The Murky World of Rx Online
At first, lots of people told lots of laudatory stories about prescriptions purchased online. But then the few online suppliers turned into many and now the horror stories are adding up.
Starting point: the FDA has a long-standing rule which permits people to import a 90-day personal supply of drugs not available in this country. That rule is often winked at and is now being stretched well beyond the breaking point, with no end in sight. In addition, according to FDA regs, US-based internet pharmacies must have a license in states that mandate them, but that rule doesn't cover the internet pharmacies which operate offshore. The feds are going after this latter group mostly for not requiring the buyers to present a prescription with their order, some for simply selling cheap or often-worthless imitation drugs. But it is tough to physically locate them and even harder to enforce compliance.
In almost every case in almost every state, a patient has to mail or fax the doctor's prescription to the online pharmacy before the medication can be shipped. However, investigators in several states recently reported that a number of online's required the buyer to release the pharmacy from liability before the actual prescription is mailed. Others include a caveat that the buyer promises to consult a physician before taking any of the pills.
Are some online's filling prescriptions that don't exist or imagine are false? Could well be, as illustrated by a recent apparently blatant attempt to sidestep the prescription requirement by a Florida online pharmacy. No prescription? They then forwarded a list on which the applicant had to indicate past and current medical problems. However, the space in which to answer already had the word none imprinted; so the recipient had to delete none to honestly answer the question. Imagining that none of the recipients-to-be would do that, the state's Attorney General shut down their website.
Even the promised great savings -- general consensus opinion is that the patient can save about 25% on prescription costs by shopping the internet -- is not always there. The California State Pharmacy Board recently did some online shopping of their own and found that some medications can cost as much as five times what they sell for at the local drug store. And there still is no set rule as to what constitutes a legal online prescription. Canadian online pharmacies cannot fill an order unless the prescription is signed by a physician licensed in that country. So American prescriptions that are forwarded to the Canadians are usually required to be cosigned by Canada-licensed doctors who never met, talked to or prescribed for that patient. Then again, in some states a prescription can be filled after a short telephone consultation with a doctor who may be in another part of the country.
A number of online pharmacies, claiming both efficacy and legitimacy, started the North American Pharmacy Accreditation Commission more than a year ago. The group now has 68 members (mostly Canadian). Each has agreed to rather-severe quality and service standards -- including reasonable delivery periods -- which earns them the commission's seal of approval on their web page.
A small postscript....Only about 97,000 of the millions covered by AARP's healthcare override plan also opted for more-expensive drug benefits coverage when they first signed on. United Healthcare, which runs the plan, recently sent a letter to these people advising them that it will now provide normal plan coverage for drugs purchased in Canada and just about anywhere else. Done with little fanfare, affecting a relatively small number in the healthcare universe, but-- as one Johns Hopkins professor put it--perhaps a warning shot across the bow of the pharmaceutical industry.
But Some May be Inventing A Better Way
In the face of all the suspicion and acrimony now encircling online pharmacies, several small start-ups are offering a third approach they hope make ordering easier and safer, assure the patient more-professional treatment, and perhaps build a business for themselves. In effect, they act as middlemen (or middlewomen) between the person ordering the drugs and the small -- and by inference, select -- number of Canadian pharmacies each deals with. They generate the business for the pharmacies, earning a portion of the normal profit made on the sale, so they claim the price to the patient is not inflated in any way. They act as a patient's advocate to the pharmacy, so they claim the buyer is assured of personal and fair treatment. Though each of these small companies is less than a year old, these claims seem to have substance.
One of these new-type onlines -- Medications4less -- is located in Princeton and is run by a former computer software consultant. Since New Jersey does not require a license-to-dispense, they seem to have a lot more freedom of operation than their competitors in other states. However, the company's website highlights its personal touch, featuring a toll-free phone number on its web pages and inviting people to call to discuss their problems and needs (and sometimes horror stories).
The company claims it deals with just two Canadian mail order pharmacies and in that way attempts to maintain maximum control for its customers. It does not handle narcotics, drugs for acute conditions or orders not accompanied by a prescription from an American doctor. Their order form asks patients to fully list their medical conditions and other drugs they are currently taking. It promotes the fact that -- due to Canada's drug price controls and shorter- term drug patent laws -- their customers can safely save between 30% and 80% off U.S. pharmacy prices (not counting the shipping fees). All prescriptions are claimed to be name brands, shipped directly to the patient -- in sealed, original bottles -- from either American or Canadian pharmaceuticals. Delivery is promised in two to three weeks.
FDA Reconsidering its Position
One side of the coin...Over the past year, the federal courts -- at every level -- have ruled against the FDA in many cases where companies in effect said the agency acted in a high-handed manner. Specific point has been that the FDA has consistently and wrongfully attempted to over-regulate what and how pharmaceuticals, and other related-field companies discuss their products with current and potential customers. The agency has stated from the first that it was simply practicing its mandate to protect consumers from possible harm. Yes, it has acted as a gatekeeper; yes, that is its function.
