Government Agencies Guiding Pharmacists to Dispense Information on Counterfeit Drugs

Counterfeit drugs within the mainstream supply chain have become so prevalent that the Royal Pharmaceutical Society of Great Britain (RPSGB) and the Medicines and Healthcare Products Regulatory Agency (MHRA), leading regulatory agencies within the United Kingdom, are guiding pharmacists to distribute information on the dangers of counterfeit drugs with the prescriptions that they dispense to all of their patients.

This is a cautionary story for all developed countries, including the United States that the issue of counterfeit medications invading its safe and ethical supply channels is coming your way.

Until now many, including leading pharmaceutical industry experts, have considered it remote that a developed country could and would be infiltrated by the scourge of counterfeit medications.

Patients to get counterfeit warning with each prescription
Tuesday , March 31, 2009

New guidance to patients to raise public awareness of fake medicine and its dangers has been launched by the RPSGB and MHRA.

Pharmacies nationwide will receive the guidance, which has been developed in conjunction with patient groups to ensure it is clear and easy to read. Pharmacies will be asked to distribute the new double-sided postcard-sized leaflet to patients in their prescription bags.

The leaflet offers advice to patients about what counterfeit medicine are, how to minimise purchasing fakes and what to do if they suspect they have been sold or supplied counterfeits.

One side of the postcard explains the safest way to purchase medicines and the other outlines 'The dangers of faking it'.

The RPSGB's head of practice Heidi Wright says: "Counterfeit medicine does not work and can make you seriously ill. It's important that people are aware that they should always get their medicine from a reputable source such as a pharmacist or a registered online pharmacy site which has the RPSGB's Internet Pharmacy Logo - and I hope these postcards will help to achieve that."

The MHRA is also looking at ways to target those that use the internet to buy counterfeit medicine.

Guidance for pharmacists explains the background to counterfeit medicine production and highlights how organised criminal gangs have become involved in the production of illegal medicines, supplying them through the internet, often to unwitting patients.

It offers pharmacists invaluable practical advice on the correct steps to take when they encounter suspected counterfeit medicines. These steps include reporting illegal websites to the MHRA to ensure immediate patient safety.

pharmafocus.com

Conference Attendees Share Concerns About Counterfeits

This month, XStream Systems’ Sales Team had the opportunity to discuss counterfeiting issues with pharmaceutical executives from pharmacy providers, manufacturers and pharmaceutical wholesalers at two industry conferences.

In an effort to ascertain industry thought leaders viewpoint on risk liability and current available anti-counterfeiting technologies, a voluntary survey was conducted. Though the survey was conducted on a relatively small statistical sampling, it represents an excellent cross section and a diverse variety of pharmacy experts from national entities, regional players, large corporations and small entrepreneurs.

The following are specific excerpts from the surveys:

• 2/3 of respondents consider the greatest vulnerability of the U.S. pharmaceutical supply chain is with pharmaceuticals from foreign countries, internet sales and loosely regulated suppliers.



• Nearly 75% of distributors and pharmacy providers who responded use some process of pharmaceutical supply security including pedigree tracking, sensor based technologies (RFID, barcodes, etc.), visual inspection, weight inspections and materials analysis but their methods are not uniform. All respondents who do use some procedure ultimately use a variety of processes because collectively they seem uncertain that the methods they have in place can properly protect their inventories from fraudulent or counterfeit products.



• 75% of all respondents were aware of drug identification and authentication system technology but 50% were not familiar with a specific technology or a particular solution.



• 75% of respondents are concerned about counterfeit drugs impacting medication safety to their distributors/providers/patients.

• 75% of respondents are concerned over their financial liability of counterfeit drugs within their inventories.



• 75% of respondents are concerned about their professional reputation being ruined if they were to have counterfeit pharmaceutical in their inventories.

• 2/3 of respondents expressed concern over the issue of counterfeit drugs within the supply chain.



• 75% of the respondents were concerned that their current methods and processes for supply security were not enough to protect their inventories.



• 50% of respondents fear a catastrophic counterfeit event within the U.S. pharmaceutical supply chain in 2009.

A complete report will available shortly on XStream Systems' website at http://www.xstreamsystems.net/

Dallas Man Convicted for Distributing Counterfeit Drugs: Viagra, Cialis, Levitra

Richard Fletcher, 57, of Dallas Texas has been convicted of distributing counterfeit drugs and trafficking in pharmaceuticals bearing false labeling and counterfeit trademarks.

