January 19, 2012

Online Pharmacies Offer Savings, but Also Present Risks

987822_95717228_01242012.jpgOnline pharmacies have become increasingly common as an alternative to brick and mortar drugstores, offering possible cost savings and saving consumers one or more errands. Many major drugstore chains now offer online ordering in addition to their in-store services. A number of companies have set up exclusively web-based services as well. Some misconceptions exist regarding businesses that sell prescription medications online. Reputable and legitimate online pharmacies invariably require valid prescriptions, and they operate under the same rules as any pharmacy with a physical location.

A minimum amount of diligence can assist a consumer in finding a good online pharmacy. They will either need to receive a paper prescription slip from the consumer by mail, or they may call the doctor to confirm the prescription. Generally speaking, reputable online pharmacies do not solicit business through e-mail marketing. Most people by now have received more than one piece of “spam” e-mail offering discounted medications over the internet. These are not part of the legitimate online pharmacy business, but some scam services mimic legitimate services very effectively.

State pharmacy boards sometimes have information pertaining to illegitimate online operations. When in doubt, the Maryland Board of Pharmacy or the National Association of Boards of Pharmacy may have helpful information. The federal Department of Justice also investigates and prosecutes illegitimate and illegal websites. In September 2011, it reached an agreement with Google in which Google agreed to forfeit $500 million for taking advertisements from and offering support to online pharmacies based in Canada. These Canadian pharmacies target U.S. consumers, although importation of prescription medications violates federal drug laws.

Congress is also weighing in on the safety of online pharmacies. Senators Dianne Feinstein (D-CA) and Jeff Sessions (R-AL) introduced a bill in December called the Online Pharmacy Consumer Protection Act. The bill would enable the government to crack down on online services that dispense medications without a valid prescription. The bill, which the two senators have previously introduced, was originally inspired by a California teen who died of an overdose of Vicodin he purchased online.

Even legitimate online pharmacies can still present risks for consumers. CBS Sacramento reports the case of a woman who repeatedly received the wrong medication from an online service. Instead of Lipitor, the company kept sending her Zocor. Her only means of addressing the problem with the pharmacy was through an 800 telephone number. They finally determined that the woman’s doctor had phoned in the wrong prescription. The virtual nature of the pharmacy proved to be a disadvantage in this situation, since the woman had only a limited ability to address the issue with an actual person by telephone.

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January 5, 2012

FDA Weighs in on Marketing Pharmaceuticals via Social Media

1260785_84481055_01052012.jpgThe U.S. Food and Drug Administration (FDA) released a memorandum in late December laying out guidelines for the use of social media, such as Facebook and Twitter, by pharmaceutical companies in marketing their products. The memo’s release came more than two years after the FDA held hearings on the matter in November 2009. Although the memo provides useful guidance, it is not nearly as comprehensive as industry insiders expected. The guidelines only deal with online discussions of off-label drug uses, those which lack explicit FDA approval.

Social media, the FDA felt, poses different challenges and risks than previous technological advances in marketing, such as television advertising, because social media allows much faster access to information and more direct contact between manufacturers and consumers. It convened hearings in November 2009 to examine these concerns. According to the New England Journal of Medicine, the FDA issued warnings to fourteen drug companies in April 2009 after it found sponsored ads for prescription drugs in search engines that lacked a clear statement of risks.

A major question for the FDA was that of “balance,” making sure consumers had access to all relevant information about a particular drug. This includes not only information about known side effects, but also, when claims are made about a drug, about the financial interests of the person or company making the claim. Among social media services, it is also increasingly difficult to determine whether a pharmaceutical company is responsible for a claim about a medication. Google and sites like Wikipedia make it increasingly easy for the general public to make claims about prescription drugs. The FDA has a responsibility to police the accuracy of claims made by the manufacturers. A major challenge for the FDA is therefore how to deal with inaccurate information widely disseminated by people other than the manufacturers.

The FDA’s guidelines address unsolicited requests from consumers for information about “off-label” uses. Generally, companies should not directly answer questions posted online about off-label uses, but should refer people to their websites or hotlines for more information. Answering such questions, the FDA says, is not unlawful per se, but could count as “evidence of a new intended use.”