Big part of the problem has been the discussion of the many possible side effects in drugs. The pharmaceuticals have understandably operated under the sales-minded minimum possible information rule in its advertising and promotion efforts. The agency understandably has almost always been on the side of full disclosure, which obviously has been seen as nit picking by aggrieved pharmaceuticals. Many of the courts' decisions have apparently turned on the question of the producers' first amendment (freedom of speech) rights, which have come up in several actions.
Most telling -- perhaps a landmark -- was a case before the Supreme Court earlier in the year; it concerned pharmacies that produced specialized mixtures of prescription drugs. The pharmacies had, without requesting FDA approval, attempted to advertise and promote these products. The agency said this, in effect, would permit them to sell prescription products without demonstrating the products' efficacy and safety. The Supreme Court came out strongly against the agency, stating quite clearly it felt the FDA was being much too paternalistic.
Reportedly the agency is now involved in an in-depth review of its mandate and responsibilities. Meanwhile, in the face of all these complaints, it was reported that, during the first nine months of 2002, the FDA filed eighteen demands that companies change not-quite-correct statements in direct-to-consumer ads. That's way down, from 64 times during the previous twelve months! Which brings us to...
FDA Accused of Playing Favorites
The other side of the coin...Coming from a completely different direction, Dr. Paul Stolley, a former consultant to the FDA has charged the agency buckles under unfair influence by the drug industry (through user fees) and by patients (who make their feelings known to the agency and to their representatives in Congress) in making its decisions. The charge was made in a recent issue of the British Medical Journal.
To prove his accusations, Dr. Stolley tells his own story. He was signed on with the FDA in 2000 to investigate a report that GlaxoSmithKline's Lotronex (for irritable bowel syndrome) had too-serious side effects. At the time, the drug had been temporarily withdrawn from the market.
Apparently under much pressure from both sources, the company and the agency met and decided to re-introduce Lotronex with risk management provisions and the recommendation that it only be used to treat the most seriously-afflicted patients, those who do not get relief from existing therapy. Dr. Stolley, obviously feeling this was bad medicine, claims the drug is too unpredictable because, due to its nature, possible complications are hard to anticipate. A spokesperson for the FDA admits to the pressure -- the major portion of it from patients -- and to the expectation that reintroduction is chancy and after all that, Glaxo says they do not consider the drug of commercial importance.
Which, when taken together, makes both these FDA stories quite confusing! Who can you trust and believe?
Moms Denied Natural Delivery
In yet another fallout of the medical malpractice problem, mothers who want -- and are physically capable of -- a natural birth after a C-section are finding it almost impossible to find doctors who will agree to this change-in-procedure.
VBAC (vaginal birth after Caesarean) was much in favor a few years ago, allowing the mother to experience the natural birth process, while saving her from the trauma of an additional surgery.
Major problem is a uterine rupture, in which the Caesarean scar from a previous birth tears; it happens in .001% of the cases and can lead to uterine death. (Chances of uterine death in natural delivery is about .002%, but it seems the malpractice lawyers are not watching so expectantly in these cases.) In the past year, hospitals in Spokane, Des Moines and upstate New York have banned the VBAC procedure. And, according to the National Center for Health Statistics, currently only 16.5% of American women who have had a C-section subsequently delivered their next child vaginally. That's a 20% drop from 2001.
Underground Antibiotics
The fear of over-use of antibiotics is becoming more-real and more-dangerous every day. Newest major problem comes from the poor -- choosing or forced to self-diagnose -- resorting to questionable antibiotics smuggled in from third-world countries and literally sold over the counter at small corner stores. No prescription needed!
This is especially rampant in southern border states, but it happens right around our own corners in stores that cater to recent immigrants.
The patients guess that a general-purpose antibiotic, such as amoxicillin, will cure that cough, sore throat or ear ache, buy a few pills and takes them for a few days. If he or she gets better, usually treatment ends right there. Providing temporary relief, but giving the bacteria (which usually must be subjected to a seven day regimen before being wiped out) the opportunity to either return to the system in often greater numbersYor to build additional and higher levels of drug-resistance. Which all-too-soon endangers all of us.
Case in point, ampicillin has been the historic antibiotics of choice for ear infections and uncomplicated cases of pneumonia. Now according to the CDC, more than a third of the multiple strains of this bacteria are resistant to ampicillin. And the CDC reports this is one of all-too-many examples!
Just another element in a problem that keeps growing as drugs designed to cure are actually hurting patients. And there seems to be no real solution in sight.
