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in this video we'll go over Federal Pharmacy law with some patient safety sprinkled in Pharmacy law is constantly changing although the focus in this video is federal law be aware that state law or the strictest law has precedent if you have any questions let me know in the comments below for the first question what are the daily and monthly limitations on pseudoephedrine sales a person can purchase 3.6 grams a day or a total of 9 grams in a month for example this package contains 10 240 milligram tablets or a total of 2.4 grams of Sudafed so they could only purchase one of these in a day if they wanted to purchase this package then they could buy three in a day because each box contains 1.2 grams mail order pharmacies Place further restrictions on Sudafed sales limiting each individual to 7.5 grams per month Sudafed must be kept behind the counter and an idea is required for purchase and here's a bonus question how many packages of this Sudafed can a person purchase in one month leave a comment below if you know the answer which law Place limitations on pseudoephyrene sales the combat methamphetamine epidemic Act of 2005 placed limitations on how much Sudafed can be purchased pseudoephedrine ephedrine and phenylpropanolamine are precursor chemicals used in the illicit manufacture of methamphetamine or amphetamines with the passage of this act a new category of substances designated as scheduled listed chemical products or slcps was created sales of Sudafed must be kept in a physical or electronic logbook for a minimum of two years after the date of sale the purchaser's name address signature products quantity sold date and time of transaction must be recorded in some states the person purchasing Sudafed must be over 18 years old but other states have no age limitations so just a valid idea is required for a full list of the landmark laws related to Pharmacy along with other helpful listing tables check out the link in the description below you can use it as a reference to help with answering a lot of the following questions which of these entities can have an NPI select all that apply an NPI or national provider identifier is a unique 10-digit identification number issued to covered entities in the United States including Healthcare Providers organizations health plans and clearinghouses that is used in HIPAA compliant transactions prior to the NPI health plans and payers assigned ID numbers to Providers and suppliers these numbers were often not standardized which would complicate the claim submission process in 2007 the centers for Medicare and Medicaid services or CMS made Provisions mandating the adoption of a standardized system NPI simplified the administration of Health Care Systems enabling efficient and effective transmission of information NPI numbers also prevent fraud by implying whether a provider is properly licensed excluded or sanctioned in practice you might look up a provider by their NPI during data entry when it's printed on a script and you can't make out the provider's name or signature insurance will often ask for a pharmacist NPI before disclosing any patient info all of these options can have an NPI what do the first group of numbers in a national drug code or NDC identify the drug listing Act of 1972 amended the federal Food Drug and cosmetic Act of 1938 so that drug establishments that are engaged in the manufacturing preparation propagation compounding or processing the drug are required to register their commercially marketed drug products with the FDA trade name dosage form route of administration package information and the NDC are required per the drug listing act for a drug to be properly listed the NDC is a 10 or 11 digit identifier separated into three segments that is assigned to every drug the first group of numbers represents the labeler code or the manufacturer the second group identifies the product and strength of the drug and the last group of numbers indicate the package size the first segment of an NDC can be four five or six digits the second segment is three or four digits and the last segment can be one or two digits CMS has created an 11 digit NDC derivative which pads segments in the NDC with leading zeros wherever they are needed to result in a fixed length of a 542 digit configuration verifying the NDC and utilizing barcodes are some of the best methods to prevent errors in the dispensing process so for this question the first group or segment of numbers identifies the labeler or manufacturer looking at these ndcs we see that the first segment is the same because they are all manufactured by apotex Corp the second segment or product code is slightly different for each the product is a tour of Statin the dosage form is a tablet but the strength is different among each of these finally the last segment of the NDC refers to the package code indicating the package form and size which DEA form is used for the ordering transfer and return of C2 medications here's a reference table for the most common DEA forms used in Pharmacy form 222 was a triplicate form that is used to purchase transfer or return schedule 1 and 2 medications with the implementation of csos or the electronic controlled substance ordering system the triplicate form was updated to be a single sheet effective as of October 2019 as of October 2021 the DEA has implemented the mandatory use of