Pharmaceutical companies discover, develop, manufacture and market drugs for medical use.
Drugs are discovered accidentally or isolated from active ingredients from traditional remedies, and designed from understanding and manipulating metabolic pathways related to a disease state or pathogen.
Once a compound is isolated, it is developed through studies and clinical trials to determine safe and appropriate formulation and dosing, and is then presented to the FDA for approval. The cost of developing a drug to approval is estimated at about $2.6 billion. There is a 12% chance that a drug entering clinical development will be approved for marketing. Some pharmaceutical companies conduct or fund clinical trials of their products, statistically report significant pro-industry findings. FDA approval facilitates commercial manufacturing and marketing of pharmaceutical drugs.
The United States has a long standing policy that it does not produce Narcotic Raw Materials for manufacturing (NRM.) Pharmaceutical manufacturers in the US import NRM from selected countries, 80% from India and Turkey, and 20% from France, Poland, Hungary, Australia, and Yugoslavia. United States pharmaceutical manufacturers account for one-third of world morphine manufacturing capacity.
Pharmaceutical manufacturers market their products for commercial use, advertising directly to the general public and employing sales reps to market to physicians and health care providers. Pharmaceutical philanthropy has influenced education curriculums and healthcare institutions to promote prescribing among doctors, while employing lobbyists that influence politicians. Some pharmaceutical companies have misrepresented the effects of their drugs, spreading misinformation among these systems.
Pharmaceutical companies sell medication in bulk to health care service providers, who distribute to pharmacies around the country. Distributors must report abnormally large orders from pharmacies in relation to county population size, to the Drug Enforcement Agency. (DEA) Some distributors have been documented failing to report suspicious orders, facing fined from the DEA. Distributors argue DEA regulations are vague.
Pharmacies distribute medication to public with prescription from a doctor. Pharmacies can refuse to fill suspicious prescriptions. Some pharmacies build relationships with indiscriminate doctors, generating easy access to medication. Prescription abusers will seek out indiscriminate doctors in a process known as “doctor shopping.”
45% of painkiller prescriptions are written by primary care doctor, 22% specialty doctor, 13% pain management clinic, 12% dentist, 5% emergency room, 1% psychiatric care, 1% other. Increase in national opioid prescribing rates started in 2006, peaking in 2012 at more than 255 million total prescriptions; a prescribing rate of 81.3 %. Prescription rates have declined since 2012, in 2017 rates were the lowest in 10 years; 191 million total opioid prescriptions a 58.7% prescribing rate. Patients in rural counties had an 87% higher chance of receiving an opioid prescription than did patients in large central metropolitan areas. 21-29% of patients misuse opioid painkillers. The majority of opioid prescription abusers are the elderly accessed through Medicare. 4-6% of patients that misuse prescription opioids will transition to heroin. The 2017 Substance Abuse and Mental Health Services Administration (SAMHSA) survey found 34% of opioid painkiller abusers have a prescription, 49.1% get pills from friends or family, 5.7% from a drug dealer, 4.5% stolen. 6.7% didn’t comment. 80% of people who use heroin, first misused prescription drugs.