Drug price cuts

Drug price cuts not yet felt everywhere

The Chinese government’s regulation that reduces the price of some self-developed medicines will not seriously affect international pharmaceutical companies, analysts say. Meanwhile foreign drugmakers are appealing for pricing policies that encourage research and development (R&D) instead of simply reducing prices.

On Monday, the day after the policy took effect, the price of related products in Guokangtang Pharmacy in northern Beijing had not yet fallen. “We are waiting for an announcement from the administration,” said a shop assistant.

“It will take time for the policy to reach the retail level, given our stocks,” said a supply manager at Anhua Hospital, a Beijing community clinic, under condition of anonymity.

But in the capital’s major hospitals prices dropped.

The National Development and Reform Commission (NDRC), the country’s top think tank, issued a statement at the end of last month announcing a cap on the retail prices of 174 self-developed medicines which started on Sunday. Of that total, 107 are produced by 40 foreign drugmakers, including Pfizer, Merck & Co, Eli Lilly, Novartis and Bayer.

Prices of the medicines, from antibiotics to cardiovascular products, will drop 19 percent on average. The retail price of Bristol-Myers Squibb’s Captopril, a high-blood-pressure treatment, has been slashed by 35 percent. Ceftriaxone, an injected antibiotic by Roche, has been cut by 30 percent.

The price reductions will have little effect on foreign drugmakers, given the 19 percent average rate, said Guo Fanli, a healthcare analyst with China Investment Consulting. A “self-developed” medicine is one developed by a pharmaceutical company on which the patent has expired. In China, these medicines are owned mainly by international pharmaceutical giants, and their prices were set by the producers.

“The maximum retail price policy, on the other hand, may facilitate these self-developed medicines being in the nation’s essential medicine system and help foreign pharmaceutical enterprises enter China’s grassroots market, including second- and third-tier cities as well as rural regions,” said Guo.

“The measure is to stabilize the cost of medicine,” said the NDRC, which estimated that the policy will help the public save 2 billion yuan annually.

Though analysts say the price-cutting will hardly affect international drugmakers, an industry lobby said: “These medicines (involved in price reduction) are companies’ branding products, thus the price-cutting will greatly affect the sales of these enterprises.”

The R&D-based Pharmaceutical Association Committee (RDPAC) under the China Association of Enterprises with Foreign Investment is a non-profit, non-governmental organization. It now has 38 member enterprises, all large R&D-based multinational companies.

It said that the manufacturers’ price of China’s generic drugs is about 22 percent to 30 percent of the international level, hence capping the price of self-developed medicine based on that of a generic drug in China will frustrate pharmaceutical companies’ enthusiasm for R&D and quality control. It will ultimately hinder healthy development of the industry.

Though RDPAC said it supports the NDRC’s price reform, it emphasized that price-setting should be achieved through a combination of government administration and market adjustment, and should be R&D-oriented.

“We will stick to our principle of providing safe and reliable products to our customers. Meanwhile, we believe that pairing high quality with high price is reasonable, and we guarantee safety and quality,” Stella Ling, communications director of Bristol-Myers Squibb China, told China Daily.

Research and Markets: Pharma Marketing in Latin America

Unified by geography, culture and language, Latin America nevertheless remains a marketing puzzle for the pharmaceutical industry.

Although the Internet is increasing in popularity, it is available only to the privileged few. Governments have health and drug programs in place, yet they are complicated and ineffective for remote communities. Drugs are widely prescribed, but for many, the cost is too high and they often do without. And while administrations support local industry, they typically favour generics over brands.

Amidst this backdrop, Latin America is booming. Boasting a market worth $30 billion in 2009 and a projected compound annual growth rate of more than 10 percent over the next seven years, the region is attracting big attention from leading firms.

And its not hard to see why. Shifting demographics as the over-65 population continues to explode offer ample opportunities for growth in drugs addressing age-related illness such as arthritis and Alzheimer s disease. Whats more, the booming middle-class is no longer immune to so-called lifestyle diseases like obesity, Type II diabetes and cardiovascular disease.

