The Changing Arena of Pharmacy Practice

Recent Developments

In the past 20 years the pharmacist’s new role as therapeutic advisor is most noticeable in the hospital setting. But the duty to oversee drug therapy in the community through the use of patient profiles is another vital aspect of pharmacy practice. Social and market forces have combined to influence the environments in which pharmacists fulfill their roles. These forces include longer life expectancy, a growing elderly population, third-party insurance coverage for prescription drugs, and a strong public desire for convenience in an increasingly busy, complex world. There are approximately 70,000 licensed pharmacies in the U.S., filling an estimated 4 billion prescriptions per year. To adapt to the demands of a changing society, pharmacy practice has become more varied and its settings more specialized.

Mail Order Pharmacies

Mail service pharmacies typically contract with health insurers, national associations or third-party payers to fill and/or formulate prescriptions. These pharmacies offer potentially lower out-of-pocket consumer costs as well as the convenience of prescription drugs delivered by mail. These entities are high volume operations, filling more than 3,000 prescriptions per day. In mail service companies, pharmacists are more likely to be found supervising the work of technicians than in filling the prescriptions themselves. They also make calls to physicians and respond to patient inquiries by telephone.

Clinical and Institutional Pharmacists

Traditionally, clinical pharmacists are found in large teaching hospitals connected with medical schools. They often specialize in specific areas like cardiology or infectious disease. In the past, institutional pharmacists were generally confined to a centralized hospital pharmacy where they filled prescriptions sent down by the medical floors. Today, institutional and staff pharmacists interact more directly with physicians and clinical pharmacists, becoming valuable information resources rather than simply the dispensers of medication. This pharmacy practice model is being adopted by smaller community hospitals as well.

Independent Pharmacies

Independent pharmacies were long considered to be pillars of the community, open long hours and readily accessible for help and advice. Today’s independent pharmacies now often specialize in home health care services, durable medical equipment, long-term care services and the compounding of specialty medications. In addition to regular dispensing services, independent pharmacies might offer services to a nursing home in the form of medical equipment, general stock items and devices like feeding tubes. Independent retail pharmacies can be very busy places, each filling 300 prescriptions a day. Because managed care companies provide lower reimbursement, retail pharmacies have had to make up the difference in income by increasing volume. As a result, they fill at least 50% more prescriptions than they did several years ago.

Chain Store Pharmacies

Chain store pharmacies generally outnumber independent retail pharmacies by 3 to 1. They are larger than most independent pharmacies and offer a greater variety of product selection. Some supermarkets also contain pharmacies in order to offer convenient one-stop shopping. Two of the largest chains are CVS and Rite-Aid, each of which owns at least 4,000 stores throughout the U.S. Chain store pharmacies are even busier than independent pharmacies, filling as many as 600 prescriptions a day. Pharmacy staff often work 12 hour shifts with few breaks in order to cope with the demand for prescriptions. This leads to stress and overwork. As the volume and variety of prescriptions continue to mount, so do concerns about work pressures and medication errors. In both chain and independent pharmacies, overburdened staff have little time to devote to patient counseling.

Contact The Orlow Firm Today

The practice of pharmacy has become more diverse and exciting, but also more pressurized and demanding. Today, it is a highly complex enterprise and prescription errors seem nearly inevitable. If you or a loved one has been injured due to a pharmacist’s mistake, contact the New York medical malpractice attorneys at The Orlow Firm to see whether you have a legal remedy.

Call (646) 647-3398 today.

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Proving Pharmacist Negligence

To prove that a person acted negligently, one must show that he or she failed to exercise a degree of care that a person of ordinary prudence would have exercised under the same circumstances. To win a pharmacist negligence case, the plaintiff must prove four elements: duty, breach of that duty, injury or harm, and proximate cause of the injury or harm.