Major pharmaceutical companies, or “Big Pharma,” spent $1 billion on online marketing in 2011, according to Ad Age. This number is expected to keep increasing, but it still represents a small percentage of pharmaceutical marketing. The industry expected clear, definitive guidelines on social media use, but got something more vague. The FDA has stated that, because of the ever-evolving nature of social media, it will not issue platform-specific guidelines for each social media service. It says it plans to issue further guidelines in the future.

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August 18, 2011

WHO Claims Hospitals Are More Dangerous Than Airline Travel

According to a recent report in Medical News Today that our Baltimore medical error injury attorneys have been following, Professor Sir Liam Donaldson has been appointed as the new Envoy for Patient Safety for the World Health Organization (WHO). Donaldson recently stated, in an effort to highlight the fact that healthcare safety around the world needs to be improved, that going to the hospital is far more dangerous than flying on an airplane, as the WHO reports that millions of people die annually from medical errors associated with healthcare—far more, according to Donaldson, than accidents on planes.

In his striking comparison, Donaldson claimed that if a patient entered the hospital he would have a 1 in 10 chance of experiencing a medical error, with the chances of wrongful death due to medical error being 1 in 300. Donaldson then stated that in comparison, the risk of dying in a plane crash is far less—approximately 1 in 10 million.

Donaldson reportedly stated that in an effort to reduce the growing number of hospital related infections resulting in patient injury or harm that happen every year, patients need to ask questions and make sure that hospitals maintain the basic hygiene standards and conform to the WHO’s healthcare checklist to prevent medical error or patient illness or injury during surgical procedures.

According to the WHO statistics, 7 in 100 patients in the hospitals throughout developed countries experience infections linked to healthcare, whereas in developing countries this number increases to 10 patients in every 100. The risk of infection is directly tied to the length of time a patient stays in the hospital's intensive care unit. The WHO figures show that risk of infection is lower in the United States than in Europe, but the death from hospital-acquired infection is higher. In the United States, 1.7 million hospital acquired infections reportedly happen every year, resulting in 100,000 deaths, and in Europe, 4.5 million hospital acquired infections happen every year, resulting in around 37,000 deaths.

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July 1, 2011

New Study Finds Electronic Medication Error Rates Consistent with Handwritten Prescriptions

In recent news that our Pharmacy error injury attorneys have been following, a new study from the Journal of the American Medical Informatics Association found that prescriptions sent electronically to pharmacies by doctors are almost as likely to have errors as the prescription medication orders handwritten by doctors.

The study examined 3,850 electronic prescriptions that a commercial pharmacy retain chain received over a period of four weeks in 2008. Out of the 3,850 e-prescriptions studied, researches found that 12%, almost 500, contained a total of 466 prescribing errors.

The researchers noted that their findings on e-prescribing error rates are consistent with their earlier study and research for error rates on handwritten prescriptions. Out of the 466 electronic prescribing errors discovered, only one-third of them could have caused patient harm or personal injury.

According to Bloomberg, the results undermine the safety benefits expected from e-prescribing, especially as the federal government paid over $158.3 million to doctors and hospitals in the beginning of 2011 to encourage doctors to switch over to electronic health records, as a way to reduce healthcare costs and eliminate medical and medication errors. The report found that although many providers are rapidly adopting electronic health records and e-prescribing, many of the expected benefits of the electronic computerized prescribing will not take effect if the electronic prescribing applications are not able to catch medication errors, or in fact cause medication errors.

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November 3, 2010

Study Shows Barcode eMAR Technology Can Help Reduce Medication Errors

In a recent blog, our Maryland pharmacy error injury attorneys discussed reducing medication error and patient injury with barcode electronic systems, that link barcodes on the patient’s wrist bracelet with the patient’s electronic records and prescriptions, to ensure that the medication and dosage match the prescription for the patient.

According to a recent study that the Agency of Healthcare Research and Quality (AHRQ) in Rockville, Maryland, has funded, barcode technology, working together with eMAR, the electronic medication administration system, can help reduce medication errors by over 50%. The study was published earlier this year, in the May issue of the New England Journal of Medicine.