So how have pharmaceutical marketers learned to straddle wealth and poverty, generics and brands, government policy and regulations while still effectively targeting market segments?

Its a compelling question, and one that is effectively answered in this latest report, Pharma Marketing in Latin America. In the report, the authors analyses the size of the Latin American market and health care sectors, reviews the existing complexand sometimes contradictoryregulatory environment and examines key influences. How is medical tourism, the Internet, social media and e-marketing tools such as Medimix impacting pharmaceutical marketing? To answer these critical questions, the fast-paced dossier draws on penetrating research and interviews with the leading voices in the Latin American arena.

The report offers insights into:
The regulatory and economic realities facing Latin American-based pharma
The strategies, innovations and methods that are most effective, and which are not

Key features:
Case studies of the health care sectors in Colombia and El Salvador
An overview of the impact of medical tourism on the industry in Mexico
A breakdown of effective marketing and PR strategies by generics and brand firms
The role of social networks and the Internet
Analysis of the potential role of e-marketing tools like Medimix
Personal insights from five leaders in the Latin American and Mexican markets

Key Topics Covered:
Executive Summary
Size of the pharmaceutical market in Latin America
A Thriving Pharmaceutical Market
The Healthcare Sector in Latin America
Health sector case studies
El Salvador
The regulatory environment in Latin America


Pharmacy Today

Nixon accepts pharmaceutical industry’s offer to track pseudoephedrine sales

Gov. Jay Nixon announced today that a new computerized system will help combat methamphetamine labs by blocking illegal sales of a decongestant at the pharmacy counter.

Legislators passed a law in 2008 requiring pharmacies to report sales of pseudoephedrine products electronically, but the mandate was never funded. Pseudoephedrine is meth’s main ingredient.

The Consumer Healthcare Products Association, a trade association representing pharmaceutical companies that make the over-the-counter product, volunteered to pay for the system.

Nixon accepted the industry’s offer, saying it will allow pharmacists and law enforcement to determine at the point of sale whether a buyer has bought large amounts of pseudoephedrine at various stores to skirt the legal limits.

Nixon said the system would allow people who legitimately need the cold medicine to purchase it, but will block sales to people trying to build an inventory to make methamphetamine.

Jim Acquisto, Product Manager at Appriss Inc., the company building the database, said the system likely will be up and running in about 90 days, and will connect Missouri’s database to those in Kentucky, Illinois and Louisiana.

Kansas and Iowa likely will be the next states to link to Appriss’ system, called Nplex.

Pharmacists will enter the buyer’s name into the database and get an immediate record of how much pseudoephedrine the person has bought along with a record of where and when the purchases were made. If the new purchase would put the buyer above daily or monthly limits, the purchase will be denied.

A buyer who is denied would receive a receipt with Appriss’ phone number asking the person to call Appriss for an explanation of the denial. The system is also able to spot fake identification cards, flag multiple purchasers living at the same address and track other suspicious patterns.

Appriss also will provide free training to pharmacy staff on how to use the system as well as law enforcement personnel on how to track suspicious purchases.

Local police agencies in Missouri are skeptical the new system will have an impact. They point to Kentucky, which had an increase in meth labs during the database’s first year of operation. They say Kentucky’s experience shows that the electronic system doesn’t stop meth labs.

Instead, police in Missouri have lobbied for prescription laws, saying electronically tracking sales won’t stop meth addicts from paying others to buy boxes of pseudoephedrine for them or shopping in groups.

So far, eight local governments have passed prescription laws, including Washington, Union, Poplar Bluff, Gerald, Kennett, Eureka, Potosi, Jefferson County and Farmington.

