Important terms

Maximum Allowable Costs (MAC) —maximum cost for a specific drug or other product paid for by a patient to a pharmacy.

Actual Acquisition Cost (AAC) —the price that a pharmacy will pay for drugs and other items, before they sell them to patients and other consumers.

Average Wholesale Price (AWP)—a published list of drug products.

Estimated Acquisition Cost (EAC)—an estimate of drugs paid for by a pharmacy.  Often used by Medicaid in reimbursement planning.

Capitation—when pharmacies are given a portion of money a month to take care of all prescriptions and services for patients belonging to a certain healthcare plan.

Coinsurance—patients pay for a percentage of their healthcare as determined by the health insurance plan.

Copayment—patients pay a fixed amount of money for healthcare services, rather than a percentage, as determined by the healthcare insurance plan.

Deductible—patient pays a certain amount of their healthcare, before insurance company pays for remaining benefits.

Pharmacy Practice Management

Pharmacy benefit manager

A pharmacy benefit manager is a company that is under contract with HMOs, government programs, and other insured healthcare companies to regulate numerous important things including developing and regulating of a prescription drug formulary for insurance companies.  They are also useful in contracting various pharmacies and obtaining drug discounts for the insurance companies from drug manufacturers.  These companies are responsible for drug utilization reviews and they can also help set-up mail order pharmacies for the insurance companies.

DEA 222 order form

Orders of scheduled or controlled drugs, classes I and II, require the use of a DEA 222 order form.  Each drug order requires three copies of the DEA 222 order form.  Each DEA 222 order has ten lines, one line per drug.  On each line is the drug name, dosage form and number of drugs or volume of the drug in each container.  The form must be filled out completely and accurately, or it will be sent back without being ordered.  Two of the three copies go to the supplier of the drug; the third copy is kept by the pharmacy.  The supplier holds onto one copy of the DEA form 222 and the last form is sent to the DEA.  Upon receiving the order, the pharmacy must record all the drugs on the form that they received and keep it for the pharmacy records.

DEA 41 forms

Damaged, expired and unwanted class II controlled drugs must be accounted for and disposed of properly.  In order to dispose of a drug, the DEA 41 form must be filled out in triplicate, with two copies sent to the DEA and one kept in the pharmacy’s records for the minimum of two years after disposal of the drug.  The records must include the DEA number, name and address of the pharmacist/pharmacy, the reverse distributors DEA number, name and address, and the amount of drug and means of disposal.  Disposal of the drug is generally handled in three ways.  1.  Contact the original supplier of the drug: some will take back the drug.  This is the easiest way for disposal.  2. Onsite disposal if disposed drugs are less than one pound is overseen by a representative from the DEA.  3.  For quantities greater than one pound, a reverse distributor must be used.  A reverse distributor is generally a DEA approved company that will resell or properly dispose of drug compounds.

DEA 106 form

When dealing with a controlled substance it is vital for the pharmacy to keep exact records for their controlled drugs and to be able to account for all drugs in their inventory and all drugs that have been prescribed.  All controlled drugs must be kept secure according to the DEA.  All CII drugs must be kept secure, usually in a locked cabinet that is firmly secured to a wall.  If a drug is lost or stolen, even if only one pill, a DEA form 106 must be filled out.  The form must be submitted to the DEA within 10 days.  Failure to report any lost or theft of a drug can lead to steep penalties and fines.

Drug Utilization Reviews

Drug Utilization Reviews are performed by hospitals and retail pharmacies, in which data is collected on drug utilization or drug use patterns.  These reviews, when performed in a hospital, can give ideas of how much drugs are used, if the drugs are being used properly according to hospital protocols, and of the safety and efficacy of a given therapy.  Commercial pharmacies often use drug utilization reviews to study which drugs are most popular or “fast-moving” and to try to keep these drugs stocked in the pharmacy.  Additionally, these reviews can be used to determine the expense being paid for a certain popular drug, if it is very expensive for the pharmacy as well as the patient, the pharmacy can use this data to push toward prescribing an equally effective and safe generic version of the same drug.

Pharmacists’ roles

Retail or community setting:

In a retail or community pharmacy setting, the pharmacist has several very important roles.  It is very important to remember that a pharmacist in a community setting is often the last medical professional that a patient may see.  This means that it is vital that a pharmacist working in the community makes sure that all medicine related questions are thoroughly answered.  This includes new medication counseling and taking the time to make sure the patient does not have any questions related to medications the patient is already taking.  Additional duties of a community pharmacist include:  prescription checking, answering medicine related questions from physicians and patients, providing vaccination services, monitoring medication interactions, and providing any additional medication counseling and training as needed.

Retail and community pharmacies can range from very small community pharmacies that have a very specific longstanding patient base and fill as little as 50 prescriptions a day to very large chain store retail pharmacies that fill over a thousand prescriptions a day.

Hospital settings:

A pharmacist’s role in the hospital setting can be extremely varied.  In the hospital setting, a pharmacist generally has two major roles: core pharmacist and clinical pharmacist.  When a pharmacist is working in the core pharmacy, they are responsible for inputting and checking orders, answering physician questions, monitoring parenteral products being mixed by technicians and if needed, helping to respond to emergency codes.

When a pharmacist is a clinical pharmacist, they are typically working in close contact with the medical staff.  Often, the clinical pharmacist goes on rounds with the medical team and directly monitors medication profiles for each patient.  Clinical pharmacist will also provide antibiotic and anticoagulation monitoring.  Many doctors in a hospital setting will have pharmacists provide all vancomycin and aminoglycoside dosing and monitoring.

Most pharmacists who work in a hospital rotate through various shifts and will switch between working in the core pharmacy and working on the floor.

HIPAA

In hospital and retail pharmacies, patient privacy is of the utmost importance.  Pharmacy management must ensure that prescription and medical records of individual patients remain private.  The Health Insurance Portability and Accountability Act (HIPAA) was passed in 1996 and makes it easier for patients to obtain their own protected health information (PHI, medical records), but harder for other non-authorized people to do so.  To maintain confidentiality of PHI, a pharmacy must adopt several regulations, including when speaking to a patient about their prescriptions, do their best to keep their voices low, have a specific semi-private or private counseling area, or ask other customers to wait a few feet back until they are done with their present patient.  Additionally it is a good idea to secure computer access to keep PHI safe, remind employees to logout of the computer before walking away, and only allow people who need to see the PHI to do certain tasks for the patient (i.e. fill prescriptions, talk to the insurance company, counsel patients or talk to physicians about the patient).

Pharmacy mistakes

While working for as well as managing a pharmacy, it is important to realize medical errors will occur.  As a pharmacy manager, it is important to treat all medical errors seriously, but with an understanding that people, machines, and general systems of operations, make mistakes.  Nothing is foolproof.

·         Mistakes should be talked about and dealt with calmly and with understanding.  In a positive environment like this, people are far more likely to fix errors rather than ignore them.

·         Records should be kept of errors that occur, not as a form of punishment, but as a means to measure frequency of errors and determine how to fix these mistakes in the future.

·         When dealing with patients’ complaints; be understanding, polite, and if reasonable fix the error as soon as possible.  Patients view mistakes harshly, because it is their health, real or perceived, that is at stake.