the single sheet dea22 form most pharmacies nowadays have elected for the electronic equivalent 222 form so that a physical record is no longer required electronic forms are digitally transmitted and signed by the purchaser's personal seesaw certificate copies of the DEA form 222 whether physical or electronic must be maintained for at least two years per federal law which of these laws reduce the fraudulent distribution and dispensing of controlled substance prescriptions obtained over the internet the Ryan hate Act of 2008 mandates with limited exceptions that the dispensing of controlled substances by means of the internet be predicated on a valid prescription issued by a practitioner acting in the usual course of professional practice who has conducted at least one in-person medical evaluation of the patient the law also outlined how online pharmacies must obtain a modified registration with the DEA as to combat the proliferation of Rogue internet sites that unlawfully dispense controlled substances exceptions have been made to the in-person visit requirement during Public Health emergencies such as the covid-19 pandemic where telemedicine became more prominent what group is responsible for accrediting and certifying Healthcare organizations The Joint Commission formerly known as Jayco is a group that accredits Healthcare organizations to guide and evaluate the organization's performance in the areas of patient safety treatment and Care Quality accreditation by The Joint Commission demonstrates that an organization is dedicated to practice safe and effective Care at the highest quality reaccreditation occurs every three years for most facilities and most state governments require that Health Care organizations receive the Joint Commission accreditation as a condition for licensing and CMS reimbursement facilities are usually given notice if a joint commission site visit so that staff can be on their best behavior but sometimes these visits are unannounced which of the following is the most severe drug recall a class one recall is the most severe type of drug recall because there is reasonable probability that using the drug will cause serious adverse Health consequences or even death a drug with a Class 2 recall has a remote probability of serious or temporary adverse Health consequences in a class 3 recall using the drug is not likely to cause any adverse Health consequences class 4 and 5 recalls do not exist ing to FDA report data there were 2163 drugs recalled in 2019 of that number 513 were class 1 recalls some of the more recent class 1 recalls were the market withdrawal of magnesium citrate saline laxative due to microbial contamination in the Zantac recall due to contamination with ndma a probable human carcinogen the active ingredient Ranitidine was never brought back to Market and Zantac 360 was rebranded with famotidine as the active ingredient other reasons for class 1 recalls might include non-sterility labeling Mix-Ups super potent drugs and the presence of particulate matter how many refills can a provider authorize on a prescription for a C3 or a C4 drug per federal law a provider can authorize a maximum of five refills lasting no longer than six months after the date of issuance State and Company law May differ generally you want to follow the strictest law but all pharmacies must at least comply with federal law some states have categorized certain drugs as controlled While others have not and some states place the same limitations on schedule 5 drugs as that of a schedule three or four While others treat schedule 5 drugs as if they were not controlled schedule 2 drugs cannot have refills and non-controlled drugs can have unlimited refills that are valid until the prescription expires what missing information is required on this prescription select all that apply when you first receive a hard copy for a prescription you want to make sure all the required information is on the script before data entry if the prescription includes a controlled medication like this one then needs a little more info to be considered valid for federal regulations per federal law a prescription for a controlled substance requires the date of issuance patient's name and address prescriber's name address DEA number drug name strength dosage form quantity prescribed directions for use number of refills and prescriber signature the patient's date of birth and phone number are not required per Federal Regulations however State and corporate policy may require this info and its best practice to include this as well in some states the patient gender and diagnosis code may be required the patient's address should be their physical residence and not a PO Box so that it gets properly reported to the prescription drug monitoring program [Music] which of these is the same as a legend drug in 1951 the Durham Helm free Act was passed this legislation separated drugs into two categories Legend and non-legend a legend drug is the same as a prescription drug prescription drugs are behind the counter and the drug labels will say RX only drug labels used to be commonly referred to as Legends which contained all the drug info which is why they are called Legend drugs non-legend drugs do not require prescription there is often confusion whether some items behind the counter in the pharmacy can be sold without a prescription if there is an RX only designation anywhere on the