Ed Lamb

Mr. Lamb is a freelance pharmacy writer living in Virginia Beach and president of Thorough Cursor Inc.

The growth of drug sales and dispensing volumes slowed dramatically in the United States during 2008. When IMS Health released its annual compilation of data on the American prescription drug market in March, the press was filled with headlines such as “Drug Sales in US Rise at Slowest Rate in 47 Years” and “Drug Sales Eke Out 1.3% Growth in 2008.”

As discouraging to drug makers as those headlines may have been, they failed to capture the full scope of the downturn in the industry. IMS Health only began publishing its drug market statistics in 1961—47 years ago&mdash;and the 1.3% increase in overall revenues for prescription medications represented a >100% decline in dollar sales growth from the 3.8% recorded for 2007. The 2007 rate had previously been the record low.

Drug sales were essentially flat in 2008 because the number of medications dispensed barely increased from 2007, ticking up a mere 0.9%.

 All but 2 of the 7 brand name products that made it into the top 20 most dispensed drugs saw their volumes decline last year. Of particular note, Lipitor (atorvastatin; Pfizer), which was once again the topselling and most prescribed product, experienced an 11% drop in prescriptions and a 3.4% drop in revenues. (See the Top 200 [Tables 1 and 2]). 

In a press release, IMS Health attributed the slow growth of drug dispensing to a reduction in demand by consumers who had less and less money to spend as the recession worsened. The research firm also noted that when patients did purchase medications, they and their health care providers increasingly opted for generic products.

 The latter conclusion is more than borne out by other data showing that of all the drugs dispensed in the United States in the 12 months beginning with September 2007, 63.7% were generic products.

The move toward generics is likely to continue. Survey research reported by the Generic Pharmaceutical Association in January 2009 revealed that 81% of American adults “would choose a generic over a brand name drug.”

 Evidence for this preference can be found in the fact that many unbranded products experienced 40% and more gains in volume during 2008, including Mylan’s amlodipine besylate and Lupin’s lisinopril. 

The leap by Mylan’s antihypertensive and antianginal medication is especially interesting. The branded version of amlodipine, Pfizer’s Norvasc, was among the top products in 2007, but it is nowhere to be found among the leading sellers or prescriptions for 2008. Norvasc went off patent on January 31, 2007.

Low, and perhaps even negative, growth in drug product revenues are being projected by IMS Health moving forward. In an analysis published online by Health Affairs last December, researchers noted that “prescription pharmaceutical costs [are] currently rising very slowly or even falling. Prescription drug spending growth is now likely to be lower than any other major medical sector.”

According to the researchers, prices will be driven downward by the market entry of generic products, cost competition among makers of generics, and the diminishing number of newly approved medications that have the potential to be become blockbusters. All of these factors are already coming into play. For example, in an unwelcome development for brand name pharmaceutical manufacturers, the FDA approved and licensed just 18 new drugs and biologics in 2007 and another 20 in 2008. Few of these products appear destined for widespread use.

 This relative trickle of new products also will be bad news for generics makers because they will have fewer high-volume products to replicate. 

One area in which generic drug makers hope to be able to grow is biopharmaceuticals. A long-sought regulatory process for reviewing and approving follow-on biologics looks to be closer than ever with the introduction in March of HR 1548, the Pathway for Biosimilars Act.

 The passage of this piece of legislation is not assured, but it seems to be only a matter of time before companies such as Amgen and Genentech’s new parent Roche can bank on high revenues from biotech drugs immune from competition.

1. Pettypiece S. Drug sales in U.S. rise at slowest rate in 47 years. Bloomberg.com Web site. March 19, 2009. www.bloomberg.com/apps/news?pid=newsarchive&sid=aVPMLnCf2IS8. Accessed April 12, 2009.

2. Staton T. Drug sales eke out 1.3% growth in 2008. FiercePharma Web site. March 20, 2009. www.fiercepharma.com/story/drug-sales-eke-out-1-3-growth-2008/2009-03-20. Accessed April 9, 2009.

3. Lamb E. Top 200 prescription drugs of 2007. 

Web site. May 2008. www.pharmacytimes.com/issues/articles/2008-05_003.asp. Accessed April 10, 2009.

4. IMS Health. IMS Health reports annual global generics prescription sales growth of 3.6 percent, to 78 billion. Press release. IMS Health Web site. March 19, 2009. www.imshealth.com/portal/site/imshealth/menuitem.a46c6d4df3db4b3d88f611019418c22a/?vgnextoid=078ce5b87da10210VgnVCM100000ed152ca2RCRD&vgnextchannel=b5e57900b55a5110VgnVCM10000071812ca2RCRD&vgnextfmt=default. Accessed April 9, 2009.

