Legal Aspects of Pharmacology PDF

Welcome To Basic principles of pharmacology YFRM202 1  Welcome to this topic Legal aspects of pharmacology in South Africa YFRM202 2  Lecture Overview In this lecture you can expect to learn about the...

Welcome To Basic principles of pharmacology YFRM202 1  Welcome to this topic Legal aspects of pharmacology in South Africa YFRM202 2  Lecture Overview In this lecture you can expect to learn about the legal aspects of pharmacology. You have previously learned about drug development and registration with the South African Health Products Regulatory Authority (SAHPRA). In this lecture you will build upon that knowledge and further explore the Medicines Act and legal prescribing practices in South Africa. Throughout this lecture it will become clear that the schedule of a medicine dictates where it can be sold and who is allowed to prescribe and dispense it. 3  Learning Outcomes At the end of this lecture, you should be able to:  Indicate the main legal acts with regards to drugs and medication in South Africa  Describe the role and functions of SAHPRA  Explain how drugs are classified into schedules and give examples  Describe what is meant by a prescription drug  Explain the requirements that must be met in order to issue a prescription in SA  Describe and decipher the various abbreviations used in prescribing medications 4 SAHPRA The South African Health Products Regulatory Authority (SAHPRA) used to be known as the Medicines Control Council (MCC) prior to 2017 SAHPRA regulates (monitors, evaluates, investigates, inspects and registers) all health products This includes clinical trials, complementary medicines, medical devices and in vitro diagnostics SAHPRA’s mandate is outlined in the Medicines and Related Substances Act (Act No 101 of 1965 as amended) as well as the Hazardous Substances Act (Act No 15 of 1973) No medicine may be sold in South Africa without it being registered with SAHPRA 5 Scheduling of medicines Schedule 0, 1, 2, 3, 4, 5, 6 YFRM202 6  Medicine schedules Medicine schedules make up the classification system used to define a medication’s level of risks and benefits. As the possible risks increase, so does the schedule of that medicine The schedule under which a certain drug is classified is affected by: The medicine’s safety and toxicity The indication for the medicine The need for professional diagnosis and management of the condition for which the medicine is used The potential for dependency or abuse https://www.alliancemidmed.co.za/assets/documents/helpfulinfo/themeaninbehindme dicineschedules.pdf 7  Medicine schedules Certain drugs are classified in more than one schedule For example: Acyclovir Acyclovir is an antiviral drug When included in a cream formulation for the treatment of cold sores, it is classified as Schedule 2 When formulated as a tablet for systemic treatment of viral infections, it is classified as Schedule 4 https://www.alliancemidmed.co.za/assets/documents/helpfulinfo/themeaninbehindme dicineschedules.pdf 8 Scheduling of medicines MEDICINE WHERE AND HOW IT MAY BE EXAMPLE SCHEDULE MADE AVAILABLE Simple analgesics In general stores or pharmacies Schedule 0 E.g. Aspirin, without a prescription Paracetamol Certain antibacterial Over the counter at a pharmacy. No Schedule 1 and antifungal skin prescription needed. creams Over the counter at a pharmacy. No Various cold and flu Schedule 2 prescription needed. preparations 9  Medicine schedules According to the Medicines and Related Substances Act, from Schedule 1 must be sold by a registered pharmacy personnel member in a pharmacy, which is why it will all be kept behind the counter. This will include basically all cold and flu preparations and NSAIDs. The duration of treatment may also determines whether a drug is S2 or S3 – see notes. https://jutapharmapedia.co.za/files/media/10742/48f3519a-5c6c-b848-f9ad- 9c0650364df2.pdf Note:- The pharmacist or the pharmacists assistant is limited with regards to the number of “over the counter” Schedule 1 and2 tablets they dispense e.g. Diclofenac –dispenses max of 9 tablets at a time : Omez – max of 14 tablets etc. Certain drugs can fall into different schedules, depending on the dosage form and quantity e.g. acyclovir cream being S2 but the tablets being S4. For NSAIDs a max of a 3 day course can be sold over the counter as S2, but if they need to be taken for longer , then they becomes a S3 drug which requires a prescription. PPIs like omeprazole are also S2 when given for max 14 days (ie. 14 tablets), but again of required for longer will require a prescription. 