label package or box then it requires a prescription other items such as certain diabetic testing supplies OTC medications ordered through the pharmacy supplier medical foods and some refrigerated probiotics kept in the pharmacy can be sold without a prescription what drug schedule has the highest abuse potential with accepted medical use controlled substances are divided into five categories based on accepted medical use and treatment relative abuse potential and likelihood of causing dependence schedule 1 Controlled Substances have the highest potential for abuse but no currently accepted medical use in the U.S schedule 2 drugs have a high potential for misuse and abuse but do have approved medical use schedule 5 drugs have a low potential for abuse and may lead to limited dependence relative to schedule 2 drugs most schedule 2 drugs are Narcotics or stimulants which can be habit-formier addictive in nature resulting in a severe physical or psychological dependency as a result there are prescribing dispensing restrictions in place at the state and federal level regulating their distribution pharmacies must maintain an accurate Perpetual inventory of schedule 2 drugs which law required that all prescription medications in the US be safe and effective in 1938 the food drug and cosmetic Act was passed requiring manufacturers to show the safety of their product before marketing then in 1962 the cathabra Harris amendment was introduced in response to the thalidomide tragedy in which thousands of children were born with birth defects as a result of their mothers taking thalidomide for morning sickness during pregnancy the 1962 amendment required drug manufacturers to provide proof of the safety and effectiveness of their drugs before approval the amendment also required drug advertising to disclose accurate information about side effects and stop cheap generic drugs from being marketed as expensive drugs under new trade names or as new breakthrough medications ing to federal law which of the following medications can be transferred to another Pharmacy select all that apply ing to correspondence between a representative of the DEA and the National Association of boards of Pharmacy and unfilled original epcs or electronic prescription for a controlled substance including schedule 2 substances can be forwarded from one DEA registered retail pharmacy to another DEA registered Pharmacy at first glance one might assume that the transfer of a schedule 2 substance is permitted however there is a difference between transferring and forwarding as of now there is no guidance in the DEA pharmacist manual regarding the transfer of a schedule 2 substance and this is confirmed with a proposed rule that DEA would like to amend its regulation to allow for the transfer of electronic prescriptions for schedule 2 through 5 Controlled Substances between registered retail pharmacies or initial filling on a one-time basis this ruling was proposed in November of 2021 and no further action has been approved yet so it is safe to assume that only schedule 3 through 5 drugs may be transferred the proposed rule only addresses prescriptions received electronically the purpose of restricting the transfer of non-electronic forms of a prescription or a controlled substance is to reduce the possibility of diversion of illegitimate Scripts scripts called into one Pharmacy can be transferred to a different Pharmacy making them harder to trace so only Xanax and modafinil may be transferred following the initial fill if the question had asked which of these medications can be forwarded to another Pharmacy then all these options would be correct as far as I know the forwarding of a schedule 2 substance can only occur between pharmacies sharing a real-time database between two stores in the same chain such as two red AIDS and very few places including Washington State or institutions like VA pharmacies most other pharmacy software do not have the capability to forward a prescription for a schedule to substance forwarding a prescription means sending the entire script data back to the transmission processor which is usually squarescripts which is then sent to another Pharmacy forwarding is a more secure method of moving a prescription between different pharmacies because transfers have the potential to create duplicates So currently the transfer of the schedule 2 substance is not allowed but the forwarding of any prescription including schedule 2 substances is allowed granted that it was received as an electronic format which of these is not a valid DEA or Drug Enforcement Agency number a DEA number is a provider's ID associated with the DEA that allows them to prescribe Controlled Substances the first letter is the registrant type the second letter is the first letter of the physician's last name the rest are not so Random digits how can we verify a DEA number looking at option A at the first third and fifth numbers together then add the second fourth and sixth numbers together and multiply that by two add those sums together to get 44 in the last digit of the total which is 4 should match the seventh or last digit of the DEA number which it does if you do the same for option b we see that they don't match so option b is not a valid DEA number because the second letter of a provider's DEA is the first letter of their last name you can use that to identify who wrote a prescription if there are multiple