by Ruth Hughes, PhD
Are you having difficulty getting your prescription for stimulant medication filled? Particularly if you have a prescription for amphetamine mixed salts (the Adderall generics), or more recently for immediate-release methylphenidate (Ritalin generics), you may find that your pharmacy is out and unable to tell you when they will get more.
In a previous blog, CHADD’s Tim MacGeorge developed some guidance on what to do if you are in this dilemma. This blog will explain what is causing the problem and what CHADD is doing to address it.
The shortages began last spring and all parties thought it would be a short-term problem. But now it is six months later and the problem is getting bigger, not smaller. To understand the problem, it helps to understand the process:
• Stimulant medications are considered Schedule II controlled substances and their production comes under the purview of the Drug Enforcement Agency (DEA). The DEA’s mission is to ensure that controlled medications are not used for nonmedical purposes.
• Pharmaceutical companies that manufacture stimulants apply to the DEA for permission to purchase a certain amount of the "active pharmaceutical ingredient" (API). This is the controlled substance within the stimulant medications.
• At the beginning of each calendar year, the DEA approves each company for a certain amount of the API. It is normally less than requested by each company, and the aggregate of all awards is the DEA’s best guess of the legitimate need for the year.
• Once approved, the company purchases the API and begins manufacturing the medications. It usually takes 8 to 12 weeks for the medications to be manufactured.
• And then they go to market.
Where Does It Go Wrong?
It only takes one company that has a problem in delivering its portion of the market share for the dominoes to begin to fall. Because each company is limited to a certain portion of the active ingredient, the companies are unable to step in when another company is having problems. Or if the DEA is wrong in its estimates of the number of legitimate prescriptions that will be written, then a shortfall can occur. Or the amount of medication may be correct, but the geographical distribution of the medications by all the companies involved may not lead to an even distribution across the country. The shortage continues until the original problem is solved.
Companies can go back to the DEA and request more of the API, but the application process is long and cumbersome. If the shortage occurs close to the end of the calendar year, companies are more likely to wait for the new annual award of API.
When all goes well, each pharmaceutical manufacturer has enough inventory to carry over into the new year until spring, when the production started in January actually reaches the market. This year the inventories are very low or nonexistent, raising concerns that there will not be sufficient medications available to make it until spring.
If the shortage continues for a while, as it has for ADHD medications, then other things begin to happen. Over time, physicians begin to change prescribing habits to other medications that are more readily available, such as the short-acting methylphenidate medications. But again, production of these medications is limited by the DEA. As a result, the shortage is spread to a new group of medications.
Some pharmacies or chain store distribution centers may begin to stockpile the medications, in anticipation of the shortages. This then aggravates the shortages in other areas.
Unfortunately, no one agency or manufacturer owns the problem. The Food and Drug Administration has responsibility for addressing medication shortages, but has no authority with the Drug Enforcement Agency. The DEA feels that it has a limited role of ensuring only the amount of medication legitimately needed is manufactured and the possibilities for diversion are reduced. And the manufacturers cannot respond quickly to shortages caused by internal problems or by other manufacturers because their production is limited by the DEA. As a result, there is a fair amount of finger pointing and little problem solving.
What Is the Short-Term Outlook?
Not great. Many of the companies that manufacture the short-acting stimulant medications report they have no inventory left or limited inventory. Given the manufacturing time lag of 8 to 12 weeks, it is unlikely that the 2012 DEA-approved medications will get to market until March at the earliest. No one seems to be able to estimate the amount of medications currently in pharmacies across the country. You should anticipate that getting your prescriptions filled for short-acting stimulants in particular, and all stimulant medications in general, may get more difficult as we move into the new year. So plan ahead.
Work closely with your physician and allow enough time before your current prescription is gone to actively search for a pharmacy that has your medication. Prescribing physicians and patients may need to consider long-acting, time-release medications rather than short-acting medications. If you have been purchasing the less expensive generic medications, you may need to consider the more expensive, name-brand medications. And you might need to consider a different delivery method such as the skin patch or liquid medication. Another option may be to try one of the nonstimulant medications that treat ADHD.
What Is CHADD Doing?
Given the manufacturing time lag, our current shortage seems destined to play out. But we can work to make sure this does not happen again. CHADD has been speaking out about the problems to the media to help raise awareness of the issue. Almost every day we are contacted by a major media outlet covering the story. We have been in touch with all the major and many smaller pharmaceutical manufacturers who make stimulant medications to clearly understand the scope of the problem and what steps might make it better. And we are organizing a coalition of concerned groups with the American Academy of Child and Adolescent Psychiatry. Other groups who have joined with us include patient advocacy, clinician, and pharmacy-related associations. The larger our coalition, the more power we will have to influence the agencies involved and Congress.
In early 2012, we will be meeting again with officials from the FDA and the DEA, and ultimately, with key senators and congressmen who can influence the policy of these agencies. We are determined to make sure this problem is solved. CHADD will continue to keep you informed about the shortages and what you can do to help us address this issue. While we may need to weather this storm, we will do all we can to make sure it does not happen again.
Ruth Hughes, PhD, is the CEO of CHADD.
PHOTO: Wikimedia Commons