Pharmacy Jurisprudence and Ethics
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<p>Jurisprudence and Ethics</p> <p> Pharmacy Jurisprudence and Ethics1</p> <p>1Disclaimer I am speaking today in my individual capacity and not as an employee of any college or organization. The information printed here should not be construed as an official explanation or interpretation22ObjectivesTo understand why technicians need to know, and understand the legislation and ethics.To outline what laws; Federal & Provincial and ACP Standards are importantTo show where to find the informationTo identify who needs to know jurisprudence and ethics</p> <p>3</p> <p>It is impossible to condense all the information on jurisprudence that you will need to know into a 1 hour session. So, I hope to answer some of your questions and also give you some direction on why, what, where and who.-Why do you need to understand legislation and ethics?-What legislation is important in pharmacy practice?-Where are you going to find the information?-Who needs to write the jurisprudence and ethics exams?3Why?4</p> <p>Why do we have legislation? Why is it important to us and how does it affect us? We have legislation in place to ensure our freedom, liberties and quality of life. We need laws to guide our behaviour and to protect our own rights and those of others. Everyone is subject to the law, regardless of status.4Why?5</p> <p>Why do we have pharmacy legislation?</p> <p>Pharmacy legislation and regulation ensures patient/client safety, quality pharmacy practice, and appropriate control of drug distribution. As regulated health care professionals we have personal, ethical and legal responsibilities in our day to day practice. It is important to know and understand the legislation so that we can practice within the law and in a safe and effective manner.5What?6What is legislation? Legislation consists of Acts, Regulations and Schedules. Acts are laws or statutes passed by parliament. For example, the Federal Food and Drug act or the Provincial Health Professions Act. It can take a long time to amend these acts because of our parliamentary process. At this time the Health Professions Act is in the process of being amended to include pharmacy technicians as regulated health care professionals. We will see how long this takes.</p> <p>Regulations to an act provide the interpretations of the procedures to be followed in carrying out the provisions of an act. Regulations are usually written in less formal language and can be amended by a committee of cabinet. This provides a more rapid means of updating legislation.For example in the pharmacy and drug act under Issuance of licenses the applicant is a clinical pharmacist and meets the licensing requirements. Under the regulation Application for license they require the name of the clinical pharmacist, the category of license applied for, telelphone# and business address etc. So you can see that the regulations have a lot more detail. Schedules of an act or regulation are detailed lists of specific items. For example in pharmacy we have lists of prescription drugs which include Schedule F, controlled drugs or narcotic drugs. They are all in different schedules under the acts and regulations.6Pharmacy Legislative Framework7The pharmacy legislative framework consists of federal legislation, provincial legislation and the Alberta College of Pharmacists Standards of Practice and Code of EthicsThese Various pieces of legislation govern pharmacy practice in Alberta. First, there is Federal legislation which governs practice all across Canada . In Canada, health care is under the jurisdiction of each province. Therefore, each province must have its own legislation to govern the practice of pharmacy. Provincial legislation can have more restrictions than Federal legislation but not less. In Canada the profession of pharmacy is self-regulated. In Alberta, this authority is given to the Alberta College of Pharmacists. This will be your regulatory body as well and we will see many changes to legislation, regulation and the Standards of practice to reflect the inclusion of certified technicians as health care professionals in Alberta. </p> <p>7Federal Legislation8Food and Drug ActFood and Drug RegulationsSchedule F-Part I & IIControlled Drugs and Substances Act (CDSA)Narcotic Control RegulationsSchedule G RegulationsPrecursor Control RegulationsBenzodiazepines and other targeted substances regulations</p> <p>The Federal Legislation that you need to be aware of includes: the Food and Drug Act and the Food and Drug Regulations. The Controlled Drugs and Substances Act, the Narcotic Control and Schedule G regulations, Precursor Control and the Benzodiazepines and other targeted substances regulations. You will also need to know the schedules (that is the detailed List of drugs) related to each of these acts and regulations.