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Editorial: Discontinued Drugs
In the past 50 years, thousands of drug products have been discontinued by manufacturers for a number of different reasons. Some of these include FDA decisions concerning safety/effectiveness, manufacturers going out of business, low sales and manufacturer deciding not to manufacture the drug any longer, companies merging together and eliminating the items that do not sell above a certain cutoff level, manufacturing problems resulting in excessive costs to continue manufacturing a drug, and various other reasons. Regardless of the reason for discontinuing a drug, the problem is that physicians and patients no longer have access to the drug to which they have become accustomed and may be dependent.
To overcome the problem, in many cases, compounding pharmacists can continue to provide the medication for the physicians/patients if the active pharmaceutical ingredient (API) is available and if the technology involved in its preparation does not prohibit compounding. Some technology, including metered dose inhalers, transdermal patch systems, liposomal injections, dry powder inhalers, and some others, are not amenable to compounding. However, the majority of discontinued drugs can be compounded.
At www.CompoundingToday.com, IJPC provides a list of thousands of drugs that have been discontinued and, in many cases, their formulations.
Companies are required to provide FDA with a six-month advance notice of the discontinuation of sole source products that are life-supporting, life-sustaining, or for use in the prevention of a debilitating disease or condition. Also, the FDA sometimes receives notification for other products. This list can be accessed at:
www.fda.gov/drugs/drugsafety/drugshortages/ucm050794.htm
Pharmacists can periodically check this list and make plans accordingly to assist physicians and patients. The future will probably see more drugs being discontinued for a number of reasons and many of these offer compounding pharmacists additional opportunities to be of service.
Loyd V. Allen, Jr., Ph.D., R.Ph.
Editor-in-Chief
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"Chip-containing Tablet" Approval Sought
Novartis plans to seek regulatory approval in a little over a year for a tablet containing an embedded microchip. The product will be for a transplant medication and will be to ensure that patients have taken the right dose of the drug at the right time. The chip activates when contacting stomach acid and will send information to a patch on the patient's skin. The information is then transmitted from the patch to a smart-phone or conveys it to the physician over the Internet.
(Novartis to place chip in transplant tablet. Tablets & Capsules, January 2011, page 6).
Look-Alike and-Sound-Alike Painkiller Names Account for Prescription Errors
Look-alike and sound-alike names contribute to painkiller prescription errors that occur in hospitals. The error rate was nearly three per 1,000 prescriptions in hospitals; error rates were higher when prescribing for children, a study found. The project involved researchers reviewing 714,290 orders for painkillers in a large database of pharmacist-detected-and-prevented prescribing errors. The contributing causes were evaluated: failure to modify therapy based on patient-specific information; inadequate drug therapy knowledge; inappropriate use of a dosage form; mistakes in dose calculations; improper dose for the route of administration; and others. The rate of potentially serious prescribing errors was 0.63 per 1,000 (449 cases). Pediatric case error rates were 243 errors in 40,996 orders (0.59 percent)-pediatric drug orders accounted for 14 percent of the mistakes considered potentially serious, according to the study. The highest error rates involved drugs that are infrequently prescribed with drug names that looked or sounded alike. The study appears in the January issue of The Journal of Pain.
http://consumer.healthday.com/Article.asp?AID=649412
30-Day Beyond-Use Date for Pradaxa After Opening Bottle
The new anticoagulant dabigatran etexilate, or Pradaxa, labeling details a 30-day beyond-use date after opening the bottle. In other words, after opening the bottle, patients are supposed to discard unused capsules after 30 days. This poses some potential problems. The container is designed as a 60-count unit-of-use bottles and blister packages to be taken at the recommended dosage of one capsule twice daily; it will last a patient precisely 30 days. However, the package insert gives a 30-day useful life once anyone opens the manufacturer-supplied bottle. If patients receive more than one Pradaxa bottle at a time, they really shouldn't open up the new bottle until the other one is gone. The unit-of-use bottles lack a tamper-evident seal, which is a problem as patients cannot rely on a seal as evidence that a bottle has not been opened. Pharmacists can tell patients to write on their bottle the date on which they first opened the container or they can provide a sticker that prompts patients to write in the bottle's beyond-use date. Pharmacists must refrain from opening Pradaxa bottles because that act starts the 30-day countdown on the capsules' useful life; this can potentially be a real problem with mail-order pharmacies.
(Per package insert)
Loss of Lethal Injection Drug May Harm Surgical Patients? Physician Experts Note Pentothal Safer Anesthesia than Newer Alternatives for Some Patients
Anesthesiologists have grave concerns over a decision by a drug manufacturer to halt production of a long-used and powerful anesthetic because of the medication's use in lethal injections in prison executions. There are no other sources of Pentothal available. American physicians and experts noted that while there are newer anesthetics on the market, Pentothal is a safer alternative for certain patients because it does not lower blood pressure as drastically as its newer counterparts do. The American Society of Anesthesiologists (ASA) issued a statement saying that its members are "extremely troubled" that they will no longer have access to Pentothal, which has been used in preoperative sedation since the 1940s.
Patients that benefit from Pentothal include those with cardiovascular problems, such as the elderly or those with heart disease and expecting or delivering mothers because there's less chance that the anesthetic will cross through the placenta into the baby and reduce its blood pressure. Also, Pentothal is used for instances in an emergency C-section, where you already have compromise of the baby. Pentothal also is preferable to other anesthetics for sedation during neurosurgery because it does not affect intracranial pressure as drastically.
http://consumer.healthday.com/Article.asp?AID=649280
Lawsuit Seeks to Block Imports of Key Execution Drug
Attorneys representing six death row prisoners sued the FDA in federal court in an attempt to block the importation of a key drug used by states to perform executions by lethal injection. The lawsuit, filed on behalf of prisoners in Arizona, California, and Tennessee, alleges that the FDA allowed states to import unapproved supplies of thiopental sodium (Pentothal) in violation of federal regulatory laws; stating that the law requires FDA to ensure that only safe, effective drugs are brought into the U.S. When the agency allowed states to import unapproved sodium thiopental, it abdicated its responsibilities and violated federal law.
States have been forced to go outside the country to obtain the drug as it is a component of a three-drug protocol used in U.S. executions. The lawsuit alleges that large amounts of unapproved sodium thiopental have been imported by at least six states: Arkansas, Arizona, California, Georgia, Nebraska, and Tennessee.
http://content.usatoday.com/communities/ondeadline/post/2011/02/lawsuit-seeks-to-block-imports-of-key-execution-drug/1
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