November 3, 2012
I have to write this. I disabled captcha so that people would be able to post that were having trouble with this. It has spawned many computer-generated comments, which fortunately the spam or delete key takes care of. First, if the comment is from “anonymous”, that is the first strike against letting the comment to be posted. Second, if they are foolish enough to think I am allowing advertising of other products or even diabetes products, I will state, at present I am not even allowing Google to place ads on my blog. If you think I will allow you – no way.
I do allow myself to write about products when I feel there is a need to make people aware of them, but that is as far as I will take it. I have a couple of anonymous posters that do not use English and I will not allow this especially after putting a few through a translator. For the few that think they are going to get their pron sites listed – forget it. I will continue to leave moderation in operation, which will prevent these comments from being posted, and I do check them. I almost let one through, but after checking a link in their blog that looked innocent enough, my anti-virus program stopped access for the link – you guessed it – I clicked on the spam key and deleted the email notification. I will not knowingly allow links to viruses,
Several of my email followers have thanked me for removing the captcha, but as of yet they have not posted to my blogs. One did ask if I would even allow him to post as “anonymous” because he will not create an account on Google. I told him yes as long as he does not try to promote his product and asks questions or makes comments like those that he does in his emails.
There are a few that have programs that post comments to blogs that don't have the captcha activated and I understand their need to flood the blogosphere with their drivel. However, with moderation activated, the delete key is very handy.
November 2, 2012
How many more deaths is it going to take to convince our congressional leaders to do what should have been done about a decade ago. Compounding pharmacies have lobbied so long and hard on Capitol Hill that they have been able to remain unregulated. This is a little-known fact about the pharmaceutical industry and how they have been able to operate without supervision for so many years and out of sight of the public. The pharmaceutical industry through their compounders has been able to lobby against regulation oversight and impress the politicians and their staffers for the need of compounding.
If congress does not act, some groups may be able to if they follow actions by Sandra Fusco, director of patient advocacy at Allergy & Asthma Network Mothers of Asthmatics. She took on the Compounding Industry and succeeded in forcing them out of the nebulizer drug business. When the nebulizers were found out to have contamination and poor potency, she and her supporters succeeded in getting insurers not to reimburse for compounded nebulizer drugs. This may be one way to force compounders to correct their errors. Don't take this to the bank as the compounders are well established on Capital Hill and know how to bring in people to plead their case for drugs not otherwise available in regular channels.
Even some of our well-known hospitals are not ordering medications from certified pharmacies. John Hopkins University had scientists investigate bacterial infections in six intensive care unit patients. They traced the infection to contaminated fentanyl from a compounding pharmacy. The trouble is they assumed any drug bought in large quantities by a healthcare facility comes from an FDA-approved and licensed manufacturer. When this information was shared with the hospital pharmacists, they said they could not stop ordering from compounders: they were the only source of the fentanyl doses the ICU needed.
Even with deaths from medications received from compounding pharmacies, only 162 of several thousand compounding pharmacies have become accredited. In order to obtain accreditation, an on-site inspection is made to assess workers' competence, equipment, record keeping, air quality and clean-room qualities meet certain standards. Even this has not made the market demanding accreditation. Who pays the price for this lack of oversight – the patients of course!
“Now, as the deaths and illnesses mount from fungal meningitis linked to a contaminated steroid injection, the question of why early concerns about pharmacy compounding did not change U.S. law is a top focus for patients, regulators and lawmakers.”
The FDA has traced the steroid injections to New England Compounding Center, or NECC, a Framingham, Massachusetts compounding pharmacy founded in 1998. Unfortunately, this is just the tip of the problem with much wider implications. It is highly doubtful that this will bring about actions necessary to bring these compounding pharmacies under FDA control or even oversight. We don't know how much is being funneled into campaigns to insure no legislation will result.
You can be sure that once the elections are over, lobbying will begin in earnest and these compounding pharmacies will go to their people that rely on their compounds to lobby on their behalf. This problem with the compounding pharmacies is one that I hope Congress will finally do something to bring them under supervision and closer regulation. I nothing more stiff penalties need to be imposed and I am not suggesting a few thousands, but a minimum of half a million since these compounding pharmacies a killing people because keeping equipment sterile seems to take second place to profits.
Other information can be read here about a congressional representative calling on the Department of Justice to conduct an investigation into whether NECC violated federal laws designed to stem illegal activity in controlled drugs. Then this article discusses some of the other compounds involved in the meningitis outbreak by NECC.
And now there is new information about the sister compounding pharmacy in Westborough, Massachusetts. This compounding pharmacy, Ameridose, has issued a recall of all its products in cooperation with the FDA investigation because of sterility issues.
October 31, 2012
Two topics have come to the fore in the last month. The first is online pharmacies and the National Association of Boards of Pharmacy and the Food and Drug Administration are both warning consumers about the dangers. The second and equally serious problem is the Compounding Pharmacies that are at present unregulated. This will be my topic for the next blog and I am focusing on online pharmacies in this blog.