prescribers on a Prescription Pad but it is not clearly labeled NPI numbers also have an algorithm that is much more complex than the method used to check a DEA number pharmacy software will oftentimes validate license numbers for you how often does the DEA require control drug inventory the DEA requires controlled drug inventory every two years which law created the DEA to regulate the distribution of controlled substances the comprehensive drug abuse prevention and Control Act of 1970 led to the establishment of the DEA in 1973 to serve as the primary agent responsible for the enforcement of federal drug laws with respect to pharmaceutical Controlled Substances the dea's responsibility is twofold to prevent diversion and misuse while ensuring an adequate and uninterrupted supplies available to meet the country's legitimate medical scientific and research needs which Daw or dispenses written code means that no product selection is indicated and substitution is allowed here's a reference table for the dot codes in practice you'll see Daw 0 for most prescriptions meaning that no product selection is indicated or substitution is allowed so this means that the pharmacy software will default to the pharmacy's preferred cheapest option usually generic if available daw9 is often used to substitute the generic for bran due to the formulary preference of a patient's insurance prescriber can really only indicate a Daw of zero or one on a prescription all the other dos selections are used by the pharmacy for billing insurance and getting a proper paid claim which committee approves patient consent forms and protects the welfare of drug research volunteers irbs are panels of scientists and non-scientists in hospitals and research institutions who ensure the safety and well-being of human subjects involved in research in 1981 formal standards for the protection of human subjects in the institutional review boards were strengthened the standards clarified FDA requirements for informed consent and provided protection of the rights and Welfare of human subjects involved in research within the fda's jurisdiction additionally drug sponsors must show the FDA results of pre-clinical testing they've done in laboratory animals what they propose to do for human testing before they can begin this information is presented in an investigational new drug application or IMD clinical trials which are drug studies in humans can begin only after an IND is reviewed by the FDA and an IRB a pharmacist has a blank for the proper dispensing of Controlled Substances a pharmacist must ensure that all prescriptions are issued for a legitimate medical Purpose By provider acting in the usual course of their professional practice the responsibility of the proper prescribing and dispensing of a controlled substance is upon the prescribing practitioner but a corresponding responsibility rests with the pharmacist who fills the prescription the standard of care requires a pharmacist to use professional judgment that entails more than filling a prescription a pharmacist must evaluate the patient prescriber and medication therapy I would argue that most disciplinary action taken by the boards of Pharmacy occurs due to a failure of exercising corresponding responsibility permitting prescriptions for Controlled Substances under suspicious circumstances without making an inquiry is an extreme departure from standard of care unprofessional conduct and negligence these pharmacists knowingly ignored red flags indicating that illegitimacy of prescriptions we'll look at some of these red flags eggs in a later question the ismp is responsible for all of the following lists except ismp is the institute for safe medication practices dedicated to error prevention strategies through research education and advocacy they published guidelines research findings and various lists in support of patient safety ismp shares error reports with the FDA in product manufacturers which have resulted in changes in U.S drug product labeling and packaging FDA regulations and guidance official joint commission and USP standards and practice modifications some examples include the federal requirement for potassium chloride for injection to have black caps and the removal of ratio Expressions on labels of epinephrine and several other medications the ismp is responsible for all of these lists except for the beers list the American geriatric Society sponsors the beers list as a guideline for potentially inappropriate medication use in older adults the beers list includes drugs that are best avoided in older adults or those that should be prescribed at reduced dosage or with caution and carefully monitored these drugs used in older adults have been found to be associated with poor health outcomes including confusion Falls and increased mortality which of the following abbreviations match up correctly the acpe is an accreditation agency recognized by the U.S Department of Education that accredits schools offering pharmd degrees apha is the first established professional Society for pharmacist in the U.S their mission is to equip members for their role as the medication experts in team-based patient-centered care USP is the official public standard setting Authority for all prescriptions OTC medicines and other health care products manufactured or sold in the U.S they create standards for the quality Purity strength and consistency of