On July 13, the Drug Enforcement Administration (DEA) announced the reinstatement of Drug Take-Back Days, with the 10th Take-Back Day scheduled for September 26, 2015 in 48 states; Take-Back Days in Pennsylvania and Delaware will take place on September 12. Visit https://www.deadiversion.usdoj.gov/SEARCH-NTBI/ to locate a collection site near you.
Termination and Reinstatement of DEA-Sponsored Take-Back Days
In September 2014, the DEA expanded the Secure and Responsible Drug Disposal Act of 2010. The act as signed in 2010 permitted law enforcement agencies to collect medications through drop-off boxes and take-back events. With the 2014 expansion, which intended to increase ongoing collection, other agencies such as pharmacies and hospitals could voluntarily be authorized collection sites as well; however, it also terminated the DEA-sponsored nationwide take-back events.
In May of 2015, ten US Senators petitioned the Attorney General to continue sponsoring nationwide Drug Take-Back Days, stressing that widespread collection methods were not yet established enough to make the transition away from DEA-sponsored Take-Back Days. The request was met with the reinstatement of the DEA-sponsored events. The 2014 expansion of the Secure and Responsible Drug Disposal Act of 2010 was not revoked, and the expansion of drug collection options is still continuing.
Also in May of 2015, President Obama appointed new DEA chief Chuck Rosenberg to replace Michele Leonhart, who departed in April 2015. In the first few months in office, Rosenberg has raised attention for reinstating Drug Take-Back Days. In his first interview as chief, Rosenberg noted his shock at the rates of drug overdose. Regarding the reinstatement of the drug take-back days, Rosenberg stated “We need you to clean out your medicine cabinet; we need you to give us the stuff in your medicine cabinet that can hurt you or your loved ones…More to come but we’re going to revive that program and we’re going to do it in every state in the country.”
State Responses to the 2014 Expansion
Following the 2014 expansion, various state-wide and county-wide policies were developed. Most notably, California’s Alameda County mandated for pharmaceutical manufacturers distributing within the county to be required to fund take-back. The industry PAC (PHRMA) challenged this in US Supreme Court, who refused to consider the case. By this mandate pharmaceutical manufacturers would be permitted to run disposal programs independently or in conjunction with other companies, and each manufacturer would have autonomy in designing their collection programs.
Following the US Supreme Court refusal to hear the case, other California counties are predicted to pass similar legislation. California state senate bill SB1014 would pass a statewide ordinance placing disposal responsibility on the pharmaceutical manufacturers.
Another bill in consideration in California, AB45, would put cost of take-back programs in pharmacies as a small tax on all consumer and business sanitation bills and establish a statewide mail-back program.
Other states have also continued working with local law enforcement to host publically-funded Drug Take-Back Days, and these efforts are expected to continue to expand.
The original petition letter from the ten senators to the DEA can be found here: http://www.upstate.edu/poison/pdf/schumer-drug-take-back.pdf.
The DEA website has a locator tool for authorized drug collection sites, where citizens can leave unwanted medications throughout the year: https://www.deadiversion.usdoj.gov/pubdispsearch/spring/main?execution=e1s1
On May 20, 2015, Dr. Karen Thacker of the Allegheny County Health Department issued a press release announcing a standing order to allow pharmacists in Allegheny County (Pennsylvania) to dispense intranasal and injectable naloxone without a prescription to at-risk patients and caregivers. This standing order is allowed by Pennsylvania Act 139, which was passed in late September 2014. This act allows:
This legislation does not mandate the administration by these providers, but rather allows first responders and pharmacists to administer it at their discretion.
What is Naloxone?
Naloxone (Narcan®) is an opioid antidote, which binds to the same receptors in the brain as narcotic drugs such as heroin or oxycodone. It binds these receptors more strongly than the narcotics, but does not elicit the same response; rather, it blocks the drugs’ response. When given to an overdosing patient, the naloxone will “kick off” the drug from the receptors and help the patient to stop overdosing.
How does Pennsylvania compare to other states?
In recent years, overdose deaths from narcotics and prescription opioids have increased greatly. Increasing naloxone availability can help reduce the risk of overdose death. Some opponents argue that providing a greater safety net through legislation such as Act 139 can lead to increased risk of opioid use, since narcotic users will feel that they can get away with using higher doses and falling back on naloxone if necessary. To the contrary, many studies have shown that harm-reduction practices such as needle exchange and increasing naloxone availability do not promote higher drug use, but rather promote lower opioid use and increased willingness to participate in rehabilitation and addiction treatment.