Conversions in compounding

Promotion

Promotion of the pharmacy is a way to advertise about prices and services provided.  Advertisements include television, radio, newspaper and internet ads.  All forms of advertising have their advantages and disadvantages.  In radio and television, ads can reach a greater number of people, but are usually more expensive and must have a relatively mass appeal for the cost of the advertisements to match the possible benefit.  Newspapers are generally cheaper and they can generally reach a pretty large audience, however, the audience is smaller than that of television or radio.  With the internet, a relatively massive amount of people can be reached at a very small cost in the guise of pop-up ads, website sponsors, and email; however, many people view this type of advertising as a nuisance.  Additionally, word of mouth, happy customers telling other people of your business, is often one of the most effective, cheapest (free), yet limited forms of advertisement.  All it takes is a good product and a good customer service.

Location

A major principle of marketing is location:  the place of business must be positioned in an area that has heavy traffic for people that would be interested in your product.  It has occurred countless times, a business that has a great product and good prices has gone bankrupt because the location was not feasible for their clientele to reach.  For example, if you have a pharmacy in a region that caters to a more geriatric (elderly) clientele, having the pharmacy on the top of a steep hill might not be the best option, as they would find it difficult to reach the pharmacy.

Pricing

Properly pricing products and services is an important aspect of pharmacy marketing.  If too expensive, customers will not purchase anything.  If the prices are too cheap, the pharmacy will not make enough money to remain in business.  It is important to set up a pricing regimen that will maintain a stable income while maintaining competitive prices.  Pricing is also considered based on the original cost of the product as well as demand of the product.  While it is wise to have prices lower than or equal to competition, the price shouldn’t be lower than the original cost of the product, otherwise the pharmacy would never thrive.  Additionally if a certain product becomes very popular or there is a high demand for it, this can be a reason to increase the price, which will both take care of the higher cost of having a greater supply of the product as well as increasing profit potential, as long as the price is not terribly different from the competition.

Customer service

The patients’ health should be the pharmacist’s utmost priority; however, as a business and in the eyes of a customer, customer service is one of the most important components.  Without proper customer service, a patient/customer will quickly go to another pharmacy.  If customer service is incredible, many customers will look past higher prices, thus increasing the profit potential of the pharmacy.  Treat each patient with respect, never with rudeness or arrogance.  Express empathy, an understanding of what the patient is going through.  If the patient asks questions answer them with a smile.  If mistakes are made, fix them quickly without argument.  If complaints are made by a customer, see to them and rectify them as quickly as possible.  If a complaint is observed, respected and fixed, most customers will return for repeat business.  If not, customers will most likely tell many more people about the awful service they had received from your business, thus causing the pharmacy to lose more customers.

Drug-seeking behavior

As a pharmacist it is important to be respectful and trusting of patients; if this is done, they too will respect and trust you.  However, as a pharmacist you must also be adept in spotting drug-seeking behavior which is often a sign of drug addiction, often of opioids or other pain medication.  Possible warning signs may include: multiple prescriptions for multiple drugs of the same class of prescriptions from multiple doctors from multiple clinics, forged prescriptions, multiple prescriptions filled at multiple pharmacies and inappropriate prescribed drug number for disease state. All of these situations will often come with a story or explanation or excuse from the patient.  While these are possible red flags of drug-seeking behavior, they are not sure signs, and any suspicions should be investigated further before accusing a patient.  Call the doctor about the prescriptions, call other pharmacies, etc.

OSHA

OSHA (Occupational Safety and Health Administration) is an agency that falls under the control of the US Department of Labor in response to the congressional law, the Occupational Safety and Health Act.  OSHA provides important regulations for work place environments to insure a safe, healthy working environment.  OSHA regulates the need for gloves, respirators and various other protective gear and clothing to reduce exposures of possible dangerous chemicals with which an employee might come into contact.  These protective gears, as regulated by OSHA, are known as personal protective equipment (PPE).  Other important OSHA regulations include permissible exposure levels (PELs) to dangerous chemicals which must be kept at a minimum.  Other important requirements that regulate everything from eye strain to muscle aches are controlled by OSHA.  If a business fails to follow OSHA guidelines, they can be held liable and suffer severe fines and possible lawsuits from injured employees.

Pharmacy Law and Regulatory Affairs

Controlled substances

Classifications of controlled substances:

I. Drugs with this classification are often abused and highly addictive but are not considered therapeutically useful.  These drugs include recreational drugs such as heroine and methamphetamines

II. Drugs that have a propensity for abuse and addiction but have use in medical treatment.  These include opioids such as morphine and oxycontin.

III. Drugs have a propensity for abuse and addiction but less than previous classifications and have a therapeutic uses.  Drugs of this class include vicodin and hydrocodone.

IV. Propensity of abuse still exists, though less than previous classes.  This class includes drugs such as soma, midrin and valium.

V. Includes over-the-counter medications which are considered low propensity for abuse or addiction, such as ibuprofen (Advil®), acetaminophen (Tylenol®) and diphenhydramine (Benadryl®).

Federal laws

Anti-Tampering act of 1982 – after a slew of post-retail contaminations occurred with cyanide in Tylenol leading to several deaths, this act was passed that makes it a federal offense to tamper with consumer products.  From this act more stringent tamper-proof and quality control mechanisms were developed to stop such a tragedy from occurring again.

Federal law of medicinal use of alcohol – if alcohol being sold is only used for medicinal purposes, a federal medicinal spirits dealer’s stamp is required, rather than an alcohol license from the US Bureau of Alcohol, Tobacco, and Firearms, which is required for alcohol sold for any other purposes.

Pure Food and Drug Act – The pure food and drug act was passed in 1906 and gave the federal government the power to regulate and inspect all food and drug products for safety, and made it a federal crime to sell food that had been tampered with or poisoned.  Additionally, this act enforced the proper labeling of foods. This act paved way for the eventual creation of the Food and Drug Administration.

The Food, Drug, and Cosmetic Act – passed in 1938 after several deaths in children occurred in response to a normally safe drug, sulfanilamide, being dissolved into a rather toxic substance, diethylene glycol, before being sold to consumers.  This prompted the government to take action and, among other things, provided authority to regulate the safety of food, drugs and cosmetics.

Durham-Humphrey Amendment – passed in 1951 in order to regulate potentially addictive and harmful drugs.  It states that these drugs must only be sold to a licensed practitioner such as a doctor who must prescribe the drugs to the patients.  After this act was passed, certain drugs could no longer be purchased by the patient directly from the manufacturer, but instead must be purchased only after a legal prescription for the drug has be written for them. The Kefauver Harris Amendment was passed in 1962 after the marketed drug thalidomide was shown to cause severe fetal disorders. This amendment proposed that a drug must be safe and show efficacy (activity against a desired disease state) before it would be approved for marketing.  Additionally, the burden of proof for the safety and efficacy of a drug now lied solely on the manufacturer.  If it could not show reasonable cost-benefit effect, a drug would not be approved for market.

