Filed under: Pharmacy
More than one in seven British adults surveyed (15%)1 admitted to bypassing the healthcare system to get hold of prescription only medicine without a prescription, a practice which 78% of GPs surveyed say is putting people’s health and potentially lives at risk3, as some of the medicines obtained in this way may be counterfeit.
New research indicating the scale of the counterfeit medicine culture was released today as part of a hard-hitting campaign to educate the public of the risks involved in purchasing fake medicines from unregulated websites. The Get Real, Get A Prescription public awareness campaign is being launched in a partnership between Pfizer, the Medicines and Healthcare products Regulatory Agency (MHRA), the Royal Pharmaceutical Society of Great Britain (RPSGB), The Patients Association and HEART UK.
Without recognising the dangers associated with counterfeit medicine, UK adults are putting too much trust in illicit websites that are potentially selling them. Research suggests that the majority (60%) of adults agree that they’re more trusting of all purchases they make online today compared to five years ago1. In addition, alarmingly almost a fifth (18%) of UK adults believe people who sell prescription only medicine without a prescription, are providing a service to the general public – offering cheaper medicines to those that need it1. A third (33%) simply think what’s being sold is real thing, sourced from legitimate places and sold on1.
David Pruce from the Royal Pharmaceutical Society of Great Britain said: “Pharmacists are very concerned about the increase in fake or counterfeit medicines. As expert professionals in medicines and medicines use, we know only too well that fake medication does not work and that it can cause harm. Stay safe by ensuring that you always get your prescriptions dispensed at a registered UK pharmacy. If you want to buy medicines online, always check that you are dealing with a genuine pharmacy. Don’t go on face value – some of the illegal sites look very professional but supply dangerous fakes. Check our website for a list of sites that have been awarded the RPSGB’s internet pharmacy logo so that you can be sure that you are dealing with a UK registered pharmacy supplying genuine medicines. This campaign is important. We want the UK to be the safest place to obtain medicines.”
Steve Poulton, Pfizer UK Commercial Director and Business Unit Head, said: “We are thrilled to be partnering the Royal Pharmaceutical Society of Great Britain in this deliberately hard-hitting campaign, aiming to push the counterfeit medicines issue up the agenda and discourage consumers from by-passing the health system. Pharmacists play a key role in delivering healthcare services and enhancing the patient experience, something Pfizer supports through a range of activities such as this campaign.” Pfizer, the RPSGB, and the other campaign partners have been working with pharmacists across the UK to help them leverage public interest in this issue, as a patient education opportunity.
A hard-hitting TV advertisement, which is considered so shocking that it can only be shown after 11pm, will kick-off the campaign on Tuesday 3rd November. A national billboard poster campaign will also run nationwide in November, with a consumer roadshow touring seven cities over the next week. Consumers can go tohttp://www.realdanger.co.uk for more information and advice.
Notes
– The Get Real, Get A Prescription campaign is supported by Pfizer, the MHRA, RPSGB (the professional and regulatory body for pharmacy), The Patients Association and HEART UK.
– It is estimated that between 50 -90%4,5 of medicines now purchased over the internet are counterfeit, with global sales in fake medicines expected to reach $75 billion by 20106. Here in the UK, two thirds of GPs surveyed (67%) have seen patients who have obtained medicines from illicit sources3.
– Fake medicines can contain harmful ingredients such as rat poison, boric acid and lead paint7,8. They’re often produced by people with no appropriate qualifications9 and can include too much, too little or none of the active ingredient they should include6. Fake medicines can cause harm to patients, which can sometimes lead to death6.
– If you have been offered what you suspect to be counterfeit medicines, or have seen them for sale, or have bought them, we would like you to tell us. The Medicines and Healthcare products Regulatory Agency (MHRA) is the medicines safety watchdog and has a dedicated 24 hour hotline: 020 7084 2701, E-mail: counterfeit@mhra.gsi.gov.uk or write to: Counterfeits, The Intelligence Unit, MHRA, Market Towers, 1 Nine Elms Lane, London, SW8 5NQ.
– If you think a medicine or herbal medicine has caused an unwanted side effect (an adverse drug reaction), please report the problem to the MHRA’s Yellow Card scheme http://yellowcard.mhra.gov.uk/. The Yellow Card scheme has been used for over 40 years to collect information on suspected side effects from all types of medicines. These include prescription medicines, medicines you can buy without a prescription, and herbal and other complementary medicines.