Pharmacy students from Andhra Pradesh bag prizes for highest marks in D Pharm & B Pharm

Three pharmacy colleges in Andhra Pradesh were among the winners of awards given away during the 62nd Indian Pharmaceutical Congress held at Manipal from December 17 to 19, 2010. The KK Acharya Memorial Award was given away to S Prakash N Kumar who was declared a topper in D Pharm from Koringa College of Pharmacy in Andhra Pradesh.

Under the ML Khurana Medal category for the highest marks in B Pharma, R Ramakrishna from Acharya Nagarajuna University, Andhra Pradesh bagged the honours. In the category of highest grade in the course, Shyamali of Manipal Pharmaceutical Sciences received the prize.

The award for BV Patel Essay competition went to SS Manikiran of the Chalapati Institute of Pharmaceutical Sciences, Andhra Pradesh. From the industry participant, the award went to Pramod R Parashuramkumar of Matrix Labs.

The Shroff Award 2010 was bagged by Gurumuthry Parathsarthy, Professor Pharmacy Practice, JSS College of Mysore.

The Indian Pharmaceutical Association instituted Eminent Pharmacist award went to Dr Prem Gupta, former Deputy Drugs Controller, government of India and current consultant for drug manufacturing for India and US-based companies.

Prof ML Khurana Award went to Praful Sheth, vice president, Federation of International Pharmacists (FIP).

The GP Srivatsava Award instituted by the Association of Pharmaceutical Teachers of India (APTI) went to D Ram Bhau, former professor, Kakatiya University in Andhra Pradesh and current advisor to Natco Pharma.

The Indian Pharmacy Graduate Association which instituted the KC Chaterjee Memorial Award went to SL Sobti, ex-deputy drugs controller, Govt of NCT of Delhi. The best drugs controller award instituted by the AIOCD went to Omprakash Advani, FDA Maharashtra.

All the awards included a cash prize, citation and a certificate.

Researchers discover human immune system has emergency backup plan

New research by scientists at the University of California, San Diego School of Medicine and Skaggs School of Pharmacy and Pharmaceutical Sciences reveals that the immune system has an effective backup plan to protect the body from infection when the “master regulator” of the body’s innate immune system fails. The study appears in the December 19 online issue of the journal Nature Immunology.

The innate immune system defends the body against infections caused by bacteria and viruses, but also causes inflammation which, when uncontrolled, can contribute to chronic illnesses such as heart disease, arthritis, type 2 diabetes and cancer. A molecule known as nuclear factor kappa B (NF-κB) has been regarded as the “master regulator” of the body’s innate immune response, receiving signals of injury or infection and activating genes for microbial killing and inflammation.

Led by Michael Karin, PhD, Distinguished Professor of Pharmacology, the UC San Diego team studied the immune function of laboratory mice in which genetic tools were used to block the pathway for NF-κB activation. While prevailing logic suggested these mice should be highly susceptible to bacterial infection, the researchers made the unexpected and counterintuitive discovery that NF-κB-deficient mice were able to clear bacteria that cause a skin infection even more quickly than normal mice.

“We discovered that loss of NF-κB caused mice to produce a potent immune-activating molecule known as interleukin-1 beta (IL-1β), which in turn stimulated their bone marrow to produce dramatically increased numbers of white blood cells known as neutrophils,” said Karin. Neutrophils are the body’s front-line defenders against infection, capable of swallowing and killing bacteria with a variety of natural antibiotic enzymes and proteases.

The new research demonstrates that the innate immune system deploys two effective strategies to deal with invasive bacterial infection, and that the IL-1β system provides an important safety net when NF-κB falls short.

“Having a backup system in place is critical given the diverse strategies that bacterial pathogens have evolved to avoid bacterial clearance,” said Victor Nizet, MD, professor of pediatrics and pharmacy, whose laboratory conducted the infectious challenge experiments in the study. “A number of bacteria are known to suppress pathways required for NF-κB activation, so IL-1β signaling could help us recognize and respond to these threats.”