“Of the 10,065 online pharmacies in the NABP study, 9,734 -- 97% -- violated state or federal laws and/or NABP safety and practice standards.” This means that 331 online pharmacies may be legitimate or only 3 percent may be trustworthy. The FDA is right in issuing warnings that online pharmacies are an emerging health threat. Personally, I will never use an online pharmacy just because of the above. In addition, the many spammers employed by these people continue to fill my one email inbox and attempt to get their garbage through comment moderation on this blog. Thank goodness for the delete or spam key that is easy to use.
What is not surprising is that when they are found out, they just shut down the site and open another often before the other is shut down. They never miss an opportunity to pedal their snake oil. Many of these fake pharmacies are so good at what they do that it takes experts to discern the fake from the real drugs. The patients often do find out when they take the fake drugs and their medical condition worsens, or when they have to go to the emergency department for unknown causes. Unfortunately, some never make it to the emergency department, but to the morgue.
“A group of interested companies has formed the Center for Safe Internet Pharmacies. The founding members of the CSIP include American Express, Discover, eNom, Go Daddy, Google, MasterCard, Microsoft, Neustar, PayPal, Visa, and Yahoo. CSIP has an online pharmacy checker at safemedsonline.org, where consumers can check out and report rogue pharmacy web sites.”
The company in the list above I really must wonder about is Yahoo. It seems like Yahoo sells their email lists to these fake pharmacies as these make up the bulk of my spam emails along with another group of sites. This is unproven, but may be what happens.
Fake online pharmacy warning signs include many of the following - The FDA warns consumers to beware online pharmacies that:
1. Online pharmacies may offer low, low prices.
2. Allow you to buy drugs without a prescription from your doctor.
3. Offer deep discounts or cheap prices that seem too good to be true.
4. Send spam or unsolicited email offering cheap drugs.
5. Are located outside of the United States.
6. Are not licensed in the United States.
The following list may indicate a safe online pharmacy:
1. Always requires a doctor's prescription for prescription drugs.
2. Provides a physical address and telephone number in the U.S.
3. Has a pharmacist available to answer your questions.
4. Is licensed with your state's board of pharmacy.
October 29, 2012
On the surface, this seems like a no-brainer, but the outcome is in the details. It is often easy to see why some practices fail and many patients are often the cause of a medical practice on the margin not staying in existence. Word of mouth is very strong among patients that are not happy with the care they receive and can be the cause of a practice not succeeding.
Many years ago, I was a patient in a practice that was not doing well and I had to evaluate if I was going to stay or try to find another doctor. More than once, I was told that a test result was in the mail and never would receive it. Then one day I happened to be in the waiting room and heard the office manager tell a patient that something was in the mail. As soon as she hung up the phone, she and the receptionist were joking about it and went back to exchanging the latest gossip about a patient. I don't know whether they knew I could hear or even cared that other patients in the waiting room could hear, among them the patient they were talking about.
I could see the patient getting very red faced and it was not long before she got up and walked out the door. Then another patient got up and left and only two of us were left to listen to the two of them continuing to run different patients down. As the two of us got up to leave, the nurse was at the door calling my name. The other fellow continued to walk out the door. The nurse wisely waited until she had me in the room and asked why patients were walking out. I told her none too politely that it was the office manager and the receptionist causing patients to leave. She stated that the office manager was the doctor's niece and nothing could be done about this. Then she stated that this was her last day at the practice, as she could not get along with the office manager.
Shortly, the doctor walked in and I admit I was not it the best of moods. When the doctor asked what was wrong with me today, I opened up with both barrels and probably said more that I should have, but I wanted him to know that I was leaving and why I was not coming back. This was long before HIPAA (Health Insurance Portability and Accountability Act of 1996), so there were no regulations in place to protect patient rights or privacy, only what the doctor determined was right and wrong. As I was walking out the door, the doctor said he would not fire his niece. I quipped that because of her he had lost four patients in less than an hour and he should reconsider.
Two months later the office closed and I heard the doctor was in a large city in another state. He did need to return for the trial against him, his niece, and the receptionist for defamation of character, which they lost. Shortly after all were gone out of town and I have heard nothing more about them. Before becoming a patient of my current doctor, I left two other practices as a patient because of overly chatty office personnel. My current primary care doctor is a hospitalist and seems to have new staff twice a year. On one visit that was my first question. He answered that seems to be the only way they could prevent overly chatty receptionists and others for violating HIPAA. The office manager is very strict about HIPAA and terminates any employee caught violating patient privacy rules with no second chances.
I did get an opportunity to visit with her and I can appreciate why the doctors like her so well. She requires every new employee to read the pertinent rules and sign that they understand them and what will happen if they are caught violating them. Her only comment that I agree and support is how often people think they can get away with looking at a patients record and then chat about it with other people. I could only say that three employees were people that I have seen for more than one year. That does not mean that there couldn't have been more tending to patients or on a day off. I do know that a few are rotated to other departments on a regular basis. I know of one that I see in different departments and she did say she likes the rotation for the variety of duties she can do.