He used the Internet to obtain and distribute counterfeit versions of Viagra®, Cialis® and Levitra® pharmaceutical drugs. These drugs are used to treat erectile dysfunction. Their patents are held by Pfizer Pharmaceuticals, Eli Lilly, and Bayer Corporation respectively.

Fletcher offered the medication over the internet at a discounted price of $1 - $1.40 a tablet. This rate was far below the normal retail price of $11 - $13 a tablet.

The U.S. Immigration and Customs Enforcement (ICE), a division of U.S. Department of Homeland Security, began an investigation in October 2007. Undercover ICE agents posing as customers purchase prescriptions through his website between February and June of 2008. The drugs were later analyzed by the trademark holders and the FDA's Forensic Chemistry Center, and determined to be counterfeit. Also found during the investigation was proof that Fletcher purchased the counterfeits from China and engaged in discussions with Chinese individuals on how to evade detection and seizure of the product.

During this time, agents were also contacted by U.S. Customs and Border Protection (CBP) who had seized 960 Viagra tablets in package addressed to Fletcher at a mail facility in California. The counterfeit Viagra and Cialis tablets obtained as a result of the investigation are valued at more than $46,000.

Watson Recalls Propafenone HCL Tablets Due to Oversized Tablets

Recent increases in recalls due to quality issues have highlighted a need for Quality Assurance (QA) and Quality Control (QC) post packaging within the supply chain especially given the high concentration of contract production/packaging done overseas. One such recall is listed below:

This week Watson Pharmaceuticals, a leading specialty pharmaceutical recalled one lot of Propafenone HCL 225 mg tables in 100 count bottles. This lot number 1112680A with an expiration date of July 31, 2010 is being recalled due to slightly higher levels of the active ingredient.

Propafenone is a medication used to treat cardiac arrhythmias (irregular heartbeats). Some patients who are sensitive may experience potentially serious side effects, including irregular heartbeats or low blood sugar.

More information on this recall is available at: www.watson.com.

FDA Expands List Of Tainted Weight Loss Pills

This past week, the U.S. Food and Drug Administration (FDA) expanded their list of tainted weight loss pills. Originally in late 2008, FDA warned consumers about 28 products which contained undeclared pharmaceutical ingredients and were marketed for weight loss. This list has since been updated twice. This latest update brings the total to 72 products, some of which are marketed as dietary supplements.

"These tainted weight-loss products pose a great risk to public health because they contain undeclared ingredients and, in some cases, contain prescription drugs in amounts that greatly exceed maximum recommended dosages," Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said in a news release. "Consumers have no way of knowing that these products contain dangerous drugs that could cause serious consequences to their health."

The active pharmaceutical ingredients contained in the products but not identified, the FDA said, include:

• fenproporex -- a controlled substance not approved for sale in the United States
• fluoxetine -- an antidepressant available by prescription only
• bumetanide -- a potent diuretic available by prescription only
• furosemide -- a potent diuretic available by prescription only
• rimonabant -- a drug not approved for sale in the United States
• cetilistat -- an experimental obesity drug not approved for sale in the United States
• phenytoin -- an anti-seizure medication available by prescription only
• phenolphthalein -- a solution used in chemical experiments and a suspected cancer-causing agent that is not approved for sale in the United States

The health risks posed by these products can be very serious and include high blood pressure, seizures, tachycardia (rapid heartbeat), palpitations, heart attack, and stroke. Sibutramine, a controlled substance, was found in many of these products at levels much higher than the maximum daily dosage for Meridia, the only FDA-approved drug product containing sibutramine. These higher levels of sibutramine can increase the incidence and severity of these health risks. Fenproporex, another controlled substance, can cause arrhythmia and possible sudden death.

According to the FDA, these products are marketed at websites, convenience stores and some beauty shops. Consumers are encourage to discontinue their use and report any side effects to the FDA MedWatch website at www.fda.gov/MedWatch/getforms.htm

A complete list of the tainted weight-loss products is available at the FDA.

Origin of Our Medicine - Does the Consumer Have a Right to Know?

The following is a summary of an editorial that appeared in the Los Angeles Times about the transparency of the global supply chain and more specifically the pharmaceutical supply chain.

We feel that it is important for the safety and security of the American Consumer to understand the extent of how many global imports affect their health and the need for adequate measures to secure them. Many of the products that we consume in the United States come directly or indirectly from countries whose track record on adulterated raw materials and counterfeit products is incredibly poor. How many contaminated or fraudulent products exist within our supply chain and what can we do to protect ourselves from them?