While helpful in short-term defense against a severe bacterial infection, the dramatic increase in neutrophil counts seen in the NF-κB-deficient mice ultimately came at a cost. Over many weeks, these activated immune cells produced inflammation in multiple organs and led to the premature death of the animals. Long-term blockade of NF-κB signaling has been explored extensively by the biotechnology and pharmaceutical industry as a strategy for anti-inflammatory or anti-cancer therapy, perhaps unaware of the risks suggested by this new research.

“One might contemplate adding a second inhibitor of IL-1β signaling to protect against the over-exuberant neutrophil response,” said Karin. “Unfortunately, loss of both the NF-κB pathway and the backup IL-1β pathway rendered the mice highly susceptible to invasive bacterial infection which they no longer cleared.”

Altogether, the UC San Diego research sheds new light on the complex and elegant regulatory pathways required for a highly effective innate immune system. The scientists noted that future investigations must take into account these interrelationships in order to design novel drugs against inflammatory diseases that achieve their treatment goals while minimizing the risk of infection.


Pharmacy News Online

Hospital Pharmacy Director Earns Membership With Stanford Who’s Who

BRISABNE, QLD, AUSTRALIA, December 11, 2010 /Stanford Who’s Who/ — Stanford Who’s Who welcomes Lynette M. Joy to the ranks of leading professionals as a result of her phenomenal work in the Pharmaceutical Industry. As Director of Pharmacy for Princess Alexandria Hospital, Lynette has consistently demonstrated the vision, dedication and diligence necessary to be considered among the best.

Princess Alexandria Hospital is one of three tertiary level facilities in Queensland, providing care in all major adult specialties, with the exception of obstetrics. It is also one of Australia’s premier teaching and research hospitals. They provide acute medical, surgical, mental health, cancer, rehabilitation and allied health services as well as statewide services.

Lynette is responsible for managing the pharmacy department of the facility as well as overseeing the daily operations. During her educational career, she earned a Bachelor’s degree in Pharmacy from the University of Queensland and a Diploma of Hospital Administration from The Society of Hospital Pharmacists of Australia. Lynette is a member of the Society of Hospital Pharmacists of Australia.

About Stanford Who’s Who
Stanford Who’s Who empowers executives, professionals and entrepreneurs around the world. Our mission is to recognize successful individuals in multiple industries by providing a forum for networking, consulting, exposure and credibility to broadening one’s future success. Realizing the power of forming business and professional relationships, we have created numerous resources that our members use for a multitude of reasons. With access to thousands of professional biographies of individuals in over 100 different industries, our members utilize our database to recruit others, to announce their career accomplishments, and for lasting, valuable relationships that extend beyond our membership program.

Generics Pharmacy targets more outlets

DRUGSTORE chain The Generics Pharmacy is set for a rapid expansion in the next three to five years driven by higher demand for cheaper generic drugs, its top executive said.

The company also wants to tap overseas markets like Vietnam and the US after gaining a foothold in the domestic market.

“In the next three years, we should have 1,500 outlets,” Benjamin Liuson, president and chief executive of The Generics Pharmacy Franchising Corp., said in an interview.

“I think we can go up to 2,000 outlets nationwide,” he added.

Bulk of The Generics Pharmacy branches, which sell antibiotics, appetite stimulants, cough and cold remedies, diuretics, food supplements and anti-allergy drugs, are in Luzon.

After only three years in franchise operations, the company has already hit 1,000 stores this month, translating to about 300 new branches per year.

The Generics Pharmacy was incorporated in 1949 and was taken over by a new management in 1959 for the importation and wholesale of pharmaceutical products. In 2007, the company started retail operations and franchising to offer cheap medicines locally.

It became the first generics retail pharmacy to franchise in the country.

Growth drivers

Mr. Liuson said the growth drivers for the company include “[medicines as] basic necessity and our affordable prices.”

“Our price difference is still big,” Mr. Liuson said, saying that for instance, in The Generics Pharmacy, Biogesic and Norvasc are sold at 60 centavos and P5.50, respectively, lower than the P3 and P22 in other stores.