Medical device amendment Act of 1976 – An amendment to the federal food and drug cosmetic act that created classes of regulation for medical devices depending on the activity and safety of the medical devices.  Class I devices require the least amounts of controls before they are sold and used, are considered to have limited possibility for causing harm,  and are also simple in design and use.  Class II devices are when controls used for class I devices are insufficient and other standardized controls are needed before the devices are allowed to reach the market and used by patients.  Class III medical devices consist of most medical devices; they need approval by the FDA before reaching the market.  These devices are generally those that are needed to save or sustain human life and health.

Orphan drug act of 1983 – This law encourages pharmaceutical companies to develop and produce drugs for rare diseases that may only affect a small percentage of patients in relation to the population as a whole.  These drugs are known as orphan drugs.  This law provides tax breaks and other incentives for pharmaceutical companies for creating these generally non-profitable drugs.

COBRA Act of 1990 – The omnibus budget act was passed in 1990 and proposes that pharmacists must properly counsel patients on new prescriptions, making sure that the patients understand the instructions that are needed to take this new drug therapy.  This is very important to decrease toxicity and increase effectiveness of the prescription.

Prescription Drug User Fee act and the FDA Modernization act – The Drug User Fee act (PDUFA) was passed in 1992, which gave the FDA the power to charge the pharmaceutical manufacturers a fee, which can be used to increase the drug review.  This law was passed to improve and modernize the drug review process.  However, this act only allowed fees to be charged until 1997.  The FDA Modernization act (FDMA) was passed in 1997, which increased the time period by which the FDA could charge drug manufacturers a fee until 2002.  This act allowed the FDA to increase the drug review process, as well as to decrease the review time of potentially life saving drugs, allowing them to reach the market faster.  This ability however, has its controversy, allowing sometimes-unsafe drugs to reach the market.

DEA

The DEA is an acronym that for the US federal Drug Enforcement Agency.  The DEA’s job is to enforce the controlled substance act that was passed in 1970 and it shares jurisdiction with the FBI, involving of selling, smuggling, and abuse of illegal narcotics in the United States.  The DEA has important authority in designating who can prescribe federally controlled therapeutic drugs and what federally controlled therapeutic drugs can be prescribed.

Health-care practitioners, as well as health-care institutions that have prescriptive authority, must register with the DEA and receive a DEA number.  The DEA number provides federally regulated prescriptive authority and tracks the use of controlled substances.  The DEA number is made up of 2 letters, six numbers, and a checksum digit.  The first letter is the letter that designates the type of registrant (i.e. practitioner versus a clinic); the second letter is the last initial of the registrant’s surname.  The seventh digit is known as a checksum digit and is used to test the validity of the DEA number.  By adding the second, fourth and sixth numbers and multiplying this sum by two, then adding the first, third and fifth numbers, then taking these two numbers and adding them together, the last digit of this answer is the checksum digit of the DEA number.  If this mathematical equation does not work with a DEA number, the DEA number is not valid.

Poison prevention act exemptions

The poison prevention act put into place the use of safety caps on medicine.  Some drugs, however, are exempt from this law.  These include nitroglycerine, isosorbide dinitrate at a dose less than 10 mg, cholestyrmine, methylprednisolone, mebendazole, potassium dietary supplements, oral contraceptives, erythromycin, ethyl succinate, colestipol, pancrelipase, and prednisone.  Some other regulations might be required like certain doses and dosage forms which make certain drugs exempt from this law.

Pharmacist liability

A pharmacist is held liable for prescription mistakes, especially if injuries are caused by apparent negligence.  Additionally, the pharmacy and pharmacists can be held liable for mistakes that are made by people working for them, including interns and technicians.  Although malpractice insurance will cover some costs, the insurance premiums can be excessive.  It is important to decrease errors as much as possible in a pharmacy and keep a close eye on technicians and interns.  Be firm about mistakes to decrease the liability, but also understand mistakes happen.  Fix any as soon as possible and always be courteous.

Biostatistics and Research Design

Statistical terms

Sample—a subset of the population that has been chosen for further data analysis, in hopes of inferences of the larger population (i.e., if you wanted to study human red-headed children, human red-headed children are a subset of a larger population of children, which in itself is a subset of a larger populations of humans as a whole).

Population—the population describes the entire class of variables in which usually a smaller subset of samples is chosen for further study (i.e. red-headed children)

Parameter—a characteristic or value of an entire population (i.e. red-hair).

Statistic—a measurable, often originally unknown characteristic of a given sample.

Mean—is also known as the average, in which the sum of the data set is divided by the sample size of the data set.

Mode—describes a certain value within a data set population that occurs the most frequently.

Median—the value that lies in the middle of the observed distribution of the data points, in which an equal number of data points possess a value larger and smaller than the median value.  Sometimes the same as the mean, but not always true.

Midrange—also known as range, it is the mean between the largest and smallest values of a given set of data points.

Standard deviation—indicates the amount/frequency of variability of a data set away from the mean of the data set.

Hypothesis testing

Hypothesis testing is an important component in statistics that involves two opposite and conflicting hypotheses about a given data set.  The concept of hypothesis testing surrounds the ideas that if one hypothesis is not correct, the other would be.  For example, if the alternative hypothesis was that A would turn into X, then the null hypothesis would be that A does not turn into X.  If the data collected significantly represents that A most certainly turns into X, than the alternative hypothesis will be accepted and the null hypothesis will be rejected.  If the data does not support the alternative hypothesis, then the null hypothesis could not be rejected, indicating that results seen may not be of a significant difference and the alternative hypothesis was incorrect.

Types of data

Qualitative data—also known as categorical data, usually involves a non-numerical set of data, such as measuring emotions in the concept of being happy, sad or indifferent.  The data represents a set of emotions, but are not quantifiable.

Quantitative data—are a numerical based measured data set. Types of quantitative data include discrete and continuous.

Discrete data—this type of data occurs if the measured values are finite and in distinct classes.  An example of this is when a group of measurements are given numerical values, such as an opinions (agree-1/ disagree-2) in a survey or emotional states due to certain tests (happy-1/sad-2/angry-3/indifferent-4).  Each subject will fall into one category with no overlap.

Continuous Data—is data that can be measured on a nearly infinite scale.  There are no set categories of values.  Examples of this can include: height, weight, length, or width.

Abuses of statistics

There are many ways statistics can be abused and misused, giving a false representation of the data.  For example, graphing data but altering axis values in order to misrepresent data significance, even though technically correct, the visual changes in data would seem larger or smaller than the actual truth.  Additionally a small sample size could provide false positives or false negatives, as it may not be a large enough representation of the entire population.  Misuse of statistical tests is also another way that statistics are often abused; often appearing that the null hypothesis was rejected and the observed changes in the data set were significant even though this was not true.  Statistics can also be abused due to loaded questions as well as missing and distorted data.

Independent vs. dependent variables

The independent variable is the variable in the experiment that is directly manipulated by the experimenter.  The dependent variable is what is measured in an experiment in response to the independent variable. For example, an experiment involves measuring at various doses of amphotericin B and their effect on liver toxicity; the different doses of amphotericin B is the independent variable, as it is changed by the experimenter, while the severity of the liver toxicity is the dependent variable, measured in response to the changes in the amphotericin B dose.