Before I pop this pill, I'd like to know where it came from
(Summary of an editorial by David Lazarus that appeared in Los Angeles Times March 22, 2009)

In his editorial, David Lazarus discusses the issue of the consumer’s right to know not only where their food comes from, but also pharmaceuticals. To prove his point he follows a rather in depth search for the origins of his Sunmark pain reliever, a generic equivalent of extra-strength Tylenol.

He shares with his readers some interesting little know facts he learned along his quest, for instance:

“What I did learn, though, is that more than half of the world's aspirin now comes from China, as does more than a third of acetaminophen and almost all synthetic vitamin C. Chinese drug imports into the United States top $700 million a year.”

He uses two recall examples to emphasis why consumers should be aware of where their medicines originate. One is the recent recall of heparin that occurred last year after more than a dozen deaths. In this case an adulterated ingredient was traced back to Shanghai, China. The second is a recall which occurred in 2006 by Perrigo, one of the world's largest manufacturers of store-brand over-the-counter medicines. Perrigo recalled 11 million bottles of acetaminophen sold under various brands due to small metal fragments which were discovered in some batches. The cause was stated as raw materials obtained from a third party, but Perrigo would not comment on the name or location of the party.

Finally, he gives his suggestions on what he sees as critical information that should be listed on each label. This is necessary in his opinion because as he states: “I'm not saying that drug makers should be required to do everything in-house. But as a consumer, I'm entitled to know exactly what I'm putting in my mouth and how it got there.”

To view the entire editorial, visit the Los Angeles Times at www.latimes.com.

Fake Drugs – Where Do They Come From and Who’s Distributing Them?

Profile of a Counterfeiter – 26 Busted in Purported International Drug Ring

It seems like every week we see a news story on fake drugs being found, being seized, or worse their effects on the unsuspecting buyer. So it lends the questions – Where do they come from? Who’s distributing them?

The answer can be almost as scary as the fake drugs themselves. Counterfeiters come from a variety of backgrounds, some with pharmaceutical experience and some not --such as in our last story about the self-taught chemist, Fernando Reis, who started off counterfeiting steroids and then expanded his operation to Fake Viagra. Perhaps the most unsettling of the group are those who are professional criminals. These individuals have a variety of interests including gun trafficking, illegal drugs, counterfeit apparel and other illegal activities.

Newsday recently reported on an international Drug Ring that was also trafficking Oxycodone, anabolic steroids, untaxed cigarettes and counterfeit sneakers. The Federal authorities have charged 26 people in the case. Twenty-one have been arrested and five are still at-large. Among those being sought are two New Jersey men, Myfit Dika of Wyckoff and Kujtim Lika of Little Falls, both 44, who are believed to be major figures in the ring.

The investigation began in 2003 in the Balkans, Canada and the Netherlands and they eventually tracked the suspects to New Jersey, New York, Philadelphia and Chicago, the FBI said.

This particular case portrays the dangers and challenges of tackling counterfeiting. Investigations into organized crime rings take longer and global supply chains involve cooperation between governmental regulatory agencies to bring them down. The longer the investigation, the longer the public is exposed.

Most disturbing is the question of medication safety and are they getting into the legitimate supply chain? Many would say not, but they have….

...And do you really feel comfortable wondering if that same guy who is supplying the fake Nikes made overseas just may be supplying the same medicine that controls your heartbeat????

Pfizer Helps Shut Down Steroid Counterfeiters

One drug class that has been susceptible to counterfeiting has been Steroids. These drugs are often sold to weightlifters and athletes wanting to bulk up.

This month, Fernando Reis, the mastermind behind the underground lab Azorian World Order as well as a large-scale British Dragon counterfeit operation pleaded guilty to 15 counts of trafficking and importing anabolic steroids and prescription drugs into Canada.

Interestingly enough, he was also manufacturing fake Viagra, which ended up being his downfall. Last year, Pfizer hired a private investigation firm to investigate the illicit business(es) of Fernando Reis after discovering counterfeit sildenafil citrate packaged to resemble brand name Viagra. Their investigation and cooperation with the local authorities led to his arrest by Waterloo Regional Police and Kitchener Royal Canadian Mounted Police (RCMP) on April 11, 2008.

