prescription drugs


Opinion: New Pregnancy Drug Guidelines A Mixed Bag For Consumers



By Dr. Adam Urato
Guest Contributor

Last week the Food and Drug Administration published a final rule that will change how drug companies present information on the risks of medications during pregnancy. This is considered a very important step as there are approximately 6 million pregnancies in the U.S. every year and the average pregnant woman takes between three and five prescription drugs during the course of a pregnancy.

For decades, the public has relied on the FDA’s Letter Category system in which a Category A drug was considered safe, Category D unsafe, with B and C falling in between, and Category X meaning contraindicated in pregnancy.

This past week the FDA announced that it is scrapping that letter system and replacing it with a new system that will offer descriptions about the effects of the drug during pregnancy and lactation. A third section (the “Females and Males of Reproductive Potential” subsection) will include information about pregnancy testing, contraception and about infertility as it relates to the drug.

So what exactly does all this mean for consumers?

As a Maternal-Fetal Medicine specialist, here’s my read on the changes:

What this means is that men and women are going to have to actually go to the drug information label and read it. No longer will a pregnant woman simply be able to look up a drug and find out that it’s a Category D in pregnancy, for instance, and then avoid it.

And this is a major problem that I see with the new system: many patients and physicians do not take the time to read through the label prior to using a medication. A description-based system risks losing the benefit of warning that the current Letter System provides when the drug is simply listed as Category D or X.

Also, it seems that the drug companies themselves are going to be asked to write these pregnancy sections on the label. This strikes me as absurd. Continue reading

AG: Caremark To Pay MassHealth $2.6M For Not Reimbursing Pharmacy Claims

This just in from Massachusetts Attorney General Martha Coakley: Caremark, the national pharmacy benefits manager that also operates mail-order pharmacies, will pay $2.6 million to MassHealth — and $4.25 million in a multistate settlement — for failing to reimburse claims.

Mass. AG Martha Coakley (Wikimedia Commons)

Mass. AG Martha Coakley (Wikimedia Commons)

Here’s the AG’s news release:

A company responsible for processing and paying prescription drug claims will pay $2.6 million to the Massachusetts Medicaid Program (MassHealth) to settle allegations that the company failed to reimburse MassHealth for pharmacy claims paid on behalf of its subscribers, Attorney General Martha Coakley announced today.

Under the terms of the settlement with Massachusetts, Arkansas, California, Delaware, Louisiana and the Department of Justice, Caremark, L.L.C. will pay a total of $4.25 million. The $2.6 million paid to MassHealth represents approximately 63 percent of the total payment by Caremark.

“This settlement is the result of an investigation into allegations that Caremark failed to properly handle and reimburse pharmacy claims for certain customers in the Commonwealth, leaving MassHealth to foot the bill,” AG Coakley said. “Our office will continue to safeguard the taxpayers’ investment in programs designed to provide care and treatment to our most vulnerable citizens.”

Caremark, operated by CVS Caremark Corp., is a California limited liability corporation with its principal place of business located in Illinois. It operates as a Pharmacy Benefit Manager (PBM) throughout the United States and contracts with its client health plans to supply prescription drug distribution and claims processing to participants in the clients’ plans. Caremark also operates mail-order pharmacies, and contracts with retail pharmacies nationwide to dispense prescriptions to its Caremark Plan participants.

This investigation began in 1999 with the filing of a whistleblower lawsuit in United States District Court in San Antonio, Texas. The plaintiff in that case amended her complaint in 2005 to add claims on behalf of the Commonwealth under the Massachusetts False Claims Act.

The investigation reviewed allegations that Caremark improperly rejected, denied or reduced the reimbursement of pharmacy charges. Continue reading

Has Prescribing Psychotropic Drugs To Kids Peaked?

Are doctors starting to ease off on prescribing psychotropic drugs to young kids?

This seems to be the conclusion of a new study published in the journal of Pediatrics this week. The study’s design was relatively simple: gather data on 2-to 5-year-olds from national health surveys, and see what trends emerge. The findings? While behavioral diagnoses in young children have increased over the past two decades, prescriptions for psychotropic medications have been cut in half.

(Southworth Sailor/flickr)

(Southworth Sailor/flickr)

Why was there a prescription peak that has now stabilized, and what could explain the drop? I contacted Dr. Tanya Froehlich, a contributing author of the study and associate professor at the University of Cincinnati Department of Pediatrics, to shed some light on this phenomenon. She responded via email.

Dr. Froehlich attributed the decline to two major factors: regulatory controls and increasingly cautious doctors. Specifically, she said, decreasing prescription rates “may be due to physician and public concern about these medications spurred by a number of FDA advisories issued in the mid- to late 2000’s, including the black box warnings on selective serotonin reuptake inhibitors (SSRI) and atomoxetine, and other advisories regarding psychostimulant-associated side effects.” Continue reading

Seniors On Drugs: Report Finds Many Taking ‘Risky’ Meds

Are we unnecessarily drugging our seniors?