these products enhancing regulatory predictability nabp works with the state boards of Pharmacy to create uniform education and licensure standards their vision is innovating and collaborating today for a safer Public Health tomorrow ncpa represents the professional and proprietary interest of Independent Community pharmacists which pregnancy category can cause the most harm here's a table summarizing the pregnancy risk categories drugs labeled with an ex-pregnancy category would likely cause the most harm to the user and the fetus although the long-standing FDA pregnancy risk categories provide a guideline for the relative safety of a drug for use in pregnancy the system is oversimplified doesn't clearly distinguish the risk obtained through animal and human studies and unjustly groups drugs in the same category even though they may not share the same risk because of this it is often hard for a practitioner to use these risk categories to decide whether the therapeutic benefit of a drug for the mother outweighs the potential adverse effects on fetal development furthermore a lack of adequate studies and conclusive data has resulted in ambiguity surrounding categories b c and d so in 2015 the FDA replaced the overly simplistic pregnancy risk categories with a new system called the pregnancy and lactation labeling rule this new system would minimize misinformation and better assist practitioners and patients in making evidence-based decisions with the new overhaul pregnancy letter categories are being phased out and replaced with three detailed subsections including pregnancy lactation and females and males of reproductive potential which of the following drugs is not associated with a Rems program metformin is not associated with the Rems program Rems is short for risk evaluation and mitigation strategies it's a drug safety program that the FDA requires for certain medications with serious safety concerns to help ensure that the benefits of the medication outweigh the risk patients receiving these medications require special monitoring such as monthly lab tests unplanned pregnancies in females of child-bearing potential that use isotretinoin commonly known as Accutane may result in fetal injury isotret known along with many of the drugs requiring are Rems are teratogenic meaning that they can disrupt the development of an embryo or fetus for isotrach Nolan and RMA a risk management authorization number must be acquired through ipledge using the associated Rems ID prior to dispensing a do not dispense date is also required that reflects the last office visit or negative pregnancy test date which law emittered a crime to tamper with packaged consumer products after seven people in Chicago died from adjusting Tylenol capsules laced with cyanide the federal anti-tamporing Act was passed in 1983 making it a crime to tamper with packaged consumer products following the incident the FDA adopted regulations modifying package requirements for OTC medications by creating standards for tamper evident packaging a tamper resistant package has one or more indicators or barriers to entry that if breached or missing can reasonably be expected to give consumers visible evidence that tampering has occurred contemporary standards for this packaging includes a foil seal under the bottle lid a plastic sealant closing the lid and flaps of the outer box that are glued shut ing to federal law how long does a pharmacy have to fill the remaining portion of partial fill for a C2 medication in 2016 the comprehensive addiction and Recovery Act or Cara was passed amending the controlled substance act here's the relevant portion taken from the 2022 edition of the DEA pharmacist manual prior to the Cara there had been a long-standing DEA rule that allowed for the partial filling of a schedule 2 substance within 72 hours if the pharmacy was unable to supply the full quantity in response to the opioid epidemic Carl was passed which now allowed pharmacies to provide partial fills of a C2 medication up to 30 days after the run date of the prescription upon request of the prescriber or patient partial fills within a 30-day time frame enables a patient to request only a few days supply of their prescription leaving them the option to return for the remainder if they still require additional treatment unused prescription drugs left in the medicine cabinet can be easily misused and abused by the patient or diverted by family or friends the new proceedings for the partial filling of a C2 has muddled the waters and Pharmacy practice because it wasn't until recently that the DEA has updated its regulations to reflect this guidance handed down by legislature as a result many state Pharmacy boards have not yet followed suit in ance with the new 30-day partial filling rule the Cara also encourages pharmacists to implement strategies to dispense the opioid overdose reversal drug naloxone or Narcan pursuant to a standing order with the passage of the Cara if a prescriber writes a prescription for a 30-day Supply an opioid naive patient can pick up the initial 7-Day Supply limited by most insurance plans in state law then return for the remainder within the 30-day time frame if additional pain treatment is warranted previously the remainder of the script was void after the first fill for seven days and the provider would have to supply an new prescription in practice this amendment also makes insurance