Abuse Deterrent Formulations and Tamper Resistant Medications

International Pain Foundation is advancing a call for state legislation, providers, insurance companies, pain patients and pharmaceutical companies to support an increase in tamper resistant medications (TRM) and abuse deterrent formulations (ADF) allowing chronically ill pain patients better access to life giving medication.

We propose moving the conversation of opioid use forward in a productive and positive patient health focus approach. Currently, there are over 100 million Americans’ who struggle with the challenges of living daily with chronic pain over 95% of them are using their medications appropriately according to the Academy of Integrative Pain Management. We need to address restricting the access to those who are abusing their medications while keeping those who are in compliance from any penalty. The pain community and legislators need to ensure the patients in pain have appropriate access to care including opioid analgesics.

The Food and Drug Administration (FDA) has worked to address this problem while ensuring patients who are in pain have appropriate access to opioid analgesics. Abuse and misuse of these products, however, have created a serious and growing public health problem. Although providers and pharmaceutical companies are working hard to provide access to care we need to decrease opioid abuse and increase Abuse Deterrent Formulations (ADF) and Tamper Resistant Medications (TRM), allowing chronically ill pain patients who are properly taking prescription better access to life giving medications.

The Institute of Medicine’s report on the state of chronic pain in the U.S. shows that pain is a major public health problem, which is costing the U.S. up to $635 billion a year in added health costs and lost productivity. Logically, these medications are a low cost and effective form of treatment, which can and will help the mass population of people who suffer with pain diseases. One potentially important step towards the goal of creating safer opioid analgesics has been the development of opioids that are formulated to deter abuse. The FDA considers the development of these products a high public health priority. Our push in the pain community should be to employ the use of opioid medications more effectively through the use of TRM & ADF’s. We can combat the issues of abuse while still giving patients who need pain relief a safe, effective and accountable access to these medications.

We believe the first step is to change our policies to develop a strong, lasting solution to this health crisis. The International Pain Foundation, strongly supports legislation which will have the most value. If ADF’s & TRM’s are universally adopted so people cannot switch to other medications that do not have the ADF & TRM components it will help us find a balance between the pain patients who truly need opioid medication for daily living and those who are abusing them. The responsible patients should not be punished by the crackdown on prescription drugs and opioid abuse. We understand that there is a need to stem the tide of drug abuse, but not at the detriment to those who need proper and timely care and access to tools for better daily living so they may function in a more productive way in our communities and provide greater benefit to society as a whole.

iPain believes in four major actions that ensure access to care remains a high priority for those millions of pain patients who need the medications and are taking them responsibly while deterring abuse.

1. Define ADF & TRM technology. States need to define ADF & TRM based on FDA guidance.
2. Push for legislation which supports non-ADF/TRM products from being substituted by pharmacists for ADF/TRM, without approval of the prescribing health professional. This legislation should ensure that unless the substituted opioid is also a non-ADF/TRM or consent is obtained from the prescribing health professional, a pharmacist would be prohibited from substituting another opioid for an ADF/TRM.
3. The pain community and future legislation should advance patient safety. State legislation should place a high priority on ADF/TRM opioid marketplaces where more ADF/TRM treatment options exist and pharmaceutical companies are encouraged to create these safer medications making them more readily available for pain patients.
4. Support the removal of barriers to non-opioid therapies as a first line of treatment for pain such as durable medical equipment, chiropractic’s, naturopathy, and functional neurology.

How can these actions be accomplished in the pain community. By removing barriers to the use of branded and non-branded, non-opioid pain medications will allow patients greater options with less chance of becoming dependent on them. Any combination of two or more of the above methods can be used to deter abuse even further. Providing medications including ADF/TRM can be done through physical and chemical barriers: chewing, crushing, cutting, grating, or grinding must be prevented.

1. Chemical barriers can resist extraction of the opioid using common solvents like water, alcohol, or other organic solvents.
2. An opioid antagonist can be added to interfere with, reduce, or defeat the euphoria associated with abuse.
3. The antagonist can be sequestered and released only upon manipulation of the product. For example, a drug product may be formulated such that the substance that acts as an antagonist is not clinically active when the product is swallowed but becomes active if the product is crushed and injected or snorted.
4. Substances can be combined to produce an unpleasant effect if the dosage form is manipulated prior to ingestion or a higher dose than directed is used.
5. Certain methods of drug delivery can offer resistance to abuse. For example, a sustained-release depot and injectable formulation that is administered intramuscularly or a subcutaneous implant can be more difficult to manipulate