– The RPSGB provides a list of legitimate, approved online pharmacies on its website for people to check before they buy from an online source:http://www.rpsgb.org.uk
About the Royal Pharmaceutical Society of Great Britain
The Royal Pharmaceutical Society of Great Britain (RPSGB) is the professional body for pharmacists and the regulatory body for pharmacists and pharmacy technicians in England, Scotland and Wales. The primary objectives of the Society are to lead, regulate, develop and represent the profession of pharmacy. The RPSGB leads and supports the development of the profession within the context of the public benefit. This includes the advancement of science, practice, education and knowledge in pharmacy. In addition, it promotes the profession’s policies and views to a range of external stakeholders in a number of different forums.
Following the publication in 2007 of the Government White Paper Trust, Assurance and Safety – The Regulation of Health Professionals in the 21st Century, the Society is working towards the demerger of its regulatory and professional roles. This will see the establishment of a new General Pharmaceutical Council and a new professional body for pharmacy in 2010.
About Pfizer
Pfizer Inc, founded in 1849, is dedicated to better health and greater access to healthcare for people and their valued animals. Every day, colleagues in more than 150 countries work to discover, develop, manufacture and deliver quality, clinically effective prescription medicines to patients. In the UK, Pfizer has its European R&D headquarters at Sandwich and its UK business headquarters in Surrey, and is the major supplier of medicines to the NHS. Pfizer invested over £5.4 billion worldwide (£104 million per week) in R&D in 2008.
About a healthy partnershipTM
a healthy partnership was launched by Pfizer in 2008 as a new approach to support the increasingly important role of community pharmacy in the delivery of healthcare and new services being offered to patients. It covers three areas highlighted as being important by pharmacists: Supporting professional development, enhancing the patient experience and delivering commercial value.
References
1. YouGov Plc data, September 2009. Participants: 2076 adults.
2. 7.1 million calculated using Office National Statistics Census 2007. 15% of UK adults aged 18 and over = 7,179,660
3. Medix UK plc (2009) Market Research Report: Counterfeit Drug Study. Participants: 205
4. WHO and IMPACT factsheet. Counterfeit drugs kill! Last accessed on 13.10.09 from here.
5. In-PharmaTechnologist News. Last accessed 08.10.08 from here.
6. WHO factsheet. Counterfeit medicines. Last revised 14 November 2006http://www.who.int/medicines/services/counterfeit/impact/ImpactF_S/en/ lastaccessed 10 October 2009
7. Soloman, S. BC Woman killed by fake drugs bought online. National Review of Medicine, 2007. 4:13.
8. Pfizer data on file
9. European Alliance for Access to Safe Medicines. The Counterfeiting Superhighway, 2008 Medicom
Source
Royal Pharmaceutical Society of Great Britain
Filed under: Pharmacy
For many people with rheumatoid arthritis, the traditional, and much cheaper, disease-modifying antirheumatic drugs (DMARDs) appear to work just as well as newer TNF blockers that target the underlying disease process, a large study shows.
The findings also suggest that a step-up approach in which patients are started on methotrexate alone, with additional drugs added only if needed, may be preferable to immediate combination treatment, says Larry W. Moreland, MD, chief of rheumatology at University of Pittsburgh.
Moreland and colleagues studied 755 patients, mostly white women. All had early rheumatoid arthritis, with an average of less than four months since diagnosis, and had not yet received disease-modifying antirheumatic drugs (DMARDs).
The study was designed to compare the older and the newer drugs and to look at the benefit of starting with combination therapy compared to step-up therapy.
The patients were divided into four groups. Two groups began with immediate combination therapy: either methotrexate combined with sulfasalazine and hydroxychloroquine (the traditional DMARDs) or methotrexate and the TNF blocker Enbrel.
The other two groups began with methotrexate alone, with step-up treatment adding either sulfasalazine/hydroxychloroquine or Enbrel only if they had persistent disease activity at six months.
Arthritis Drugs: No Difference between DMARDs, TNF Blockers
Two years later, there was no significant difference in disease activity between patients taking triple DMARD therapy or methotrexate + Enbrel. This held true whether they received immediate combination treatment or step-up therapy.
“What this means in real clinical practice is that patients should be started on methotrexate alone, with other drugs added only if they don’t respond,” Moreland says.
“You always want to try to expose the patient to as few drugs as possible,” he says.
Although the traditional DMARDs worked just as well in the study as the TNF blocker, Moreland isn’t ready to conclude that holds true for all patients.