</p> <p> Schedule F drugs part I and II are listed under the regulations to the Food and Drug Act. Drugs in part I always require a prescription and those in part II only require a prescription if they are for human use. Those in part II can be dispensed without a prescription if they are labelled for veterinary use only or if they are in a form unsuitable for human use. Most drugs that require a prescription are in Schedule F. These drugs will have the Pr symbol on their label.</p> <p>Controlled Drugs used to be included in the Food and Drug Act under Schedule G of the regulations and Narcotics were regulated under the Narcotic control Act. The Narcotic control Act and Schedule G of the Food and Drug Act have been repealed and replaced with the CDSA. I mention this because, although the Acts have been repealed the new regulations are not in place so we are currently following the regulations to Schedule G and the Narcotic Control Act.</p> <p>Benzodiazepines and other targeted substances are also regulated under the CDSA. When I first graduated benzodiazepines were included in the Food and Drug Regulations. Once their abuse potential became apparent they were rescheduled into the CDSA.</p> <p>The CDSA includes Precursor Control Regulations. These regulations were developed to help prevent the drug diversion of legal drugs into substances that are misused or abused. For example: ephedrine and Pseudoephedrine are precursor drugs that can be converted into methamphetamine. Now we have to keep single entity pseudoephedrine in the pharmacy.8Prescription RequirementsCategoryNarcotics, Narcotic preparations, Controlled Drugs or preparations, benzodiazepines & Schedule FPrescription TransmissionWritten or VerbalRefillsPermitted or NotIs an time interval requiredPart fills (Narcotics)TransfersFilingOrdersElectronically, Written, Faxed or Verbally over the phoneDocumentationRecording receipt or sale</p> <p>9The different categories of drugs: narcotics, narcotic preparations, controlled drugs or preparations, benzodiazepines and Schedule F each have different prescription requirements. Does the prescription need to be written or can it be taken verbally over the phone? Are refills permitted or not? Is a time interval required?In the case of narcotics, refills are not allowed but part fills are if the Dr writes a total quantity with a certain amount to be dispensed at an indicated interval for example 200 tablets of Tylenol #3 dispense 50 at 30 day intervalsTransfers- Is the prescription allowed to be transferred. Narcotic and controlled drugs can not be transferred. Benzodiazepines can only be transferred once. Schedule F drugs are not limited in the amount of transfers.</p> <p>Where is the prescription to be filed. Narcotics and controlled drugs need to be filed separately from Schedule F drugs. Benzodiazepines can be filed with the regular prescriptions.</p> <p>When ordering drugs from the wholesale, do the orders have to be sent electronically or can they be faxed or phoned in?</p> <p>Finally, which drugs do we need to record the receipt and sale of?</p> <p>You will need to know these requirements for each category of drugs.910</p> <p>This is a screen shot of the Alberta College of pharmacists prescription regulations. This 1st page includes the list of drugs that require a triplicate prescription.1011</p> <p>The 2nd page is The Alberta College of Pharmacists Prescription Regulations Chart. It is a condensed version of the federal regulations concerning Schedule F, G and narcotic drugs. It is a handy reference guide describing each class of drugs and detailing the requirements for each category. I have included this chart in your hand out. This is a very brief overview of the Federal Acts, Regulations and Schedules. You will find it on the ACP website under info sheets and posters.11Provincial Legislation The Health Professions ActPharmacists Profession Regulation</p> <p>The Pharmacy and Drug ActPharmacy and Drug Regulation</p> <p>12In Alberta we have The Health Professions Act and the Pharmacists Profession Regulation that relate to the professional aspects of pharmacy practice</p> <p>And The Pharmacy and Drug Act and the Pharmacy and Drug Regulation which relate to the operational aspects of the pharmacy</p> <p>12Provincial LegislationHealth Profession ActSelf regulationRestricted activitiesTransparency to the publicMandatory registrationContinuing competenceDisciplinary processPharmacists Profession Regulation13All self regulating health professions are governed under the Health Professions Act, not just pharmacists. The purpose of this act is to protect the public by regulating health care professionals. It ensures that a complaint process is available to the public and identifies high-risk activities that must be restricted to specific personnel. The Act ensures that professionals have educational & competency standards. There is also a disciplinary process.</p> <p>The Pharmacists Profession Regulation is specific to pharmacy and governs pharmacist practice with respect to the health professions act. It specifies the restricted activities of pharmacists, student pharmacists, pharmacy technicians and pharmacy employees, For example it identifies which activities can be performed by certified technicians under either the direct or indirect supervision of the pharmacist.