Pennsylvania is among a growing number of states allowing greater access to naloxone. Currently, 34 total states and the District of Columbia have passed legislation allowing increased access to naloxone; 26 states and the District of Columbia have passed Good Samaritan laws to those administering naloxone or summoning medical aid in an overdose emergency. The following map shows the current distribution of naloxone policy in the continental states. Additionally, Alaska has the Good Samaritan law but not increased access to naloxone and Hawaii does not have either.
PHSI sees the change to naloxone laws as another step forward for pharmacy. Not every pharmacist or pharmacy will need to provide naloxone, but being prepared through education and training is prudent. These opportunities will continue to guide pharmacy into being healthcare providers.
If you have provided naloxone to a patient, which product/dosage form was it?
The Centers for Medicare & Medicaid Services (CMS) issued a new guidance on biosimilar reimbursement on March 30, 2015 was needed based on FDA approval of the biosimilar Zarxio™ (filgrastim-sndz). The guidance describes the Medicare Part B reimbursement for biosimilars.
Reimbursement for drugs provided through Medicare Part B uses Average Sales Price (ASP) as the cost basis plus a markup. Since biosimilars are expected to have lower prices than the originator, Medicare is expecting to save money with biosimilars. The challenge seen by providers is that with a lower ASP for the biosimilar, the markup provides the same percentage but a lower dollar value margin than the originator. The incentive for the provider is to use the originator product with the higher dollar markup.
The CMS guidance changes this incentive by making the biosimilar reimbursement use the biosimilar ASP but the originator ASP markup. This keeps the markup the same and incentivizes the use of the lower cost product.
It may sound easy, but how do you add the markup factor from one drug to another? With only a few biosimilars, this could certainly be handled manually. As more and more biosimilars launch, this will be a daunting task. All the more reason for the drug compendia to group the biosimilar with the originator. The drug compendia will most likely try to fit the biosimilars into their current groupings. Even if the compendia don’t link biosimilars to the originator product using the current methods, they may be influenced to add a new biosimilar specific linking mechanism.
Thinking ahead, when will CMS release the next guidance to account for the scenario that the originator has exited the market and only the biosimilar(s) are left? Without the ASP from the originator, the provider markup could change to the biosimilar ASP. This scenario may not be required for years.
PHSI experts understand the drug compendia and the impacts on pharmaceutical manufacturers, PBMs, and pharmacies. The expectations for biosimilars are uncertain but will become clearer with additional guidances expected in 2015. Please contact us to discuss the biosimilar impacts and challenges you are experiencing or expecting.biosimilar
The Drug Enforcement Agency (DEA) began sponsoring the National Prescription Drug Take-Back Day in September 2010, with bi-annual Take-Back Days in April and September, running through September 2014. Over a five year period, the DEA sponsored nine total Drug Take-Back Days and collected over 4 million pounds of prescriptions drugs. The DEA originally created the events to provide patients with an opportunity to get rid of unwanted controlled substances without throwing them in the trash or flushing them down the toilet. The DEA has no plans to sponsor more nationwide Take-Back Days in order to give authorized collectors the opportunity to provide the service to their communities.
The 2010 Secure and Responsible Drug Disposal Act of 2010 developed regulations allowing authorized collectors to dispose of prescription drugs. The DEA’s final regulations were published in September 2014, making the need for bi-annual Take-Back Days unnecessary. New disposal rules provide for convenient, ongoing disposal opportunities for patients’ unwanted medications. The Final Rule authorizes certain DEA registrants, including manufacturers, distributors, reverse distributors, narcotic treatment programs, retail pharmacies, and hospitals/clinics with an on-site pharmacy, to become authorized collectors. Any organization may still partner with law enforcement to conduct take-back events.