“While the results may show that, overall, both treatments have similar outcomes, we still are not certain how to best treat individual patients,” he says.
Moreland tells WebMD that X-ray images, taken during the study, may show whether one strategy is better at halting disease progression. But those images aren’t available yet.
“We clearly need better predictors of who will benefit from which treatment,” says Mayo Clinic rheumatologist John Davis, MD. He moderated a news conference to discuss the new studies at the annual meeting of the American College of Rheumatology.
In the meantime, Davis tells WebMD he tries to prescribe the least aggressive treatment that works. “I have patients that do very well on methotrexate alone,” he says.
SOURCES:
American College of Rheumatology Annual Meeting, Philadelphia, Oct. 17-21, 2009.
Larry W. Moreland, MD, chief of rheumatology, University of Pittsburgh.
John Davis, MD, assistant professor of medicine, division of rheumatology, Mayo Clinic, Rochester, Minn.
© 2009 WebMD, LLC. All rights reserved.
Filed under: Uncategorized
If you’re worried about swine flu, resist the temptation to stock up on dubious medicines being hawked online.
The Food and Drug Administration ordered a bunch of stuff on the Web recently that was supposed to fight or prevent the flu and doesn’t recommend you do the same.
One package from India that should have contained the flu-fighter Tamiflu, or oseltamivir, instead had some plain, white tablets that turned out to be a mixture of talc and acetaminophen. The Web site where the meds were offered “disappeared” shortly after the FDA placed its order, the agency said.
Other shipments included products that contained some oseltamivir but they weren’t approved for sale in the US.
The FDA has come up with a neat little widget (check it out on the right) to help people separate the impostors from the real deals when it comes to H1N1 products.
The proliferation of scams doesn’t exactly surprise us. A few months back the cosmopolitan cops at Interpol blew the whistle on swine flu spam, saying as much as 4 percent of spammy email at the time was about swine flu.
Add the swine flu stuff to that folder where you keep the Nigerian get-rich-quick schemes. “By responding to spam swine flu emails or attempting to order medication online through illegal and unregulated websites, people are risking their well-being and their money,” Interpol’s Jean-Michel Louboutin said in a statement in May.
Filed under: Pharmacy
The Post and Courier recently reported that the “Help is Here Express” bus tour visited the Piggly Wiggly at 445 Meeting Street in Charleston to help the uninsured and financially struggling learn about programs that provide free or nearly free prescription medications.
The tour is part of the Partnership for Prescription Assistance, a nationwide effort sponsored by pharmaceutical research companies to raise awareness of patient assistance programs. Visitors can also learn about medicines in development to fight chronic illnesses.
The bus, sponsored by the Pharmaceutical Research and Manufacturers of America (PhRMA), travels around the country helping people get information about programs that offer prescription assistance.
Jeff Gilbert, a spokesman for PhRMA, said there are about 475 patient assistance programs designed to help people get the medicines they need for free or nearly free. Gilbert said about 130,000 South Carolina residents have applied for help through the program since it began in 2005.
Source: Pharmaceutical Research and Manufacturers of America
Filed under: Pharmacy
NPR reports on how prescription drug advertising drives up consumer demand, which drives up medical costs. The story, done in partnership with the public radio program,This American Life, is the third in a three-part series about why American health care costs are so high. “Prescription drug spending is the third most expensive cost in the U.S. health care system. The average American gets 12 prescriptions a year, and this number only seems to grow larger.”
Estimates from the Nielsen Company indicate “there’s an average of 80 drug ads every hour of every day on American television. And those ads clearly produce results: ‘Something like a third of consumers who’ve seen a drug ad have talked to their doctor about it,’ says Julie Donohue, a professor of public health at the University of Pittsburgh who is considered a leading expert on this subject. ‘About two-thirds of those have asked for a prescription. And the majority of people who ask for a prescription have that request honored.’ Whether the increase in the number of prescription drugs taken is good or bad for patient health is an open question. There’s evidence on both sides. What’s not up for debate is this: By taking their case to patients instead of doctors, drug companies increased the amount of money we spend on medicine in America” (Spiegel, 10/13).
This information was reprinted from kaiserhealthnews.org with kind permission from the Henry J. Kaiser Family Foundation. You can view the entire Kaiser Daily Health Policy Report, search the archives and sign up for email delivery a tkaiserhealthnews.org.
