congress. Often called the 'congressional watchdog,' GAO investigates how the federal government spends taxpayer dollars," according to its web site.

The three health care-pharma reports issued Monday are here, using the titles chosen by the agency:

Electronic Drug Labeling: No Consensus on the Advantages and Disadvantages of Its Exclusive Use, GAO-13-592, July 8. Link here.

PhillyPharma synopsis:

Drug labels are the multi-page documents that brand-name pharmaceutical companies are responsible for producing and are very much a part of the drug approval process with the U.S. Food and Drug Administration. The labels are supposed to explain what the drug is made of, what it is for and the possible side effects. The labels are often folded very tightly inside the medicine box you get from the pharmacy. You probably don't read every word. You might never have unfolded any of them. You know the drug commercial on TV, where half of the wording is about possible side effects, but you hardly notice because of the pretty pictures?

The official label is often more than a dozen pages in tiny type with none of the pretty pictures. Some doctors are pressed for time. Some who write prescriptions don't like having to use computers - for writing the scripts or researching the medicine they are suggesting for patients. Use of computers, hand-held devices and smart phones is increasing by the minute, but how many people dream of the newest gadget to read drug labels to relieve heartburn or foot ulcers or the pain of cancer? While the official label can be found on the government web sites, dozens of other web sites claim to have drug information. Accuracy and consistency of format varies. And plenty of people don't don't use computers or don't have access to one.

Currently, the official label is available electronically and on paper. Retail pharmacists and patient groups like the current system. Public health advocates worry that even fewer patients, doctors and pharmacists will read the labels if drug companies only have to produce them electronically. Retail pharmacists don't want to change either because under the current system, drugmakers print and distribute copies of the label for pharmacists to distribute to patients. If the system is all electronic and patients want a printed label, the retail pharmacist will have to pay for printing costs. The GAO says that in 2011, retail pharmacies filled approximately 3.8 billion prescriptions for drugs. Drug companies prefer exclusive electronic drug labeling to save money on printing costs and reduce potential liability.

Internet Pharmacies: Federal Agencies and States Face Challenges Combating Rogue Sites, Particularly Those Abroad, GAO-13-560, July 8. Link here.

Caveat emptor. This situation is nearly hopeless. Unless the Internet disappears. Or a batch of nice people die at the same time from using tainted, counterfeit medicine purchased through an online pharmacy in an otherwise friendly nation, prompting enough collective and concentrated agony that people start to be more careful and the online pharmacy market dries up. The often exceedingly high prices for legitimate drugs in the United States prompts consumers to look online from alternative sources and the GAO report suggests that one in four U.S. adults buys medicine from online pharmacies. Unfortunately, Americans spend more time shopping online for electronics and airline tickets than they do reading their medicine labels and asking their doctor about the medicine (and if she/he takes money from drug companies). What color are the pills you take?

The problem in catching the "rogue" online pharmacies is that many are overseas, electronically shadowy and beyond the regulatory reach of the U.S. Food and Drug Administration, the Drug Enforcement Administration and the Justice Department, all of which have other demands, priorities and strained budgets. However, there is another federal agency with computer skills and experience connecting Americans with foreigners. Maybe this is a job for the National Security Agency.

President's Emergency Plan for Aids Relief: Millions Being Treated, but Better Information Management Needed to Further Improve and Expand Treatment, GAO-13-688, July 8. Link here.

PhillyPharma synopsis:

Some would argue the greatest accomplishment of the presidency of George W. Bush was his efforts to fight HIV/AIDS in the developing world. On July 30, 2008, Bush signed a key piece of legislation in that effort, the Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008. In this age of Democratic-Republican polarization in Congress, it's worth recalling that Lantos were leaders in the House of Representatives, Lantos a Democrat from California and Hyde a Republican from Illinois. Both men died before law was signed. Alas, there was no bipartisanship in the request to the GAO for the report, as five current Republican senators asked for it.

The law is referred to as the President's Emergency Plan for AIDS Relief (PEPFAR). We'll let the GAO take it from here, and as suggested, keep America's dilemma in mind:

What GAO Found

The President's Emergency Plan for AIDS Relief (PEPFAR) has expanded treatment programs and increased their efficiency and effectiveness.

• According to the Department of State's (State) Office of the U.S. Global AIDS Coordinator (OGAC), from 2005 to 2011, PEPFAR's per-patient treatment costs declined from about $1,053 to about $339. PEPFAR's increasing use of generic products and declining antiretroviral (ARV) drug prices have been a key source of savings. Programs also benefited from economies of scale and program maturity.

• PEPFAR and partner countries have achieved substantial increases in the number of people on ARV drug treatment and have increased the percentage of eligible people receiving treatment. According to OGAC, treatment retention rates are at or above 80 percent at PEPFAR-supported treatment facilities in 10 partner countries.

• PEPFAR has also worked with U.S. implementing agencies, international donors, and partner countries to increase the efficiency and reliability of ARV drug supply chains.

• PEPFAR implementing agencies have evaluated a wide variety of PEPFAR program activities, demonstrating a clear commitment to program improvements.

Better information management is crucial to helping countries improve and expand treatment programs to meet the needs of the estimated 23 million people eligible for ARV treatment under 2012 international guidelines. GAO's reviews of PEPFAR treatment costs, results, and ARV drug supply chains have revealed limitations in the completeness, timeliness, and consistency of key program information. GAO also found important information lacking in PEPFAR program evaluations, plans, and results reporting. GAO has made a series of recommendations to improve the quality of this information in order to make PEPFAR programs more efficient and effective. The potential benefits that could be realized if GAO's recommendations are implemented include the following:

• More complete and timely cost data could help countries manage costs and plan treatment expansion more effectively.

• More consistent, complete, and timely information on treatment results could enhance the quality of treatment programs, including patient, clinic, and program management.

• Plans to help countries improve inventory management and record keeping and tracking their progress could help supply chains operate more efficiently.

• A more systematic and rigorous approach to planning and conducting program evaluations could result in evaluations that better inform PEPFAR stakeholders about how to improve programs.

• OGAC could provide better context for understanding PEPFAR's achievements and challenges by comparing program results with targets and discussing efforts to ensure the quality of reported information.

 

 

David Sell
About this blog
David Sell blogs about the region's pharmaceutical industry. Follow him on Facebook.

For Inquirer.com. Portions of this blog may also be found in the Inquirer's Sunday Health Section.

Reach David at dsell@phillynews.com.

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