Barcode eMAR combines technology to ensure that each patient is given the proper medication with the correct dosage at the right time, in order to prevent medication errors or patient injury. When this combination of technology is used, before administering the medication, the nurses must scan the barcode on the patient’s wrist bracelet, and then scan the medication. If both barcodes don’t match the approved medication, or the timing is not correct for the patient’s next dose, an alert is issued by the system. If the patient’s medication is overdue, warnings are also sent out to the nurses.

In the study, researchers at Boston’s Brigham and Women’s Hospital compared 6,723 medication administrations given on hospital units before the barcode eMAR was introduced with the 7,318 administrations of medication given after the barcode system was introduced.

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August 2, 2010

E-prescribing Usage Increases with Doctors, but Not Without Problems

As our Washington D.C. Pharmacy Error Injury Attorneys reported in a recent blog, physicians who are not prescribing medications electronically, or e-prescribing, by 2012 will be financially penalized by the federal government.

Although the use of electronic prescribing has increased in years, and evidence shows that e-prescribing can reduce pharmacy misfills that can lead to patient injury or even wrongful death, many local doctors reportedly clam that overall acceptance of this important technology is lagging.

According to a study published last week by the Washington-based think tank, the Center for Studying Health System Change, less than one-third of this country’s physicians in office settings, are e-prescribing. The study also revealed that even fewer physicians that were e-prescribing were using the beneficial aspects of the system, like searching for serious drug interactions and using the system to cross reference patient insurance for prescription drug verifications to ensure health plan payment coverage. The study also found that even fewer doctors who used the electronic system would actually prescribe medications electronically, opting to use the fax machine instead for prescription submittal.

The Institute of Medicine (IOM) claims 1.5 million people in this country are injured by preventable medication errors, with nearly 7,000 deaths every year.

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April 30, 2010

Electronic Prescriptions and the Path to Preventing Medication Errors

In yesterday's blog, our pharmacy error attorneys in Baltimore, Maryland, discussed the rapidly growing numbers of doctors switching from hand-written prescriptions to electronic prescriptions—to create a more efficient system that helps to prevent medication errors in every step of the prescribing and pharmacy process.

The Wall Street Journal documented an example of possible prescription error with 59-year old Debbie Kenny, who was prescribed a new hypertension medication by her doctor that had just become available at the end of last year. Unknown to both Kenny and her doctor, the medication had the potential to interfere with her asthma—a dangerous side effect. Kenny consequently had trouble breathing after coming down with a cold, still not understanding the side effects of the medication.

After Kinney’s doctor started to e-prescribe the following month, the new electronic system indicated very clearly that Kinney should not be taking that particular hypertension drug, because of her asthma, and the drug’s side effects. She was promptly switched to another medication for hypertension that was compatible with her asthma. Kinney said that she feels more comfortable now with the new electronic system. If her doctor prescribes a new drug, she can ask for a clear computerized diagram of the side effects or the drug interactions before taking the medication—to avoid any personal injury.

As of last year, the Center for Medicare and Medicaid Services (CMS) was helping to promote the switch to electronic prescribing by enticing doctors and paying them a bonus for e-prescribing. As of the beginning of 2012, a stronger encouragement will appear, as CMS will begin penalizing doctors who haven’t embraced the electronic system to issue patient’s prescriptions.

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April 26, 2010

Hollywood Prescription Drug Abuse —Illegal Drug Rackets and “Doctor Shopping”

In a blog from last week, our Washington-D.C. area Pharmacy Error Attorneys at Lebowitz and Mzhen covered the topic of illegal prescription drugs, after a Maryland pharmacist was sentenced to federal prison for selling illegal painkillers to a drug dealer—drugs that were meant to be used under the supervision of a doctor, that could lead to personal injury, drug overdose and death.

According to the Baltimore Sun, prescription drugs are currently the number one cause of death overdose in the country. The Office of National Drug Policy claims that in his past year of drug abuse, prescription pain killers now rank second, behind marijuana as the nation’s most prevalent illegal drug problem. The National Institute of Medicine reports that 20 percent of people in the United States have used prescription drugs for non-medical reasons, leading to addiction.