10 Scheduling of medicines MEDICINE WHERE AND HOW IT MAY EXAMPLE SCHEDULE BE MADE AVAILABLE Medication for chronic In pharmacy dispensary on conditions (E.g. blood Schedule 3 prescription only pressure, diabetes) ; Longer term use of NSAIs , PPIs etc In pharmacy dispensary on Antimicrobials such as Schedule 4 prescription only antibacterials and antifungals Psycho-active drugs (E.g. In pharmacy dispensary on Schedule 5 antidepressants, sedatives, prescription only antipsychotics) 11 Scheduling of medicines MEDICINE WHERE AND HOW IT MAY EXAMPLE SCHEDULE BE MADE AVAILABLE In pharmacy dispensary on Narcotic analgesics (E.g. Schedule 6 prescription only for max 30 morphine), stimulants such as day supply methylphenidate (Ritalin®) Prohibited items that are only Schedule 7 used in scientific studies, due Heroin to their high abuse potential May only be obtained with a Amphetamine, Schedule 8 permit from the Director- dexamphetamine and General nabilone 12 Prescription writing xxx YFRM202 13  Prescriptions A prescription is an order from an authorised prescriber for a drug to be dispensed to the patient Image source: https://www.neurologyindia.com/viewimage.asp?img=ni_2016_64_5_1106_190248_f2. jpg 14  What must be on a prescription? Specified in Regulation 33 of the Medicines Act: A prescription can only be prepared by an authorised prescriber (e.g. medical practitioner) Must be written in legible print, hand or typewritten, or prepared electronically The prescription must be signed in person or with an advanced electronic signature The date of issue must be included on the prescription https://pharmaciae.org.za/keeping-up-to-date-with-legislation-2/ Image source: https://www.istockphoto.com/search/2/image?mediatype=illustration&phrase=compou nding+pharmacy 15  What about electronic prescriptions? Electronic prescriptions are permissible provided that the electronic prescription has an advanced electronic signature as per Section 13 of the Electronic Communications and Transactions Act, 2002. An advanced electronic signature is an electronic signature which results from a process which has been accredited i.e. it is a product/service offered by a service provider who has applied to and been approved by the.za Domain Name Authority/Accreditation Authority. https://pharmaciae.org.za/keeping-up-to-date-with-legislation-2/ Image source: https://www.processmaker.com/blog/how-an-electronic-signature- service-can-save-you-time-and-money/ 16  What must be on a prescription? Prescriber Details: Prescriber name Prescriber’s qualification Prescriber’s registration number with the relevant statutory health council e.g. MP123456 Physical address of prescriber https://pharmaciae.org.za/keeping-up-to-date-with-legislation-2/ Image source: https://www.processmaker.com/blog/how-an-electronic-signature- service-can-save-you-time-and-money/ 17  What must be on a prescription? Patient Details: Patient name Patient’s identification (ID) number Age and gender of the patient Address of the patient In the case of a neonate, the details of the parent/guardian For children, the body mass should be included (although not a legal requirement) https://pharmaciae.org.za/keeping-up-to-date-with-legislation-2/ Image source: https://www.processmaker.com/blog/how-an-electronic-signature- service-can-save-you-time-and-money/ 18  What must be on a prescription? Details about the medication prescribed: Generic name or trade name of the medication Best practice is to use the generic name (e.g. Paracetamol instead of Panado®) Medication dosage form (e.g. tablet) Medication strength (e.g. 500mg) Quantity of the medicine to supply – number of tablets/ capsules Instructions for the administration of the dosage and frequency of administration e.g. 2 tablets orally every 6 hours https://pharmaciae.org.za/keeping-up-to-date-with-legislation-2/ Image source: https://www.processmaker.com/blog/how-an-electronic-signature- service-can-save-you-time-and-money/ 19  How is a schedule 6 prescription different? Same particulars regarding: Prescriber details Patient details Medication details – must write out the quantity e.g. methylphenidate