</p> <p> Compounding and the filling and checking of blister packs can be performed under indirect supervision. This regulation is intended to protect the public by ensuring competent, ethical & professional practice in the pharmacy setting.</p> <p>13Provincial LegislationThe Pharmacy and Drug ActPharmacy and Drug Regulations14This act and the regulations are concerned more with the operational aspects of a pharmacy. For example: the licensing of pharmacies. There are 4 different categories of pharmacy licenses: Community pharmacy license, compounding and repackaging license, mail order pharmacy license and a satellite pharmacy license.A clinical pharmacist who is registered with the ACP must be the holder of the license (the licensee). The owner does not have to be a pharmacist, but the licensee does. It requires that pharmacies meet certain specifications with regard to infrastructure, qualified staff, the facility, equipment and policies and procedures. . Protection of the public and discipline is included in this act. The ACP conducts random inspections and assessments and also investigates complaints. These inspections are performed to ensure compliance with the regulations and our own professional Standards of Practice. If infringements are detected the matter can be investigated and brought before an investigating committee, Disciplinary measures can be taken, depending on the infringement.</p> <p> The Alberta Drug Schedules are found in this Act.</p> <p>The regulations give more details on operating procedures for example: lock and leave, hours of operation, specialized pharmacy service, information to be posted in the pharmacy and general prescription requirements. Prescription can only be dispensed within 12 months of being written. Also, in Alberta refills of prescriptions can only be dispensed for 18 months from the original fill date, no matter how many refills are remaining. Faxed prescriptions are acceptable but electronic versions are not acceptable at this time. General prescription requirements are outlined: The requirements on the doctor's prescription, the information that needs to be found on the hard copy from the filled prescription (always attached to the Rx) and the prescription label requirements.For more complete information you will need to look at the regulations and the standards of practice. 14Alberta Drug SchedulingSchedule 1Prescription required, includes all federally scheduled drugs and those specific to AlbertaSchedule 2No prescription required, no public access, information must be recordedSchedule 3No prescription, self-selection, only sold in pharmacy, lock and leaveUnscheduledNo prescription required, not restricted to pharmacies</p> <p>15In Alberta all vaccines require a prescription except the influenza vaccine</p> <p>Schedule 2 drug examples-Gravol, Tylenol #1, Muro 128, iron products containing 30 mg or more of elemental iron</p> <p>Schedule 3 hydrocortisone 0.5%, Nystatin topical, Canesten vag </p> <p> 15Triplicate ProgramA provincial program established to reduce the misuse of certain prescription drugsPrescriptions for these drugs can not be written on a regular prescription pad, only on a triplicate prescriptionMust be taken to a pharmacy with 72 hours16-usually narcotics</p> <p>This is a 3 part prescription where the 1st part is kept by the dr. The pharmacy will receive 2 copies and once the pharmacists portion is filled out, one copy will be sent to the College of Physician and Surgeons and the other will be kept on file.You will find the list of drugs that require a triplicate on the 1st page of the ACPs prescription regulations. The current list can also be found on the College of Physician and Surgeons website.16Regulatory Bodies and Organizations (ACP)Standards for Pharmacist PracticeStandards for Operating Licensed PharmaciesCode of Ethics17The Alberta College of Pharmacists (ACP) is responsible for quality pharmacist practice in Alberta. Major activities include ensuring that only qualified pharmacists are licensed in the province, and that Alberta pharmacists maintain their knowledge and skills. It also ensures that pharmacies provide a practice environment that supports quality practice and the safety of their clients by developing the Standards for Pharmacist practice, the Standards for Operating licensed pharmacies and the Code of Ethics. These are also components of the Pharmacy Legislative Framework.</p> <p>17Standards for Pharmacist Practice18These Standards are mandatory and set out the minimum standards for pharmacist practice. The Standards for Pharmacist Practice are legally required under the Health Professions Act. The standards have a basic statement followed by detailed rules on how to meet the expectations. The purpose of the Standards of Practice is to provide detailed expectations of the practice of pharmacy and to protect the public. They provide a reference against which perfor...</p>
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