Accuracy vs. precision

Accuracy involves how close the measured data is to the “true” value.  Precision involves how close replicated measurements are to each other.  A measurement can be accurate, close to the true value, but not have great precision, thus lousy repeatability.  Also a measurement could be off from the “true” value, thus not accurate, although the repeated measurements could be close to each other, and thus very precise.  Measured data can be all over the place, thus show little accuracy and little precision.  Finally, if the values are close to the “true” value of the experiment, and the replicates are very close, the measurement would be both accurate and precise. In scientific research, accuracy is not important because the true value is not known, although precision is very important.  When a “true” value is known, the bioavailability of a drug for example, than accuracy can become very important.

Type I and type II errors

A type I error (α) indicates a false positive, in which the null hypothesis was rejected, although it should not have been.  A type I error is not wanted, because it can lead to false conclusions, which can prove fatal if it goes unnoticed during drug development.  The probability of a type I error is generally recorded as a p-value of less than 0.05 or 0.01, which states that there is only a 5% or 1% chance of a type I error occurring in a specific experiment.  This percentage is generally accepted as significantly different in experiments.  A type II error (β) is known as a false negative, when the null hypothesis was not rejected, when it should have been.  Type II errors are unwanted, as important findings could have gone undiscovered, which could have disastrous effects during drug development as well.  Type II errors depend on statistical power of the experiment; as power of an experiment increases the probability of type II error occurring decreases.  Power depends on significance level, sample size, and accuracy of the measurements.

Statistical and clinical significance

Statistical significance deals mainly with population size and measures the probability of a certain outcome from occurring not from chance alone.  While important in research, statistical significance may not have a strong bearing in the hospital or clinical setting.  Clinical significance has little to do with statistics but more to do with judgment and feasibility of a certain treatment to be effective in treating a certain population.  If a hospital needs to treat another hundred people to get a significant difference in a population, the clinical effects are not considered significant.  In other words statistics lies in the realm of probability and mathematics, while clinical significance lies in the real world.

Student’s T-test

Students T-test is a statistical test that analyzes the significance of two different groups.  Often the groups are an experimental population compared to a control population.  The T-test must have some assumptions to work including a normal distribution of the data and equal variance.  The samples can be dependent or independent.  Dependent T-tests are used when the samples that are tested are the same, such as in the case of replicates.  Independent T-tests can be used to measure two different groups of data if the population size (n) is equal between the two groups.  If the sample size is different, variable calculations are used.

Normal and binomial distribution

Normal distributions are sometimes known as bell-curves and generally have an equal distribution of data and point closer to the means.  The shape of a normal distribution can change due to differences in the standard deviation and the mean.  Binomial distribution is a statistical model that measures the distribution of data that is considered mutually exclusive; it is either one or the other.  For example a flip of the coin can only be heads or tails, not both.  A person is either experiencing an adverse effect of a drug or they are not.  Binomial distributions must assume that outcomes are independent, mutually exclusive, randomly selected and fall into one of two categories.

Kurtosis and skewness

Kurtosis is a statistical measurement that describes the peak of a statistical distribution, which usually differs from highly peaked to flat distribution.  Kurtosis examines and measures the level of distribution of data around the mean of the population.  Skewness measures the level of symmetry around the center-point or mean of a distribution.  There are negative and positive measurements of skewness.  Negative skewness occurs when most of the data is right of what is observed in a normal distribution.  Positive skewness occurs when most of the data is left of what is observed in a normal distribution.

Evidence-based medicine

Evidence based medicine has become a staple of modern healthcare.  For this reason primary literature is a valuable asset in the hospital setting.  A pharmacist has the important role of keeping physicians informed of new medical findings and techniques that can be used to treat a particular patient.  This use of evidence based medicine is simultaneously a blessing and a bane of healthcare.  It can keep the healthcare team on top of the newest trends in healthcare and can give ideas of reasonably safe approaches to treating the patients.  Unfortunately evidence based medicine can also lead to stagnation.  If a physician and a healthcare team rely solely on evidence based medicine, this leaves little room for creativity and adaptation, which are often necessary when dealing with any particular patient.  Like any research or therapy, medicine should be based both on previous used techniques and creative therapy (within reason).

Internet databases

The internet has provided an incredible means of achieving articles and data to support both research and evidence based medicine, linking to both primary and secondary scientific literature for both basic science and clinical studies. A few of these websites include:

·         Cochrane database (evidence based medicine):  http://www.cochrane.org/index.htm

·         FDA:  http://www.fda.gov–A thorough guide on drug information

·         Pharmaceutical industry news tidbits:  http://www.coreynahman.com

·         Web of Science: http://scientific.thomson.com/products/wos/– A large database of primary and secondary forms of literature from numerous journals.

·         Natural medicines database: http://www.naturaldatabase.com/–a thorough database of the efficacy and safety of natural products and dietary supplements.

·         Toxnet: Toxnet.nlm.nih.gov—a referenced database of various drug and compound safety and toxicity profiles.

·         Medline: www.pubmed.com –A large database of primary and secondary forms of literature from numerous journals.

Translational research

Translational research is a relatively new approach to biomedical sciences.  It combines the clinic and hospital with basic laboratory science.  It usually involves going into hospitals and observing what is needed, e.g., observing patients of a particular disease state, including biopsies, and taking this information into the lab to guide research and create new possible therapies that can be taken and used again in the clinic as potential therapy.  While this approach has always been the general underlying concept of biomedical sciences, it takes a more direct approach in research, allowing for less blind guessing in the quest for new therapies, and instead leading to a shorter research and development time for safer and more effective drugs.

Basic experimental design

Generally any experiment starts out with a vague concept, an idea that wants to be tested.  When this vague concept has been developed, a literature search should be done, such as in Pubmed to see if this idea has any validity or if anyone has tested it yet.  There is no purpose for doing an experiment if it’s already been done.  From this Pubmed search, enough information should be garnered to create a more succinct idea or concept that will be tested.  Additionally an educated guess, a hypothesis, of what is expected to happen should be developed.  After these initial parts of the experiment have been performed, several sets of experiments should be performed to prove the hypothesis.  If the experiments are unable to prove the hypothesis as wrong, the hypothesis in relation to the experiment is considered as correct.  Experiments should be repeated numerous times and statistics should be performed to determine significance.

Ethical Decision Making

Drug development

Pharmaceutical companies develop and screen new drugs for various disease states, and for any that show promise, the companies will patent them immediately.  The patent allows protection for approximately seventeen years on a drug.  However, it will take eleven of those years for this patented compound to reach the market.  The compound must go through pre-clinical and clinical trials to show safety and efficacy in a human population, before the FDA will approve it.  The problem lies in that this only gives the pharmaceutical companies a seven-year window to make a profit over the 800 million dollars spent in the development of the drug, if the compound passes all the requirements.  This type of process builds an intense pressure to get drugs to market, which could lead to relatively unsafe drugs reaching the market with unforeseen toxicities.  The pharmaceutical companies must often strike a balance between proper testing and pushing the drug to market.  Unfortunately if the gamble fails, it can lead to loss or damage to human life.

