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Each issue will include an editorial on a topic that is important for the profession of pharmacy, as well as a review of a new drug that includes a comparison of the new drug with previously marketed drugs that are most similar in activity, and a New Drug Comparison Rating (NDCR) for the new drug. Read on for this month's issue.
March 2011 Issue
New Drug Review
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Both Patients and Health Care Have a Great Need for a Personal Touch!
Hardly a week goes by when I don't see a published paper or other commentary about the lack of patient adherence with instructions for using medications. I have had a strong interest in this topic since the time that I first published a paper in 1975 on patient compliance (a term that I still consider preferable to patient adherence). I wish I could report that the pharmacists and others who read that paper or have heard me speak on this topic were so impressed and motivated by what they learned that we have made great advances in improving patient adherence. But we haven't. Indeed, most of what I wrote in 1975 could be reprinted verbatim today and be just as valid and current.
Why have we not made substantial progress in improving patient adherence and markedly reducing the occurrence of other drug-related problems? We certainly recognize the extent of these problems and have even identified some strategies that have been effective in the limited patient populations in whom they have been evaluated. However, in many respects, our health care system and health professionals have failed to come close to our potential to provide optimum health care for our patients. An explanation that insurance companies, government programs, and others are responsible for the shortcomings of our health care system has considerable validity but must not preclude a challenge to the health professions as to why we have not been more effective. This challenge should begin with a very fundamental but essential question - Do health professionals demonstrate the interest, caring, and commitment (i.e., the "personal touch") that I would contend are essential for the relationship of health professionals and their patients to be effective and result in positive outcomes. In my opinion, it is this personal touch that is necessary (but is too often missing) for much greater effectiveness in addressing challenges such as improving patient adherence.
The personal touch of pharmacists
In considering the settings in which most pharmacists practice, it is quickly apparent that there is wide variation in the extent of the opportunities to provide a personal touch:
Community pharmacies - This is the setting in which there is the greatest opportunity for pharmacists to provide a personal touch for the largest number of patients. However, the extent to which this is done is highly dependent on the level of staffing of pharmacists, student pharmacists, and pharmacy technicians, the stress in the work environment, and the degree to which the owner/management encourages this communication with patients. In many community pharmacies there is no interaction between the pharmacist and the patient in a process in which patients are instructed by a technician to "sign here" and are then sent on their way. Although some community pharmacies have established adherence programs featuring automatic refills and/or telephone calls from the pharmacy to patients, the motivation is often based on the anticipated economic return with an emphasis on the number of calls and the time in which they are completed.
Hospital pharmacies - In certain hospitals pharmacists have excellent opportunities to provide a personal touch to selected inpatients, patients with special needs in certain clinics, and in meetings with patients who are being discharged. However, in many hospitals, the responsibilities of the pharmacists are primarily distributive in nature, there is little or no interaction with inpatients, and the provision of medications to clinic patients often involves minimal communication.
Mail-order pharmacies - There is no personal touch provided by pharmacists for the patients for whom they prepare prescriptions. Even the pharmacists who speak with patients by phone often have incentives to keep such discussions brief (e.g., part of their evaluation is based on the number of calls during a designated time period).
The inescapable conclusion of these observations is that pharmacy as a profession is falling far short of our potential in providing a personal touch for patients that will contribute to better drug therapy and health care.
A great communicator
The pharmacist who was the best communicator and motivational speaker whom I have known was the late Robert Henry. I know that just the mention of his name will prompt a positive memory and smile for every pharmacist who ever heard him speak. I considered the content, eloquence, and style of his message to be so effective that I invited him to speak in many of my classes at the Philadelphia College of Pharmacy. I was blessed and motivated by my friendship with him.
Robert Henry was an advocate for the personal touch and the responsibility that he insisted that pharmacists had in providing this touch for the patients they served. He would conclude many of his presentations by sharing the following poem, "The Touch of the Master's Hand," that was written by Myra Brooks Welch in 1921.
It was battered and scarred, and the auctioneer
Thought it scarcely worth his while
To waste much time on the old violin
But he held it up with a smile.
"What am I bid, good folks," he cried,
"Who will start the bidding for me?"
"One dollar, one dollar, do I hear two?"
"Two dollars, who makes it three?"
"Three dollars once, three dollars twice, going for three,"
From the room far back a gray bearded man
Came forward and picked up the bow,
Then wiping the dust from the old violin
And tightening up the strings,
He played a melody, pure and sweet
As sweet as the angel sings.
The music ceased and the auctioneer
With a voice that was quiet and low,
Said "What now am I bid for this old violin?"
As he held it aloft with its' bow.
"One thousand, one thousand, do I hear two?"