PHSI spoke with a local pharmacy registered with the DEA as an authorized controlled substance disposal location. The pharmacy does not have the appropriate system to support the disposal of medications yet, but is actively working to set it up. The pharmacist indicated that the owner of the medication or someone authorized to handle the medication must be present to dispose of the drug product. There will be no charge to drop off the medication for disposal. The pharmacy offered two alternative solutions for drug disposal until their system is available to accept drugs for disposal:
Nearby collection sites can be found by visiting the DEA’s website at www.deadiversion.gov, clicking on the “Got Drugs?” icon, selecting “Search for an Authorized Collection Location” and entering their zip code. Even though the DEA is no longer sponsoring Prescription Drug Take-Back days, many local communities continued the tradition by holding their own events in April 2015. Publicizing local events any time throughout the year may be a good way for communities to ensure that the public is aware of a safe way to dispose of their prescription medications.
Although it is discouraging that the national effort has ended, PHSI sees this as an opportunity for pharmacies. As the medication experts, pharmacists should be involved in all aspects of medication use, including disposal of expired and unused prescription products. Pharmacies that offer this service can initiate a discussion with the patient/authorized individual about their current medications and market to new potential patients. PHSI believes that it should be the individual pharmacy’s decision to charge or not charge a fee to take back expired medications to offset their cost for drug disposal. What discussions about drug take-backs have you had? If your pharmacy is an authorized collection location, what impact have you seen from this initiative?
Following a scientific review of hydrocodone combination products that began in 2009, the FDA recommended in December 2013 that the DEA reclassify these as Schedule II Controlled Substances. The DEA ruling was published August 22, 2014 and rescheduling of hydrocodone combination products took effect on October 6, 2014. For retail pharmacists, this is old news. By now, problems such as patient and physician education of the changes have been recited hundreds of times, and pharmacists have learned to comply with the stricter DEA schedule.
Six months after rescheduling, PHSI looked back to see what effect this had on the pharmacy cost of hydrocodone combination products. Our findings show that the rescheduling of hydrocodone containing products did result in increased pharmacy costs for three common strengths of these products. Manufacturer published prices began to increase approximately one week before the rescheduling. While the published AWP and WAC increased by 25%-35%, the pharmacy acquisition cost per tab doubled between October 2014 and December 2014. At a time when many generic drug prices are increasing rather than decreasing, this is not a surprise. Pharmacies now pay wholesalers and manufacturers more for hydrocodone combination products to cover higher costs of storage and reporting, and possibly with the concern of a lower volume of sales due to the Schedule II classification.Tags: generic
Retail pharmacy is innovating by expanding clinical services. To obtain the best results, the clinical service implementation should be thoroughly evaluated. Listed below are suggested questions to use when evaluating the introduction of new retail pharmacy clinical services.
Have you implemented a clinical service without answering these questions? How would the results have changed if you had considered these questions? What changes would you make to these questions and decision criteria?
Please send your feedback to PHSI through our contact page.Tags: chain, independent, service
PillFill is a medication management app that can pull healthcare information from a variety of sources and store it in one convenient location on the user’s phone. Prescription medication information can be collected from any pharmacy that supports online medication histories. These include major chains such as CVS, Walgreens, Rite Aid, and Target. The app can also pull medication history from Express Scripts and Caremark. If a user has a prescription that is not found on any of these accounts, it can be easily added to the profile manually with the use of a barcode scanning tool within the app.
The app is intended for anyone looking to organize and manage their medication regimen. It would be particularly useful to patients with chronic disease, who are likely taking multiple medications and utilizing multiple doctors and pharmacies. This app may also be a good tool to improve medication adherence, as the user is able to set reminders about refills and daily doses.
Once the medication profile is complete, the user can select any one of their medications to view contact information about the prescribing doctor or the dispensing pharmacy. Manufacturer information regarding the product is also accessible through the medication profile. The user has the ability to check for any drug interactions with an OTC product by simply scanning the UPC code found on the package. Safety notifications such as drug interactions, duplicate medications, and duplicate mechanisms of action are sent out to the user. While this is a useful tool, there are potential drawbacks. It is easy to envision a scenario in which a patient, on a complex medication regimen that may be flagged for such interactions, abruptly stops taking their medication upon receiving a warning without first consulting a doctor or pharmacist. Fortunately, there are disclaimers stating to contact a doctor or pharmacist, and this was likely one of the reasons developers included contact information for a user’s care team. Having said that, the possibility of the above scenario is not enough to recommend against using the app. PHSI believes that if the user is able to realize that the app cannot replace real world expertise available through doctors and pharmacists, it should be a helpful tool for anyone wanting to have a more active role in their health care and in the management of their medications.