billing easier for certain medications for instance Medicaid limits patients to a two-week trial Supply on schedule 2 stimulant medications when they are new to therapy so if the provider wrote the script for a month's Supply a patient could return in two weeks for the remainder of the same prescription granted State and Company law permits which law created two classes of medications prescription and non-prescription the Durham Humphrey amendment of 1951 divided drugs into either prescription or non-prescription which law prioritized the FDA review process for shortage drugs included PPE in the Strategic National stockpile and significantly funded Public Health efforts the coronavirus Aid relief and Economic Securities or cares Act of 2020 is a 2.2 trillion dollar economic stimulus bill that was signed into law March of 2020 in response to the economic Fallout of covid of that 2.2 trillion 150 billion was allocated towards the Strategic National stockpile and public health efforts that included adding PPE diagnostic tests vaccines and other biologic products it also required Medicare and health insurance to cover covid-19 testing and vaccines and funded for the expedited research and manufacturing of therapeutic countermeasures which of the following is not a characteristic of an illegitimate prescription a prescription missing a diagnosis code is not a red flag characteristic of an illegitimate prescription here's a list of some possible red flags one might encounter when receiving a prescription that was not issued for a legitimate medical purpose and here's an example of a prescription a patient walks into your Pharmacy and hands you a written prescription that doesn't look like chicken scratch the prescription is for oxycontin 80 milligrams number 120 Xanax 2 milligrams number 90 and Promethazine with Codeine one pint the patient has no fill history provides an address 100 miles away from the pharmacy and 200 miles from the provider's office the patient insists on paying out of pocket would you fill this prescription pharmacies must register every blank years with the DEA using DEA form blank pharmacies must register every three years using DEA form 224 registering with the DEA gives the pharmacy the authority to order dispense and distribute controlled substances how many times can a prescription for Ativan be transferred between different pharmacies Ativan brand name for Lorazepam is a schedule 4 controlled substance a schedule 3 4 5 prescription can only be transferred on a one-time basis between different pharmacies pharmacies sharing a real-time database such as two stores within the same chain like two CVS stores can transfer C3 through C5 drug as many times as refills allow state law may be more strict for example in the state of New York the transfer of any controlled substance is prohibited regardless of the schedule which of the following are air prevention strategies select all that apply medication errors are a leading cause of mortality in the United States dispensing errors account for about 21 percent of all medication errors amcr methods that should be used to prevent errors Tallman lettering refers to capitalizing parts of a drug name to bring attention to the difference between sound alike look-alike drugs such an example would be hydroxyzine and hydralazine trailing zero should not be used because decimal points can be easily missed and a 2.0 might be mistaken as a 20. however leading zeros are encouraged for example 0.2 might be mistaken as two so leading zero is used to make the decimal point clear scanning barcodes is universal in any industry to ensure correct product ID using abbreviations might save time but could result in errors during transcription or data entry and multitasking is a good way to increase the amount of mistakes you make which laws amended the CSA with respect to the use of controlled substances in the medical treatment of opioid addiction select all that apply the narcotic addiction treatment Act of 1974 amended the CSA to provide for the registration of practitioners conducting narcotic treatment programs in 2000 the drug addiction treatment act permitted Physicians who met certain qualifications to treat opioid dependency with buprenorphine and treatment settings other than opioid treatment programs this expanded the ability of Physicians to combat the opioid epidemic giving them an easier process to help patients compared to the traditional methadone treatment that can only be administered at a narcotic treatment facility the car of 2016 raised the total number of patients a prescriber can have for the purposes of dispensing buprenorphine from 30 to 100 patients per year under certain conditions and restrictions after one year at the 100 patient limit qualifying practitioners who meet criteria can apply to increase their patient limit to 275. the support for substance use disorder prevention that promotes opioid recovery and treatment for patients in communities Act of 2018 is a mouthful and expanded the use of medication assisted treatment programs to additional practitioners such as MPS and PAs in various settings which of the following drugs are scheduled for select all that apply Lorazepam Zolpidem and tramadol are scheduled for substances lamotil and vimpat are schedule 5 substances which of the following responsibilities can a pharmacy technician perform a pharmacy technician is allowed to process