Furthermore, franchisers that book profits usually open more stores.

“We have low expenses,” Mr. Liuson said, adding that the company does not spend much on marketing and advertising.

The generics drug industry has been able to break out of the stigma that generic and cheap drugs are fake or ineffective.

Medicines that are past the patent protection can be freely produced by drug companies worldwide.

On its Web site, The Generics Pharmacy has 1,050 pre-approved locations that franchisees can readily tap to start a business.

“We are going into second-, third- and fourth-class municipalities,” Mr. Liuson said.

Furthermore, the company wants to expand operations overseas and is looking at Indonesia, Bangladesh, Vietnam, and the US.


Pharmacy News: December, 11

ObamaCare Cuts Drug Discounts to Children’s Hospitals

Nancy Pelosi said that we wouldn’t know what was in ObamaCare until it was passed.

It’s been passed, and now we are finding out exactly what a nightmare it really is.

Case in point; for the past 18 years, Congress has ordered that specialized drugs, better known in the pharmaceutical industry as ‘orphan drugs’, to be sold to children’s hospitals at a discount rate that ranged anywhere from 30%-50%.

That was before ObamaCare.

In an article by the notoriously liberal New York Times, it is stated that “The reason behind the change is murky”, but the Times did a less than murky about face when it reported that “Under the new law, hundreds of rural hospitals became eligible for discounts for the first time, but the discounts are not available on orphan drugs, which account for a surprisingly large share of their outpatient pharmacy costs. At the same time, children’s hospitals lost access to discounts on the drugs.”

It was Ronald Reagan who first protected orphan drugs when he signed into law the two acts that have, until the changes made by Barack Hussein Obama and the Democrat-supported ObamaCare, had the greatest impact on the American supply of medicines. In 1984, Reagan signed the Drug Price Competition and Patent Restoration Act. This law opened the gates for American consumers to enjoy the price advantage of generic drugs and antibiotics.

In 2002, President George W. Bush further protected orphan drugs when he signed the Rare Diseases Act and the Rare Diseases Orphan Product Development Act.

Drug industry favors Missouri’s pseudoephedrine database over governor’s call to require prescriptions

Some leaders in the pharmaceutical industry expressed their disappointment Wednesday in Gov. Jay Nixon’s recent announcement regarding pseudoephedrine, instead favoring a state database already in place to block sales of the drug.

In a series of visits Tuesday, Nixon announced he’d like Missouri to become the third state in the country to require a doctor’s prescription to purchase medications such as Sudafed, Claritin-D and Advil Cold and Sinus, which all contain pseudoephedrine, a key ingredient in manufacturing methamphetamine.

According to the Consumer Healthcare Products Association, in just two months, and with less than half of Missouri’s pharmacies connected to the tracking database, the system has blocked the sale of more than 18,000 grams of pseudoephedrine.

Because the database has only been online a short time, representatives from CHPA and the Missouri Pharmacy Association say Nixon hasn’t given the initiative a chance to prove its worth.

“If the tracking system has time to work, we’ll start seeing less purchases and more busts,” Chaffee Medicap Pharmacy owner Kevin Teegarden said.

The tracking database is sophisticated, Teegarden said, and, given the opportunity to be fully implemented, could be another tool for law enforcement. Requiring a prescription for pseudoephedrine is only a burden for consumers, he said.

A visit to a “quickie clinic,” he said, could cost a patient up to $50 and alternative sinus medications just don’t clear the nasal passages like pseudoephedrine.

“When used properly, pseudoephedrine is a very, very good drug. It dries you up and really takes care of sinus problems,” Teegarden said.

Mandy Hagan, CHPA’s director of state government relations, added that a visit to the doctor could be even more costly for someone paid by the hour who misses work or who has to get their child to a day care center while getting a prescription.

When using the system, pharmacists plug in a buyer’s name, date of birth and ask for their signature. The intention is to prevent people from buying more than the maximum amount of pseudoephedrine allowed by law.