PillFill is free to use and compatible with Android or iOS devices. More information and links to download are available at http://pillfill.com.
Glooko is a cloud-based mobile system incorporating an app to allow for data from blood glucose meters, fitness monitors, and manual input to be evaluated in a single program. The system has been FDA 510(k) cleared and is HIPAA compliant, but is not yet available for purchase. Once marketed, the system will be available for patients, providers, payers, and caregivers to use in diabetes control. The cloud-based system, MeterSync Blue, connects compatible blood glucose meters to mobile devices. The Glooko system was designed to be compatible with over 30 different glucose and fitness monitors.
Some features of the app include:
Patient Use: Gives patients with diabetes the ability to sync glucose tracking to a mobile device, add fitness tracker data, input food/carbohydrate intake and medication, and share reports of data with physicians.
Provider Use: Allows providers remote monitoring of patient’s disease state, medication compliance, glucose levels and lifestyle data in order to make interventions. This helps promote improved patient-provider communication.
Payer Use: Presents risk stratified diabetes data and analytics to target earlier treatment in members with diabetes control out of range.
Glooko and the MeterSync system allow for better access to patient disease state information, potentially improving disease state management and adherence. A pilot of this system was done at the Boston Joslin DM Center and showed improvements in diabetes management, specifically hypoglycemia. PHSI believes the integration of FDA approved devices such as Glooko will augment prescription medication usage and help support healthy activities leading to improved patient outcomes. Once marketed, Glooko can allow for better engagement of the healthcare team to improve diabetes control.
Iodine.com is a new drug information database that is accessible to the public and combines clinical information with patient reviews of medications. Time magazine is quoted as saying the website is “the Yelp of medicine”.
After a thorough review of Iodine.com we have come up with some positives about the website, and some areas for improvement.
Room for improvement:
Pharmacists are the medication experts and patient counseling should be individualized to help patients meet their treatment goals. No website will replace this interaction, but rather help supplement it with medication related information. If a resource causes confusion or potential non-adherence it should direct patients to discuss the information with their pharmacist or physician. Sharing patient experiences with a drug on Iodine.com may better prepare future patients to conquer challenges related to the specific medication. Like any other customer reviews, these need to be carefully considered and not be the primary focus for determining therapy.
Healthcare professionals are always looking for ways to provide their patients with accurate and easy to understand drug information. Iodine.com is on its way to becoming the type of resource physicians and pharmacists can direct patients to, but it cannot be at the risk of non-adherence to essential medications. Iodine.com is a certified National Association of Boards of Pharmacy e-Advertiser program which makes it even more imperative to provide the full scope of medication information.
PHSI was introduced to the RxOrange App through a comment on another post about brand drug patents and generic launch. RxOrange provides details from the FDA Orange Book in the convenience of a mobile app. The App is available for purchase ($3.99) on Apple’s iPhone, iPod touch and iPad.
The home screen of the App starts on a drug search and scroll screen. Any drug in the FDA Orange Book is available. When you find the drug, selecting it displays the drug, manufacturer, and any pharmaceutically equivalent product (both brands and generics). You can continue to drill down to find the strengths and dosage forms, route of administration, therapeutic equivalence code, the approval date, and some information about patents and exclusivity. This information is based on a data file from the FDA that is updated monthly.
The bottom of the screen always offers 5 areas to find information.
1. Drug Search (where you start and find what was described above)
2. Patent Expiration (a list by date of potential brand drug patent expirations when generics may be expected)
3. FDA Approvals (a list by date of FDA approvals that can be searched, or filtered to display only brands or generics)
4. Special Topics (a handful of drugs where substitution or drug classification may be difficult to determine)
5. Info (general info about the App and the supporting sources)
Once you download RxOrange, you do not need an internet connection to access the data because it is stored on your device (19.2mb installed size). You will need an internet connection to update the device with new data. This App is dependent on data from the FDA so new generics and new brands will not be in the App until the next monthly update. There are also some products that are not included in the FDA Orange Book (i.e. Enbrel, Humira) that will not be included in the App. RxOrange does not contain drug information such as side effects, dosing, or drug interactions. PHSI believes that if you find yourself regularly utilizing the FDA Orange Book to find therapeutic equivalence, drugs and their manufacturers, and potential new generics, RxOrange would benefit you with portability of this data.