Archive

Archive for January, 2012

FDA, Pharmaceutical Companies, and Stimulant Shortages


 

Maryland Public Television has invited me to a live interview by Jeff Salkin on Direct Connection with Jeff Salkin on January 30, 2012 Monday at 7:30 pm to discuss the recent problematic shortage of ADHD stimulant medications. I will review the possible causes and make suggestions to “work around” the shortages for parents and patients.

As a preview to the show and for those who read my blogs, I have provided the FDA’s recent tables highlighting the manufacturers explanations for shortages. You will notice there are several companies making the medications so no one company can be held to blame. This is an industry issue entailing regulatory, manufacturing and economic factors.

Join us Monday night for my detailed explanations. Following the program, I will blog the detailed information I offered in the interview with further links.

http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050792.htm

Amphetamine Mixed Salts, ER Capsules  (updated 10/31/2011)

Company/Products Reason Related Information
Shire Customer Service:
1-800-828-2088Adderall XR capsules
5 mg – 100 count (NDC 54092-0381-01); 10 mg – 100 count (NDC 54092-0383-01); 15 mg – 100 count (NDC 54092-0385-01); 20 mg – 100 count (NDC 54092-0387-01); 25 mg – 100 count (NDC 54092-0389-01); 30 mg – 100 count (NDC 54092-0391-01)
API supply issues and uneven product distribution patterns. Product availability for all dosage strengths is adequate.
Teva Customer Service
(888)838-28725 mg – 100 count (NDC 00555-0790-02); 10 mg – 100 count (NDC 00555-0787-02); 15 mg – 100 count (NDC 00555-0791-02); 20 mg – 100 count (NDC 00555-0788-02); 25 mg – 100 count (NDC 00555-0792-02); 30 mg – 100 count (NDC 00555-0789-02)
API supply issues Teva continue to release product as it becomes available.
Global Customer Service:
(215)558-430010 mg ,100 count (NDC 00115-1329-01); 15 mg, 100 count (NDC 00115-1330-01); 20 mg, 100 count (NDC 00115-1331-01); 25 mg, 100 count (NDC 00115-1332-01); 30 mg, 100 count (NDC 00115-1333-01)
Inadequate finished product supply to support current market demand All finished product strengths are currently available on an allocated basis.

Amphetamine Mixed Salts Immediate-Release Tablets (updated 1/12/2012)

Company/Products Reason Related Information
Sandoz Customer Service:
1-609-627-85005 mg tablets, 100 count (NDC 00185-0084-01)10 mg tablets, 100 count (NDC 00185-0111-01)

20 mg tablets, 100 count (NDC 00185-0401-01)

30 mg tablets, 100 count (NDC 00185-0404-01)

Increase in demand Releasing product as it becomes available.
CorePharma
1-800-850-27195 mg tablets, 100 count (NDC 64720-0130-10)10 mg tablets, 100 count (NDC 64720-0132-10)

20 mg tablets, 100 count (NDC 64720-0135-10)

30 mg tablets, 100 count (NDC 64720-0136-10)

Increase in demand CorePharma is releasing product as it becomes available.
Teva Customer Service:
1-888-838-28725 mg tablets, 100 count (NDC 00555-0971-02)7.5 mg tablets, 100 count (NDC 00555-0775-02)

10 mg tablets, 100 count (NDC 00555-0972-02)

12.5 mg tablets, 100 count (NDC 00555-0776-02)

15 mg tablets, 100 count (NDC 00555-0777-02)

20 mg tablets, 100 count (NDC 00555-0973-02)

30 mg tablets, 100 count (NDC 00555-0974-02)

Adderall, 5 mg tablets, 100 count (NDC 00555-0762-02)

7.5 mg tablets, 100 count (NDC 00555-0763-02)

10 mg tablets, 100 count (NDC 00555-0764-02)

12.5 mg tablets, 100 count (NDC 00555-0765-02)

15 mg tablets, 100 count (NDC 00555-0766-02)

20 mg tablets, 100 count (NDC 00555-0767-02)

30 mg tablets, 100 count (NDC 00555-0768-02)

API supply issues Teva continue to release product as it becomes available.

Dextroamphetamine Tablets (1/12/2012)

Company/Products Reason Related Information
Teva Pharmaceuticals
1-800-545-88005 mg tablets, 100 count (NDC 00555-0952-02)
10 mg tablets, 100 count (NDC 00555-0953-02)
Manufacturing delays Teva has dextroamphetamine 5 mg and 10 mg, 100 count tablets, will be on intermittent back order through mid-2012. Product will be released as it becomes available.

Methylphenidate HCl (updated 1/12/2012)

Company/Products Reason Related Information
Sandoz Customer Service:
1-609-627-85005 mg (100s – NDC 00781-8840-01 & 00781-5748-01; 1000s – NDC 00781-8840-10), 10 mg (100s – NDC 00781-5749-01 & 00781-8841-01; 1000s – NDC 00781-1749-10), 20 mg (100s – NDC 00781-8842-01 & 00781-5753-01; 1000s – NDC 00781-1753-10)20 mg (100s – NDC 00781-8843-01 & 00781-5754-01)
Capacity constraints and receiving API orders. Expect sporadic backorders for the next couple of months.
Mallinckrodt Customer Service:
(800) 325-88885 mg (100s – NDC 00406-1121-01; 1000s – NDC 00406-1121-10), 10 mg (100s – NDC 00406-1122-01; 1000s – NDC 00406-1122-10), 20 mg (100s – NDC 00406-1124-01; 1000s – NDC 00406-1124-10) Methylin ER, 10 mg (100s – NDC 00406-1423-01) and 20 mg (100s – NDC 00406-1451-01)
Continued recovery as a result of previously unavailable raw material All strengths of methylphenidate IR and ER tablets will be increasingly available as supply recovery continues, with most contracted orders being met.
UCB Customer Service:
1-800-477-78775 mg (100s – NDC 53014-0531-07), 10 mg (100s – NDC 53014-0530-07), and 20 mg (100s – NDC 53014-0532-07)Metadate ER Tablets, 20 mg (100s – NDC 53014-0594-07)