Drug promotion

Drug promotion is an important part of pharmaceutical companies.  They spend hundreds of millions of dollars on advertising to the public and to doctors.  How can they sell their product if no one knows about it?  Sounds like good business practice.  However, when human health and human lives are at stake, normal business practices do no always apply, at least not without raising some major ethical concerns.  While drug promotion to the public has some concerns, drug promotion to the doctors is a real concern.  Through free lunches, free merchandise, and relatively high-pressured sale tactics, doctors are often bombarded with pharmaceutical drug representatives, who are attempting to convince the doctor to prescribe their new treatment.  The problem arises due to these high-pressure sales: commercial businesses that are trying to gain a profit are manipulating and to some degree are controlling healthcare, potentially altering how a doctor treats a patient.

Ethical situations

One big ethical issue that pharmacists will need to face when dealing with patients or dealing with fellow pharmacists, is the issue of morals and dispensing of prescriptions and other drugs.  So as a pharmacist you must ask yourself if your personal beliefs are more important than that of the health of a patient.  This is a major controversy in the realm of pharmacy and healthcare, because many believe that it is not the right of pharmacists or physicians to “choose” who they treat or not treat.  However, many healthcare personnel do not believe they should have to do something that they are morally against.  There is no correct choice, but there are important choices that need to be made nonetheless.  One example could be selling needles to drug addicts; on one hand this might be construed as propagating illegal narcotic use, however, it can be also be a means to decrease the possible exchange of dangerous infectious diseases such as HIV and hepatitis.

Randomized drug tests

Randomized drug tests are a rather effective means to control drug use and abuse.  Many employers have adopted this type of test to deter drug abuse among their employees.  Government agencies also use this form of drug testing, such as for police and firefighters.  Randomized drug tests are also used in prisons, schools, and the military.  This form of drug testing is used in healthcare and various businesses.  There is significant success with this form of drug testing, however, there are many controversies surrounding this form of drug testing.  Randomized drug testing is arguably unconstitutional and is thought to violate the fourth amendment which states that privacy of the person is protected from unwarranted search and seizure.  To get past this, most companies will require agreement to randomized drug testing in some form, usually in a signed agreement before the employee is hired.

End-of-life care

In healthcare it is generally thought that patients’ lives exceed all else, and many times doctors will go against the direct wishes of patients to save their lives.  A patient will often need to have a “do not resuscitate” order, a legal blockade that doctors must follow, which ceases any life-saving techniques if vital signs fall below a certain point.  The ethical question that involves much of end-of-life care surrounds the concept of quality of life versus quantity of life.  Should a life be saved at all costs (a person with no readable brainwave activity be stuck in a bed for the rest of their life) or should quality of life be of importance as well?  In general it is thought that healthcare personnel, pharmacists included, should do no harm.  But the question that every person should ask themselves is this—”What does it mean to do harm to someone?”

Individual vs. society

One particular ethical dilemma that pharmacists and other healthcare personnel will have to face is the question of the individual versus society.  This type of ethical dilemma can be observed when quarantining a patient with a very infectious disease.  The patient’s freedom is taken from them, sometimes against their wishes; however, this quarantine will save the life of many other people in society. One another example of this ethical dilemma can be observed in clinical trials, where some patients may be receiving less than ideal treatment, such as a placebo, rather than a new experimental drug.  At one point this does not seem fair, that a patient would not be given a treatment that could potentially save their life, on the other hand, the experimental drug could one day be marketed and used to treat many sick patients if the experiment is performed properly and shows a strong safety and efficacy profile.

Placebos

There are certain ethical considerations that should be met in a clinical trial before placebos should be used (although this does not mean that these considerations are always met before placebos are used in research).  A placebo can be used if there is no truly effective standard of treatment, the therapy is no better than a placebo, recent evidence has suggested that the standard of treatment might be less than ideal and possibly dangerous, or if cost-effectiveness of using the treatment is not feasible for the entire patient population.  It would always be best to compare new drugs to standard treatments.  This will provide a better understanding of the treatments effectiveness and safety than against a placebo.

External vs. internal validity

External validity relates to how well results from a study (clinical trial) can be generalized to a larger population.  If the results of a study are shown to extrapolate to a larger population is it thought to have a high external validity; on the flip-side, if the results cannot be generalized to a larger population, the study is thought to have a low external validity.

Internal validity involves determining a cause and effect relationship between two variables such as drug X leads to disorder Y.  The stronger the relationship and the more alternative cause/effect relationships can be ignored, then the higher the internal validity of the experiment.  An experiment with low internal validity would show little to no cause/effect relationship between two variables, or it would show many possible alternative cause/effect relationships.

Evidence-based medicine application

When applying evidenced-based medicine (EBM) in healthcare, one should closely compare the patient with the subjects in the study.  This is necessary to determine if the study is actually a valid option for treatment.  If differing variables exist between the patients studied, such as different population subtype, different disease state, etc. this may lead to some issues when applying the EBM.  It is also important to determine the cost-benefit ratio of the EBM when applied to the patient.  Are possible risks and costs worth the possible benefit of the EBM that is suggested by the study?  Finally, patients should be spoken to about the EBM in order to determine if the type of healthcare intervention that would be provided is something they feel comfortable with or agree to.

Nuremberg Code

The Nuremberg code came about after the atrocities of the Nazis during World War II and came about during the Nuremberg trials.  These codes were written in August of 1947 and are one of the first historical guidelines set out for human experiments and informed consent.  These guidelines stated that people’s consent must be obtained before a test is performed, tests must be socially valuable, intentional injury is not permitted (tests must be used to heal not hurt), animal studies must be performed first, all the research must be closely supervised, the benefits of the tests must always outweigh the risks, and tests must be ended as soon as it appears the experiments are causing more pain than help.

Institutional Review Boards

The Institutional Review Board (IRB) is an independent ethics committee that has been designated to oversee human testing (clinical trials) at hospitals and research facilities.  The IRB is empowered with important regulations by the United States department of Food and Drug Association (FDA) and the United States Department of Health and Human Services, allowing the IRB to approve or disapprove research as well as monitoring the validity and safety of the research.  The safety of the patient is the IRB’s most important focus.  The research act of 1974 defines the regulatory powers of the IRB.

Belmont report

The Belmont report was created by the United States department of Health and Human Services in 1979 and was an important document that provided guidelines for modern medical ethics.  The Belmont report puts forth three important ethical components of human research that should be followed in any experiment.  These include respect for the patients, always to strive to do well, and that all patients with similar disease states in the test should be treated the same without any bias.

Professional Communication

Communication

Communication is vital for healthcare when purveying important information to patients as well as colleagues about potential diagnostic therapies and medication.  Verbal communications consists of spoken words but also can consist of written words as well.  It is essential when speaking to a patient, for example, during counseling of a new prescription, to make sure the patient understands what is being said, to speak clearly and answer a lot of open-ended questions to make sure the patient understands about the drugs.  It is also essential for written instructions on a medicine to be clear and easily understandable.  Confusing written instructions can easily be a serious problem with a patient needing to follow a specific prescription.

