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More on that in this post. The other appointments were to an optometrist and then an ophthalmologist. I started out seeing an optometrist in Puerto Rico for some dry eye issues, only to find out that optometrists in Puerto Rico are barred from writing prescriptions, even though all 50 US states allow it. More on that nonsense here. Thanks in part to that crazy rule, seeing an ophthalmologist in Puerto Rico generally involves a 3-month wait. At the time, I already had a flight booked to see my mom in a month, so I just made an appointment in Missouri. I saw a doctor for 5 minutes who told me the same information — I have chronic dry eye and need to be on Restasis eye drops for a minimum of 1 year. I accepted this, and had the doctor send my prescription over to my pharmacy. When I went to pick up the eye drops, I thought I would be free of my glasses and back wearing contacts in no time. Then the pharmacist told me my total. I nearly choked. Obviously, I hit the first stage of grief right away. Next up was bargaining. I called my insurance company and begged. I skipped right over guilt and rocketed into anger. How could the United States allow a company to charge such insane prices for a simple eye drop? Stay with me here. My hope came from the realization that the problem was based in the United States. Who said I had to get my medication there? I immediately started researching the costs of the prescription in other countries and was both appalled and relieved to find that it was a fraction of the price in every single country I investigated. Pair that with the facts that JetBlue was having a sale, and that my friends Dani and Jorge just happened to be in Colombia at the time, and the decision was easy. This is what my carryon suitcase looked like when I went through TSA. The first thing I did was confirm that the pharmacies in Colombia actually carried Restasis and check if they required a prescription. Thankfully, Dani was already in Colombia so she just walked into a pharmacy and asked. Farmalisto is a good place to start. However, I can tell you right now that I have flown with the eye drops which come in tiny daily vials in a box, not a less-conspicuous bottle many times since then and literally no one has asked to see my prescription. Thanks, TSA, for your super helpful and universally enforced regulations! They only had 3 months on hand, so they sent me to another nearby pharmacy for the rest. Think about that for a minute. No really, take a second to consider that I took an awesome trip to an incredible country, bought some much-needed medication, and with my affordably clear eyes I got to see beautiful things like colonial towns draped in flowers and city walls covered in intricate street art. Flower-covered streets in Villa De Leyva, Colombia. Absolutely one of my favorite pieces of streetart that I saw in Colombia. However, as much as I love having an excuse to visit Colombia again, I realize that not everyone in the United States can just hop on a plane to go buy medicine in Colombia. For now, all I can do is pay attention to healthcare reform initiatives, and vote for what I feel is right. Designed by Melissa Otero. More on that in this post The other appointments were to an optometrist and then an ophthalmologist. More on that nonsense here Thanks in part to that crazy rule, seeing an ophthalmologist in Puerto Rico generally involves a 3-month wait. Is this drug run? Follow IndecisiveRease. From fresh faces to sweaty selfies to morning afte. Need to spend some time in idealized fictional wor. IndependentBookstoreDay got my bank account fight. Load More Follow on Instagram.

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Need to know about regulation, pricing and reimbursement in Colombian pharma? Read on! This is a decentralized agency of the Ministry of Health, created in More information available at invima. Each of these Decrees has been subject to additional regulations:. It is mandatory to obtain a marketing authorization MA or health registration to manufacture, sell, import or export a drug product. Requirements and procedures depend on the product, its background, indications of use and risks. Usually, the marketing authorization for a new medicinal product may take between 9 months to 12 or 20 months depending on the product supporting information. Usually, the marketing authorization for drug products included in Official Pharmacological Regulations may take from 4 months to 9 or 12 months depending on the product supporting information. Marketing authorizations are valid for five years.. Renewals shall be requested for no later than the third month prior to the expiration date. There is no specific regulation for combination drug or biological products. According to what is set in this Decree, combination products will be ruled according to their main indication or function. If it has a pharmacological action, then it will be ruled under drugs regulations. If the main indication or function is to work as a device and the role of the drug is more of an accessory, then the product will be ruled under medical device dispositions. Compliance with regulation is monitored and evaluated by INVIMA, as Colombian regulatory authority through periodical inspections scheduled by the authority or upon complaints received anonymously or from third parties. Penalties include fines of up to In case the investigation is transfer to the Superintendence of Industry and Commerce, penalties are much higher and can reach up to 5. Colombia has a Social Security System with universal healthcare coverage which is regulated by the National Government through the Health Ministry. Colombian citizens benefit from the healthcare system by being affiliated to the system, either under the contributory private or subsidized public regime. This price is considered a regulatory tool to establish the price for each commercial presentation of the medicinal product. Whose supply was guaranteed to its affiliates and prescribed by the health professional or ordered by tutela judgments. The applicable type of distribution varies according with the marketing authorization required for each drug or device. First, they must comply with all regulations applying to reception, storage, transport, distribution and dispensing of drug products. The professional must ask for the prescription document before dispensing the medicine and should verify the prescription requirements. It is forbidden for drugstores to have free samples in their store or to have empty packages of pharmaceuticals. In case a person or a company finds that a drug store has medical samples and is selling them, the interested party may initiate legal action against the establishment before competent authorities In any case, drugstores must provide accurate, verifiable, sufficient and clear information to patients as required in accordance with the drug product, indications, warning or precautions. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? What is the regulatory framework for the authorization, pricing, and reimbursement of drugs, biologicals, and medical devices? In Colombia there are two types or regimes of price control for drugs and medical devises: Price report, under which prices are set freely but it has to be reported to SISMED Direct Price control which the authority sets the maximum price. Circular No. This new piece of law regulated the supervised freedom regime for some products and created the system to report information on prices of medical devices. What are the steps to obtaining authorization to develop, test, and market a product? What are the approximate fees for each authorization? How does the authorization process differ between brand-name products and generic products? Are there differences for local manufacturers versus foreign-owned manufacturers? If it is an innovator or new drug product, the authorization process takes longer because the scientific and technical information is completely new Besides, there is no worldwide data about safety nor efficacy of the new drug. If it is a generic product or a drug product listed on the Colombian Official Pharmacopeia, the authorization process will be shorter because the technology is sufficiently demonstrated. This rule applies equally for both local and foreign-owned manufacturers. The first phase of the application to market a drug in the country begins with the pharmacological evaluation. In the case of some generic drugs, Bioequivalence a medicine is equivalent in terms of quality, efficacy, and security in the patient in respect to a reference one and considers that both have the same active principle and doses, but different manufacturing origins. For products of biological origin there are no generics, and biosimilars may take as long as the innovator, but depending on the type of molecule and its size, INVIMA may allow abbreviated routes that may expedite the process. How is compliance with regulation monitored and evaluated? What is the potential range of penalties for noncompliance? Is there a national healthcare system? If so, how is it administered and funded? How does the government or public healthcare system function with private sector healthcare? The Social Security System functions as follows: Contributory Regime private sector : Refers to all affiliates paying or contributing to the system through a legal fixed monthly fee as employees or independents. In some special cases people economically dependent on the contributor children, parents, and relatives up to the third degree of consanguinity may be included. Are prices of drugs and devices regulated and, if so, how? In Colombia there are two types or regimes of price control for drugs and medical devises: Price report, under which prices are set freely but it must be reported to SISMED Direct Price control which the authority sets the maximum price. How are drugs and devices used by patients paid for? What roles do public and private payers play? Who dispenses drugs and devices to patients and how are those dispensers compensated? What are the professional and legal responsibilities of those who dispense drugs and devices? What role do they play in providing patient care, information, and safety? Drug Product included in the Pharmacological Code. Good Manufacturing Practice Certificate.