insurance claims all other options are responsibilities of a pharmacist or intern which of the following abbreviations is not on the ismp do not use lists the idea is not on the ismp do not use list all other choices are listed under the list of error-prone abbreviations symbols and dose designations Au and OD might be confused for any of these other abbreviations if the handwriting is not legible magnesium sulfate might be confused with morphine sulfate and HS which is a common abbreviation for bedtime might be confused for half strength QD is a common abbreviation used in the community setting but is prohibited in the hospital setting by The Joint Commission the idea is okay though which of the following examples are Lassa drugs select all that apply all of these drug pairs are considered lookalike sound like drugs tall man lettering draws attention to the dissimilarities between similar drug names using bolded uppercase letters as shown here unfortunately tall man lettering cannot be used when receiving or giving verbal orders recently a provider was calling in an order for triazolam and I heard Alprazolam I repeated the order back saying Xanax and they corrected me good practice is to always read back any verbal order and here's a fun fact about look-alike sound like drugs Prilosec the brand name for Omeprazole was previously lowsec which was a play on word short for lower secretions but there were too many medication errors documented confusing lossec with Lasix or furosemide so they changed the brand name lossec to Prilosec which of the following entities have prescribing Authority select all that apply all of these professions have prescribing Authority pharmacists are also gaining momentum in their scope of practice and have limited prescribing Authority in some states and institutions the classification of drugs into controlled substance schedules is based upon the drugs potential for abuse and dependence which law encourages drug companies to develop drugs for rare diseases the orphan Drug Act of 1983 was passed to encourage of the development of Orphan drugs orphan drugs are drugs used to treat rare diseases such as Huntington's disease and Tourette Syndrome which affect a small number of people in the U.S pharmaceutical companies didn't see it worthwhile or profitable to pursue the time and research to investigate rare disease States so the government provided tax benefits patent protection marketing exclusivity and other incentives [Music] which of the following elements is required on a prescription for buprenorphine indicated for opioid use disorder buprenorphine is among the most effective treatment option for people with opioid use disorder practitioner wanting to prescribe buprenorphine for opioid use disorder or opioid dependency outside of a narcotic treatment facility must obtain an X waiver under the drug addiction treatment Act of 2000 the x-waver assigns providers with a narcotic addiction DEA number or Nadine sometimes called a unique identification number permitting them to prescribe buprenorphine for the treatment of opioid use disorder in the outpatient setting the Nadine replaces the first letter of a provider's DEA with an X previously practitioners required additional training and certification but as of April 2021 this barrier was lifted allowing eligible practitioners to treat up to 30 patients A Year Without receiving the long-time required training the restoring hope for mental health and well-being act 2022 awaiting Senate consideration would eliminate the need for clinicians to apply for an ex-waver from the Substance Abuse and Mental Health Services this movement to X the X waiver is an important step forward in reducing barriers to treatment and will help more people find recovery which of these drugs is a schedule to substance select all that apply schedule 2 substances are prescription drugs with the most potential for misuse and abuse all of these drugs are scheduled to substances OTC drugs are regulated by what organization OTC drugs are regulated by Cedar the center for drug evaluation and research a branch under the FDA they also monitor items not typically thought of as drugs such as toothpaste antiperspirants dandruff shampoos and sunscreens OTC drug advertising is regulated by the Federal Trade Commission or FTC which of these programs monitors the dispensing of scheduled drugs pdmp is the prescription drug monitoring program that monitors dispense controlled substances the goal of pdmp is to assist medical pharmacy and public health professionals in the identification and prevention of prescription drug abuse pdmp can be used by pharmacists to Aid in determining whether patients are utilizing their Controlled Substances safely and appropriately ensuring they are not obtaining care from multiple prescribers frequenting multiple pharmacies obtaining early refills traveling far distances to prescribers or pharmacies consistently paying cash or attempting to fill high doses of opioids or benzos when they are naive to either medication one can a facsimile serve as the original prescription for a schedule 2 substance select all that apply the DEA has granted three exceptions for one effect similar effects copy of a prescription for a schedule 2 substance may serve as an original prescription the first exception is when a practitioner prescribes a drug that is to be compounded for direct Administration to a patient