Duty

When one has a duty to another, he or she is required to behave in a certain manner for the benefit of that other person. Pharmacists owe a duty to their clientele to fill prescriptions correctly. This means that a pharmacist is required to make sure that the drug dispensed is exactly the same as the drug that was prescribed. A pharmacist also has a duty to dispense the correct drug in the correct dosage. In addition, the pharmacist is responsible for labeling the medication with the proper use instructions. Additional duties may include patient counseling and maintaining accurate patient drug profiles. Most states require pharmacists to review patient profiles for drug allergies and harmful interactions between medications. Other duties are not quite so clear and courts may vary from state to state in interpreting and enforcing them. For example, with a few exceptions, most jurisdictions hold that doctors, not pharmacists, are responsible for warning patients of a drug’s risks and side effects. On the other hand, a pharmacist may be found negligent for dispensing what he knew to be a lethal dose or for failing to warn of a drug’s adverse reaction with alcohol when he knew the patient to be an alcoholic. Therefore, a pharmacist may be held liable for failing to act on specific knowledge that he or she possesses regarding a drug’s dangers to a specific customer. In general, however, pharmacists are required to take reasonable steps to prevent foreseeable harm.

Breach

A pharmacist’s duty to a patient is breached when the duty is either not performed or performed incompletely or incorrectly. Filling a prescription with the wrong drug or dosage are breaches of duty, as is labeling the medication with improper use instructions. Other breaches of duty are less clear-cut. It may be difficult to determine the adequacy or correctness of patient counseling or drug use review. Testimony by expert witnesses may be required to establish the standard of care and whether the pharmacist’s actions conformed to that standard.

Injury or Harm

A plaintiff in a pharmacist negligence case must prove a resulting injury or harm. For example, a pharmacist who fills a prescription incorrectly may cause an overdose resulting in a fatal or life-threatening condition. Or, a pharmacist may substitute a generic drug for a brand-name drug without a doctor’s authorization. In this case, the pharmacist may be liable for negligence because the substitution caused an adverse or allergic reaction or was less effective than the drug that was prescribed. In many states, a claim for emotional injuries such as stress or anxiety must be based on actual bodily injury. Patients harmed due to pharmacist negligence may seek damages for loss of income, value of life or, if appropriate, compensation for emotional injuries.

Proximate Cause

In order to prevail in a pharmacist negligence case, the plaintiff must prove that her injuries were proximately caused by the pharmacist’s breach of duty. This element is not always easy to prove and often requires expert testimony. For example, it may be difficult to determine whether the patient’s symptoms were caused by an incorrectly filled prescription or by his or her underlying illness or condition. Or, a patient’s injuries may be caused by something other than pharmacist error. In one case, a pharmacist, with proper authorization, substituted a generic drug which contributed to the patient’s death. The court concluded that the drug, a fentanyl patch, had been defectively designed and that the pharmacist had violated no legal duty to the plaintiff.

Defenses

A pharmacist may avoid liability for negligence by disproving only one of the required elements- duty, breach, injury or cause of injury. Further, a pharmacist may argue that the plaintiff’s injuries resulted from an intervening cause and not his or her negligence. A pharmacist may also claim contributory negligence on the part of the plaintiff such as failure to follow instructions for use of the prescription drug.

Contact The Orlow Firm Today

If you or a loved one has been injured due to pharmacist negligence, consult an attorney as soon as possible. Quick action will help to preserve valuable evidence. The New York medical malpractice attorneys at the Orlow firm are well-versed in this complicated area of law and can assist you in exploring your rights and remedies.

Contact our law office in New York City to schedule a consultation by calling (646) 647-3398.

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Medication Errors: The Duties of the Pharmacist

The practice of pharmacy has greatly evolved from ancient times to the present. In colonial America, the village apothecary served as both doctor and pharmacist. Later, as “druggists,” pharmacists acquired the skills to compound and formulate more complex medicines. The rise of the pharmaceutical industry after WWII diminished the pharmacist’s role as compounder of drugs. Since the 1960s, the duties of the pharmacist have changed to encompass a need for patient education and monitoring of drug therapy.

Pharmacy’s Expanded Role

The principal duties of the 21 st century pharmacist are:

  • Preparation and dispensing of prescription drugs and medical devices
  • Ensuring that prescriptions are filled accurately as to name of medication, dosage, form and directions for use
  • Maintaining and monitoring a profile of the patient’s drug therapy
  • Counseling patients as to the correct use of the medication

The pharmacists must carefully consider possible harmful interactions with other drugs the patient is currently taking, as well as any drug allergies he or she might have. Computerized patient profiles must be kept up to date with all data and instructions entered correctly.