In a recent Hollywood tragedy, Corey Haim, star of the 80’s film The Lost Boys, died in what officials from the Los Angeles Police Department claim was an accidental overdose of prescription drugs. After an investigation, Haim’s name surfaced in connection with an illegal prescription drug ring in Southern California with the painkiller OxyContin. The drug ring was linked to as many as 5,000 prescriptions—by ordering prescription pads from authorized vendors and stealing doctors’ identities.

Prescription drug overdose has been ruling news headlines over the past few years, after deaths of high profile celebrities like Michael Jackson, Heath Ledger, Anna Nicole Smith.

Many addicts are reportedly getting their prescriptions drugs by “doctor shopping," or going from doctor to doctor to collect prescriptions. According to the Sun, Maryland needs a system to monitor the number of prescriptions that are written for every patient, which if abused by "doctor shopping" can lead to medication error and injury. The Sun calls for Maryland Legislators to set up a drug task force to better monitor and control this drug epidemic.

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February 26, 2010

New Legislation for the Safe Disposal of Nursing Home Resident Drugs

In a recent news story that our Maryland Medication Error Attorneys have been following, state legislators across the country have proposed bills that are aiming for the disposal of unused or expired medicine at nursing homes, for resident health and safety and the protection of the environment

According to ABC News, Maryland, Maine, Minnesota, Colorado, and Washington have all proposed new legislation that is trying to address the issue of dealing with excess and expired prescription medicine from nursing homes that end up in landfills and water sources every year, or if accidentally accessed by residents or other people, can cause serious harm or personal injury.

The Associated Press did a study in 2009, and reported that at least 250 million pounds of pharmaceuticals and contaminated medication packaging are generated in medical facilities every year. Some states are working on bills that would give nursing homes a choice to donate unused medication to charities in other countries. Other states are trying to send the unused medication back to the prescription drug manufacturers, with ‘take back’ programs, returning the responsibility back to the pharmaceutical company for disposal.

When a prescription is written for a resident in a nursing home, the pills aren’t reportedly dispensed in the same way that they are in a pharmacy. When the prescription is ordered for a nursing home resident, the pharmaceutical companies allegedly ship out 30-day supply cards, with each pill nestled in a small bubble pocket so nurses can easily pop the pill out of the card. If the patient has a bad reaction to the medication, if the patient passes away, or there is a medication mistake with the prescription, the medicine is most likely thrown out.

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October 26, 2009

Medication Error Injury Prevention—Study Recommends Knowing Your Pharmacist

A recent American Pharmacists Association (APhA) survey, that our Maryland Pharmacy Error Injury Attorneys have been following, revealed that 1.5 million people are injured by medication-related errors every year. The APhA commissioned the consumer survey, led by Harris Interactive, to investigate how consumers interact with their pharmacists, and how building relationships with pharmacists can avoid patient error and reduce medication mistakes and pharmacy misfills.

The APhA always recommends that people carry an updated list of their current prescription medications, over-the-counter (OTC) drugs, herbal supplements and vitamins. The list should include the name of the medications, the dosage, as well as the conditions that the medications treat. Any patient allergies should also be included in the list.

The study reports that while a large percentage of Americans have an up-to-date list of medications, only 28% of consumers actually carry the list with them at all times—an act that could prevent personal injury and medication mistakes, by providing emergency personnel and pharmacists with lifesaving information regarding drug names, proper dosing, allergy information, and drug interactions and side effects.

According to Kristen Binaso, pharmacist and national APhA spokesperson, until electronic medical records are used as the standard in sharing patient information in the health care industry, consumers should protect themselves by keeping a current medication list with them at all times, to show the doctor and pharmacist—to avoid the risk of improper dosing, medication duplication, pharmacy misfill, and harmful drug side effects and interactions. In a recent post, our Maryland Mistake Attorneys further discussed how these electronic health records will help pharmacists and doctors to eliminate medication errors.

Next to doctors, pharmacists are the second most trusted health care providers and trained medication experts, yet the survey found that 77% of consumers do not know their pharmacists names, and only 40% of consumers have asked their pharmacists valuable questions about their medication needs.

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May 27, 2009

Maryland Law Encourages Maryland Doctors to Computerize Patient Records

In prior posts concerning Maryland medication mistakes, the attorneys at Lebowitz & Mzhen, LLC have discussed how computerized health records help doctors and pharmacists eliminate medication errors.

