Massachusetts holds public hearings on in-store clinics
BOSTON State officials in Massachusetts held on Sept. 5 the first of two public hearings for its proposed regulatory changes for in-store health clinics.
The proposed regulations are in response to CVS’ recent application to open in-store health clinics in the state, and it delays the decision whether to allow the pharmacy retailer to open the first of 20 to 30 MinuteClinics there.
As previously reported, CVS executives hope to open the first in-store health clinic in a CVS store in Weymouth, Mass. The retailer had submitted an application for the Weymouth location, which it hopes to use as a template that can be applied to the additional locations.
In the application, CVS has reportedly asked the Department of Public Health to waive some of the state’s requirements for licensing clinics. For example, because none of the conditions treated require a blood test, CVS is reportedly seeking approval to waive the requirement for blood collection equipment and facilities.
Rather than considering applications that require numerous waivers, state officials decided to consider an alternative set of regulations that, if approved, would make the application process for operating limited service medical clinics “transparent.” The Department of Public Health set two public hearings—Sept. 5 and 18—so that the public could comment on the matter.
“MinuteClinic looks forward to working with the Massachusetts Department of Public Health as it develops the regulations that will guide limited service clinics in the state, and we are pleased to be part of the public dialogue today,” said MinuteClinic chief executive officer Michael Howe in a statement from the Sept. 5 hearing in Boston on 105 CMR 140.000, Licensure of Clinics. “Massachusetts is leading the nation in health care reform, and limited scope clinics have an important role to play. MinuteClinic offers convenient, affordable access to quality health care. MinuteClinic also ensures continuity of care through electronic health records and by referring patients without a primary care provider to doctors who are accepting new patients.”
Speaking on behalf of the Convenient Care Association at the hearing was Steven Cooley, MD, a founding member of the CCA and chief executive officer of SmartCare Family Medical Centers.
In his testimony, Cooley urged officials to make such amendments to the proposed rules as removing the requirement that clinics must limit the number of repeat encounters with individual patients. In his testimony, Cooley said that such a requirement is “an arbitrary and unnecessary restraint on patient freedom and CCC operations.” He also said that the CCA requests they redraft the rule to remove the requirement that all patient records be automatically submitted to a primary care physician following a patient’s visit, prior to receiving the patient’s informed consent.
“While CCA members encourage all patients to share their health records with a primary care provider (if the patient has one), CCA members also believe that patients should have control over their own personal health records,” Cooley stated in the testimony.
The second hearing on Sept. 18 is scheduled to be held in Worcester, Mass.
Court denies Novartis injunction against Teva
JERUSALEM, Israel Teva Pharmaceutical Industries announced Wednesday that the U.S. District Court for the District of New Jersey denied a motion filed by Novartis for a preliminary injunction related to Teva’s famciclovir tablets, the generic version of Novartis’ Famvir.
The Food and Drug Administration already has approved Teva’s abbreviated new drug application for famciclovir tablets. As the first company to file an ANDA containing a paragraph IV certification for this product, Teva has been awarded a 180-day period of marketing exclusivity.
Famvir had U.S. annual sales of approximately $200 million for the twelve months ended June 30, according to IMS sales data.
Prescription drug abuse up among young adults
WASHINGTON More young adults are abusing prescription medications, according to the 2006 National Survey on Drug Use and Health from the U.S. Department of Health and Human Services. According to the results, 7 million Americans over 12 years old used prescription psychotherapeutic drugs—including pain relievers, tranquilizers, stimulants or sedatives—nonmedically in the month preceding the survey.
Overall prescription drug abuse among U.S. young adults increased from 5.4 percent in 2005 to 6.4 percent in 2006. Of the nonmedical prescription drug users in 2006, 5.2 million used prescription pain relievers, an increase from 4.7 million in 2005.
“The abuse of prescription drugs for nonmedical reasons is of increasing concern,” agency chief Terry Cline stated. “These are potent drugs that can have serious and life-threatening consequences if misused. Parents in particular need to be aware of this problem and take steps to prevent these medications from falling into the wrong hands.”
In 2006, 2.6 million people over 12 years old used psychotherapeutic drugs nonmedically for the first time, with the most significant increase being among the use of stimulants. The primary source of the drugs (55.7 percent) were friends and relatives who gave them away for free. About 19 percent were obtained from a doctor, and only 0.1 percent were purchased over the Internet.