Legal Responsibilities of Pharmacists

In 1990 the U.S. Congress passed the Omnibus Budget Reconciliation Act (OBRA) which mandated certain pharmacy services for Medicaid recipients. Nearly all 50 states have now enacted OBRA-like statutes designed to improve the overall standard of pharmacist care. One of the most important provisions of these laws, drug use review, requires maintenance of patient profiles. Patients often have various prescriptions from different doctors. In such cases, the pharmacist might be the only health care provider able to identify all of the medications a patient is taking. Competent, thorough drug use review enables pharmacists to avert harmful interactions between drugs. Further, the patient profile provides valuable information as to the state of the patient’s medical condition and known allergies.

Another of OBRA’s essential mandates is the requirement for patient counseling. At a minimum, pharmacists must offer guidance to patients and caregivers on the following subjects:

  • The name and description of the medicine.
  • The route of administration (oral or non-oral).
  • Dosage.
  • Proper medication storage.
  • Special instructions for preparing, administering and using the drug.
  • Common serious side-effects, adverse effects, drug interactions and contraindications the patient may encounter.
  • Techniques for patient self-monitoring.
  • Prescription refill information.
  • What to do in the event of a missed dose.

Legal Liabilities of Pharmacists

The expanding role of the pharmacist has also increased potential liability. Lawsuits for pharmacist negligence have involved harms such as those caused by compounding and preparation errors, wrong dosages, illegal substitution of generic drugs and failure to recommend and oversee patient monitoring, especially for those taking medications of high toxicity. Under the current standard of care, it is not enough to simply follow a written prescription to the letter. An Illinois pharmacist was recently held liable for filling a prescription for a drug containing aspirin, even though the patients had told him she was allergic to aspirin. The patient developed life-threatening anaphylactic shock and required emergency treatment. The court found that the pharmacist had a duty to call the doctor and advise him that the patient was allergic to aspirin.

The patient counseling function has become such a vital element of pharmacy practice that pharmacists have been held liable for failure to counsel or for providing inadequate or incomplete counseling.

Contact The Orlow Firm Today

If you or a loved one has been harmed due to a pharmacist’s negligence, the Orlow firm can assist you in determining the proper course of legal action.

Contact the experienced New York medical malpractice attorneys at the Orlow Firm at (646) 647-3398 or message us online to schedule a consultation.

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Top Ten Drugs Involved in Medication Errors

Every year, as many as 7,000 Americans die because of medication errors. Many of these deaths are preventable and, in spite of efforts to reduce prescription mistakes, these tragedies persist. Developing an understanding as to how these problems arise is the best way to anticipate problems and avoid being hurt by drugs that, for the most part, help to heal our pain, treat our illnesses and prolong out lives.

Adverse Events

Certain medications are more frequently involved than others in adverse drug events. These are situations where the use or misuse of the medication causes negative health consequences, often requiring treatment in a hospital emergency room. On this list of drugs are several that are quite familiar and commonly used—insulin, aspirin, ibuprofen, acetaminophen and some antibiotics. Unintentional overdose is the greatest cause of injury, followed by side effects and allergic reactions. The widespread use of these medicines also adds to their potential for misuse, by taking incorrect doses, taking doses at the wrong times, forgetting to take the medication and stopping use too soon.

30 million Americans take non-steroidal anti-inflammatory drugs (NSAIDs, such as aspirin and ibuprofen) for arthritis and joint pain, either by prescription or over the counter. Misuse of these drugs translates to well over 100,000 hospitalizations a year, 16,000 deaths and avoidable side effects like digestive problems, peptic ulcer and gastrointestinal bleeding. Another high volume prescription item, antibiotics, are often prescribed inappropriately for colds, upper respiratory infections and bronchitis, all caused by viruses and none of them treatable by antibiotics.

Drug Errors

A medication error is an unintentional act committed by a healthcare provider, usually involving the misuse or mishandling of a drug. Commonly occurring errors include mistaking one drug for another with a similar name or packaging, misreading dosage amounts, or improperly reconstituting the medication, such as by using alcohol instead of distilled water.