Today, Governor Martin O’Malley, signed a bill that is designed to increase the speed with which Maryland doctors implement electronic patient records. The new law hopes to reduce the high costs that doctors must pay to implement electronic patient records systems by requiring private insurance companies to give physicians financial incentives to implement electronic patient records. Under the law, after a doctor implements a computerized records system, insurance companies may offer the doctor increased reimbursements for procedures they perform, a lump sum payment, or some other monetary advance. Additionally, under the new law, the state will fine physicians who have not adopted a computerized records system by 2015.

Since 2003, Maryland has been on the cutting edge of the movement towards computerized patient records. In that year, The Montgomery County Health Information Exchange Collaborative began a pilot program that linked community hospitals, the county’s health department, and area health clinics. The link allowed participating health care providers to easily access patient records.

The program developers believed that their medical information network would have the greatest impact on the county’s poorer citizens and those without health insurance. These individuals generally receive care in a number of different locations, and often times, the facilities do not share vital patient information. The link allowed the facilities to share patient information and reduce the risk of medication errors.

Maryland medication mistake attorneys will review the impact this law has on patient safety, and the state’s progress towards completely computerized patient records.

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January 30, 2009

New York Pharmacies to Provide Foreign Language Prescription Instructions

Maryland pharmacy error attorneys serve a number of clients who do not speak English as their first language. Some of these clients have raised the issue of not being able to receive prescriptions or dosage instructions written or spoken in their native languages from big box pharmacies. The attorneys at Lebowitz & Mzhen, LLC believe that this shortcoming places a large number of citizens in danger of harmful pharmacy errors. According to the 2000 US Census, 667,357 Marylanders speak a language other than English in their homes.

As we discussed in an earlier post, Maryland pharmacists must provide medication counseling to patients when requested, and must provide written dosage instructions with prescriptions. Counseling and written instructions in English are useless to a pharmacy patient that has difficulty understanding the language.

Pharmacy Today reports that following an undercover investigation by New York Attorney General, Andrew Cuomo, Rite Aide and CVS have agreed to provide medication instructions in languages other than English at their New York locations. The investigation began after reports that pharmacies failed to provide side effect information and drug interaction warnings in patients’ native language. New York Rite Aid and CVS locations will now provide dosage and side effect information to patients in Russian, Spanish, Chinese, Italian, French and Polish. The companies also agreed to provide assistance using an over the phone translation service.

Our attorneys believe that Maryland pharmacies should follow suit and help ensure that all patients fully understand their medication dosage instructions and other relevant information.

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January 19, 2009

Maryland Passes Law to Regulate Pharmacy Technicians

In the past, when you filled a prescription at a Maryland pharmacy, you may have wondered about the training received by the technicians behind the counter. In some cases, technicians have attended nationally accredited pharmacy technician training programs. Other time, however, the pharmacy technician training is limited to training received on the job.

Under a new state law, all Maryland pharmacy technicians must attend and successfully complete training approved by the Maryland Board of Pharmacy.
By February 28, 2009, any person working in a pharmacy, except for clerical workers, must receive certification from the Board of Pharmacy. In order to receive the certification, the applicant must already be a registered pharmacy technician or be enrolled in an accredited training program approved by the Maryland Board of Pharmacy. After an applicant completes a Board approved training class, the technician must then pass an examination within six months to continue working at the Maryland pharmacy.

This new law is clearly a step in the right direction to reduce the number of unqualified employees from holding the important job of working with powerful medicines that can do harm and injure when carelessly or negligently dispensed. The law also is an indication that the Maryland legislature, and Governor O’Malley appreciate the dangers posed by the busy modern pharmacy.

Maryland prescription error attorneys will follow whether this new law will result in fewer misfilled prescriptions. We will report back.

January 15, 2009

Maryland Pharmacists Must Offer to Educate Patients on Medication Errors

We recently posted that pharmacists owe a duty of care to patients filling their prescriptions in Maryland pharmacies. Pharmacists owe a duty to accurately fill these prescriptions. Maryland law, however, increases the duty of care owed to Medicare pharmacy patients in the state by requiring pharmacists to offer to discuss issues pertaining to the prescription being filled. A Maryland pharmacist may be responsible for injuries that occur as a result of a failure to comply with this expanded duty of care.