The RCMP seized 600,000 capsules and 582,000 tablets of various anabolic steroids and prohormones, ancillary medications and other prescription drugs, as well as dietary supplements from a Kitchener U-Haul storage unit and his Kitchener residence. Also, unprocessed anabolic steroids and erectile-dysfunction drugs from China were seized from a private mail box at the Instant Print Copy Centre & Mail Boxes in Markham.

Federal prosecutor Catrina Braid said in an agreed statement of facts that the steroid seizure is believed to be one of the biggest ever in Canada. More than $1 million in deposits were made to various bank accounts held by Reis between 2002 and 2008.

In a plea deal, he was sentenced to 22 months in jail and 2 months probation.

Nigerian Taskforce Destroys Stock of Counterfeit Drugs

Earlier this month in Nigeria, the Lagos State Task Force on Counterfeit, Fake Drugs and Unwholesome Processed Foods raided a local establishment and destroyed counterfeit drugs values at more than N50 million ($340,000 USD) and arrested seven people.

Also confiscated was foods and alcohol. The owner,Mr. Ige Abel, was arrested at Ayobo while producing the local gin in an unhygienic environment. Six other individuals were also arrested.

Commissioner for Health Dr. Jide Idris said the raid was necessitated by the ongoing and prosperous counterfeit drug business which places the public's health at risk. Sample drugs were tested after the death of at least 10 people following the consumption of local a concoction known as Ogogoro.

The Task Force has been conducting a series of raids on illegal pharmacies in the past several months. They have arrested at least 524 illegal operators and sealed at least 3031 illegal premises within the last 12 months due to the high prevalence of illegal operators in many parts of Lagos.

Arizona Couple Pleads Guilty to Peddling $2.5M in Fake Drugs

According to the Seattle Times, Mr. and Mrs. French, a middle-age couple from Arizona, pleaded guilty to selling counterfeit drugs over the internet.

From 2004 – 2006 their illegal prescription drug business, Prescription Buyers Group, offered over 600 name-brand medicines that were in fact Indian knock-offs to unsuspecting customers. The revenue generated from these illegal sales amounted to over $2.5 million and included drugs such as Viagra, Celebrex, and Lipitor.

The couple will be sentenced Sept. 21. They are facing up to five years in federal prison for the conspiracy charge, and the introducing misbranded drugs charge could net them up to three years in prison. The couple also agreed to forfeit all profits to the government, United States Attorney's Office spokeswoman Sandy Raynor said.

This story is just one of many examples of how counterfeiting has increased in the United States and one should certainly heed the saying "Buyer Beware." Consumers should be cautious of buying prescriptions over the internet from anyone other than VIPP certified pharmacies. Distributors should not only verify their suppliers but also verify their supply itself through molecular authentication.

The life you protect could be your own or one who depends on you to keep their medicine safe.

Counterfeit Drug Policy Stalled in India

For the past decade, regulatory authorities and pharmaceutical companies have been battling counterfeit and substandard drugs in India. It is estimated that 10% of the drugs in India are counterfeit, which sadly results in many thousands of deaths annually.

Regulatory authorities have been pushing for stricter laws, but have met with resistance from mid-size companies and states who now hold the regulatory authority over medications in their area.

As reported in the New Ledger, the current Indian health minister, Anbumani Ramadoss from Tamil Nadu proposed amendments that would have created a central drug authority, which in principle would have administered the entire drug regulatory system, overseeing drug quality and authorizing product marketing. Unfortunately, the bill failed to pass the lower house and with elections only two months away, we will have to wait to see if the new administration will push it forward.

Meanwhile, the Food and Drug Administration (FDA) is establishing an office in India to oversee exports to the United States. This measure follows a ban on 30 drugs from India’s largest generic manufacturer, Ranbaxy, in 2008

To view the entire news article visit: http://newledger.com/2009/03/counterfeit-drug-policy-in-india/

ICE, CBP, IPR Center Recognized for Outstanding Work in Trademark Protection

$272.7 million in counterfeits seized in 2008

Yesterday, Proctor and Gamble presented awards to United States Immigration and Customs Enforcement (ICE), U.S. Customs and Border Protection (CBP), and the National Intellectual Property Rights Coordination Center (IPR Center) for the successful partnership to further protect the company's trademark.

Companies are teaming with ICE and CBP in a united front against rampant counterfeiting. These agencies seized a variety of counterfeit goods with a market value of $272.7 million in 2008. This was an increase in seizures of 38 percent over seizures in 2007.