"Two thousand, who makes it three?"
"Three thousand once, three thousand twice,
Going and gone," said he.
The audience cheered,
But some of them cried,
"We just don't understand."
"What changed its worth?"
Swift came the reply.
"The touch of a master's hand."
And many a man with life out of tune,
And battered and scarred with sin,
Is auctioned cheap to the thoughtless crowd,
Much like the old violin.
A mess of pottage, a glass of wine,
A game, and he travels on,
He is "going" once, and "going" twice,
He is "going" and almost "gone."
But the Master comes and the foolish crowd
Never can quite understand
The worth of a soul and the change that is wrought
By the touch of the Master's hand.
A spiritual dimension
The latter part of this poem reflects a spiritual dimension - something that is not often considered as health professionals interact with their patients. However, with increasing frequency there have been suggestions that knowledge of a patient's spiritual "history" is of value in communications, decisions, and plans regarding a patient's health care.
My son, Eric, is a pharmacist-physician. When he concludes an office visit or a visit with a hospitalized patient, he will often ask the patient if he would like him to pray for him. Of the hundreds of times that he has offered to do this, less than ten patients have declined. Following the prayer, many patients have voiced their heartfelt appreciation. I have to think that this personal touch will also contribute to these individuals giving careful attention to the medical and drug therapy advice he has provided them.
Daniel A. Hussar
New Drug Review
Collagenase clostridium histolyticum
(Xiaflex - Auxilium)
Agent for Dupuyten's Contracture
New Drug Comparison Rating (NDCR) = 5
in a scale of 1 to 5, with 5 being the highest rating
For intralesional administration for the treatment of adult patients with Dupuytren's contracture with a palpable cord.
Most important risks/adverse events:
- First drug to be approved for the treatment of patients with Dupuytren's contracture;
- Recurrence rate is lower than with surgical procedures
Tendon rupture or other serious injury to the injected extremity (drug should be injected only into the collagen cord with a metacarpophalangeal [MP] or a proximal interphalangeal [PIP] joint contracture, and care should be taken to avoid injections into tendons, nerves, blood vessels, or other collagen-containing structures of the hand); allergic reactions; risk of bleeding may be increased by the concurrent use of warfarin, clopidogrel (Plavix), prasugrel (Effient), or aspirin (dosages higher than 150 mg/day).
Most common adverse events:
Peripheral edema (73%), contusion/ecchymosis (70%), injection site hemorrhage (38%), injection site reaction (35%), pain in extremity (35%).
Administered intralesionally into a palpable cord; 0.58 mg per injection (i.e., 0.25 mL of reconstituted solution in cords affecting MP joints, and 0.20 mL for cords affecting PIP joints); approximately one-third of the dose is administered at each of three positions in the cord; if a contracture remains when the patient is evaluated the following day, a passive finger extension procedure should be performed to facilitate cord disruption; if the cord has not been disrupted after the first treatment and the contracted cord persists for four weeks, a second treatment may be performed.
Single-use vials - 0.9 mg (should be stored in a refrigerator); is reconstituted with 0.39 mL (for a MP joint) or 0.31 mL (for a PIP joint) of the sterile diluent supplied with the medication (0.3 mg/mL calcium chloride dihydrate in 0.9% sodium chloride); injection should be administered by a healthcare provider experienced in treating Dupuytren's contracture; product labeling should be consulted for detailed guidelines for reconstitution, preparation prior to injection, and the injection procedure.
Dupuytren's contracture is a connective tissue disease in which collagen is deposited beneath the skin in the palm of the hand. When too much collagen builds up, thick, rope-like cords of tissue are formed that extend to the base of the fingers and may reduce the ability to straighten and use the fingers in the normal manner.
Collagenase clostridium histolyticum consists of two microbial collagenases obtained from the fermentation of Clostridium histolyticum bacteria. The two enzymes are thought to act synergistically in hydrolyzing collagen with a resultant lysis of collagen deposits. The effectiveness of the new product was demonstrated in two studies in which the primary endpoint was a reduction in contracture of the selected primary joint (MP or PIP joint). Treatment was successful in 64% and 44% of the patients treated with the new drug, compared with 7% and 5%, respectively, of the patients receiving placebo. Patients treated with the medication also showed a greater increase from baseline in the range of motion of the joints.
Prior to the availability of collagenase clostridium histolyticum, the only effective treatment for Dupuytren's contracture was surgery. However, surgery is usually associated with a long recovery and a need for physical therapy. The availability of the new product represents an important advance in the treatment of this condition. In addition, the recurrence rate with the new drug (4%) is considerably lower than that following surgery.
Daniel A. Hussar