Pharmacology (I)
Subtopic:
National Drug Authority (NDA)
The National Drug Authority (NDA) is defined as a regulatory organization composed of highly reputable individuals. It is tasked with the crucial responsibility of overseeing the implementation of the national drug policy. The primary goal of the NDA is to guarantee the availability, quality, and safe utilization of pharmaceutical products throughout the nation. The NDA is essential for safeguarding public health by effectively regulating medications and pharmacies, ensuring that vital treatments are accessible to everyone in need.
Functions of the National Drug Authority
The NDA’s responsibilities cover a wide range of areas vital for pharmaceutical regulation and public health protection:
Pharmacy and Drug Development & Regulation: The NDA is responsible for creating policies related to the establishment and management of pharmacies. It also verifies that all medications sold within the country adhere to established regulatory standards and are safe for consumer use.
Approval of the National List of Essential Drugs: The NDA holds the authority to approve the National List of Essential Drugs, which identifies medications considered indispensable for the national healthcare system. This list is also periodically reviewed and updated in collaboration with the Minister of Health.
Estimation of National Drug Needs: The NDA is tasked with assessing the country’s pharmaceutical requirements to ensure a consistent and sufficient supply of medications that are also economically accessible to the population.
Control over Pharmaceutical Import, Export, and Sales: The authority regulates the movement of drugs both into and out of the country, ensuring that only safe and approved pharmaceutical products are available in the market.
Drug Quality Control Measures: The NDA guarantees the quality of drugs available to the public through rigorous quality control measures, including routine inspections and laboratory testing.
Promotion of Local Pharmaceutical Manufacturing: The NDA actively supports the domestic production of essential drugs to enhance national self-reliance and lessen dependence on imported medications.
Support for Herbal Medicine Research: The NDA encourages research and development in herbal medicine, aiming to integrate traditional medicine practices into the broader healthcare framework.
Promotion of Rational Medicine Use: The NDA works to promote the appropriate and rational use of medicines by providing training to healthcare professionals and disseminating information that ensures medications are prescribed, dispensed, and used correctly.
Establishment of Professional Practice Guidelines: The NDA is responsible for creating and updating professional guidelines for healthcare providers, ensuring they have access to the necessary information for appropriate drug prescription and use.
Advisory Functions: The NDA serves in an advisory capacity to the Minister of Health and other relevant bodies on matters concerning the implementation of the national drug policy.
Additional Functions as Legally Mandated: The NDA may undertake other responsibilities as required by the country’s legal framework.
The National List of Essential Drugs
The National List of Essential Drugs is a compilation of vital medications needed to address the primary healthcare needs of the majority of the population. This list undergoes periodic review to maintain its relevance and effectiveness in addressing evolving public health demands.
The National Formulary is a comprehensive document that encompasses the National List of Essential Drugs alongside other approved medications. It acts as a reference guide for healthcare professionals in making informed prescribing decisions.
Essential Drugs
Essential drugs are defined as those medications that address the most critical healthcare needs of a population. Selection of these drugs is based on factors such as disease prevalence, proven effectiveness, safety profiles, and cost-effectiveness.
Characteristics of Essential Drugs:
Availability: Must be consistently available in healthcare facilities and pharmacies.
Adequate Supply: Sufficient quantities must be maintained to meet patient needs.
Assured Quality: Must meet high standards of quality and efficacy.
Appropriate Dosage Forms: Must be available in suitable formulations for different patient populations and routes of administration.
Affordability: Must be priced to be accessible and affordable for both individual patients and the community as a whole.
Selection Criteria for Essential Drugs:
Disease Prevalence: Prioritized based on the most common health problems affecting the population.
Efficacy: Requires strong clinical evidence demonstrating the drug’s effectiveness in treating the intended condition.
Safety: Must exhibit an acceptable safety profile, with a favorable balance between benefits and potential risks.
Cost-effectiveness: Must be economically viable for both patients and the healthcare system.
Scientific Data Support: Requires robust scientific evidence validating the drug’s effectiveness and safety.
Safety Monitoring: Should be subject to ongoing monitoring to identify and address any safety concerns.
Single Active Ingredient (Preferred): Ideally, contain only one active pharmaceutical ingredient, unless fixed-dose combinations offer proven advantages in terms of patient compliance or synergistic effects.