Filed under: Pharmacy
Many consumers looking for ways to reduce their health care costs are taking potentially dangerous steps such as foregoing prescription drug medications altogether or skipping necessary refills, according to a new survey from Consumer Reports. In tough economic times, the survey underscores the need for consumers to examine prescription drug cost-savings options such as the increased use of generic medicines and mail-service pharmacies, the Pharmaceutical Care Management Association (PCMA) said today.
“Greater use of mail-service pharmacies, generic medications, and a thorough medication review with a physician to determine other available prescription drug options are all avenues for consumers faced with difficult health care decisions and looking for ways to save,” said PCMA President and CEO Mark Merritt. “This survey is also a reminder that any reforms in health care must address controlling costs for consumers and payers. Creating a real pathway for biogenerics to increase competition for high cost biotech products along with providing greater incentives for mail-service pharmacies in public programs are common sense proposals which both lower costs and increase access.”
The Consumer Reports survey found that people have tried to cut back on health care costs in a variety of ways, including:
- 25 percent have been unable to afford medical care or medications.
- 20 percent skipped filling prescriptions.
- 15 percent took expired medication.
- 15 percent skipped scheduled dosages of prescriptions.
PCMA believes policymakers should explore prescription drug cost-savings options for consumers and payers in the health reform debate, including:
- Address the biotech cost-crisis through real biogenerics reform. Legislation creating a workable and meaningful biogeneric pathway is essential to curb the skyrocketing cost of biotech medicines. Like the White House, PCMA believes that offering seven additional years of ‘market exclusivity’ to the handful of companies who make biologics would be ‘generous.’
- Expand seniors’ mail-service pharmacy options. While numerous independent studies have documented that mail-service pharmacies reduce drug costs and provide greater safety and convenience, Medicare beneficiaries are not given the same incentives to use this proven delivery system as the under-65 population. Congress would help seniors – and taxpayers – save billions if health reform expands seniors’ access to chronic care medications delivered through mail-service pharmacies.
- Promote more competition in Medicare by requiring brand-name drugmakers to negotiate on all Part D drugs. Regrettably, Medicare Part D insulates drugmakers from competition by requiring drug plans to cover “all of substantially all” drugs in at least six different drug classes, despite no evidence that patients have had difficulty accessing these drugs. In doing so, this provision merely allows brand-name drugmakers to charge higher prices because they know plans are required to include their drugs on formularies, whether they offer discounts or not. According to CMS, removing this pharma-friendly requirement would save Medicare $4.2 billion over ten years.
Source
Pharmaceutical Care Management Association
Filed under: Pharmacy
New pill bottle caps that connect to AT&T Inc.’s wireless network may soon remind you to take your meds. The State.com reports.
If the bottle isn’t opened at the appointed time, the cap and night light start blinking to remind the owner to take the medication. If that doesn’t serve as enough of a hint, they start playing jingles as well. If the bottle stays unopened, the night light will send a message to Vitality’s system, which can then place an automated phone call or send a text message with a reminder.
A price for the new system hasn’t been disclosed. Vitality hopes insurance and drug companies will get on board with the system and cover the cost.
Read full article.
Related: - SIMpill: Medication reminders via SMS – A wireless monitoring and support service for patients on chronic medication sends an SMS to the central server when the pill bottle is opened – allowing to check against a database that the incoming SMS is within the appointed time tolerance set for the patient, or should no message be received, the server can produce a number of responses such as sending a reminder to the patient’s handset, a family member, or a healthcare professional.
Filed under: Pharmacy
Studies Show Taking Vitamin D Supplements May Cut Fall Risk After Age 65, if Dose Is High Enough
Taking vitamin D supplements, at a dose of 700-1,000 international units per day, may make falling 19% less likely for people aged 65 and older.
That news comes from a research review published online in BMJ, formerly called theBritish Medical Journal.
The review is based on eight studies of people aged 65 and older who took vitamin D supplements or placebos. Doses of vitamin D differed among the studies. Participants lived in nursing homes or in their own homes.
The reduction in fall risk was only seen in people who took at least 700 international units (IU) per day of vitamin D. Taking smaller doses didn’t appear to help.
The reviewers — who included Heike Bischoff-Ferrari, MD, MPH, director of the Centre on Aging and Mobility at Switzerland’s University Hospital Zurich — also noticed that the reduction in fall risk was only seen in people who achieved a vitamin D blood level of at least 60 nanomoles per liter.
Vitamin D affects muscle strength, and stronger muscles could mean less likelihood of falling, note Bischoff-Ferrari and colleagues.
The reviewers aren’t ruling out the possibility that higher doses of vitamin D supplementation might be even more effective at preventing falls. But the studies they reviewed didn’t include doses higher than 1,000 IU per day.