This One Goes to The Top
The U. S. Supreme Court has agreed to hear the class action suit brought by two plaintiff doctors, representing thousands of others, against a number of HMOs led by UnitedHealthcare and Pacific Health systems. The plaintiffs have accused the HMOs of violating the anti-crime Racketeer Influenced and Corrupt Organizations Act (better known as RICO) and other federal and state laws by consistently cheating the doctors of fair compensation for their work .
All the doctors involved in this class action, at the insistence of the HMOs, signed releases that would, in case of disagreement, eliminate their right to sue and only leave open the right to arbitration. If upheld by the court, they said, this essentially would put them in the weakest possible position because the rules of arbitration permit the person who claims wrongful treatment to receive much smaller awards than the court may sanction; and that this was more than a "disagreement", with hugh potential amounts (including possible damages) at stake. So the doctors called "foul" on this one.
They called "foul" once again, saying that the HMOs' actions were criminal and that the rules of arbitration simply did not apply to criminal actions.
A federal court judge initially ruled the doctors could not be forced to arbitrate their RICO claims. The companies then brought the case to a federal appeals court, which upheld the lower court's verdict.
The Supreme Court, somewhat surprisingly to court watchers, has now decided to hear the case early next year. A decision is expected before the court recesses for the summer.
Success Story: JoAnn Heisen
Chief Information Officer and corporate VP, head of a worldwide staff of over 4,000, in charge of a budget that goes well over $1 billion, and still growing strong! That's the current bio of a 47-year-old mother of four who hired on at Johnson & Johnson as assistant treasurer thirteen years ago. Claims these days she uses emotional triage to give her all to job, family and especially to four teenagers.
JoAnn Heisen has reached these heights (have we mentioned she is the first woman to become a member of J&J's Executive Committee?) by accepting some big challenges along the way. She quickly moved up the finance ladder at J&J -- to corporate controller -- and was then asked to go off in an entirely new direction with a rather daunting charge: put a new, more-effective and less-expensive face on the corporation's Information Technology. In other words, take over a division in a field in which she had modest expertise at best.
Apparently she did it by calling in the techies and saying we can do it together: I'll do the planning and you do the doing. And it has worked; today she is in charge of all facets of IT, including networking and computing services, plus the corporation's human resources and finance department.
In her free time, Ms. Heisen serves on the board of the Women's Research and Education Institute, a group dedicated to providing Congress and other legislative bodies with key-issue facts on women's needs and goals. In her spare time, she also serves on the board of Princeton Medical Center.
The Next Antibiotic Frontier
At least two teams of Australian scientists have dreams of producing a world of new antibiotics -- and other therapies -- from flies and insects. To date, one group has patented an antibiotic derived from bull ants, a large species of the ant world that is basically indigenous to Australia. One of the major drug companies is now experimenting with it in order to select specific targets of use. Decisions and product launches are admittedly many years away.
Theory behind the team's work is simple and obvious. Many of these flying and creepy crawlers often live off the most revolting of often-rotting fare. They have proved in life and in the lab, that they can do it with relative impunity, pointing to the obvious conclusion that they have tremendous resistance to infection. Since many of them -- such as ants, of course -- live in highly organized societies, they also have the interaction and ability to pass along this resistance from generation to generation.
According to the Australian scientists, the opportunities are potentially limitless because there are currently millions of insect species waiting to be inspected, analyzed, evaluated; some almost-certainly will contain life-saving medical qualities for humans. For example, very-preliminary evaluation of compounds produced by some species of flies seemed to be effective against staph and E coli.
Coding Tips
Appendiceal Epiplociae Infarction
An appendiceal eplilociae infarction is the sudden insufficiency of one or more appendix epiploica, which is one of a number of little processes or sacs of peritoneum filled with adipose tissue that project from the large intestine (excluding the rectum).
Patients may present with pelvic or abdominal pain that may mimic appendicitis or other intra-abdominal processes, and often require an exploratory laparotomy to determine the origin of the pain.
The correct diagnosis code for appendices epiplociae infarction is 557.0, Acute vascular insufficiency of the intestine. Code 54.4 describes the excision or removal of an appendices epiplociae, also known as an epiploectomy.
The correct CPT code for the physician performing the procedure is code 49255, Omentectomy, epiploectomy, resection of omentum (separate procedure).
Transcription Tips
Numbers, numbers, numbers...
It is no longer acceptable to use a comma in numbers of four digits. For example, "The infant weighed 3400 kg." (not 3,400 kg). This is to be used in all instances of medical transcription in keeping with the rules of The International System of Units (SI). In addition, SI specifications include dropping the comma in ANY case of a number that contains a decimal point, e.g. 12345.67 (not 12,345.67).
Speaking of numbers, when making a horizontal list (that which occurs within the text of a paragraph), arabic numerals are to be enclosed ON BOTH SIDES with parentheses. For example: "The patient has a past medical history of (1) hypertension, (2) diabetes mellitus, and (3) hypercholesterolemia. However, when making a vertical list, the arabic numerals are displayed with the number and a period only, followed by one space.