by parenteral intravenous intramuscular subcutaneous or intraspinal infusion the second exception is prescribing for residents of a long-term care facility a ltcf is defined in the code of federal regulations as a nursing home retirement Care Mental care or other facility or institution which provides extended Health Care to resident patients the third exception is prescribing for a patient enrolled in a Hospice Care Program certified and or paid for by Medicare under Title 18 or a hospice program which is licensed by the state in each case the facsimile prescription serves as the original written prescription and no further documentation is required ing to federal law how long is a prescription for a schedule 2 substance valid for under federal law a prescription for a schedule 2 substance has no expiration date however state law May place an expiration ranging anywhere from 30 days to one year a pharmacist must use their professional judgment to decide whether the prescription is still being used for a legitimate medical purpose would a reasonable pharmacist fill a prescription indicated for acute pain eight months after the prescription was issued ing to federal law how long is a prescription for a non-controlled substance valid for federal law places no expiration date on prescription for a non-controlled substance meaning a pharmacist can legally dispense a prescription that was written a decade ago however many states corporations and insurance companies have adopted their own limitations Most states mandate that a non-controlled prescription cannot be filled after one year from the data was issued as of January 2020 these six states allow for a prescription duration longer than one year other States including California and New York still have no defined expiration limit which law required pharmacists to engage in durs counseling and record-keeping of patients over 90 placed expectations on the pharmacist in terms of prospective drug utilization review requirements counseling obligations and record-keeping mandates as part of the pro dor a pharmacist must screen for the following elements before dispensing a patient's medications in regard to Patient counseling a pharmacist may discuss any of the following if necessary and a pharmacist must make reasonable efforts to obtain record and maintain certain info as shown here while Oprah 90 was originally geared to ensure that Medicaid patients receive specific pharmaceutical care the overall result of the legislation provided the same type of care be rendered to all patients how long after receiving an oral order for a schedule 2 substance must a written copy be obtained provider can call in a prescription for a schedule 2 substance in an emergency situation under DEA regulations an emergency situation in this context means that the prescribing practitioner has determined that immediate administration of the drug is necessary for proper treatment of the intended user that no appropriate alternative treatment is available including a drug which is not a schedule to controlled substance and it is not reasonably possible for the prescribing practitioner to provide a written prescription for the drug at that time a pharmacist has a corresponding responsibility to determine whether the circumstances warrant an emergency situation the quantity prescribed and dispensed is limited to the amount adequate to treat the patient during the emergency period within seven days after authorizing an emergency oral prescription the prescribing practitioner must furnish the pharmacist with a written signed prescription for the Emergency quantity of the controlled substance prescribed the prescription must have written on its face authorization for emergency dispensing and the date of the oral hoarder upon receipt the dispensing pharmacist must attach this written prescription to the rural emergency prescription which had earlier been reduced to writing by the pharmacist for electronic prescriptions the pharmacist must annotate the record of electronic prescription with the original authorization date of the oral order ultimately the liability falls on the prescriber to produce the written or electronic prescription in light of the recent public health emergency the DEA has extended the duration to 15 days and allows for the practitioner to send a fax or even a photo of the paper prescription in place of a written or electronic version partially filled schedule 2 prescriptions for patients and on the ltcf or eternally ill patients are valid for how long they are valid for a period not to exceed 60 days from the issue date unless sooner terminated by the discontinuance of medication the pharmacist must record on the prescription whether the patient is terminally ill or a ltcf patient a schedule 2 prescription that is partially filled and does not contain either notation is a violation of the controlled substance Act keep in mind that the pharmacist has a corresponding responsibility to assure that a controlled substance is being dispensed in line with the code of federal regulations that's all for this video thank you guys for watching make sure to check out the spicy Link in the description for a list of the landmark Pharmacy laws and other helpful Pharmacy info if you enjoyed the video don't forget to leave me a thumbs up subscribe if you haven't already check out my other content and I'll see you in the next one [Music]