Taking too much vitamin D can cause nausea, constipation, confusion, abnormal heart rhythm, and kidney stones.
In the U.S., the Institute of Medicine (IOM) considers 200 IU of vitamin D to be an “adequate” daily intake for people up to 50 years old, an intake of 400 IU for people aged 51-70, and an intake of 600 IU for people aged 71 and older. The IOM also considers the tolerable upper limit for vitamin D intake to be 2,000 IU per day (1,000 IU per day in the first year of life).
However, many experts argue that the adequate daily intake for vitamin D should be higher. The IOM is reviewing its vitamin D recommendations and is expected to announce the results of that review next year.
SOURCES:
Bischoff-Ferrari, H. BMJ, Oct. 2, 2009; “Online First” edition.
WebMD Health News: “Supplement Your Knowledge of Vitamin D.”
National Institute of Health Office of Dietary Supplements:
“Dietary Supplement Fact Sheet: Vitamin D.”
Filed under: Pharmacy
Giving two low-cost prescription drugs to reduce cholesterol and blood pressure in people with diabetes or heart disease — along with encouraging them to take a daily aspirin — can slash their risk of hospitalization for heart attack or stroke by 60%, according to a new study.
”If you have diabetes or heart disease, the biggest killer is likely to be a heart attack or stroke,” says study researcher Robert James Dudl, MD, the director of the diabetes program at the Kaiser Permanente Care Management Institute in Oakland, Calif.
While researchers have previously shown that cholesterol-lowering statins and blood-pressure-lowering drugs taken individually reduce strokes and heart attacks, their combined effectiveness in large populations is not documented, Dudl and colleagues note.
So the researchers studied a new, simplified approach in which everyone was given a standard dose of the statin and blood-pressure-lowering drugs, rather than the common practice of starting people out on a low dose and monitoring and adjusting the dose several times.
For the study, the researchers tracked more than 170,000 members of the Kaiser Permanente health plan in California who had heart disease or were over 55 with diabetes — or had both conditions.
In all, 77.8% had diabetes with or without heart disease, while 31.7% had heart disease only. The median age was 68 (half were younger, half older).
Besides being encouraged to take a daily aspirin, patients were prescribed a medication bundle, typically lovastatin (40 milligrams a day) to lower cholesterol and lisinopril (20 milligrams a day) to lower blood pressure.
During an initial doctor’s office visit, patients were asked about medical history to rule out reasons they shouldn’t be on the drugs, such as liver disease.
Next, patients were divided into three groups:
- 21,292 participants were in the high-exposure group, taking the drugs more than half the time in 2004 and 2005, based on their prescription refill habits.
- 47,268 people were in the low-exposure group, taking the drugs less than half the time during 2004 and 2005.
- 101,464 people were in the no-exposure group, taking neither drug or just one of the two prescription drugs during 2004 and 2005.
The aspirin could not be tracked through prescription records.
Reducing Risk of Heart Attacks and Strokes
The risk reduction in heart attacks and strokes varied by group and how faithfully participants took the medications.
Compared with the no-exposure group, the low-exposure group (whose members picked up medicines less than half the time) had a 60% reduction in hospitalizations for heart attack and stroke.
”People who picked up the medicine more than half the time had more than a 60% reduction in heart attack and stroke in the third year of follow-up,” says Marc Jaffe, MD, director of the Kaiser Permanente Northern California Cardiovascular Risk Reduction Program, who oversaw more than half the study participants.
Among the 21,292 people in the high-exposure group, there were 545 fewer heart attacks and strokes. That translates to a reduction in the hospitalization rate for heart attack or stroke by 26 per 1,000 members compared to those who had no exposure to the drug.
The approach, Jaffe and Dudl say, focused less on adjusting doses, which saves time and the number of office visits for doctors and patients. “It was a focus on starting at a reasonable, fixed dose that would work for most people,” Jaffe tells WebMD. That dose was adjusted when needed, however, he says.
”The simplicity [of the approach] makes it easier for people to deal with,” Dudl says. Typically, patients are told to start the drugs at a low dose, then asked to come back in three or four weeks for monitoring.
Side effects, such as muscle aches with statins, were found in about the same numbers as in studies in which participants took the drugs separately, Dudl says.
