Prescription drug monitoring programs: Keeping good drugs from going bad
Regulators, healthcare providers and the public at large have taken note of the rise in prescription drug substance abuse. A recent article titled "Oxycodone Prescriptions Rose Sharply" in the New York Times (1/11/2012) describes trends of double-digit percentage increases in the dispensing of certain narcotic based painkillers. And many states have, or will be, implementing prescription drug monitoring programs — also known as prescription monitoring programs — that track the physicians prescribing and the patients receiving controlled substances. The National Alliance for Model State Drug Laws reports on its website that, as of January 2012, there are prescription drug monitoring programs in 40 of the 50 states that are operational. At their heart, many of those programs operate in a similar manner, with the key elements being:
- Pharmacies reporting on a regular basis the dispensing of controlled substances. This includes who prescribed the drug, which pharmacy dispensed it and who the patient is.
- The dispensing data is compiled into a database and typically made available by a secure website.
- Healthcare professionals can log in to the secure website to determine suitability of prescribing and dispensing drugs.
- Law enforcement also may access this secure information.
The programs are designed to provide the best balance for appropriate access to needed medications versus managing the potential for drug abuse. Additionally, they provide the ability to monitor trends in the use of controlled substances and to assist with educating the public and healthcare providers alike.
So where should prescription drug monitoring programs go from here?
Here are a few trends that the pharmacy industry should be advocating to help improve formal tracking systems:
- Faster (real-time) collection of prescription dispensing information. More timely data can allow improved, proactive prevention of abuse rather than the more reactive model that is in place today. For example, a real-time system can notify a pharmacy that it is about to dispense the fifth Vicodin prescription to the same “patient” on the same day.
- Improved system accessibility. Think mobile access! Of course, expanded access must have the proper privacy structure and controls to prevent unauthorized access.
- Improved sharing of information from the various collection agencies. There are several initiatives underway between certain states to allow cross-border information sharing; those initiatives could be expanded to allow greater access to the data. Too many of the abusers are aware of and take advantage of the cross-border limitations.
- Normalization of reporting requirements among the states. States may have different time frames for reporting, different lists of controlled substances and differing requirements for checking patients in the databases. That may cause issues, especially for chain pharmacies that conduct business across multiple states.
- Once the rollout of e-prescribing of controlled substances is complete, the industry should examine the possibility of using this electronic means of reporting and managing controlled substance abuse. This could prevent inappropriate prescriptions from ever getting to the pharmacy.
We are all motivated by the same thing: to improve the monitoring and managing of the potential abuse of controlled substances. By actively looking to improve the data collection and the monitoring systems, we can achieve greater access and may be able to offer proactive insight into assisting prescription medications to be dispensed properly.
Emdeon VP Pharmacy Network Services
As VP pharmacy network services at Emdeon, Paul Hooper directs the company’s pharmacy network services initiatives with a focus on developing programs, standards and partnerships that increase pharmacy efficiency and reduce healthcare costs. Paul has spent more than 25 years in the healthcare industry with a predominant focus in pharmacy. During this time, he has held roles in product development, systems, finance and operations at various recognized industry leaders: BASF, Abbott Laboratories, Cardinal Health, ArcLight and Emdeon. He holds a master’s degree in business administration from Ohio University and a bachelor of science in food science from Pennsylvania State University.
Emdeon Manager of Government Business Development, Pharmacy Services
As manager of government business development with Emdeon, Nathan Ludvigson directs policy and business development for pharmacy services related to electronic prescribing; health information exchange (HIE); medication therapy management (MTM); prescription monitoring programs (PMP); durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS); in addition to supporting Emdeon’s participation with the Massachusetts electronic prescribing of controlled substances (EPCS-MA) research project. Ludvigson combines extensive pharmacy industry experience with legislative policy experience in both the U.S. Congress and Texas Senate. He earned his bachelor of science degree in political science from Texas Christian University and a master’s degree in public administration from the University of Houston.
FDA accepts Pfizer application for genetic disease drug
NEW YORK — The Food and Drug Administration will review a regulatory approval application from Pfizer for a drug to treat an extremely rare and fatal degenerative disease, Pfizer said Wednesday.
Pfizer announced that the FDA had accepted its application for tafamidis meglumine, a treatment for transthyretin familial amyloid polyneuropathy. The disease, also known as TTR-FAP, is a fatal genetic illness that affects about 8,000 people worldwide and causes severe sensory loss, pain, weakness and organ dysfunction.
The FDA expected to reach a decision on the drug by June. The European Commission approved the drug in November 2011 under the brand name Vyndaqel.
Mylan rebrands Dey Pharma unit
PITTSBURGH — Mylan is changing the name of its branded specialty pharmaceutical business, the company said Wednesday.
The drug maker announced that it would change the name of Dey Pharma to Mylan Specialty. Dey makes treatments for respiratory diseases, psychiatric disorders and severe allergic reactions, including the EpiPen (epinephrine).
The rebranding of the subsidiary comes just months after a similar change to the name of another subsidiary, Matrix Labs, whose name the company changed to Mylan Labs in 2006. Mylan acquired Hyderabad, India-based Matrix in 2006.