In 1990, Congress passed legislation that increased the responsibilities of pharmacists with regard to Medicare recipients. The Omnibus Budget Reconciliation Act of 1990 (the “OBRA”) required pharmacists to offer to educate individuals receiving Medicare on the medications that they are taking. Under federal law, a pharmacist’s patient counseling must address a number of topics designed to reduce the chance of prescription errors. In the OBRA, Congress also suggested that individual states develop their own laws that require pharmacists to educate consumers about the risks of medication errors pose.

Maryland’s legislature passed laws that increase a pharmacist’s duty of care in the state that helps protect patients from prescription errors. Under Maryland law, a pharmacist must offer to discuss information pertaining to a Medicare recipient’s prescription. A Maryland pharmacist must offer this consultation through face to face communication, or by way of pamphlets included within the prescription’s packaging, signs posted throughout the pharmacy, or communication by telephone. The topics addressed during the consultation may include the following:
1. the name and description of the medication;
2. how to take the medication;
3. any special directions and precautions for preparation, administration and use by the patient;
4. common severe side effects or drug interactions;
5. techniques for the patient to monitor the drug’s effectiveness;
6. proper drug storage;
7. prescription refill information; and
8. actions to be taken in the event of a missed dose.

However, the law does not make these consultations mandatory, and a patient may waive his or her right to talk with their pharmacist. The medication error attorneys at Lebowitz & Mzhen, LLC suggest that our readers take full advantage of the protections provided by Maryland law and consult with their pharmacists when receiving their prescriptions.

Related external source

Article discussing how the OBRA 1990 has affected pharmacists' duty of care

Maryland law requiring pharmacists to educate patients

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January 12, 2009

Maryland and D.C. Pharmacies Among Those Requesting Federal Aid

In the past year Americans have watched the federal government bail out failing banks, and the lagging automobile industry. As the economic downturn progresses, the flow of government funds into the flagging commercial sector is likely to continue. The pharmacists’ lobby has added its name to a growing list of corporations seeking federal stimulus dollars. Recently, representatives from the American Pharmacists Association and similar organizations wrote a letter on behalf of America’s pharmacists to Congress. The letter sought federal stimulus money to help employ cutting edge health information technology (“Health IT”) in more pharmacies.

According to the U.S. Department of Health and Human Services, Health IT can help reduce medical errors, improve health care quality, and reduce health care costs. In an earlier post, we noted how the use of technology reduced the number of medication errors in cancer outpatient clinics. The attorneys at Lebowitz & Mzhen, LLC recognize the important role technology will play in reducing the threat caused by prescription errors.

However, medication error attorneys believe that increased technology alone is not the solution to the widespread problem of prescription misfills. Lebowitz & Mzhen, LLC urges Congress to, for example, require pharmacies to implement better training of their technicians, and to increase the number of pharmacists who staff busy pharmacies in order to reduce the number of prescriptions filled per pharmacist, per day. Additionally, Congress should better monitor and enforce the requirement that pharmacists review all prescriptions before they are dispensed.

January 2, 2009

The Maryland Board of Pharmacy Accepts Complaint Forms When Pharmacy Errors Occur

Maryland law does not require pharmacies to report medication errors. The Maryland Board of Pharmacy, the body that licenses pharmacists in the state, relies upon inspections and consumer complaints to assist in keeping drug stores and pharmacies operating safely.

The Maryland Board of Pharmacy provides a pharmacy error complaint form on its website. Once the Board receives a consumer complaint, a Disciplinary Committee initiates an investigation. If the Maryland Board of Pharmacy concludes that a pharmacy error has occurred, it may take several types of actions, including:

1. Letter of Education (informal, non-public discipline): This is a letter aimed at improving the pharmacist’s adherence to safety procedures in the pharmacy.
2. Letter of Admonishment (informal, non-public discipline): This letter is normally issued following the Board’s determination that a minor violation has occurred.
3. Formal Disciplinary Action: Formal discipline can result in fines, or more severe discipline, including suspension or revocation of a pharmacist’s license.

If you are the victim of a pharmacy misfill, or any other type of pharmacy error, please consider filing a complaint. Your involvement will assist in the process of making Maryland pharmacies safer.

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