Metadate CD, 10 mg (100s – NDC 53014-0579-07), 20 mg (100s – NDC 53014-0580-07), 30 mg (100s – NDC 53014-0581-07), 40 mg (100s – NDC 53014-0582-07), 50 mg (100s – NDC 53014-0583-07), and 60 mg (100s – NDC 53014-0584-07)

Increased demand
UCB is currently out of stock of our 5 mg IR, 10 mg IR and 20 mg IR and our 20 mg ER products.  UCB expects resupply by February.
Watson Customer Service:
(973) 355-83005 mg (100s – NDC 00591-5882-01), 10 mg (100s – NDC 00591-5883-01), and 20 mg (100s – NDC 00591-5884-01)
n/a Watson has all 3 strengths available for contracted customers only.
Noven Customer Service:
866.663.2539 
Daytrana (Methylphenidate Transdermal System)
10 mg (30s – NDC 68968-5552-3)
15 mg (30s – NDC 68968-5553-3)
20 mg (30s – NDC 68968-5554-3)
30 mg (30s – NDC 68968-5555-3)
Not applicable
Currently all product is available
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ADHD Drug Shortage on Maryland Public TV Jan 30 7:30pm


With the increasing shortage of ADHD stimulant medications, Maryland Public Television invited me to a live interview by Jeff Salkin on Direct Connection with Jeff Salkin on January 30, 2012 Monday at 7:30 pm. I had been invited on his show a few years ago about adults with ADHD.

I will discuss the possible explanations for these shortages in addition to the large picture of drug shortages across all medication categories. As is frequently the case, there is no one cause. I hope to lay out the explanations. More importantly, I’ll offer suggestions to work around these shortages for you and your family members.

Join us this Monday night. I want to thank my patients who have offered their stories about the impact of the shortages.

David W. Goodman, M.D.

ADHD Stimulant Shortage on Maryland Public Television Jan 30, 2012 7:30 pm


Because of my recognized expertise in ADHD, I’m honored to have been invited to speak as a featured quest on Maryland Public Television’s program, Direct Connection with Jeff Salkin on January 30, 2012 Monday at 7:30 pm.

I will be addressing the stimulant shortage over the past several months-possible causes, the routes of manufacturing medications, the distribution of medications across the country, the sporadic availability of these medications, suggestions to physicians and patients on how to avoid shortages or alternative medications when shortages occur.

This problem now plagues those patients and family who use these medications in order to function at their highest level. The absence of medication may severely compromise ones ability to perform consistently thus increasing anxiety.

Join us and listen to my commentary and suggestions.

David W. Goodman, M.D.

Why is my ADHD bothering me now?


ADHD (or ADD without the H) is a disorder whose symptoms start in childhood. Two of three of these children will continue to have symptoms to an impairing degree beyond age 18 . Of the adults with ADHD who are diagnosed in adulthood, only 25% were ever diagnosed as a child (Kessler et al 2007). One reason for the under-identification of children with ADHD is that only those children who are disruptive come to the attention of teachers and parents. Non-disruptive children with ADHD may not get diagnosed until later in life. So the question is, what would cause them to seek an evaluation later in life. “If you lived with it all this time, it can’t be that bad.” Right? Well, not exactly.

In our recent publication on ADHD throughout the Lifespan (Journal of Clinical Psychiatry February 2012), we discuss the developmental phases of life that prompt the question “Why is my ADHD bothering me now?” When reading this article, please note the authorship of internationally recognized experts in the field that include Drs. Atilla Turgay (Canada), Phillip Asherson (United Kingdom), myself and Russell Barkley (United States).

Each developmental phase of life takes on more responsibility. For example, moving from middle school to high school means the academic demands and workload increases. As you move from high school to college, you need to be able to organize yourself to get to classes, do assignments on time, schedule time for study, sleep, play, and classtime. If you go onto first job, you need to be punctual, respond appropriately to supervisors, and complete work on time. When you get married, you need to negotiate household responsibilties and complete tasks timely and consistently to be a team player in your marriage. And then you go on to have children which adds additional layers of tasks and responsibilities requiring increasing levels of organization and efficiency. How about a job promotion with more tasks and the oversight of others. So, each developmental phase of adult life has its set of tasks and responsibilities and your ability to adapt and compensate becomes more difficult. At some point, your daily performance suffers whether at work or home.  At this point, either you or someone close (employer, family, friend) to you will bring it to your attention. Sometime this is done kindly, sometimes it is the result of an argument because you haven’t followed through as expected by others.

Our publication was written for physicians and psychiatrists so that they would understand why an adult with ADHD who had never gotten treatment might come to their office for an evaluation. We hope that this publication will disuade physicians from discounting an adult’s compliant of daily function and look for ADHD when indicated.

If you are not a physician, I think the article is still quite readable for most people and may provoke some thoughts and discussions amongst those effected by ADHD.

Thank you for your time and interest in reading my postings.

David W. Goodman, M.D.