For example:
1. Hypertension.
2. Diabetes mellitus
3. Hypercholesterolemia.
Point of Information
Midway through the 17th century, when lensmaking was in its infancy, a draper's apprentice and cloth merchant by the name of Antoine van Leeuwenhoek started using an enlarger as a basic tool in examining the threads of his fabrics. From there, for some reason lost to time, he moved on to putting micro-organisms and human tissue samples under what had become the first basic microscope.
Carefully reporting his findings, he recorded the discovery of then-unknown bacteria, blood cells, sperm and protozoa (which he labeled animalcules). Switching trades, van Leeuwenhoek produced more than 350 microscopes by hand, some with the ability to magnify as much as 270 times. He apparently was the first tradesman elected to the Royal Society of England.
Auditing the News
According to latest reports, New Jersey is home to 75% of the top pharmaceutical companies, dozens of medical device makers and more than 120 biotech companies. It all adds up to over 100,000 jobs and a $25 billion contribution to the state's economy.
Which has led others to try to entice some of this business and these jobs into their states, with a bit of success. According to a report out of Rutgers, New Jersey's share of pharmaceutical jobs slipped from 19% to 15% over the past ten years.
The American Academy of Family Physicians has launched an online directory of just under 42,000 of its 54,000 active members as an adjunct to its website www.familydoctors.org. Physicians are listed by state and then city. All doctors have the option of supplementing this basic information with a variety of personal/professional information such as office hours and phone numbers, educational background and their personal philosophy.
The www.familydoctors website has been in operation since 1996. It also offers a variety of drug, health and healthy living recommendations on a daily basis...plus advice on "common conditions" from addictions to sports injuries. The website is offered in English and Spanish.
A report in The New England Journal of Medicine concludes that people who inherit a common type of two specific genes have ten times the risk of developing congestive heart failure. Next step is to develop a drug that would work to impede the action of these genes, and to test patients seemingly at risk to learn if they have this dangerous piece of genetic makeup.
The discovery has been met with great applause by a number of scientists, who say this could be the first step in a new approach to developing drugs and treatment that can mount pre-emptive attacks against people particularly at risk for certain life-threatening illnesses.
The Cancer Institute of New Jersey (at RWJ, New Brunswick) has been named a Comprehensive Cancer Center by the National Cancer Institute. It is one of only 39 facilities so designated nationwide, and the only one in New Jersey. To earn this rating a facility must submit to a year-long peer review process, meeting exacting standards of lab research and then exhibiting a commitment to putting findings into practice.
The AHA and many hospital executives are furious about a recently-released report from the Center for Studying Healthcare System Change that blamed the bulk of rising costs on increased hospital services and outpatient care.
All the heated replies were built around the fact that constantly more-effective and more-expensive treatments and tests have been devised.
This increases the level of patient care and confidence in the effectiveness of our healthcare system; and isn't that what we are mandated to accomplish?
More about too-little exercise. A recent poll of 1,500 Americans found that 88% of adults and 84% of teens said they were exercising enough to maintain good health. The National Association for Sport and Physical Ed, which sponsored the survey in effect said that people were kidding themselves, and that the Surgeon General's last report (1996) on the subject is still right on-target today.
That showed 60% of Americans simply aren't active enough. Depending on who you listen to, active enough means anywhere from 30 to 60 minutes of dedicated exercise a day.
Websites are becoming a more-popular vehicle for today's hospitals. They represented approximately 60% of hospitals in 2000, that figure went up to 70% last year. Highest percentage by region is currently 83% in New England; the lowest percentage is 54% in Mountain states.
Currently about 75% of urban hospitals have websites; rural hospitals are just under 60%. So even the lowest numbers have become big numbers in just a few years.
Great Britain, with its own nursing shortage problem, has initiated a novel approach to training workers from overseas. A hospital in the Manchester area has made the viewing of Coronation Street, England's long-running soap opera, part of the get-to-know-us indoctrination of 24 nurses from the Philippines. Feeling is that, though each of the nurses speaks acceptable English, they aren't into the nuances and vernacular of the country; which could lead to misunderstandings.
Example given was a patient saying I want to spend a penny, which is slang for "I have to go to the lavatory".
(figure this is an extra, no need to print I up if not needed)
New hope for the 40 million American facing osteoporosis.
Lab animals afflicted with bone wasting have experienced excellent regrowth after being injected with a synthesized form of vitamin D. The new compound is called 2MD and acts as direct support of osteblasts, the cells responsible for making bone. Results were recently reported in the Proceedings of the National Academy of Sciences.
Another form of vitamin D is currently being used, but with limited success. A variety of other previously-used methods are no longer favored because of potential dangerous side effects.
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