Non-verbal communication is also very important in healthcare.  Non-verbal communication consists of techniques that do not require spoken or written words to get a particular meaning across.  Non-verbal communications consist of kinesics, a technique that uses body language to convey a message, whether intentional or unintentional.  Body language can include changes in posture, nervous tics, etc.  Unintentional nervous tics can non-verbally tell a doctor or pharmacist a lot about a patient’s state of mind and can help a lot with further verbal communication, in treatment, and in understanding the patient.

Cultural competency

In the most general terms, cultural competency relates to the capacity for one person to perceive and understand another person’s cultural beliefs.  This is especially vital for healthcare professionals who encounter a variety of patients from a variety of cultural backgrounds.  In the healthcare industry, cultural competency relates to the ability to not only find appropriate ways to communicate with patients from other cultures, but also to not discriminate or judge solely based on a patients cultural background.  The best way to gain cultural competency is to learn about a variety of cultural customs and ask appropriate questions to your patients.  Often, patients are very honest and love to explain their cultural views if asked in a non-judgmental way.

In the healthcare profession, communication is key.  This is especially the case when you are working with patients that have a different cultural background.  While not always the case, language barriers are a large part of working with a patient from a different cultural background.  It is important to find a way to properly communicate with patients that do not speak English.  Ideally, there is a bilingual medical professional available to translate.  If this is not possible, there are many resources that can translate important medical information to the patient over the phone.  In addition, most pharmacies have medication information in several different languages.  This is not to be used as the only means of communicating with a patient who does not speak English, but used as a resource that a patient can use at home.

Health literacy

Health literacy in its most basic form relates to a patient’s ability to comprehend and utilize health resources.  Health resources can include various health related services such as: health care in a clinic or hospital, receiving health information in the form of informational pamphlets, understanding information related to medication usage and education related managing chronic illnesses.  In more specific terms, health literacy relates to a patient’s ability to utilize and understand health resources within a specific cultural and social paradigm.

Language and social barriers are the most common reasons a patient has low health literacy.  Most healthcare and healthcare related information is in English and geared toward a general population that has lived in the United States for a long period of time and is familiar with the general framework of this healthcare system.

It is easy to assume that healthcare professionals have a high level of health literacy, but this is not always true.  For health care providers, health literacy is focused on continuing education and cultural sensitivity.  For health care providers to have continued good health literacy, it is vital that they keep up-to-date with current healthcare related research and clinical trials.  This can be accomplished in several ways including:  reading journal articles, being involved in journal clubs and grand rounds, attending local continuing education forums and good communication with peers.  Continuing education related to cultural sensitivity involves further education related to the culture, religion and customs of the patient base being seen.  It can also include learning how to speak relevant languages and specific education relating to various cultural beliefs and religions.

There are numerous ways that healthcare providers can improve health literacy.  In general, providing culturally sensitive healthcare material and translating educational pamphlets into multiple languages will improve health literacy a great deal.  Additionally, wording educational pamphlets in easier to understand terms will also improve health literacy.  Staff education is also vital to improve patient health literacy.  As clinic staff is often who a patient speaks and interacts with first, it is vital that staff is trained in cultural sensitivity.  This way, patients are treated appropriately from the very beginning and are more likely to return for further healthcare.

As a pharmacist, you can improve health literacy by translating medication information in the appropriate language and if possible, counsel in the appropriate language.  It is also vital that important medication auxiliary labels are also translated into the appropriate language.

Pharmacist-medical team communication

Effective communication is vital when there is limited time to present pertinent information about a patient to the medical team.  Rounds or morning rounds is usually the only time when each patient case is discussed with the entire medical team.  It is important that the pharmacist has reviewed each patient that is going to be discussed during rounds for medication related problems.  This includes reviewing pertinent lab values and performing any antibiotic kinetics before rounds.  Questions that need to be directed to the medical team should be formulated before rounds if possible, especially if a primary literature search is necessary.  During rounds, pharmacist questions should be asked succinctly to the medical team and primary literature should be presented if asked for.  If someone on the medical teams asks you a question about a patient that you cannot answer appropriately, you should offer to look up the information after rounds are complete.  It is better to give physicians a more complete answer slightly after rounds than an incomplete answer during rounds.

Social and Behavioral Aspects of Pharmacy Practice

Patient misconceptions

Only recently have patients begun to trust pharmacists; however, this trust is limited.  Often patients only see pharmacists in a retail setting and really do not grasp the role a pharmacist has in healthcare.  This is partially due to the patients’ misconceptions; they see that a pharmacist puts drugs in a bottle and nothing else.  In the patients’ eyes, a pharmacist has a reasonably simple job.  On the flip-side pharmacists have not done much to contradict these misconceptions until recently.  Pharmacists often do not deal with patients as much, they approach patients coldly, and unfortunately many pharmacist, particularly in the retail setting, simply do not treat patients with respect either.  Respect must be given both ways.  Additionally, the way companies advertise pharmacies, with drive-thru windows, with the promise of one hour prescription filling (which often is not met), patients often do not view pharmacies with much higher regard then they do a fast-food restaurant.  These misconceptions can be changed, if the pharmacist desires to change them.

In a hospital setting, pharmacists are often invisible.  Healthcare is a team effort, however, ingrained notions of medical doctors being the sole providers of healthcare has tainted patients’ views.  Additionally, pharmacists often do not get to know their patients as readily as other healthcare providers and often go unnoticed.  Also patients often don’t trust pharmacists in relation to other healthcare providers.  A patient will often not trust a pharmacist to give them immunizations, or they would feel uncomfortable, although this comfort level is higher in a hospital setting (mainly because many patients don’t realize that the person administering the injection is a pharmacist) than retail settings.  As a pharmacist it is essential that the patients’ trust is gained, and to do this, it is important that the pharmacist talks to the patient and does not simply focus on lab values.  Those lab values often have a name.

Perception of pharmacists

Pharmacists are an important component of healthcare; however, trust must be earned.  It is important to be respectful to the healthcare team, keep them informed of important lab values and drug information of the patient.  Pharmacists should be readily available to look up important primary literature to answer any questions that a physician or other healthcare personnel might have on a given case.  A pharmacist should be willing to stand firm about a treatment of a patient, physicians might be overlooking a key component necessary in the treatment of the patient.  It is also wise to know when to pick your battles and that at times realize that compromise is necessary.  Older doctors unfortunately often are not always amenable to pharmacist intervention, partially for the reason that the role of a pharmacist has evolved greatly in recent years, compared to their role ten to twenty years ago.  Men and women who have recently become doctors are generally more amenable to pharmacist intervention and view them as an important healthcare resource.

Patient profile documentation

Do not forget that, as a pharmacist, you are a vital part of the healthcare continuum and as such it is vital that you document patient information and patient encounters.  Ideally, every encounter you have with a patient should be documented in the patient’s permanent file.  If you are working in a hospital or group setting where you have access to the patient’s electronic medical record, you should document patient encounters in the pharmacy notes section of the medical record.  When you are documenting patient encounters always provide: a brief history of present illness (HPI), relevant prescriptions, drug allergies, assessment, plan and any other piece of information that is relevant to that specific encounter.