If a person attempts to buy more than the limit, the system will block the purchase at any pharmacy connected to the database. If used regularly by authorities, Hagan said, it would provide them the probable cause they need to catch manufacturers and “smurfers” — traffickers hired to acquire large quantities of precursor chemicals.

“If you get pseudoephedrine by filling a prescription, it leaves a huge hole in law enforcement,” Teegarden said. “You lose tracking capability.”

Ron Fitzwater, CEO of the Missouri Pharmacy Association, said pharmacies have been in support of a tracking system since 2005 and that they’ve put in a lot of effort to see that legislation got passed to make the database effective.

With the governor’s announcement, Fitzwater said, all the work seems to have had no effect.

“They’ve been lobbied very heavily from law enforcement,” Fitzwater said, referring to the governor’s office. “To just look at it as a pure law enforcement issue is going to be wrong for the state of Missouri.”


Pharmaceutical News

Pharma tweets, but lacks social media values

As a general statement its probably fair to say that people value health care. And that they trust that access to medications is an important part of ensuring health and defeating diseases in many cases. Yet paradoxically the manufacturers of sometimes life-saving medicines, the pharmaceutical industry, are generally reviled. Surveys have found that people hold big pharma in about as high esteem as they hold big oil and big tobacco.
Mexican online pharmacy
What gives? Several things, but central to this is the tension between social good and business practice. And social media and business practices provide a great, if somewhat oversimplified, case study into how this tension plays itself out.

Pharma widely touts the amount they purportedly invest in research and development because people respect that: It sounds like innovation needed to cure disease and maintain good health. (We’ll set aside for a moment the fact that most new drugs are in fact “me-too” products rather than new molecular entities, and that manufacturers increasingly buy innovative discoveries from smaller, more lithe and innovative up-starts.) They do not, however, divulge how much is spent on marketing. That sounds too much like profit maximization. The claim is that publicizing the amount spent on marketing would put them at a competitive disadvantage, since competitors would then have their marketing secrets to exploit. But that explanation likely leaves a bad taste in most peoples mouth.

So what does this have to do with social media? Every pharmaceutical manufacturer has a robust social media presence. But as presenters at the recent Justmeans conference on Social Media, Technology and Change so clearly pointed out, social media is about a lot more than linking a Twitter feed loaded with #pharma hashtags and Facebook page to your website. Those are just some of the tools. Social media in its truest sense is about creating values-based relationships. Its about embracing ideals of authenticity, transparency, and honesty. Its not enough to simply tell me you are doing good, I need to be convinced. I need to be able to interact with you and have it feel genuine.

India not to compromise pharma interest in EU pact: Khullar

New Delhi: Assuring the $22 billion generic pharmaceutical industry, the government on Wednesday said India will not compromise its interest while negotiating the free trade and investment agreement with the European Union (EU).

“I can give you assurance that I will not enter into any bargain…which binds me to a commitment that in anyway compromises my domestic policy,” commerce secretary Rahul Khullar told reporters.

He said the understanding to this effect was reached between commerce and industry minister Anand Sharma and EU trade commissioner Karel De Gucht in Brussels on 29 November.

“It was agreed that all this business of generic (drugs) was off the table,” he said.

Indian pharma industry, which exports $10 billion worth of affordable medicines around the world, follows the multilateral WTO rules on patents (Trade Related Intellectual Property Rights).

Under TRIPS, the off-patent generic medicines can be manufactured and exported anywhere in the world. However, the EU regulations insists on extra binding regime.

European negotiators, in the ongoing Bilateral Investment and Trade Agreement (BITA) talks have insisted that India should follow TRIPS plus regime to enable the opening of the trade through the bilateral pact, which will reduce duties.

As the two sides are nearing the completion of BITA talks, several non-government organizations in India and even in Europe have raised concerns about impact on affordable medicines, in case India were to fall in line with the EU regulations.