The National Intellectual Property Rights Coordination Center is the largest investigative arm of Department of Homeland Security, U.S. Immigration and Customs Enforcement (ICE) and targets those who manufacture, smuggle and distribute counterfeit and substandard products that put our citizens at risk.

We applaud those involved in this taskforce which include agents and analysts from ICE, U.S. Customs and Border Protection, and the FBI, who coordinate the U.S. government’s domestic and international law enforcement attack on IPR violations.

To learn more about IPR Center visit the ICE website at http://www.ice.gov.

COMING ATTRACTIONS

Charles R. Earl, M.A., ABD,
www.minoosha.blogspot.com

Not tonight, I have a headache. You see, I’ve been perusing the proposed federal budget. In the US budgetary process, the President submits his proposal (wish list), the House of Representatives writes the necessary legislation, and then the Senate mucks it up…big time. So, it is with a high level of caution that I comment on the President’s proposals. As a participant in the political process (candidate, office holder, campaign consultant) for most of my adult life, I find myself becoming quite skeptical…and very cynical when analyzing the ebb and flow of certain policies.

Aside from my personal uneasiness with the geometric growth of government, and its negative impact on our day-to-day living, I absolutely abhor the governmental practice of ignoring alternative consequences and outcomes. Our fearless (just kidding) political leaders seem to believe that if they proclaim something “is” then it surely will be. Concepts like intervening variables and cognitive dissonance are alien to their planning process. So, years or decades later we discover that the proposed program isn’t working, or indeed, might be counter-productive. The response is “O.K., we need more funding,” and meanwhile, a new program is germinated and funded to address the original problem.

Geeesh! Head throbbing, stomach burning…body in shutdown mode.

Government bureaucracies are notoriously “penny-wise and pound-foolish.” They will pursue the ‘little guy’ for over/under payments, deny vital benefits to worthy claimants, but allow the most egregious violators to avoid the consequences their actions have earned. These anecdotal observations are what drive my apprehension about the President’s proposed expansion of the federal role in healthcare. The glorious notion of free care and cheap drugs spurs the overreaching federal government as its seeks to control and manage one-seventh of the nation’s GDP.

If President Obama’s proposals escape Capitol Hill relatively unscathed, what will be the unforeseen and unintended consequences that become manifest in the years ahead. Rationed care? Long, and sometimes deadly, waiting lists for procedures? Inexpensive or free pharmaceuticals but with no coherent system in place to protect against counterfeits and adulterated product? The Coming Attractions have us curious about what’s coming. Let’s hope that it isn’t Waterworld II.

Tainted Teething Syrup Kills 84 Babies-12 Arrested

This is an update on the tragic story about babies dying in Nigeria from the tainted teething syrup, “My Pinkin” that was originally posted in December – “Diethylene Glycol Killer On Prowl.”

My Pikin," which means "my child" in local pidgin is now responsible for 84 children aged two months to seven years died from kidney damage linked to My Pinkin -- around three out of four of the 111 children known to have ingested the product.

The actual count is presumed to be higher as many potential victims are in rural areas and have not been included in the count. "Due to the low literacy level in Nigeria and the fact that many people self-medicate and don't go to hospitals, there is the risk some children might have died in villages unreported," said National Agency for Food, Drug Administration and Control (NAFDAC). spokesman Abubakar Jimoh.

Twelve suspects have been arrested -- five from Barewa Pharmaceuticals, the manufacturer and seven marketers of the fake chemical used for the production of the drug. Three individuals including Kola Okunola, the CEO of Barewa Pharmaceuticals were arraigned on a six-count charge relating to manufacturing adulterated drugs on March 5, 2009. The three pleaded not guilty and have been remanded at the Ikoyi prison in Lagos pending trial of the case.

So far, more than 5,000 bottles have come off the market. But it is unclear how many bottles were produced from a tainted batch or whether any were exported outside Nigeria by small-scale traders.

This is an outrageous tale of betrayal – a tale of greed with a reckless lack of regard for the safety – the safety of small innocent children who ultimately were poisoned at the unsuspecting hands of those who love them most.

BBC: Seized Drugs 'Were Counterfeit'

The following story about a major counterfeit drug raid in the UK was posted on the BBC Online. This story illustrates how pervasive and relatively common counterfeit and fraudulent medications are becoming within communities and everyday life within developed countries:

More than £250,000 of counterfeit, unlicensed and withdrawn medicines have been seized during raids in Stoke-on-Trent, the drug regulatory agency said.

A woman aged 50 was bailed on suspicion of illegally selling prescription drugs after the morning raids on Tuesday, March 3rd.