5. Generic Pharmaceutical Association. GPhA says new Harris poll confirms that consumers believe generic medicines are the right choice for better health and increased savings. Press release. Generic Pharmaceutical Association Web site. January 26, 2009. www.gphaonline.org/media/press-releases/2009/02/12/gpha-says-new-harris-poll-confirms-consumers-believe-generic-medicin. Accessed April 12, 2009.

6. Lamb E. Watch for blockbuster generics over next year. 

Web site. November 2007. www.pharmacytimes.com/issues/articles/2007-11_005.asp. Accessed April 12, 2009.

7. IMS Health. New report highlights dramatic change in U.S. drug spending trends, policy implications. Press release. IMS Health Web site. December 23, 2008. www.imshealth.com/portal/site/imshealth/menuitem.a46c6d4df3db4b3d88f611019418c22a/?vgnextoid=841365272046e110VgnVCM100000ed152ca2RCRD&vgnextchannel=41a67900b55a5110VgnVCM10000071812ca2RCRD&vgnextfmt=default. Accessed April 12, 2009.

8. U.S. Food and Drug Administration. CDER New Molecular Entity (NME) Drug and New Biological Approvals for Calendar Year 2008: Updated through November 30, 2008. FDA Web site. www.fda.gov/CDER/rdmt/InternetNME08.pdf. Accessed April 11, 2009.

9. U.S. Food and Drug administration. FDA approves drug for patients with advanced prostate cancer. Press release. December 29, 2008. Available at: www.fda.gov/bbs/topics/NEWS/2008/NEW01935.html. Accessed April 11, 2009.

10. Reps Eshoo, Inslee, and Barton Introduce Pathway for Biosimilars Act. Press release. Congresswoman Anna G. Eshoo Web site. March 17, 2009. http://eshoo.house.gov/index.php?option=com_content&task=view&id=581&Itemid=79. Accessed April 12, 2009.

11. IMS Health. Top-line Industry Data: 2008 U.S. Sales and Prescription Information. IMS Health Web site. www.imshealth.com/portal/site/imshealth/menuitem.a46c6d4df3db4b3d88f611019418c22a/?vgnextoid=85f4a56216a10210VgnVCM100000ed152ca2RCRD&cpsextcurrchannel=1. Accessed April 9, 2009.

Articles

Top 200 Drugs of 2008

Mr. Lamb is a freelance pharmacy writer living in Virginia Beach and president of Thorough Cursor, Inc.

The Centers for Medicare & Medicaid Services (CMS) this week published 

that include an expanded list of “Serious Reportable Adverse Events” whose occurrence will result in the denial of reimbursement. The list was first created for the fiscal year 2008 Medicare program, and this year’s list includes a total of 14 preventable medical errors, with 6 being identified as “never events.”

Following the National Quality Forum, CMS defines 

 as “errors in medical care that are clearly identifiable, preventable, and serious in their consequences for patients, and that indicate a real problem in the safety and credibility of a health care facility.” For fiscal year 2009, CMS identifies never events as:

Deep vein thrombosis following certain orthopedic surgeries

Infections following elective surgeries (eg, bariatric surgery)

Acting CMS Director Kerry Weems noted in a press statement that since CMS began withholding reimbursements for the remediation of medical errors, his agency has been “hearing from hospitals around the country about the efforts they have undertaken…to improve staff training and other measures to reduce the incidence of these preventable conditions.” 

Infections from improper catheterization and infections following heart surgery also are on the list of problems that are not covered under Medicare. CMS also has specified that health care facilities will have to bear the cost of remedying adverse events caused by medication errors involving the wrong drug, wrong dose, wrong patient, wrong time, wrong rate, wrong preparation, or wrong route of administration. This underscores the importance of hospital pharmacists being part of the health care team and making sure protocols are in place to prevent medical errors from ever reaching the patient.

Nosocomial infections and hypoglycemia/hyperglycemia have been added to the agency's list of problems that should never occur and whose resolution will not be covered.

CMS Denying Payments for Many Preventable Errors-August 2008

 and catch yourself thinking, “I work with that guy!” take heart. You should soon be experiencing less condescension, foul language, and abuse from bad-acting colleagues.