Khullar said that while he would not like to disclose his negotiating strategy, “you must not judge me by what is being negotiated but (by) what the outcome is.”

He is leaving for Brussels on Wednesday night to join Sharma, who will be present for the India-EU Summit that will be attended by Prime Minister Manmohan Singh on Friday.

Khullar said the communique issued after the summit would give a clear timeline for the signing of the trade opening agreement. He added that it is likely to be concluded in March next year.

EU is India’s largest trading partner with the two-way commerce of about $75 billion in 2009-10.


Pharmacy News

AIHW: arthritis and osteoporosis drugs

Early use of DMARDs is now common practice in managing rheumatoid arthritis with methotrexate the most frequently recommended medication, according to a report from the Australian Institute of Health and Welfare (AIHW).

The report summarises data on the use of medications for osteoarthritis, rheumatoid arthritis and osteoporosis using information from the 2004–05 National Health Survey and the Bettering the Evaluation and Care of Health (BEACH) general practitioner surveys from 1998–99 to 2007–08.

“In the last decade, the variety of medicines available for managing arthritis and osteoporosis has expanded considerably,” said Dr Kuldeep Bhatia from the AIHW’s National Centre for Monitoring Arthritis and Musculoskeletal Conditions.

Complementary medicines were commonly used for arthritis and osteoporosis, especially by women.

“While GPs do recommend complementary medicines, the rates are much lower than for pharmaceutical medications,” Dr Bahtia added.

People with osteoarthritis and rheumatoid arthritis most commonly used NSAIDs, and GPs commonly recommended paracetamol for these conditions as well.

For RA, GPs most commonly recommended methotrexate, and for osteoporosis they prescribed bisphosphonates.

Methotrexate was estimated to cost consumers $1.1 million and the Australian Government $2.5 million in 2007, with more than 100,000 subsidised prescriptions dispensed.

More than 1.6 million subsidised prescriptions for meloxicam were dispensed in 2007, costing consumers $7.4 million and the Australian Government $36.9 million.

The report also found that the recall of rofecoxib in 2004 and lumiracoxib in 2007 led to less GP recommendation of other COX-2 inhibitors such as celecoxib, from 32 per 100 encounters in 2000–01 to 8 per 100 in 2007–08.

In 2007, alendronate, alendronate with cholecalciferol, and risedronate with calcium carbonate for the treatment of osteoporosis cost the Australian Government more than $129 million and consumers $19 million.

Drug interactions can lead to Implanon failure: TGA

Women using the Implanon etonogestrel implant are being warned to use “barrier protection” by the Therapeutic Goods Administration (TGA) following evidence of contraceptive failures when used with other medications.

In an announcement this week, the TGA said it had received 32 reports of contraceptive failure leading to unintended pregnancy due to a suspected interaction between Implanon and hepatic-enzyme inducing medicines.

The drug regulator listed a number of products that may lead to a decrease in the efficacy of the contraceptive implant, which included popular complementary medicine, St John’s wort.

“Interactions between hormonal contraceptives and other medicines leading to a decreased contraceptive effect are well recognised.

“For example, carbamazepine can reduce the effect of oral and implantable hormonal contraceptives by inducing cytochrome P450 enzymes, with increases clearance of sex hormones,” the TGA said.

The administration stressed health care professionals should tell women using Implanon to use condoms or the intrauterine device depending on the length of co-administration of a medication that may decrease the effects of the implant.

“Women taking hepatic-enzyme inducing drugs should use a barrier method in addition to Implanon during the time of concomitant drug administration and for 28 days after discontinuation.

“In women on long-term treatment with hepatic-enzyme inducing drugs, [health professionals should recommend] removing Implanon and recommend a non-hormonal method instead,” the TGA said.


Pharmacy News

New Data on Pharmacy Industry Market Share

With little fanfare, NACDS just released its new estimates of 2009 pharmacy revenues and prescriptions. See Industry Facts-at-a-Glance.