The Medicines and Healthcare products Regulatory Agency (MHRA) said a couple in their 60s was being questioned.

It said the drugs were the "tip of the iceberg" of an expected multi-million-pound illegal online medicine business.

For the full story follow this link:
http://news.bbc.co.uk/go/em/fr/-/2/hi/uk_news/england/staffordshire/7924072.stm

MISSION IMPOSSIBLE: IMPORTATION, DEPORTATION & LEVITATION

Charles R. Earl, M.A., ABD
CEO, Communication Connections

One of the elements of President Obama’s Healthcare proposal for the 2010 budget allows for the importation of foreign-made drugs. The supporters claim that off shore sources can provide top-notch pharmaceuticals at prices significantly lower than are available from domestic manufacturers. I have lived a large portion of my life in the Toledo, Ohio area and can recall with clarity the senior citizen bus trips to Canada for the purpose of purchasing lower cost meds. I do not know, however, if the effectiveness of those medications was, at the very least, comparable to those available from US-based sources. If quality can be guaranteed, and if patients and physicians can have absolute confidence in the purity and the efficacy of the drugs, then importation could be a good thing. But…

Most off-shore nations subsidize their pharmaceutical manufacturing and distribution. Will they continue to do so for those meds that are shipped to the United States? Perhaps they may. The Airbus competes with Boeing in the commercial aviation market, and Airbus is highly subsidized by the EU. On the other hand, with exponentially growing demands of their healthcare systems, these nation states may decide that they cannot afford to underwrite a portion of the US system.

In my personal view, people often give the government too much credit for compassion, competence and brains. With the golden ring of universal healthcare within his grasp, the President and his minions have factored in offshore med prices for Medicaid, Medicare, VA and the general population. They sell the concept with compassion, but manage the system like some massive, cold-hearted HMO. Although I am not privy to their formulating the healthcare (634B) portion of the budget, I surmise that they have not calculated for the potential removal of the offshore subsidies or for the possibility that quality control will be seriously compromised. The government is looking only at the buck that they might save. It is a similar attitude that they accuse domestic manufacturers of harboring.

So, regarding importation: domestic manufacturers should be in the room when the plan is implemented, and strict, unyielding safety measures should be utilized to protect the integrity of the drugs. I fear that my beloved Uncle Sam will promise and legislate goodies, but will not follow through on safety. Same old crap.

Now, about deportation. It’s a difficult problem.

And levitation: an uplifting subject whose interest is rising.

Ahead of the Curve

Charles R. Earl, M.A., ABD
CEO, Communication Connections

The major portion of our discussions on these pages has focused on the impact of counterfeiting and adulteration on patient safety and supply chain reliability. This is where the primary consideration should be, but there are other important factors in play, too. Much of the recent news coverage has chronicled the challenges facing the national … and global economies. Corporations and businesses everywhere are belt-tightening, downsizing or closing. Some businesses will thrive in this environment by becoming leaner and more efficient while others will enter “panic mode” and never fully recover from these trying times.

From my experience as a business manager and as a corporate and business trainer, I have had the opportunity to witness how truly successful leaders cope with difficult circumstances. Although the “right now” requires intensely concentrated effort and resources, successful leaders never fail to look ahead to tomorrow. They do not abdicate their duties for visionary thinking and acting. They race ahead of the curve.

It is difficult for a corporate officer or manager to justify purchasing new technology when the market is uncharacteristically tough. Concentration is directed to monthly P&L’s, quarterly statements, and annual reports. Every nickel that can be saved and every penny pinched become important for day-to-day operations. “No major expenditures” and “no new commitments” become the rallying cries for weathering the economic storm. Count the pens! Inventory the paper clips! Use both sides of the printer paper! I could go on, but you get the idea.

While the market, the governments, customers and patients are clamoring for safer and more reliable pharmaceutical delivery, you cannot afford to retreat into a posture of preservation. You, as a leader, who wants to guide a leading company of the industry must seize the initiative. The old reliable aphorism “if you’re not moving forward, then you’re falling backward” is still true. Offer more for your customers—better service and safer product.

Imagine this scenario: A customer calls your office and asks you to submit an RFIP. This company is impressed with your innovative efforts to supply safe, trustworthy products as well as your obvious commitment to top-rate customer service. Another customer calls your competitor, and the receptionist responds,” I’m sorry, he can’t come to the phone right now. He’s in the supply closet counting paperclips.”