That’s the subtext of an analysis by public health researchers at Brown University which found that more than 1 in five seniors with Medicare Advantage plans got a prescription for a “potentially harmful high risk medication,” a.k.a. “Drugs To Avoid In The Elderly,” during 2009.

Researchers report that 21.4 percent of the patients — more than 1.3 million people — “received at least one high-risk medication, for which there is often a safer substitute.”

medicationGetting a prescription for a “risky” medication (among a list of 110 drugs agreed upon by a group of clinicians and other experts) was more common in the Southeast, among women and people living in relatively poor areas, the study found. In terms of geography, it was least prevalent in New England; indeed, Worcester, Mass. had “the best rate of single and multiple high-risk prescription use, respectively,” researchers report.

Amal N. Trivedi, an associate professor of Health Services Policy and Practice at Brown said one of the key take-home messages is that patients should regularly “review their medication lists with pharmacists and their health care providers.”

(According to the report, high-risk medicines in the elderly are broadly defined as “medications that should be avoided among patients 65 years of age or older because the associated adverse effects outweigh potential benefits or because safer alternatives are available.) Continue reading

Prescription Nation: 4 Billion A Year, Antipsychotics Lead Psych Meds

To share these mind-boggling (and I use the term advisedly, because so many of these drugs act on the mind) statistics, I’m passing along a press release just in from the American Chemical Society in full:

People in the United States took more prescription drugs than ever last year, with the number of prescriptions increasing from 3.99 billion (with a cost of $308.6 billion) in 2010 to 4.02 billion (with a cost of $319.9 billion) in 2011. Those numbers and others appear in an annual profile of top prescription medicines published in the journal ACS Chemical Neuroscience.

Journal Editor-in-Chief Craig W. Lindsley analyzed data on 2011 drugs with a focus on medications for central nervous system (CNS) disorders. So-called antipsychotic medicines — including those used to treat schizophrenia, bipolar disorder, obsessive-compulsive disorder, Tourette syndrome and some forms of depression — ranked as the fifth most-prescribed class of drugs by sales. Antidepressants, for conditions that include depression and anxiety, ranked No. 7.

XanaxTM, CelexaTM and ZoloftTM were the most-prescribed psychiatric medicines, with other depression and anxiety medications rounding out the top 10. Two antipsychotics were among the 10 drugs that Americans spent the most on, with AbilifyTM in fourth place. Lindsley explains that while antidepressants continued to be the most-prescribed class of CNS drugs in 2011, prescriptions for ADHD medicines increased by 17 percent and multiple sclerosis medications by 22.5 percent in sales from 2010. While expiring patents on major antipsychotics in the next few years will put pressure on drug makers to innovate, the industry should be heartened by the growth of the number of prescriptions and spending.

The full paper is here, including this chart of the top 10 drugs:

Top 10 drugs

Top 10 drugs in 2011 (Source: IMS Health via ACS Chemical Neuroscience)

Mass., 50th State, Now Allows Drug Coupons: What You Need To Know

An example of a drug coupon on

By Karen Weintraub
Guest Contributor

For years, the small print at the bottom of prescription drug coupons offered by magazines and Websites has included the words “not valid in Massachusetts.”

But the next batch that’s printed won’t need that language, because when Gov. Deval Patrick signed his 2013 budget into law last week, it included a provision legalizing the use of drug coupons here – at least on medications for which no generics are available.

Massachusetts is the last state in the nation to make coupons legit.

This change may actually add to patients’ confusion, at least in the short-run. Many of the coupons in your favorite magazine are for products that have generic equivalents. That Prilosec coupon still needs to go in the recycling, along with those for Lipitor, Zantac and Seroquel.

The wrangling over whether to legalize these coupons led to some weird political bedfellows.
 A quick check of the website reveals a large number of drugs that would be covered, though, including the depression and anxiety medication Cymbalta, the rheumatoid arthritis drug Humira, the sleep aid Lunesta, the mental health drug Abilify, and the heartburn medication Nexium. (See a fuller list at the bottom of this post.)

Coupons for over-the-counter medications have always been allowed in Massachusetts.

The wrangling over whether to legalize these coupons led to some weird political bedfellows. Healthcare For All, the advocacy group concerned with health access for the poor, allied with insurance companies to lobby against the provision. Allowing coupons, the group said, would drive up the cost of healthcare by encouraging people to use name-brand drugs, instead of lower-cost alternatives. As insurance companies’ expenses rise, they will push their added costs onto customers, said Alyssa Vangeli, a policy analyst with the group. Continue reading

Public Health Committee Hears Of Dire Drug Shortages, Crisis In Care Delivery

Drugs, particularly generic injectables, are running dangerously short, health officials say.

Yesterday, the state’s joint committee on public health held hearings on the critical shortage of prescription drugs, including cancer medications, antibiotics, anesthetics for surgery and more.

Here’s the news release:

Chairman Jeffrey Sánchez and Chairwoman Susan Fargo hear testimony from hospitals, physicians, and pharmaceutical industry leaders detailing the impact of drug shortages on patient care and the cost of pharmaceuticals.