Leader characteristics

A good leader is necessary to run an efficient pharmacy that will both serve the needs of the patient’s health and financial situation, while at the same time maintaining the financial needs of the healthcare and insurance companies.  A leader is not the same thing as a manager, although a good manager is often also a good leader.  A leader is someone who has a vision for improvement and can easily pull others toward this vision and lead the pharmacy into a new era.  A good leader must have both a decent personal ethical system by which they always abide and a strong professional outlook toward pharmacy. A leader must have a strong vision and develop relationships with ease in order to pull people into that vision so that the vision will not be a simple idea, but can soon be turned into a reality.  As a leader it is important to never stop learning and to continually adapt ideas as healthcare evolves, and finally it important to pass knowledge to future generations of leaders by mentoring these people so that they too can one day lead healthcare into the future.

Developing strong relationships are one of the most important aspects of leadership.  Without proper relationships, little will get done.  A strong leader must adopt appropriate relationship skills with all aspects of the pharmacy, treating each and every person that works for them with kind firmness and respect.  Additionally, relationships are needed outside the pharmacy as well, including with patients, as well as other healthcare colleagues.  A strong leader with strong relationship skills can help connect all aspects of healthcare with the pharmacy.

Exceptions to informed consent

There are times that exceptions to informed consent can occur.  When these exceptions occur, details of healthcare do not need to be addressed to patients.  These exceptions occur during: 1) public health emergencies (e.g., outbreak of a disease when quarantine is needed). 2) Medical emergencies (in matters of life and death it is not necessary particularly if the patient is incapacitated).  3)  Incompetency (a patient is unable to make a correct informed decision.  This is controversial and often times a court order is needed to deem someone as incompetent).  4) The patient waives the right to informed consent, which could be for any number of reasons such as cultural or religious, but this waiver can be retracted at any time by the patient.

Medication Dispensing and Distribution Systems

FDA medication guides

The FDA has mandated that certain medications must have an FDA approved and written medication guide dispensed each time the medication is dispensed.  Providing these medication guides is mandatory and a pharmacy can be fined if an agent finds that prescriptions were dispensed without the FDA approved medication guide. The following website has updated information:  http://www.fda.gov/cder/Offices/ODS/labeling.htm

Current medication guides:

OBRA dosage guidelines

Sedative hypnotic drugs should be avoided, if possible, in the geriatric population.  These medications are not meant to treat any type of sleeping disorder and the minimum dosage that can be used should be used.  A gradual dosage reduction should be attempted after 10 days of continuous use and attempted an additional two times within a six month time period.

Long acting benzodiazepines are considered a last resort medication.  They should only be used after a trial of short acting benzodiazepines has been used and shown ineffective.  If the maximum suggested dosage should only be exceeded in exceptional cases and typically only after a case review by a board of health care professionals.  Long acting benzodiazepines should not be used for more than four months on a continuous basis.  A gradual dose reduction should be utilized at least twice in a year long period.

These guidelines are exempt when a long acting benzodiazepine is being used for a seizure disorder or bipolar disorder.

If a benzodiazepine is required for a geriatric patient, a short acting benzodiazepine should be used before utilizing any other type of longer acting medication.  The geriatric dose maximum should not be exceeded, unless there is a documented medical reason that has been approved by a review board of health care professionals. A gradual dose reduction should be utilized at least twice in a year long period.

Medication-use Systems

Adverse drug events (ADEs) are accidents which can, in a worst-case scenario, result in the wrong dosage of the wrong medication being delivered in the wrong manner to the wrong patient. To combat this, hospitals and pharmacies may institute plans, training, or ‘systems’ to address weak links in the medication administration pathway, including prescription of the drug itself, its dispensation, or administration. That is, “medication-use systems” is a broad term which encompasses any system that helps to guard against ADEs.

To help ensure proper prescription, medication-use systems might emphasize attention to patient demographic and clinical information or the drug information. In some cases, the wrong medication is given to the consumer; here, a system might recognize the importance of proper communication of drug information between hospital and pharmacy staffs or better methods of drug labeling, packaging, storage, or distribution. To protect from drugs being administered improperly, some plans may focus on the education of staff and patients who handle and administer the drugs. Medication-use systems may also suggest higher standards of staff competency or increased quality and risk assessment and management.

Medication Errors

Medication errors include any and all avoidable incidents that allow the possibility of inappropriate medication use or harm to the patient while the medication is in the control of the administrator. Not all ‘medication errors’ necessarily end with real harm to the patient: the term also includes any actions which (though prevented) could have resulted in harm or wrongful use of medications.

Medication errors can be due to miscommunication, such as poor handwriting or inaccurate information requests, confusion of similar drug names or dosing units, or improper amounts or directions supplied to the administrator. They may also include improper labeling, packaging, compounding, monitoring, and use of the medication itself.

The most important response to medication errors (besides their correction) is to properly report them to prevent future incidents. Medication errors are initially reported to Medwatch before being reviewed by a branch of the FDA, the Department of Medication Error Prevention and Analysis (DMEPA), where causality and circumstances are analyzed to provide recommendations for future similar cases.

Medication-distribution Technology

There are three chief models for medication distribution in hospitals: centralized, decentralized, and hybrid. The centralized distribution is typical of most traditional hospitals: a single pharmacy is in charge of filling all orders required by the practitioners and sending them to the proper nursing stations for administration. The decentralized distribution uses multiple housing stations for medications, e.g. automated dispensing cabinets (ADCs); a single pharmacy is again in charge of processing practitioner orders, but the medications are released to nurses by the housing stations. The hybrid case combines both models, usually specific to each case of medication or strength.

Other variations of medication distribution include: satellite pharmacies, which consist of smaller pharmacies with limited resources spread throughout the hospital; bulk distribution of medication to nurse stations rather than single-dose distribution; robots in stations similar to ADCs which fill required variable orders; pneumatic tubes (usually with PIN or ID locks) which range throughout the hospital from a pharmacy to areas of interest; and mobile carts which may move throughout the hospital and nursing areas.

Drug event terms

Adverse drug event (ADE):  Relates to any event that occurs when a drug is being used at standard dosing and something happens that was not expected or wanted.  ADE’s typically require that the drug be stopped or the dosage changed and can potentially require additional supportive care and hospitalization.  ADE’s can be related to unexpected or unwanted reactions to medication and/or mistakes in administration of the drug.

Adverse drug reaction (ADR):  Relates specifically to an event where a patient takes a medication at standard human dosing and has a reaction that causes an unwanted reaction.  This can be related to any type of medication administration mistake or can be an unexpected allergic reaction to a medication that had previously not caused a reaction.

Side Effects (SE): Relates to medication induced reactions.  These are often known reactions and include common drug reactions such as stomach ache, vomiting and rash.

Potential adverse drug event (PADE):  Relates to any medication dispensing error that could possibly harm a patient.

High alert medications

High alert medications, such as digoxin, are drugs that generally have a narrow therapeutic range and have a high potential to cause patient harm if they are not properly prescribed and dispensed.  High alert medications do not necessarily have a higher rate of medication error and near miss medication error, but the potential for patient harm is much greater with these drugs if a medication error does occur.  Most hospital and retail pharmacy computer programs flag specific medications as high alert medications and require that the pharmacist double check the written prescription and dose.  Some programs even require a second pharmacist to double the check the first pharmacist.  It is important that, as a pharmacist, you do not undermine these double checks in your computer system.  They are there to protect the patient and the patient is always your priority.