The approach used in the Kaiser study is simple and doesn’t require frequent doctor’s office visits or blood tests, says Ravi Dave, MD, a cardiologist at Santa Monica–UCLA and Orthopaedic Hospital in Santa Monica, Calif., and associate professor of medicine at the University of California, Los Angeles David Geffen School of Medicine, who reviewed the study for WebMD.
“This [study] establishes the safety and efficacy of this approach,” he says. “It’s good for patients, with their busy lives.”
The study, he adds, also supports the concept of cholesterol lowering in high-risk patients whose cholesterol levels may be deemed acceptable for the general population, but not for high-risk people.
SOURCES:
Robert James Dudl, MD, director of the diabetes program, Kaiser Permanente Care Management Institute, Oakland, Calif.
Marc Jaffe, MD, director, Kaiser Permanente Northern California Cardiovascular Risk Reduction Program, South San Francisco.
Dudl, R. American Journal of Managed Care, online October 2009.
© 2009 WebMD Inc. All rights reserved.
Filed under: Health News
1. Why is FDA concerned about unlawful drug sales on the Internet?
Patients who buy prescription drugs from Websites operating outside the law are at increased risk of suffering life-threatening adverse events, such as side effects from inappropriately prescribed medications, dangerous drug interactions, contaminated drugs, and impure or unknown ingredients found in unapproved drugs.
The current system of federal and state safeguards for protecting patients from the use of inappropriate or unsafe drugs has generally served the country well. These laws require that certain drugs be dispensed only with a valid prescription because they are not safe for use without the supervision of a licensed health care practitioner. Generally, before the practitioner issues a prescription for a drug the patient has never taken before, he or she must first examine the patient to determine the appropriate treatment. Subsequently, the patient receives the drug from a registered pharmacist working in a licensed pharmacy that meets state practice standards.
The Internet makes it easy for unscrupulous people to sell drugs to patients without these safeguards in place. A Website may appear to be associated with a legitimate pharmacy when in fact it is not. Websites that sell prescription drugs without a valid prescription deny consumers the protection provided by an examination conducted by a licensed practitioner.
Are there any benefits to purchasing approved drugs online?
Yes. Legitimate pharmacy sites on the Internet provide consumers with a convenient, private, way to obtain needed medications, sometimes at more affordable prices. The elderly and persons in remote areas can avoid the inconvenience of traveling to a store to purchase medications. Many reputable Internet pharmacies allow patients to consult with a licensed pharmacist from the privacy of their home. Moreover, Internet pharmacies can provide customers with written product information and references to other sources of information like the traditional storefront pharmacy. Finally, the increasing use of computer technology to transmit prescriptions from doctors to pharmacies is likely to reduce prescription errors.
How many web sites sell prescription drugs?
The National Association of Boards of Pharmacy has identified approximately 200 domestic web sites that dispense prescription drugs but do not offer an online prescribing service. According to a recent Chicago Tribune article cited by the American Medical Association, there are at least 400 web sites that both dispense and offer a prescribing service — half of these sites are located in foreign countries. Some have estimated that the number of Websites selling prescription drugs may now be closer to 1,000. The number of Websites, however, fluctuates from day to day, and seems to be growing.
How many people have been harmed from drugs purchased over the Internet?
It is impossible to accurately quantify adverse event rates because FDA’s postmarketing surveillance system receives reports on only a relatively small percentage of all adverse events caused by drugs. However, as a result of postmarketing surveillance data collected by FDA, we know that the sale of unapproved drugs and the illegal sale of approved drugs over the Internet poses a serious public health risk. We know, for example, of many adverse events resulting from the use of the drug GBL and the date rape drug GHB, which are unapproved drugs sold illegally
over the Internet. FDA learned recently of a person who was harmed by the use of Viagra purchased from a Website without an examination by a healthcare professional. Unfortunately, the man had a family history of heart disease and died after taking the drug.
We also know of cases where people choose the Internet for treatment to avoid consulting a health care professional. These consumers, however, run the risk of purchasing inappropriate drugs or unknowingly purchasing counterfeit or sub-potent drugs.
5. If FDA is not aware of adverse events associated with approved drugs sold online, why does the agency think that unlawful online sale is a big problem?
We know that adverse events are under-reported and we know from history that tolerating the sale of unproven, fraudulent, or adulterated drugs results in harm to the public health. It is reasonable to expect that the illegal sale of drugs over the Internet and the number of resulting injuries will increase as sales on the Internet grow. Without clear and effective law enforcement, violators will have no reason to stop their illegal practices. Unless we begin to act now, unlawful conduct and the resulting harm to consumers most likely will increase.