The ten medications most often involved in drug errors are:

  1. Insulin
  2. Morphine
  3. Potassium Chloride
  4. Albuterol
  5. Heparin
  6. Vancomycin
  7. Cefazolin
  8. Acetaminophen
  9. Warfarin
  10. Furosemide

Contact The Orlow Firm Today

If you or a loved one has been harmed by pharmacist negligence involving these or other drugs, the attorneys at The Orlow Firm are available to assist you with a caring and competent legal consultation.

Contact our New York City personal injury law firm today by calling (646) 647-3398.

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Top Ten Drugs Involved in Medication Errors: Heparin

#5 Heparin

Basic Characteristics

Heparin is an anticoagulant. It is used to reduce the clotting ability of the blood and to prevent the formation of harmful clots in blood vessels. Heparin is sometimes called a blood thinner but it does not actually thin the blood. Although it will not dissolve clots that have already formed, Heparin aids in preventing clots from becoming larger and more serious.

Heparin is used in the treatment and prevention of certain heart, lung and blood vessel conditions. It may be used to prevent blood clotting during surgery, kidney dialysis and blood transfusions. People taking Heparin should not take aspirin or ibuprofen or other anti-inflammatory medicines as they may affect the way Heparin works and increase the chance of bleeding.

A High-Alert Drug

Heparin was identified as a high-alert medication more than 20 years ago. It remains among the top 6 drugs involved in serious and fatal events and is one of the top 10 drugs involved in serious preventable injuries. Medication safety experts warn that, as the drug has become more familiar and more commonly used, health care providers have become less conscious of Heparin’s risks and more likely to bypass safety procedures. A culture of safety and oversight is especially important in the use of Heparin, since even a small mistake can cause significant harm.

Babies at Risk

Over the past few years some of the most high profile victims of Heparin overdose have been very young children. Pre-term babies are generally at higher risk of drug error because they receive so much medication. In 2008, 17 infants in a Texas hospital neonatal intensive care unit (NICU) received as much as 100 times the intended dose of Heparin. Two infants died but the error was discovered in time to reverse the effects of Heparin in the other children. Errors in the hospital pharmacy’s mixing process went undetected until after the drugs had been administered. In 2006, 3 premature infants were killed by Heparin overdose in an Indianapolis hospital. A toddler being treated for post-surgical infection in a Nebraska hospital died after receiving a lethal dose of Heparin. In a Los Angeles hospital, three patients were given exponentially high doses of Heparin. One patient died. The two who survived were the newborn twins of actor Dennis Quaid. In reviewing the incidents, hospital officials determined that a pharmacy technician had retrieved a vial containing 10,000 units/mL of Heparin instead of 10 units/mL. The error went undetected because there were no double-checks by the hospital pharmacist, the pediatric satellite pharmacy or by the nurse who administered the medication.

Label Changes

Lawsuits against Heparin’s manufacturer have charged that the label is difficult to read accurately and that, since blood thinners are commonly packaged in adult-sized doses, it is far too easy to give an improperly high dose to a child. Previously, Heparin in 10,000 units/mL and 10 units/mL both came in blue vials, although in different shades. Due to dramatic changes made by the manufacturer, the 10,000 unit vial is now made to resemble a large firecracker without a fuse. The font on the label is 20% bigger and placed against a black rather than a blue background. Experts caution, however, that merely differentiating colors and fonts will not substitute for careful reading and review of medication labels.

Name Confusion

Multiple mix-ups have occurred involving pre-mixed bags of Heparin and Hespan. Not only are the names similar, but the bags contain similar coloring and are often stored next to each other in dispensing cabinets. Hespan is a drug that restores blood plasma that has been lost due to severe bleeding. Administering Heparin to a patient that is actively bleeding can have deadly consequences. Safety experts have urged Hespan’s manufacturer to change the look, coloring and labeling on the drug’s container.

A Culture of Safety

Many errors involving Heparin begin in the pharmacy: the pharmacist may select the wrong vial and mix up the wrong strength. These errors are detectable and preventable with proper labeling and storage and with multiple reviews and verifications to ensure that patients are receiving the intended drug in the proper dosage.

Contact The Orlow Firm Today

If you or a loved one has been injured due to a pharmacist error involving Heparin, contact the New York prescription error attorneys at The Orlow Firm for a caring and knowledgeable legal consultation.

Call (646) 647-3398 or contact us online.

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