GGuuiiddaannccee ffoorr CCllaassssiiffyyiinngg tthhee PPrreessccrriippttiioonn && DDiissttrriibbuuttiioonn SSttaattuuss ooff MMeeddiicciinnaall PPrroodduuccttss Version 1.0 Draft [Not for implementation and published for comment purposes] Date of publication 16/11/2017 1 Guidance for Classifying the Prescription & Distribution Status of Medicinal Products Version 1.0 Drug Sector Saudi Food & Drug Authority Please review and send your comments or suggestions within 90 days of publication to: [email protected] Please visit SFDA’s website at http://www.sfda.gov.sa/en/drug/drug_reg/Pages/default.aspx for the latest update 2 Drug Sector Vision and Mission Vision To be the leading regional Drug Regulatory Authority for pharmaceuticals and cosmetic products, with professional excellence and services that contribute to the protection and advancement of public health in the Kingdom of Saudi Arabia. الرؤية أن يكون قطاع ادلواء رائدًا اقلميي ًا يف الرقابة عىل ا لدوية ومس تحرضات التجميل، ويقدم خدماته مبهنية م متزية تسهم يف حامية وتعزيز الصحة يف اململكة العربية السعودية. Mission Protecting public health by ensuring safety, quality, efficacy and accessibility of human, veterinary drugs and biological products, and safety of cosmetics, through administration of a national regulatory system which is consistent with international best practice. Through our mission, we also provide accurate and scientific-based information to the public and healthcare professionals. الرساةل حامية الصحة العامة من خﻻل ضامن أمان وجودة وفعالية وتوفر ا لدوية البرشية والبيطرية واملنتجات احليوية وسﻻمة مواد التجميل عرب تطبيق نظام وطين للرقابة متوافق مع أفضل املامرسات ادلولية وتقدمي املعلومات ادلوائية املبن ية عىل أسس علمية للعامة واملهنيني الصحيني. 3 Document Control Version Date Department Comments 1.0 16/11/2017 National Drug and Poison Draft for comments Information Center 4 Contents Introduction: .................................................................................................................................... 6 Scope: .............................................................................................................................................. 6 Definitions: ...................................................................................................................................... 6 Part I: Criteria and Requirements for Classifying the prescription Status of Medicinal Products .. 7 1. Criteria for classification as Prescription Only Medicinal Product (POM) ......................... 7 2. Criteria for Classification as Over-The-Counter (OTC) Product: ..................................... 10 3. Requirements: .................................................................................................................... 12 PART II: Criteria for Classifying the Distribution Status of Medicinal Products ......................... 13 References: .................................................................................................................................... 16 5 Introduction: This guidance addresses the criteria to be followed by SFDA when determining the prescription and distribution status of medicinal products. This guidance is classified into two main parts: - PART I: Criteria and requirements for classifying the prescription status of medicinal products in Saudi Arabia. - PART II: Criteria for setting the distribution status of medicinal products in Saudi Arabia. Scope: This guidance is applicable to SFDA registered or under-registration medicinal products intended for human use in Saudi Arabia. Definitions: - Controlled Medicinal Product: a prescription only medicine that is subject to Law of Narcotics Control in Saudi Arabia. - Distribution Status: places where patients / consumers can purchase or gain access to medicinal products (i.e. pharmacies, hospitals). - Hospital: includes governmental hospitals pharmacies, private hospitals inpatient pharmacies, and primary care clinics. - Over-The-Counter (OTC) Product: a medicinal product subject to SFDA authority that could be obtained by patients in Saudi Arabia without a physician’s prescription. - Prescription or legal Status: the conditions and restrictions under which the medicinal product should be made available to patients. - Prescription Only Medicine (POM): a medicinal product that is subject to SFDA authority and that is available to patients in Saudi Arabia only based on a licensed physician’s prescription in Saudi Arabia. - PIL: Patient Information Leaflet - SFDA: Saudi Food and Drug Authority. - SPC: Summary of Product Characteristics 6 Part I: Criteria and requirements for classifying the prescription status of medicinal products 1. Criteria for classification as Prescription Only Medicinal Product (POM) 1.1.Safety: Medicinal products shall be subject to medical prescription when the supervision by a healthcare practitioner is necessary for the diagnosis, treatment, and prevention or monitoring of a disease with respect to the appropriate choice of a medicinal product. In addition, medicinal products shall be subject to medical prescription when they are likely to present a danger directly or indirectly, even when used correctly, if utilized without medical supervision. In considering whether this criterion applies, the following factors should be addressed: 1.1.1 The drug is used in the treatment of a serious disease not easily diagnosed by the public. In these situations, the involvement of a practitioner in the diagnosis, treatment and monitoring of the disease, including selecting and monitoring the use of the drug can help decrease the chances of harm occurring, as well as increase the benefits. Example - Human patients with hypothyroidism [low thyroid function]. 1.1.2 The use of the drug may mask other diseases, and may result in any of the following: A lack of timely diagnosis and treatment A significant worsening of the underlying disease; or Otherwise putting at risk the chance of more successful therapy, the drug will likely be given prescription status. 1.1.3 The use of the drug requires complex or individualized instructions: There are two main reasons why individualized instructions may be necessary: when the use of a drug needs to be tailored to a patient’s specific 7 circumstances or when the drug information cannot be easily understood by the general population. 1.1.4 The drug has a narrow margin of safety. For some drugs, the difference between a therapeutic (helpful) dose, and a toxic one, is very small, so it is critical that the patient receive precisely the right amount of drug to prevent serious consequences. 1.1.5 At normal therapeutic dosage levels, the drug has potential or is known to cause serious adverse reactions or serious interactions with food or other drugs. A drug would be typically authorized as a prescription drug if when used at a normal dosage level, it can cause serious adverse reactions or can result in serious interactions with food or other drugs. Practitioner involvement is required for communicating and managing the risks to patients. o Example: Warfarin is a drug used to prevent clots in the blood. If human patients eat too much of certain foods (e.g., dark leafy green vegetables) while taking this drug, this can lead to an increased potential for blood clots. 1.1.6 The use of the drug may lead to indirect danger to human health, even when used correctly, if used without medical supervision. A medicinal product would increase the risk of resistance to the product, in particular in the general population, to such an extent that the usefulness of any medicinal product is likely to be compromised e.g. Antibiotic. 1.1.7 The drug has frequent incorrect use which could lead to direct or indirect danger to human health. 1.1.8 Practitioner expertise is necessary to administer the drug or oversee the drug’s administration, as with the following classes: Parenteral Product Enemas Irrigations used wholly or mainly for wounds, bladder, vagina or rectum 8 1.2.Limited Marketing Experience: Medicinal products shall be subject to medical prescription when they contain substances or preparations where the activity and/or side-effects require further investigation. In considering whether this criterion applies, the following factors should be addressed: 1.2.1 Recent authorization/limited marketing experience of the drug. Further investigation may be necessary when a medicinal product has only recently been granted a marketing authorisation or because of limited experience/use of the product e.g. Orphan drugs. Even if clinical trial data are extensive and reassuring, it is important to have post-marketing experience in the general population, that is evidence of patients, which may be imposed by the design of clinical trials e.g. the elderly, children, certain racial or phenotypic groups and those having certain medical conditions. Products which have different safety or efficacy profiles in different racial or phenotypic groups may need special warnings. 1.2.2 New strength, dose, route of administration, indication, new age group or combination of substances. A drug may have been on the market but is now being proposed for sale with a change to its conditions of use (e.g., a new use, strength, dose, species, age group, or route of administration). In some cases, there may be gaps in the information regarding the long-term consequences associated with the new use. In these cases, prescription status would help to ensure practitioner oversight. 1.3.Risk of Abuse/Dependence: Medicinal products