BOSTON—The Joint Committee on Public Health held an oversight hearing today to investigate the impact of drug shortages on patient care in Massachusetts. Within the last several years, drug shortages have greatly increased in frequency and severity, directly impacting patient safety in Massachusetts. According to the American Society of Health-System Pharmacists, drug shortages quadrupled in the last five years.

“This dire situation has evolved into a public health crisis that threatens our ability to not only provide routine and timely medical care to patients in need, but also to save the lives of people from what should be treatable and curable conditions,” Representative Jeffrey Sánchez said. “Hospitals can’t get the drugs they need, doctors are being forced to alter or delay the course of treatment for their patients, and patients are left wondering if the drug they need to get well will be available for them.” Continue reading

Dropping Co-Pays Boosts Adherence, Health After Heart Attack

Can free medications help solve the problem of poor adherence among heart attack patients?

A new study by researchers at Brigham & Women’s Hospital (and funded, in part, by the insurer Aetna) concludes that eliminating co-pays for drugs prescribed after a heart attack improves patients’ medication adherence rates and health outcomes without increasing overall costs.

The research, published online in The New England Journal of Medicine, split heart attack patients into two groups: one with full insurance coverage — including all prescription drugs routinely prescribed after a heart attack, including statins, beta-blockers, angiotensin-converting-enzyme (ACE) inhibitors, and angiotensin-receptor blockers — and another with usual insurance coverage, including co-pays.

While adherence rates were incredibly low in both groups, study authors write: “Rates of adherence ranged from 35.9 to 49.0% in the usual-coverage group and were 4 to 6 percentage points higher in the full-coverage group.” Continue reading

Herald: Co-Pay Nightmare With Cost Hike From $42 To $600 For Meds

When your co-pay for a critical medication jumps from $42 to $600 a month, you know something’s gone wrong.

That’s the sad fate of retired pressmann Ken Helgeson, as told by Margery Eagan in today’s Boston Herald. Helgeson is just a regular guy trying to care for his daughter and paraplegic wife. He “could be you” Eagan writes, “simply another man who played by the rules, and now faces a nightmare.”

In what he calls “a sellout,” Helgeson says Medicare has changed its deal for covering the prescription drug that kept him working for 10 years with increasingly severe rheumatoid arthritis. Enbrel used to cost him a $42 per month co-pay. Now it costs him $600 a month. He can’t afford it. So he stopped taking Enbrel four months ago.

“Six hundred a month is an awful lot of money on a fixed income,” he said. “I just can’t pay.” Continue reading

Study: Rogue Online Pharmacies Linked To Increased Drug Abuse

The proliferation of easily available medications from “rogue” online pharmacies may be driving the epidemic of prescription drug abuse, researchers report.

Investigators from Massachusetts General Hospital and the University of Southern California found “states with the greatest expansion in high-speed Internet access from 2000 to 2007 also had the largest increase in admissions for treatment of prescription drug abuse.”

The report, which focused on online pharmacies that dispense drugs without a doctor’s prescription, was published today online by the journal Health Affairs.

According to the news release:

In their report, [Dana] Goldman, PhD, director of the Schaeffer Center for Health Policy and Economics at USC and lead author Anupam B. Jena, MD, PhD, of the MGH Department of Medicine, note that the recent marked rise in the abuse of prescription narcotic painkillers – drugs like Percocet and Oxycontin – corresponds with an increase in the presence of online pharmacies, many of which do not adhere to regulations requiring a physician’s prescription. Drugs that are frequently abused – painkillers, stimulants, sedatives and tranquilizers – often can be purchased from rogue sites that may be located outside the U.S. The current study was designed to examine the potential link between online availability and prescription drug abuse, an association that has been suspected but not investigated in depth.

Using data available from the Federal Communications Commission, the researchers first compiled statistics on access to high-speed Internet service in each state during the years studied. Since actual rates of prescription drug abuse would be difficult if not impossible to calculate, they used information on admissions to substance abuse treatment facilities from a database maintained by the U.S. Substance Abuse and Mental Health Administration. Changes in both measures over the seven years were analyzed on a per-state basis, and treatment admissions were categorized by the particular types of abused substances involved.

The analysis indicated that each 10 percent increase in the availability of high-speed Internet service in a state was accompanied by an approximately 1 percent increase in admissions for prescription drug abuse. The increases were strongest for narcotic painkillers, followed by anti-anxiety drugs, stimulants and sedatives. During the same period admissions to treat abuse of alcohol, heroin or cocaine, substances not available online, showed minimal growth or actually decreased.

For more on the prescription drug abuse epidemic — accidental overdose deaths from these medications now exceed crack deaths in the 1980s — listen to this segment of On Point. The program examines the “pill mills” in Florida that funnel the drugs into poor communities of West Virginia, Kentucky and Tennessee, and includes interviews with former addicts on how oxycontin and other prescription narcotics decimated their lives.