ten(10) milligrams(mgs) Dosing frequency must be clearly stated e.g. methylphenidate 10mg at 8 am (08H00) and 10 mg at 2pm(14H00) The quantity of medicine to be supplied must be indicated in figures and in words (e.g. thirty tablets (30)) The medication may be prescribed for a maximum of 30 days’ supply https://pharmaciae.org.za/keeping-up-to-date-with-legislation-2/ Image source: https://www.processmaker.com/blog/how-an-electronic-signature- service-can-save-you-time-and-money/ 20  How do repeat prescriptions work? Schedule 0-5: Prescriptions may be repeated up to a maximum of 6 months I.e. The original prescription + 5 repeats (6 months in total) If repeated 5 times, the prescription expires after 6 months E.g. If the patient only collected it twice in the 6 months, they can’t receive it after the 6 months as the prescription has expired Schedule 6: No repeat prescriptions are allowed Patient must obtain a new prescription every month https://pharmaciae.org.za/keeping-up-to-date-with-legislation-2/ Image source: https://www.processmaker.com/blog/how-an-electronic-signature- service-can-save-you-time-and-money/ 21 Abbreviations on prescriptions Historically many types of abbreviations have been used which original stemmed from the use of Latin terms for dispensing; these terms is still used in medical notes and prescription charts: Stat dose – means a single dose to be given immediately e.g. 10mg Adrenaline IV stat Mane – in the morning ; Nocte – in the evening – Now specify the time exactly Daily – abbreviated to dly ; /day ; d – now use the term daily and when e.g. 8 am , noon , 6pm , midnight Twice daily – bd ; bid – now use the term 12 hourly or 12 hrly Three times a day – tds ; tid – Now use the term 8 hourly or 8 hrly Four times a day – qid – Now use the term 6 hourly As required – prn – now write as required for….(pain / nausea) etc. 22 Abbreviations on prescriptions The following terms have and are still in use with regards to the modes of delivery or medication to patients Oral – per os or p.o. Intramuscular – IM or IMI Intravenous – IV or IVI Subcutaneous – Subcut or S.C. Rectal – per rectum or P.R. Vaginal – per vagina or P.V. Via Nasogastric tube – Vis N.G.T. or NG Tube For intravenous infusions – millimeters per hour e.g. 1000ml IVI 8 hrly or infusion rates e.g. 125ml/hr at 30drops/min for a 15 drops/ml IVI infusion set. 23  Checklist Can you...  Indicate the main legal acts with regards to drugs and medication in South Africa?  Describe the role and functions of SAHPRA?  Explain how drugs are classified into schedules and give examples?  Describe what is meant by a prescription drug?  Explain the requirements that must be met in order to issue a prescription in SA?  Describe and decipher the various abbreviations used in prescribing medications 24  References Republic of South Africa. 1965. Medicines and Related Substances Act 101 of 1965. Government Gazette 40869 dated 26 May, 2017. Available online: https://www.sahpra.org.za/wp-content/uploads/2019/09/Medicines-and- Related-Substances-Act_101-of-1965_Act_GG-40869_2017-05-26.pdf (Date accessed: 3 September 2024) SAHPRA. 2022. SAHPGL-CEM-NS-02: Guideline to the scheduling of substances and medicines. Available at: https://www.sahpra.org.za/wp-content/uploads/2022/05/SAHPGL-CEM-NS-02_v3-Guideline_Scheduling-of- Substances-and-Medicines.pdf (Date accessed: 3 September 2024) South African National Department of Health. 2021. Consolidated schedules 25 May 2021. Section 22A of the Medicines and Related substances Act (Act 101 or 1965). Available at: https://www.sahpra.org.za/wp- content/uploads/2021/06/Consolidated-schedules_25-May-2021.docx.pdf (Date accessed: 3 September 2024) South African National Department of Health. 2021. General regulations 25 May 2017. Section 35 of the Medicines and Related substances Act (Act 101 or 1965). Available at: https://www.sahpra.org.za/wp- content/uploads/2021/11/Medicines-Act-General-Regulations-2017.pdf (Date accessed: 3 September 2024) 25  Feedback Please be kind enough to take a minute and rate this lesson and provide a little feedback to help us gain a better understanding of your learning experience. Let us know what you really enjoyed and what we can do better for you. Click on the link at the bottom of the lesson page on I-learn to provide feedback for this lesson. +- (2mins) 26 27 28