The above is just one reason that physician practices fail. There are others – financial mismanagement, not making the patients feel welcome, doctor indifference, and communication failures. Yes, some practices hang around because the patients are totally passive and as long as they get the pill they need to resolve a health problem, the patients are none the wiser and care less about how they or the office is handling their records and problems within the office.
As patients learn more about HIPAA and become more empowered, this is slowly changing for the best. Patients are demanding better health care, respect as patients, patient privacy, and access to their health records. In many cases, patients are active in opposition of some budget cuts by Medicare that is damaging good doctors financially. One doctor that is in a clinic knows me and that I can advocate, asked if I would support him and others by writing our federal elected officials. He looked rather hurt when I said no. He did have the courage to ask why. I pointed out several personnel deficiencies I could see just standing in the hallway. We had an unobstructed view to the receptionist and billing department. Three employees could see us, but they continued chatting and one pulled out a patient file and they started talking about that patient.
The doctor was getting the idea and we moved to the other side of the hallway and closer to the talk. No, they were not talking about a coding problem in billing and it was rather clear they were talking about a patient and what the medical problems were. The doctor admitted he had heard enough and asked me to go to the waiting room and return with the two patients closest to where the employees were talking. I was surprised that no questions were raised when the three of us headed down the hall to the doctor's office. When we got to his office, he directed them into his office and got them seated. He then carefully asked them if they had overheard what the employees were talking about. One of the patients said she knew who they were talking about and was clearly upset about this. The other patient said she knew that they were talking about a patient, but did not know the person. At that point the nurse who had been with the doctor's next patient knocked and entered the office. When she saw the three of us, she apologized and started to leave, but the doctor asked her to stay.
He asked if these were his last two patients for the day and the nurse checked the schedule and said there was one more already waiting to see him. He asked if they could wait an hour while he corrected a problem and the two said they could come back another day, and they understood and appreciated his need to correct the problem. The doctor asked the nurse to take their names and phone numbers to call them later or the next day and reschedule them. He thanked the three of us for our information, said it would be taken care of immediately, and asked the nurse to escort the two patients back to the waiting room to leave. I started to leave and he asked me to stay and got the nurse to check if the patient was the one that was going to be leaving for vacation and he would see her if that was the case. She was not and agreed that she could come back another day.
The doctor accompanied the last patient out and asked the three employees to come to his office while the nurse and I answered the phone and took care of anyone coming in. The nurse was still in the dark and once the door to his office was closed, she asked if there was anything I could say. I said “HIPAA violation.” She said “good” and that was the end of the conversation. The nurse went to a filing cabinet, pulled out a stack of papers, sat down, and started looking through them. She stopped and asked what my position was and I stated just a friend of the doctors. I asked if she knew where the HIPAA file was. She said in the doctor's office, and I asked if any of the computers were hooked to the Internet and she stated only in the doctors office. Then someone came in and the nurse sent her directly to the doctor’s office and then said to me, “the payroll clerk.”
The doctor called the nurse and asked her to find three boxes for personal belongings and to stand by to enter his office when he brought each employee out. The doctor brought one employee at a time to remove her personal belongings and then escorted them to the door. When he was finished, he asked the nurse to get him the applications file. She handed him the file and she said the three positions for each were clipped together in the order she thought would help him. She said your friend has something to discuss about HIPAA. The doctor instead said he wanted to apologize to his nurse for not taking her serious and having a friend make him realize that things were not right.
Then he asked what was on my mind. I asked him if he had the HIPAA rules and he said he did. I told him it would be a good idea to have a copy together with a paper stating that the employee had read and understood them and a place for them to sign to that effect. Then a second page stating that if they chose to violate the HIPAA rules that they could be dismissed immediately and a place for their signature stating that they understood this. This would become part of their employee file. In addition another copy would be placed where they would see it each day.
He thanked me for the advice and asked if in the next three days I would come in and get this accomplished. I agreed and he asked if I would also be the receptionist for the next two days and that I would be compensated. Then he asked the nurse to clear and reschedule the next day's patients and if I could stay while he looked over the applications and assist with some calls. We changed desks and he started looking at the applications. We were fortunate to find seven applicants still looking for work and scheduled four for interviews the next morning and three in the afternoon. We reviewed what had been done and only one patient had not been actually contacted, but a message had been left. Other partners in the clinic were stopping by and they were sent to the doctor's office. Sheryl, the nurse, and I finished up and she asked if I could be there by 7:30 the next morning and when I said yes, she told the doctor we were leaving. He asked if I needed a key and Sheryl said she would be in by then. The doctor stated he would have a laptop hooked up in case I needed the Internet and have it also connected to a printer
The office returned to normal the following week and the doctor and I do not talk about it. Sheryl says things are better than before and they have lost a position when one employee decided she did not like the work, but that the other two are doing what three were before. She said that one of the billing employees from another office does help occasionally.