The latest revision and reorganization of the Joint Commission addresses standards for the accreditation of health care facilities to define and enforce professional behavior among physicians and all other providers and staff. The new Leadership standard (LD.03.01.01), which will take effect January 1, 2009, includes the following criteria:

Element of Performance 4: The hospital/organization has a code of conduct that defines acceptable and disruptive and inappropriate behaviors

Element of Performance 5: Leaders create and implement a process for managing disruptive and inappropriate behaviors

that codes of conduct are necessary in the organizations it assesses because “intimidating and disruptive behaviors can foster medical errors, contribute to poor patient satisfaction and to preventable adverse outcomes, increase the cost of care, and cause qualified clinicians, administrators, and managers to seek new positions.” The commission also cautioned that “organizations that fail to address unprofessional behavior through formal systems are indirectly supporting it.”

Numerous studies have revealed that unprofessional behavior is both widespread among health care professionals and harmful for colleagues and patients. In 2005, for instance, nurses rated disruptive behavior as the primary reason they were dissatisfied with their workplace. An earlier survey of nurses, pharmacists, and other caregivers conducted by the Institute for Safe Medication Practices (ISMP)showed that “88% of respondents encountered condescending language or voice intonation (21% often); 87% encountered impatience with questions (19% often); and 79% encountered a reluctance or refusal to answer questions or phone calls (14% often).” Among pharmacists, 50% told the ISMP they had been strongly verbally abused by another provider.

In suggesting measures health care organizations can take to develop and enforce a code of professional conduct, the Joint Commission drew from an article Grena Porto, RN, MS, and Richard Lauve, MD, MBA, published in the July/August 2006 issue of 

. According to Porto and Dr. Lauve, the code must be written with input from all the groups that will be covered by it, and the code must be accompanied with clear statements of potential interventions and disciplinary actions, according to Porto and Dr. Lauve. The authors also wrote that organizations should work to prevent unprofessionalism by implementing “known best strategies designed to improve relationships between members of the health care team.”

Citing evidence that intimidating and disruptive behavior by health care professionals is preventable and adversely affects patient care, the Joint Commission is adding professionalism elements to its Leadership standard.

Tolerating Bad Behavior May Impact Health Facilities Accreditation-August 2008

When new California Medicaid rules took effect July 1, pharmacists across the state faced the decision of dispensing prescriptions to Medi-Cal beneficiaries at a loss or referring patients to other providers. A court ruling has temporarily relieved pharmacists of that choice, but unless further legal action is taken, pharmacists may soon again have to choose between caring for their neediest patients or staying in business.

 pharmacists stems from the state’s budget crisis. Recognizing the possibility of a deficit running up to $20 billion for the 2009 fiscal year, Republican Gov Arnold 

Schwarzenegger ordered 10% cuts to all state programs.

 learned that at least one longtime independent pharmacist had begun directing patients with Medi-Cal prescriptions to the local hospital. Another independent pharmacist quoted by the paper in a July 2 article said he would continue serving Medi-Cal beneficiaries but would be losing money by doing so. “At $250 [for a prescription], it would be a $17 loss,” Fremont Center Pharmacy owner Bob Migliori said. A Longs Drug executive assured the paper his chain would fill all Medi-Cal prescriptions but noted that a significant number of drugs would be reimbursed at a rate that was below their cost of acquisition.

Relief came when the US Court of Appeals for the Ninth Circuit remanded 

Independent Living Center of Southern California, et al. v Shrewry

 and ordered that the Medi-Cal cuts to pharmacist reimbursement be suspended until at least August 14. At issue in the case is whether 

’s rules meet federal requirements that public health programs be funded at levels that ensure adequate treatment and access for beneficiaries.

The California Pharmacists Association (CPhA) is supporting the 

 plaintiffs. In a statement, CPhA Chief Executive Officer Lynn Rolston said, “

The court’s action will prevent additional patient harm.” She noted, however, that the ruling applies only to pharmacists and that a class action suit involving his organization and 6 other 

 health care provider associations is also currently before a federal appeals court. 

 that if the Medi-Cal cuts stand, “Any pharmacy currently servicing Medi-Cal could experience huge reductions in staff services and workload or could actually be forced to go out of business. Pharmacies could be overwhelmed with needy patients going from store to store trying to get their medications that could be broadly unavailable.”

A federal appeals court has temporarily suspended 10% reductions in Medi-Cal reimbursements for medications that had forced pharmacists to take losses or stop serving Medicaid beneficiaries.