Failure Mode and Effects Analysis

Failure mode and effects analysis (FMEA) is used to better understand what type and frequency of medications errors.  A FMEA involves forming a committee and/or using specialized computer programs to look at near miss medication errors and to evaluate potential holes in existing computer technology. The goal of a FMEA is to flag areas that could be contributing to medication errors and to develop techniques or alter computer technology in such a way that medication errors are significantly reduced.  A FMEA can especially be beneficial in a hospital setting where a single computer system is being used by many different healthcare personnel.

FDA monitoring

While the FDA does not have a formal drug medication error monitoring system, they do keep a watchful eye on medication error rates in hospitals and retail pharmacies across the United States.  The FDA accomplishes this by compiling and monitoring information that is passed on to them via the United States Pharmacopeia (USP) and the Institute for Safe Medication Practices (ISMP).  By compiling data that is collected by several agencies, the FDA is able to gain a good perspective on the types of medication errors that are occurring in hospitals and pharmacies.  Additionally, the FDA monitors adverse drug event information that is entered by healthcare professionals on their website, MedWatch (http://www.fda.gov/medwatch/).  MedWatch is voluntary and anonymous and is extremely valuable, especially as it relates to drugs that are new to the market that may have adverse reactions that were not originally found in clinical trials.

Drug point of entry errors

Point of entry (POE) relates specifically to when a prescription or a drug order set is being prescribed by the physician.  It is important to remember that physicians will often give a verbal drug order to the pharmacist, nurse or other healthcare professional.  Misheard information from a verbal order is a common area where a medication error can occur.  Always read back the medication order to the physician to confirm the verbal order was taken correctly.  POE errors can also occur when the physician is distracted and accidentally picks the wrong medication, dose or strength.  POE errors can also occur when a physician writes a prescription that is illegible or is missing information.  It is very important to call a physician and verify any information that is in anyway ambiguous.  It is interesting to note that the use of computers during the initial order entry process can reduce medication errors by up to 50%.

Drug dispensing errors

In a retail pharmacy setting, dispensing drug relates to the action of physically filling and checking a prescription before it is given to a patient.  In a hospital setting, drug dispensing can be more complicated.  In this situation, medications may get filled and sent directly to the patient, or the medication may go to a pixys type machine where a nurse retrieves the drug based on a timed medication record (MAR).  Medication errors related to drug dispensing can occur any time between the initial medication fill to right before the patient takes the medication.  As a pharmacist, it is important to double check medication orders for patients before they are officially entered into the computer system.  In a hospital setting, it is also important to check a new medication order against the current MAR.  This can help you discover patient specific medication errors.

Drug administration errors

Medication errors related to drug administration can occur in hospital and outpatient settings.  Common hospital related administration medication errors include improper administration method (giving an IM shot subcutaneously), giving the medication at the wrong time, giving the wrong amount, setting improper IV infusion rates or even giving the medication to the wrong patient.  Retail related administration medication errors include dispensing the wrong medication to the patient, improper directions on the medication label and the patient misinterpreting medication instructions.  Drug administration medication errors can be avoided in both settings by checking and re-checking medication orders and routes of administration.  In a retail setting, it is important to make sure the right prescription gets to the right patient.  Always verify that you are handing the correct prescription bottle to the correct patient.

Reducing medical errors

Physicians, pharmacists, nurses, and other healthcare staff make mistakes, unfortunately medical errors lead to numerous deaths in the US.  These can be contributed to misdiagnosis, poor patient history, development of allergies, miscommunication of a therapy, drug-drug interactions, etc.  Pharmacists are the last resource before a drug therapy reaches the patient, and as a pharmacist, it is vital for them to learn how to minimize medical errors.  These can include being very careful in distributing the correct drug to the correct patient.  It is also important for the pharmacist to have knowledge of other prescriptions the patient may be on, in order to decrease chances of undesired drug-drug interactions.  A pharmacist must be willing to question a prescription or a diagnosis by a physician, if a possible mistake has been made.  Additionally, another way to reduce medical errors, as a pharmacist, is to clearly counsel patients on their prescriptions, making sure they understand the instructions for their medicine.

In order to reduce confusion of similarly sounding names of drugs, the FDA regulates the brand names that pharmaceutical companies are allowed to use, decreasing the likelihood of one ore more drugs sounding similar and thus decreasing the chance of miss-prescribing. Also, more hospitals and pharmacies are adopting a barcode approach to regulating drugs.  A barcode is on the drug and the patient.  Before the drug is administered, the patient and the drug are scanned to make sure the drug, and dose of the drug are correct for the correct patient.  Additionally, a law was recently passed to make it illegal for prescriptions to be written in cursive.  Instead they must be clearly printed by hand or printed by a computer to decrease chances of confusion about the prescription.

Common medication errors

This is a very basic list of some of the common drugs that frequently cause medication errors. Any drug can cause a medication error, so always double check if the medication, dosage form and strength make sense for the patient taking it.  Always take the time to double check calculations

Drugs that have similar names, that sound alike when spoken or look alike on a shelf are often drugs involved in medication errors. Always double check medications that could be mistaken for another medication to make sure the correct medication is dispensed. The following is a list of some medications that are common sound alike or look alike medication error culprits.

·         Fosamax and Flomax

·         Prilosec and Prozac

·         Celebrex and Cerebryx

·         Zantac and Zerit and Zyrtec

·         Metadate and Methadone

·         Depakote and Depakene and Depacon

·         Taxol and Taxotere

·         Keppra and Kaletra

·         Narcan and Norcuron

·         Lamictal and Lamisil

·         Serzone and Seroquel

·         Reminyl and Amaryl

In the fast paced medical world, it is not surprising that almost every medical term or instruction can be abbreviated in some way. While abbreviations will always be a part of the medical vernacular, it is important to recognize that abbreviations can be easily mistaken and misunderstood. Always double check any abbreviation that could potentially mean more than one drug or instruction. Below is a very brief list of common abbreviations that can be interpreted multiple ways.

·         QD, means daily. Interpreted as QOD, write daily instead

·         SC or SQ, means subcutaneously. Interpreted as SL, spell specific route instead.

·         Per OS, means orally. Interpreted as OS or OU, write orally instead.

·         TIW, means thrice weekly. Interpreted as TID, spell out three times weekly.

·         D/C, means dispense at discharge. Interpreted as discontinue medication, spell out instead.

·         Ug, means micrograms. Interpreted as mg, spell out instead.

·         U, AS, AD, means ear. Interpreted as OU, OS, always check route.

Medication error statistics

While statistics related to medication errors always change, it is important to have a good general knowledge of medication error rates. Always remember that the goal of a pharmacist is to be as error free as possible. Below is a list of recent statistics related to medication error rates:

·         Medication errors have been attributed to over 7,000 deaths a year.

·         At least 30% of patients receiving medical care in a hospital have been subjected to a medication error.

·         The most common medication error in a hospital setting is a medical error related to drug administration.

·         Medication errors cost hospitals millions of dollars each year.

·         The medication error rate in ambulatory and retail setting is over 25%.

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