Check out the charts below for my summary of prescription revenues and number of prescriptions for the five major drug dispensing formats. The data nicely illustrate key trends that are transforming the pharmacy industry:
The shift to high-cost specialty pharmaceuticals

The dampening effect of generic drugs on retail revenues

The slowdown in mail prescription growth

The slow-motion decline of independent pharmacies
Don’t just take my word for it. Please post your thoughts and predictions about these newly-released data in the comments below.

NCPA’s New CEO and the Pharmacy Industry’s Future

On Sunday, the National Community Pharmacists Association (NCPA) announced the appointment of Kathleen Jaeger as Executive Vice President and CEO. Ms. Jaeger was most recently President and CEO of the Generic Pharmaceutical Association (GPhA).

I’m impressed by this selection. NCPA has chosen an experienced association director and Washington insider. I expect her to upgrade NCPA into a more professional organization, assuming that the old guard doesn’t block her from making the necessary changes.

Ms. Jaeger’s appointment illustrates how the balance of power is shifting in U.S. drug channels.

GPhA became a powerful lobbying organization during Ms. Jaeger’s tenure—a period which also corresponded to an increase in the retail generic dispensing rate (GDR) from about 40% in 2002 to more than 70% today. Retail GDR will exceed 80% within two years, so generics represent the future of the pharmaceutical industry.

But generic drugs turn pharmaceutical channel economics upside down. The costs of distributing and dispensing a traditional (non-specialty) generic drug far exceed the actual cost of the medicine, which is the opposite of brand-name drugs. As a result, the economic interests of companies within the U.S drug channel—pharmacies, wholesalers, and PBMs—are diverging from brand-name drug manufacturers.

Intriguingly, GPhA often aligned with the Pharmaceutical Care Management Association (PCMA), which represents the pharmacy benefit management (PBM) industry. Members of both associations gain with increases in the generic dispensing rate. Members of NCPA also gain from a higher GDR because the average generic prescription is more profitable for a pharmacy than the average brand-name prescription. (Yes, this really is true despite the howls of protest that you often read in comments on Drug Channels.)

In contrast to the PCMA-GPhA relationship, NCPA and PCMA are usually at odds on most issues due to the underlying economic relationship between PBMs and pharmacies. Ms. Jaeger’s background implies that she understands the true economics of the PBM business today, such as the fact that the majority of a PBM’s profits come from dispensing generic drugs from their own mail-order pharmacies while retail network spreads are a comparatively small source of profits. Can we presume that NCPA’s messaging will start to more accurately reflect the real economics of today’s drug channels? Perhaps no more odd reactions to Walmart announcements?

This appointment also fuels NCPA’s expanding political ambitions. As I note in The Politics of Pharmacy, the NCPA’s Political Action Committee (PAC) has become one of the largest association PAC in the country. Whether it’s good or bad…well, that’s a different question.

I counsel my pharmaceutical manufacturer clients to break down functional silos and improve cross-departmental collaboration as channels consolidate and converge. Effective channel management starts with an economic understanding of how the revenue from an individual prescription gets divided between the manufacturer, the wholesaler, the pharmacy, and the PBM. The growing political savvy of trade associations makes this effort more important than ever.

NACDS honors pharmacy industry leaders

The National Association of Chain Drug Stores (NACDS) recognized Charles Vance Burnett, JD, BS Pharm, and Stanley F. Barshay, with its highest honors at the 2010 annual meeting in Palm Beach, Fla.

Burnett, senior vice president, pharmacy, Costco, received the Sheldon W. Fantle Lifetime Achievement Award. Barshay, former chairman of Schering-Plough Consumer Health Care Products, was honored with the Robert B. Begley Award.

Established in 1989, the Lifetime Achievement Award was renamed in 1996 in honor of the late Sheldon “Bud” Fantle of People’s Drug Stores. The Begley Award, established in 1980, is named in memory of former NACDS Chairman of the Board Robert B. Begley and honors great personal warmth, generous spirit, and long-time service to the industry.