Essential Drugs in Uganda
| Class | Drug Name(s) |
| Antimalarials | Artemether, Artemether/lumefantrine, Dihydroartemisinin/piperaquine, Quinine, Primaquine |
| Antiamoebics | Metronidazole, Tinidazole |
| Antibacterials | Amoxicillin, Amoxicillin + clavulanic acid, Benzathine penicillin, Benzylpenicillin, Ceftriaxone, Cefuroxime, Flucloxacillin, Cloxacillin, Chloramphenicol, Ciprofloxacin, Cotrimoxazole, Doxycycline, Gentamicin, Erythromycin |
| Antituberculosis | Ethambutol, Isoniazid, Pyrazinamide, Rifampicin, Streptomycin |
| Antifungal | Amphotericin B, Clotrimazole, Fluconazole, Griseofulvin, Ketoconazole, Miconazole, Nystatin |
| Antileprosy | Clofazimine, Dapsone, Rifampicin, Thalidomide |
| Antiepileptics/Anticonvulsants | Carbamazepine, Clonazepam, Diazepam, Ethosuximide, Magnesium sulfate injection, Phenobarbitone, Phenytoin, Valproic acid |
| Anthelmintics | Mebendazole, Albendazole, Ivermectin, Praziquantel, Diethylcarbamazine |
| Analgesics/Antipyretics | Acetylsalicylic acid (Aspirin), Diclofenac, Paracetamol (Acetaminophen) |
| Antigout | Allopurinol, Colchicine, Indomethacin, Probenecid |
| Opioid Analgesics | Codeine, Morphine, Pethidine, Dihydrocodeine |
| Antivirals | Acyclovir, Ganciclovir |
| Cardiovascular | Atenolol, Isosorbide dinitrate, Nifedipine, Propranolol, Verapamil, Captopril, Hydralazine, Methyldopa, Lisinopril, Digoxin |
| Dermatological | Benzoic acid + salicylic acid, Miconazole, Clotrimazole, Benzyl peroxide, Coal tar, Dithranol, Podophyllum resin, Salicylic acid (2%, 5%), Silver nitrate pencil (40%), Betamethasone cream, Calamine lotion (15%), Hydrocortisone cream/ointment (1%), Malathion lotion (0.5%), Benzyl benzoate lotion (25%), Silver sulphadiazine cream (1%), Neomycin + bacitracin ointment, Chlorhexidine cream (5%) |
| Antiulcer | Cimetidine, Omeprazole, Ranitidine, Magnesium trisilicate compound |
| Antiemetics | Domperidone, Promethazine, Metoclopramide, Cyclizine |
| Laxatives | Bisacodyl, Senna |
| Antidiabetics | Insulin, Glibenclamide, Metformin, Tolbutamide |
| Cytotoxic Drugs | Asparaginase, Calcium folinate, Cyclophosphamide, Cytarabine, Dacarbazine, Dactinomycin, Fluorouracil, Doxorubicin, Hydroxyurea, Mercaptopurine, Methotrexate, Mustine, Stilboestrol, Thioguanine, Vincristine |
Rational Use of Medicines
Rational use of medicines is defined as a situation where patients receive medications that are clinically appropriate for their needs, in correct dosages, for an adequate duration, and at a cost that is affordable to both the individual and the wider community.
Rational Drug Use Principles:
| Principle | Description |
| Right Indication | Prescribing medication only when truly necessary, based on a correct diagnosis. |
| Right Drug | Selecting the most effective, safest, and most cost-effective treatment option. |
| Right Dose | Adjusting the dosage to meet the specific needs of each patient, considering individual factors like age and weight. |
| Right Duration/Time | Administering the medication for the appropriate length of time required for treatment. |
| Patient Education | Educating patients about the correct medication use, potential side effects, and the importance of treatment adherence. |
“Rights” of Medication Administration (Expanded): Right patient, Right medicine, Right dosage, Right route, Right time, Right storage, Right formulation, Right disposal, Right site, Right equipment.
Irrational Use of Medicines
Irrational drug use occurs in various scenarios, including:
Polypharmacy: Prescribing too many medications for a single patient.
Inappropriate Drug Selection: Choosing the wrong medication for a particular health condition.
Suboptimal Dosing: Administering doses that are too low to be effective.
Overuse of Injections: Unnecessarily using injectable medications when oral formulations are suitable.
Antibiotic Misuse: Indiscriminate use of antibiotics, such as for viral infections where they are ineffective (e.g., common cold, viral diarrhea).
Factors Contributing to Irrational Use of Medicines:
High Patient Volume: Overburdened healthcare providers may rush consultations, leading to less thorough prescribing.
Poor Communication Skills: Inadequate communication between healthcare providers and patients resulting in misunderstandings about treatment.
Lack of Professional Ethics: Unethical practices by some healthcare professionals, such as overprescribing for personal gain.
Misinterpretation of Diagnostic Tests: Incorrect interpretation of laboratory or diagnostic results leading to inappropriate treatment decisions.
Negative Work Attitude: Lack of motivation or professionalism among healthcare providers contributing to careless prescribing.
Patient Misconceptions: False beliefs held by patients, such as demanding injections or antibiotics even when not indicated.
Inconsistent Drug Supply: Unpredictable availability of essential medications forcing providers to prescribe less suitable alternatives.
Absence of Drug Formularies: Lack of standardized medication guidelines or formularies leading to inconsistent prescribing practices.
Misleading Drug Promotions: Deceptive marketing and promotional activities by pharmaceutical companies influencing prescribing habits.
Inadequate Regulatory Oversight: Insufficient regulation and enforcement allowing substandard or unnecessary drugs to enter the market.
Consequences of Irrational Drug Use
Antibiotic Resistance: Overuse of antibiotics is a major driver of antibiotic resistance, making bacterial infections increasingly difficult to treat.
Resource Wastage: Inefficient use of healthcare resources due to unnecessary or inappropriate medication prescriptions.
Increased Healthcare Costs: Higher financial burden on patients from unnecessary medications and treatments.
Adverse Drug Reactions (ADRs): Polypharmacy increases the risk of ADRs and harmful drug interactions.
Loss of Patient Trust: Erosion of patient confidence in the healthcare system due to ineffective or inconsistent treatment.
Poor Health Outcomes: Increased likelihood of treatment failure, complications, delayed recovery, or worsening of health conditions.